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Laboratory products for “Research Use Only” (RUO) – often a dangerous claim

Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories still use RUO products in diagnostic procedures, sometimes even with the knowledge of the manufacturers. This can have consequences – not just for manufacturers and operators but for patients as well.

In this article, you will learn

• what the “Research Use Only” (RUO) label means,
• what the requirements for RUO products are,
• how to avoid legal problems, and
• what alternatives there are to RUO products.

1. “Research Use Only” – what does it mean?

Products labeled “For Research Use Only” are hardly subject to any regulatory controls. Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) aims to distance itself from RUO products clearly:

The scope of application of this Regulation should be clearly delimited from other legislation concerning products, such as medical devices, general laboratory products and products for research use only. IVDR Foreword (7)

a) Institutions affected

The following institutions, in particular, use RUO products:

• Medical laboratories can utilize RUO products, but doing so designates them as the manufacturer, carrying all the associated consequences.
• If medical laboratories utilize RUO products for purposes beyond research, this can potentially render them liable for damages and subject to criminal liability in the worst-case scenario.

You can find more information on “Lab Developed Tests” in our article The EU regulates medical laboratories – Are Laboratory Developed Tests still allowed?

• Manufacturers can incorporate RUO products as components in their IVD, but they are subsequently responsible for ensuring the conformity of the end device with the IVDR. The RUO labeling of the component is not mandatory.
• If manufacturers designate their devices as “RUO,” the intended use of these devices must be interpreted accordingly and, if required, substantiated. For instance, reasonably foreseeable misuse should be taken into account. The RUO label should not be applied to the device as a mere “protective claim,” as this may result in legal consequences.

b) Definition

There is no standardized definition for “Research Use Only” (RUO) products. Generally, they can be understood as products designed for analysis intended solely for scientific research purposes, as the name implies. Their main distinction from medical devices lies in their inability to be used for medical purposes.

Nevertheless, the interpretation of “Research Use Only” varies between Europe and the USA.

Definition in Europe

In Europe, the  MEDDEV 2.14/2  guidance document ( IVD Guidance: Research Use Only products – A guide for manufacturers and notified bodies ) provides a definition of RUOs. This guidance was written within the framework of the now obsolete Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) and, in the absence of an up-to-date replacement, it can still be considered the state of the art.

MEDDEV 2.14/2 states:

“for a product to be categorized as an RUO product it must have no intended medical purpose or objective.” Source: MEDDEV 2.14/2 rev.1

This means that an RUO product must not have a medical purpose, even not a rudimentary one.

This also applies to tests developed in-house (Laboratory Developed Tests) that are only used in a health institution for research purposes.

The IVDR also addresses RUO products. Article 1 (3) a) of the IVDR excludes RUO products from its scope:

This Regulation does not apply to: (a) products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; Source: IVDR, Article 1 (3) a)

Furthermore, Article 2 (45) specifies:

“A device intended to be used for research purposes, without any medical objective , shall not be deemed to be a device for performance study;” IVDR, Article 2 (45)

Devices for performance studies are:

“‘device for performance study ’ means a device intended by the manufacturer to be used in a performance study” IVDR, Article 2 (45)

The IVDR thus distinguishes RUO products from IVDs and products for performance studies. The EU regulation also highlights the lack of a medical intended purpose for RUO products.

Definition in the USA

In 2013, the FDA published a guidance document on RUOs  entitled “ Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only .”

This guidance defines RUO products as follows:

“ An RUO product is an IVD product that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812” [NB: Part 812 concerns the provision of devices for performance evaluation purposes as a preliminary step to IVDs] FDA guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only”, Chapter III A

Some examples of products that the FDA believes fall into this research phase of development are:

• Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured.
• Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods.
• Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.

However, the FDA further specifies:

“FDA also recognizes that there are certain products, such as instruments, systems, and reagents that are labeled for research use only and intended for use in the conduct of nonclinical laboratory research with goals other than the development of a commercial IVD product […].” FDA guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only”, Chapter III A

And subsequently gives examples of such research purposes in which the product itself is not the subject of research.

The FDA thus sees two “types” of RUO products: First, IVD devices whose development is ongoing and which are themselves the subject of the research purpose, and second, products for nonclinical research.

In both cases, the FDA requires a clearly visible RUO label to be affixed to the products. The RUO label is intended to prevent use for clinical diagnostics, patient management, and other investigations with a medical purpose.

c) What are the consequences of using the “Research Use Only” label?

Normally, IVDs are subject to regulatory requirements (for example, according to the IVDR or FDA) based on their risk class.

However, RUO products do not fall within the definition of “in vitro diagnostic medical devices” given by the IVDR or the  relevant FDA regulations . This means that these regulations do not apply to RUO products.

‘ In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

(a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

Source: Article 2 IVDR

“In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.”

Source: 21 CFR 809.3

However, RUO products do not automatically fall entirely outside the regulatory scope in the EU. Depending on the product, they may still have to comply with requirements that are not specifically intended for IVDs (such as the  REACH regulation  for chemicals or the  Machinery Directive ).

Read more about the Machinery Directive: Which parts apply to medical devices .

Since RUO products are subject to considerably fewer controls than IVDs, it is necessary to severely restrict their use. Therefore, in particular they may not be used to

• make diagnoses and
• conduct performance studies.

2. Use and misuse of “Research Use Only” labels

A) what should ruo products be used for.

As the name “For Research Use Only” indicates, products with RUO labeling are intended for research purposes only. RUO products are particularly attractive for the research sector due to the simplified process and lower hurdles for placing them on the market.

MEDDEV. 2.14/2 rev.1 provides a precise list of areas where RUO products may potentially be used:

• basic research
• pharmaceutical research
• better identification and quantification of individual chemical substances or ligands in biological specimens
• in-house manufacturing of so called “Laboratory Developed Tests” for research purposes

And of areas where the use of RUOs is expressly  not  permitted:

• use of raw materials which are labeled “For Research Use Only” but which are incorporated into a finished product
• so called “research use products” being tested against a comparator IVD product that bears the CE mark
• products for market studies/feasibility studies

These products can be assigned a medical purpose.

b) What RUO products are often used for

However, the low hurdles are also the reason why RUO products are often used for purposes they are not intended for. This poses significant dangers for manufacturers, operators, and patients.

Sale of RUO products to medical laboratories

RUO products are sold by manufacturers to medical laboratories. Although doctors sometimes also conduct research, this is not really the main purpose of a medical laboratory.

Therefore, when discussing sales with doctors, it should always be assumed that there is a medical reason behind the use of the product. This means that anyone who knowingly sells RUO products to medical laboratories is potentially under suspicion of using the pretext “For Research Use Only” to ignore an intended medical purpose and thus avoid responsibility for a medical device.

Avoid reference to any specific diagnostic procedures in your advertising materials for products that clearly do not have a medical purpose. You should always stay on the technical or purely analytical level.

Use of RUO products in medical laboratories

The issue of selling RUOs to medical laboratories is not limited to manufacturers alone. The laboratories themselves may also not be acting in line with their status as operators and may, as a result, be liable under certain circumstances.

• Medical laboratories are free to develop in-house tests themselves. In such cases, RUO products are often used in diagnostic procedures. The laboratory bears full responsibility for these tests. Even under the IVDD,  MEDDEV 2.14/2  saw this topic critical. However, with the IVDR, the EU is explicitly placing more restrictions on the routine use of such Lab Developed Tests.

Read more in our article  The EU regulates medical laboratories – Are Laboratory Developed Tests still allowed?

• Due to the low regulatory hurdles, purchasing RUO products is very affordable. As a result, medical laboratories prefer them over expensive CE-IVD devices if they can achieve the same level of performance. Nevertheless, the use of RUO products for purposes other than research, even in cases where they provide similar results, is not permitted.

3. Consequences of incorrect classification

Lack of controls can have a negative effect on quality. As a result, the relevant authorities (e.g., authorities during inspections) take a closer look at whether a product is actually intended “For Research Use Only.”

Manufacturers should also be aware that simply sticking an RUO label on a product does not on its own mean that the product no longer has to comply with requirements for IVDs that would otherwise apply.

The RUO status is determined solely by the actual intended use of a device. To this end, authorities (both European and FDA) also use marketing material or other information as evidence.

Manufacturers and operators who misuse the RUO label could face severe penalties, as such behavior can cause serious harm to patients or even the general public.

a) Consequences for manufacturers and operators

Improperly selling IVDs with an RUO label or using RUO products for purposes other than research is not a trivial offense.  Manufacturers who intentionally conceal or attempt to conceal a diagnostic purpose behind the RUO label should anticipate legal consequences in Germany. The same applies for operators who misuse RUO products. There is the possibility of a fine or even prison sentences. In addition, there is potential liability for harm suffered by patients.

b) Consequences in the USA

There are also severe penalties in the USA. If an RUO label is deemed to have been incorrectly used for a product, the product would be considered misbranded under sections 502(a) and 502(o) of 21 US Code, 352(a), 352(o) [A1] and would be considered adulterated under section 501(f) of 21 US Code 351(f).

c) Consequences for patients

However, the consequences can be even worse for patients. After all, the regulatory requirements for IVDs aren’t just plucked out of thin air to annoy manufacturers and operators. The regulations are intended to protect patients against incorrect results and subsequent wrong decisions. False-negative results can lull patients into a false sense of security and an existing undetected disease may worsen. One example would be the metastasis of an undetected cancer due to a test not performing as intended.

Some incorrect diagnoses could even be so severe that they can cause the death of a lot of people: an undetected viral infection can cost many lives in the early stages of an epidemic or pandemic, as the coronavirus pandemic sadly demonstrated.

4. Alternatives to “Research Use Only” products

To avoid legal problems and risks to third parties, manufacturers and users should use general laboratory equipment as an alternative to RUO products.

There are laboratory products that obviously have no specific medical purpose, such as

• pure chemicals,
• culture media,
• reaction vessels,
• washing solutions,
• qPCR cycler,
• sequencers,
• centrifuges.

Read more on the topic here: General laboratory equipment: What manufacturers and laboratories need to know to avoid problems and unnecessary expense

5. Ways to protect yourself

Manufacturers, operators, and patients can take the following steps to avoid legal and other negative consequences when using RUO products:

a) Manufacturers

In the case of manufacturers, it is particularly important that they narrowly define the intended purpose of their product.

Analyte specific reagents should only be labeled as RUO products for specific non-medical purposes.

SARS-CoV-2 and its mutations: a test kit that uses specific primers and probes to distinguish the variants B.1.1.7 (alpha variant) and B.1.351 (beta variant) from the initial variant following a positive result may be an RUO product if it is only intended to be used to determine the prevalence of the variant in the population.

A specific intended purpose in this case would be: “ Intended solely for epidemiological research for the purpose of surveying the prevalence of SARS-CoV-2 variants in the general population. ”

If a medical laboratory subsequently, based on new findings, used this test to provide the best possible treatment for infection by a specific variant, this would be an off-label use. The laboratory would then be responsible for the test’s conformity.

Tip: Provided the manufacturer did not advertise the product with this clinical benefit, it would be adequately protected.

b) Operators

Operators should record exactly for what they use IVDs and RUO products.

Medical laboratories are operators of medical devices and IVDs and, therefore, are responsible for only using medical devices according to their intended purpose and in accordance with the generally accepted rules of the technology. This is stipulated in Section 4 of the German Medizinprodukte-Betreiberverordnung (MPBetreibV).

To be on the safe side, laboratories should keep a record of which medical devices and IVDs are in operation and routine use. This record should include a reference to the applicable test procedure and the intended purpose of the IVD.

This record can also be used to identify investigational procedures for which there are no adequate CE-IVDs available on the market. The lack of alternatives would justify the use of RUOs in validated processes as in-house IVD, provided that the laboratory verifies and demonstrates that the general safety and performance requirements and the additional requirements of Article 5(5) of the IVDR are met.

Read more about the requirements for LDTs in our article .

c) Patients

Patients lack the knowledge to recognize what is and isn’t an RUO on their own. They are often given little to no information about the test they are undergoing. So, patients should follow this basic rule: ask your doctor or pharmacist!

• Patients can ask for the complete test report from the laboratory so that they can get a second opinion in case of doubt. The report should also indicate which specific test was performed.
• Patients should inform themselves about how “well” or “poorly” a test works, as well as the benefit-risk ratio.
• In the future, patients and doctors will also be able to get information about medical devices from EUDAMED and use this information to decide whether or not the test was performed with certified and thus legally compliant IVDs.

6. Conclusion

In the opinion of the EU Commission and the FDA, products “For Research Use Only” have no place in diagnostics. To be used for diagnostic purposes, products have to go through the necessary controls. But these controls do not apply to RUO products.

Anyone who ignores this prohibition and uses or sells RUO products for purposes other than pure research is playing with fire. Manufacturers and operators run the risk of legal trouble and could even endanger patients’ health. Therefore, RUO products should only be used for research purposes. For other uses, manufacturers and operators should use the alternatives mentioned.

If you, as a manufacturer or medical laboratory, find that an RUO product is particularly well-suited for in vitro diagnostics, consider whether further development and conformity assessment to make it an IVD is worthwhile.

Thanks to Dr. Boris Handorn , lawyer and partner at PRODUKTKANZLEI , Augsburg, for his valuable input on this article.

Benefit from the support of our IVD experts:

• They will help you qualify your devices or examination procedures, for example, with in-house workshops on approval strategy and in-house IVDs.
• They provide you with expert opinions on the qualification of your device, which you can submit to your customers and/or notified bodies.
• They support you in all activities up to the “certification” of your device (e.g., performance evaluation) and beyond (e.g., post-market surveillance).

Or use our e-learning platform : Learn how to meet the regulatory requirements and get access to our IVD-specific templates and tutorials on how to get your device approved.

Change history

• 2024-02-01 Complete revision; section “The thing with analyte-specific reagents” removed; shortening of chapter 4 (deletion of subchapters a) to c)); reference to article on general laboratory equipment
• 2021-11-16 First publication

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An Introduction to Research Use Only (RUO)

In this blog, we recap our eBook, “An Introduction to Research Use Only (RUO)” – Click HERE to download the entire publication.

Learn how it differs from adjacent labels, the FDA and EU guidance, its appropriate use, and the consequences of mislabeling products RUO.

Introduction

In the complex world of medical device development, regulation, and distribution, finding the appropriate label to put on a device may not be simple. When is one label appropriate over another? Does a device need to go through additional testing, verification, or validation? And what are the consequences of using the wrong label? In this eBook, we’ll cover the differences between Research Use Only (RUO) and a medical device – although, it’s generally a very clear distinction.

Using the right language and label is critical to complying with best practices. This is why Regulatory Affairs works with the regulatory bodies to ensure that the limitations of the product are properly documented. In a rush to get products to market, it may be tempting to use a Research Use Only (RUO) label to avoid additional regulatory processes while still empowering other researchers and developers. However, there are risks to using the RUO label inappropriately that can have serious consequences for developers, users, and patients. In fact, mislabeling a product is illegal, and punishable. You can see an example warning letter the FDA sent to Carolina Liquid Chemistries Corp after finding intentional mislabeling in 2019 here.

This introduction will provide an overview of the Research Use Only label, how it differs from similar, adjacent labels, its appropriate use, and the consequences of mislabeling products RUO.

What is Research Use Only (RUO)?

The label Research Use Only (RUO) is generally used to indicate products that are intended for scientific research only. They cannot be used for diagnostic or medical purposes. However, there is no standard definition of “research use only,” and the label has slightly different meanings in the European Union and the United States. With the IVDR regulations, RUO products that are being used in the LDT space are going to be revisited and potentially reclassified as a medical device. With this new classification, teams will likely need to follow design controls, best practices, and industry standards.

What is the FDA guidance on Research Use Only products?

Under the FDA’s guidance issued in 2013 , a product labeled Research Use Only is an In Vitro Diagnostic (IVD) product “that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812.” The agency includes in this category:

• “Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured.
• “Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods.
• “Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.”

The European guidance document MEDDEV 2.14/2 states that a product categorized as an RUO product “must have no intended medical purpose or objective.” The guidance does exempt some tests developed for in-house use as long as the products are not sold to other companies. Some examples of items that can be classified as “research use only” under this exemption include PCR enzymes, gel component agars, and primers.

RELATED: FDA released new draft guidance of premarket submissions for medical devices – are you ready?

What is the difference between ruo and ivd.

An IVD is an “In Vitro Diagnostic Medical Device,” and the general term applies to any device or product that either alone or with other products is intended to be used for diagnostic, monitoring, or compatibility purposes. There are four different regulatory levels for IVDs:

• Research Use Only (RUO)
• General Laboratory Use (GLU)
• For Performance Studies Only (PSO)
• In Vitro Diagnostic Medical Device (IVD)

The simplest explanation for these different levels is that each increasing level requires more testing and oversight. Research Use Only products are at the lowest level of regulation, and In Vitro Diagnostic Medical Devices are at the highest level. Occasionally in the US, products will be labeled as “RUO IVD,” which means an in vitro device that is intended for research use only.

Products labeled with the “CE-IVD” label indicate that they have progressed through the applicable regulatory process and standards (such as IVDD or IVDR). These products are approved for diagnostic use and must include the IVD symbol to be used for medical purposes.

In the EU, as of May 2022, IVDs must comply with Regulation (EU) 2017/746 (IVDR) . The IVDR defines IVDs as follows:

“‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

(a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures.”

All IVDs that comply with the IVDR must carry the CE Mark if marketed in the EU.

Research Use Only products are not subject to regulatory requirements in either the US or the EU, but because they don’t meet the same compliance standards as IVDs, they must be clearly labeled as RUO products and cannot be used for medical purposes.

A known exception is the lab developed test (LDT) pathway for clinical purposes.

What are the requirements for an RUO product?

In the US, RUO products are basically unregulated and do not need to meet any specific requirements to carry the RUO label. The FDA does not specify any restrictions or limitations on RUO products, provided they are clearly labeled “For Research Use Only. Not for use in diagnostic procedures.” For this reason, RUO products can be an excellent solution for laboratories that need research materials for testing and research purposes. Because products with the RUO label do not require extensive testing, verification, and validation, they tend to be more cost-effective for research purposes.

The EU rules are similar. Because RUO products do not have clinical applications, they are not considered medical devices, and there are no requirements for RUO products defined by either the IVDD or the IVDR. These products should not be marked with the IVD mark, and they should be clearly labeled as “Research Use Only.”

RELATED: See how Jama Software ® helped Össur improve the mobility of millions by replacing process rigidity with speed and agility.

Are there alternatives to ruo labels.

Given the significant differences between labeling a product as RUO and labeling a product as IVD, manufacturers and users can’t be too careful when it comes to assigning labels or using products for specific purposes. If there is a risk to using products labeled as RUO, manufacturers and users should opt for products that have attained a higher compliance level. For example, for a doctor’s office or home use, IVD is the right path. For clinical purposes or hospital labs, RUO could be used as LDT as long as they are CAP/CLIA certified, such was the case with COVID-19 testing kits when the pandemic first hit.

For products that meet a higher degree of compliance, it is possible to assign General Laboratory Use (GLU), Performance Studies Only (PSO), or even In Vitro Diagnostic Medical Device (IVD) labels. However, depending on the intended use for the Research Use Only products, pursuing these additional levels of compliance may or may not make sense.

What is CLIA certification?

CLIA stands for Clinical Laboratory Improvement Amendments. The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the United States through CLIA.

What is a CAP accreditation?

CAP stands for The College of American Pathologists (CAP) . The purpose of CAP laboratory accreditation is to ensure laboratories provide precise test results for accurate patient diagnoses, meet CLIA and CAP requirements, and demonstrate compliance with professionally and scientifically sound and approved laboratory operating standards.

What are RUO products used for?

As the name implies, RUO projects should be used for research purposes only. They may be used for basic research, pharmaceutical research, or in-house manufacturing of “home brew kits” for research purposes and potentially for clinical applications via the LDT pathway. RUO products are specifically not to be used to make diagnoses, conduct performance studies, or as a substitute or comparator for a CE-IVD device. They may also not be used for market or feasibility studies. Raw ingredients labeled as RUO products may not be incorporated into a finished IVD product.

Learn more about the advantages and disadvantages of the RUO label (and more) by downloading the entire eBook HERE .

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In Vitro Diagnostic Use (IVD) versus Research Use Only (RUO) in the Clinical Laboratory

by Lindsey Drake | Clinical , Molecular

Publish Date: April 3, 2023

Previously, in this series we highlighted the importance of external and third-party quality control products in the clinical laboratory, emphasizing that quality control, by design, should add layers of removal from the assay to ensure the utmost degrees of objectivity. External, third-party quality control materials fulfill this QC requirement by removing bias in the quality control process. However, in addition to adding objectivity to the quality control process, it is critical that clinical laboratories consider the quality and the regulatory status of their quality control products.

The IVD and RUO labels are so commonplace in diagnostic laboratories that they easily go unnoticed. Clinical laboratory professionals may not pause to remember that these labels stand for In Vitro Diagnostics (IVD) and Research Use Only (RUO). Even clinical laboratory professionals who are familiar with these regulatory designations for assays or instruments sometimes do not realize the full significance that these labels have for certain products, including quality controls. Therefore, even though the quality and the regulatory status of quality control products is essential to consider, many clinical laboratories may not know the status of their quality control materials and products. This lack of understanding inadvertently puts both patients and the clinical laboratory at risk.

This blog post will examine the differences between RUO and IVD and the importance of choosing the right quality control products in the clinical laboratory. For additional information on RUO and IVD, check out our webinar highlighting the critical differences between RUO and IVD and the importance of choosing the right clinical diagnostic products. We partnered with CAP Today and industry expert Dr. Sebastian Grömminger to bring you this webinar.

Research Use Only (RUO)

RUO stands for Research Use Only. The RUO label serves as a warning to clinical laboratory professionals that the materials in question are not intended for use with patient diagnostics. RUO products are in the laboratory phase of development and must have no intended medical purpose or objective, as these materials do not require validations or regulatory compliance. 2   RUO materials are not defined in the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) and do not have any regulatory requirements. Therefore, RUO materials are to be used only for testing with no direct impact on patient diagnostics.

According to United States Food and Drug Administration (FDA), 3

• Similar to the case in the EU, RUO refers to products in the “laboratory phase of development,” which are “not approved for clinical diagnostic use”
• RUO products are “exempt from most regulatory controls,” so it is therefore “important that they are not distributed for clinical diagnostic uses”
• All product labeling for these products must bear a prominent user notification: “‘For Research Use Only. Not for use in diagnostic procedures.’”
• RUO Labeling is intended to “serve as a warning, to prevent such products” from being used in manners that will impact patient testing and treatment outcomes.
• Companies selling RUO materials are limited in their marketing in some regions. In these regions, manufacturers may be forbidden from providing technical support for RUO materials. Availability of technical support is thus an important advantage of IVD products. Since the clinical diagnostic field is complex, having experts to rely on is an indispensable service exclusive to IVD controls.

Since RUO materials are in the laboratory phase of development, their inappropriate use in clinical diagnostics may pose unnecessary threats to diagnostic precision, laboratory efficiency, operating margins, and risk management systems. Therefore, clinical laboratories should not use these materials for reporting patient results. Thus, the RUO label is a warning to the clinical laboratory professional that this material is not intended for use in clinical diagnostics. Rather than using the RUO material, a clinical laboratory professional should look for the right IVD product for any test that could directly impact patient health outcomes.

In Vitro Diagnostic (IVD)

IVD stands for In Vitro Diagnostic. In contrast to RUO, according to global regulations and standards, IVD products are used for medical applications or purposes. According to the FDA, “In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.” 4 According to the IVDR in the European Union and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), IVD medical devices have a medical application or purpose. 4

IVD products must undergo extensive validations to be registered by the FDA, IVDR, and the MHRA. Registrations are required in most countries. Table 1 highlights the regulatory criteria comparison between IVD and RUO products. As shown in the table, IVD products are subject to numerous regulatory requirements, from labeling to post-market surveillance. 6,7 RUO materials do not share these requirements, thus laboratories using RUO materials take on increased risk. 8

Since the manufacturer of the IVD product has invested in extensive studies to validate the performance of IVD product, the clinical laboratory can benefit by reducing the validations required on part of the clinical laboratory. Laboratories choosing to use RUO materials will need to perform more extensive validations than those using IVD products. Thus, clinical laboratories choosing RUO materials take on increased risk and must invest more time into validation and documentation efforts.

Table 1. IVD vs. RUO Regulatory Criteria Comparison. As shown in the table, IVD products are subject to numerous regulatory requirements from labeling to post market surveillance. RUO materials do not share these requirements, thus laboratories using RUO materials take on increased risk.

IVD products also have stringent product development requirements according to IVDR and FDA as shown in Table 2. IVD products have requirements for clinical performance, analytical performance, manufacturing and reproducibility, shipping and stability, failure mode analysis and labeling requirements. RUO materials do not specify requirements for these processes. Again, IVD products are required to demonstrate stringent performance characteristics and regulatory requirements whereas RUO materials do not.

Table 2. IVD: Product Development Requirements. Here we see the product development process requirements under IVDR and FDA for IVD Designation. The IVDR is aligned with FDA here. As shown in the table, IVD products have requirements for clinical performance, analytical performance, manufacturing and reproducibility, shipping and stability, failure mode analysis and labeling requirements. RUO materials do not specify requirements for these processes.

As mentioned above, the unavailability of technical support for RUO materials in certain regions may further limit their ability to fulfill the demands of quality control in clinical settings. Since quality control aims to provide confidence in the laboratory’s analytical processes, QC must bring together the right technical expertise and the right products. Given the complexity of clinical diagnostics, technical support is an indispensable service offered by IVD manufacturers.

Sometimes, IVD products may not be available for a particular assay.  In certain cases, non-IVD-labelled products may be permissible in clinical diagnostics, such as when testing materials receive Emergency Use Authorizations because IVD products are not yet available. When used in these extenuating circumstances, non-IVD-labelled products will require the laboratory professional to perform additional steps to satisfy regulatory demands for quality control.

Quality controls help reveal blind spots, biases, material defects, and other causes of inaccurate diagnostic results. By design, quality control allows the clinical laboratory to test their analytical processes in a controlled manner to ensure assays and instruments perform as expected before their use for patient samples. Because approximately 70% of healthcare decisions rely on the results of laboratory testing, accurate diagnostic processes are critical to patient care. Therefore, quality control is foundational to the quality management system of a clinical laboratory, and its role cannot be understated.

Because of this critical role, clinical laboratories must not only use quality control materials with an intended use in clinical diagnostics, but also must choose products meeting the highest standards for quality, precision, and scientific rigor. When clinical laboratories choose an IVD product, they put their confidence not only in the regulatory status of the material for use in clinical diagnostics, but also confidence that manufacturer has invested time and care to ensure the product has been properly validated and subject to stringent quality requirements before its release as a product offering.

Clinical laboratories should keep in mind that, according to global regulations (e.g., European Commission, FDA, etc.), RUO materials have no place in routine clinical diagnostics. Clinical laboratories that choose to use RUO materials are putting their patients and laboratory at risk. In addition to not having an intended use in clinical diagnostics, RUO materials are exempt from most regulatory controls which may impact product quality. Additionally, a lack of technical support may intensify these drawbacks.

Choosing IVD quality control products is essential in the clinical laboratory as these products have undergone extensive validations required to be registered with FDA, European Commission, MHRA, and other regulatory bodies for an intended use in clinical diagnostics. An IVD label signifies exactly what you look for in an external, third-party control: uncompromising quality, according to the highest standards. The IVD label represents product quality and confidence and strengthens the clinical laboratory’s risk management program. The IVD label allows technical support assistance. Reliance on a reputable third-party, IVD quality control manufacturer gives back the clinical laboratory time, money, and peace of mind.

Find IVD controls for your assays at Microbiologics.com .

1. European Commission. (2004, February). Guidance document – In vitro diagnostic medical devices – Research Use Only products – MEDDEV 2.14/2 rev.1. European Commission. https://ec.europa.eu/docsroom/documents/10292/attachments/1/translations

2. Center for Devices and Radiological Health. (2013, November 25). Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only. Guidance for Industry and Food and Drug Administration Staff. U.S. Food and Drug Administration. https://www.fda.gov/media/87374/download

3. Center for Devices and Radiological Health. (2013, November 25). Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only. Guidance for Industry and Food and Drug Administration Staff. U.S. Food and Drug Administration. https://www.fda.gov/media/87374/download

4. Center for Devices and Radiological Health. Overview of IVD Regulation. U.S. Food and Drug Administration. Retrieved March 6, 2023, from https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation

5. Regulation (EU) 2017/746 In Vitro Diagnostic Medical Devices (IVDR) https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0746&from=EN

6. Center for Devices and Radiological Health. (2021, October 21). Overview of IVD Regulation. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation#1

7. 21CFR809, Subpart B, In Vitro Diagnostic Products for Human Use. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=809&showFR=1

Written by Lindsey Drake

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Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only Guidance for Industry and FDA Staff November 2013

FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products are properly labeled “for research use only” (RUO) or “for investigational use only” (IUO).

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Oversight of Research Use Only Products

By Jeffrey N. Gibbs

March 1, 2010 (Vol. 30, No. 5)

RUO Assays and Instruments Face Greater Scrutiny

The FDA actively regulates medical devices intended for diagnostic use. Diagnostic kits intended for diagnostic use face the full panoply of FDA regulation. In sharp contrast, research use only (RUO) products are essentially unregulated. In fact, although RUO products are often discussed as though they are a kind of medical device, RUOs are not devices at all.

A commercially important class of products, RUOs are defined very briefly by FDA regulations. RUO products are described as products “in the laboratory research phase of development and not represented as an effective in vitro diagnostic product.” This definition has created some uncertainty as to what products fall into the RUO category.

The same regulation establishing the RUO category requires that RUO products bear the following labeling statement: “For Research Use Only—Not for use in diagnostic procedures.” Although not authorized by the regulation, many companies have shortened the statement to just the first clause. FDA regulations do not prescribe any other restrictions or limitations on RUO products beyond this labeling statement. Thus, FDA regulations define the category and prescribe labeling, and nothing more.

Given that RUO products are not intended to diagnose “a disease or other condition,” it is not clear that they are even subject to FDA’s jurisdiction. The intended use of an RUO product—research,  not diagnosis—presumptively removes it from the definition of a device and FDA’s authority.

In any event, aside from bearing the mandated statement, RUO products are not regulated by the agency. For example, they do not need to be listed with FDA or comply with the Quality System Regulation (QSR). They can be sold without any FDA clearance or approval. As a practical matter an RUO is essentially unregulated by FDA.

Over the years, the paramount regulatory issue for products bearing the RUO label has been whether or not they actually do belong within the RUO category. There have been multiple instances in which RUO products have become widely used by laboratories for clinical applications. There have also been a number of occasions where companies have labeled products as RUO but then promoted them for diagnostic use. In some instances, companies have made specific diagnostic claims for their assay or instrument but still labeled the product as RUO.

Biomarker kits are often labeled as RUO because it is not known whether the product has any clinical use or, if so, what that use might be. The assay’s developer may expect that a particular biological substance will be of some clinical value, but not be sure what that value is. Labeling a product RUO, allows it to get into the hands of researchers who can then evaluate whether the product may be potentially valuable for some specific diagnostic purpose.

Often, no clinical use is ever identified. Some assays maintain their true RUO status indefinitely. While the product may be helpful to researchers in understanding basic biological mechanisms, a diagnostic use may never be discovered.

Guidance Documents

FDA has initiated several attempts to try to regulate RUO products more tightly. In the early 1990s, FDA issued a draft Compliance Policy Guide (CPG) document that sought to significantly restrict the availability of RUO products. This guidance document went through several iterations but was never finalized. There is still no guidance document setting out FDA’s policy regarding RUO products, however, reports have recently surfaced that a new RUO policy may finally be released.

One of the elements set forth in the draft CPG was that the distributor of the RUO product should receive a certification from the laboratory customer that the product will be used for research purposes only. Although the CPG was not adopted, some vendors have asked laboratories to sign some type of acknowledgement form. While this will help support a vendor’s position that its product is intended only for research use, it is not currently required. FDA has, however, “encouraged” some instrument suppliers to adopt certification programs. 

Concerned by the proliferation of RUO products, in 1997 FDA tried a different tack. That year, FDA promulgated the Analyte Specific Reagent (ASR) regulation. ASRs were broadly defined as the building blocks of diagnostic assays. Unlike RUOs, ASRs were subject to FDA requirements, including QSRs and Medical Device Reporting. This regulation was prompted, in part, by the belief that it would result in the availability of higher quality materials for laboratory tests and displace some of the lower quality RUOs.

To some degree, that plan succeeded. Many different products were offered to laboratories as ASRs. However, while many of these were basic chemical components, more complex products were also sold as ASRs. Ultimately, FDA concluded that the ASR regulation was being used as a vehicle for  products that didn’t fit the intent of the regulation.

FDA therefore released a guidance document in 2007 that substantially curbed the availability of ASRs by prohibiting companies from combining more than one active component. With the advent of molecular diagnostics, selling a single component was often impracticable, e.g., a primer and probe pair need to be offered together. This narrow interpretation of ASRs has essentially precluded the sale of ASRs for use in molecular diagnostics. Somewhat predictability, a number of companies responded by relabeling their ASRs as RUOs. This has helped lead to a renewed focus on RUOs by FDA.

For years, the principal regulatory question for products labeled as RUOs has been whether they qualify for this classification and hence are not subject to regulation as devices. While FDA has not issued either a regulation or guidance delineating how companies can promote RUOs, the agency has taken enforcement action against a number of RUO companies.

Even absent regulations or guidance, it is apparent that in FDA’s view a product forfeits its RUO status if certain types of claims are made—claims that the product can diagnose a disease or condition, provide clinical sensitivity or specificity data, or offers a clinical benefit. Correspondingly, the instructions for use (IFU) accompanying the product need to be brief.

While the bulk of RUO products have been assays, the RUO category also encompasses instruments and equipment. This can present its own set of regulatory challenges, particularly when an IVD applicant has used an RUO instrument in conjunction with developing its assay, a situation that is now occurring with greater frequency. 

The utilization of RUO instruments in assay development has led to the submission of applications that reference RUO instruments. This may result in naming the RUO instrument in the draft IFU, i.e., the applicant states that the assay is to be performed on an RUO instrument, or the data for the IVD were generated on an RUO instrument.

While FDA had accepted these practices, that has seemingly changed. Therefore, an IVD company that has tested and validated its assay on an RUO instrument or is using RUO assays in its test system should discuss with FDA at an early stage how to address the regulatory implications that may arise from this situation. Simultaneously, companies that are selling RUO-labeled instruments that are being widely used in diagnostics may find that they will be receiving more regulatory scrutiny from FDA.

Over the past few years, RUO products have received relatively little attention from FDA. That regulatory lull seems to be ending.

Jeffrey N. Gibbs ( [email protected] ) is a director at Hyman, Phelps & McNamara. Web: www.hpm.com.

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Thus, they are mostly for the research purpose only , and the impact of research outputs on the landscape planning remains low.

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The probes were provided at no charge for those patients in whom FISH analysis was done for research purpose only .

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2 nonstandard abbreviations:.

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“Research Use Only” Reagents: Is There an Imperative for Increased FDA Oversight?

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Timothy J O'Leary, “Research Use Only” Reagents: Is There an Imperative for Increased FDA Oversight?, Clinical Chemistry , Volume 57, Issue 12, 1 December 2011, Pages 1681–1683, https://doi.org/10.1373/clinchem.2011.174268

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On June 1, 2011, the US Food and Drug Administration (FDA) 2 Office of In Vitro Diagnostic Device Evaluation and Safety issued draft guidance for industry and FDA staff intended to provide guidance regarding the FDA's thinking about in vitro diagnostic device (IVD) products labeled for “Research Use Only” (RUO) or “Investigational Use Only” (IUO) ( 1 ). Reagents may be marketed under either of these labels without FDA premarket review and are partially or totally exempt from compliance with the Quality Systems Regulation (21 CFR 820). Therefore, an IVD manufacturer might it very tempting to avoid the trouble and expense of a 510(k) or premarket-approval submission by labeling a product as RUO or IUO, despite knowing full well that the product is likely being used as an IVD under conditions in which there is no research protocol and no oversight by an institutional review board.

There is no doubt that the FDA's intent is to improve patient safety. Compliance with the Quality Systems Regulation provides assurance that an IVD meets manufacturing specifications and that lot-to-lot variations are minimized and well understood. FDA clearance provides further assurance that the performance characteristics of laboratory tests are sufficiently well understood as to enable their intelligent use. Furthermore, the use by clinical laboratories of FDA-cleared IVD products likely reduces interlaboratory variation in testing and increases the ease with which results can be “ported” from one healthcare facility to another, potentially reducing healthcare costs that arise from duplicate testing. Nevertheless, the laboratory community is right to be concerned about the guidance document statement that manufacturers should not sell RUO or IUO reagents “to laboratories that they know use the product for clinical diagnostics use.” This statement could have unintended consequences that adversely affect patient care. In particular, the molecular diagnostics community has expressed concern that such reagents as PCR primers and sequencing reagents and equipment could become unavailable and that this outcome could affect many aspects of medical care, including newborn screening, HLA testing, and human papilloma virus genotyping, among others.

When considering approaches by which the FDA and the laboratory community can improve patient care and safety, it is important to consider the overall medical and regulatory environment in which laboratory tests that currently use RUO and IOU IVDs are conducted. In the remainder of this Opinion, I consider potential deficits in laboratory testing that currently do not rely on FDA-cleared IVDs and discuss principles that the FDA and other agencies may wish to consider when determining whether a regulatory solution is the most appropriate way to address the perceived deficits in laboratory testing.

The design and implementation of regulations entail substantial costs on the part of both regulator and regulated, both of which must ultimately be borne by the public. Therefore, regulators should take a measured approach when deciding to implement a regulatory solution to a perceived problem. In my opinion, such decisions should be based on a careful and narrow definition of the public health problem to be addressed, a scientifically valid and quantitative assessment of the magnitude of this problem, and strong evidence that the overall cost of implementing the regulatory approach (including both the cost to the regulator and the cost to the regulated entities) is cost-effective. The regulatory reasoning and the cost–benefit analysis should be published together to facilitate public scrutiny and comment. Implementation of this approach would unquestionably be associated, at least initially, with an adverse financial impact on regulatory agencies, because the assessment of regulatory impact would undoubtedly be more costly than is currently the case. The overall cost to the public seems likely to be offset, at least in part, by avoidance and/or rescission of ineffective and costly regulatory interventions. The recent FDA guidance document does not implement such an approach, so I consider some of the issues that the agency may have attempted to address.

Several potential problems are associated with the use of RUO and IUO reagents in clinical laboratory testing: ( a ) the creation of an uneven playing field for manufacturers; ( b ) the perception that manufacturers or laboratories are defying FDA regulatory authority; and ( c ) the reporting of inaccurate, misleading, or inconsistent results, either within a laboratory or among several laboratories. There is no question that the cost avoidance produced by ignoring regulatory requirements creates an economic environment that gives unfair advantage to commercial manufacturers, compared with institutions that play by the FDA interpretation of the law. Both the clinical investigations and the paperwork requirements associated with FDA submissions are costly. These costs may come at the expense of profit or at the expense of healthcare organizations and insurers (including the federal government).

Inaccurate or misleading results can occur when a clinical laboratory result does not mean what a clinician believes that it means. That situation could arise, for example, if an RUO or IUO reagent is not what the vendor says it is or performs in a manner that both is inconsistent with what the vendor states and is unexpected by the clinical laboratory. It is thus incumbent on laboratories to conduct their quality-assurance activities in a manner that ensures that reported results mean exactly what they purport to mean, whether or not a laboratory test has been cleared by the FDA. Under the framework proposed above, increased regulatory effort by the FDA might be appropriate if evidence of harm exists, although CLIA also provides a framework for achieving this objective.

Although the FDA has not officially elucidated the reason for issuing the guidance document, there have been a number of reports of inaccurate testing with laboratory-developed tests. Perhaps the most prominent is prescribing Herceptin® based on the results of immunohistochemical tests for HER2 (human epidermal growth factor receptor 2) overexpression. 3 Some of these results have depended on the use of uncalibrated laboratory-developed tests; indeed, some authors have postulated that as much as 20% of immunohistochemical HER2 testing used for selecting patients for Herceptin therapy has not been correlated, either directly or indirectly, with response to the drug ( 2 ). If true, that finding demonstrates a clear failure of the CLIA framework alone to adequately protect public health, and it seems likely that the burden of regulatory compliance, if narrowly directed to this issue, is proportionate to the problem. Inaccurate or misleading results have also been associated with direct-to-consumer genetic testing ( 3 ), which is widespread. The magnitude of the harm associated with such testing is uncertain but may be considerable, and oversight under the CLIA mechanism has failed to address the issue.

The potential reach of the FDA guidance document is broader than necessary to deal with HER2 assessment and direct-to-consumer testing. There are substantial numbers of important laboratory-developed tests for which only RUO and IUO reagents are currently available. The FDA guidance document (which, I should note, is nonbinding) could lead to withdrawal of these tests from clinical practice. In my opinion, FDA officials should work to minimize the likelihood of such an occurrence. In addition, there is a risk that innovative new tests for which only RUO and IUO reagents are available will not be deployed in a timely way, further compromising patient well-being. There is clearly a role in medical practice for laboratory-developed and -validated tests that will, of necessity, use reagents that have not passed FDA muster. The failure of CLIA oversight mechanisms is not a reason for the FDA to act unilaterally. Enforcement of both the Food Drug and Cosmetics Act and the Public Health Service Act [which created the CLIA 88 (CLIA amendments of 1988) framework] falls to the Department of Health and Human Services. It is thus appropriate for the FDA and the Centers for Medicare and Medicaid Services to work cooperatively, not only with each other but also with industry and laboratory communities, to develop a robust framework for reducing inaccurate and unreliable laboratory testing while maintaining access to high-quality laboratory testing and minimizing its economic burden.

US Food and Drug Administration

in vitro diagnostic device

Research Use Only

Investigational Use Only

human epidermal growth factor receptor 2

CLIA amendments of 1988.

HER2 is used in this Opinion to refer to the protein encoded by the gene with HUGO-approved gene symbol ERBB2 [v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog (avian)], as HER2 is the name commonly used in practice.

Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article .

Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the Disclosures of Potential Conflict of Interest form. Potential conflicts of interest:

Employment or Leadership: T.J. O'Leary, Association for Molecular Pathology and Journal of Molecular Diagnostics .

Consultant or Advisory Role: None declared.

Stock Ownership: None declared.

Honoraria: None declared.

Research Funding: None declared.

Expert Testimony: None declared.

Disclaimer: The views or opinions expressed in this paper are those of the author and are not to be construed as official or as representing the views of the Department of Veterans Affairs or any other entity of the United States government.

U.S. Food and Drug Administration . Draft guidance for industry and FDA staff-commercially distributed in vitro diagnostic products labeled for research use only or investigational use only: frequently asked questions . http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253307.htm (Accessed October 2011) .

Carlson B . HER2 tests: How do we choose? Biotechnol Healthc 2008 ; 5 : 23 – 7 .

Google Scholar

U.S. Government Accountability Office . Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices . http://www.gao.gov/new.items/d10847t.pdf (Accessed October 2011) .

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Airport Passenger-Related Processing Rates Guidebook (2009)

Chapter: chapter 3 - defining the research: purpose, focus, and potential uses.

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

14 Chapter 3 identifies roles, relationships, and responsibilities of stakeholders. It examines principal steps involved in planning an airport passenger-rate data collection effort. It begins with the ques- tion of whether the potential benefits of the proposed effort outweigh the anticipated cost; describes different types of research (i.e., exploratory, descriptive, inferential); summarizes the questions each type addresses; and notes the ends to which the data might be used. 3.1 Roles and Responsibilities When an airport data collection event is first mentioned, it invariably raises numerous ques- tions: Who is asking for the data? How will it be used? What’s the budget? What’s the schedule? What kind of resources can be made available? Without answers to these fundamental questions, the success of your research is in jeopardy. This section will help the researcher establish the role of key stakeholders and their interrelationships within the team. Many entities can sponsor a data collection study, including airports, airlines, manufacturers, and various agencies. Likewise, there are many ways of managing and staffing the event and pro- moting involvement with stakeholders. There are therefore myriad ways of organizing a study. Exhibit 3-1 is an example of how a study could be arranged with the airport as the sponsor. 3.1.1 Client/Sponsor For airports, oversight is guided by a board, commission, or an authority consisting of appointed or elected officials. While these agencies typically provide oversight to airport man- agement and approve long-term plans and large capital expenditures, usually it is the airport director or manager who makes day-to-day decisions. Depending on the size of the airport, there may be several departments, each having its own manager. In such cases, passenger terminal-related studies would typically fall within the purview of the planning and/or engineering department and would be managed by its director. Regardless of the affiliation of the project sponsor(s), it is essential that the following ques- tions be answered clearly and unambiguously as they pertain to the sponsor at the beginning of any project: • Who has primary responsibility for defining the questions the study is intended to address? • What preference does this person or group have regarding ongoing involvement with the project? – What information would they like to receive, in what format, and with what frequency? – Who should be the principal point-of-contact (POC) on the client’s side for questions that might emerge related to the study’s focus, direction, etc.? C H A P T E R 3 Defining the Research: Purpose, Focus, and Potential Uses

Defining the Research: Purpose, Focus, and Potential Uses 15 • Who is the designated project manager, and what information would he or she like to receive, in what format, and with what frequency? • If the person given responsibility for day-to-day issues pertaining to access, authorizations, etc. is different from the project manager, who is that person, and what is the scope of issues he or she is authorized to address? • If problems or obstacles arise in implementing the study, and the project manager is not able or authorized to resolve them, what is the chain of persons through which the issue should be escalated? 3.1.2 Study Team The size of the study team will depend on the team’s depth and organization, and the size, duration, and complexity of the study itself. For a typical medium- to large-scale study, the roles listed in the following sections are the most typical. Multiple roles might be assumed by a single person or distributed across multiple persons. Titles vary as well, but the functions are largely universal. Project Manager The project manager is typically a mid-level to senior person who has the long-term, day-to- day relationship with his or her client counterpart. The need for the passenger-related process- ing rate study may initially originate from discussions between the project manager and those within the airport or airline. Survey Manager The survey manager is usually a mid-level staff person. His/her role on the project would be to oversee the day-to-day management of the data processing rate study, including leading the development of the scope, schedule, and budget; developing the team; and assigning roles and responsibilities. The survey manager would have the responsibility of ensuring the survey goals were adequately defined and met. Decision Maker Survey Manager Admin. Support Staffing Source (e.g., airport personnel, mkt. research firm) Surveyor Surveyor Surveyor Sponsor/Client (Airport) (Large Airport: Dir./Mgr.) Project Manager (Large Airport: Dir. Planning/Eng.) (Small Airport: Apt. Mgr.) Project Manager (Typ. oversees multiple tasks of which survey is but one part) Study Team (Typically, Consultant) Statistical Technical Expert Survey Assistant Data Analyst IT Analyst Other Stakeholders • Airlines • Agencies • Concessionaires Exhibit 3-1. Typical sponsor and study team roles (assuming an airport is the sponsor).

16 Airport Passenger-Related Processing Rates Guidebook Research and Statistical Expert A person(s) with expertise in research methodology and quantitative/statistical analysis should be consulted to develop, or provide comments and recommendations about, the overall methodology, the sampling plan, and so forth. Most of this person’s input would occur at the project’s initiation. A distinction is sometimes drawn in the consulting literature among differ- ent approaches to consulting. One such approach, generally referred to as process consultation might be of particular appeal.1 When acting in this role, the consultant not only provides tech- nical expertise related to the specific project, but also works with the client to develop expertise. This arrangement has the goal of, over time, reducing the reliance on the consultant. Survey Assistant The survey assistant has primary responsibility for assisting the survey project manager and secondarily to assist others on the project team throughout the duration of the study. Typically, this staff person will be at a junior level. The degree of assistance this person can provide is based on his/her level of education and current skill sets. Data Analyst The data analyst should not only be well-versed in technical analysis, but should also have a strong familiarity with the airport terminal environment. This person could be a terminal or air- port planner or aviation architect. The analyst is often largely responsible for documenting results, and responsibilities might extend to presenting findings to the client. Administrative Support Data collection efforts are inherently complex and, as such, often require a significant level of coordination and administration. The staff person serving this function would be responsible for such things as making travel plans, scheduling visits to the airport’s security office, buying supplies, shipping and receiving materials, scheduling meetings, preparing invoices and con- tracts, and editing/proofing the report. Data Collection Staff For small studies (e.g., small airports where only a few functional elements are being observed for a limited time period), airport/airline or consultant staffing may be used. For larger studies, typically examining multiple functional elements of a medium or large airport over a multi-day period, a market-research firm is frequently employed. The data collection staff reports directly to the survey manager. 3.2 Is the Study Needed? While the need for data collection is often justifiable, the benefit of validating the need, and avoiding what might be a costly, and possibly unjustified, effort well exceeds the relatively minor cost of pausing to consider a few basic questions (see Appendix C for more information). Exhibit 3-2 illustrates these questions. 3.3 Research Fundamentals This section summarizes a number of fundamental issues and terms related to the research process. (Additional detail is included in Appendix C.) 1 Schein, E. H. (1999). Process Consultation Revisited: Building the Helping Relationship. NY: Addison Wesley.

Research is a dynamic process with both deductive and inductive dimensions. This differs in some ways from what some present as the “traditional” approach to research, i.e., that theory drives hypothesis testing. Sometimes it does, but sometimes it doesn’t work this way. 3.3.1 Theory, Hypotheses, and Evidence The word “theory” often implies a formal set of laws, propositions, variables, and the like, whose relationships are clearly defined. A related implication is that theory may not be particu- larly germane to the everyday world of work. This view of theory is not incorrect, but neither is it complete. While theory can be abstract and complex in its detail, it does not necessarily have to be abstract, complex, or formal. It can be thought of more broadly and simply as an explanation of “how the world works.” For exam- ple, an organization might develop a mission or a value statement (or both); engrave the words in a medium intended to last millennia; and prominently display the statement in the workplace with the intent of communicating to all its perspective clients on issues pertinent to its view. In Defining the Research: Purpose, Focus, and Potential Uses 17 Question Things to Consider Have relevant data been collected at this airport in the past that might be used rather than collecting new data? Might you be able to get data from another airport similar in key ways to this airport? Are there data available that might help answer the research question? Might access to the data be blocked due to proprietary or security issues? Sometimes the data are perceived to be so sensitive that the “owner” of the data may not give permission to share it. Has the decision already been made, and the data are being collected to legitimize the decision? Is there anything to suggest that the study is an attempt to “prove” something true or false? What role will the results play in the decision being considered? To what extent will the decision makers be persuaded by the results? What will the decision makers accept as credible evidence? Before collecting data, make certain that the research plan will result in data that the sponsors will accept. It is better to learn beforehand, for example, that the proposed sampling plan does not meet the sponsor’s criteria for rigor. What is the cost of the potential investment that the data will help inform? What is the cost of conducting the research? Does the benefit equal or outweigh the cost? Cost should be considered not only in economic terms, but as safety, inconvenience, and so forth. Exhibit 3-2. Considerations to determine need for data collection.

2008, British Airways announced a new venture: OpenSkies. The “theory” OpenSkies used to define its clients is reflected in its advertising as shown in Exhibit 3-3. So, how does this relate to airport processing rate studies? It relates in the following two ways: 1. The published research literature may well contain formal theories relevant to what data to collect and how to collect it. For example, Appendix B includes a bibliography of recent research articles related to passenger and baggage processing in airports. It is intended to illustrate the scope and diversity of research available on a given topic. Before embarking on an investigation, review the literature to see how it might enhance the quality of the planned research. The Internet provides access to numerous sources for such scholarly documents. 2. Informally, the key decisions about how to go about collecting data are grounded in assump- tions about how things work (i.e., one’s own theory). For example, you might choose to col- lect passenger security screening data between 6:00 a.m. and 8:00 a.m. on a Monday because your experience is that this time period reflects peak checkpoint activity. While this “theory” may be correct in some circumstances, it may also be wrong in others. For example, at many vacation-oriented airports, the peak at the checkpoint occurs in the late morning due to check-out times at hotels. Another common view of research is of the stereotypical scientist, objectively testing hypothe- ses (or an “educated guess”) arising from theory. Exhibit 3-4 reflects this general approach to research. This is certainly one way in which research proceeds, but, similar to theory, it is not the only way. Before considering an “evidence first” approach, we wish to mention a variation on the tra- ditional approach displayed in Exhibit 3-4 that has been gaining dominance in recent years. In particular, this is a confidence interval (CI) approach rather than a hypothesis driven approach. In a hypothesis driven approach, the researcher’s primary interest is in testing a population parameter, and uses a sample drawn from the population. When the researcher takes a CI approach, the intent is to calculate an interval within which the population parameter is likely 18 Airport Passenger-Related Processing Rates Guidebook Exhibit 3-3. OpenSkies advertisement. Question key assumptions, even if they seem to be “common sense,” by checking with informants, look- ing at the literature, etc.

to fall. Hypotheses are stated before data collection; CIs are calculated after data are collected.2 In conducting passenger-processing rate research in airport environments, the CI approach is going to be the most appropriate in most instances. A markedly different approach to those described above is shown in Exhibit 3-5. In contrast to beginning with a theory and then collecting evidence to test the theory or estimate a popula- tion parameter within some CI, this approach begins with evidence for which one seeks poten- tial explanations, or “theories” to explain the evidence. This approach is subsumed under the broad heading of Bayesian Law, so named after the 18th Century English clergyman, Thomas Bayes, credited with developing the approach. Depending on where one begins can result in potentially dramatic conclusions (see Exhibit 3-6). This is important because limiting oneself to a particular perspective of how research should be conducted and how data ought to be gathered may impose unnecessary constraints. What is important is that the research is executed systematically and with rigor. The documented ways in which science proceeds are often idealized: portraying what is inherently a very dynamic and nonlinear process as logical and linear. 3.3.2 Research Questions and Purposes A basic issue in research is specifying the question the research will help answer. Penning a specific question also helps in determining what approach might be best used in seeking an Defining the Research: Purpose, Focus, and Potential Uses 19 Theory Drives questions & hypotheses Hypothesis: Installing n kiosks will reduce the average time of passengers waiting in line by 10% over check-in agents. Leading to a conclusion Drives data collection Followed by analysis Exhibit 3-4. Hypothesis driven approach. Evidence leads to speculation about possible explanations Which may or may not drive more data collection & analysis Theory Exhibit 3-5. Bayesian approach. 2 While these approaches are presented here as mutually exclusive, they might be integrated in practice.

answer. One classic text in research methodology5 suggests that a research question should express a relationship between two or more variables, and it should imply an empirical approach, that is, it should lend itself to being measured using data. A variable is, not surprisingly, some- thing that can vary, or assume different values. In the next section, illustrative questions are given, categorized by the purpose of research with which they are best matched. The five research purposes are presented as the following: 1. Explore, 2. Describe, 3. Test, 4. Evaluate, and 5. Predict. The distinctions among these purposes are not absolute, nor are they necessarily exclusive of one another. A research initiative might be directed at answering questions with multiple pur- poses. Indeed, this is but one of many ways of classifying research. In addition, the reader whose practice lies primarily in the arena of modeling and simulation might note their absence from this list. Although modeling and simulation applications require input data, for example, to gen- erate distributions and parameters for use as stochastic varieties in modeling, the techniques used to collect data are largely independent of specific applications (such as simulation and model- ing). Those issues unique to modeling are beyond the scope of this guidebook. Explore (Exploratory Research) Exploratory research is sometimes defined as “what to do when you don’t know what you don’t know.” Its aim is discovery and to develop an understanding of relevant variables and their interactions in a real (field) environment. Exploratory research, as such, is appropriate when the 20 Airport Passenger-Related Processing Rates Guidebook If your intent is to… And take action based on… Use… Example Test a hypothesis regarding a population parameter Whether you reject or fail to reject the null hypothesis Hypothesis testing approach The proportion of coach passengers checking in more than 60 min prior to scheduled departure is 80% H A : p > .80 3 H 0 : p .804 Estimate a population parameter The confidence interval selected CI approach Plus or minus 5%, what is the average time coach passengers check in prior to scheduled departure? Determine the likelihood of an event given some evidence The calculated probability Bayesian approach What is the probability that a passenger’s carry on- luggage will be subject to secondary security screening given that the passenger is boarding an international flight? Exhibit 3-6. Research approaches. 3 This is the research, or Alternative, hypothesis. It reads: The proportion is greater than 80%. 4 This is the null hypothesis. It is what is tested, and reads: The proportion is less than or equal to 80%. 5 Kerlinger F. & Lee, H. (2000). Foundations of Behavioral Research, 4th ed. NY: Harcourt Brace.

problem is not well defined. For example, passenger complaints about signs within a facility might prompt the following exploratory question: • “Where should signage be located to minimize passenger confusion?” As another example, if a new security checkpoint configuration is proposed, it may be too novel to rely on variables used in other studies. The question, therefore, might then be the following: • “How does a given alternative security checkpoint configuration affect capacity?” This type of research is often qualitative rather than quantitative. That is, it employs verbal descriptors of observations, rather than counts of those observations (see Appendix C for more information). Describe (Descriptive Research) Descriptive research, as the name implies, is intended to describe phenomena. While descrip- tive research might involve collecting qualitative data by asking open-ended questions in an interview, it typically employs quantitative methods resulting in reporting frequencies, calculat- ing averages, and the like. The following two questions illustrate the nature of descriptive research. Each implies that the relevant variables have been identified as well as the conditions under which the data should be collected. • “What is the average number of passengers departing on international flights on weekday evenings in July at a given airport?” • “How many men use a given restroom at a particular location at a given time?” Test (Experimental and Quasi-experimental Research and Modeling) Often, the intent of the research is not simply to describe something, but to test the impact of some intervention. In an airport environment, such research might be initiated to evaluate the relative effectiveness of a security screening technology in accurately detecting contraband. It is similar in approach to research conducted to assess the relative effectiveness of an experimental drug in comparison to a control (placebo) or another drug. Variables are often manipulated and controlled. This research lies largely outside the scope of this guidebook and, as such, will not receive much attention. Examples of questions that might be asked in this type of research include the following: • “What is the impact of posting airline personnel near check-in waiting lines on the average passenger waiting time?” In addition to the classic “experiment,” simulation modeling might be used, employing rep- resentative data to help answer questions such as the following: • “What would be the impact on processing time of a new security measure being considered?” • “How many agents are needed to keep passenger waiting time below an average of 10 min?” Evaluate (Evaluative Research) Sometimes, the intent of the research is to assess performance against some standard or stated requirement. Basically, evaluation research is concerned with seeing how well something is work- ing, with an eye toward improving performance, as illustrated by the following two questions: • “Is the performance of a given piece of equipment in the field consistent with manufacturer’s specifications?” • “On average, what proportion of passengers waits in a security checkpoint line longer than the 10-minute maximum threshold specified by an airline?” Defining the Research: Purpose, Focus, and Potential Uses 21

Predict Finally, research might be initiated to attempt to predict or anticipate potential emerging pat- terns before they occur. This is related to environmental scanning, insofar as it represents a delib- erate attempt to monitor potential trends and their impact. For example, in the early 1970s, one might have posed the following question: • “What would be the impact of an increase in the number of women in the workforce on air- port design?” There are numerous documented approaches to answering questions such as these. While well beyond the scope of this guidebook, here is one as illustrative: scenario planning. This method involves convening persons with relevant expertise to identify those areas that might most impact the industry (e.g., regulation, fuel costs, demographic changes), and then to systemati- cally consider what the best, worst, and might likely scenarios might be. The principal value of such an approach is that it facilitates deliberate consideration of future trends, and in so doing, presumably leaves people better prepared. When the goal of the research is to predict, data from multiple sources might be sought. The scenario planning example relies, to an extent, on the judgments of experts. Probabilities can also be drawn from historical data to help identify patterns and trends. Exhibit 3-7 is a summary of the key characteristics of each research type. 3.4 Developing the Research Plan Large research studies, particularly when funding is being requested, often require the researchers to adhere to a specific set of technical requirements. The Research Team is aware that the ad hoc and short timeline of many airport-planning research efforts makes developing a “for- mal” research plan impracticable. Nonetheless, even though you might not have the “luxury” of 22 Airport Passenger-Related Processing Rates Guidebook Research Purpose Characteristics Explore Primary purpose: to better define or understand a situation. Data will help answer the research question. The benefit of conducting the research justifies the cost. Qualitative data are recorded, using observation. Describe Primary purpose: to provide descriptive information about something. Test Primary purpose: to assess the impact of a proposed change in procedure or policy. Evaluate Primary purpose: to assess performance against requirements. Predict Primary purpose: to consider possible future circumstances with the purpose of being better prepared for emerging trends. Exhibit 3-7. Summary of research types.

developing such a plan, there are benefits to considering the issues described in this section, as well as documenting basic information. The following are the three major elements the Research Team believes worth documenting, regardless of the size of the research endeavor.6 1. Goals or aims. 2. Background and significance. 3. Research design and methods. Each is described in the sections that follow. 3.4.1 Goals or Aims Specify the question the research is intended to help answer or the specific purpose of the research. The experience of having to translate an intended purpose into words can help clarify your intent. In addition, a written statement can serve as a way of ensuring that your understand- ing of the purpose of the research is consistent with that of the sponsor and other stakeholders. Two examples follow: Statement of Purpose—Example 1 The purpose of this study is to aid decision makers in determining if extending the dwell time of the airport’s automated guideway transit system (AGTS) vehicles from 30 sec to 35 sec at the Concourse C station might improve overall system capacity by providing more boarding time for passengers. Statement of Purpose—Example 2 The goal of this study is to provide airport management with recent data showing the percent- age of arriving flights whose first checked bag reaches the claim device within the airport’s goal of 15 min. 3.4.2 Background and Significance Document what is already known, and specify how the proposed research initiative will add to this knowledge. Consider a “devil’s advocate” perspective by asking what the consequences of not doing the research might be. 3.4.3 Research Design and Methods In this section, describe how you will go about collecting and analyzing data. Additional infor- mation about these issues, including sampling strategies and sample size, is presented in Chapter 5 and in Appendix C. The research plan does not need be lengthy. It should, however, capture key information that, were it not documented and those familiar with the research were not available, would be diffi- cult to ascertain. Defining the Research: Purpose, Focus, and Potential Uses 23 6 This section is partly based on guidelines published by the Agency for Healthcare Research and Quality, Department of Health and Human Services. http://www.ahrq.gov/fund/esstplan.htm.

TRB’s Airport Cooperative Research Program (ACRP) Report 23: Airport Passenger-Related Processing Rates Guidebook provides guidance on how to collect accurate passenger-related processing data for evaluating facility requirements to promote efficient and cost-effective airport terminal design.

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What is Research? – Purpose of Research

• By DiscoverPhDs
• September 10, 2020

The purpose of research is to enhance society by advancing knowledge through the development of scientific theories, concepts and ideas. A research purpose is met through forming hypotheses, collecting data, analysing results, forming conclusions, implementing findings into real-life applications and forming new research questions.

What is Research

Simply put, research is the process of discovering new knowledge. This knowledge can be either the development of new concepts or the advancement of existing knowledge and theories, leading to a new understanding that was not previously known.

As a more formal definition of research, the following has been extracted from the Code of Federal Regulations :

While research can be carried out by anyone and in any field, most research is usually done to broaden knowledge in the physical, biological, and social worlds. This can range from learning why certain materials behave the way they do, to asking why certain people are more resilient than others when faced with the same challenges.

The use of ‘systematic investigation’ in the formal definition represents how research is normally conducted – a hypothesis is formed, appropriate research methods are designed, data is collected and analysed, and research results are summarised into one or more ‘research conclusions’. These research conclusions are then shared with the rest of the scientific community to add to the existing knowledge and serve as evidence to form additional questions that can be investigated. It is this cyclical process that enables scientific research to make continuous progress over the years; the true purpose of research.

What is the Purpose of Research

From weather forecasts to the discovery of antibiotics, researchers are constantly trying to find new ways to understand the world and how things work – with the ultimate goal of improving our lives.

The purpose of research is therefore to find out what is known, what is not and what we can develop further. In this way, scientists can develop new theories, ideas and products that shape our society and our everyday lives.

Although research can take many forms, there are three main purposes of research:

• Exploratory: Exploratory research is the first research to be conducted around a problem that has not yet been clearly defined. Exploration research therefore aims to gain a better understanding of the exact nature of the problem and not to provide a conclusive answer to the problem itself. This enables us to conduct more in-depth research later on.
• Descriptive: Descriptive research expands knowledge of a research problem or phenomenon by describing it according to its characteristics and population. Descriptive research focuses on the ‘how’ and ‘what’, but not on the ‘why’.
• Explanatory: Explanatory research, also referred to as casual research, is conducted to determine how variables interact, i.e. to identify cause-and-effect relationships. Explanatory research deals with the ‘why’ of research questions and is therefore often based on experiments.

Characteristics of Research

There are 8 core characteristics that all research projects should have. These are:

• Empirical  – based on proven scientific methods derived from real-life observations and experiments.
• Logical  – follows sequential procedures based on valid principles.
• Cyclic  – research begins with a question and ends with a question, i.e. research should lead to a new line of questioning.
• Controlled  – vigorous measures put into place to keep all variables constant, except those under investigation.
• Hypothesis-based  – the research design generates data that sufficiently meets the research objectives and can prove or disprove the hypothesis. It makes the research study repeatable and gives credibility to the results.
• Analytical  – data is generated, recorded and analysed using proven techniques to ensure high accuracy and repeatability while minimising potential errors and anomalies.
• Objective  – sound judgement is used by the researcher to ensure that the research findings are valid.
• Statistical treatment  – statistical treatment is used to transform the available data into something more meaningful from which knowledge can be gained.

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Types of Research

Research can be divided into two main types: basic research (also known as pure research) and applied research.

Basic Research

Basic research, also known as pure research, is an original investigation into the reasons behind a process, phenomenon or particular event. It focuses on generating knowledge around existing basic principles.

Basic research is generally considered ‘non-commercial research’ because it does not focus on solving practical problems, and has no immediate benefit or ways it can be applied.

While basic research may not have direct applications, it usually provides new insights that can later be used in applied research.

Applied Research

Applied research investigates well-known theories and principles in order to enhance knowledge around a practical aim. Because of this, applied research focuses on solving real-life problems by deriving knowledge which has an immediate application.

Methods of Research

Research methods for data collection fall into one of two categories: inductive methods or deductive methods.

Inductive research methods focus on the analysis of an observation and are usually associated with qualitative research. Deductive research methods focus on the verification of an observation and are typically associated with quantitative research.

Qualitative Research

Qualitative research is a method that enables non-numerical data collection through open-ended methods such as interviews, case studies and focus groups .

It enables researchers to collect data on personal experiences, feelings or behaviours, as well as the reasons behind them. Because of this, qualitative research is often used in fields such as social science, psychology and philosophy and other areas where it is useful to know the connection between what has occurred and why it has occurred.

Quantitative Research

Quantitative research is a method that collects and analyses numerical data through statistical analysis.

It allows us to quantify variables, uncover relationships, and make generalisations across a larger population. As a result, quantitative research is often used in the natural and physical sciences such as engineering, biology, chemistry, physics, computer science, finance, and medical research, etc.

What does Research Involve?

Research often follows a systematic approach known as a Scientific Method, which is carried out using an hourglass model.

A research project first starts with a problem statement, or rather, the research purpose for engaging in the study. This can take the form of the ‘ scope of the study ’ or ‘ aims and objectives ’ of your research topic.

Subsequently, a literature review is carried out and a hypothesis is formed. The researcher then creates a research methodology and collects the data.

The data is then analysed using various statistical methods and the null hypothesis is either accepted or rejected.

In both cases, the study and its conclusion are officially written up as a report or research paper, and the researcher may also recommend lines of further questioning. The report or research paper is then shared with the wider research community, and the cycle begins all over again.

Although these steps outline the overall research process, keep in mind that research projects are highly dynamic and are therefore considered an iterative process with continued refinements and not a series of fixed stages.

Scientific misconduct can be described as a deviation from the accepted standards of scientific research, study and publication ethics.

The term monotonic relationship is a statistical definition that is used to describe the link between two variables.

Is it really possible to do a PhD while working? The answer is ‘yes’, but it comes with several ‘buts’. Read our post to find out if it’s for you.

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The unit of analysis refers to the main parameter that you’re investigating in your research project or study.

Choosing a good PhD supervisor will be paramount to your success as a PhD student, but what qualities should you be looking for? Read our post to find out.

Chloe is a 2nd year PhD student at Bournemouth University, researching the mental health of postgraduate researchers and is designing interventions that may improve their wellbeing.

Dr Karki gained his PhD in the field of Nuclear and Particle Physics from Ohio University in March 2020. He is currently working as a postdoctoral associate in Prof. Haiyan Gao’s research group in Duke University.

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• Knowledge Base

Methodology

Research Methods | Definitions, Types, Examples

Research methods are specific procedures for collecting and analyzing data. Developing your research methods is an integral part of your research design . When planning your methods, there are two key decisions you will make.

First, decide how you will collect data . Your methods depend on what type of data you need to answer your research question :

• Qualitative vs. quantitative : Will your data take the form of words or numbers?
• Primary vs. secondary : Will you collect original data yourself, or will you use data that has already been collected by someone else?
• Descriptive vs. experimental : Will you take measurements of something as it is, or will you perform an experiment?

Second, decide how you will analyze the data .

• For quantitative data, you can use statistical analysis methods to test relationships between variables.
• For qualitative data, you can use methods such as thematic analysis to interpret patterns and meanings in the data.

Table of contents

Methods for collecting data, examples of data collection methods, methods for analyzing data, examples of data analysis methods, other interesting articles, frequently asked questions about research methods.

Data is the information that you collect for the purposes of answering your research question . The type of data you need depends on the aims of your research.

Qualitative vs. quantitative data

Your choice of qualitative or quantitative data collection depends on the type of knowledge you want to develop.

For questions about ideas, experiences and meanings, or to study something that can’t be described numerically, collect qualitative data .

If you want to develop a more mechanistic understanding of a topic, or your research involves hypothesis testing , collect quantitative data .

You can also take a mixed methods approach , where you use both qualitative and quantitative research methods.

Primary vs. secondary research

Primary research is any original data that you collect yourself for the purposes of answering your research question (e.g. through surveys , observations and experiments ). Secondary research is data that has already been collected by other researchers (e.g. in a government census or previous scientific studies).

If you are exploring a novel research question, you’ll probably need to collect primary data . But if you want to synthesize existing knowledge, analyze historical trends, or identify patterns on a large scale, secondary data might be a better choice.

Descriptive vs. experimental data

In descriptive research , you collect data about your study subject without intervening. The validity of your research will depend on your sampling method .

In experimental research , you systematically intervene in a process and measure the outcome. The validity of your research will depend on your experimental design .

To conduct an experiment, you need to be able to vary your independent variable , precisely measure your dependent variable, and control for confounding variables . If it’s practically and ethically possible, this method is the best choice for answering questions about cause and effect.

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Your data analysis methods will depend on the type of data you collect and how you prepare it for analysis.

Data can often be analyzed both quantitatively and qualitatively. For example, survey responses could be analyzed qualitatively by studying the meanings of responses or quantitatively by studying the frequencies of responses.

Qualitative analysis methods

Qualitative analysis is used to understand words, ideas, and experiences. You can use it to interpret data that was collected:

• From open-ended surveys and interviews , literature reviews , case studies , ethnographies , and other sources that use text rather than numbers.
• Using non-probability sampling methods .

Qualitative analysis tends to be quite flexible and relies on the researcher’s judgement, so you have to reflect carefully on your choices and assumptions and be careful to avoid research bias .

Quantitative analysis methods

Quantitative analysis uses numbers and statistics to understand frequencies, averages and correlations (in descriptive studies) or cause-and-effect relationships (in experiments).

You can use quantitative analysis to interpret data that was collected either:

• During an experiment .
• Using probability sampling methods .

Because the data is collected and analyzed in a statistically valid way, the results of quantitative analysis can be easily standardized and shared among researchers.

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If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Chi square test of independence
• Statistical power
• Descriptive statistics
• Degrees of freedom
• Pearson correlation
• Null hypothesis
• Double-blind study
• Case-control study
• Research ethics
• Data collection
• Hypothesis testing
• Structured interviews

Research bias

• Hawthorne effect
• Unconscious bias
• Recall bias
• Halo effect
• Self-serving bias
• Information bias

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
• If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

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What Is Research, and Why Do People Do It?

• Open Access
• First Online: 03 December 2022

Cite this chapter

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• James Hiebert 6 ,
• Jinfa Cai 7 ,
• Stephen Hwang 7 ,
• Anne K Morris 6 &
• Charles Hohensee 6  

Part of the book series: Research in Mathematics Education ((RME))

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Abstractspiepr Abs1

Every day people do research as they gather information to learn about something of interest. In the scientific world, however, research means something different than simply gathering information. Scientific research is characterized by its careful planning and observing, by its relentless efforts to understand and explain, and by its commitment to learn from everyone else seriously engaged in research. We call this kind of research scientific inquiry and define it as “formulating, testing, and revising hypotheses.” By “hypotheses” we do not mean the hypotheses you encounter in statistics courses. We mean predictions about what you expect to find and rationales for why you made these predictions. Throughout this and the remaining chapters we make clear that the process of scientific inquiry applies to all kinds of research studies and data, both qualitative and quantitative.

You have full access to this open access chapter,  Download chapter PDF

Part I. What Is Research?

Have you ever studied something carefully because you wanted to know more about it? Maybe you wanted to know more about your grandmother’s life when she was younger so you asked her to tell you stories from her childhood, or maybe you wanted to know more about a fertilizer you were about to use in your garden so you read the ingredients on the package and looked them up online. According to the dictionary definition, you were doing research.

Recall your high school assignments asking you to “research” a topic. The assignment likely included consulting a variety of sources that discussed the topic, perhaps including some “original” sources. Often, the teacher referred to your product as a “research paper.”

Were you conducting research when you interviewed your grandmother or wrote high school papers reviewing a particular topic? Our view is that you were engaged in part of the research process, but only a small part. In this book, we reserve the word “research” for what it means in the scientific world, that is, for scientific research or, more pointedly, for scientific inquiry .

Exercise 1.1

Before you read any further, write a definition of what you think scientific inquiry is. Keep it short—Two to three sentences. You will periodically update this definition as you read this chapter and the remainder of the book.

This book is about scientific inquiry—what it is and how to do it. For starters, scientific inquiry is a process, a particular way of finding out about something that involves a number of phases. Each phase of the process constitutes one aspect of scientific inquiry. You are doing scientific inquiry as you engage in each phase, but you have not done scientific inquiry until you complete the full process. Each phase is necessary but not sufficient.

In this chapter, we set the stage by defining scientific inquiry—describing what it is and what it is not—and by discussing what it is good for and why people do it. The remaining chapters build directly on the ideas presented in this chapter.

A first thing to know is that scientific inquiry is not all or nothing. “Scientificness” is a continuum. Inquiries can be more scientific or less scientific. What makes an inquiry more scientific? You might be surprised there is no universally agreed upon answer to this question. None of the descriptors we know of are sufficient by themselves to define scientific inquiry. But all of them give you a way of thinking about some aspects of the process of scientific inquiry. Each one gives you different insights.

Exercise 1.2

As you read about each descriptor below, think about what would make an inquiry more or less scientific. If you think a descriptor is important, use it to revise your definition of scientific inquiry.

Creating an Image of Scientific Inquiry

We will present three descriptors of scientific inquiry. Each provides a different perspective and emphasizes a different aspect of scientific inquiry. We will draw on all three descriptors to compose our definition of scientific inquiry.

Descriptor 1. Experience Carefully Planned in Advance

Sir Ronald Fisher, often called the father of modern statistical design, once referred to research as “experience carefully planned in advance” (1935, p. 8). He said that humans are always learning from experience, from interacting with the world around them. Usually, this learning is haphazard rather than the result of a deliberate process carried out over an extended period of time. Research, Fisher said, was learning from experience, but experience carefully planned in advance.

This phrase can be fully appreciated by looking at each word. The fact that scientific inquiry is based on experience means that it is based on interacting with the world. These interactions could be thought of as the stuff of scientific inquiry. In addition, it is not just any experience that counts. The experience must be carefully planned . The interactions with the world must be conducted with an explicit, describable purpose, and steps must be taken to make the intended learning as likely as possible. This planning is an integral part of scientific inquiry; it is not just a preparation phase. It is one of the things that distinguishes scientific inquiry from many everyday learning experiences. Finally, these steps must be taken beforehand and the purpose of the inquiry must be articulated in advance of the experience. Clearly, scientific inquiry does not happen by accident, by just stumbling into something. Stumbling into something unexpected and interesting can happen while engaged in scientific inquiry, but learning does not depend on it and serendipity does not make the inquiry scientific.

Descriptor 2. Observing Something and Trying to Explain Why It Is the Way It Is

When we were writing this chapter and googled “scientific inquiry,” the first entry was: “Scientific inquiry refers to the diverse ways in which scientists study the natural world and propose explanations based on the evidence derived from their work.” The emphasis is on studying, or observing, and then explaining . This descriptor takes the image of scientific inquiry beyond carefully planned experience and includes explaining what was experienced.

According to the Merriam-Webster dictionary, “explain” means “(a) to make known, (b) to make plain or understandable, (c) to give the reason or cause of, and (d) to show the logical development or relations of” (Merriam-Webster, n.d. ). We will use all these definitions. Taken together, they suggest that to explain an observation means to understand it by finding reasons (or causes) for why it is as it is. In this sense of scientific inquiry, the following are synonyms: explaining why, understanding why, and reasoning about causes and effects. Our image of scientific inquiry now includes planning, observing, and explaining why.

We need to add a final note about this descriptor. We have phrased it in a way that suggests “observing something” means you are observing something in real time—observing the way things are or the way things are changing. This is often true. But, observing could mean observing data that already have been collected, maybe by someone else making the original observations (e.g., secondary analysis of NAEP data or analysis of existing video recordings of classroom instruction). We will address secondary analyses more fully in Chap. 4 . For now, what is important is that the process requires explaining why the data look like they do.

We must note that for us, the term “data” is not limited to numerical or quantitative data such as test scores. Data can also take many nonquantitative forms, including written survey responses, interview transcripts, journal entries, video recordings of students, teachers, and classrooms, text messages, and so forth.

Exercise 1.3

What are the implications of the statement that just “observing” is not enough to count as scientific inquiry? Does this mean that a detailed description of a phenomenon is not scientific inquiry?

Find sources that define research in education that differ with our position, that say description alone, without explanation, counts as scientific research. Identify the precise points where the opinions differ. What are the best arguments for each of the positions? Which do you prefer? Why?

Descriptor 3. Updating Everyone’s Thinking in Response to More and Better Information

This descriptor focuses on a third aspect of scientific inquiry: updating and advancing the field’s understanding of phenomena that are investigated. This descriptor foregrounds a powerful characteristic of scientific inquiry: the reliability (or trustworthiness) of what is learned and the ultimate inevitability of this learning to advance human understanding of phenomena. Humans might choose not to learn from scientific inquiry, but history suggests that scientific inquiry always has the potential to advance understanding and that, eventually, humans take advantage of these new understandings.

Before exploring these bold claims a bit further, note that this descriptor uses “information” in the same way the previous two descriptors used “experience” and “observations.” These are the stuff of scientific inquiry and we will use them often, sometimes interchangeably. Frequently, we will use the term “data” to stand for all these terms.

An overriding goal of scientific inquiry is for everyone to learn from what one scientist does. Much of this book is about the methods you need to use so others have faith in what you report and can learn the same things you learned. This aspect of scientific inquiry has many implications.

One implication is that scientific inquiry is not a private practice. It is a public practice available for others to see and learn from. Notice how different this is from everyday learning. When you happen to learn something from your everyday experience, often only you gain from the experience. The fact that research is a public practice means it is also a social one. It is best conducted by interacting with others along the way: soliciting feedback at each phase, taking opportunities to present work-in-progress, and benefitting from the advice of others.

A second implication is that you, as the researcher, must be committed to sharing what you are doing and what you are learning in an open and transparent way. This allows all phases of your work to be scrutinized and critiqued. This is what gives your work credibility. The reliability or trustworthiness of your findings depends on your colleagues recognizing that you have used all appropriate methods to maximize the chances that your claims are justified by the data.

A third implication of viewing scientific inquiry as a collective enterprise is the reverse of the second—you must be committed to receiving comments from others. You must treat your colleagues as fair and honest critics even though it might sometimes feel otherwise. You must appreciate their job, which is to remain skeptical while scrutinizing what you have done in considerable detail. To provide the best help to you, they must remain skeptical about your conclusions (when, for example, the data are difficult for them to interpret) until you offer a convincing logical argument based on the information you share. A rather harsh but good-to-remember statement of the role of your friendly critics was voiced by Karl Popper, a well-known twentieth century philosopher of science: “. . . if you are interested in the problem which I tried to solve by my tentative assertion, you may help me by criticizing it as severely as you can” (Popper, 1968, p. 27).

A final implication of this third descriptor is that, as someone engaged in scientific inquiry, you have no choice but to update your thinking when the data support a different conclusion. This applies to your own data as well as to those of others. When data clearly point to a specific claim, even one that is quite different than you expected, you must reconsider your position. If the outcome is replicated multiple times, you need to adjust your thinking accordingly. Scientific inquiry does not let you pick and choose which data to believe; it mandates that everyone update their thinking when the data warrant an update.

Doing Scientific Inquiry

We define scientific inquiry in an operational sense—what does it mean to do scientific inquiry? What kind of process would satisfy all three descriptors: carefully planning an experience in advance; observing and trying to explain what you see; and, contributing to updating everyone’s thinking about an important phenomenon?

We define scientific inquiry as formulating , testing , and revising hypotheses about phenomena of interest.

Of course, we are not the only ones who define it in this way. The definition for the scientific method posted by the editors of Britannica is: “a researcher develops a hypothesis, tests it through various means, and then modifies the hypothesis on the basis of the outcome of the tests and experiments” (Britannica, n.d. ).

Notice how defining scientific inquiry this way satisfies each of the descriptors. “Carefully planning an experience in advance” is exactly what happens when formulating a hypothesis about a phenomenon of interest and thinking about how to test it. “ Observing a phenomenon” occurs when testing a hypothesis, and “ explaining ” what is found is required when revising a hypothesis based on the data. Finally, “updating everyone’s thinking” comes from comparing publicly the original with the revised hypothesis.

Doing scientific inquiry, as we have defined it, underscores the value of accumulating knowledge rather than generating random bits of knowledge. Formulating, testing, and revising hypotheses is an ongoing process, with each revised hypothesis begging for another test, whether by the same researcher or by new researchers. The editors of Britannica signaled this cyclic process by adding the following phrase to their definition of the scientific method: “The modified hypothesis is then retested, further modified, and tested again.” Scientific inquiry creates a process that encourages each study to build on the studies that have gone before. Through collective engagement in this process of building study on top of study, the scientific community works together to update its thinking.

Before exploring more fully the meaning of “formulating, testing, and revising hypotheses,” we need to acknowledge that this is not the only way researchers define research. Some researchers prefer a less formal definition, one that includes more serendipity, less planning, less explanation. You might have come across more open definitions such as “research is finding out about something.” We prefer the tighter hypothesis formulation, testing, and revision definition because we believe it provides a single, coherent map for conducting research that addresses many of the thorny problems educational researchers encounter. We believe it is the most useful orientation toward research and the most helpful to learn as a beginning researcher.

A final clarification of our definition is that it applies equally to qualitative and quantitative research. This is a familiar distinction in education that has generated much discussion. You might think our definition favors quantitative methods over qualitative methods because the language of hypothesis formulation and testing is often associated with quantitative methods. In fact, we do not favor one method over another. In Chap. 4 , we will illustrate how our definition fits research using a range of quantitative and qualitative methods.

Exercise 1.4

Look for ways to extend what the field knows in an area that has already received attention by other researchers. Specifically, you can search for a program of research carried out by more experienced researchers that has some revised hypotheses that remain untested. Identify a revised hypothesis that you might like to test.

Unpacking the Terms Formulating, Testing, and Revising Hypotheses

To get a full sense of the definition of scientific inquiry we will use throughout this book, it is helpful to spend a little time with each of the key terms.

We first want to make clear that we use the term “hypothesis” as it is defined in most dictionaries and as it used in many scientific fields rather than as it is usually defined in educational statistics courses. By “hypothesis,” we do not mean a null hypothesis that is accepted or rejected by statistical analysis. Rather, we use “hypothesis” in the sense conveyed by the following definitions: “An idea or explanation for something that is based on known facts but has not yet been proved” (Cambridge University Press, n.d. ), and “An unproved theory, proposition, or supposition, tentatively accepted to explain certain facts and to provide a basis for further investigation or argument” (Agnes & Guralnik, 2008 ).

We distinguish two parts to “hypotheses.” Hypotheses consist of predictions and rationales . Predictions are statements about what you expect to find when you inquire about something. Rationales are explanations for why you made the predictions you did, why you believe your predictions are correct. So, for us “formulating hypotheses” means making explicit predictions and developing rationales for the predictions.

“Testing hypotheses” means making observations that allow you to assess in what ways your predictions were correct and in what ways they were incorrect. In education research, it is rarely useful to think of your predictions as either right or wrong. Because of the complexity of most issues you will investigate, most predictions will be right in some ways and wrong in others.

By studying the observations you make (data you collect) to test your hypotheses, you can revise your hypotheses to better align with the observations. This means revising your predictions plus revising your rationales to justify your adjusted predictions. Even though you might not run another test, formulating revised hypotheses is an essential part of conducting a research study. Comparing your original and revised hypotheses informs everyone of what you learned by conducting your study. In addition, a revised hypothesis sets the stage for you or someone else to extend your study and accumulate more knowledge of the phenomenon.

We should note that not everyone makes a clear distinction between predictions and rationales as two aspects of hypotheses. In fact, common, non-scientific uses of the word “hypothesis” may limit it to only a prediction or only an explanation (or rationale). We choose to explicitly include both prediction and rationale in our definition of hypothesis, not because we assert this should be the universal definition, but because we want to foreground the importance of both parts acting in concert. Using “hypothesis” to represent both prediction and rationale could hide the two aspects, but we make them explicit because they provide different kinds of information. It is usually easier to make predictions than develop rationales because predictions can be guesses, hunches, or gut feelings about which you have little confidence. Developing a compelling rationale requires careful thought plus reading what other researchers have found plus talking with your colleagues. Often, while you are developing your rationale you will find good reasons to change your predictions. Developing good rationales is the engine that drives scientific inquiry. Rationales are essentially descriptions of how much you know about the phenomenon you are studying. Throughout this guide, we will elaborate on how developing good rationales drives scientific inquiry. For now, we simply note that it can sharpen your predictions and help you to interpret your data as you test your hypotheses.

Hypotheses in education research take a variety of forms or types. This is because there are a variety of phenomena that can be investigated. Investigating educational phenomena is sometimes best done using qualitative methods, sometimes using quantitative methods, and most often using mixed methods (e.g., Hay, 2016 ; Weis et al. 2019a ; Weisner, 2005 ). This means that, given our definition, hypotheses are equally applicable to qualitative and quantitative investigations.

Hypotheses take different forms when they are used to investigate different kinds of phenomena. Two very different activities in education could be labeled conducting experiments and descriptions. In an experiment, a hypothesis makes a prediction about anticipated changes, say the changes that occur when a treatment or intervention is applied. You might investigate how students’ thinking changes during a particular kind of instruction.

A second type of hypothesis, relevant for descriptive research, makes a prediction about what you will find when you investigate and describe the nature of a situation. The goal is to understand a situation as it exists rather than to understand a change from one situation to another. In this case, your prediction is what you expect to observe. Your rationale is the set of reasons for making this prediction; it is your current explanation for why the situation will look like it does.

You will probably read, if you have not already, that some researchers say you do not need a prediction to conduct a descriptive study. We will discuss this point of view in Chap. 2 . For now, we simply claim that scientific inquiry, as we have defined it, applies to all kinds of research studies. Descriptive studies, like others, not only benefit from formulating, testing, and revising hypotheses, but also need hypothesis formulating, testing, and revising.

One reason we define research as formulating, testing, and revising hypotheses is that if you think of research in this way you are less likely to go wrong. It is a useful guide for the entire process, as we will describe in detail in the chapters ahead. For example, as you build the rationale for your predictions, you are constructing the theoretical framework for your study (Chap. 3 ). As you work out the methods you will use to test your hypothesis, every decision you make will be based on asking, “Will this help me formulate or test or revise my hypothesis?” (Chap. 4 ). As you interpret the results of testing your predictions, you will compare them to what you predicted and examine the differences, focusing on how you must revise your hypotheses (Chap. 5 ). By anchoring the process to formulating, testing, and revising hypotheses, you will make smart decisions that yield a coherent and well-designed study.

Exercise 1.5

Compare the concept of formulating, testing, and revising hypotheses with the descriptions of scientific inquiry contained in Scientific Research in Education (NRC, 2002 ). How are they similar or different?

Exercise 1.6

Provide an example to illustrate and emphasize the differences between everyday learning/thinking and scientific inquiry.

Learning from Doing Scientific Inquiry

We noted earlier that a measure of what you have learned by conducting a research study is found in the differences between your original hypothesis and your revised hypothesis based on the data you collected to test your hypothesis. We will elaborate this statement in later chapters, but we preview our argument here.

Even before collecting data, scientific inquiry requires cycles of making a prediction, developing a rationale, refining your predictions, reading and studying more to strengthen your rationale, refining your predictions again, and so forth. And, even if you have run through several such cycles, you still will likely find that when you test your prediction you will be partly right and partly wrong. The results will support some parts of your predictions but not others, or the results will “kind of” support your predictions. A critical part of scientific inquiry is making sense of your results by interpreting them against your predictions. Carefully describing what aspects of your data supported your predictions, what aspects did not, and what data fell outside of any predictions is not an easy task, but you cannot learn from your study without doing this analysis.

Analyzing the matches and mismatches between your predictions and your data allows you to formulate different rationales that would have accounted for more of the data. The best revised rationale is the one that accounts for the most data. Once you have revised your rationales, you can think about the predictions they best justify or explain. It is by comparing your original rationales to your new rationales that you can sort out what you learned from your study.

Suppose your study was an experiment. Maybe you were investigating the effects of a new instructional intervention on students’ learning. Your original rationale was your explanation for why the intervention would change the learning outcomes in a particular way. Your revised rationale explained why the changes that you observed occurred like they did and why your revised predictions are better. Maybe your original rationale focused on the potential of the activities if they were implemented in ideal ways and your revised rationale included the factors that are likely to affect how teachers implement them. By comparing the before and after rationales, you are describing what you learned—what you can explain now that you could not before. Another way of saying this is that you are describing how much more you understand now than before you conducted your study.

Revised predictions based on carefully planned and collected data usually exhibit some of the following features compared with the originals: more precision, more completeness, and broader scope. Revised rationales have more explanatory power and become more complete, more aligned with the new predictions, sharper, and overall more convincing.

Part II. Why Do Educators Do Research?

Doing scientific inquiry is a lot of work. Each phase of the process takes time, and you will often cycle back to improve earlier phases as you engage in later phases. Because of the significant effort required, you should make sure your study is worth it. So, from the beginning, you should think about the purpose of your study. Why do you want to do it? And, because research is a social practice, you should also think about whether the results of your study are likely to be important and significant to the education community.

If you are doing research in the way we have described—as scientific inquiry—then one purpose of your study is to understand , not just to describe or evaluate or report. As we noted earlier, when you formulate hypotheses, you are developing rationales that explain why things might be like they are. In our view, trying to understand and explain is what separates research from other kinds of activities, like evaluating or describing.

One reason understanding is so important is that it allows researchers to see how or why something works like it does. When you see how something works, you are better able to predict how it might work in other contexts, under other conditions. And, because conditions, or contextual factors, matter a lot in education, gaining insights into applying your findings to other contexts increases the contributions of your work and its importance to the broader education community.

Consequently, the purposes of research studies in education often include the more specific aim of identifying and understanding the conditions under which the phenomena being studied work like the observations suggest. A classic example of this kind of study in mathematics education was reported by William Brownell and Harold Moser in 1949 . They were trying to establish which method of subtracting whole numbers could be taught most effectively—the regrouping method or the equal additions method. However, they realized that effectiveness might depend on the conditions under which the methods were taught—“meaningfully” versus “mechanically.” So, they designed a study that crossed the two instructional approaches with the two different methods (regrouping and equal additions). Among other results, they found that these conditions did matter. The regrouping method was more effective under the meaningful condition than the mechanical condition, but the same was not true for the equal additions algorithm.

What do education researchers want to understand? In our view, the ultimate goal of education is to offer all students the best possible learning opportunities. So, we believe the ultimate purpose of scientific inquiry in education is to develop understanding that supports the improvement of learning opportunities for all students. We say “ultimate” because there are lots of issues that must be understood to improve learning opportunities for all students. Hypotheses about many aspects of education are connected, ultimately, to students’ learning. For example, formulating and testing a hypothesis that preservice teachers need to engage in particular kinds of activities in their coursework in order to teach particular topics well is, ultimately, connected to improving students’ learning opportunities. So is hypothesizing that school districts often devote relatively few resources to instructional leadership training or hypothesizing that positioning mathematics as a tool students can use to combat social injustice can help students see the relevance of mathematics to their lives.

We do not exclude the importance of research on educational issues more removed from improving students’ learning opportunities, but we do think the argument for their importance will be more difficult to make. If there is no way to imagine a connection between your hypothesis and improving learning opportunities for students, even a distant connection, we recommend you reconsider whether it is an important hypothesis within the education community.

Notice that we said the ultimate goal of education is to offer all students the best possible learning opportunities. For too long, educators have been satisfied with a goal of offering rich learning opportunities for lots of students, sometimes even for just the majority of students, but not necessarily for all students. Evaluations of success often are based on outcomes that show high averages. In other words, if many students have learned something, or even a smaller number have learned a lot, educators may have been satisfied. The problem is that there is usually a pattern in the groups of students who receive lower quality opportunities—students of color and students who live in poor areas, urban and rural. This is not acceptable. Consequently, we emphasize the premise that the purpose of education research is to offer rich learning opportunities to all students.

One way to make sure you will be able to convince others of the importance of your study is to consider investigating some aspect of teachers’ shared instructional problems. Historically, researchers in education have set their own research agendas, regardless of the problems teachers are facing in schools. It is increasingly recognized that teachers have had trouble applying to their own classrooms what researchers find. To address this problem, a researcher could partner with a teacher—better yet, a small group of teachers—and talk with them about instructional problems they all share. These discussions can create a rich pool of problems researchers can consider. If researchers pursued one of these problems (preferably alongside teachers), the connection to improving learning opportunities for all students could be direct and immediate. “Grounding a research question in instructional problems that are experienced across multiple teachers’ classrooms helps to ensure that the answer to the question will be of sufficient scope to be relevant and significant beyond the local context” (Cai et al., 2019b , p. 115).

As a beginning researcher, determining the relevance and importance of a research problem is especially challenging. We recommend talking with advisors, other experienced researchers, and peers to test the educational importance of possible research problems and topics of study. You will also learn much more about the issue of research importance when you read Chap. 5 .

Exercise 1.7

Identify a problem in education that is closely connected to improving learning opportunities and a problem that has a less close connection. For each problem, write a brief argument (like a logical sequence of if-then statements) that connects the problem to all students’ learning opportunities.

Part III. Conducting Research as a Practice of Failing Productively

Scientific inquiry involves formulating hypotheses about phenomena that are not fully understood—by you or anyone else. Even if you are able to inform your hypotheses with lots of knowledge that has already been accumulated, you are likely to find that your prediction is not entirely accurate. This is normal. Remember, scientific inquiry is a process of constantly updating your thinking. More and better information means revising your thinking, again, and again, and again. Because you never fully understand a complicated phenomenon and your hypotheses never produce completely accurate predictions, it is easy to believe you are somehow failing.

The trick is to fail upward, to fail to predict accurately in ways that inform your next hypothesis so you can make a better prediction. Some of the best-known researchers in education have been open and honest about the many times their predictions were wrong and, based on the results of their studies and those of others, they continuously updated their thinking and changed their hypotheses.

A striking example of publicly revising (actually reversing) hypotheses due to incorrect predictions is found in the work of Lee J. Cronbach, one of the most distinguished educational psychologists of the twentieth century. In 1955, Cronbach delivered his presidential address to the American Psychological Association. Titling it “Two Disciplines of Scientific Psychology,” Cronbach proposed a rapprochement between two research approaches—correlational studies that focused on individual differences and experimental studies that focused on instructional treatments controlling for individual differences. (We will examine different research approaches in Chap. 4 ). If these approaches could be brought together, reasoned Cronbach ( 1957 ), researchers could find interactions between individual characteristics and treatments (aptitude-treatment interactions or ATIs), fitting the best treatments to different individuals.

In 1975, after years of research by many researchers looking for ATIs, Cronbach acknowledged the evidence for simple, useful ATIs had not been found. Even when trying to find interactions between a few variables that could provide instructional guidance, the analysis, said Cronbach, creates “a hall of mirrors that extends to infinity, tormenting even the boldest investigators and defeating even ambitious designs” (Cronbach, 1975 , p. 119).

As he was reflecting back on his work, Cronbach ( 1986 ) recommended moving away from documenting instructional effects through statistical inference (an approach he had championed for much of his career) and toward approaches that probe the reasons for these effects, approaches that provide a “full account of events in a time, place, and context” (Cronbach, 1986 , p. 104). This is a remarkable change in hypotheses, a change based on data and made fully transparent. Cronbach understood the value of failing productively.

Closer to home, in a less dramatic example, one of us began a line of scientific inquiry into how to prepare elementary preservice teachers to teach early algebra. Teaching early algebra meant engaging elementary students in early forms of algebraic reasoning. Such reasoning should help them transition from arithmetic to algebra. To begin this line of inquiry, a set of activities for preservice teachers were developed. Even though the activities were based on well-supported hypotheses, they largely failed to engage preservice teachers as predicted because of unanticipated challenges the preservice teachers faced. To capitalize on this failure, follow-up studies were conducted, first to better understand elementary preservice teachers’ challenges with preparing to teach early algebra, and then to better support preservice teachers in navigating these challenges. In this example, the initial failure was a necessary step in the researchers’ scientific inquiry and furthered the researchers’ understanding of this issue.

We present another example of failing productively in Chap. 2 . That example emerges from recounting the history of a well-known research program in mathematics education.

Making mistakes is an inherent part of doing scientific research. Conducting a study is rarely a smooth path from beginning to end. We recommend that you keep the following things in mind as you begin a career of conducting research in education.

First, do not get discouraged when you make mistakes; do not fall into the trap of feeling like you are not capable of doing research because you make too many errors.

Second, learn from your mistakes. Do not ignore your mistakes or treat them as errors that you simply need to forget and move past. Mistakes are rich sites for learning—in research just as in other fields of study.

Third, by reflecting on your mistakes, you can learn to make better mistakes, mistakes that inform you about a productive next step. You will not be able to eliminate your mistakes, but you can set a goal of making better and better mistakes.

Exercise 1.8

How does scientific inquiry differ from everyday learning in giving you the tools to fail upward? You may find helpful perspectives on this question in other resources on science and scientific inquiry (e.g., Failure: Why Science is So Successful by Firestein, 2015).

Exercise 1.9

Use what you have learned in this chapter to write a new definition of scientific inquiry. Compare this definition with the one you wrote before reading this chapter. If you are reading this book as part of a course, compare your definition with your colleagues’ definitions. Develop a consensus definition with everyone in the course.

Part IV. Preview of Chap. 2

Now that you have a good idea of what research is, at least of what we believe research is, the next step is to think about how to actually begin doing research. This means how to begin formulating, testing, and revising hypotheses. As for all phases of scientific inquiry, there are lots of things to think about. Because it is critical to start well, we devote Chap. 2 to getting started with formulating hypotheses.

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Hiebert, J., Cai, J., Hwang, S., Morris, A.K., Hohensee, C. (2023). What Is Research, and Why Do People Do It?. In: Doing Research: A New Researcher’s Guide. Research in Mathematics Education. Springer, Cham. https://doi.org/10.1007/978-3-031-19078-0_1

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11.1 The Purpose of Research Writing

Learning objectives.

• Identify reasons to research writing projects.
• Outline the steps of the research writing process.

Why was the Great Wall of China built? What have scientists learned about the possibility of life on Mars? What roles did women play in the American Revolution? How does the human brain create, store, and retrieve memories? Who invented the game of football, and how has it changed over the years?

You may know the answers to these questions off the top of your head. If you are like most people, however, you find answers to tough questions like these by searching the Internet, visiting the library, or asking others for information. To put it simply, you perform research.

Whether you are a scientist, an artist, a paralegal, or a parent, you probably perform research in your everyday life. When your boss, your instructor, or a family member asks you a question that you do not know the answer to, you locate relevant information, analyze your findings, and share your results. Locating, analyzing, and sharing information are key steps in the research process, and in this chapter, you will learn more about each step. By developing your research writing skills, you will prepare yourself to answer any question no matter how challenging.

Reasons for Research

When you perform research, you are essentially trying to solve a mystery—you want to know how something works or why something happened. In other words, you want to answer a question that you (and other people) have about the world. This is one of the most basic reasons for performing research.

But the research process does not end when you have solved your mystery. Imagine what would happen if a detective collected enough evidence to solve a criminal case, but she never shared her solution with the authorities. Presenting what you have learned from research can be just as important as performing the research. Research results can be presented in a variety of ways, but one of the most popular—and effective—presentation forms is the research paper . A research paper presents an original thesis, or purpose statement, about a topic and develops that thesis with information gathered from a variety of sources.

If you are curious about the possibility of life on Mars, for example, you might choose to research the topic. What will you do, though, when your research is complete? You will need a way to put your thoughts together in a logical, coherent manner. You may want to use the facts you have learned to create a narrative or to support an argument. And you may want to show the results of your research to your friends, your teachers, or even the editors of magazines and journals. Writing a research paper is an ideal way to organize thoughts, craft narratives or make arguments based on research, and share your newfound knowledge with the world.

Write a paragraph about a time when you used research in your everyday life. Did you look for the cheapest way to travel from Houston to Denver? Did you search for a way to remove gum from the bottom of your shoe? In your paragraph, explain what you wanted to research, how you performed the research, and what you learned as a result.

Research Writing and the Academic Paper

No matter what field of study you are interested in, you will most likely be asked to write a research paper during your academic career. For example, a student in an art history course might write a research paper about an artist’s work. Similarly, a student in a psychology course might write a research paper about current findings in childhood development.

Having to write a research paper may feel intimidating at first. After all, researching and writing a long paper requires a lot of time, effort, and organization. However, writing a research paper can also be a great opportunity to explore a topic that is particularly interesting to you. The research process allows you to gain expertise on a topic of your choice, and the writing process helps you remember what you have learned and understand it on a deeper level.

Research Writing at Work

Knowing how to write a good research paper is a valuable skill that will serve you well throughout your career. Whether you are developing a new product, studying the best way to perform a procedure, or learning about challenges and opportunities in your field of employment, you will use research techniques to guide your exploration. You may even need to create a written report of your findings. And because effective communication is essential to any company, employers seek to hire people who can write clearly and professionally.

Writing at Work

Take a few minutes to think about each of the following careers. How might each of these professionals use researching and research writing skills on the job?

• Medical laboratory technician
• Small business owner
• Information technology professional
• Freelance magazine writer

A medical laboratory technician or information technology professional might do research to learn about the latest technological developments in either of these fields. A small business owner might conduct research to learn about the latest trends in his or her industry. A freelance magazine writer may need to research a given topic to write an informed, up-to-date article.

Think about the job of your dreams. How might you use research writing skills to perform that job? Create a list of ways in which strong researching, organizing, writing, and critical thinking skills could help you succeed at your dream job. How might these skills help you obtain that job?

Steps of the Research Writing Process

How does a research paper grow from a folder of brainstormed notes to a polished final draft? No two projects are identical, but most projects follow a series of six basic steps.

These are the steps in the research writing process:

• Choose a topic.
• Plan and schedule time to research and write.
• Conduct research.
• Organize research and ideas.
• Draft your paper.
• Revise and edit your paper.

Each of these steps will be discussed in more detail later in this chapter. For now, though, we will take a brief look at what each step involves.

Step 1: Choosing a Topic

As you may recall from Chapter 8 “The Writing Process: How Do I Begin?” , to narrow the focus of your topic, you may try freewriting exercises, such as brainstorming. You may also need to ask a specific research question —a broad, open-ended question that will guide your research—as well as propose a possible answer, or a working thesis . You may use your research question and your working thesis to create a research proposal . In a research proposal, you present your main research question, any related subquestions you plan to explore, and your working thesis.

Step 2: Planning and Scheduling

Before you start researching your topic, take time to plan your researching and writing schedule. Research projects can take days, weeks, or even months to complete. Creating a schedule is a good way to ensure that you do not end up being overwhelmed by all the work you have to do as the deadline approaches.

During this step of the process, it is also a good idea to plan the resources and organizational tools you will use to keep yourself on track throughout the project. Flowcharts, calendars, and checklists can all help you stick to your schedule. See Chapter 11 “Writing from Research: What Will I Learn?” , Section 11.2 “Steps in Developing a Research Proposal” for an example of a research schedule.

Step 3: Conducting Research

When going about your research, you will likely use a variety of sources—anything from books and periodicals to video presentations and in-person interviews.

Your sources will include both primary sources and secondary sources . Primary sources provide firsthand information or raw data. For example, surveys, in-person interviews, and historical documents are primary sources. Secondary sources, such as biographies, literary reviews, or magazine articles, include some analysis or interpretation of the information presented. As you conduct research, you will take detailed, careful notes about your discoveries. You will also evaluate the reliability of each source you find.

Step 4: Organizing Research and the Writer’s Ideas

When your research is complete, you will organize your findings and decide which sources to cite in your paper. You will also have an opportunity to evaluate the evidence you have collected and determine whether it supports your thesis, or the focus of your paper. You may decide to adjust your thesis or conduct additional research to ensure that your thesis is well supported.

Remember, your working thesis is not set in stone. You can and should change your working thesis throughout the research writing process if the evidence you find does not support your original thesis. Never try to force evidence to fit your argument. For example, your working thesis is “Mars cannot support life-forms.” Yet, a week into researching your topic, you find an article in the New York Times detailing new findings of bacteria under the Martian surface. Instead of trying to argue that bacteria are not life forms, you might instead alter your thesis to “Mars cannot support complex life-forms.”

Step 5: Drafting Your Paper

Now you are ready to combine your research findings with your critical analysis of the results in a rough draft. You will incorporate source materials into your paper and discuss each source thoughtfully in relation to your thesis or purpose statement.

When you cite your reference sources, it is important to pay close attention to standard conventions for citing sources in order to avoid plagiarism , or the practice of using someone else’s words without acknowledging the source. Later in this chapter, you will learn how to incorporate sources in your paper and avoid some of the most common pitfalls of attributing information.

Step 6: Revising and Editing Your Paper

In the final step of the research writing process, you will revise and polish your paper. You might reorganize your paper’s structure or revise for unity and cohesion, ensuring that each element in your paper flows into the next logically and naturally. You will also make sure that your paper uses an appropriate and consistent tone.

Once you feel confident in the strength of your writing, you will edit your paper for proper spelling, grammar, punctuation, mechanics, and formatting. When you complete this final step, you will have transformed a simple idea or question into a thoroughly researched and well-written paper you can be proud of!

Review the steps of the research writing process. Then answer the questions on your own sheet of paper.

• In which steps of the research writing process are you allowed to change your thesis?
• In step 2, which types of information should you include in your project schedule?
• What might happen if you eliminated step 4 from the research writing process?

Key Takeaways

• People undertake research projects throughout their academic and professional careers in order to answer specific questions, share their findings with others, increase their understanding of challenging topics, and strengthen their researching, writing, and analytical skills.
• The research writing process generally comprises six steps: choosing a topic, scheduling and planning time for research and writing, conducting research, organizing research and ideas, drafting a paper, and revising and editing the paper.

Writing for Success Copyright © 2015 by University of Minnesota is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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Purpose of Research – Objectives and Applications

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Purpose of Research

Definition:

The purpose of research is to systematically investigate and gather information on a particular topic or issue, with the aim of answering questions, solving problems, or advancing knowledge.

The purpose of research can vary depending on the field of study, the research question, and the intended audience. In general, research can be used to:

• Generate new knowledge and theories
• Test existing theories or hypotheses
• Identify trends or patterns
• Gather information for decision-making
• Evaluate the effectiveness of programs, policies, or interventions
• Develop new technologies or products
• Identify new opportunities or areas for further study.

Objectives of Research

The objectives of research may vary depending on the field of study and the specific research question being investigated. However, some common objectives of research include:

• To explore and describe a phenomenon: Research can be conducted to describe and understand a phenomenon or situation in greater detail.
• To test a hypothesis or theory : Research can be used to test a specific hypothesis or theory by collecting and analyzing data.
• To identify patterns or trends: Research can be conducted to identify patterns or trends in data, which can provide insights into the behavior of a system or population.
• To evaluate a program or intervention: Research can be used to evaluate the effectiveness of a program or intervention, such as a new drug or educational intervention.
• To develop new knowledge or technology : Research can be conducted to develop new knowledge or technologies that can be applied to solve practical problems.
• To inform policy decisions: Research can provide evidence to inform policy decisions and improve public policy.
• To improve existing knowledge: Research can be conducted to improve existing knowledge and fill gaps in the current understanding of a topic.

Applications of Research

Research has a wide range of applications across various fields and industries. Here are some examples:

• Medicine : Research is critical in developing new treatments and drugs for diseases. Researchers conduct clinical trials to test the safety and efficacy of new medications and therapies. They also study the underlying causes of diseases to find new ways to prevent or treat them.
• Technology : Research is crucial in developing new technologies and improving existing ones. Researchers work to develop new software, hardware, and other technological innovations that can be used in various industries such as healthcare, manufacturing, and telecommunications.
• Education : Research is essential in the field of education to develop new teaching methods and strategies. Researchers conduct studies to determine the effectiveness of various educational approaches and to identify factors that influence student learning.
• Business : Research is critical in helping businesses make informed decisions. Market research can help businesses understand their target audience and identify trends in the market. Research can also help businesses improve their products and services.
• Environmental Science : Research is crucial in the field of environmental science to understand the impact of human activities on the environment. Researchers conduct studies to identify ways to reduce pollution, protect natural resources, and mitigate the effects of climate change.

Goal of Research

The ultimate goal of research is to advance our understanding of the world and to contribute to the development of new theories, ideas, and technologies that can be used to improve our lives. Some more common Goals are follows:

• Explore and discover new knowledge : Research can help uncover new information and insights that were previously unknown.
• Test hypotheses and theories : Research can be used to test and validate theories and hypotheses, allowing researchers to refine and develop their ideas.
• Solve practical problems: Research can be used to identify solutions to real-world problems and to inform policy and decision-making.
• Improve understanding : Research can help improve our understanding of complex phenomena and systems, such as the human body, the natural world, and social systems.
• Develop new technologies and innovations : Research can lead to the development of new technologies, products, and innovations that can improve our lives and society.
• Contribute to the development of academic fields : Research can help advance academic fields by expanding our knowledge and understanding of important topics and areas of inquiry.

Importance of Research

The importance of research lies in its ability to generate new knowledge and insights, to test existing theories and ideas, and to solve practical problems.

Some of the key reasons why research is important are:

• Advancing knowledge: Research is essential for advancing knowledge and understanding in various fields. It enables us to explore and discover new concepts, ideas, and phenomena that can contribute to scientific and technological progress.
• Solving problems : Research can help identify and solve practical problems and challenges in various domains, such as health care, agriculture, engineering, and social policy.
• Innovation : Research is a critical driver of innovation, as it enables the development of new products, services, and technologies that can improve people’s lives and contribute to economic growth.
• Evidence-based decision-making : Research provides evidence and data that can inform decision-making in various fields, such as policy-making, business strategy, and healthcare.
• Personal and professional development : Engaging in research can also contribute to personal and professional development, as it requires critical thinking, problem-solving, and communication skills.

When to use Research

Research should be used in situations where there is a need to gather new information, test existing theories, or solve problems. Some common scenarios where research is often used include:

• Scientific inquiry : Research is essential for advancing scientific knowledge and understanding, and for exploring new concepts, theories, and phenomena.
• Business and market analysis: Research is critical for businesses to gather data and insights about the market, customer preferences, and competition, to inform decision-making and strategy development.
• Social policy and public administration: Research is often used in social policy and public administration to evaluate the effectiveness of programs and policies, and to identify areas where improvements are needed.
• Healthcare: Research is essential in healthcare to develop new treatments, improve existing ones, and to understand the causes and mechanisms of diseases.
• Education : Research is critical in education to evaluate the effectiveness of teaching methods and programs, and to develop new approaches to learning.

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A Practical Guide to Writing Quantitative and Qualitative Research Questions and Hypotheses in Scholarly Articles

Edward barroga.

1 Department of General Education, Graduate School of Nursing Science, St. Luke’s International University, Tokyo, Japan.

Glafera Janet Matanguihan

2 Department of Biological Sciences, Messiah University, Mechanicsburg, PA, USA.

The development of research questions and the subsequent hypotheses are prerequisites to defining the main research purpose and specific objectives of a study. Consequently, these objectives determine the study design and research outcome. The development of research questions is a process based on knowledge of current trends, cutting-edge studies, and technological advances in the research field. Excellent research questions are focused and require a comprehensive literature search and in-depth understanding of the problem being investigated. Initially, research questions may be written as descriptive questions which could be developed into inferential questions. These questions must be specific and concise to provide a clear foundation for developing hypotheses. Hypotheses are more formal predictions about the research outcomes. These specify the possible results that may or may not be expected regarding the relationship between groups. Thus, research questions and hypotheses clarify the main purpose and specific objectives of the study, which in turn dictate the design of the study, its direction, and outcome. Studies developed from good research questions and hypotheses will have trustworthy outcomes with wide-ranging social and health implications.

INTRODUCTION

Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses. 1 , 2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results. 3 , 4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the inception of novel studies and the ethical testing of ideas. 5 , 6

It is crucial to have knowledge of both quantitative and qualitative research 2 as both types of research involve writing research questions and hypotheses. 7 However, these crucial elements of research are sometimes overlooked; if not overlooked, then framed without the forethought and meticulous attention it needs. Planning and careful consideration are needed when developing quantitative or qualitative research, particularly when conceptualizing research questions and hypotheses. 4

There is a continuing need to support researchers in the creation of innovative research questions and hypotheses, as well as for journal articles that carefully review these elements. 1 When research questions and hypotheses are not carefully thought of, unethical studies and poor outcomes usually ensue. Carefully formulated research questions and hypotheses define well-founded objectives, which in turn determine the appropriate design, course, and outcome of the study. This article then aims to discuss in detail the various aspects of crafting research questions and hypotheses, with the goal of guiding researchers as they develop their own. Examples from the authors and peer-reviewed scientific articles in the healthcare field are provided to illustrate key points.

DEFINITIONS AND RELATIONSHIP OF RESEARCH QUESTIONS AND HYPOTHESES

A research question is what a study aims to answer after data analysis and interpretation. The answer is written in length in the discussion section of the paper. Thus, the research question gives a preview of the different parts and variables of the study meant to address the problem posed in the research question. 1 An excellent research question clarifies the research writing while facilitating understanding of the research topic, objective, scope, and limitations of the study. 5

On the other hand, a research hypothesis is an educated statement of an expected outcome. This statement is based on background research and current knowledge. 8 , 9 The research hypothesis makes a specific prediction about a new phenomenon 10 or a formal statement on the expected relationship between an independent variable and a dependent variable. 3 , 11 It provides a tentative answer to the research question to be tested or explored. 4

Hypotheses employ reasoning to predict a theory-based outcome. 10 These can also be developed from theories by focusing on components of theories that have not yet been observed. 10 The validity of hypotheses is often based on the testability of the prediction made in a reproducible experiment. 8

Conversely, hypotheses can also be rephrased as research questions. Several hypotheses based on existing theories and knowledge may be needed to answer a research question. Developing ethical research questions and hypotheses creates a research design that has logical relationships among variables. These relationships serve as a solid foundation for the conduct of the study. 4 , 11 Haphazardly constructed research questions can result in poorly formulated hypotheses and improper study designs, leading to unreliable results. Thus, the formulations of relevant research questions and verifiable hypotheses are crucial when beginning research. 12

CHARACTERISTICS OF GOOD RESEARCH QUESTIONS AND HYPOTHESES

Excellent research questions are specific and focused. These integrate collective data and observations to confirm or refute the subsequent hypotheses. Well-constructed hypotheses are based on previous reports and verify the research context. These are realistic, in-depth, sufficiently complex, and reproducible. More importantly, these hypotheses can be addressed and tested. 13

There are several characteristics of well-developed hypotheses. Good hypotheses are 1) empirically testable 7 , 10 , 11 , 13 ; 2) backed by preliminary evidence 9 ; 3) testable by ethical research 7 , 9 ; 4) based on original ideas 9 ; 5) have evidenced-based logical reasoning 10 ; and 6) can be predicted. 11 Good hypotheses can infer ethical and positive implications, indicating the presence of a relationship or effect relevant to the research theme. 7 , 11 These are initially developed from a general theory and branch into specific hypotheses by deductive reasoning. In the absence of a theory to base the hypotheses, inductive reasoning based on specific observations or findings form more general hypotheses. 10

TYPES OF RESEARCH QUESTIONS AND HYPOTHESES

Research questions and hypotheses are developed according to the type of research, which can be broadly classified into quantitative and qualitative research. We provide a summary of the types of research questions and hypotheses under quantitative and qualitative research categories in Table 1 .

Research questions in quantitative research

In quantitative research, research questions inquire about the relationships among variables being investigated and are usually framed at the start of the study. These are precise and typically linked to the subject population, dependent and independent variables, and research design. 1 Research questions may also attempt to describe the behavior of a population in relation to one or more variables, or describe the characteristics of variables to be measured ( descriptive research questions ). 1 , 5 , 14 These questions may also aim to discover differences between groups within the context of an outcome variable ( comparative research questions ), 1 , 5 , 14 or elucidate trends and interactions among variables ( relationship research questions ). 1 , 5 We provide examples of descriptive, comparative, and relationship research questions in quantitative research in Table 2 .

Hypotheses in quantitative research

In quantitative research, hypotheses predict the expected relationships among variables. 15 Relationships among variables that can be predicted include 1) between a single dependent variable and a single independent variable ( simple hypothesis ) or 2) between two or more independent and dependent variables ( complex hypothesis ). 4 , 11 Hypotheses may also specify the expected direction to be followed and imply an intellectual commitment to a particular outcome ( directional hypothesis ) 4 . On the other hand, hypotheses may not predict the exact direction and are used in the absence of a theory, or when findings contradict previous studies ( non-directional hypothesis ). 4 In addition, hypotheses can 1) define interdependency between variables ( associative hypothesis ), 4 2) propose an effect on the dependent variable from manipulation of the independent variable ( causal hypothesis ), 4 3) state a negative relationship between two variables ( null hypothesis ), 4 , 11 , 15 4) replace the working hypothesis if rejected ( alternative hypothesis ), 15 explain the relationship of phenomena to possibly generate a theory ( working hypothesis ), 11 5) involve quantifiable variables that can be tested statistically ( statistical hypothesis ), 11 6) or express a relationship whose interlinks can be verified logically ( logical hypothesis ). 11 We provide examples of simple, complex, directional, non-directional, associative, causal, null, alternative, working, statistical, and logical hypotheses in quantitative research, as well as the definition of quantitative hypothesis-testing research in Table 3 .

Research questions in qualitative research

Unlike research questions in quantitative research, research questions in qualitative research are usually continuously reviewed and reformulated. The central question and associated subquestions are stated more than the hypotheses. 15 The central question broadly explores a complex set of factors surrounding the central phenomenon, aiming to present the varied perspectives of participants. 15

There are varied goals for which qualitative research questions are developed. These questions can function in several ways, such as to 1) identify and describe existing conditions ( contextual research question s); 2) describe a phenomenon ( descriptive research questions ); 3) assess the effectiveness of existing methods, protocols, theories, or procedures ( evaluation research questions ); 4) examine a phenomenon or analyze the reasons or relationships between subjects or phenomena ( explanatory research questions ); or 5) focus on unknown aspects of a particular topic ( exploratory research questions ). 5 In addition, some qualitative research questions provide new ideas for the development of theories and actions ( generative research questions ) or advance specific ideologies of a position ( ideological research questions ). 1 Other qualitative research questions may build on a body of existing literature and become working guidelines ( ethnographic research questions ). Research questions may also be broadly stated without specific reference to the existing literature or a typology of questions ( phenomenological research questions ), may be directed towards generating a theory of some process ( grounded theory questions ), or may address a description of the case and the emerging themes ( qualitative case study questions ). 15 We provide examples of contextual, descriptive, evaluation, explanatory, exploratory, generative, ideological, ethnographic, phenomenological, grounded theory, and qualitative case study research questions in qualitative research in Table 4 , and the definition of qualitative hypothesis-generating research in Table 5 .

Qualitative studies usually pose at least one central research question and several subquestions starting with How or What . These research questions use exploratory verbs such as explore or describe . These also focus on one central phenomenon of interest, and may mention the participants and research site. 15

Hypotheses in qualitative research

Hypotheses in qualitative research are stated in the form of a clear statement concerning the problem to be investigated. Unlike in quantitative research where hypotheses are usually developed to be tested, qualitative research can lead to both hypothesis-testing and hypothesis-generating outcomes. 2 When studies require both quantitative and qualitative research questions, this suggests an integrative process between both research methods wherein a single mixed-methods research question can be developed. 1

FRAMEWORKS FOR DEVELOPING RESEARCH QUESTIONS AND HYPOTHESES

Research questions followed by hypotheses should be developed before the start of the study. 1 , 12 , 14 It is crucial to develop feasible research questions on a topic that is interesting to both the researcher and the scientific community. This can be achieved by a meticulous review of previous and current studies to establish a novel topic. Specific areas are subsequently focused on to generate ethical research questions. The relevance of the research questions is evaluated in terms of clarity of the resulting data, specificity of the methodology, objectivity of the outcome, depth of the research, and impact of the study. 1 , 5 These aspects constitute the FINER criteria (i.e., Feasible, Interesting, Novel, Ethical, and Relevant). 1 Clarity and effectiveness are achieved if research questions meet the FINER criteria. In addition to the FINER criteria, Ratan et al. described focus, complexity, novelty, feasibility, and measurability for evaluating the effectiveness of research questions. 14

The PICOT and PEO frameworks are also used when developing research questions. 1 The following elements are addressed in these frameworks, PICOT: P-population/patients/problem, I-intervention or indicator being studied, C-comparison group, O-outcome of interest, and T-timeframe of the study; PEO: P-population being studied, E-exposure to preexisting conditions, and O-outcome of interest. 1 Research questions are also considered good if these meet the “FINERMAPS” framework: Feasible, Interesting, Novel, Ethical, Relevant, Manageable, Appropriate, Potential value/publishable, and Systematic. 14

As we indicated earlier, research questions and hypotheses that are not carefully formulated result in unethical studies or poor outcomes. To illustrate this, we provide some examples of ambiguous research question and hypotheses that result in unclear and weak research objectives in quantitative research ( Table 6 ) 16 and qualitative research ( Table 7 ) 17 , and how to transform these ambiguous research question(s) and hypothesis(es) into clear and good statements.

a These statements were composed for comparison and illustrative purposes only.

b These statements are direct quotes from Higashihara and Horiuchi. 16

a This statement is a direct quote from Shimoda et al. 17

The other statements were composed for comparison and illustrative purposes only.

CONSTRUCTING RESEARCH QUESTIONS AND HYPOTHESES

To construct effective research questions and hypotheses, it is very important to 1) clarify the background and 2) identify the research problem at the outset of the research, within a specific timeframe. 9 Then, 3) review or conduct preliminary research to collect all available knowledge about the possible research questions by studying theories and previous studies. 18 Afterwards, 4) construct research questions to investigate the research problem. Identify variables to be accessed from the research questions 4 and make operational definitions of constructs from the research problem and questions. Thereafter, 5) construct specific deductive or inductive predictions in the form of hypotheses. 4 Finally, 6) state the study aims . This general flow for constructing effective research questions and hypotheses prior to conducting research is shown in Fig. 1 .

Research questions are used more frequently in qualitative research than objectives or hypotheses. 3 These questions seek to discover, understand, explore or describe experiences by asking “What” or “How.” The questions are open-ended to elicit a description rather than to relate variables or compare groups. The questions are continually reviewed, reformulated, and changed during the qualitative study. 3 Research questions are also used more frequently in survey projects than hypotheses in experiments in quantitative research to compare variables and their relationships.

Hypotheses are constructed based on the variables identified and as an if-then statement, following the template, ‘If a specific action is taken, then a certain outcome is expected.’ At this stage, some ideas regarding expectations from the research to be conducted must be drawn. 18 Then, the variables to be manipulated (independent) and influenced (dependent) are defined. 4 Thereafter, the hypothesis is stated and refined, and reproducible data tailored to the hypothesis are identified, collected, and analyzed. 4 The hypotheses must be testable and specific, 18 and should describe the variables and their relationships, the specific group being studied, and the predicted research outcome. 18 Hypotheses construction involves a testable proposition to be deduced from theory, and independent and dependent variables to be separated and measured separately. 3 Therefore, good hypotheses must be based on good research questions constructed at the start of a study or trial. 12

In summary, research questions are constructed after establishing the background of the study. Hypotheses are then developed based on the research questions. Thus, it is crucial to have excellent research questions to generate superior hypotheses. In turn, these would determine the research objectives and the design of the study, and ultimately, the outcome of the research. 12 Algorithms for building research questions and hypotheses are shown in Fig. 2 for quantitative research and in Fig. 3 for qualitative research.

EXAMPLES OF RESEARCH QUESTIONS FROM PUBLISHED ARTICLES

• EXAMPLE 1. Descriptive research question (quantitative research)
• - Presents research variables to be assessed (distinct phenotypes and subphenotypes)
• “BACKGROUND: Since COVID-19 was identified, its clinical and biological heterogeneity has been recognized. Identifying COVID-19 phenotypes might help guide basic, clinical, and translational research efforts.
• RESEARCH QUESTION: Does the clinical spectrum of patients with COVID-19 contain distinct phenotypes and subphenotypes? ” 19
• EXAMPLE 2. Relationship research question (quantitative research)
• - Shows interactions between dependent variable (static postural control) and independent variable (peripheral visual field loss)
• “Background: Integration of visual, vestibular, and proprioceptive sensations contributes to postural control. People with peripheral visual field loss have serious postural instability. However, the directional specificity of postural stability and sensory reweighting caused by gradual peripheral visual field loss remain unclear.
• Research question: What are the effects of peripheral visual field loss on static postural control ?” 20
• EXAMPLE 3. Comparative research question (quantitative research)
• - Clarifies the difference among groups with an outcome variable (patients enrolled in COMPERA with moderate PH or severe PH in COPD) and another group without the outcome variable (patients with idiopathic pulmonary arterial hypertension (IPAH))
• “BACKGROUND: Pulmonary hypertension (PH) in COPD is a poorly investigated clinical condition.
• RESEARCH QUESTION: Which factors determine the outcome of PH in COPD?
• STUDY DESIGN AND METHODS: We analyzed the characteristics and outcome of patients enrolled in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) with moderate or severe PH in COPD as defined during the 6th PH World Symposium who received medical therapy for PH and compared them with patients with idiopathic pulmonary arterial hypertension (IPAH) .” 21
• EXAMPLE 4. Exploratory research question (qualitative research)
• - Explores areas that have not been fully investigated (perspectives of families and children who receive care in clinic-based child obesity treatment) to have a deeper understanding of the research problem
• “Problem: Interventions for children with obesity lead to only modest improvements in BMI and long-term outcomes, and data are limited on the perspectives of families of children with obesity in clinic-based treatment. This scoping review seeks to answer the question: What is known about the perspectives of families and children who receive care in clinic-based child obesity treatment? This review aims to explore the scope of perspectives reported by families of children with obesity who have received individualized outpatient clinic-based obesity treatment.” 22
• EXAMPLE 5. Relationship research question (quantitative research)
• - Defines interactions between dependent variable (use of ankle strategies) and independent variable (changes in muscle tone)
• “Background: To maintain an upright standing posture against external disturbances, the human body mainly employs two types of postural control strategies: “ankle strategy” and “hip strategy.” While it has been reported that the magnitude of the disturbance alters the use of postural control strategies, it has not been elucidated how the level of muscle tone, one of the crucial parameters of bodily function, determines the use of each strategy. We have previously confirmed using forward dynamics simulations of human musculoskeletal models that an increased muscle tone promotes the use of ankle strategies. The objective of the present study was to experimentally evaluate a hypothesis: an increased muscle tone promotes the use of ankle strategies. Research question: Do changes in the muscle tone affect the use of ankle strategies ?” 23

EXAMPLES OF HYPOTHESES IN PUBLISHED ARTICLES

• EXAMPLE 1. Working hypothesis (quantitative research)
• - A hypothesis that is initially accepted for further research to produce a feasible theory
• “As fever may have benefit in shortening the duration of viral illness, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response when taken during the early stages of COVID-19 illness .” 24
• “In conclusion, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response . The difference in perceived safety of these agents in COVID-19 illness could be related to the more potent efficacy to reduce fever with ibuprofen compared to acetaminophen. Compelling data on the benefit of fever warrant further research and review to determine when to treat or withhold ibuprofen for early stage fever for COVID-19 and other related viral illnesses .” 24
• EXAMPLE 2. Exploratory hypothesis (qualitative research)
• - Explores particular areas deeper to clarify subjective experience and develop a formal hypothesis potentially testable in a future quantitative approach
• “We hypothesized that when thinking about a past experience of help-seeking, a self distancing prompt would cause increased help-seeking intentions and more favorable help-seeking outcome expectations .” 25
• “Conclusion
• Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.” 25
• EXAMPLE 3. Hypothesis-generating research to establish a framework for hypothesis testing (qualitative research)
• “We hypothesize that compassionate care is beneficial for patients (better outcomes), healthcare systems and payers (lower costs), and healthcare providers (lower burnout). ” 26
• Compassionomics is the branch of knowledge and scientific study of the effects of compassionate healthcare. Our main hypotheses are that compassionate healthcare is beneficial for (1) patients, by improving clinical outcomes, (2) healthcare systems and payers, by supporting financial sustainability, and (3) HCPs, by lowering burnout and promoting resilience and well-being. The purpose of this paper is to establish a scientific framework for testing the hypotheses above . If these hypotheses are confirmed through rigorous research, compassionomics will belong in the science of evidence-based medicine, with major implications for all healthcare domains.” 26
• EXAMPLE 4. Statistical hypothesis (quantitative research)
• - An assumption is made about the relationship among several population characteristics ( gender differences in sociodemographic and clinical characteristics of adults with ADHD ). Validity is tested by statistical experiment or analysis ( chi-square test, Students t-test, and logistic regression analysis)
• “Our research investigated gender differences in sociodemographic and clinical characteristics of adults with ADHD in a Japanese clinical sample. Due to unique Japanese cultural ideals and expectations of women's behavior that are in opposition to ADHD symptoms, we hypothesized that women with ADHD experience more difficulties and present more dysfunctions than men . We tested the following hypotheses: first, women with ADHD have more comorbidities than men with ADHD; second, women with ADHD experience more social hardships than men, such as having less full-time employment and being more likely to be divorced.” 27
• “Statistical Analysis
• ( text omitted ) Between-gender comparisons were made using the chi-squared test for categorical variables and Students t-test for continuous variables…( text omitted ). A logistic regression analysis was performed for employment status, marital status, and comorbidity to evaluate the independent effects of gender on these dependent variables.” 27

EXAMPLES OF HYPOTHESIS AS WRITTEN IN PUBLISHED ARTICLES IN RELATION TO OTHER PARTS

• EXAMPLE 1. Background, hypotheses, and aims are provided
• “Pregnant women need skilled care during pregnancy and childbirth, but that skilled care is often delayed in some countries …( text omitted ). The focused antenatal care (FANC) model of WHO recommends that nurses provide information or counseling to all pregnant women …( text omitted ). Job aids are visual support materials that provide the right kind of information using graphics and words in a simple and yet effective manner. When nurses are not highly trained or have many work details to attend to, these job aids can serve as a content reminder for the nurses and can be used for educating their patients (Jennings, Yebadokpo, Affo, & Agbogbe, 2010) ( text omitted ). Importantly, additional evidence is needed to confirm how job aids can further improve the quality of ANC counseling by health workers in maternal care …( text omitted )” 28
• “ This has led us to hypothesize that the quality of ANC counseling would be better if supported by job aids. Consequently, a better quality of ANC counseling is expected to produce higher levels of awareness concerning the danger signs of pregnancy and a more favorable impression of the caring behavior of nurses .” 28
• “This study aimed to examine the differences in the responses of pregnant women to a job aid-supported intervention during ANC visit in terms of 1) their understanding of the danger signs of pregnancy and 2) their impression of the caring behaviors of nurses to pregnant women in rural Tanzania.” 28
• EXAMPLE 2. Background, hypotheses, and aims are provided
• “We conducted a two-arm randomized controlled trial (RCT) to evaluate and compare changes in salivary cortisol and oxytocin levels of first-time pregnant women between experimental and control groups. The women in the experimental group touched and held an infant for 30 min (experimental intervention protocol), whereas those in the control group watched a DVD movie of an infant (control intervention protocol). The primary outcome was salivary cortisol level and the secondary outcome was salivary oxytocin level.” 29
• “ We hypothesize that at 30 min after touching and holding an infant, the salivary cortisol level will significantly decrease and the salivary oxytocin level will increase in the experimental group compared with the control group .” 29
• EXAMPLE 3. Background, aim, and hypothesis are provided
• “In countries where the maternal mortality ratio remains high, antenatal education to increase Birth Preparedness and Complication Readiness (BPCR) is considered one of the top priorities [1]. BPCR includes birth plans during the antenatal period, such as the birthplace, birth attendant, transportation, health facility for complications, expenses, and birth materials, as well as family coordination to achieve such birth plans. In Tanzania, although increasing, only about half of all pregnant women attend an antenatal clinic more than four times [4]. Moreover, the information provided during antenatal care (ANC) is insufficient. In the resource-poor settings, antenatal group education is a potential approach because of the limited time for individual counseling at antenatal clinics.” 30
• “This study aimed to evaluate an antenatal group education program among pregnant women and their families with respect to birth-preparedness and maternal and infant outcomes in rural villages of Tanzania.” 30
• “ The study hypothesis was if Tanzanian pregnant women and their families received a family-oriented antenatal group education, they would (1) have a higher level of BPCR, (2) attend antenatal clinic four or more times, (3) give birth in a health facility, (4) have less complications of women at birth, and (5) have less complications and deaths of infants than those who did not receive the education .” 30

Research questions and hypotheses are crucial components to any type of research, whether quantitative or qualitative. These questions should be developed at the very beginning of the study. Excellent research questions lead to superior hypotheses, which, like a compass, set the direction of research, and can often determine the successful conduct of the study. Many research studies have floundered because the development of research questions and subsequent hypotheses was not given the thought and meticulous attention needed. The development of research questions and hypotheses is an iterative process based on extensive knowledge of the literature and insightful grasp of the knowledge gap. Focused, concise, and specific research questions provide a strong foundation for constructing hypotheses which serve as formal predictions about the research outcomes. Research questions and hypotheses are crucial elements of research that should not be overlooked. They should be carefully thought of and constructed when planning research. This avoids unethical studies and poor outcomes by defining well-founded objectives that determine the design, course, and outcome of the study.

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Barroga E, Matanguihan GJ.
• Methodology: Barroga E, Matanguihan GJ.
• Writing - original draft: Barroga E, Matanguihan GJ.
• Writing - review & editing: Barroga E, Matanguihan GJ.

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Definitions

Term Definitions

• Authorization for Release of Protected Health Information
• De-identified Data

Engaged in Research

Exempt review, expedited review, financial interest, full committee review, human subject, irb review types, key personnel.

• Limited Data Set

Minimal Risk

Principal investigator.

• Protected Health Information
• Waiver of Authorization

Research is defined as a

“…systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”   [45 CFR 46.102(l)]

Research includes, but is not limited to, observations, formal interviews, responses to questionnaires, and related activities that may be quantified as part of study data. Research does not include interviews used to provide quotes or illustrative statements — as in journalism or related activities.

COUHES does not consider surveys, questionnaires or interviews to be research if (1) they are carried out as part of an administrative responsibility of the investigator AND 2) the use is limited to MIT purposes only.

The following activities do not meet the definition for research and do not require a COUHES submission:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected;
• Public health surveillance activities, including the collection & testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority [with limitations];
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes;
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 

Human subject is defined as

" … a living individual about whom an investigator (whether professional or student) conducting research obtains (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or  (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. ” [45 CFR §46.102(e)(1)]

" Intervention" includes “both physical procedures by which information or biospecimens” (e.g., drawing blood) and “manipulations of the subject or the subject's environment that are performed for research purposes. ” (45 CFR § 46.102(2))

"Interaction" includes communication or interpersonal contact between investigator and subject.

COUHES does not consider research to involve "human subjects" where the research uses only coded private data, specimens or cells: provided that (1) the data, specimens or cells were not collected specifically for the proposed research by an intervention with a living individual, AND (2) the researcher cannot identify the individual(s) from whom the data, specimens or cells were obtained (for example, because the key to decipher the code has been destroyed or an agreement exists prohibiting the release of the key to the investigators).

COUHES also takes jurisdiction over research involving blood, tissue or other specimens derived from human subjects.

In general, an institution is considered engaged in a particular human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. awardee institutions) are considered to be engaged in human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution.

Please see OHRP guidance on Engagement of Institutions in Human Subjects Research

See sample scenarios: Engaged in Research: Scenarios

COUHES reviews all protocols that fall within the definition of human subjects research in the Federal Regualtions that govern the conduct of human subjects research ( 45 CFR 46.102) .

Investigators are required to obtain approval from COUHES prior to the start of any research activites. There are three types of review: Exempt, Expedited, and Full Committee.

Exempt status research is excluded from the requirements of the Regulations and from policies dictacted by the Common Rule. Exempt status research must however, comply with COUHES Policy, as outlined in the   Investigator Responsibilities for Exempt Research .

To qualify for Exempt status, research activities must be:

• Minimal risk
• The only involvement of human subjects will be in one or more of the exempt categories detailed below
• Not involve use of drugs or devices

To qualify for Exempt status, investigators must submit an Exempt Evaluation using  COUHES Connect , and must be granted Exempt status before  initiating their research activities. Research conducted prior to receiving an exempt determination is a violation of MIT policy. Investigators approved for the conduct of Exempt status research are required to comply with the policies as outlined in the  Investigator responsibilities for Exempt Research .

If the Exempt Evaluation process determines that the research activities do not meet the exempt criteria then investigatiors are required to submit a  Comprehensive Review  application.

Categories of Exempt

Note: Research that qualifies for Limited IRB Review (see Category 2.3, Category 3.i.C, Category 7 and 8) as well as Category 4.ii and 4.iv must submit a comprehensive application for full review by COUHES.

Some of the exempt categories do NOT apply to research involving children. All of the exempt categories do NOT apply to research involving prisoners. For more information, see Exemptions (2018 Requirements.

Category 1: Education Research

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.  [§__.104(d)(1)]

Category 2: Surveys, Interviews, Educational Tests, and Public Observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation;
•  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7).  [§__.104(d)(2)]  

Category 3: Benign Behavioral Intervention

• Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
• For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
• If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.  [§__.104(d)(3)(i)]

Category 4: Analysis of Existing Data or Biospecimen

Secondary research, for which consent is not required, uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

• The identifiable private information or identifiable biospecimens are publicly available;
• Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
• The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.  [§__.104(d)(4)]   

Category 5: Public Benefit or Service Program

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

• Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.  [§__.104(d)(5)]

Category 6: Taste & Food Quality Studies

• If wholesome foods without additives are consumed, or
• If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.  [§__.104(d)(6)]

Category 7: Storage or Maintenance of Identifiable Data\Biospecimens

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).   [§__.104(d)(7)]

Category 8: Use of Identifiable Data\Biospecimens

Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

• Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
• Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
• An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
• The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results. [§__.104(d)(8)]

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Help your employees find purpose—or watch them leave

If the tumult of 2020 has prompted your organization or leadership team to reconsider people priorities such as employee well-being, resilience, or purpose, then you’re in good company.

Your employees are reconsidering you, too.

Nearly two-thirds of US-based employees we surveyed said that COVID-19 has caused them to reflect on their purpose in life. And nearly half said that they are reconsidering the kind of work they do because of the pandemic. Millennials were three times more likely than others to say that they were reevaluating work.

Such findings have implications for your company’s talent-management strategy and its bottom line. People who live their purpose at work are more productive than people who don’t. They are also healthier, more resilient, and more likely to stay at the company. Moreover, when employees feel that their purpose is aligned with the organization’s purpose, the benefits expand  to include stronger employee engagement, heightened loyalty, and a greater willingness to recommend the company to others.

Nonetheless, if you’re like most senior executives, you haven’t given the individual purpose of your employees much thought. The topic is intensely personal, potentially inaccessible to employers, and seemingly as uncomfortable to discuss as it is to actively encourage.

Despite these challenges, our research found that 70 percent of employees said that their sense of purpose is defined by their work. So, like it or not, as a company leader you play an important part in helping your employees find their purpose and live it. And you have your work cut out: our survey also found disparities in how frontline employees and other groups feel supported—or thwarted—in living their purpose at work.

In this article, we describe the role that work can play in individual purpose, highlight what employees want from employers and what they aren’t getting, and describe what you can start doing about it. The prize? If you get this right, you can help your company become a better place to work and tap the enormous business potential of a purposeful workforce aligned with a purpose-driven organization.

But be careful: purpose is not just “another corporate initiative.” You can’t mandate this. And if you approach your people with inconsistency, hypocrisy, or arrogance, you will likely do the organization—and your reputation—more harm than good.

Understanding purpose at work

To understand the challenge, we surveyed more than a thousand US employees about individual purpose and the work and life outcomes associated with it. 1 This article draws upon a survey we conducted in August 2020 of 1,021 US workers. The respondents represented a range of ages, incomes, roles, and tenures. The survey is part of an ongoing McKinsey research effort to better understand the role of purpose in organizations.

Before exploring the findings, though, it’s useful to consider the context in which individual purpose operates at work, as well as the unique challenges it presents for employers. Individual purpose can be thought of as an enduring, overarching sense of what matters in a person’s life; people experience purposefulness when striving toward something significant and meaningful to them. There are clear patterns, or purpose archetypes , that help employers categorize what people find meaningful, but ultimately someone’s purpose can be as varied as people themselves.

The upshot is that while companies and their leaders can have a big influence on the individual purpose of their employees, they have limited direct control over it. Companies therefore need to meet employees where they are in order to help them optimize their sense of fulfillment from work.

To better understand how to accomplish this, consider the conceptual relationship between an individual’s purpose and their work, as depicted by the three concentric circles in Exhibit 1. Everyone’s purpose may be unique, but some part of it—large or small—comes from forces outside work, just as some part comes from the daily work itself. These are the outermost and middle circles, respectively, and they vary in proportion to each other from person to person.

If an employee gets very little purpose from their work, the size of the middle circle will be smaller. By contrast, if another person finds their work very purposeful, it will be larger. Intuitively, then, the size of the middle circle represents the portion of one’s purpose that is accessible by work—and also how much purpose employees want from their work—and it may grow or shrink. Employers should view this middle circle as a target they strive to understand and meet. They should influence the expansion of this circle if they can.

The innermost circle (purpose from the organization) depicts the company’s means of influence; it’s the only aspect of purpose that organizations control. How so? By establishing a corporate purpose that considers the company’s role and contribution to society, and by providing employees with meaningful ways to reflect on the company’s efforts and their impact. Companies can also exert influence by improving the underlying health of the organization and its culture, bolstering inclusiveness and the employee experience, and changing the work itself.

As a company leader, you want to see the organization’s relatively small sphere of influence expand to match the size of the employee’s own sense of purpose from work (the middle circle). The closer the company gets, the more fulfilled the employee is. Moreover, a closer match earns the company more opportunities for employees to seek—and expect—more purpose from work, and to feel more aligned with the organization’s purpose.

The operative word here is “earn.” Remember that when it comes to purpose, you have access only to what your people grant you access to. Your first task is to learn what they want, and then to see if they’re getting it.

What employees want—and what they get

Chances are, your employees want more purpose from work than they’re getting. For starters, we know that employees at all levels in the organization say that they want purpose in their lives. Eighty-nine percent of our survey respondents agreed, a proportion that tracks closely with academic research.

Moreover, 70 percent of the employees we surveyed said that their sense of purpose is largely defined by work. Senior executives in our sample nudged that average upward, but even so, two-thirds of nonexecutive employees said that work defines their purpose. This signals a clear opportunity for employers and leaders—an open door to encourage your employees at all levels to develop and live their purpose at work.

Yet when we asked if people are living their purpose in their day-to-day work, the gap between executives and others mushroomed. Whereas 85 percent of execs and upper management said that they are living their purpose at work, only 15 percent of frontline managers and frontline employees agreed. Worse, nearly half of these employees disagreed , compared with just a smattering of executives and upper management (Exhibit 2).

Meet the parents

Any parent will tell you that having children is life altering. Intriguingly, this axiom appears to extend to purpose as well. Parents in our survey were 1.6 times more likely than nonparents to say that they had a clear understanding of their purpose, and they were more than twice as likely to say that that they relied on work for purpose.

Time always feels scarce, so given the trade-offs that parents make between work and home, our findings suggest that parents are keen to make work time as meaningful as possible. These findings could also reflect the “big picture” shift in perspective that many people describe as a consequence of parenthood.

Both sentiments were echoed in focus groups that we conducted independent of the survey mentioned in this article. In that forum, one parent remarked: “I felt more invested in the future after having kids. It changed my vision of the long game.” While another noted, “Being a parent has made my priorities more clear about my impact on the world. I want to make my children proud.”

This “purpose hierarchy gap” extends to feeling fulfilled at work. Executives are nearly eight times more likely than other employees to say that their purpose is fulfilled by work. Similarly, executives are nearly three times more likely than others to say that they rely on work for purpose. Interestingly, the group most reliant on work for purpose—across roles—are parents (see sidebar, “Meet the parents”).

Finally, we sought to quantify the scope of the overall challenge for companies by comparing respondents’ answers, regardless of their role, to questions about their desired and actual states. 2 We did this by mapping employees’ answers to two questions: “How much of your work needs to be aligned with your purpose?” and “To what extent is your purpose defined by work?” This revealed that only 18 percent of respondents believed that they get as much purpose from work as they want. Sixty-two percent said that while they get some purpose from work, they want to get even more.

Understand the implications

You might consider “getting some but wanting even more” to be pretty good, particularly if you lead or manage big groups of people. You’d be wrong. These less satisfied respondents reported lower average work and life outcomes than more satisfied peers did—everything from reduced feelings of energy and life satisfaction to lower engagement, satisfaction, and excitement about work (Exhibit 3). Negative work and life outcomes for employees inevitably translate to negative outcomes for the business.

Moreover, the subtlety of some of the findings around frontline employees masks deeper issues. Why, for example, are frontline managers and employees so much less likely than others to rely on work for purpose? The numbers suggest that shortsighted leaders may be conditioning them to feel this way. Indeed, when we dug further into the data we saw that frontline managers and employees were ten times less likely than management-level colleagues to say that they’d had opportunities to reflect on their purpose, and nine times less likely to say that they’d had a manager foster opportunities for them to work on purposeful projects. Similarly, managers don’t seem to be doing much to share the “big picture” with frontline colleagues, who were three times less likely than leaders to say that they can see a connection between their daily work and the organization’s purpose.

While such gaps should distress you—many of the employees closest to your products and customers may have stopped relying on you for the purpose they say they want—the findings also offer hope.

When employees at any level say that their purpose is fulfilled by their work, the work and life outcomes they report are anywhere from two to five times higher than those reported by their unfulfilled peers. And this finding holds regardless of whether employees currently rely on work for purpose. In other words, organizations should aspire to ensure that their employees’ purpose is fulfilled at work, whether or not employees initially think they rely on work for this. Employees—and the organization—stand to benefit anyway.

Take action, thoughtfully

The choices that company leaders and managers make are the X factor in helping employees fulfill their purpose at work. By making better choices—starting now—you can make a positive difference in the lives of your colleagues and the performance of the company. Here are three ways to focus your efforts:

1. Start with the organization’s purpose (hint: the only thing you control directly)

It may seem counterintuitive to look first to the organization’s purpose in hopes of supporting the life purpose of your employees, but remember: this part you control. Does your company meaningfully consider its role in society? Do senior executives use the company’s purpose as a North Star to make difficult decisions and trade-offs? If your company’s purpose is just a poster on the wall, you’re wasting everyone’s time . If you talk about purpose but don’t follow through, the results can be devastatingly bad.

If you aren’t sure your leaders are following through, start checking. Some companies use internal scorecards to track the commitment of leaders, employees, and other stakeholders to organizational purpose. Routine measurement helps leaders encourage buy-in, spot problems early, and take appropriate action. A few companies go further and embed purpose metrics into the performance assessments of people leaders.

One action you can take today is to start spending time with your team reflecting on the impact the company has on the world. Again: this must be earned. Cringeworthy emails to your team about corporate social responsibility efforts that seem disconnected from the team’s day-to-day experience will only inspire cynicism. You want dialogue, not monologue. Still, when authentic and handled well, reflections on the bigger picture can inspire a sense of purpose. Our survey found that employees are five times more likely to be excited to work at a company that spends time reflecting on the impact it makes in the world.

2. Reflect, connect, repeat

When employees have a chance to reflect on their own sense of purpose, and how it connects to the company’s purpose, good things happen. Survey respondents who have such opportunities are nearly three times more likely than others to feel their purpose is fulfilled at work. Make this a habit in your company.

While leadership workshops and storytelling sessions can be good forums for this, keep in mind that the underlying problem you’re trying to solve might be in your leadership environment. Managers must be prepared to share their own purpose with others, for example, and be vulnerable in ways they’re likely not used to in order to role model these skills and pass them along to colleagues. And pass them along you must: people in our survey whose managers didn’t provide them opportunities to reflect on purpose stood just a 7 percent chance of fulfilling their purpose at work.

Look closely at your managers and leaders. Do they cultivate compassionate leadership , or is the attitude more akin to “stop whining”? Ask yourself: Is my team comfortable sharing personal things with me? Few things are more personal than one’s purpose in life, and if psychological safety  is low at your company you will never learn that firsthand. When employees in our survey said they experienced little psychological safety, they stood a 0.5 percent chance of saying their purpose was fulfilled at work.

3. Help people live their purpose at work

Sixty-three percent of people we surveyed said they want their employer to provide more opportunities for purpose in their day-to-day work. You need to find ways to deliver.

Many companies are tempted to scratch this itch by implementing programs that support employees’ purposeful impulses wherever they find them—in the community, for example, or even elsewhere in the world. Some companies offer paid time off for these pursuits.

While such efforts are laudable, and even beneficial, they are not a good solution to the problem our survey identified. Your starting point should be opportunities that help employees find more personal meaning in their day-to-day work. By doing your part to help employees live their purpose at work, you will enable them to feel more fulfilled. And when the work is aligned with the company’s own purpose, that sense of fulfillment will ultimately benefit the company, too.

Consider the example of North American insurer USAA under then-CEO Joe Robles. To establish commitment to its core customer base in the US military community, Robles (who retired from USAA in 2015) saw to it that every employee went through a four-day orientation. Town hall meetings and other forums reinforced the effort by encouraging employees to ask questions and share ideas about how to fulfill their purpose. 3 For more, see Robert E. Quinn and Anjan V. Thakor, “Creating a purpose-driven organization,” Harvard Business Review , July–August 2018, Volume 96, Number 4, pp. 78–85, hbr.org.

Purposeful employees try harder and are more apt to innovate. As reported in 2018 , USAA’s employees had collectively submitted more than 10,000 ideas to the company each year to improve the customer experience. About 900 had been awarded patents, including 25 authored by one of the company’s security guards.

Town hall meetings and immersive, small-group sessions may not sound as sexy as a paid leave of absence to do good in the world, but they are a lot more effective at helping employees start to see the good they can do in their day-to-day work. Many people spend the majority of their waking hours at work, so creating space for the little things to become purposeful can quickly snowball into better work experiences—and better work environments—for everyone.

The COVID-19 pandemic has people everywhere reevaluating their lives and work, and many now expect their jobs to be a significant source of purpose in their lives. Employers—ready or not—will need to help meet this need, or be prepared to lose talent to companies that will. The good news? The benefits of getting individual purpose right are substantial, self-reinforcing, and extend not only to the well-being of employees but also to the company’s performance.

Naina Dhingra is a partner in McKinsey’s New York office, Andrew Samo is an alumnus of the Montreal office, Bill Schaninger is a senior partner in the Philadelphia office, and Matt Schrimper is a consultant in the New Jersey office.

The authors wish to thank Jonathan Emmett, Nicolette Rainone, Charlotte Seiler, Svetlana Andrianova, Abby Hartman, and Randy Lim for their contributions to this article.

This article was edited by Tom Fleming, an executive editor in the Chicago office.

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25 Great Ways to Find Your Purpose

Wise ways to find your north star — and a happier, healthier life.

Matt Alderton,

Like gas in your car, purpose is fuel. With it, your engine will rev. Without it, it will stall and sputter. But finding purpose — especially if you’ve lost it — may require reprogramming your life. We’ve assembled 25 ideas to help you get started. Consider which ones might work for you, then weigh in with your own tips at the bottom of the page .

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1. Find your people

The number one contributor to happiness is meaningful relationships with other people, according to researchers Robert Waldinger and Marc Schulz. Their book, The Good Life: Lessons From the World’s Longest Scientific Study of Happiness, was expanded from the Harvard Study of Adult Development, which began in 1938 as a decades-long effort to track the happiness of more than 700 men. Meaningful relationships might also be the key to finding purpose, says Steve Cole, professor of medicine and psychiatry and biobehavioral sciences at the UCLA School of Medicine. Cole says purpose typically requires partnership. “There’s almost nothing we really want to do that we can do by ourselves,” he says. “It’s very hard to save the whales, for example, unless you’ve got a community of other people to help you. Because the whales are just too big.” If purpose requires community, social groups can be good places to find it, suggests Cole, who recommends joining a club, church or other organization.

2. Start a ‘purpose club’

If you can’t find a group to join, create your own, suggests Aaron Hurst, author of The Purpose Economy: How Your Desire for Impact, Personal Growth and Community is Changing the World . “Purpose ideally is not a solo sport. It’s a team sport. Finding people to be on the journey with you not only makes it much more likely to be fulfilling but also much more likely that you’ll actually do it,” Hurst says. “You’ve had a book club. Why not create a purpose club? … We know that purpose extends lifespan and that connection extends lifespan. When you combine the two of them, you’re in the zone.”

3. Share your knowledge

Michelle Carlson, a professor of mental health at Johns Hopkins University, wondered if having a sense of purpose could improve the health of older adults. She designed an intervention to study the question: Experience Corps, a program through which older adults volunteered in public school classrooms. Those who participated saw improvements in mobility, memory, strength and cognition, as well as social and psychological engagement — which led Carlson to conclude that teaching, mentoring and other forms of knowledge sharing can be effective conduits to finding purpose. “As a culture, we need to think about aging as not just a time to get stale and avoid disease, but a time to harness the wisdom that it took a lifetime to accumulate, and then channel it back to a new generation,” Carlson says. 

4. Take care of someone or something

Anyone who’s had to care for an ill spouse or an aging parent knows that caregiving can be extremely challenging and depleting. It also can be extremely rewarding and beneficial, research finds. A 2023 study published in the journal Advances in Life Course Research found that becoming a caregiver to a loved one can decrease symptoms of depression. Researchers at Johns Hopkins University similarly have found that caregivers tend to live longer than non-caregivers, presumably because the positive rewards of caregiving buffer the negative stress it can cause. And it’s not just caring for people. Studies have found health benefits in people who care for plants, pets or even vehicles. “If I love taking care of my car, and I go off to a car show every weekend where there’s 100 other people with well-polished cars, what good does that do? It’s not like we’ve solved global warming or eradicated cancer, but there is something about the experience of making the world more beautiful and more inspiring that’s very strong for the human spirit,” Cole says.  

5. Commit random acts of kindness

Small gestures can make a big impact. A 2022 study published in  The Journal of Positive Psychology  showed that when participants performed three random acts of kindness on two days of the week for five weeks, those with symptoms of anxiety and depression felt less depressed and anxious, had fewer negative feelings and reported being more satisfied with life. “Almost everybody is happy to get a little bit of help here and there,” Cole says. “These are powerfully rewarding experiences in the human brain — having another human being say: ‘You’ve helped me.’ ‘You’ve reduced my suffering.’ ‘You’ve helped make the world a better place.’ This is one of the secret sauces of human existence, because we are strongly wired to self-reward when other people appreciate us.”  

6. Find your gift

If you want to find your purpose, find your talent. [Purpose] has to come from your values and what you care about, but it should also serve on your talents,” Cole says. “It’s not just about picking something that’s meaningful to you. It’s also about picking something that you do well, where you can easily make a contribution without too much strain.” If you’re a skilled computer programmer, for example, you might find purpose in teaching coding to disadvantaged youth or in lending your expertise to a philanthropic organization that could use a software-based solution to help with its mission. “Purpose is finding a fit between what you care about and what you naturally do well,” continues Cole, who says people often take their skills for granted. 

7. Give what you’ve got

If you can find purpose in sharing your skills and talents, you might also share your resources. Although charitable giving can be a fantastic pathway to purpose for philanthropists, your resources don’t have to be financial. The important thing is to be intentional, says Kim Serrano, director of the Center for Inclusion and Belonging, a project of the nonprofit American Immigration Council, whose mission is building a more welcoming, inclusive and cohesive America. “Pursuing purpose … is inherently outward-focused and generous,” Serrano notes. “To get started, it can … be helpful to think about, ‘What is something I have in abundance that I can offer to others?’ One of the things I know many older adults have an abundance of is time. Availability is the best ability. If you like driving, that could look like offering to provide rides to the airport or medical appointments for people in your life. If you enjoy cooking, it could look like meal prepping and meal sharing with loved ones who just can’t find the extra minutes in the day to get it all done. If you are a walker, you can offer to take a neighbor’s dog with you on your next neighborhood stroll.” 

8. Mind the gaps

For more than 20 years, Todd Kashdan has been studying curiosity. A professor of psychology at George Mason University and author of Curious? Discover the Missing Ingredient to a Fulfilling Life , he says his research has demonstrated that curiosity is closely linked to psychological well-being, including feelings of autonomy, competence and belonging. According to Kashdan, a good recipe for purpose is combining external curiosity — that is, curiosity about the world around you — with internal curiosity: curiosity about yourself. “Use external curiosity to ask yourself, ‘What does the world need?’ Find the gap,” Kashdan suggests. “Then, direct your curiosity inward to figure out what are the particular strengths, experiences, life events, perspectives and relationships that make you unlike anyone else who will ever walk the Earth again. When you combine those things together, you can begin to see what you uniquely can contribute to the world. And that will help you determine what your purpose should be.”

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9. Connect to your work

Purpose often lives at the intersection of what the world needs and what skills you possess, and the Japanese concept of “ikigai”  adds two variables to the equation, according to Chip Conley, founder of Modern Elder Academy and author of  Learning to Love Midlife: 12 Reasons Why Life Gets Better With Age . Picture a Venn diagram with four overlapping circles, he suggests. One circle is what the world needs, and another is what you’re good at; the two remaining circles are what you love and what you can be paid to do. Your purpose is what fits in the middle of all four. Though each of ikigai’s pillars is important, the notion of compensation could be particularly potent. “One’s purpose doesn’t have to be found at work … but a recent McKinsey & Co. survey found that 70 percent of people said that their primary sense of purpose is defined by their work,” Conley notes. “Individuals with a connection to purpose in the workplace feel more fulfilled, are more engaged, more productive and report more fulfilling work relationships.” If you’re working, find ways to reconnect with your job’s inherent value, or consider looking for an employer whose mission you support. If you’re retired, think about how you could start a business or work part-time in ways that allow you to be compensated for your unique skills and contributions.

10. Create something

People who make art may experience pleasure and better moods, feeling less stress and anxiety. A 2017 study involving more than 23,000 British participants found that people who regularly made art were happier and had better mental health compared with those who didn’t. It stands to reason, then, that a good place to look for purpose might be on a canvas, on a pottery wheel or in the lens of a camera. “Artistic expression can be very purposeful,” Cole says. “When you talk to artists, they’re speaking something that they see, and speaking inherently connects us to other human beings.” If it doesn’t give your life purpose, art can at least give your day purpose. 

11. Think short-term (and long-term)

A 2020 study in the journal Science determined that dopamine — a neurotransmitter that’s responsible for feelings of pleasure, motivation and reward — plays an important role in the decision to pursue difficult tasks by influencing the brain to focus more on benefits than costs. With that in mind, it’s important that people seeking purpose choose attainable goals that can satisfy their dopamine cravings by delivering fast and frequent wins in the short term. “When we look at a person who has a lot of purpose in their everyday life, or someone who is pursuing something that they care about, we can look at their biology and see a lot of activity in the brain systems that are responsible for value, hoping, seeking and wanting,” Cole says. “Purpose, as I think about it, is whatever activates that dopamine-rich brain circuit.” Goals shouldn’t be too easy, because if you accomplish them too quickly, you’ll find yourself purposeless again in a heartbeat. To realize the benefits of having purpose, you need to stay engaged in that purpose for years, not months, Cole points out. For that reason, he says, the best-case scenario is to choose as your purpose a destination that you can easily move toward but probably never reach. “That’s the trick. Find something where the work will never be done but where the work will never happen if you don’t do it.”

12. Read poetry

In 2023, British researchers discovered a surprising source of well-being: poetry. In a study funded by the U.K.’s Arts and Humanities Research Council of 400 people who used poetry as a coping mechanism during the COVID-19 pandemic, researchers concluded that reading and/or writing poetry can help people deal with feelings of loneliness or isolation and can reduce feelings of anxiety and depression. Poetry isn’t just good for mental health. It’s also good for finding purpose, says Nancy McGaw, author of Making Work Matter: How to Create Positive Change in Your Company and Meaning in Your Career . As a senior adviser of the Aspen Institute Business & Society Program, she helps business leaders find purpose in their work, and one of her favorite exercises is reading poetry. “It slows you down,” explains McGaw, by forcing readers to take their time, to pause, to reflect and to think differently — all of which can foster an “aha” moment in those seeking purpose.

13. Look for leadership opportunities

Whether you’re working or retired, there’s a good chance that your career has given you a sense of purpose at various points in your life. If that’s the case, you might correlate purpose with productivity and professional advancement — the pinnacle of which is leadership. But climbing the corporate ladder isn’t the only way to be a leader. “Leadership doesn’t always mean having a group of people who report to you,” observes McGaw, who says leadership isn’t about having control but about having influence. “Even people who are not working anymore can influence others to achieve goals or be their best selves.” If you derive purpose from having influence, look for leadership opportunities wherever they exist — philanthropic organizations, community groups or even condo boards.

14. Clarify your values 

Purpose requires prioritization, Kashdan says, suggesting it can be helpful to create a set of values. “If you had to list what are the fundamental values that you live by, what would they be? You might list things like compassion, caring for other people or your physical health,” he says. “You have to understand what values are prominent in your life, what values are important to you but not prominent, and what values are basically irrelevant to you.” Research has shown that students who remind themselves what their core values are — by spending as little as 10 minutes writing about them, for example — can experience prolonged academic achievement. You can turn values into purpose by making them actionable, says behavioral scientist Vic Strecher, a professor at the University of Michigan and author of Life on Purpose: How Living for What Matters Most Changes Everything . “Write down what matters most to you and add the word ‘be’ at the beginning,” suggests Strecher, who says someone who writes down “grandchildren” as important might turn that into “I’m here to be a really good grandparent.” “That helps you form a purpose,” he says. 

15. Tell your stories

For 40 years, social psychologist James Pennebaker has been studying the benefits of “expressive writing” — writing about emotional experiences as a form of therapy. His research and hundreds of derivative studies have found that people who write about their most traumatic experiences are happier and healthier. They enjoy lower blood pressure; stronger immune systems; less stress, anxiety and depression; better sleep; and superior focus. Expressive writing teacher Allison Fallon, author of  The Power of Writing It Down: A Simple Habit to Unlock Your Brain and Reimagine Your Life , says, “Writing your stories … forces you to think about yourself as the hero of your story.” Fallon says heroes face adversity and overcome it, often transforming in the process. “If you’re the hero in your story and you’re in the process of transforming, what is your life transformation all about? Who are you becoming? When you write your stories, you have to answer those questions to uncover what’s called a through line — what the hero’s story is all about. When you uncover that through line, it gives you clarity of purpose.”

16. Mine your grief

Strecher’s personal quest to find purpose began after the sudden death of his 19-year-old daughter from a heart attack. During a period of deep depression, he had a moment that he describes as his daughter’s spirit urging him to overcome his grief. Rattled, he set to work making a list of all the things that mattered in his life — such as his students. “I decided I was going to teach every student as if they were my daughter. … And when that happened, my teaching changed completely,” he recalls. “I started teaching with my heart rather than just my head. The duty of teaching and the pleasure of teaching merged, and suddenly there was no difficulty in it. It became a complete joy. And it became what I realized was a purpose.” Strecher says he now recognizes grief as an opportunity to turn something lost into something gained. “It could be a divorce, the loss of a job, the loss of a loved one, illness. We all go through things. And if we can just think about those tragedies as transitions, it can help us repurpose our lives.” 

17. Seek civic engagement

Purpose and belonging can supercharge each other, Serrano says. “When one has a strong sense of life purpose and direction and is among others who share those goals, it is likely that they will feel a deeper sense of belonging. … Relatedly, when one feels high belonging in any life setting, they are better equipped to direct energy toward tackling big challenges.” A 2023 report from the Center for Inclusion and Belonging titled “The Belonging Barometer: The State of Belonging in America” found that belonging is associated with increased civic engagement and trust — in neighbors, in local government and in institutions. Unfortunately, trust, social engagement and belonging are trending downward. More than half of Americans report a lack of connection to their neighborhood. “Civic engagement can look so many different ways — from serving on a jury to volunteering as a poll worker, participating in a public forum or even serving in an elected or appointed office, among others,” Serrano says.  

18. Solve a problem

Find “something that agitates you,” Conley suggests. This is how the world’s best inventions often come to be. People who were concerned with the fire risk posed by candles and oil lamps found solace in light bulbs, for example. People who hated throwing spoiled food away were delighted by refrigeration. And people who were exasperated by encyclopedias and libraries were among the first to celebrate the internet. Those and countless other innovations would not exist without people who recognized problems and dedicated their lives to solving them. That’s not to say you need to become an inventor. You might find purpose by devoting yourself to something that irks you. If you’re bothered by litter, clean up your neighborhood. If you’re irritated by people’s lack of manners, teach etiquette classes. If you’re vexed by high food prices, start a community garden.

19. Embrace your faith

Studies show that people who are religious tend to be happier than people who aren’t. In a 2022 poll of about 800 Americans, Gallup found that 92 percent of people who attended church services weekly said they were satisfied with their life, compared with 82 percent of those who attended church less than monthly. In 2019, the Pew Research Center reported that among U.S. adults, 36 percent who were religiously active said they were very happy compared with 25 percent who were religiously unaffiliated. “A large body of research shows religiosity to be positively associated with not just physical health but mental health. And those two things are very tightly intertwined,” says Michael Price, a senior lecturer in psychology at the U.K.’s Brunel University London. He attributes religiosity’s positive impact on health and happiness in part to its association with a sense of purpose. That doesn’t mean everyone should join a church. It does suggest that faith — whatever that means to you — could be a promising realm in which to seek purpose.

20. Expand your horizons

Kashdan says that finding your passions or purpose often takes legwork — pursuing new skills, studying new subjects and trying new activities. “Treat the world like it’s a high school where there’s hundreds of clubs to choose from,” he suggests. “You go for the first session of robotics club, and then you try out for the football team, and then you try out for the lawn bowling team, and then you study abroad in Italy for a semester. You’re not going to like everything, but you’re exploring.” If you’ve always wanted to learn a language or an instrument, now’s the time. If you’ve been wondering about pickleball or windsurfing, seize the day. And don’t just pursue interests that are comfortable. Try things that truly test you, advises Hurst, who says an important ingredient in purpose is growth — feeling like you’re always evolving. “You need to feel like you’re being pushed beyond your comfort zone,” Hurst says.  

21. Create your third act

If you’re like a lot of older adults, you spent the first part of your life dedicated to one or two purposes in particular: raising children and/or building a career. If you feel like those purposes have been fulfilled or are no longer relevant, Hurst suggests crafting a third identity. “There’s your work identity and, if you had kids, your parent identity. Now you want to cultivate your next identity,” he explains. “Maybe you want to develop yourself as an adventurer, so you make friends who also want to be adventurers, and you travel and explore. Or maybe you want to focus on health and well-being. You’ve spent 40 years neglecting yourself, so you’re going to devote yourself to caring for your body, mind and soul by getting back to the gym and going to yoga retreats, or whatever that looks like to you. Another option is volunteering and service. You want to be a change agent, so you develop an identity around that.” Think of it this way: If you had to describe the person you want to be in one sentence at a cocktail party, what would you say?

22. Cultivate a ‘purpose mindset’

You might not need to find purpose. With the right frame of mind, you might discover that you already have it. “People tend to think about purpose as a revelation or as something that will sort of come to them when, in fact, it’s something they need to cultivate,” Hurst says. “A purpose mindset at its core is about recognizing that we create meaning in our lives. It’s not something that’s given to us. We have the ability to live meaningful lives if we choose to do so.” The key to unlock a purpose mindset is reflection, according to Hurst. “I work with a lot of executives at nonprofits — doctors and educators who say their life has no meaning. Meanwhile, they’re saving babies all day. But they’re not taking time to reflect on it, which means they’re never actually storing that meaning in their meaning bank, and that’s preventing them from feeling like they have purpose.” Scholars have confirmed the benefits of self-reflection: A 2023 research review published in the journal Annual Review of Organizational Psychology and Organizational Behavior concluded that self-reflection can lead to “improved performance,” “enhanced health and well-being” and “more harmonious social relationships” — all of which could be useful in the pursuit of purpose.

23. Write your own book review

When he decided to write his book, Life on Purpose , Strecher had no idea where to begin. His editor suggested he start by penning a review of his book as if it had already been written and published. “He said … ‘That will force you into thinking about exactly what you want people to think and feel once they’ve read your book,’ ” recalls Strecher, who found the exercise so valuable that he recommends it as a tool for people who seek purpose. “Instead of a book, write a review of your life. What do you want people to say about you? It’s very much like the headstone test — if you died today, what would you want your epitaph to be?”

24. Name your heroes

You might find your purpose by way of admiring others who found theirs, Strecher suggests, citing Aristotle’s ancient treatise Rhetoric , in which the Greek philosopher describes the emotion of emulation — the realization that another person has acquired “good things that are highly valued.”  “In terms of finding purpose, Aristotle talked a lot about using other people who you respect that you might want to emulate,” says Strecher, who recommends making time to determine who your heroes are — loved ones, public figures or even fictional characters — why you admire them and how you can embody the same values that you perceive them possessing.

25. Affirm your purpose

Finding your purpose is only the first step toward actually living it, according to Strecher. He says it’s just as important to affirm your purpose as it is to discover it. “Once you have it, view it as a draft. Just try it out for size,” Strecher advises. “Then, as it starts forming and solidifying, maybe put it on your computer or your smartphone or on the wall of your office and start thinking about it on a regular basis. Affirming your purpose every day … really does help ground you.” Strecher likens affirming your purpose to waking up every morning and looking at the weather forecast to decide if you need a jacket or umbrella. “It’s about being anticipatory and prepared and asking yourself, What am I going to need in order to engage in my purpose today? You want to be just as prepared to engage in your purpose every day as you are to go outside.”

Matt Alderton has written about everything from classic cars and climate change to farming robots and fighter jets for publications such as USA Today, The Washington Post and Forbes . Originally from Denver, which boasts 300 days of sunshine a year, he now resides in Chicago, which boasts three. You can reach him on his website, MattAlderton.com.

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Physical Review Research

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Simplicity of mean-field theories in neural quantum states

Fabian ballar trigueros, tiago mendes-santos, and markus heyl, phys. rev. research 6 , 023261 – published 10 june 2024.

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The utilization of artificial neural networks to represent quantum many-body wave functions has garnered significant attention, with enormous recent progress for both ground states and nonequilibrium dynamics. However, quantifying state complexity within this neural quantum states framework remains elusive. In this study, we address this key open question from a complementary point of view: Which states are simple to represent with neural quantum states? Concretely, we show on a general level that ground states of mean-field theories with permutation symmetry require only a limited number of independent neural network parameters. We analytically establish that, in the thermodynamic limit, convergence to the ground state of the fully connected transverse-field Ising model (TFIM), the mean-field Ising model, can be achieved with just one single parameter. Expanding our analysis, we explore the behavior of the one-parameter ansatz under breaking of the permutation symmetry. For that purpose, we consider the TFIM with tunable long-range interactions, characterized by an interaction exponent α . We show analytically that the one-parameter ansatz for the neural quantum state still accurately captures the ground state for a whole range of values for 0 ≤ α ≤ 1 , implying a mean-field description of the model in this regime.

• Received 29 August 2023
• Accepted 8 April 2024

DOI: https://doi.org/10.1103/PhysRevResearch.6.023261

Published by the American Physical Society under the terms of the Creative Commons Attribution 4.0 International license. Further distribution of this work must maintain attribution to the author(s) and the published article's title, journal citation, and DOI.

Published by the American Physical Society

Physics Subject Headings (PhySH)

• Physical Systems

Authors & Affiliations

• Theoretical Physics III, Center for Electronic Correlations and Magnetism, Institute of Physics, University of Augsburg, 86135 Augsburg, Germany

Article Text

Vol. 6, Iss. 2 — June - August 2024

Subject Areas

• Quantum Physics
• Strongly Correlated Materials

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Permutation-invariant artificial neural networks and training. (a) An unconstrained structure of a general feed-forward network with one hidden layer. Dashed lines carry no variational parameters, whereas solid lines denote the fact that we compute the product between the input spin and a variational parameter. (b) Enforcing permutation symmetry leads effectively to a modified neural network architecture, where the input spin configuration is first transformed into a collective total spin before further processing occurs. (c) Training convergence and scaling of the ground state search process for the fully connected transverse-field Ising model for different numbers of hidden spins K at a fixed system size L = 12 . Here, ε rel is the relative energy error of the neural quantum state with the exact diagonalization result as a reference.

Relative energy for one variational parameter K = 1 under training iterations for several system sizes L . We used exact sampling when averaging over spin configurations.

Normalized energy fluctuations of the long-range interacting transverse-field Ising model are shown as a function of interaction range α for various system sizes. The fluctuations are normalized by the coupling J due to the inaccessibility of the gap in the thermodynamic limit for nonzero values of α . In red we show the limiting curve in the thermodynamic limit.

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