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Research methods--quantitative, qualitative, and more: overview.

  • Quantitative Research
  • Qualitative Research
  • Data Science Methods (Machine Learning, AI, Big Data)
  • Text Mining and Computational Text Analysis
  • Evidence Synthesis/Systematic Reviews
  • Get Data, Get Help!

About Research Methods

This guide provides an overview of research methods, how to choose and use them, and supports and resources at UC Berkeley. 

As Patten and Newhart note in the book Understanding Research Methods , "Research methods are the building blocks of the scientific enterprise. They are the "how" for building systematic knowledge. The accumulation of knowledge through research is by its nature a collective endeavor. Each well-designed study provides evidence that may support, amend, refute, or deepen the understanding of existing knowledge...Decisions are important throughout the practice of research and are designed to help researchers collect evidence that includes the full spectrum of the phenomenon under study, to maintain logical rules, and to mitigate or account for possible sources of bias. In many ways, learning research methods is learning how to see and make these decisions."

The choice of methods varies by discipline, by the kind of phenomenon being studied and the data being used to study it, by the technology available, and more.  This guide is an introduction, but if you don't see what you need here, always contact your subject librarian, and/or take a look to see if there's a library research guide that will answer your question. 

Suggestions for changes and additions to this guide are welcome! 

START HERE: SAGE Research Methods

Without question, the most comprehensive resource available from the library is SAGE Research Methods.  HERE IS THE ONLINE GUIDE  to this one-stop shopping collection, and some helpful links are below:

  • SAGE Research Methods
  • Little Green Books  (Quantitative Methods)
  • Little Blue Books  (Qualitative Methods)
  • Dictionaries and Encyclopedias  
  • Case studies of real research projects
  • Sample datasets for hands-on practice
  • Streaming video--see methods come to life
  • Methodspace- -a community for researchers
  • SAGE Research Methods Course Mapping

Library Data Services at UC Berkeley

Library Data Services Program and Digital Scholarship Services

The LDSP offers a variety of services and tools !  From this link, check out pages for each of the following topics:  discovering data, managing data, collecting data, GIS data, text data mining, publishing data, digital scholarship, open science, and the Research Data Management Program.

Be sure also to check out the visual guide to where to seek assistance on campus with any research question you may have!

Library GIS Services

Other Data Services at Berkeley

D-Lab Supports Berkeley faculty, staff, and graduate students with research in data intensive social science, including a wide range of training and workshop offerings Dryad Dryad is a simple self-service tool for researchers to use in publishing their datasets. It provides tools for the effective publication of and access to research data. Geospatial Innovation Facility (GIF) Provides leadership and training across a broad array of integrated mapping technologies on campu Research Data Management A UC Berkeley guide and consulting service for research data management issues

General Research Methods Resources

Here are some general resources for assistance:

  • Assistance from ICPSR (must create an account to access): Getting Help with Data , and Resources for Students
  • Wiley Stats Ref for background information on statistics topics
  • Survey Documentation and Analysis (SDA) .  Program for easy web-based analysis of survey data.

Consultants

  • D-Lab/Data Science Discovery Consultants Request help with your research project from peer consultants.
  • Research data (RDM) consulting Meet with RDM consultants before designing the data security, storage, and sharing aspects of your qualitative project.
  • Statistics Department Consulting Services A service in which advanced graduate students, under faculty supervision, are available to consult during specified hours in the Fall and Spring semesters.

Related Resourcex

  • IRB / CPHS Qualitative research projects with human subjects often require that you go through an ethics review.
  • OURS (Office of Undergraduate Research and Scholarships) OURS supports undergraduates who want to embark on research projects and assistantships. In particular, check out their "Getting Started in Research" workshops
  • Sponsored Projects Sponsored projects works with researchers applying for major external grants.
  • Next: Quantitative Research >>
  • Last Updated: Aug 6, 2024 3:06 PM
  • URL: https://guides.lib.berkeley.edu/researchmethods

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Research Basics: an open academic research skills course

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Lesson 2: What is Human Subjects Research?

Please note: This lesson will take approximately 1 hour and 35 minutes to complete. Use the next and previous buttons to advance through the course. You will be able to print a completion certificate for your records at the end of this training. OHRP does not collect information about who accesses it.

Do not refresh your browser. Refreshing your browser will restart the lesson.

Purpose of this Lesson

This lesson will explain how the Common Rule regulations define “research” and “human subjects” and explain what it means to be exempt from the regulations. This lesson focuses on the Revised Common Rule (or 2018 Requirements) that became effective in 2018.

Lesson Overview

This lesson contains four parts:

Part 1: Background of Human Subjects Research

Part 2: is the activity research, part 3: does the research involve human subjects, part 4: is the human subjects research exempt.

You will answer quiz questions throughout each part to test your knowledge. A correct response is required to advance in the lesson.

Learning Objectives

After completing this lesson, you will be able to:

  • Identify if a certain activity meets the regulatory definition of research.
  • Identify if research involves human subjects based on the regulatory definition.
  • Determine whether a particular project is non-exempt human subjects research under the Common Rule.

Go to Section: Introduction > The Concept of Non-exempt Human Subjects Research > Identifying Non-Exempt Human Subjects Research > Quiz Questions

Introduction

Cover page of Subpart A of 45 CFR Part 46

The Common Rule applies to human subjects research that is supported or conducted by a Common Rule agency. For research supported or conducted by the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) is the office with the authority to enforce the regulations. Many research institutions choose to apply the Common Rule to all of their human subjects research regardless of funding source.

This lesson focuses on the Revised Common Rule that became effective in 2018.

The Concept of Non-exempt Human Subjects Research

laboratory staff looking at a computer

Even when funded by a Common Rule agency, not all research involving humans is required to follow the Common Rule. The Rule only applies to activities that qualify as human subjects research under the regulation and that do not qualify for an exemption. This is commonly referred to as non-exempt human subjects research.

Note that, in addition to the Common Rule (subpart A), non-exempt human subjects research funded by HHS must also comply with subparts B, C, & D of the regulations at 45 CFR 46. These subparts provide additional protections for certain special populations involved in research.

This lesson explains how the regulations define research and human subjects and explains what it means to be exempt from the regulations. Understanding these concepts is important to knowing when the regulations apply and when they do not.

Identifying Non-Exempt Human Subjects Research

laboratory staff looking at a computer

To figure out whether a particular activity is non-exempt human subjects research under the Common Rule, ask the following three questions, in this order :

  • Is the activity research according to the regulations?
  • Does the research involve human subjects based on the definition in the regulations?
  • Is the human subjects research exempt?

The determination of whether a research study is non-exempt human subjects research is usually made by an institution’s Human Research Protection Program (HRPP) or IRB office. In addition to applying the Common Rule’s basic protections for human subjects in research, the HRPP or IRB office also may ensure that the activity aligns with institutional policies, ethical guidelines, and other regulations and policies that might be relevant.

What is non-exempt human subjects research?

All research involving human volunteers in the United States is required to follow the Common Rule. True or false?

An investigator plans to do a research project involving human subjects that is not funded by the Federal government. Can she proceed with her proposed project without IRB review?

In an institution, who usually determines whether a research study is non-exempt human subjects? (Select all that apply)

In deciding whether a project is non-exempt human subjects research under the Common Rule, what is the first question you should ask?

Go to Section: Defining Research > Categories of Activities Deemed Not to Be Research > Quiz Questions > Determining When the Common Rule Requirements Apply

Defining Research

Let’s start with the first question: Is the activity research according to the regulations?

Not all work that we would colloquially call ‘research’ is considered to be research under the Common Rule. The Common Rule defines research as:

“a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

To decide if a certain activity meets the regulatory definition of research, consider:

  • It would likely involve a hypothesis, research question, and a plan to systematically collect and analyze data.
  • The systematic investigation adds information and contributes to generalizable knowledge in the field.
  • For example, lots of information is published that comes from activities that do not meet the Common Rule’s definition of research. And sometimes results from research that meets the Common Rule definition never get published.

Categories of Activities Deemed Not to Be Research

The revised Common Rule also lists four specific types of activities that are deemed not to be research:

  • Scholarly and journalistic activities that focus on information specifically about certain individuals.
  • Certain public health surveillance activities.
  • Certain activities solely for criminal justice or criminal investigative purposes.
  • Certain operational activities in support of national security missions.

Review the regulatory descriptions of these four categories of activities deemed to be not research under §46.102(l).

Watch the video to learn more.

The Common Rule defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalize knowledge.” True or false?

What are the criteria for the regulatory definition of research? (Select all that apply)

Select all activities deemed not to be research under the Common Rule. (Select all that apply)

Clipboard Checked

Determining When the Common Rule Regulatory Requirements Apply

So, when deciding if a specific activity comes under the Common Rule,

First, ask whether it meets the regulatory definition for research—and remember to consider the four categories of activities deemed not to be research.

If the answer is “No,” then the Common Rule does not apply and, as a result, the activity does not have to be reviewed and approved by an IRB before starting. However , investigators should always check with their institution’s HRPP or IRB office to see whether there are institutional policies to follow even if the regulations don’t apply.

If, however, the answer to the first question is “ Yes ” – the activity does meet the regulatory definition of research, THEN ask the second question: Does the research involve human subjects?

Lesson 2 part 2 Determining When the Common Rule Requirements Apply

Go to Section: Defining Human Subject > Living Individuals > Identifying the Subject > Interaction and Intervention > Identifiable Private Information > Quiz Questions > Determining When the Common Rule Requirements Apply

Defining Human Subject

The revised Common Rule defines human subject as:

“a living individual about whom an investigator (whether professional or student) conducting research: (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.”

While there is a lot of detail in the definition of human subject, it generally boils down to this:

An investigator:

The research likely involves human subjects.

It is important to understand the key terms in this definition to determine when a research study involves human subjects according to the regulations.

Living Individuals

Human Subject: “ a living individual about whom an investigator (whether professional or student) conducting research: (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.”

laboratory staff holding a test tube

First of all, notice that it specifies living individuals. Therefore, for the purpose of the Common Rule, research that only involves information or biospecimens from deceased persons would not be considered human subjects research.

Identifying the Subject

Human Subject: “a living individual about whom an investigator (whether professional or student) conducting research: (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.”

A mother talking to a pediatrician

The phrase ‘about whom’ is important. A human subject is the person that the information is about, not necessarily the person providing the information. In the case of biospecimens, the human subject is the person from whom the specimen was taken.

For example:

An investigator gathers information about newborns by asking mothers questions only about the babies Only the babies are the human subjects
The investigator asks for information only about the mothers Only the mothers are human subjects
The investigator asks the mothers what they think about their babies’ behavior Only the mothers are human subjects
The investigator asks the mothers how the babies behave and what the mothers think about their behavior Both are human subjects

Interaction and Intervention

A patient talking with a doctor

  • Interactions occur when investigators communicate or have interpersonal contact with research participants, for example verbally, in writing, or electronically, to obtain information about them for the research.
  • Interventions , on the other hand, include both physical procedures by which investigators collect information or biospecimens and manipulations of the subjects or the subjects’ environment for the purpose of the research.
  • Examples of interventions include assigning subjects to take a particular drug in a clinical trial, asking subjects to complete a certain task for research purposes, and changing the background noise level to study how subjects’ stress levels vary.

Identifiable Private Information

Human Subject: “a living individual about whom an investigator (whether professional or student) conducting research: (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 .”

Closeup of a medical form

Note, also, that the researchers may or may not have interacted or intervened with the subject at all – for example, they might use leftover blood samples from clinical tests; but if the blood sample is identifiable, then the person is considered to be a human subject.

A proposed research project involves studying tissue samples from cadavers being used in a local medical school to train students. Personal information about the deceased individuals will be used in the research. Is this human subjects research?

Question 10

A proposed research project involves asking participants to complete a task and answer questions on a computer. No identifiable information will be recorded about participants. Is this human subjects research?

Question 11

A proposed research project will use leftover blood samples from clinical tests to check for levels of a certain metabolite. Investigators will also review patients’ identifiable medical records to obtain other necessary health information. Is this human subjects research?

Question 12

Which of the following activities, when carried out for the purpose of research, would constitute research involving human subjects under the Common Rule? (Select all that apply)

Question 13

Research that only involves specimens from deceased persons would not be considered human subjects research. True or false?

Apply this definition of “human subjects” to your research to determine whether your research study constitutes human subjects research under the Common Rule. If the answer is “no,” then the Common Rule does not apply.

If, on the other hand, the answer to this second question is “yes,” and it is human subjects research, then you go on to the third question: Is it exempt?

Lesson 2 Part 3 Determining When the Common Rule Requirements Apply

Go to Section: Could the Human Subjects Research Be Exempt? > Exempt Human Subjects Research > Quiz Questions > Determining When the Common Rule Requirements Apply

Could the Human Subjects Research Be Exempt?

There are eight exemption categories listed in the revised Common Rule. If all of the activities in a human subjects research study meet the criteria for one or more of these exemption categories, the study is exempt from the Common Rule requirements for oversight. This means, for example, that the research does not need to undergo initial or continuing IRB review for approval as required by the regulations.

laboratory staff holding a test tube

The Common Rule does not specify who can make determinations about exemptions. Most institutions require that investigators submit proposed research to the institution’s HRPP or IRB office for the determination about whether it meets the criteria for an exemption. Additionally, certain exemptions require a “limited IRB review” to determine that specific conditions are met for the exemption to apply.

Exempt Human Subjects Research

An entire human subjects research projects that has been determined to meet the conditions for one or more exemption categories in the Common Rule can generally proceed without having to comply with the regulatory requirements.

Staff discussing in a meeting

One thing to remember, however, is that if investigators make changes to the research at a later time, they should check with their institution’s HRPP or IRB office to make sure that the research still meets the exemption criteria. If the changes cause the research study to no longer meet the criteria for exemption, then the research is no longer exempt and must comply with the regulatory requirements and undergo IRB review . Investigators should work closely with their HRPP or IRB office to avoid surprises like this that could affect the progress of their research.

Click here to watch a video explaining the exemption categories.

Question 14

What does it mean for a research project to be exempt?

Question 15

The Common Rule specifies who should make determinations about exemptions. True or false?

Question 16

Where should a researcher go to inquire whether something qualifies as an exemption? (Select all that could apply)

Question 17

Once a research study is determined to be exempt, it will always be exempt regardless of any subsequent changes that might be made to it. True or false?

Human subjects research studies that do not qualify for an exemption are referred to as non-exempt human subjects research. Unless there is a Secretarial waiver, they must comply with the Common Rule regulatory requirements, including IRB review and approval, before the research can begin. For non-exempt cooperative research studies involving multiple institutions, the review would generally be done by a single IRB.

Lesson 2 Part 3 Determining When the Common Rule Requirements Apply

Go to Section: Wrap Up > Completion Certificate

Lab technicians working at a laboratory

This lesson explained the process of determining whether a research project meets the criteria for being non-exempt human subjects research under the Common Rule. Remember that if it doesn’t satisfy the regulatory definition of either research or human subject, or if all of the activities in the human subjects research meet the criteria for one or more of the exemptions, then the Common Rule regulatory requirements do not apply to the project, but investigators may still be subject to any institutional policies that are in place. Investigators should work with their institution’s Human Research Protection Program (HRPP) or IRB office to find answers and determine how to proceed.

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Human subjects research at Harvard University is guided by the ethical principles set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56 .

Consider Your Tools and Timing

Knowing what resources are available as well as how long a review might take are important to consider. See below for information on these aspects.

tool bench with hanging tools

We’re happy you found the HUA IRB website which is your first stop for all things that involve human subjects research.

Quick Access Resources

Not sure where to start or if your research even requires IRB review? Check out our IRB Lifecycle Guide which takes you through the IRB review process step-by-step.

Consider perusing the IRB News tab and signing up for our Newsletter .

Deep Dive Resources

Harvard University Human Research Protection Program (HRPP) Plan - This is the "30,000 foot view" document that ties all of the pieces of our program together. It defines roles and mission and includes a complete outline of the regulatory requirements that must be met. Please also see the HRPP Overview page for more information.

Investigator Manual   - This is your comprehensive guide - Keep it close by! The Investigator Manual covers all topics here on our website plus many more, including: reporting financial interests, consent considerations, conflict of interest, data management/security, research in schools, secondary data analysis, deception and incomplete disclosure, subject pools, additional requirements for federally funded research, HIPAA privacy rule, Principal Investigator responsibilities and assurance statement, Provostial review, and more.

ESTR is the Electronic Submission Tracking and Reporting tool that researchers and the IRB use for all study submissions. You will need to be a Harvard Researcher to access it. Resources for using ESTR are:

  • IRB Study Submission Guide
  • ESTR Support Site

Watch face close up

Timing is of great concern for many researchers. HUA IRB reviews studies on a first come, first served basis. We do our best to honor urgent needs however, it is best to allow a minimum of 4 to 6 weeks from the time of submission to a complete review. The time of review is impacted by many factors: the complexity of the study, the need for ancillary reviews, and the office workload. 

What is an Ancillary Review?

As you begin to plan your research project, consider that your study may require reviews beyond just the IRB. Below are a few factors to keep in mind that may add time to your overall IRB study review timeline:

Reliance Agreements/Collaborations - These are managed by our office and involve collaboration with another institution. 

Ancillary Reviews – Below are a sample of reviews that happen outside of the IRB office.

  • Harvard Research Data Security Policy (HRDSP)
  • Provostial Review
  • Conflict of Interest Disclosure
  • International Projects and Collaboration

Upon receipt of your submission, the IRB will conduct an initial review and refer any ancillary reviews to the appropriate office. Only once these reviews are completed can the IRB reviewer complete the human subjects review

IRB Office Metrics

Interested in knowing how long a particular type of review might take? The Harvard IRB office publishes metrics and other key performance activities on our website. You can access the Report on Operations here .

Seal_2

Defining Research with Human Subjects

A study is considered research with human subjects if it meets the definitions of both research AND human subjects, as defined in the federal regulations for protecting research subjects.

Research.  A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

Human subject:  A living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The following sections will explain some of the words in the previous definitions.

The regulatory language:

A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

The explanation:

Understanding what constitutes a systematic inquiry varies among disciplines and depends on the procedures and steps used to answer research questions and how the search for knowledge is organize and structured.

Pilot Studies and Research Development

Pilot studies are designed to conduct preliminary analyses before committing to a full-blown study or experiment.

Research development includes activities such as convening a focus group consisting of members of the proposed research population to help develop a culturally appropriate questionnaire.

Practical applications:

  • You are conducting a pilot study or other activities preliminary to research; or
  • You have designed a study to collect information or biospecimens in a systematic way to answer a research question; or
  • You intend to study, analyze, or otherwise use existing information or biospecimens to answer a research question.

Human Subjects

Human subjects are living individuals about whom researchers obtain information or biospecimens through interaction, intervention, or observation of private behavior, to also include the use, study, and analysis of said information or biospecimens.

Obtaining, using, analyzing, and generating identifiable private information or identifiable biospecimens that are provided to a researcher is also considered to be human subjects.

To meet the definition of human subjects, the data being collected or used are about people. Asking participants questions about their attitudes, opinions, preferences, behavior, experiences, background/history, and characteristics, or analyzing demographic, academic or medical records, are just some examples of human subjects data.

  • Interacting with people to gather data about them using methods such as interviews, focus groups, questionnaires, and participant observation; or
  • Conducting interventions with people such as experiments or manipulations of subjects or subjects' environments; or
  • Observing or recording behavior, whether in-person and captured in real time or in virtual spaces, like social media sites (e.g., Twitter) or online forums (e.g., Reddit); or
  • Obtaining existing information about individuals, such as students’ school records or patients’ health records, or data sets provided by another researcher or organization.

Interactions and Interventions

Interventions are manipulations of the subject or the subject's environment, for example is a behavioral change study using text messages about healthy foods.

Interactions include communication or interpersonal contact between investigator and participant.

A study may include both interventions and interactions.

Interactions and interventions do not require in-person contact, but may be conducted on-line.

Private Information

Private information  includes information or biospecimens: 1) about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place; 2) that has been provided for specific purposes by an individual; and 3) that the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for the information to constitute research involving human subjects.

The regulations are clear that it is the subjects’ expectations that determine what behaviors, biospecimens, and identifiable information must be considered private. Subjects’ understanding of what privacy means are not universal, but are very specific and based on multiple interrelated factors, such as the research setting, cultural norms, the age of the subjects, and life experiences. For example, in the United States, health records are considered private and protected by law, but in some countries, health information is not considered private but are of communal concern. 

Identifiable Information

The identity of the subject is associated with the data gathered from the subject(s) existing data about the subjects. Even if the data (including biospecimens) do not include direct identifiers, such as names or email addresses, the data are considered identifiable if names of individuals can easily be deduced from the data.

If there are keys linking individuals to their data, the data are considered identifiable.

Levels of Review

Not all projects that meet the definition of research with human subjects need review by the actual committee. For example, projects that pose  negligible risk to participants may be reviewed and recommended for approval by IRB staff ; other projects may need to undergo review and approval by at least one member of the IRB committee or a quorum of the full board. Determination as to the need for review should always be made by the IRB staff.

Examples of Studies That MAY Meet the Definition of Research with Human Subjects

The following examples will likely require further consultation with an IRB staff member.

Analysis of existing information with no identifiers

If researchers have no interaction with human subjects, but will be conducting a secondary analysis of existing data without individual identifiers, the analysis of those data may not be research with human subjects. 

Expert consultation

Key words in the definition of a human subject are "a living individual about whom" a researcher obtains, uses, studies, analyzes, or generates information. People can provide you information that is not about them but is important for the research. For example, a researcher may contact non-governmental organizations to ask about sources of funding.

Program evaluations and quality improvement studies

Program evaluations are generally intended to query whether a particular program or curriculum meets its goals. They often involve pre- and post-surveys or evaluations.

Some program evaluations include a research component. If data are collected about the characteristics of the participants to analyze the relationship between demographic variable and success of the program, the study may become research with human subjects.  Research question:  Are there different learning outcomes associated with different levels of participant confidence?

Classroom research

Classes designed to teach research methods such as fieldwork, statistical analysis, or interview techniques, may assign students to conduct interviews, distribute questionnaires, or engage in participant observation. If the purpose of these activities is solely pedagogical and are not designed to contribute to a body of knowledge, the activities do not meet the definition of research with human subjects. 

Vignettes: Applying the Definitions

Art in Cambodia

An art history student wants to study art created by Cambodians in response to the massacres committed by the Khmer Rouge. The art she will study includes paintings, sculpture, video, and the performing arts.

Much of the research will be archival, using library and online resources. In addition, she will visit Cambodia. While there, she will speak with several museum curators for assistance locating and viewing art collections related to the massacres.

Is this research with human subjects?

No. Although the student will speak with curators, they are not the subjects of her research and she is not interested in learning anything about them. They will, in effect, serve as local guides.

What would make the study research with human subjects?

The student interviews people as they interact with art to understand the role of the arts in evoking and/or coming to terms with traumatic past events. She interviews people who view the art, such as visitors to museums, and discusses what the art means to them. She may collect information about their experiences during the genocide and compare those experiences with their reactions to the art. 

Bank-Supported Micro-Finance in Chile

A researcher is interested in the practice of microfinance in the Chilean Mapuche community. She meets with bankers and asks about the criteria for granting loans, the demographics of the people who receive loans, the types of businesses to which the bank prefers to grant loans, how many loans they give, the payback rates, and other data about the bank’s loan practices.

No. Although the researcher is interviewing bankers, the bankers are only providing information about their banking practices and are not providing any information about themselves. The questions are about “what” rather than “about whom.” The bankers are not human subjects. This type of interview is sometimes referred to as expert consultation.

The researcher explores the impact of small loans, both intended and unintended, on the recipients of the loans. The researcher interviews the recipients of the loans and gathers information from them about their lives before and after they received funding, how the loans affected their relationships with family members and other community members, the impact of the loans on their aspirations, and so on. He asks “about whom” questions designed to understand the impact of micro-loans.

Developing Teaching Materials

A researcher goes to a country in which the infrastructure has been severely damaged to help rebuild schools. The student interviews community members about what curricular materials they need, develops some materials, and teaches a math class.

No. Although interviews are conducted, the intent of interviewing is to assist in resource development rather than answer a research question designed to contribute to a field of knowledge.

If the researcher does pre- and post-testing to assess student learning in his class, is this research with human subjects?

No. The intent is to find out if the materials are effective. This is sometimes referred to as program assessment.

What would make this research with human subjects?

The researcher studies the impact of nutrition and personal variables on learning. He assesses the nutritional composition of the local diet, assesses students’ general health, and compares those data with test scores. He also measures motivation, family composition, and other characteristics of the students using written questionnaires.

Water Conservation

A researcher wants to find out if the campus water conservation program is effective. She will gather some information about water volume usage from the University engineering department. She will also survey residential students about their water usage habits over the last six months, their perceptions of the campus drought education program, and their reactions to the incentives offered by the program (water-saving competitions, free water-saving devices, etc.) She will report her findings to the program’s steering committee and administrators.

No. Although the researcher will systematically survey other students and will be collecting information about them, her intention is to assess the effectiveness of the conservation program.

The researcher designs an online survey to collect information that may help understand factors that influence the residential students’ responses to the conservation program. She asks questions about green attitudes and behaviors, positions on social and political issues, as well as motivation and narcissism.

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Are you planning on conducting human subjects research? Learn more about research that meets the definition human subjects research, Federal regulation requirements, and whether your project may be considered exempt. Also, learn about NIH-specific considerations and become more familiar with NIH policies, and other regulations as it relates to human subjects research protections.

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Learn about the process of applying for a grant, cooperative agreement, or R&D contract, as it relates to the involvement of human subjects research. Find useful resources on how to prepare your Protection of Human Subjects section, and learn about next steps after submitting your grant application or proposal.

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If you are submitting a grant application or responding to a contract proposal to NIH that includes a clinical trial, or are involved with conducting, managing, or overseeing clinical trials, learn about NIH policies, and find resources to guide you in your work.

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NIH is committed to supporting clinical research that benefits individuals of all sexes/genders, races, ethnicities, and ages. The information provided on this website is designed to assist the extramural community in addressing inclusion, including the Inclusion of Women and Minorities policy and the Inclusion Across the Lifespan policy, in NIH grant applications and progress reports.

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Module 1: Introduction: What is Research?

Module 1

Learning Objectives

By the end of this module, you will be able to:

  • Explain how the scientific method is used to develop new knowledge
  • Describe why it is important to follow a research plan

Text Box: The Scientific Method

The Scientific Method consists of observing the world around you and creating a  hypothesis  about relationships in the world. A hypothesis is an informed and educated prediction or explanation about something. Part of the research process involves testing the  hypothesis , and then examining the results of these tests as they relate to both the hypothesis and the world around you. When a researcher forms a hypothesis, this acts like a map through the research study. It tells the researcher which factors are important to study and how they might be related to each other or caused by a  manipulation  that the researcher introduces (e.g. a program, treatment or change in the environment). With this map, the researcher can interpret the information he/she collects and can make sound conclusions about the results.

Research can be done with human beings, animals, plants, other organisms and inorganic matter. When research is done with human beings and animals, it must follow specific rules about the treatment of humans and animals that have been created by the U.S. Federal Government. This ensures that humans and animals are treated with dignity and respect, and that the research causes minimal harm.

No matter what topic is being studied, the value of the research depends on how well it is designed and done. Therefore, one of the most important considerations in doing good research is to follow the design or plan that is developed by an experienced researcher who is called the  Principal Investigator  (PI). The PI is in charge of all aspects of the research and creates what is called a  protocol  (the research plan) that all people doing the research must follow. By doing so, the PI and the public can be sure that the results of the research are real and useful to other scientists.

Module 1: Discussion Questions

  • How is a hypothesis like a road map?
  • Who is ultimately responsible for the design and conduct of a research study?
  • How does following the research protocol contribute to informing public health practices?

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1000+ FREE Research Topics & Title Ideas

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Select your area of interest to view a collection of potential research topics and ideas.

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PS – You can also check out our free topic ideation webinar for more ideas

How To Find A Research Topic

If you’re struggling to get started, this step-by-step video tutorial will help you find the perfect research topic.

Research Topic FAQs

What (exactly) is a research topic.

A research topic is the subject of a research project or study – for example, a dissertation or thesis. A research topic typically takes the form of a problem to be solved, or a question to be answered.

A good research topic should be specific enough to allow for focused research and analysis. For example, if you are interested in studying the effects of climate change on agriculture, your research topic could focus on how rising temperatures have impacted crop yields in certain regions over time.

To learn more about the basics of developing a research topic, consider our free research topic ideation webinar.

What constitutes a good research topic?

A strong research topic comprises three important qualities : originality, value and feasibility.

  • Originality – a good topic explores an original area or takes a novel angle on an existing area of study.
  • Value – a strong research topic provides value and makes a contribution, either academically or practically.
  • Feasibility – a good research topic needs to be practical and manageable, given the resource constraints you face.

To learn more about what makes for a high-quality research topic, check out this post .

What's the difference between a research topic and research problem?

A research topic and a research problem are two distinct concepts that are often confused. A research topic is a broader label that indicates the focus of the study , while a research problem is an issue or gap in knowledge within the broader field that needs to be addressed.

To illustrate this distinction, consider a student who has chosen “teenage pregnancy in the United Kingdom” as their research topic. This research topic could encompass any number of issues related to teenage pregnancy such as causes, prevention strategies, health outcomes for mothers and babies, etc.

Within this broad category (the research topic) lies potential areas of inquiry that can be explored further – these become the research problems . For example:

  • What factors contribute to higher rates of teenage pregnancy in certain communities?
  • How do different types of parenting styles affect teen pregnancy rates?
  • What interventions have been successful in reducing teenage pregnancies?

Simply put, a key difference between a research topic and a research problem is scope ; the research topic provides an umbrella under which multiple questions can be asked, while the research problem focuses on one specific question or set of questions within that larger context.

How can I find potential research topics for my project?

There are many steps involved in the process of finding and choosing a high-quality research topic for a dissertation or thesis. We cover these steps in detail in this video (also accessible below).

How can I find quality sources for my research topic?

Finding quality sources is an essential step in the topic ideation process. To do this, you should start by researching scholarly journals, books, and other academic publications related to your topic. These sources can provide reliable information on a wide range of topics. Additionally, they may contain data or statistics that can help support your argument or conclusions.

Identifying Relevant Sources

When searching for relevant sources, it’s important to look beyond just published material; try using online databases such as Google Scholar or JSTOR to find articles from reputable journals that have been peer-reviewed by experts in the field.

You can also use search engines like Google or Bing to locate websites with useful information about your topic. However, be sure to evaluate any website before citing it as a source—look for evidence of authorship (such as an “About Us” page) and make sure the content is up-to-date and accurate before relying on it.

Evaluating Sources

Once you’ve identified potential sources for your research project, take some time to evaluate them thoroughly before deciding which ones will best serve your purpose. Consider factors such as author credibility (are they an expert in their field?), publication date (is the source current?), objectivity (does the author present both sides of an issue?) and relevance (how closely does this source relate to my specific topic?).

By researching the current literature on your topic, you can identify potential sources that will help to provide quality information. Once you’ve identified these sources, it’s time to look for a gap in the research and determine what new knowledge could be gained from further study.

How can I find a good research gap?

Finding a strong gap in the literature is an essential step when looking for potential research topics. We explain what research gaps are and how to find them in this post.

How should I evaluate potential research topics/ideas?

When evaluating potential research topics, it is important to consider the factors that make for a strong topic (we discussed these earlier). Specifically:

  • Originality
  • Feasibility

So, when you have a list of potential topics or ideas, assess each of them in terms of these three criteria. A good topic should take a unique angle, provide value (either to academia or practitioners), and be practical enough for you to pull off, given your limited resources.

Finally, you should also assess whether this project could lead to potential career opportunities such as internships or job offers down the line. Make sure that you are researching something that is relevant enough so that it can benefit your professional development in some way. Additionally, consider how each research topic aligns with your career goals and interests; researching something that you are passionate about can help keep motivation high throughout the process.

How can I assess the feasibility of a research topic?

When evaluating the feasibility and practicality of a research topic, it is important to consider several factors.

First, you should assess whether or not the research topic is within your area of competence. Of course, when you start out, you are not expected to be the world’s leading expert, but do should at least have some foundational knowledge.

Time commitment

When considering a research topic, you should think about how much time will be required for completion. Depending on your field of study, some topics may require more time than others due to their complexity or scope.

Additionally, if you plan on collaborating with other researchers or institutions in order to complete your project, additional considerations must be taken into account such as coordinating schedules and ensuring that all parties involved have adequate resources available.

Resources needed

It’s also critically important to consider what type of resources are necessary in order to conduct the research successfully. This includes physical materials such as lab equipment and chemicals but can also include intangible items like access to certain databases or software programs which may be necessary depending on the nature of your work. Additionally, if there are costs associated with obtaining these materials then this must also be factored into your evaluation process.

Potential risks

It’s important to consider the inherent potential risks for each potential research topic. These can include ethical risks (challenges getting ethical approval), data risks (not being able to access the data you’ll need), technical risks relating to the equipment you’ll use and funding risks (not securing the necessary financial back to undertake the research).

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10.1 Overview of Single-Subject Research

Learning objectives.

  • Explain what single-subject research is, including how it differs from other types of psychological research.
  • Explain what case studies are, including some of their strengths and weaknesses.
  • Explain who uses single-subject research and why.

What Is Single-Subject Research?

Single-subject research is a type of quantitative research that involves studying in detail the behavior of each of a small number of participants. Note that the term single-subject does not mean that only one participant is studied; it is more typical for there to be somewhere between two and 10 participants. (This is why single-subject research designs are sometimes called small- n designs, where n is the statistical symbol for the sample size.) Single-subject research can be contrasted with group research , which typically involves studying large numbers of participants and examining their behavior primarily in terms of group means, standard deviations, and so on. The majority of this book is devoted to understanding group research, which is the most common approach in psychology. But single-subject research is an important alternative, and it is the primary approach in some areas of psychology.

Before continuing, it is important to distinguish single-subject research from two other approaches, both of which involve studying in detail a small number of participants. One is qualitative research, which focuses on understanding people’s subjective experience by collecting relatively unstructured data (e.g., detailed interviews) and analyzing those data using narrative rather than quantitative techniques. Single-subject research, in contrast, focuses on understanding objective behavior through experimental manipulation and control, collecting highly structured data, and analyzing those data quantitatively.

It is also important to distinguish single-subject research from case studies. A case study is a detailed description of an individual, which can include both qualitative and quantitative analyses. (Case studies that include only qualitative analyses can be considered a type of qualitative research.) The history of psychology is filled with influential cases studies, such as Sigmund Freud’s description of “Anna O.” (see Note 10.5 “The Case of “Anna O.”” ) and John Watson and Rosalie Rayner’s description of Little Albert (Watson & Rayner, 1920), who learned to fear a white rat—along with other furry objects—when the researchers made a loud noise while he was playing with the rat. Case studies can be useful for suggesting new research questions and for illustrating general principles. They can also help researchers understand rare phenomena, such as the effects of damage to a specific part of the human brain. As a general rule, however, case studies cannot substitute for carefully designed group or single-subject research studies. One reason is that case studies usually do not allow researchers to determine whether specific events are causally related, or even related at all. For example, if a patient is described in a case study as having been sexually abused as a child and then as having developed an eating disorder as a teenager, there is no way to determine whether these two events had anything to do with each other. A second reason is that an individual case can always be unusual in some way and therefore be unrepresentative of people more generally. Thus case studies have serious problems with both internal and external validity.

The Case of “Anna O.”

Sigmund Freud used the case of a young woman he called “Anna O.” to illustrate many principles of his theory of psychoanalysis (Freud, 1961). (Her real name was Bertha Pappenheim, and she was an early feminist who went on to make important contributions to the field of social work.) Anna had come to Freud’s colleague Josef Breuer around 1880 with a variety of odd physical and psychological symptoms. One of them was that for several weeks she was unable to drink any fluids. According to Freud,

She would take up the glass of water that she longed for, but as soon as it touched her lips she would push it away like someone suffering from hydrophobia.…She lived only on fruit, such as melons, etc., so as to lessen her tormenting thirst (p. 9).

But according to Freud, a breakthrough came one day while Anna was under hypnosis.

[S]he grumbled about her English “lady-companion,” whom she did not care for, and went on to describe, with every sign of disgust, how she had once gone into this lady’s room and how her little dog—horrid creature!—had drunk out of a glass there. The patient had said nothing, as she had wanted to be polite. After giving further energetic expression to the anger she had held back, she asked for something to drink, drank a large quantity of water without any difficulty, and awoke from her hypnosis with the glass at her lips; and thereupon the disturbance vanished, never to return.

Freud’s interpretation was that Anna had repressed the memory of this incident along with the emotion that it triggered and that this was what had caused her inability to drink. Furthermore, her recollection of the incident, along with her expression of the emotion she had repressed, caused the symptom to go away.

As an illustration of Freud’s theory, the case study of Anna O. is quite effective. As evidence for the theory, however, it is essentially worthless. The description provides no way of knowing whether Anna had really repressed the memory of the dog drinking from the glass, whether this repression had caused her inability to drink, or whether recalling this “trauma” relieved the symptom. It is also unclear from this case study how typical or atypical Anna’s experience was.

Figure 10.2

Freud's

“Anna O.” was the subject of a famous case study used by Freud to illustrate the principles of psychoanalysis.

Wikimedia Commons – public domain.

Assumptions of Single-Subject Research

Again, single-subject research involves studying a small number of participants and focusing intensively on the behavior of each one. But why take this approach instead of the group approach? There are several important assumptions underlying single-subject research, and it will help to consider them now.

First and foremost is the assumption that it is important to focus intensively on the behavior of individual participants. One reason for this is that group research can hide individual differences and generate results that do not represent the behavior of any individual. For example, a treatment that has a positive effect for half the people exposed to it but a negative effect for the other half would, on average, appear to have no effect at all. Single-subject research, however, would likely reveal these individual differences. A second reason to focus intensively on individuals is that sometimes it is the behavior of a particular individual that is primarily of interest. A school psychologist, for example, might be interested in changing the behavior of a particular disruptive student. Although previous published research (both single-subject and group research) is likely to provide some guidance on how to do this, conducting a study on this student would be more direct and probably more effective.

A second assumption of single-subject research is that it is important to discover causal relationships through the manipulation of an independent variable, the careful measurement of a dependent variable, and the control of extraneous variables. For this reason, single-subject research is often considered a type of experimental research with good internal validity. Recall, for example, that Hall and his colleagues measured their dependent variable (studying) many times—first under a no-treatment control condition, then under a treatment condition (positive teacher attention), and then again under the control condition. Because there was a clear increase in studying when the treatment was introduced, a decrease when it was removed, and an increase when it was reintroduced, there is little doubt that the treatment was the cause of the improvement.

A third assumption of single-subject research is that it is important to study strong and consistent effects that have biological or social importance. Applied researchers, in particular, are interested in treatments that have substantial effects on important behaviors and that can be implemented reliably in the real-world contexts in which they occur. This is sometimes referred to as social validity (Wolf, 1976). The study by Hall and his colleagues, for example, had good social validity because it showed strong and consistent effects of positive teacher attention on a behavior that is of obvious importance to teachers, parents, and students. Furthermore, the teachers found the treatment easy to implement, even in their often chaotic elementary school classrooms.

Who Uses Single-Subject Research?

Single-subject research has been around as long as the field of psychology itself. In the late 1800s, one of psychology’s founders, Wilhelm Wundt, studied sensation and consciousness by focusing intensively on each of a small number of research participants. Herman Ebbinghaus’s research on memory and Ivan Pavlov’s research on classical conditioning are other early examples, both of which are still described in almost every introductory psychology textbook.

In the middle of the 20th century, B. F. Skinner clarified many of the assumptions underlying single-subject research and refined many of its techniques (Skinner, 1938). He and other researchers then used it to describe how rewards, punishments, and other external factors affect behavior over time. This work was carried out primarily using nonhuman subjects—mostly rats and pigeons. This approach, which Skinner called the experimental analysis of behavior —remains an important subfield of psychology and continues to rely almost exclusively on single-subject research. For excellent examples of this work, look at any issue of the Journal of the Experimental Analysis of Behavior . By the 1960s, many researchers were interested in using this approach to conduct applied research primarily with humans—a subfield now called applied behavior analysis (Baer, Wolf, & Risley, 1968). Applied behavior analysis plays an especially important role in contemporary research on developmental disabilities, education, organizational behavior, and health, among many other areas. Excellent examples of this work (including the study by Hall and his colleagues) can be found in the Journal of Applied Behavior Analysis .

Although most contemporary single-subject research is conducted from the behavioral perspective, it can in principle be used to address questions framed in terms of any theoretical perspective. For example, a studying technique based on cognitive principles of learning and memory could be evaluated by testing it on individual high school students using the single-subject approach. The single-subject approach can also be used by clinicians who take any theoretical perspective—behavioral, cognitive, psychodynamic, or humanistic—to study processes of therapeutic change with individual clients and to document their clients’ improvement (Kazdin, 1982).

Key Takeaways

  • Single-subject research—which involves testing a small number of participants and focusing intensively on the behavior of each individual—is an important alternative to group research in psychology.
  • Single-subject studies must be distinguished from case studies, in which an individual case is described in detail. Case studies can be useful for generating new research questions, for studying rare phenomena, and for illustrating general principles. However, they cannot substitute for carefully controlled experimental or correlational studies because they are low in internal and external validity.
  • Single-subject research has been around since the beginning of the field of psychology. Today it is most strongly associated with the behavioral theoretical perspective, but it can in principle be used to study behavior from any perspective.
  • Practice: Find and read a published article in psychology that reports new single-subject research. (A good source of articles published in the Journal of Applied Behavior Analysis can be found at http://seab.envmed.rochester.edu/jaba/jabaMostPop-2011.html .) Write a short summary of the study.

Practice: Find and read a published case study in psychology. (Use case study as a key term in a PsycINFO search.) Then do the following:

  • Describe one problem related to internal validity.
  • Describe one problem related to external validity.
  • Generate one hypothesis suggested by the case study that might be interesting to test in a systematic single-subject or group study.

Baer, D. M., Wolf, M. M., & Risley, T. R. (1968). Some current dimensions of applied behavior analysis. Journal of Applied Behavior Analysis , 1 , 91–97.

Freud, S. (1961). Five lectures on psycho-analysis . New York, NY: Norton.

Kazdin, A. E. (1982). Single-case research designs: Methods for clinical and applied settings . New York, NY: Oxford University Press.

Skinner, B. F. (1938). The behavior of organisms: An experimental analysis . New York, NY: Appleton-Century-Crofts.

Watson, J. B., & Rayner, R. (1920). Conditioned emotional reactions. Journal of Experimental Psychology , 3 , 1–14.

Wolf, M. (1976). Social validity: The case for subjective measurement or how applied behavior analysis is finding its heart. Journal of Applied Behavior Analysis, 11 , 203–214.

Research Methods in Psychology Copyright © 2016 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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Whole Person Health: What It Is and Why It's Important

.header_greentext{color:greenimportant;font-size:24pximportant;font-weight:500important;}.header_bluetext{color:blueimportant;font-size:18pximportant;font-weight:500important;}.header_redtext{color:redimportant;font-size:28pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;font-size:28pximportant;font-weight:500important;}.header_purpletext{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.header_yellowtext{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.header_blacktext{color:blackimportant;font-size:22pximportant;font-weight:500important;}.header_whitetext{color:whiteimportant;font-size:22pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;}.green_header{color:greenimportant;font-size:24pximportant;font-weight:500important;}.blue_header{color:blueimportant;font-size:18pximportant;font-weight:500important;}.red_header{color:redimportant;font-size:28pximportant;font-weight:500important;}.purple_header{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.yellow_header{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.black_header{color:blackimportant;font-size:22pximportant;font-weight:500important;}.white_header{color:whiteimportant;font-size:22pximportant;font-weight:500important;} what is whole person health.

Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote either health or disease. It means helping and empowering individuals, families, communities, and populations to improve their health in multiple interconnected biological, behavioral, social, and environmental areas. Instead of just treating a specific disease, whole person health focuses on restoring health, promoting resilience, and preventing diseases across a lifespan.

Multilevel Whole Person Health Framework

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} Why is whole person health important?

Health and disease are not separate, disconnected states but instead occur on a path that can move in two different directions, either toward health or toward disease.

On this path, many factors, including one’s biological makeup; some unhealthy behaviors, such as poor diet, sedentary lifestyle, chronic stress, and poor sleep; as well as social aspects of life—the conditions in which people are born, grow, live, work, and age—can lead to chronic diseases of more than one organ system. On the other hand, self-care, lifestyle, and behavioral interventions may help with the return to health.

Chronic diseases, such as diabetes, cardiovascular disease, obesity, and degenerative joint disease, can also occur with chronic pain, depression, and opioid misuse—all conditions exacerbated by chronic stress. Some chronic diseases increase the immediate and long-term risks with COVID-19 infection. Understanding the condition in which a person has lived, addressing behaviors at an early stage, and managing stress can not only prevent multiple diseases but also help restore health and stop the progression to disease across a person’s lifespan.

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Some health care systems and programs are now focusing more on whole person health.

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The VA’s Whole Health System of Care and Whole Health approach aims to improve the health and well-being of veterans and to address lifestyle and environmental root causes of chronic disease. The approach shifts from a disease-centered focus to a more personalized approach that engages and empowers veterans early in and throughout their lives to prioritize healthy lifestyle changes in areas like nutrition, activity, sleep, relationships, and surroundings. Conventional testing and treatment are combined with complementary and integrative health approaches that may include acupuncture, biofeedback, massage therapy, yoga, and meditation.

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The Total Force Fitness program arose within the U.S. Department of Defense Military Health System in response to the need for a more holistic approach—a focus on the whole person instead of separate parts or only symptoms—to the demands of multiple deployments and the strains on the U.S. Armed Forces and their family members. The focus extends the idea of total fitness to include the health, well-being, and resilience of the whole person, family, community, and U.S. military.

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Established in 2020, the Whole Health Institute’s Whole Health model helps people identify what matters most to them and build a plan for their journey to whole health. The model provides tools to help people take good care of their body, mind, and spirit, and involves working with a health care team as well as tapping into the support of family, friends, and communities.

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The North Carolina Department of Health and Human Services has incorporated a whole person health approach into its health care system by focusing on integrating physical, behavioral, and social health. The state has taken steps to encourage collaborative behavioral health care and help resolve widespread inequities in social conditions, such as housing and nutritious food access.

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The Ornish Program for Reversing Heart Disease is an intensive cardiac rehabilitation program that has been shown to reverse the progression of coronary heart disease through lifestyle changes, without drugs or surgery. The program is covered by Medicare and some health insurance companies. The program’s lifestyle changes include exercise, smoking cessation, stress management, social support, and a whole-foods, plant-based diet low in total fat. The program is offered by a team of health care professionals who provide the support that individuals need to make and maintain lasting changes in lifestyle.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} What does research show about whole person health?

A growing body of research suggests the benefits of healthy behaviors, environments, and policies to maintain health and prevent, treat, and reverse chronic diseases. This research includes several large, long-term epidemiological studies—such as the Framingham Heart Study, Nurses’ Health Study, and Adventist Health Studies—that have evaluated the connections between lifestyle, diet, genetics, health, and disease.

There is a lack, however, of randomized controlled trials and other types of research on multicomponent interventions and whole person health. Challenges come with conducting this type of research and with finding appropriate ways to assess the evidence. But opportunities are emerging to explore new paths toward reliable and rigorous research on whole person health.

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Yes, NCCIH plans to fund research on whole person health . (Details can be found in the NCCIH Strategic Plan FY 2021–2025: Mapping a Pathway to Research on Whole Person Health . )

By deepening the scientific understanding of the connections that exist across the different areas of human health, researchers can better understand how conditions interrelate, identify multicomponent interventions that address these problems, and determine the best ways to support individuals through the full continuum of their health experience, including the return to health.

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Nccih clearinghouse.

The NCCIH Clearinghouse provides information on NCCIH and complementary and integrative health approaches, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

Toll-free in the U.S.: 1-888-644-6226

Telecommunications relay service (TRS): 7-1-1

Website: https://www.nccih.nih.gov

Email: [email protected] (link sends email)

Know the Science

NCCIH and the National Institutes of Health (NIH) provide tools to help you understand the basics and terminology of scientific research so you can make well-informed decisions about your health. Know the Science features a variety of materials, including interactive modules, quizzes, and videos, as well as links to informative content from Federal resources designed to help consumers make sense of health information.

Explaining How Research Works (NIH)

Know the Science: How To Make Sense of a Scientific Journal Article

Understanding Clinical Studies (NIH)

A service of the National Library of Medicine, PubMed® contains publication information and (in most cases) brief summaries of articles from scientific and medical journals. For guidance from NCCIH on using PubMed, see How To Find Information About Complementary Health Approaches on PubMed .

Website: https://pubmed.ncbi.nlm.nih.gov/

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  • Aggarwal M, Ornish D, Josephson R, et al. Closing gaps in lifestyle adherence for secondary prevention of coronary heart disease. American Journal of Cardiology. 2021;145:1-11.
  • Centers for Medicare & Medicaid Services. Decision Memo for Intensive Cardiac Rehabilitation (ICR) Program—Dr. Ornish’s Program for Reversing Heart Disease (CAG-00419N). Accessed at https://www.cms.gov/ on April 26, 2021.
  • Deuster PA, O’Connor FG. Human performance optimization: culture change and paradigm shift. Journal of Strength and Conditioning Research. 2015;29(suppl 11):S52-S56.
  • Gaudet T, Kligler B. Whole health in the whole system of the Veterans Administration: how will we know we have reached this future state? Journal of Alternative and Complementary Medicine. 2019;25(S1):S7-S11.
  • Malecki HL, Gollie JM, Scholten J. Physical activity, exercise, whole health, and integrative health coaching. Physical Medicine and Rehabilitation Clinics of North America. 2020;31(4):649-663.
  • National Center for Complementary and Integrative Health. NCCIH Strategic Plan FY 2021–2025: Mapping a Pathway to Research on Whole Person Health. National Center for Complementary and Integrative Health website. Accessed at https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025 on May 14, 2021.
  • North Carolina Department of Health and Human Services website. Healthy Opportunities and Medicaid Transformation. Accessed at https://www.ncdhhs.gov/about/department-initiatives/healthy-opportunities/healthy-opportunities-pilots/healthy on April 26, 2021.
  • Military Health System website. Total Force Fitness. Accessed at https://health.mil/Military-Health-Topics/Total-Force-Fitness on April 26, 2021.
  • Tilson EC, Muse A, Colville K, et al. Investing in whole person health: working toward an integration of physical, behavioral, and social health. North Carolina Medical Journal. 2020;81(3):177-180.
  • U.S. Department of Veterans Affairs website. Whole Health. Accessed at https://www.va.gov/wholehealth/ on April 26, 2021.
  • U.S. Department of Veterans Affairs website. Whole Health Library. Accessed at  https://www.va.gov/wholehealthlibrary/ on April 26, 2021.
  • Vodovotz Y, Barnard N, Hu FB, et al. Prioritized research for the prevention, treatment, and reversal of chronic disease: recommendations from the Lifestyle Medicine Research Summit. Frontiers in Medicine (Lausanne). 2020;7:585744.
  • Whitehead AM, Kligler B. Innovations in care: complementary and integrative health in the Veterans Health Administration Whole Health System. Medical Care. 2020;58(9S)(suppl 2):S78-S79.

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  • Alborzkouh P, Nabati M, Zainali M, et al. A review of the effectiveness of stress management skills training on academic vitality and psychological well-being of college students. Journal of Medicine and Life. 2015;8(4):39-44.
  • Bisht K, Sharma K, Tremblay M-È. Chronic stress as a risk factor for Alzheimer's disease: roles of microglia-mediated synaptic remodeling, inflammation, and oxidative stress. Neurobiology of Stress. 2018;9:9-21.
  • Buettner D, Skemp S. Blue Zones: lessons from the world’s longest lived. American Journal of Lifestyle Medicine. 2016;10(5):318-321.
  • Chen T-L, Chang S-C, Hsieh H-F, et al. Effects of mindfulness-based stress reduction on sleep quality and mental health for insomnia patients: a meta-analysis. Journal of Psychosomatic Research. 2020;135:110144.
  • Conversano C, Orrù G, Pozza A, et al. Is mindfulness-based stress reduction effective for people with hypertension? A systematic review and meta-analysis of 30 years of evidence. International Journal of Environmental Research and Public Health. 2021;18(6):2882.
  • Katz DL, Karlsen MC, Chung M, et al. Hierarchies of evidence applied to lifestyle medicine (HEALM): introduction of a strength-of-evidence approach based on a methodological systematic review. BMC Medical Research Methodology. 2019;19(1):178.
  • Kruk J, Aboul-Enein BH, Bernstein J, et al. Psychological stress and cellular aging in cancer: a meta-analysis. Oxidative Medicine and Cellular Longevity. 2019;2019:1270397.
  • Levesque C. Therapeutic lifestyle changes for diabetes mellitus. Nursing Clinics of North America. 2017;52(4):679-692.
  • Ni Y, Ma L, Li J. Effects of mindfulness-based stress reduction and mindfulness-based cognitive therapy in people with diabetes: a systematic review and meta-analysis. Journal of Nursing Scholarship. 2020;52(4):379-388.
  • Ornish Lifestyle Medicine website. The Ornish Reversal Program: Intensive Cardiac Rehabilitation. Accessed at https://www.ornish.com/intensive-cardiac-rehab/ on April 26, 2021.
  • Schneiderman N, Ironson G, Siegel SD. Stress and health: psychological, behavioral, and biological determinants. Annual Review of Clinical Psychology. 2005;1:607-628.
  • Seal KH, Becker WC, Murphy JL, et al. Whole Health Options and Pain Education (wHOPE): a pragmatic trial comparing whole health team vs primary care group education to promote nonpharmacological strategies to improve pain, functioning, and quality of life in veterans—rationale, methods, and implementation. Pain Medicine. 2020;21(suppl 2):S91-S99.
  • Tamashiro KL, Sakai RR, Shively CA, et al. Chronic stress, metabolism, and metabolic syndrome. Stress. 2011;14(5):468-474.
  • Whayne TF Jr, Saha SP. Genetic risk, adherence to a healthy lifestyle, and ischemic heart disease. Current Cardiology Reports. 2019;21(1):1.
  • Whole Health Institute website. Accessed at https://www.wholehealth.org/ on May 19, 2021.

Acknowledgments

NCCIH thanks Mary Beth Kester, M.S., and Helene M. Langevin, M.D., NCCIH, for their review of this publication.

This publication is not copyrighted and is in the public domain. Duplication is encouraged.

NCCIH has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by NCCIH.

Related Topics

NCCIH Strategic Plan FY 2021–⁠2025 Mapping a Pathway to Research on Whole Person Health

Methodological Approaches for Whole Person Research Workshop

Transforming Veterans’ Health: Implementing a Whole Health System of Care

Complementary, Alternative, or Integrative Health: What’s In a Name?

UNC Research

Introducing the New Subject Injury Language Process – Effective June 15, 2024

By murphyjl

subject research work

Dear Research Colleagues: I hope this message finds you well. I am pleased to announce that UNC-Chapel Hill is adopting standardized subject injury language (SIL) for industry sponsored clinical trials to increase patient transparency and simplify the IRB approval process.

Effective June 15, 2024, UNC-CH will no longer require a Subject Injury Approval Letter with the submission of the IRB application. Please see the language options at the end of this email.

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OPTION A: Injury language when there is no industry sponsor: investigator-initiated, Federally-funded (e.g. NIH), foundations, non-profit organization If you think you have been injured because of taking part in this study, tell the study doctor or the contact on the front page of this document as soon as possible. You can provide this information in person or call them at the phone number listed in this consent form. The study doctor or someone on the study team can help you get the care you need. If you are injured because of this study, UNC will provide necessary medical treatment. You can also see another doctor for treatment, or if you have an urgent injury call 911.

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OPTION B: Injury language for industry sponsored studies. This section cannot be modified without the approval of the Clinical Research Compliance Office (CRCO). Doing so may result in IRB approval delay. Contact CRCO at [email protected] if you have questions. If you think you have been injured because of taking part in this study, tell the study doctor or the contact on the front page of this document as soon as possible. You can provide this information in person or call them at the phone number listed in this consent form. The study doctor or someone on the study team can help you get the care you need. If you are injured because of this study, UNC will provide necessary medical treatment. You can also see another doctor for treatment, or if you have an urgent injury call 911.

The study sponsor [enter sponsor name] may pay for the cost of medical treatment for your injury. Your study doctor and the study sponsor will work together to determine what costs associated with your injury may be covered by the study sponsor.

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There are no plans to pay you directly or give you any other type of compensation should you be injured because of taking part in this study. However, signing this consent form does not mean you give up or otherwise waive your rights to seek payment for injuries arising from the study.

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The benefits of single-subject research designs and multi-methodological approaches for neuroscience research

1. introduction.

The scientific method is neither singular nor fixed; it is an evolving, plural set of processes. It develops and improves through time as methodology rises to meet new challenges (Lakatos, 1978 ; Hull, 1988 ; Kuhn and Hacking, 2012 ). “It would be wrong to assume that one must stay with a research programme until it has exhausted all its heuristic power, that one must not introduce a rival programme before everybody agrees that the point of degeneration has probably been reached” (Lakatos, 1978 ). These insights apply not least to experimental design approaches.

For better and for worse, no experimental design comes without limitation. We must accept that the realities of the world cannot be simplistically verified against universal standard procedures; we are free instead to explore how the progressive evolution of experimental design enables new advancement. This paper proposes support for a shift of focus in the methodology of experimental research in neuroscience toward an increased utilization of single-subject experimental designs. I will highlight several supports for this suggestion. Most importantly, single-subject methods can complement group methodologies in two ways: by addressing important points of internal validity and by enabling the inductive process characteristic of quality early research. The power of these approaches has already been somewhat established by key historical neuroscience experiments. Additionally, the individuated nature of subject matter in behavioral neuroscience makes the single-subject approach particularly powerful, and single-subject phases in a research program can decrease time and resource costs in relation to scientific gains.

2. Complimentary research designs

Though the completely randomized group design is considered by many to be the gold standard of evidence (Meldrum, 2000 ), its limitations as well as ethical and logistical execution difficulties have been noted: e.g., blindness to group heterogeneity, problematic application to individual cases, and experimental weakness in the context of other often-neglected aspects of study design such as group size, randomization, and bias (Kravitz et al., 2004 ; Grossman and Mackenzie, 2005 ; Williams, 2010 ; Button et al., 2013 ). Thus, the concept of a “gold standard” results not from the uniform superiority of a method, but from an implicit valuing of its relative strengths compared to other designs, all things being equal (even though such things as context, randomization, group size, bias, heterogeneity, etc. are rarely equal). There is an alternative to this approach. Utilizing a wider array of methods across studies can help compensate for the limitations of each and provide flexibility in the face of unequal contexts. In a multi-methodological approach, different experimental designs can be evaluated in terms of complementarity rather than absolute strength. If one experimental design is limited in a particular way, adding another approach that is stronger in that aspect (but perhaps limited in another) can provide a more complete picture. This tactic also implicitly acknowledges that scientific rigor does not proceed only from the single study; replication, systematic replication, and convergent evidence may proceed from a progression of methods.

I suggest adding greater utilization of single-subject design to the already traditionally utilized between-subject and within-subject group designs in neuroscience to achieve this complementarity. The advantages and limitations of these designs are somewhat symmetrical. Overall, single-subject experiments carry with them more finely-focused internal validity because the same subject (together with their array of individual characteristics) serves in both the experimental and control conditions. Unlike in typical within-subject group comparisons, the repetition of comparisons in single-subject designs control for other confounding variables, rendering n = 1 into a true experiment. While an unreplicated single-subject experiment by itself cannot establish external validity, systematic replication of single-subject experiments over the relevant range of individual differences can. On the other hand, group designs cannot demonstrate an effect on an individual level, but within-individual group studies can characterize the generality of effects across large populations in a single properly sampled study, and may be particularly suited to analyzing combined effects of multiple variables (Kazdin, 1981 ). Single subject and group approaches can also be hybridized to fit a study's goals (Kazdin, 2011 ). In the following sections, I will describe aspects of each approach that illustrate how the addition of single-subject methodology to neuroscience could be of use. I do not mean to exhaustively describe either methodology, which would be outside the scope of this paper.

2.1. Group designs

Group experimental designs 1 interrogate the effect of an independent variable (IV) by applying that variable to a group of people, other organisms, or other biological units (e.g., neurons) and usually—but not always—comparing an aggregated population measure to that of one or more control groups. These designs require data from multiple individuals (people, animals, cells, etc.). Group experiments with between-group comparisons often assign these individuals to conditions (experimental or control) randomly. Other group experiments (such as a randomized block design) assign individuals to conditions systematically to explicitly balance the groups according to particular pre-considered individual factors. In both cases, the assumption is that if alternative variables influence the dependent variable (DV), they are unlikely to do so differentially across groups. Group experiments with within-subject comparisons expose each individual to both experimental and control conditions at different times and compare the grouped measures between conditions; this approach assures that the groups are truly identical since the same individuals are included in both conditions.

Because they involve multiple individuals, some group designs can provide important information about the generality of an effect across the included population, especially in the case of within-subject group designs. Unfortunately, some often-misused aspects of group designs tend to temper this advantage. For example, restricted inclusion criteria are often necessary to produce clear results. When desired generality involves only such a restricted population (e.g., only acute stroke patients, or only layer IV glutamatergic cortical neurons), this practice carries no disadvantage. However, if the study aims to identify more widely applicable processes, stringent inclusion criteria can produce cleaner but overly conditional results, limiting external validity (Henrich et al., 2010 ). Further, the analysis approach taken in many group designs that narrowly examines changes in central tendency (such as the mean) of groups can limit the assessment of generality within the sampled population since averaging will wash out heterogeneity of effects. Other aspects of rigor in group designs can also affect external validity (e.g., Kravitz et al., 2004 ; Grossman and Mackenzie, 2005 ; Williams, 2010 ; Button et al., 2013 ).

Another limitation of group design logic is the practical difficulty of balancing individual differences between groups. In the case of between-group comparisons, these difficulties arise from selection bias, mortality, etc. Even well controlled studies can still produce probabilistically imbalanced groups, especially in the small sample sizes often used in neuroscience research (Button et al., 2013 ). Deliberately balanced groups or post-hoc statistical control may help, but the former introduces a potential problem with true randomization, and the latter is weaker than true experimental control. Within-subject group comparisons implement both experimental and control conditions for each individual in a group and therefore better control for individual differences, however these designs still do not experimentally establish effects within the individual since single manipulations of experimental conditions can be confounded with other changes on an individual level.

The typical focus on parameters such as the mean in the analysis of group designs can also threaten internal as well as external validity, particularly if the experimental question concerns biological or behavioral variables that are highly individually contextualized or developmentally variant. 2 This problem extends from the fact that aggregate measures across populations do not necessarily reflect any of the underlying individuals (e.g., Williams, 2010 ); for example, average brain functional mapping tends not to apply to individual brains (Brett et al., 2002 ; Dworetsky et al., 2021 ; Fedorenko, 2021 ; Hanson, 2022 ). This kind of problem is particularly amplified in the study of human behavior and brain sciences, which both tend to be highly idiosyncratic. In these cases, aggregated measures can mask key heterogeneity including contradictory effects of IVs. This can complicate the application of results to individuals: an issue especially relevant in clinical research (Sidman, 1960 ; Williams, 2010 ). Relatedly, the estimation of population-based effect size provides scant information with which to estimate effects and relevance for an individual. Post-hoc statistical analysis may help to tease out these issues, but verification still requires new experimentation. True generality of a scientific insight requires not only that effects occur with reasonable replicability across individuals, but that a reasonable range of conditions that would alter the effect can be predicted: a difficult point to discern in group studies. Thus, while group designs carry advantages insofar as they can be used to characterize effects across a whole population in a single experiment, those advantages can be and often are subverted. Perhaps counter-intuitively, single-subject approaches can be ideal for methodically discovering the common processes that underlie diversity within a population, which have made it particularly powerful in producing generalizable results (see next section).

2.2. Single-subject designs

Single-subject designs compare experimental to control conditions repeatedly over time within the same individual. Like group designs with within-subject comparisons, single-subject designs can control for individual differences, which remain constant. However, single-subject designs take individual control to a new level. Since other confounding changes may coincide with a single change in the IV, single-subject designs also require multiple implementations of the same manipulation so that the comparison can be repeated within the individual, controlling for the coincidental confounds of a single condition change. Additionally, single-subject designs measure multiple data points through time within each condition before any experimental change occurs to assess pre-existing variation and trends in comparisons with the subsequent condition. Of course, a single-subject experiment without inter-individual replication has no generality—systematic replications across relevant individual characteristics and contexts are generally required to establish external validity. However, the typical group design also often requires similar replication to establish the same validity, and unlike group designs single-subject studies are also capable of rigorously interrogating even the rarest of effects.

Because single-subject experiments deal well with individual effects, they are often used in clinical and closely applied disciplines, e.g., education (Alnahdi, 2015 ), rehabilitation and therapy (Tankersley et al., 2006 ), speech and language (Byiers et al., 2012 ), implementation science (Miller et al., 2020 ), neuropsychology (Perdices and Tate, 2009 ), biomedicine (Janosky et al., 2009 ), and behavior analysis (Perone, 1991 ). However, the single-subject design is not limited to clinical applications or to the study of rare effects; it can also be used for the study of generalizable individual processes via systematic replication. Serial replications often enable detailed distillation of both common and uncommon relevant factors across individuals, making the approach particularly powerful for identifying generalizable processes that account for within-population diversity (although this process can be challenging even on the single-subject level; see Kazdin, 1981 ). Single-subject methodology has historically established some of the most generalizable findings in psychology including the principles of Pavlovian and operant conditioning (Iversen, 2013 ). Establishing this generalizability requires a research program rather than a single study, however since each replication (and comparisons between them) can potentially add information about important contextual variables, systematic progression toward generality can be more efficient than in one-shot group studies.

Single-subject designs are sometimes confused with within-subject group comparisons or n-of-1 case studies, neither of which usually include multiple implementations of each condition for any one individual. N-of-1 case studies sometimes make no manipulation at all or may make a single comparison (as with an embedded AB design or pre-post observation), which can at best serve as a quasi-experiment (Kazdin and Tuma, 1982 ). A single subject design, in contrast, will include many repeated condition changes and collect multiple data points inside each condition (as in the ABABABAB design as well as many others, see Perone, 1991 ). As is the case for group designs, the quality of evidence in a single-subject experiment increases with the number of instances in which the experimental condition is compared to a control condition; the more comparisons occur, the less likely it is that an alternative explanation will have tracked with the manipulation. A strong single-subject design will require a minimum of three IV implementations for the same individual (i.e., ABABAB, with multiple data points for each A and each B), and a robust effect will require many more.

Because single-subject designs implement conditions across time, they are susceptible to some important limitations including sequence, maturation, and exposure effects. The need to consider within-condition stability, serial dependence in data sets, reversibility, carryover effects, and long experimental time courses can also complicate these designs. Still, manipulations common in neuroscience research is often amenable to these challenges (Soto, 2020 ). Single-subject designs for phenomena that are not reversable (such as skill acquisition) can also be studied using approaches such as the within-subject multiple baseline. Multiple baselines experiments across behaviors, across cell populations, or across homotopic brain regions may be reasonable if independence can be established (Soto, 2020 ). A variety of single-subject methods are available that can help to address the unique strengths and limitations in single-subject methodology; the reader is encouraged to explore the variety of designs that cannot be enumerated in the scope of the current paper (Horner and Baer, 1978 ; Hains and Baer, 1989 ; Perone, 1991 ; Holcombe et al., 1994 ; Edgington, 1996 ; Kratochwill et al., 2010 ; Ward-Horner and Sturmey, 2010 ).

2.3. A note about statistical methods

Issues relating to statistical analysis are commonly erroneously conflated with group experimental design per se . Problems with the frequentist statistical approach commonly used in group designs has greatly impacted its efficacy; frequentist statistical methods carry limitations that have been treated thoroughly elsewhere [e.g., the generic problems with null-hypothesis statistical testing NHST (Branch, 2014 ), the inappropriate use of frequentist statistics contrary to their best use and design (Moen et al., 2016 ; Wasserstein and Lazar, 2016 ), and the inappropriate reliance on p -values (Wasserstein and Lazar, 2016 )]. I do not expand on these issues in my summary of group design because such critiques need not apply to all between-group comparisons. The use and applicability of analysis techniques are separable from the experimental utility of group designs in general, which are not limited to inferential statistics. Group experiments can also be analyzed using alternative, less problematic statistical approaches such as the probability of replication statistic or P-rep (Killeen, 2015 ) and Bayesian approaches (Berry and Stangl, 2018 ). Well-considered statistical best practices for various forms of group analysis (e.g., Moen et al., 2016 ) can help a researcher to address limitations.

The conflation of statistical methods with group designs has also led to the misconception that single-subject designs cannot be analyzed statistically. Most scientists have less familiarity with statistical analyses appropriate for use in single-subject designs and the serially-dependent data sets that they produce. While pronounced effects uncovered in single-subject experiments can often be clearly detected using appropriate visual analysis, rigorous statistical methods applicable to single-subject designs are also available (e.g., Parker and Brossart, 2003 ; Scruggs and Mastropieri, 2013 ).

3. Single-subject design and the inductive process

The advantages highlighted above suggest not only compatibility between single-subject and group approaches, but a potential advantage conferred by an order of operations between methods. Early in the research process, inductive inference based on single-subject manipulations are ideal to generate likely and testable abstractions (Russell, 1962 ). Using single-subject approaches for this inductive phase requires fewer resources compared to fully powered group approaches and can be more rigorous than small-n group pilots. An effect can be isolated in one individual, then systematically replicated across relevant differences and contexts until it fails to replicate, at which time explanatory variables can be adjusted until replicated results are produced. The altered experiment can then be analyzed in comparison to previous experiments to form a more general understanding that can be tested in a new series of experiments. After sufficient systematic replication, hybrid and group designs can assess the extent to which inductively and contextually informed abstractions generalize across the widest relevant populations.

4. Precedent of within-subject methods

Although within-subject group experiments are common in human neuroscience and psychology, e.g., Greenwald ( 1976 ) and Crockett and Fehr ( 2014 ), full-fledged single-subject designs are virtually unknown in many subfields. Still, high-impact neuroscience experiments have occasionally either implicitly or deliberately implemented within-subject reversals, demonstrating the power of these approaches to advance the science. To name just a few high-impact examples, Hodgkin et al. ( 1952 ) classic work on voltage clamping utilizing the giant squid neuron involved multiple parametric IV implementations on single neurons. The discovery of circadian rhythms in humans also involved systematic single-subject experiments comparing circadian patterns at various light intensities, light-dark schedules, and control contexts, which allowed investigators to establish that outside entrainment overrode the cycle-altering effects of different light intensities (Aschoff, 1965 ). This fruitful precedent of single-subject-like experiments at the very foundation of historical neuroscience together with the well-established efficacy of single-subject design in other fields imply that the wider adoption of the full methodology can succeed.

5. Single-subject design and individuality in neuroscience

As suggested earlier in this paper, individual variation dominates the scene in behavioral and brain sciences and constitutes a basic part of the evolutionary selection processes that shaped them. In human neuroscience, individual developmental and experience-dependent variation are of particular importance. Human brains are so individuated that functional units across individuals cannot be discerned via typical anatomical landmarks, and even between-group designs often need to utilize individuated or normalized measures (Brett et al., 2002 ; Dworetsky et al., 2021 ; Fedorenko, 2021 ; Hanson, 2022 ). A shift toward including rigorous single-subject research therefore holds particular promise for the field. For example, systematically replicated individual analyses of functional brain networks and their dynamics may more easily lead to generalizable ideas about how they develop and change, and these purportedly general processes could in turn be tested across individual contexts.

6. Time and resource logistics

Group methodology often requires great time and resources in order to produce properly powered experiments. This can lead to problems with rigor, particularly in contexts of limited funding and publish-or-perish job demands (Bernard, 2016 ; Button, 2016 ). Especially in early stages of research, single-subject methodology enables experimenters to investigate effects more critically and rigorously for each subject, to more quickly answer and refine questions in individuals first before systematically exploring the generality of findings or the importance of context, and to do so in a cost-effective way. Thus, both cost and rigor could be served by conscientiously adding single-subject methodology to the neuroscience toolbelt.

7. Suggestions for neuroscience subfields that could benefit

Cognitive, behavioral, social, and developmental neuroscience each deal with individual variation in which later stages are often dependent on earlier stages and seek to identify generalizable processes that produce variant outcomes: a task for which the single-subject and multi-method approach is ideal. Neurology and clinical neuroscience also stand to benefit from a more rigorous tool for investigating clinical cases or rare phenomena. While I do not mean to suggest that the method's utility should be limited to these subfields, the potential benefit seems particularly pronounced.

8. Discussion

In summary, greater utilization of single-subject research in human neuroscience can complement current methods by balancing the progression toward internal and then external validity and enabling a low-cost and flexible inductive process that can strengthen subsequent between-group studies. These methods have already been incidentally utilized in important neuroscience research, and they could be an even more powerful, thorough, cost-efficient, rigorous, and deliberate ingredient of an ideal approach to studying the generalizable processes that account for the highly individuated human brain and the behavior that it enables.

Author contributions

AB conceived of and wrote this manuscript.

Acknowledgments

The author would like to thank Daniele Ortu, Ph.D. for helpful comments.

Funding Statement

AB was funded by the Beatrice H. Barrett endowment for research on neuro-operant relations.

1 This discussion intentionally excludes assignment to groups based on non-manipulable variables because of the qualitative difference between correlational approaches and true experimental approaches that manipulates the IV. The former carries a very different set of considerations outside the scope of this paper.

2 If the biological process under investigation actually occurs at the population level (e.g. natural selection), the population parameter precisely applies to the question at hand. However, group comparisons are more often used to study processes that function on the individual level.

Conflict of interest

The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher's note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

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Letters (Correspondence)

A letter from Ermengol, Count of Urgell

Constance, countess of Urgell ; Ermengol, count of Urgell

This is a letter from "Epistolae: Medieval Women's Letters". Epistolae is a collection of medieval Latin letters to and from women. The letters collected date from the 4th to the 13th centuries, and they are presented in their original Latin as well as in English translation. Dr. Joan Ferrante, Professor Emerita of English and Comparative Literature of Columbia University, has, with her colleagues, collected and translated these letters mainly from printed sources. She worked with the Columbia Center for New Media Teaching and Learning to develop this unique open online collection for teaching and research purposes.

  • Latin letters
  • Women authors
  • Latin language--Translating into English
  • Manuscripts, Latin (Medieval and modern)

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The city beautiful movement, 1890–1920.

  • John D. Fairfield John D. Fairfield Department of History, Xavier University
  • https://doi.org/10.1093/acrefore/9780199329175.013.558
  • Published online: 26 April 2018

The City Beautiful movement arose in the 1890s in response to the accumulating dirt and disorder in industrial cities, which threatened economic efficiency and social peace. City Beautiful advocates believed that better sanitation, improved circulation of traffic, monumental civic centers, parks, parkways, public spaces, civic art, and the reduction of outdoor advertising would make cities throughout the United States more profitable and harmonious. Engaging architects and planners, businessmen and professionals, and social reformers and journalists, the City Beautiful movement expressed a boosterish desire for landscape beauty and civic grandeur, but also raised aspirations for a more humane and functional city. “Mean streets make mean people,” wrote the movement’s publicist and leading theorist, Charles Mulford Robinson, encapsulating the belief in positive environmentalism that drove the movement. Combining the parks and boulevards of landscape architect Frederick Law Olmsted with the neoclassical architecture of Daniel H. Burnham’s White City at the Chicago’s World Columbian Exposition in 1893, the City Beautiful movement also encouraged a view of the metropolis as a delicate organism that could be improved by bold, comprehensive planning. Two organizations, the American Park and Outdoor Art Association (founded in 1897) and the American League for Civic Improvements (founded in 1900), provided the movement with a national presence. But the movement also depended on the work of civic-minded women and men in nearly 2,500 municipal improvement associations scattered across the nation. Reaching its zenith in Burnham’s remaking of Washington, D.C., and his coauthored Plan of Chicago (1909), the movement slowly declined in favor of the “City Efficient” and a more technocratic city-planning profession. Aside from a legacy of still-treasured urban spaces and structures, the City Beautiful movement contributed to a range of urban reforms, from civic education and municipal housekeeping to city planning and regionalism.

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  • municipal reform
  • urban beautification
  • public sculpture
  • World’s Columbian Exposition
  • urban aesthetics
  • Frederick Law Olmsted
  • Daniel H. Burnham
  • Charles Mulford Robinson

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  • Research Objectives | Definition & Examples

Research Objectives | Definition & Examples

Published on July 12, 2022 by Eoghan Ryan . Revised on November 20, 2023.

Research objectives describe what your research is trying to achieve and explain why you are pursuing it. They summarize the approach and purpose of your project and help to focus your research.

Your objectives should appear in the introduction of your research paper , at the end of your problem statement . They should:

  • Establish the scope and depth of your project
  • Contribute to your research design
  • Indicate how your project will contribute to existing knowledge

Table of contents

What is a research objective, why are research objectives important, how to write research aims and objectives, smart research objectives, other interesting articles, frequently asked questions about research objectives.

Research objectives describe what your research project intends to accomplish. They should guide every step of the research process , including how you collect data , build your argument , and develop your conclusions .

Your research objectives may evolve slightly as your research progresses, but they should always line up with the research carried out and the actual content of your paper.

Research aims

A distinction is often made between research objectives and research aims.

A research aim typically refers to a broad statement indicating the general purpose of your research project. It should appear at the end of your problem statement, before your research objectives.

Your research objectives are more specific than your research aim and indicate the particular focus and approach of your project. Though you will only have one research aim, you will likely have several research objectives.

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Research objectives are important because they:

  • Establish the scope and depth of your project: This helps you avoid unnecessary research. It also means that your research methods and conclusions can easily be evaluated .
  • Contribute to your research design: When you know what your objectives are, you have a clearer idea of what methods are most appropriate for your research.
  • Indicate how your project will contribute to extant research: They allow you to display your knowledge of up-to-date research, employ or build on current research methods, and attempt to contribute to recent debates.

Once you’ve established a research problem you want to address, you need to decide how you will address it. This is where your research aim and objectives come in.

Step 1: Decide on a general aim

Your research aim should reflect your research problem and should be relatively broad.

Step 2: Decide on specific objectives

Break down your aim into a limited number of steps that will help you resolve your research problem. What specific aspects of the problem do you want to examine or understand?

Step 3: Formulate your aims and objectives

Once you’ve established your research aim and objectives, you need to explain them clearly and concisely to the reader.

You’ll lay out your aims and objectives at the end of your problem statement, which appears in your introduction. Frame them as clear declarative statements, and use appropriate verbs to accurately characterize the work that you will carry out.

The acronym “SMART” is commonly used in relation to research objectives. It states that your objectives should be:

  • Specific: Make sure your objectives aren’t overly vague. Your research needs to be clearly defined in order to get useful results.
  • Measurable: Know how you’ll measure whether your objectives have been achieved.
  • Achievable: Your objectives may be challenging, but they should be feasible. Make sure that relevant groundwork has been done on your topic or that relevant primary or secondary sources exist. Also ensure that you have access to relevant research facilities (labs, library resources , research databases , etc.).
  • Relevant: Make sure that they directly address the research problem you want to work on and that they contribute to the current state of research in your field.
  • Time-based: Set clear deadlines for objectives to ensure that the project stays on track.

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

Methodology

  • Sampling methods
  • Simple random sampling
  • Stratified sampling
  • Cluster sampling
  • Likert scales
  • Reproducibility

 Statistics

  • Null hypothesis
  • Statistical power
  • Probability distribution
  • Effect size
  • Poisson distribution

Research bias

  • Optimism bias
  • Cognitive bias
  • Implicit bias
  • Hawthorne effect
  • Anchoring bias
  • Explicit bias

Research objectives describe what you intend your research project to accomplish.

They summarize the approach and purpose of the project and help to focus your research.

Your objectives should appear in the introduction of your research paper , at the end of your problem statement .

Your research objectives indicate how you’ll try to address your research problem and should be specific:

Once you’ve decided on your research objectives , you need to explain them in your paper, at the end of your problem statement .

Keep your research objectives clear and concise, and use appropriate verbs to accurately convey the work that you will carry out for each one.

I will compare …

A research aim is a broad statement indicating the general purpose of your research project. It should appear in your introduction at the end of your problem statement , before your research objectives.

Research objectives are more specific than your research aim. They indicate the specific ways you’ll address the overarching aim.

Scope of research is determined at the beginning of your research process , prior to the data collection stage. Sometimes called “scope of study,” your scope delineates what will and will not be covered in your project. It helps you focus your work and your time, ensuring that you’ll be able to achieve your goals and outcomes.

Defining a scope can be very useful in any research project, from a research proposal to a thesis or dissertation . A scope is needed for all types of research: quantitative , qualitative , and mixed methods .

To define your scope of research, consider the following:

  • Budget constraints or any specifics of grant funding
  • Your proposed timeline and duration
  • Specifics about your population of study, your proposed sample size , and the research methodology you’ll pursue
  • Any inclusion and exclusion criteria
  • Any anticipated control , extraneous , or confounding variables that could bias your research if not accounted for properly.

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