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Examples of Full Proposals

Proposals using the "full proposal" form.

Experiments in Virtual Reality (Crawford, Twedt, et al)

The full research proposal submission, Experiments in Virtual Reality , consists of four components: (1) the completed full proposal form , (2) the proposal consent form , (3) a debriefing form to be used with subjects after their participation in the study, and (4) recruiting materials which announce the study and solicit participants.

Mindsets Matter: An interdisciplinary approach for increasing female involvement and acheivement in STEM: Renewal (Burnette, Hoyt, Lawson et al)

The full research proposal submission, Mindsets Matter , consists of two components: (1) the full proposal form , which also includes information needed by the IRB for the renewal of the proposal, and (2) additional materials , which include the consent form, instruments to be used in the research, and other materials.

"Unique" Proposals That do not Fit the Full Proposal Form

Examples of approved unique full proposals from past years follow. Note that some of these proposals may not include all of the information currently required by the IRB.

Example of Unique Faculty Psychology Proposal .

Example of Unique Student Geography Proposal .

In some cases, a professor may want to submit a proposal that incorporates various components of separate student surveys or interviews. An example of such a classroom proposal can be downloaded HERE .

• IRB Proposal Creation Guidelines
• Campus Resources & Services

Guidelines detailing obligatory and optional documentation to be included in proposals submitted to Colgate’s Institutional Review Board, as well as example proposals.

All proposals submitted for either expedited or full review must contain four primary sections:

• Purpose of investigation and procedures
• Anticipated risk and potential benefits to participants
• Steps taken to protect the participants
• Manner of obtaining participants

Details regarding what should be included in each of the four sections are shared below.

Additional documents may also be required in an appendix, depending on the nature of the proposal.

In general, this section should briefly outline what the researcher plans on doing and why. This section should begin with a brief background literature review (complete with citations) centered on the research question at hand.

The background portion of this section should be followed by a full description of what the anticipated participants will be asked to do during the course of the study. For example, if in-depth interviews will be employed, the researcher must address where the interviews will take place, along with whether or not the interviews will be recorded.

Any non-standardized material used in a given study (e.g., questionnaires, interview protocols, vignettes, etc.) should be included with the proposal in an appendix, and referenced in this section.

The IRB is composed of Colgate faculty and staff from a broad range of backgrounds. Thus, your proposal should be written for a general audience, and not rely on terminology specific to any particular field of study. If the purpose and/or procedures are unclear, your proposal will be returned with a request for clarification.

This section must address all reasonable risks. These include physical, emotional, legal, and potential threats to one’s reputation.

If the researcher has deemed that the risks within their study are no greater than risks associated with everyday living, then the researcher should discuss why that is the case.

Typically, there are no benefits to participants in Colgate-sponsored research. Benefits are typically present only in medical research in which participation provides tangible benefits (e.g., experimental medical procedures) that would otherwise be unavailable. Promotion of science, personal insight, participation credit, and payment are not considered benefits in this context.

This section should contain a full account for how the researcher plans on maintaining participant confidentiality or anonymity.

Specificity of Terms

Please be sure to use the terms confidential and anonymous carefully, and according to the following definitions:

• Confidential : This means that only certain authorized people will have access to the data and that appropriate measures will be taken to ensure that a given participant’s data will never be available and identifiable to others. This might entail discussion of how the data will be stored, ways in which personally identifiable information will be removed from the original surveys, notes, and computer files, and whether names will be replaced with code numbers. If names will be replaced with code numbers, please detail how the list of numbers and names will be stored. If data are recorded in audio or video format, then the researcher must specify what will happen to those recordings once the study is complete.
• Anonymous : There is a high threshold for being able to claim that data will be anonymous. In order for data to be truly anonymous, there must be no viable mechanism by which the identity of the respondent could be connected to the data. Thus, even if investigators with a warrant sought the identity of the respondents, they would be unable to make the connection between names and data. Interview data is almost never anonymous, since the interviewer is likely to recall who said what. Lab-based data might be anonymous, but only if all identifiable information is removed and the order of completion is randomized. Anonymity would be violated if data were stored by order of completion, and the order of completion was recorded on the original sign-up sheet. 

Please note that either confidential or anonymous are acceptable forms of protecting the privacy of potential participants, therefore, if anonymity cannot be guaranteed, promising confidentiality will suffice.

It is important that the researcher specifically explains to the IRB just how confidentiality or anonymity will be maintained in this section. Any study involving surveys, in-depth interviews, or experimental manipulation (broadly construed) that do not explicitly state how either confidentiality or anonymity will be maintained will be returned to the researcher for clarification.

If you have any questions about maintaining either confidentiality or anonymity, please seek advice from your faculty supervisor, or the chair of Colgate’s IRB at [email protected] .

This section should also clearly state how participants will be reminded that their participation will be completely voluntary.

Finally, should your study require a debriefing statement, the debriefing statement should be included in the appendix, and referenced in this section.

This section should briefly outline how the experimenter plans on acquiring participants.

If participants will be recruited from Colgate (e.g., PSYC 150), this section should describe how they will be approached. If data collection is to involve actual class time, the researcher should note that the faculty have specific preferences for how they would like to be approached about the use of class time for data collection.

If you have any questions regarding data collection during class time, please contact the chair of Colgate’s IRB at [email protected] .

Certificate of Informed Consent

Download consent form template

It is important that researchers retain a copy for their records and provide a copy to every participant for their records. It is therefore necessary to provide a place for both the experimenter and the potential participant to sign the Certificate of Informed Consent. If this form represents the only record of a participant’s identity, then the IRB may, at its discretion, waive some or all of the sections listed on the template provided. 

The Certificate of Informed Consent should be written in clear, simple language at the 5th grade level. It should be written in the second person (e.g., “you,” “your”) and not the first person (e.g., “I”). In accordance with federal regulations, the CIC should address specific concerns, outlined as follows:

A brief paragraph clearly and succinctly explaining what the participant will do and/or experience during the research project. It is permissible to omit certain details if necessary for methodological purposes (e.g., the hypothesis of the study). However, information that might reasonably make a potential participant choose to opt out of a study may not be withheld. This section must also include the expected duration of participation in this study.

This typically refers to participation credit, direct payment, or participation in a raffle of some sort. Raffles should reveal the expected odds of winning and the value of the prize. If a study is completely voluntary (i.e., no compensation), then this portion should simply state that there is no compensation.

Participant Debriefing Form

A debriefing form is typically read aloud to the participant once he or she has completed the study. The form itself should explain to the participant the full aim of the study he or she has just completed.

If the proposed study involves some degree of deception, or manipulation of behavior that could lead to moderate (or greater) levels of physical and/or psychological distress, a debriefing form (signed by both the participant and the experimenter) must accompany the proposal as a part of the appendix. If a proposed study does not contain either of the above, a debriefing form is not required, but may be included at the researcher’s discretion (but does not need to be signed by the participant).  

Example Proposals

Examples for expedited review.

• Example experiment-based proposal
• Example external survey proposal
• Example internal survey proposal
• Example interview proposal  

Examples proposals for full review

• Full review proposal example 1
• Full review proposal example 2
• Example full-review proposal involving children

Information for Researchers Planning Audio or Video Recordings

Some research may include audio or video recordings taken of participants. If this applies to your research then please note the following:

• The informed consent needs to inform participants that there will be such recordings.
• After the study is complete, participants must be given an audio/video release form to be signed by participants indicating whether or not they provide permission for the recordings to be used by a) researchers working on the study and/or b) future participants, depending on the intentions of the researchers. Samples of such audio/video release forms appear below.
• Sample release for recordings used only by researchers
• Sample release for recordings used by researchers and future participants

Information for Researchers Planning to Conduct Research in Daycare or Schools

If you plan to conduct research within K-12 schools, please fill out and submit the form below (unsigned) with your proposal. Then, once you receive IRB approval for your study, you should submit this form (signed) to the IRB Chair as a modification request.

Approval to Conduct Research in Schools

Tips and Tricks for a Successful IRB Submission and Review Process

Here are some tips for completing the Research Protocol to ensure that the IRB has the information it needs to review the study. Keep in mind that the IRB is reviewing the study to determine that it meets the criteria for approval. The more information the IRB has, the easier it can be to make the required determinations.

1. When completing the IRB application, remember to describe the entirety of the study. Imagine when completing the Research Protocol that you will give this to a future investigator who has never heard about the study before, and will help you conduct the research. If they read your protocol, could they complete all the study procedures without needing copious amounts of additional information? Is it clear who, in terms of collaborating institutions, is responsible for each research activity?

What am I supposed to write in my research protocol?

2. Be realistic with your enrollment size, feasibility of study, resources (financial, staffing, physical space, materials needed, etc), amount of time study will take, use of vulnerable populations, etc.

3. Use lay language – The IRB application should be written in a way that all can understand. The IRB recommends writing in a narrative form, explaining the specifics of what the participant will experience if they take part in the study, from beginning to end. If the Research Protocol is written in too technical of a manner (i.e., it’s not clear what you are doing), it may unnecessarily go to the Convened IRB. TIP: Have a non-scientist friend or family member read the protocol and consent forms…do they understand?

Here is an example of an overly technical description of study procedures vs. how the IRB would recommend study procedures are written:

Speaking Different Languages

“ Pre-Operative Measurements”

• Prior to surgery, the labial keratinized tissue will be measured at the mid aspect of the tooth to be extracted as follow:
• -Gingival width; Distance from the Free Gingival Margin (FGM) to the Mucogingival Margin (MGJ) measured at the midbuccal aspect of the tooth
• -Vestibular depth (using a bilateral retractor and a UNC 15mm probe)
• -Alveolar ridge: width measured on the CT scan at 5mm apical to the bone crest in the mid-mesial-distal aspect of the tooth to be extracted
• -The vertical distance of the line connecting neighboring Cemento-Enamel Junctions (CEJ) to the buccal FGM (measured just prior to surgery)

IRB (for the same procedures):

Prior to the surgery measurements will be taken:

• Gums will be measured by placing a periodontal probe (a small ruler) on top of the tissue
• Gum thickness will be measured with a thin needle and rubber stopper
• -Intra-operative dimensional measurements will be taken during tooth extraction. The patient will still be numb.
• -Bone width will be measured with a caliper (an instrument that gently goes around the bone).
• -Teeth and bone will be measured by placing a periodontal probe (small ruler) on top of the structures.

4. Use pictures in your application documents, if possible (e.g. graph in Research Protocol of what surveys are given to which participant groups and when, picture in the consent form of the device used, etc.)

5. If you’re collecting prospective data from participants, you need to think about your recruitment process.

• Recruitment materials may be an email, letter, or script and must be included for IRB review. Providing participants with a recruitment document prior to consent gives them the opportunity to decide if they even want to participate in the type of research being conducted before having to go through the entire consent process.
• In most research studies, initial contact with a potential participant through an email or letter is customary. Cold calling or showing up at someone’s house to recruit them should be well-justified in the Research Protocol, if such methods are necessary for the study. In some international settings, this type of recruitment is the norm. The IRB will honor any local customs or procedures so these should be described in the protocol.
• If you are using an established organization, site, or group to assist you with recruitment please include the names of these organizations/groups and confirm that you have approval from the leaders/administrators of the groups to assist you with recruitment (e.g. the moderator of a list serve agrees to send your recruitment email out to their list; the administrator of a social media group agrees to post your recruitment message to the group board; the leader/administrator of a company agrees to give the PI a list of their employee emails to use for recruitment purposes, etc.).

6. Think about your consent process:

• If you are recruiting participants into the study, you must obtain consent. Consent is not just a signature, it is a process involving a discussion with the participant. The IRB wants to see a well thought out process described in the IRB application, not just a means to get a signature.
• Give potential participants time to review the consent, ask questions, talk over their decision to participate with family and friends, etc.
• For Exempt and NHSR studies that involve interactions with or data collection from participants, a signature on the consent form is not required per the regulations. However, if an investigator wants to collect a signature, they may. The Exempt consent template includes all the required elements of consent for this type of research. In this type of research, it is often typical for consent to be either a verbal yes/no or indicated by completion of an online survey, questionnaire, etc. The process of consent still applies but the signature requirements are not as stringent and the consent form is not as long.
• For Expedited and Convened IRB studies, a full consent form that includes Key Information must be used. There are few, but some in special cases, exceptions to this so if you have concerns about using the full form, talk to your IRB Review Specialist .
• Adapt the consent process to your study. Are you working with a vulnerable population, will you ever interact with participants, are you meeting with participants before the study? If it is not practicable to obtain a signature, explain why and write in your protocol that you’re requesting a waiver. Below are two such waivers that can be requested:

• Final thoughts on consent: remember that practicable is not synonymous with possible . Although it may be inconvenient to meet with participants to obtain consent (i.e. because their appointment schedule doesn’t match the PI’s work schedule, the consent process will lengthen their appointment, the consent is long, etc.), the investigator should be obtaining consent when they can. Being impracticable would be if the investigator never interacts with the participant (online survey/medical record review/secondary data analysis only) or if the participant is not in the same physical location as the investigator (interview via phone or Zoom).

7. Plan ahead if you plan to travel to conduct your research. You cannot begin human subjects research before obtaining Harvard and in-country IRB approval, even if you’ve booked your flight! Be sure to discuss your project with in-country collaborators to check on any special approvals or permissions needed before you arrive.

8. Report if things happen (which they do sometimes!). Reportable Events include unexpected events that may be out of your control or reports from local IRBs, sponsors, DSMB, etc. It is not intended to be punitive, the intention is to utilize the IRB’s resources to resolve or respond to the issue. You must adhere to the IRB’s Prompt Reporting Requirements . Keep in mind that reportable events may not be limited to huge problems. Reportable events could be a DSMB report or new information that has come to light because of routine study or data monitoring. Sometimes events reported are out of the study team’s control. The IRB will work with you to resolve any reports of new information; the report is not meant to penalize the researchers! Keep these things in mind when completing this section. (Link to RNI instructions)

9. Explore reliance agreements with collaborating institutions – Are you already on the personnel roster of an existing study? You may be able to join that study rather than submit a new application through the HLC IRB. See our website for more instruction on ceding review to another IRB . Note: Reliance agreements can only be executed if the study is considered non-Exempt research.

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The IRB Process

The IRB reviews protocols to ensure appropriate safeguards to protect the rights and welfare of research subjects are in place, according to 45 CFR 46.111 . Federal regulation and institutional operating procedure require that the IRB reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews.

The IRB process can be broken down into three sections:

Criteria of Approval

Estimated time of review, categories of review.

Before any human subject is involved in research in relationship to this institution, the IRB will give proper consideration to:

The risks to subject are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risks and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes 45 CFR 46.111(a).

It is necessary, therefore, that the IRB assess the validity of the study design in relation to the risks to human subjects. Research that is not scientifically valid exposes research subjects to risks of harm without any possibility of benefit. At BYU the validity of the study design can be accomplished in several ways as outlined in this guidance . 

Other factors that contribute to sound study design: evidence that key personnel are qualified by virtue of training and experience to conduct the research; a clear, well-written protocol that adheres to established principles of the discipline help to establish qualifications of the principal and co-investigators and ensures that the operational aspects of the research have been thought through. 

On the other hand, poorly written protocols that do not demonstrate principles of sound scientific design cannot be approved. Poorly written and designed protocols are the most common reasons for delay in IRB approval.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result...

The investigator should proceed by doing the following:

• Assessment of all of the risks associated with the research by identifying all potential harms that could befall a subject and the magnitude and the probability of those harms;
• Ensuring that the appropriate steps have been taken to  minimize the risks  that are identified; and
• Assessment of the possibility and importance of potential benefits to subjects (if any) and to science and society.

The research may be approved by the IRB provided that the benefits outweigh the risks to participants.

Factors that impact risk include:

• the procedure (possible harms);
• the person performing the procedure (training, experience, skill);
• the setting (privacy protections, availability of resuscitation equipment, etc.); and
• the characteristics of the research subject (age, health status).

It is the investigators obligation to explain what will be done, by whom and to whom and where it will be done. Protocols and applications that incompletely describe the study procedures frequently result in requests for more information.

The IRB takes into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. 

This criterion comes from the ethical principle of justice. No group is unduly burdened or will unfairly benefit from the research. Equitable selection does not mean that all groups are represented in proportion to the population. It means that the selection criteria should be both fair and appropriate to the research question. 

Researchers should be mindful of their study design and assess if it is feasible to include non-English speakers as subjects. The exclusion of non-English speakers must be scientifically supported and not used as a mere inconvenience to the researchers. In some cases, this exclusion is supported when surveys tests, questionnaires are not available in other languages. Some tests are not valid in any other language than English.

The protection of privacy applies to the human subjects in the study and confidentiality is the protection of their data. 

Privacy focuses on the environment where the study will take place, how researchers contact prospective subjects, and how research activities will be realized. Privacy issues depend on the study design and the target population. 

Confidentiality should consider the following : 

• How will access to data be managed? 
• Who should be permitted access to the study documents?
• Who should be allowed to know the identities of those participating as subjects?
• What security plan (password protections, locked cabinets, encryption methods, separate storage of Master Lists from study data) is sufficient to adequately protect the subjects given the inherent sensitivity of the data?

It is important to note that the degree of data security depends on the sensitivity of the data. However, it is good practice to limit identifiable data to research personnel that need to know only. It is also good practice to de-identify data as soon as possible. Investigators should consult with their area data security to create a plan that is up to date and appropriate for the sensitivity of data.

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by federal regulations for the protection of human subjects.

Informed consent will be appropriately documented, in accordance with, and to the extent required by federal regulations for the protection of human subjects.

The consent process involves providing the information that a reasonable person would want to know in language that is understandable to the subject. Understandable means at a grade level that they can understand and in their native language.

The IRB has the authority to approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations. The IRB has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with serious harm to subjects. The IRB has the authority to observe or have a third party observe the consent process and/or the research if the IRB determines it to be indicated.

The IRB processes the protocols when they are received. Once protocols are logged in iRIS, an email is sent to the PI indicating receipt of the protocol, the designated IRB number, and that it is in the queue for assignment to an IRB staff member. The IRB staff initially screens submissions to determine the completeness and the appropriate type of review.  Submissions may be returned to the study team for changes before the review type is assigned.  The review type may be reassessed at any time during the review process.

There are several factors that will determine the time frame for approval. Depending on risk level and subject populations, attention to appropriate detail, protocols will proceed for exempt and expedited on a continual basis.  Full board reviews are due the 10th of the month to go to the following month’s meeting, typically, the first Thursday of each month. The processing time is dependent on when you are able to respond to the issues.  Please see the below chart for a visual depiction of this process.

Exempt reviews:   If your protocol qualifies for one of the exemption categories, once you address any issues we can provide approval. Please allow 2-3 weeks from submission to approval. 

Expedited review :  The protocol will be sent to one or two IRB members for their review. Once you have addressed any issues we can provide approval. Please allow 4-5 weeks from submission to approval. 

Full Board review :  The protocol will be placed on an IRB meeting agenda. Full board protocols must be ready (all pre-review issues addressed) before it may be placed on an agenda at least 2 weeks before the scheduled meeting. 

Review time is dependent on the Board’s stipulations and the duration for these to be resolved. Please keep in mind that these timelines may be shorter or longer depending on how busy our office is and how quickly you respond to any issues/questions.

Getting Started

JacqueLENS PhD

How to Write an IRB Proposal

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Writing for an IRB Review

When writing protocols, consent forms, assent forms, etc., researchers often mistakenly use the same writing style in materials for both the IRB and participants. However, it is important to distinguish between writing for a general audience , versus an academic or scientific audience. Discipline-specific language or jargon might not be appropriate for use with your participants. For instance, when conducting research with children, you will want to ensure that the assent form includes age-appropriate language.

Additionally, when working in international settings, you want to strive for cultural competence and sensitivity, especially with individuals of culturally and linguistically diverse backgrounds. 

What is Cultural Competence?

Cultural competence  describes a concerted effort to incorporate special knowledge about individuals and groups of people into standards, policies, procedures, and practices. An individual with cultural competence expresses appreciation of individuals, families, communities, and their unique backgrounds, and aims to increase the quality and effectiveness of communication, interactions, and engagement with others in order to produce better outcomes. Becoming culturally competent takes time, effort, and a commitment to understanding the moods, values, and motivations of individuals with culturally and linguistically diverse backgrounds. While cultural competence is a learned experience, researchers can consider the following goals along this path: 

• Strive to learn and understand the moods, values, and motivations of others.
• Incorporate cultural knowledge into daily practices.
• Establish values, procedures, systems, and principles that recognize diversity.
• Include accessibility in research practices, and provide accessibility options for individuals.
• Demonstrate behaviors, attitudes, policies, and structures to value diversity, and enable others to work effectively in cross-cultural contexts.
• Conduct regular self-assessments in order to ensure sensitivity to cultural and linguistic characteristics.
• Recognize limitations, and acknowledge misunderstandings if they arise.
• Aim to improve upon missteps, miscommunications, or digressions.
• Adapt to diversity and the cultural contexts of communities.

To learn more about initiatives concerning community, diversity, civility, equity, and anti-discrimination, visit  TC's Office for Diversity and Community Affairs.

IRB Submissions vs. Participant Materials

For an IRB protocol submission, you will want to include specific details about the study location and context that explain risks, benefits, measures, and justifications for the use and selection of human subjects. When writing your IRB protocol, you can use the  TC Reviewer Questions  as a guide for what IRB reviewers will look for in your protocol. The following is a table to help prepare you for the different kinds of writings you may need to submit with an IRB protocol.

Readability and Language of Participant Materials

Identify how “readable” your document is for your target population. There are two common tests that score readability and determine how difficult it is to understand your writing.

Microsoft Word can calculate your readability scores. After you have typed your text in Word for Windows devices, click the following: File menu > Options > Proofing tab. 

Under the “When correcting spelling and grammar in Word” heading, check the box labeled “Show readability statistics.” Then, exit the options menu and return to your document text. Next, run a standard spelling and grammar check and review your readability scores. The first score is the Flesch Reading Ease test, and the second is the Flesch-Kincaid Grade Level score. 

For Apple products, on open Microsoft Word and select "Preferences" in the menu. Find the folllowing: under "Authoring and Proofing Tools" > click "Spelling and Grammar" > under "Grammar" > click "Check grammar with spelling check box"> then select "Show readability statistics" checkbox" and close the box. On the "Tools" menu, click "Spelling & Grammar". Word will finish checking and will display the reading level of the document.

For further assistance, please visit this website .

If your document scores at least 60, it should be relatively easy to read, although you can aim for higher scores to improve readability. The grade-level score is equivalent to the reading level of students. An 8, for example, would mean that the material is appropriate for an 8th-grade reader. A score of 8 is typical for adults competent to consent.

You should translate all relevant participant materials into the preferred language of your participants. For examples of translated participant forms, please download the following documents:

• English to Spanish Translated Site Permission Form
• English to Chinese Translated Parental Permission Form
• English to Portuguese Translated Parental Permission Form

No matter your population of interest, always make sure your writing is clear and concise. To learn more about the writing process, you can visit  TC's Graduate Writing Center  or review a Guide to Writing for the IRB .

Institutional Review Board

Address: Russell Hall, Room 13

* Phone: 212-678-4105 * Email:   [email protected]

Appointments are available by request . Make sure to have your IRB protocol number (e.g., 19-011) available.  If you are unable to access any of the downloadable resources, please contact  OASID via email [email protected] .

West Liberty University

Institutional Review Board

Complete the initial Research Proposal Application FORM .

Preparing Your Proposal / FAQ

Preparing your irb proposal submission: helpful hints and special cases..

SCROLL DOWN FOR FAQ’s:

Step 1. Before submitting your research project to the IRB, determine if it meets the requirements of human subject research.

If yes, go to Step 2. If no, then the project does not have to be reviewed by the IRB. Ethical research practices should still be followed.

Step 2. Note submission deadlines for IRB committee reviews. See Timeline page for due dates and IRB meeting dates.

Step 3. Complete the required CITI training. Certificates are active for three years, after that a new or refresher course is required. Everyone that will be involved with human subjects as part of the study must complete the required training before the study can be reviewed.

Step 4. Read over the IRB initial submission form. This asks for details about your study. This is so the IRB can determine the level of review required, and the potential risks and benefits to human subjects.

Overview of what the IRB needs to know

Short version:  your METHODS (proposed participants, materials (including informed consent/assent document, procedures)

Long version: who is your target population and how will people be sampled, is sampling equitable, do you have any needed research permissions (i.e. K-12 superintendent for children research), what will the people be asked to do (in detail, including any surveys or protocols), what are the benefits and risks beyond normal everyday life, what (if anything) do the people get out of participating, and how will the data be handled, stored, and used. The IRB wants to make sure that people can understand what is being asked of them, and that their safety and confidentiality (if applicable) is put first and foremost.

Overview of what the IRB does NOT need to know

Typically the IRB does not need any background literature review information, unless it pertains to supporting why certain materials or questionnaires are being used. The IRB does NOT review your application for  spelling, grammar, or other non human subject safety content errors. The IRB is here to assist regarding the protection of human subjects, however, we will not write or revise your proposal for you.

Step 5. Make sure you have all the research study proposal information available BEFORE completing the application. Getting a study ready for IRB review can take a significant amount of time and effort. All study methodology including recruiting, sampling, and procedural details have to be determined BEFORE submitting your application. Missing or unclear information can lengthen the review process. Students should work closely with their faculty sponsors and have them review all materials before submission.

Step 6. Submit proposal to the IRB.

Step 7 . Check your email for any communications from the IRB. They may request additional information or clarification. Please respond to the IRB in an appropriate and timely manner. The IRB may request for you to attend the meeting to discuss your project.

Step 8. Notification of decisions. See due dates and IRB committee meeting times. The IRB meets one week after each submission due date. Typically you will get a response from the IRB within one week from that meeting date.

Step 9. Conduct your research as planned. Contact the IRB in a timely manner for any unanticipated aversive events related to human subjects. If you have ANY changes related to human subjects (i.e. have to add in a survey question), you must submit an Amendment form and receive approval BEFORE implementing any changes.

Why do we need an IRB?

Common question from students: “Why do I have to submit my research to the IRB? It seems like a lot of work, especially since all I want to do is ask a few anonymous survey questions”

Answer: As discussed in the CITI training, there was a need to ensure and provide guidance for the protection of human subjects. Although some research may be simplistic in nature, all human subjects research is still research and needs to adhere to the same guidelines. Ultimately this is to protect people, so when thinking about your research, take the perspective of a person who does not know anything about your project and may have little to no knowledge about university research.

Recruiting participants

Question: How do I recruit WLU people to participate in my study?

Answer: We want to avoid multiple mass emails to everyone at WLU. Each IRB proposal is required to include intended recruitment and sampling techniques. We are suggesting that people use “Hilltopper Headlines” to recruit people to participate in research studies. Include your contact information and deadlines for participating. Flyers can also be used, however, they should be removed at the end of the recruitment period.

Note that electronic recruiting and data collection pose some additional challenges to human protections, especially in the area of confidentiality.

Classroom projects & Program assessment – WHEN IN DOUBT…. ASK!

Question: Do classroom projects or program assessment require IRB review?

Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review. It is about the purpose and INTENT of the project. If the purpose is to teach about research and NOT contribute to generalizable knowledge then it is not considered research (for the IRB).

Examples of activities that may not need IRB review are:

• Data collection for internal departmental, school, or other college administrative purposes (e.g. teaching evaluations, course evaluations)
• If your research is a class project or term paper and will not be published in any form at any time.
• Reviews and searches of existing literature and research involving a living individual, such as a biography, that is not generalizable beyond that individual.

Use the following guidelines to determine if your activities in the classroom are subject to IRB review. IRB review is NOT required if all of the following are true:

1. The project is limited to surveys/questionnaires/interviews/observations of public behavior directly related to topics being studied in an official college course and will not be professionally published or presented outside the requirements of the course.

2. The above surveys/questionnaires/activities, etc. contain no sensitive personal questions (e.g., no questions about drug use, sexual behavior or attitudes, criminal activity, grades, medical history) or other personal information that could stigmatize an individual.

3. No identifying information is recorded to link a person with the data such that it could reasonably harm the individual’s reputation, employability, financial standing, or place them at risk for criminal or civil liability.

4. The participants in the project are not from a vulnerable or special population (e.g., pregnant women, prisoners, minors, cognitively impaired individuals).

5. The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data are shared only with that entity.

6. No WLU employee or student is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.

If not all of these conditions are met, or if your project does not fall into any of these categories, your project will require IRB notification and may require formal IRB approval before you can start with your project.

When in doubt – email the irb and ask!

• Preparing Your Proposal
• IRB Forms – Information

WLU INSTITUTIONAL REVIEW BOARD West Liberty University College of Sciences 208 University Dr. West Liberty, WV 26074

• IRB Chair: Tifani Fletcher   Email
• IRB Administrator: Karen Kettler   Email

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Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

Regulations: Good Clinical Practice and Clinical Trials . Comprehensive list of regulations governing human subject protection and the conduct of clinical trials. Guidance for Institutional Review Boards and Clinical Investigators .  A series of Information Sheets providing the Agency's current guidance on the protection of people who are subjects of research.  Topics include Institutional Review Boards and Sponsor-Investigator-IRB interrelationships, FDA clinical investigator inspections and sanctions, clinical trials protocols, informed consent, and documents necessary for the conduct of clinical trials.

Information for Health Professionals .  Additional links to information on subject protection from FDA and other government agencies.

Clinical Safety Data Management (PDF - 49KB) .   Provides the definitions and terminology associated with clinical safety experience and the standards for expedited reporting of adverse drug reactions that occur during clinical trials.

FDA Compliance Program 7348.809 - BIMO for Institutional Review Boards (PDF - 1050MB).

FDA Compliance Program 7348.811 - Bioresearch Monitoring: Clinical Investigators.

Institutional Review Board Questions: Contact the Office of Good Clinical Practice, 301-796-8340, or [email protected]

• Whitepapers
• Ethics in Clinical Research
• FDA & ICH
• Regulatory Compliance

Drafting a Research Plan for IRB Review and Research Conduct: Information That Must Be Included in a Clinical Trial Protocol

A clinical trial is an interventional clinical study, in which participants are recruited for the administration of a specific intervention (use of a study drug, a procedure with a medical device, an educational intervention, etc.). Planning for a clinical research trial includes the development of a clinical protocol document. There are several reasons to have a clear and well-written protocol:

• So that the research plan is clearly defined to everyone who will participate in conducting the study, and all processes and procedures are clearly and completely described to avoid variation in procedures and the introduction of assessment bias into the study conduct
• So that oversight committees and agencies (Institutional Review Boards (IRBs)/Research Ethics Committees, scientific review committees, radiation safety or other committees, and regulatory agencies such as the Food and Drug Administration (FDA)) can review the research proposal in enough detail to ensure that it meets regulatory requirements to grant approval for the research conduct
• So that the endpoints, study design, data collection parameters, and the data analysis plan are prospectively defined prior to the research being conducted, and bias cannot be introduced by changing the design or analysis plan during the study (for this reason, many journals now require public posting of the full research protocol along with the publication of study results).

There are many ways to outline and describe the necessary components of the research protocol and plan, and there are many protocol templates that are available to serve as guidelines for protocol development. In this paper, we are addressing these requirements from the perspective of the IRB. Federal regulations dictate specific criteria against which the IRB must review all protocol submissions , to make an independent determination regarding whether the prospective research plan can be approved. If the protocol (or other documents such as the IRB submission form and consent documents that accompany the protocol in the submission) does not provide adequate or complete information for the IRB to make a determination that all criteria have been met, the IRB cannot approve the research plan. This document is intended to assist investigators and research teams by providing a list of the necessary information that they can use as a writing guide, or use as a checklist against the protocol and submission document package, to ensure that all the necessary information is included prior to submitting the protocol and plan for review by an IRB.

TABLE 1 lists the criteria for the approval of research (paraphrased here from the full regulatory language in 21 CFR 56.111 ) by an IRB, and describes the information that is necessary for the clinical protocol (or elsewhere in the research plan submitted for review), for the IRB to be able to make determinations regarding whether a research plan can be approved.

TABLE 2 describes additional components or documents that may need to be included, based on specifics of the study product or the study plan.

In addition, all protocol documents should:

• Be final documents. Draft protocols or other study documents should not be submitted for IRB review as the IRB must review final and complete study plans. If edits or changes are made after IRB review, the amended protocol must be resubmitted for approval of the changes.
• Include page numbers and/or section or outline numbering so that the location of content can be identified
• Include a table of contents
• Include some kind of version control notation (either a version number or version date) so that revisions of the documents can be clearly tracked.

TABLE 1: Necessary Information for All Protocol Submissions

Criterion for approval of the research proposal:.

That risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Corresponding Information required in the Protocol/Research Plan:

• A clear and detailed list of all study procedures, including screening and follow-up procedures (often in tabular format, describing the procedures to be conducted at each study visit). “Procedures” includes (but is not limited to) study visits; interviews for the collection of safety or other data; vital sign measurements; surveys, questionnaires, or diary completion; study drug administration or other investigational study intervention; invasive and non-invasive procedures including blood draws, radiologic tests or other diagnostic testing.
• The protocol should very clearly define what visits, assessments and procedures would be occurring as part of standard care
• If participants need to leave the study early or suddenly, the protocol should include any specific testing or follow-up that may need to occur for safety purposes.

That risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

• the scientific knowledge expected to result from the research project
• the potential direct benefits to individual research participants in the study
• The protocol should also contain a clear and complete description of the study drugs/study intervention including (as appropriate) dosing information, storage information, and criteria for dose modification or dose adjustments.

That the selection of subjects is equitable.

• Eligibility criteria should be designed to make the study as inclusive as possible while excluding persons with factors or conditions that unacceptably increase the potential risks, or unreasonably confound the measurement of study endpoints
• Consider demographics, medical history and co-morbidities, concomitant medications, and whether the protocol must include testing for the presence or absence of conditions specified in the criteria
• It is not necessary to specify opposite factors in both lists, i.e., if inclusion criterion is age ≥ 18, the exclusion does not need to specify age < 18.

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.

Informed consent will be appropriately documented or appropriately waived.

• While the protocol submission must include a written informed consent document, it should also describe the process of obtaining informed consent from participants; how they will be identified and contacted, who will approach them about the study, and how they will be given adequate opportunity to ask questions during the consent discussion
• The written informed consent document must provide all of the elements required by federal regulations
• If potential participants may be incapable of providing informed consent and consent must be provided by legally authorized representatives, the consent process must describe this and the consent form must have appropriate signature spaces
• While there are circumstances in which the regulations allow either a waiver of documentation of consent (no signature) or a waiver of obtaining consent for standard or for emergency research , if a waiver is requested the submission should describe how the proposed research meets the specific requirements for these waivers, and how participants’ rights and privacy will be protected if the waiver is granted.

When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.

• The protocol should include an adequate description of the safety and efficacy data points that will be collected, including how adverse events will be collected, recorded, graded, and assessed
• How will safety data be monitored on an ongoing basis to identify any unanticipated safety issues during the study? Who will review the data, and will the study include a Data Safety Monitoring Committee, Data Monitoring Committee, or Adjudication Committee?

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

• The protocol or associated documents should describe how the privacy of participants will be protected (including if appropriate how people will be approached about the study and given the opportunity to ask questions in a private setting), as well as how the data being collected will be anonymized or de-identified, stored, transferred and analyzed to maintain confidentiality.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

• Note that federal regulations have specific sections for additional precautions required in the research when research is conducted on children , pregnant persons , and prisoners . Inclusion or exclusion of these groups should be specified in the eligibility criteria.
• Consideration should also be given to whether the protocol should include specific steps for the protection of participants who may be unable to make consent decisions (temporarily or permanently).

TABLE 2: Additional Components to Include when Appropriate

Circumstance or condition:.

If the protocol is evaluating the safety and/or efficacy of a drug, biologic or medical device (even if the drug, biologic or medical device is already FDA approved).

Additional information or documents that must be provided:

The regulatory status of the drug/device must be provided to the IRB, either via

• a description in the protocol,
• the submission form, or
• a copy of a letter from the FDA.

For drugs or biologics , the documentation must include an (Investigational New Drug (IND) number or a regulatory-based rationale for why the product is considered IND-exempt (21 CFR 312.2).

For medical devices , the documentation must specify whether the device is used ‘on label’ (for exactly the same indication and circumstances for which is has already been FDA-cleared or approved) or is investigational. If the device is investigational, the documentation must include an Investigational Device Exemption (IDE), an NSR justification, or a regulatory-based rationale for why the device is considered IDE-exempt.

When the protocol is evaluating interventions for foods , herbal products , dietary and other supplements, vitamins , and cosmetics , a regulatory-based justification for why that agent is not considered a drug or biologic as used in the research must be provided. Remember that foods that are being researched for possible use as drug products (looking for evidence of action in diagnosing, treating or mitigating a disease or condition) are regulated as drugs.

The IRB must ensure that research is being conducted in compliance with FDA regulations, so submitting appropriate documents or explanations may prevent questions during the review process. If the IRB cannot confirm documentation, or if the IRB is not completely sure that the FDA would agree with the justification for why certain research would not need FDA oversight (i.e., would be IND- or IDE- exempt), the IRB must ask the researcher/sponsor to consult with FDA and obtain documentation that FDA agrees that their oversight is not indicated.

Some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant persons, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

When persons from vulnerable populations may be enrolled in the research the research plan must always specify this and consideration should also be given to whether the protocol should include specific steps for the protection of participants who may be unable to make consent decisions (temporarily or permanently).

Note that federal regulations have specific sections for additional precautions required in the research when research is conducted on children , pregnant persons , and prisoners .

The study includes the use of surveys, questionnaires or other instruments (quality of life assessments, etc.).

If the protocol includes the use of surveys, all survey questions must be submitted as part of the protocol, an attachment to the protocol, or a supplemental document. If standardized questionnaires or instruments are being used, these must also be submitted. The IRB is required to review all participant-facing materials, including participant diaries and participant recruitment materials [note: some IRBs, including WCG IRB, do not require submission of common, standard instruments such as the SF-36, but if there is any doubt about whether submission is required it is better to add it and avoid possible delays].

Study participants must provide written informed consent.

The informed consent document must be provided for review and must have all the elements required by regulations .

A waiver of informed consent documentation is being requested.

In addition to the regulatory-based justification for the waiver (see Table 1), a Participant Information Sheet must be included in the submission.

A waiver or alteration of HIPAA requirements is being requested.

A regulatory-based justification must be provided specifying how the research is eligible for the waiver or alteration.

For researchers new at conducting clinical research or writing protocols, developing a new clinical trial protocol that is complete and sufficient for the purposes for which it will be needed is often a larger and more time-consuming project that was initially expected. While IRBs are generally happy to provide information and to answer specific regulatory questions in advance of a protocol being submitted, most do not have the resources or capacity to provide one-on-one guidance to researchers who have protocols that need major revisions to meet the criteria for approval.

Researchers may find it best to work with an experienced medical writer or clinical research consultant; while the cost of these services can be significant, this may be the most cost-effective plan when balanced against the time saved by the researcher and the facilitation of the review and approval process when guided by someone who is familiar with clinical research regulations.

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Institutional Review Board (IRB)

The Institutional Review Board (IRB) reviews research involving human participants to ensure that the rights and welfare of human participants are protected. The IRB has the authority to approve, require modifications, disapprove, suspend, terminate and observe the consenting process for research that falls within its scope of review, as specified by federal regulations and institutional policy. UT Austin has two IRBs: a Social Behavioral and Educational Research IRB (SBERIRB) and a Health Sciences IRB (HSIRB).

The HRPP and the UT IRBs have been accredited by the Association for the Accreditation of Human Research Participants (AAHRPP) since 2006.

Activities Requiring IRB Review

UT’s IRB’s provide ethical oversight to all activities that meet the regulatory definitions of research involving human subjects conducted by UT faculty, staff or students.

Research requires IRB review under Department of Health and Human Services (DHHS) regulations if the project is a systematic investigation designed to develop or contribute to generalizable knowledge AND involves living individuals about whom an investigator:

• Obtains information or biospecimens through intervention or interactions with the individuals, and uses, studies or analyzes the information or biospecimens
• Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens

Additionally, research requires IRB review under FDA regulations if the project meets the definition of a clinical investigation — any experiment that involves one or more human subjects and an FDA-regulated test article (drug, device, biologic, human food additive, electronic product) other than in the course of standard medical practice — AND involves a human subject defined as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may either be a healthy individual or a patient.

If a research project meets either two scenarios above, IRB review and determination is required prior to beginning any research activities involving human subjects.

If an activity does not meet the regulatory definition of “research,” no IRB review is required. Similarly, if an activity is research, but it does not involve human subjects, the research does not require IRB review. Failure to meet either definition means that the activity is not human subjects research.

For help determining if research meets these regulatory definitions before submitting to the IRB, contact the IRB staff at [email protected] or online chat.

Determining When to Submit Activities to the IRB

Examples of activities that may or may not be human subjects research NIH Decision Tool: Am I Doing Human Subjects Research? HRP-310 – Worksheet:  Human Research Determination

PI Eligibility

The principal investigator (PI) of a human research study is the individual with ultimate responsibility for the conduct of the activities described in the IRB submission and for protecting the rights and welfare of human participants involved in the research. The PI must be available to devote adequate time and attention to the study to ensure its responsible conduct.

• Tenure-track faculty
• Research assistant, associate or full professor
• Non-tenure-track faculty who are paid UT employees
• Directors, chairs, deans, VPs or AVPs
• Affiliate of clinical faculty when all of the research will be conducted in a UT, Dell or Seton facility
• Research scientists
• Research associates
• Faculty instructors
• Emeritus faculty
• Adjunct faculty
• Visiting faculty and scholars
• Postdoctoral fellows
• Research assistants
• Graduate students
• Undergraduate students

Faculty Sponsors

A faculty sponsor, who is eligible to serve as a PI, is required for all students conducting human subjects research and should oversee the conduct of student conducted research. Students and their faculty sponsors are responsible for human subjects protections. The faculty sponsor is typically the student’s dissertation or thesis chair; however, this is not always the case. The sponsor will provide valuable recommendations about experimental designs aimed at reducing the risk to human subjects.

In the UTRMS-IRB system, the faculty sponsor will be listed as the PI and the student investigator should be designated as the PI Proxy. The PI Proxy will be able to submit actions in the UTRMS-IRB system.

Review Process

In the UT Research Management Suite – IRB Module, researchers can see at a glance where their submission is within the review process. At the top of the study action workspace is the workflow.

The RMS system uses “states” to classify where a submission is in the process. The following table defines the possible study states for a new study submission during the course of its review.

Pre-Submission The application is under preparation by the PI/submission preparer. The study will remain in this state until the PI/PI Proxy clicks Submit.

Pre-Review The submission is in the queue / is being reviewed by the assigned IRB Analyst.

Clarifications Requested Pre-Review The IRB Analyst has requested changes or clarification. The PI, PI Proxy and Primary Contact will receive an email notification advising them of the request. Details regarding the request can be found in the study workspace.

IRB Review The submission is currently being reviewed by an IRB member.

Clarifications Requested IRB Review The IRB member has requested changes or clarifications regarding the submission under review.

Post Review The IRB letter advising the PI of the IRB member or IRB committee’s decision is being prepared.

Modifications Required The IRB has requested additional modifications to secure final approval. The PI, PI Proxy and Primary contact will receive an email notification advising them of this request.

Review Complete The PI will receive the final approval/determination letter and IRB review is complete.

Departmental Review 

Some academic areas have a departmental review process for research submitted to the IRB. Researchers must follow all departmental requirements for review and approval, if applicable. For questions about the rules and procedures for departmental review or the applicability of this information to a submission, please contact the appropriate department.

IRB Review Types

Depending on the type of research conducted, it may be exempt, expedited or require full board review. The type of review is determined by risk level and categories as defined by federal regulations. Minimal risk is defined by federal regulations as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(j)].

Federal regulations identify several different categories of minimal risk research as being exempt from the regulations. This does not mean that they are exempt from IRB review, only that some of the federal requirements that apply to non-exempt studies are not applicable to studies deemed exempt. For example, exempt studies are not required to obtain written informed consent and are not required to submit modifications prior to implementation (unless they may affect the exempt status of the study).

Exempt reviews are performed administratively by the IRB Minimal Risk Research Team. For detailed information on the exempt categories and exempt submissions, refer to the IRB Policies and Procedures Section 5.4 Exempt Research . FDA regulated studies are not eligible for exemption under these categories.

Unlike exempt review, expedited review falls under the full scope of the regulations and is reviewed by a designated IRB member reviewer. Expedited studies must fall into one of the Expedited Review Categories .

All expedited studies must adhere to the requirements for informed consent or its waiver or alteration. Expedited studies may or may not be required to undergo continuing review. All modifications must be approved by the IRB prior to implementation, unless they are necessary for the immediate safety of participants.

Studies that are not eligible for expedited review (do not meet the definition of minimal risk and/or do not fit into an expedited category) must be reviewed by the convened IRB.

All full board studies must adhere to the requirements for informed consent or its waiver or alteration. Full board studies must undergo continuing review at least annually. All modifications must be approved by the IRB prior to their implementation, unless they are necessary for the immediate safety of participants.

Please email [email protected] with questions or to set up a consultation. Include information about the proposed research study or UT IRB Study Number (if available) along with questions to facilitate an efficient response.

Electronic Submission

All new human subjects research applications must be submitted electronically via the UT Research Management Suite – IRB Module (UTRMS-IRB) . If a study was originally approved in the legacy system, historical study documents and IRB determinations can be accessed in IRBaccess .

Submitting to the IRB

All new human subjects research must be reviewed by the IRB prior to the commencement of any study activity. The IRB Application Guide will assist UT Austin faculty, staff and students who are planning to conduct research involving human subjects.

Once IRB approval or determination has been granted, researchers must follow IRB Policies and Procedures for follow-on submissions during the course of their research study to remain in compliance. Examples of follow-on submissions include modifications, continuing reviews (when applicable), and reportable new information reports.

• See the step-by-step instructions on submitting new studies via UTRMS.
• Forms and templates are available for download via the UTRMS-IRB Library, “Templates” tab .
• Guidance documents help with questions during the submission process.

IRB Dates, Deadlines and Fees IRB Reliance Frequently Asked Questions

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The Abdul Latif Jameel Poverty Action Lab (J-PAL) is a global research center working to reduce poverty by ensuring that policy is informed by scientific evidence. Anchored by a network of more than 900 researchers at universities around the world, J-PAL conducts randomized impact evaluations to answer critical questions in the fight against poverty.

• Affiliated Professors Our affiliated professors are based at 97 universities and conduct randomized evaluations around the world to design, evaluate, and improve programs and policies aimed at reducing poverty. They set their own research agendas, raise funds to support their evaluations, and work with J-PAL staff on research, policy outreach, and training.
• Board Our Board of Directors, which is composed of J-PAL affiliated professors and senior management, provides overall strategic guidance to J-PAL, our sector programs, and regional offices.
• Diversity, Equity, and Inclusion J-PAL recognizes that there is a lack of diversity, equity, and inclusion in the field of economics and in our field of work. Read about what actions we are taking to address this.
• Initiatives J-PAL initiatives concentrate funding and other resources around priority topics for which rigorous policy-relevant research is urgently needed.
• Events We host events around the world and online to share results and policy lessons from randomized evaluations, to build new partnerships between researchers and practitioners, and to train organizations on how to design and conduct randomized evaluations, and use evidence from impact evaluations.
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• News Browse news articles about J-PAL and our affiliated professors, read our press releases and monthly global and research newsletters, and connect with us for media inquiries.
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• Overview J-PAL is based at MIT in Cambridge, MA and has seven regional offices at leading universities in Africa, Europe, Latin America and the Caribbean, Middle East and North Africa, North America, South Asia, and Southeast Asia.
• Global Our global office is based at the Department of Economics at the Massachusetts Institute of Technology. It serves as the head office for our network of seven independent regional offices.
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• Overview Led by affiliated professors, J-PAL sectors guide our research and policy work by conducting literature reviews; by managing research initiatives that promote the rigorous evaluation of innovative interventions by affiliates; and by summarizing findings and lessons from randomized evaluations and producing cost-effectiveness analyses to help inform relevant policy debates.
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Introduction to randomized evaluations

The elements of a randomized evaluation

Teaching resources on randomized evaluations

Resources for researchers new to randomized evaluations

Formalize research partnership and establish roles and expectations

Assessing viability and building relationships

Checklist for launching a randomized evaluation in the United States

Administrative steps for launching a randomized evaluation in the United States

Ethical conduct of randomized evaluations

Institutional Review Board (IRB) proposals

Power calculations

Quick guide to power calculations

Grant proposals

Grant and budget management

Trial registration

Pre-analysis plans

Resources for conducting remote surveys

Introduction to measurement and indicators

Survey design

Repository of measurement and survey design resources

Design and iterate implementation strategy

Define intake and consent process

Randomization

Implementation monitoring

Real-time monitoring and response plans: Creating procedures

Increasing response rates of mail surveys and mailings

Survey programming

Data quality checks

Survey logistics

Surveyor hiring and training

Field team management

Working with a third-party survey firm

Questionnaire piloting

Using administrative data for randomized evaluations

Evaluating technology-based interventions

Data security procedures for researchers

Data cleaning and management

Data visualization

Data analysis

Conducting cost-effectiveness analysis (CEA)

Pre-publication planning and proofing

Data de-identification

Data publication

Communicating with a partner about results

Coding resources for randomized evaluations

Institutional Review Boards (IRBs) review research involving human subjects to ensure that participants are protected from potentially harmful research. This resource provides an overview of the roles of IRBs and ethics guidelines. It also includes practical tips for researchers preparing IRB proposals, including an annotated informed consent checklist, guidance on timeline planning and responding to common concerns of IRBs, and handling unanticipated events. Researchers who are already familiar with the roles of IRBs and obtaining human subjects training certificates may wish to begin at the section "Preparing the proposal."

Important terms

• Institutional Review Board (IRB): Ethics review committee. US requirements often govern the contents and elements of an IRB application, even if you also submit the application to an ethics board somewhere else. All J-PAL funded projects need to pass IRB review at MIT or cede authority to another host institution.
• Common Rule: Shorthand term for the Federal (US) Policy for the Protection of Human Subjects, which outlines the criteria and mechanisms for IRB review of human subjects research.
• Exempt research involves minimal risk and fits under one of the exempt review categories described in the Common Rule. Exempt status means the study is exempted from some (but not all) regulatory review, though not from ethics review, and IRBs may still place conditions on exempt research. It is up to the IRB, not the researcher, to determine whether the study qualifies for exempt status 1 . The revisions to the Common Rule include new categories and clarification of existing categories of exemption. See Human Subjects Decision Chart 2 : “Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.104(d)?” 
• Expedited review involves research with minimal risk and fulfills a set of other  criteria listed by the US Department of Health and Human Services, Office of Human Research Protections (DHHS OHRP, 2017). Expedited review is carried out by one member of the IRB Committee.
• Full review is required if the protocol is greater than minimal risk and/or does not fall into one of the expedited or exempt review categories, according to both pre-2018 and 2018 regulations. This may happen, for example, when a study targets a vulnerable population. Full review requires that the protocol is discussed by the full Board, which requires a Board meeting (DHHS OHRP  2009 & 2018 ).
• Amendment : You should submit an amendment request to the IRB to make any change to the original protocol. This includes updates to personnel, consent scripts or processes, surveys questions, funding, and participating institutions.
• IRB Authorization Agreements (IAA):  Agreements between two IRBs that one of them will take on all reviewing responsibilities for a project for both of them. For example, if a research team includes a principal investigator (PI) at Tufts University and one at Cornell, Cornell can cede reviewing responsibilities to Tufts. DHHS OHRP provides a  sample IAA  , though many IRBs now process IAAs online via  Smart IRB . Please check with your IRB to see which is preferred.
• Adverse event:  A violation of IRB protocols or an event during the research that carries the risk of potential harm to the subjects. This includes data breaches. Adverse events must be reported to the IRB.

Institutional Review Boards (IRBs) review research involving human subjects to ensure protection of research participants from potentially harmful research.

Research involving human subjects obtains information through interventions or generates  identifiable private information  (including bio-specimens).  Identifiable information  means that the identity of the subject may readily be ascertained or associated with an individual.  Private information  refers to behavior taking place in a context in which an individual can reasonably expect no observation, recording, or information that the individual provided for a specific purpose and can reasonably expect will not be made public (e.g., a medical record).

The  "Common Rule"  is the popular term for the  Federal (US) Policy for the Protection of Human Subjects ,  45 CFR part 46 , which outlines the criteria and mechanisms for IRB review of human subjects research. The revised Common Rule went into effect January 21, 2019. All new protocols submitted after January 21, 2019, are required to comply with the revised requirements. It is up to individual IRBs, however, whether to apply the previous or revised version of the regulations to ongoing studies that were submitted before that transition date (DHHS OHRP 2019a).

J-PAL IRB requirements

All research projects that are either funded or implemented by J-PAL must be reviewed by the IRB at the host institutions of all PIs on the project and adhere to all policies and protocols approved by the IRB. Effective all rounds of J-PAL funding starting October 1, 2022, and for all projects where data collection is supposed to start after January 1, 2023, at least one of the IRBs reviewing the project must have status as an IRB Organization (IORG). An IRB’s status can be found by consulting the database of IORGs .

Under the revised Common Rule, only one institution will be named the “IRB of Record,” and the other institutions will cede authority to it. If MIT is the IRB of Record, then all key personnel must have completed CITI training (see below). J-PAL also requires this of  all J-PAL research staff. Field surveyors generally do not need CITI training but should be given training by the study staff on ethical research procedures and sign confidentiality agreements before contact with research participants 2 . Some IRBs may require CITI training for all staff; it is important to check specifics with your IRB.

CITI/Human Subjects training certification

• IRBs have different requirements as to which study personnel must receive CITI human subjects training and certificates , though requiring it of key personnel is common. As stated above, CITI training is required if MIT is the main IRB of record and of all J-PAL research staff. All US research institutions require human subjects training of their staff.
• The CITI training course on “Social and Behavioral Research Investigators” is preferred by MIT (and most US institutions) — you can find the course either via your host institution’s IRB or by going to the  MIT COUHES website  and following the links for MIT affiliates or unaffiliated personnel. See also  this guide  for instructions on navigating the CITI site. 3
• NIH training course recognized by MIT and the NBER:  Protecting Human Research Participants (PHRP ) . This course now charges a fee for learners, but CITI can be taken for free via the MIT link above.
• Make sure to also  keep your certificate updated ; it requires refreshing every three years (if you give CITI a permanent email address they will remind you). One way to complete this renewal requirement more efficiently is to take the  refresher course in social and behavioral research ; these courses are designed to be shorter and test learners on the most important content. Note that the reviewing agency may need to have the original certification on file for these courses to be acceptable (CITI Program). See also  this guide , particularly highlights on page 3, for instructions on enrolling in CITI courses, including refresher courses.

Ethics guidelines and principles for research

The principles of ethical research are detailed in IRB training. These principles, described below, are  formulated in the Belmont report  (DHHS OHRP 2017). For a more detailed overview of the role of ethics in social science research, see our  resource on ethical conduct of randomized evaluations. 

Respect for persons

Research subjects need to be given a chance to independently decide and volunteer to participate in the study given knowledge of all aspects of the study that concern them: procedures, costs, risks, and benefits. Derived from this principle is the obligation for researchers to:

• Carry out an   informed consent procedure  or an assent   procedure  (for a minor), and
• Protect vulnerable populations , such as prisoners and children.

Beneficence

Researchers should consider the burdens and risks of the research in all aspects, including the length and effort of the survey, possible embarrassment from answering questions, psychological burden on subjects and surveyors, and risk of personal data being exposed. In medical research, beneficence is interpreted very strictly; for example, researchers must end a trial and begin treating the whole study population if it becomes clear that the treatment significantly increases welfare.

Note: The rules of beneficence (not doing harm and minimizing possible harm) should be applied not just to the subjects of your research but all human actors involved, for example your  surveyors  (who need to be protected from, e.g., psychological harm from conducting very difficult interviews, say, with torture survivors). They apply to both the  study procedures  (e.g., how burdensome the interview process is) and any  interventions  you conduct (e.g., how burdensome the policy is).

Researchers should ensure that a just distribution of burdens and benefits governs the selection of the sample, subjects, and treatment recipients. The justice principle requires that the  benefits of research don't go only to one group and the burdens to another . 

Random assignment and the justice principle

It may appear that simply randomly assigning a program to some people but not others falls under the definition of "injustice" above. Do the phrases "when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly" and "equals ought to be treated equally" rule out randomized designs? An article by  Glennerster and Powers (2016)  discusses this question in some detail. The relevant part starts on p. 12 of the  ungated version .

Here are some additional thoughts:

• Suppose the  intervention is part of your research  and provides a  benefit to some subjects but not all of them . These benefits do not represent an entitlement: if you do not conduct the research then  no one  will receive the benefit. The hypothetical alternative of giving the benefit to all study subjects (which makes the study worthless) is not relevant if the intervention is not implemented by the researchers.
• If the  intervention is implemented by someone else , and the research is only measuring the effects of an existing program, the benefit or harm from the intervention should not be a factor in the decision if the research is ethical. We need to study programs that are conducted by governments or NGOs,  especially  if they may be unethical.
• The  real ethical questions arise in the gray area in between . What if the researchers implement a program that poses a risk? What if the researchers get involved in the randomization or implementation of a program carried out by another organization? The latter is particularly problematic if a government program is tested that is in principle available to all study subjects: in this case, a benefit might be withheld as part of the research design to which the study subjects are actually entitled. In such cases, real ethical trade-offs need to be made between the inherent, general benefits of studying a program, and the potential for harm or injustice done to specific subjects. The benefits from learning may sometimes justify the disadvantages to the study subjects from receiving or not receiving a study treatment, but if they do not, the researchers may have to reconsider the randomized design. A possible alternative might be a so-called encouragement design, in which all study subjects have access to the program, but only a random subset is given additional information or "nudges" to encourage use.

Roles of researchers and the IRB

Weighing the general benefits of research against individual costs  is the key task of an IRB. However, you should, of course, also ask yourself this question. You should only go ahead with study procedures after you have made every effort to minimize the burden on your subjects and any other affected parties, and made sure that  you don't find your own research ethically questionable . A first check as to whether a given research protocol is problematic or not might be introspection:  Would you feel upset, treated unfairly, or subjected to considerable potential for harm in your own study? Knowing all the details of the study, would you choose to participate? 

More on ethics considerations are covered in the corresponding resource , and Glennerster & Powers (2016) discuss gaps in IRB review and ethics frameworks.

Only if you are sure that you can justify the research to yourself should you turn to the matter of describing your research protocol, and its acceptability from an ethical standpoint, to the IRB.  Having thought through these questions will help you design procedures that truly minimize the burden on subjects and anticipate questions from the IRB. We will discuss some common concerns and issues that you should consider and be able to address further below in the section "Responding to common concerns of IRBs." 

Choosing an IRB and planning a timeline

• Biomedical testing or any health procedures  more invasive than measuring weight or height typically have to be reviewed by a medical review board.  Social science research  can go to a  general IRB  or a social and behavioral science IRB .
• An  IRB at the institution of each PI  must review the project, either as a full IRB application or as a cede to another institution. 
• A local IRB  (for J-PAL projects, typically at the host university of the J-PAL regional office) may need to review as well if the study is in a different country. Keep in mind that regulatory procedures, standards, and timelines can all vary substantially by country. For example, Zambia requires both IRB approval and research approval from the government; a research review and an ethics review would therefore be distinct processes there. If you are not sure which institution should be reviewing your project, especially in countries where J-PAL has not established a regional office, it may take some additional time to research and identify the appropriate institution to conduct a review. You might start this research process by consulting the OHRP's (incomplete) lists of  general international standards and regulations  or  social and behavioral research standards , or searching the OHRP's  database of registered IRBs & IORGs , but you should still confirm your specific project country's regulatory procedures with local staff or experts (Department of Health and Human Services, Office of Human Research Protections 2018).
• J-PAL-funded projects must be reviewed by  MIT COUHES , either as a full IRB application or as a cede (ceding is preferable if the project has no MIT PIs involved). 
• Many US institutions can sign IAAs between them, so only  one US institution  needs to review the project. Under the new Common Rule, IRB oversight for most federally-funded collaborative research projects located in the U.S. is required to use a single IRB (commercial, academic, or hospital-based).

Timeline planning (based on experience with US IRBs)

Plan when to submit your IRB application by calculating backwards from the piloting and study start. Typically, the  procedure  is that an IRB officer reviews the application first for completeness and then a Board member receives it. For full review, the proposal is then discussed at the next Board meeting; otherwise the decision is made by the Board reviewer. If you are not entirely sure if you will need a full review, plan for the full review and also budget for needing to resubmit.

• Find out  when the relevant IRBs meet : some do not meet in the summer or winter break. Some US IRBs don't have more than one or two meetings between the Spring and Fall terms.
• Inquire about the  turnaround times  of the IRBs you can submit to - sometimes expedited reviews can take longer than submitting to a well-timed Board meeting (particularly if the IRB is busy around the Board meeting time).
• Some ethics boards outside the US   may have different procedures, e.g. require a  presentation   of your project to the Board (e.g., the Comité National d'Ethique pour la Santé et les Sciences de la Vie, CNESS, in Mali).
• Some IRBs (e.g., at Brown University) use a " cultural consultant " to make sure the study protocols are culturally appropriate. 
• Resubmission : The Board may give only conditional approval and/or   request changes  that require a second submission.

Some additional notes on the timing:

• Two IRBs:  if one of two IRBs  requests protocol changes  you may need to resubmit to the other one.  Make sure you plan for this.
• Initial submission plus amendment:  Often, it is  faster to get an amendment  to an existing study approved rather than submitting a completely new protocol. Therefore, it may be better to submit an initial proposal that outlines the study and describes pilot procedures, for example, and then to submit protocol amendments as you get a better idea of the exact study procedures. In some cases, you need initial IRB approval for a study to receive funding so your study will typically later require an amendment (e.g., J-PAL funded projects require IRB approval before funds can be released; this is an MIT requirement). 

Administrative data

Research involving  administrative data   is very likely to be considered human subjects research and thus subject to review by the IRB of the researcher’s home institution, particularly if the data contains identifiers. Beyond the purview of the IRB, an overlapping web of U.S. federal laws and regulations, state laws and regulations, and institutional restrictions and procedures governs access, storage, and use of administrative data.

Because compliance requirements and definitions of “identifiable” data differ by field, source, and geography, the guidance of an IRB and legal counsel at the researcher’s home institution can be critical in sorting through compliance and reporting requirements. Local regulations may apply as well (e.g., research involving the use of European data conducted by a US-based PI may involve IRB review by the PI’s home university, and would also be subject to the EU’s General Data Protection Regulation (GDPR)). 

A  Data Use Agreement  (DUA) documents the terms under which a data provider shares data with a researcher’s home institution for use by the researcher. This agreement, which typically must be approved by legal counsel at the researcher’s home institution, contains a number of provisions that can significantly impact the underlying research. Many universities have a standard template that includes terms and conditions that are acceptable to the university, and were created with researchers’ needs in mind. More on DUAs is covered under the resource Using administrative data for randomized evaluations .

IRBs often require researchers to furnish signed DUAs before approving a study protocol, and data providers often require IRB approval before signing a DUA. Research teams may request provisional approval from one party, making clear to all parties the process and constraints, to find a path forward. Research teams can facilitate the process by proactively and frequently communicating with the IRB and data partners. 

More information on working with IRBs and DUAs with administrative data can be found in the IDEA Initiative’s Handbook on Using Administrative Data for Research and Evidence-based Policy and in the resource Using administrative data for randomized evaluations . 

Preparing the proposal

This section is based on experience with US IRBs. Check if your IRB has a submission form that pre-specifies the information they want to see. These are typically found on each IRB’s website along with templates for consent forms and other helpful documents. With the revised Common Rule, some universities such as MIT have changed the application and forms (e.g., closure, adverse event, etc.). Please download these forms directly from the y our IRB's site rather than using old versions you have on hand.

Contents of a proposal

The information required is very similar across most proposals.

• Research objectives and purpose : Be brief on the purpose or scientific background of the study. A comprehensive literature review is not required. Make this accessible to a well-educated lay person.
• Submit all the  interview guides ,  survey instruments , and  recruitment materials  you want to use, and provide translations. Translations may need to be certified; ask the IRB about that.
• Describe the  consent procedure  in full and submit the consent form exactly as you plan on using it. Waivers or alterations of consent/assent may require additional materials. Once approved, the  consent form cannot be changed  without an amendment so it's worth putting some work into this (see next section and our resource on intake and consent processes ). You may need to use the IRB-stamped form.
• Data handling: An important risk of study participation for subjects is that their personal data is exposed in some way. Make sure you have good procedures for both physical and electronic data protection, including storing data in locked files and clearly stating the timeline and process for storage/destruction of personal information. Moreover, make sure you describe in the consent form to whom and how the subjects' data will be accessible. State clearly which specific information will not be shared with others. This is particularly important if you intend to publish the study data (which most researchers now want to do). Make sure you describe how you will de-identify the data and  use language in the consent form that does not prevent you from publishing the de-identified data  later on. See the “Permission to publish” section of our data publication resource for sample consent language that permits subsequent data publication.
• Deception and debriefing: The IRB will need a good explanation if you need to withhold information from subjects or deceive them. Some journal referees have rejected papers that they perceive to contain unnecessary deception. If you do use deception, the IRB will likely require that you debrief subjects afterwards and explain the true study purpose or procedures to them. A good rule of thumb is that the subjects will need enough information about the risks, costs, and benefits so that they can make an informed decision if they want to participate; everything else will require special reasons and/or a debriefing. 4
• Are you working with vulnerable populations (children, prisoners, pregnant, mentally disabled, or developmentally challenged individuals), and if so, why?
• Subject numbers: you cannot use more subjects than you originally planned to enroll unless you submit an amendment. If you are not sure of the final subject numbers, provide an upper bound estimate. There is no penalty for surveying fewer  subjects than stated, but IRBs do not like to see approved subjects exceeded.
• For an RCT, describe the selection method for treatment and control groups.
• IRBs will read this very closely and they may come up with risks that you feel are remote. You may be required to safeguard in some way against such identified risks.
• Whatever risks and benefits you identify you need to mention in your consent form (see below and in our Define consent and intake process resource ). 

Some additional hints, based on experience:

• There may be  elements of your study that change  later. If these changes are not substantial, you should  write your protocol to allow for them . For example, you may want to adjust the amounts paid to subjects, change your estimate of how long it takes to conduct a survey, or rephrase some survey questions. If you get a reasonable range of options for these fields approved in your initial application then making the needed adjustments will be easy. For changes not written into the protocol always submit an amendment (and wait for approval) before implementing them in the field, even changes as small as the contact information on a consent form.
• Similarly, if you  plan to   choose between two different procedures , say, based on piloting results, you may  request approval for both of them , and explain that you will choose one (and how). This can save you time later on. 
• Note that even if you  do not identify any risks , IRBs may still require you to mention risks and benefits in the consent form, e.g., by saying "there are no risks or benefits to you from this study." There is no need to try and bend over backwards to convince yourself, the IRB, or the subjects that there is absolutely zero risk. Depending on your study population and context, this can make subjects actually more suspicious or at least confused: if there are no risks, and so far the study sounded completely harmless, why is this explicitly mentioned? Thus, on balance it is actually not necessarily going to reduce participation or harm your relationship with the subjects if you mention small risks. It can help the subjects see that you thought carefully about this but that these are the only risks you came up with. 

Procedure for informed consent

Normally,  written, signed consent is required  from all study subjects.

Consent procedures for research involving minors are more complicated, so you should check with your IRB on the specifics. Depending on the age of the child (typically seven or older)  children  have to give assent  to study procedures that involve them, though the method of obtaining assent will vary depending on age. In addition,  parent(s) have to consent  to research involving their children. If the study involves more risk, both parents' consent may be required. MIT requires that research involving minors have written informed consent of a parent as well as the suitably documented assent of the minor, if the child is over seven years old. 

The revised Common Rule includes a new "Key Elements" section and a rearrangement of content that is designed to facilitate a potential subject's decision of wheter to participate. Under the revised 2018 Common Rule, the requirements for informed consent have changed, with the addition of: 

• "Key information" to be presented at the beginning of the consent form
• New consent elements
• Changes to waiver criteria and documentation (plus other process changes)
• A "broad consent" option for unspecified future use of identifiable data/bio-specimens

There are  exceptions to the need for written consent . These may be important if the written consent procedure deters or prevents subjects from participating in the research. Examples could be subjects who cannot read, who do not want to be linked with their study answers, or who are in a rush and do not want to sign unfamiliar documents before studying them carefully. 

Some of the alternatives available for such cases are:

• Oral consent with a witness (witness signature replaces subject signature)
• Waivers of written consent (replaced by an oral procedure), especially in the case of minimal risk
• Consent from only one or none of the child's parents (e.g., unavailable parents or risks from involving the parents, e.g., in cases of abuse)
• Waivers of assent (e.g., if the child is too young or incapable of assenting)

See Human Subjects Decision Chart 13 : “When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f)?” for more details.

In our experience, for studies involving young students, where getting every parent to consent would be impossible, typically the head of school consents for all students. Examples of such scenarios include boarding schools or when it is likely parents will not all read or return the forms and when the study consists of non-invasive research such as math games conducted on school time. For high school students involved in educational interventions, both students and the head of school (or parent) provide legal binding consent. 

An important provision of US law is a so-called  Certificate of Confidentiality,  which prevents law enforcement from accessing research data by subpoena for the purpose of criminal persecution. 5 The National Institutes of Health offers helpful resources on  what a certificate of confidentiality is  and answers some  frequently asked questions  about how it works. The law on certificates of confidentiality was originally conceived to allow research on illegal drug use by Vietnam veterans without compromising subjects or deterring them from participating. These certificates can help a researcher protect their subjects and assure subjects of the confidentiality of their responses. For some background, see for example  Wolf et al. (2015, 76 pages) .

More details on informed consent are covered in J-PAL's Define intake and consent process resource.

Consent Forms

MIT has useful  guidelines  on providing and communicating adequate information and ensuring comprehension when obtaining informed consent. In particular, the language researchers use in their consent forms should be simple and clear. They include the following:

• Wording should be understandable to those with an 8th grade reading level.
• Avoid technical language or jargon.
• Use commonly recognizable terms.
• Explain terms that may not be easily understood.
• When minors are involved, use age-appropriate language.
• Note that one needs explicit permission from the IRB to obtain verbal consent, in place of the usual written consent, even if the survey is conducted over the phone. See Transitioning to CATI: Checklist and Resources for additional adaptations that should be made for phone surveys

Researchers should at a minimum include the following in their consent forms, even if an oral consent: 

• A brief explanation of the purpose of the study 
• That subjects can stop at any time or choose not to answer any questions they want 
• A local contact and phone number/email for questions. 

Subjects should get a copy of the consent form with this information. They should also receive a link to the local university's IRB office in case they have concerns they do not want to voice to the study researchers, e.g., “If you feel you have been treated unfairly, or you have questions regarding your rights as a research subject, you may contact the Chairman of the Committee on the Use of Humans as Experimental Subjects, MIT, Room E25-143b, 77 Massachusetts Ave, Cambridge, MA 02139, phone +1-617-253-6787."

MIT has  consent templates  on their website that researchers can use. The consent templates have also undergone changes with the Common Rule revisions. Check with your IRB with questions about modifying a consent template provided by MIT or another institution.

If you plan to collect personal data from participants residing in the European Union you should include additional language in your consent forms, in accordance with the European Union's General Data Protection Regulation ( GDPR). This should include information on how long you will retain subjects' information, whether their personal information will be transferred to the US (which may not offer the same level of protection as the EU), etc.

You should review the  Annotated informed consent checklist , based on the  OHRP checklist , to make sure you are including all elements of informed consent in your form. The checklist document contains information on:

• The various exceptions to written consent above, 
• Elements of a written consent statement, and 
• Sample language that makes sure J-PAL data management and data publication requirements are met and the study data can be published in de-identified form .

Broad Consent

The Revised Common Rule allows "Broad Consent" in lieu of informed consent. Broad consent is obtained only with respect to storage, maintenance, and secondary research use of individuals' identifiable data without obtaining additional consent. You are not required to obtain informed consent through broad consent; this is simply an option that is now available to researchers.

Broad consent under Common Rule has several mandated elements, including:

• A general description of the types of research that may be conducted with the identifiable private information.
• Whether sharing of identifiable private information might occur.
• Types of institutions or researchers that might conduct research with the identifiable private information.
• Description of the period of time that the identifiable private information may be stored and maintained and description of period of time that they may be used for research.

You can find the complete list of mandatory elements to broad consent on the   HHS website . If an individual refuses to provide broad consent, the researcher can choose to de-identify the subjects' data to conduct further research. Your IRB can provide guidance on institutional policies regarding refusals, including on re-requesting broad consent or obtaining informed consent.

Not all IRBs have implemented use of Broad Consent. Be sure to check with your IRB to understand whether this option is available for your research. Implementing Broad Consent requires careful thought about the language of the consent form. When the IRB evaluates secondary research proposals, it must determine that the proposed secondary research is within the scope of the identified types of research in the original consent form.

Responding to common concerns of IRBs

Your IRB may ask you for clarification or flag things in your research protocols as problematic that may seem surprising to you. It is useful to know ahead of time what type of designs and issues can raise concerns or are particularly important to IRBs. Conversely, there are research design considerations you should keep in mind that may help you overcome some common concerns an IRB might have.

• Who is conducting the intervention?  Recall the principle above: it is an injustice if "some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly." Researchers are not allowed to commit injustices in their research.  You are still allowed to study programs, policies, or events that constitute an injustice  by this definition. If an NGO carries out a questionable program (say, re-education camps for transgender youth) you can study the effects of these programs (and it may be a great service to humanity if you do). However you cannot  run  such a re-education camp, or help the NGO run it, or even select subjects from a potential pool for them. That would be unethical because there is good reason to think that these re-education efforts harm the children who are subjected to them. The more involved you are in the design, administration, targeting, or any other aspect of the intervention you are studying, the more the intervention itself falls under the scrutiny of the IRB and under your obligation as a researcher.  
• The IRB will be particularly concerned if you get involved in a  study of a benefit that people are legally entitled to receive . Note the phrasing "some benefit to which a person  is entitled  is denied." If part of your research plan is to suggest to the government to withhold an official program for research purposes, you will probably (rightfully) not be allowed to do that by your IRB. As another example, say there is a policy that could be harmful or unpleasant to some people. For example, suppose the government is choosing some households for tax audits. It is possible that the IRB will be concerned if you as the researcher  get involved in the selection process  (for example, by proposing a randomization strategy to pick households for auditing). It can help to make the argument very explicit that the government would have audited someone either way, and that without the randomization it may just have been a different, arbitrarily chosen person.
• Related to the argument above,  IRBs are typically much more concerned if there is potential for undue burden or harm  to the study participants or subjects, as opposed to potential benefits. Helping the government to randomly assign a benefit is often an easier case to make than helping to randomly assign a burden. This means, for example, if you are studying a demand elasticity and you want to vary prices, it will be looked upon more kindly by the IRB if you reduce prices (i.e., provide subsidies) to a random subset of people rather than increase prices. 
• You may not always agree with the concerns that are raised by the IRB — take the example of the audit study. You may think, for example, that it is not unethical to audit people based on random selection rather than let the government choose by some other criteria that may actually be more questionable. If you truly think so, you should make your case to the IRB. In the author's experience, a request by the IRB for clarification is sometimes just that: there is not necessarily an issue, they just want clarity. Therefore, do not back away from protocol details that are important to your study unless you find that the IRB's concerns about the research design are justified. You may have to be prepared to explain your procedures at length. However,  if you truly think that what you are doing is (a) ethical and (b) important research,  do not self-censor in order to take the path of least resistance.
• IRBs can be particularly sensitive if the  cultural context is unfamiliar to them  or they feel that research  interferes with traditions or deeply-held beliefs of subjects . Your IRB may, for example, worry about a special burden on women from conducting research on things like sexually transmitted diseases, gender empowerment, or fertility in a very patriarchal or religiously conservative society. In those cases, the IRB may consult a cultural advisor or require special protections for subjects. It often helps to demonstrate a deep understanding of the cultural context of your study and to have local researchers on the research team.
• Physical contact  as part of your research is almost always subject to special scrutiny. For example, if you interview mothers about the health of their child, the child's assent is typically not required, but if you measure the kid's weight or even take their blood for a malaria test, not only do you need assent, you need the consent of one or both parents (and typically biomedical clearance). Relatedly, as soon as any  body fluids  are involved in your research procedures, biomedical IRBs will get involved. You need to think about things like how to safely dispose of any contaminated waste products. Note that some IRBs may go a bit overboard, and require for example that your medical testing is done by trained nurses, even if the procedures are designed to be safely carried out by lay persons (like a rapid detection test for malaria). In those cases, it is again sometimes worth pushing back and making your argument that it is not unethical to instead train your surveyors to carry out these procedures.
• Inclusiveness and screening : even after asking you a lot of questions about the potential harm that your study might do to subjects, some IRBs will then turn around and ask if your procedures are not unfairly  excluding  some people from the research. This is the flip side of fairness; if you are not sure that the research is harmful or beneficial, preventing someone from participating, say, based on their physical condition, age, gender, or race, or based on literacy or education, can be considered unjust. If you screen out some subjects from your study procedures make sure to carefully explain why.
• The general consensus within the ethical community is that payments are not “coercive” if the study passes the bar of risk to potential benefit (to an individual or society) assessment (with the payments not in the “benefit” side of the calculation). 
• The concern over payments is particularly strong when it involves vulnerable populations. For example, IRBs typically do not allow you to pay mothers for the enrollment of their children in a study . Rather, you can reward study participation by giving a gift to the child. This is in order to prevent mothers from silencing their concerns over the study and agreeing to their child's participation in order to collect the payment. 
• The IRB may also ask that the payment is not emphasized in the recruitment materials, and you cannot call payments a "benefit" of the study in the consent form.
• Both sides of this argument have some truth to them, and you should carefully weigh the costs and benefits of each approach. One way of dealing with the problem may be to  not mention the full amount you are paying when you ask subjects if they agree to participate (to avoid coercion) but  still pay an amount that fully compensates them for their time later (to avoid exploitation). This could be done by paying a baseline participation reward which everyone receives who "shows up" (essentially a token of appreciation for hearing you out, even if the subject later withdraws from the study or does not complete the survey). In addition, you can then pay an hourly fee at the end of a completed survey. 
• A good approach may also be to  first get approval from a local IRB  and use their agreement when submitting the protocol to the US IRB, because they will often defer to what is considered appropriate by local ethics committees.

Handling IRB violations, unanticipated problems, and adverse events

After your study starts, you will need to remain aware of potential changes or issues with the study that require reporting and/or other processes.   Researchers should ensure that there is a good communication system between field staff and PIs so that any changes or events are communicated to the PIs to then report to IRB. 

It is the researchers' obligation to report the following to the IRB that approved the study:

• Violations of the IRB-approved study protocols.
• "Unanticipated problems" with the research.

Protocol violations or incidents

Protocol violations  are any unapproved changes, deviations or departures from the study design or procedures of a research project that are under the investigator’s control and that have not been reviewed and approved by the IRB. Protocol violations are divided into two categories: major (reportable) or minor (non-reportable). 

Changes to the study, such as to study team members, sample size, survey instrument, consent forms, etc. must be reviewed and approved by the IRB before implementation.  Any changes in the research study design and/or procedures that are both within the investigator’s control and implemented prior to IRB approval, must be reported as protocol violations.  Such changes concern the IRB because they may unintentionally affect the participant’s rights, safety, or well-being, or the completeness, accuracy, and reliability of the study data. 

If the changes in the research study design and/or procedures do not have a major impact on either the participants' rights, safety or well-being, or the completeness, accuracy and reliability of the study data you do not need to report them to the IRB but should document them in the study files.

Any problematic or unanticipated events involving the conduct of the study or participant participation also need to be reported to the IRB. This could include, for example, breaches of study participants' privacy or confidentiality (see below), non-compliance, and changes to measures to mitigate risks to participants.

Data security and personally identifiable information

Potential breaches of privacy or confidentiality of study participants’ data are “major (reportable) incidents” that must be submitted to the IRB. The PI is responsible for ensuring that research data is secure when it is collected, stored, transmitted, or shared. All members of the research team should receive appropriate training about securing and safeguarding research data.

Note that IRB protocol violations often involve the exposure of confidential data, accidental or not (such as losing tablets, computers or cameras which have subjects’ data – whether or not it is encrypted). When personal or identifiable data is exposed, the IRB needs to make a determination on what risk of harm this exposure inflicts on the subjects, and what mitigating measures the research team needs to undertake in order to address these risks. They might decide, for example, that the researchers need to contact the study subjects to inform them of the breached data, or that additional psychological or legal assistance must be offered to subjects to deal with any consequences of the data breach. The IRB may also decide that data collected in violation of the study protocols or without full informed consent from the subjects cannot be used in research, though this is an extreme outcome that only rarely occurs. In most cases, the risk of harm is low, and the IRB will only request to halt data collection and amend the study protocols to ensure compliance with the original IRB proposal. 

Unanticipated problems and adverse events

You must also report any unanticipated problem involving potential risk to participants or others.  An unexpected, research-related event is one where the risk exceeds the nature, severity, or frequency described in the protocol, study consent form or other study information previously reviewed and approved by the IRB. OHRP  gives further guidance on "unanticipated problems," including how and when researchers should report the problems to the IRB. Unanticipated problems that are serious adverse events should be reported to the IRB within one week of the investigator becoming aware of the event, while other unanticipated problems should be reported within two weeks. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research but can occasionally occur in the context of social and behavioral research. If an adverse event is an unanticipated problem, then it must be reported to IRB. Some examples of adverse events are listed below.

Emergencies/when do you have to report or stop?

Any time that there is a significant adverse event, the IRB of Record should be contacted immediately to see what needs to be done (e.g., does the study need to stop or do you just need to file an Adverse Event Form?). This is at the IRB’s discretion. Significant adverse events include:

• Non-consented surveying, sampling, or data use
• Participant deaths
• Work in dangerous situations
• Breaches by staff

For example, an unexpected death is a serious adverse event and must be reported to the IRB. Typically, unexpected deaths must be reported within 48 hours, although it is best to report as soon as possible. An unexpected death is defined as the death of a participant that was not related to a risk of participation listed in the protocol or consent document, and was more likely than not caused by the research procedures and/or study interventions. 

Depending on the circumstances, the IRB may need to take immediate action to minimize further harm to participants, such as halting the enrollment of additional participants or suspending approval of the research. 

Continuing review

The IRB is required to review and approve all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once per year. This is called "continuing review." 

Under the revised Common Rule, continuing review is not required for:

• Research that is eligible for expedited review,
• Exempt research conditioned on limited IRB review,
• Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable,
• Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

Under the new Common Rule, for the MIT IRB new protocols approved under expedited review (not going to the Board meeting) no longer require yearly renewals unless otherwise determined by COUHES. Instead, investigators must submit an annual progress report (very minor) and a Continuing Review Questionnaire every three years. Previously approved studies still need to be reviewed annually. MIT also requires annual review until the project is completely done with data analysis.

For continuing review, researchers must give a report to their IRB before the approval expires. MIT requires researchers to submit a Continuing Review Questionnaire, updating the IRB on the progress of their research, 60 days before the IRB approval expiration date. The form includes information on activities conducted in the past year, subject recruitment and attrition, adverse events, subject complaints and publications. If researchers do not submit the form by the required date, the study will be automatically terminated, research grants related to the study will be suspended, and no further research with human subjects can be conducted under the protocol.

The IRB makes its determination on whether to re-approve research based on whether there is any new information, especially with respect to potential benefits or risks to the subjects, that could alter its decision. Such information may also require the IRB to update its risk assessment for the protocol and its corresponding review category, so be aware that this is a possibility when budgeting the review time for your study's continuing review. The IRB also assesses whether there is any new information that would necessitate revision of the protocol and/or the informed consent document.

For more information, see Human Subjects Decision Chart 11 : “Is Continuing Review Required Under 45 CFR 46.109(f)?”

Reporting and publishing

Publishing:  Researchers should report once a study has been published as a working paper or other publication in their yearly review form. Often IRB protocols are kept open for years after field work is complete, as multiple papers may come out of one study. MIT’s IRB allows you to close a study once “the study is closed to enrollment; all subjects have completed all study procedures; data collection is complete; AND data analysis is complete.” Researchers should report when de-identified data is made public in their IRB Closure.

Trial registry:  Researchers should include their IRB information when registering their trial with the  AEA RCT Registry . Specifically, they should state whether they received IRB approval (mandatory), the IRB name, approval date, and approval number.

For J-PAL projects:  All researchers conducting research projects funded or implemented by J-PAL should submit IRB certificates and consent forms to J-PAL.

Last updated March 2023.

These resources are a collaborative effort. If you notice a bug or have a suggestion for additional content, please fill out this form .

We are grateful to Jack Cavanagh, Sarah Kopper, Jim Shen, Keesler Welch, and Evan Williams for review and copy-editing of this resource. Any errors are our own.

CITI Program, " Social-Behavioral-Educational (SBE) Refresher 1 " (last accessed September 2019). 

Department of Health and Human Services, Office of Human Research Protections, 2017, " Institutional Review Board (IRB) Authorization Agreement " (last accessed Dec 2017). A sample IAA.

Murphy, Kathleen. 2020. “ Collaborating with the Institutional Review Board (IRB). ” In: Cole, Dhaliwal, Sautmann, and Vilhuber (eds), Handbook on Using Administrative Data for Research and Evidence-based Policy. Accessed at https://admindatahandbook.mit.edu/book/latest/irb.html on 2021-03-18.

O’Hara, Amy. 2020. “ Model Data Use Agreements: A Practical Guide. ” In: Cole, Dhaliwal, Sautmann, and Vilhuber (eds), Handbook on Using Administrative Data for Research and Evidence-based Policy. Accessed at https://admindatahandbook.mit.edu/book/latest/dua.html on 2021-03-18.

Staats, Alyssa, Kristianna Post, Lindsey Shaughnessy, and Anita Desai, 2019. " Human Subjects and IPA IRB. " Delivered at 2019 J-PAL/IPA Global Staff Training. An overview of the IRB process and how it applies to IPA/J-PAL projects.

Department of Health and Human Services, Office of Human Research Protections, 2019, " The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)) " (last accessed September 2019). 

Department of Health and Human Services, Office of Human Research Protections, 2018a, " Electronic Code of Federal Regulations " (last accessed September 2019). 

Department of Health and Human Services, Office of Human Research Protections, 2018b, " Table 1: Social-Behavioral Research Standards: Description " (last accessed September 2019).

Department of Health and Human Services, Office of Human Research Protections, 2017, " OHRP Expedited Review Categories " (last accessed Dec 2017). 

Department of Health and Human Services, Office of Human Research Protections, 2009, " Pre-2018 Requirements " (last accessed September 2019). 

Department of Health and Human Services, Office of Human Research Protections, 2007, " Unanticipated Problems involving Risks & Adverse Events Guidance " (last accessed September 2019).  

Glennerster, Rachel and Shawn Powers, 2016. " Balancing Risk and Benefit: Ethical Tradeoffs in Running Randomized Evaluations ". In: George DeMartino and Deirdre McCloskey, Oxford Handbook of Professional Economic Ethics, Oxford University Press. 

MIT Committee on the Use of Human Subjects website, " Forms and Templates ," (last accessed January 18, 2019).

National Institutes of Health (NIH). " Certificates of Confidentiality: FAQs " (last accessed September 2019). 

National Institutes of Health (NIH). " What is a Certificate of Confidentiality? " (last accessed September 2019). 

Wolf, Leslie E., Patel, Mayank J., Williams Tarver, Brett A., Austin, Jeffrey L., Dame, Lauren A., and Laura M. Beskow, 2015,  "Certificates of confidentiality: protecting human subjects research data in law and in practice" , Minn J Law Sci Technol. 14(1): 11–87.

In this resource

All submissions and reviews are completed via ESTR, our Electronic Submission Tracking and Reporting System , which automates the IRB review process for the Harvard IRBs (Harvard University Area and Harvard Longwood Campus). You will fill in a SmartForm and be prompted to attach other documentation if needed (information on forms and templates is below).

About the Submission Process:

• The PI must submit the initial application. A Primary Contact can be added at the time of submission. That person can complete many actions and be the main point of contact but cannot submit formal requests. Once the study is approved, a PI Proxy can be added via ESTR and can submit formal modification and continuation requests on behalf of the PI.
• An HUID is required to log in to ESTR. See the ESTR Job Aids page for information on getting an HUID and logging in.
• You will be required to attest that you understand and will adhere to the Principal Investigator Responsibilities and ESTR Assurance Statement, which you can review in the ESTR library.
• You will receive an email notification when an action has been taken that requires you to respond or act.
• You can leave comments/questions for your reviewer.   

ESTR How-To Guidance

• The ESTR Study Submission Guide will walk you through the submission process.
• You can also find more information in the ESTR Help Center
• Contact ESTR Support for technical assistance.
• The Protocol Template and other documents you may need can be downloaded via the ESTR Library . You will need to be logged in to ESTR for access.   

Templates, Forms and Other Ancillary Documents

You may need to prepare one or more forms to be submitted with your application. These forms can be downloaded via the ESTR Library .

• Click on the "Templates and Forms" tab.
• Navigate to pages 2 and 3 to find the documents labelled with “HUA” (these are the documents of the Harvard University Area IRB).
• Download the forms, fill them out, and attach them to your submission in ESTR. ESTR will prompt you when one or more of these forms is needed. If one is missed, don’t worry – IRB staff will let you know.  
• IRB TIP! Be sure to download documents labelled “HUA” when you are in the ESTR Library. These are specific to the “Harvard University Area” (do not use HLMA or HLC documents; they are specific to the Longwood Medical Area - Harvard Longwood Campus). 

The most commonly used initial review forms are:

• HUA Research Protocol Template (HRP-503) - This is the main application form where you will provide most of the details of your study. 
• Not Human Subjects Research Determination Request (HRP-213) - Used to apply for a formal determination that your activities do not constitute research with human subjects. You may use IRB Worksheet HRP-310 for reference (see "Worksheets" tab in ESTR Library). 
• HUA Adult Consent Form Template (HRP-502) - For Expedited and Convened IRB research with individuals who are considered adults. 
• HUA Exempt Research Consent Script (HRP-502-c) – For Exempt research with individuals who are considered adults. See HRP-312 - Worksheet – Exemption.
• HUA Child Assent Form Template (HRP-502-a) - For Expedited and Convened IRB research with individuals who have not attained the legal age for consent to participate in research under applicable law of the jurisdiction in which the research will be conducted. Generally, the law considers any person under 18 years old to be a child. 
• HUA Parental or Guardian Permission Template (HRP-502-b) - For Expedited and Convened IRB research with parents or guardians of those considered a ‘child.’ 
• HUA Short Form Consent Template (HRP-507) - For the unexpected involvement of individuals with limited English proficiency. If you expect to enroll more than one participant with limited English proficiency, or if your study is being conducted internationally, you are expected to translate all study documents provided to participants into the appropriate language(s) and not use this form. See HRP-317 - Worksheet - Short Form of Consent Documentation.
• GDPR Notification for Participants (HRP-502-d) – For use with studies that include individuals located in the European Economic Area. Note that this notification is only for research that began prior to May 25, 2018 will involve the collection of new data for the same research purpose as the pre-May 25, 2018 data, such that the new data collection falls within the scope of the terms of the original consent obtained. For all other research involving individuals located in the EEA, please use the informed consent form according to your research (see above) as these forms include a “GDPR Addendum” located at the end of the form. See HRP-325 - Worksheet - GDPR.

Supplemental Forms

• Non-Harvard Study Personnel Form (HRP-220) - Used to report study staff only if they do not have a Harvard ID. Be sure to attach human subjects training certificates for these staff. 
• Financial Interest Disclosure Form (HRP-221) - Must be submitted for any member of the study staff with a financial interest related to the research. 
• Individual Investigator Agreement (HRP-225) - Used to request inclusion of a study team member who is neither affiliated with a Harvard University Area School nor under another institution’s IRB. 

Helpful Resource Links

Click for helpful resource links if you would like information on the following:

• Research-related Harvard offices
• Research-related Harvard policies and guidance
• Harvard research study participant pools
• Federal resources

Preparing for Your IRB Application                              What to Expect When Expecting IRB Review       

IRB Sample Applications

The following applications and guidance documents are meant to assist new researchers in completing their IRB applications. PI permission has been obtained and PIs had the option of retaining their names on the application or removing identifying information.

These sample applications are meant for training University researchers in completing a Montclair State University IRB application. For any other use please contact the  IRB office for permission.

NOTE: Use of the content in these examples does not automatically confirm that your application will be approved. Each study and protocol is different and reviewed on a case-by-case basis under the guidance provided in the  IRB P&P Manual .

• Example 1: Interview/Focus Group: Sample Cayuse IRB Appliation
• Example 2: Online/Survey: Sample Cayuse IRB application
• Example 3: Online/Survey with compensation
• Example 4: School-Based research: Sample Cayuse IRB Application
• Example 5: Benign Behavioral Intervention: Sample Cayuse IRB Application
• Application Instructions: Exempt 1 Application Guidance – (existing classroom educational practices)

IRBs and psychological science: Ensuring a collaborative relationship

Thomas Eissenberg (Virginia Commonwealth University)

Sangeeta Panicker (American Psychological Association)

Sheri Berenbaum (Pennsylvania State University)

Norma Epley (University of South Florida)

Michael Fendrich (University of Illinois at Chicago)

Rosemary Kelso (Virginia Commonwealth University)

Louis Penner (University of South Florida)

Mary Simmerling (University of Chicago)

Institutional Review Boards (IRBs) are federally-mandated, locally-administered groups charged with evaluating risks and benefits of human participant research at their institution. To a greater or lesser extent, risks and potential benefits exist in virtually any research with human participants, including research in the behavioral/social sciences. Federal law and APA standards require IRB review of all human participant research projects. IRB review and approval will likely bring an investigator into contact with two inter-related groups: the IRB and the professional staff that administers IRB activities. Due to a variety of factors, including increased IRB and faculty workload and enhanced federal oversight, the potential for conflict among IRB members, IRB administrators, and investigators may be great. Indeed, anecdotal evidence suggests that this potential for conflict may be particularly high for behavioral scientists, and that dissatisfaction with IRB review may jeopardize compliance with federal regulations, research participant protection, and research itself. The purpose of this paper is to suggest specific strategies that IRB members, IRB administrators, and investigators can use to avoid potential conflict and facilitate human research participant protection. We contend that when these groups understand and face these responsibilities collaboratively, conflict will be minimized and safe, ethical, high quality research will flourish.

IRBs are federally-mandated, locally-administered groups charged with evaluating human participant research. IRBs, and human participant research in general, have come under increased scrutiny by legislators, regulators, the media, and the public, in part because of recent events where research participation resulted in harm to some participants (see Beh, 2002 and Oakes, 2002). At many institutions, this increased scrutiny has had a tremendous impact on the IRB review process. For example, IRB members are required to understand increasingly complex federal and state regulations when evaluating research protocols in the biomedical, behavioral, and social sciences. IRB administrators are required to oversee the training of local investigators and IRB members, and to process large numbers of research protocols submitted for local IRB review. Investigators are often required to describe even the most unlikely research risks in unprecedented detail, and use increasingly complex submission forms and procedures when preparing protocols for IRB review. Not surprisingly, these growing requirements have increased the potential for conflict among IRB members, IRB administrators, and investigators. For example, the potential for conflict arises between:

• IRBs and administrators, when IRB members are presented with ever-increasing number of protocols for review.
• Administrators and investigators, when submission procedures change frequently to comply with changes in federal or institutional policy.
• Investigators and IRBs, when IRB review is seen as a challenge to independent research.

These and other potential conflicts can be damaging to all, especially if they limit thorough review, compliance with federal law, or detailed description of risks and safeguards. For example, relative to psychology faculty who are satisfied with IRB functioning, psychology faculty who are dissatisfied are less likely to comply with IRB policies and procedures (Liddle & Brazelton, 1996). In extreme cases, conflict among these three groups may jeopardize an institution’s ability to conduct safe, ethical, high quality research. In the sections below, we review briefly how IRBs are mandated and organized, and then present strategies for reducing conflict in human participant research.

IRBs are federally mandated

Federal regulations that pertain to the IRB are specified in Title 45 Code of Federal Regulations Part 46 (45 CFR 46) and Title 21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56). Individuals who submit research proposals to an IRB should be aware that federal regulations frame all IRB action. The ethical foundations for this regulatory framework are contained in the report of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research entitled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Office for Protection from Research Risks, OPRR, 1979). As described in these documents, IRBs consider a variety of important issues, including participant safety and freedom from coercion, and the potential benefits and risks of research. Potential research benefits include improvement of physical and mental health, and knowledge that contributes to the welfare of society (OPRR, 1993). Risks in research include physical, psychological, social, or economic harms, invasion of privacy, and violations of certain basic human rights (OPRR, 1979). To a greater or lesser extent, these risks and potential benefits exist in virtually any research with human participants, including psychological research. Thus, members of the American Psychological Association (APA) and similar professional societies are expected to conduct human participant research in strict adherence to applicable federal laws and regulations, which includes prior review and approval by an IRB (APA, 2002).

IRBs include scientists and nonscientists

IRBs are made up of a panel of reviewers constituted according to the rules set forth in the federal regulations (The Common Rule). 1 An IRB usually includes individuals drawn from the following groups: (1) Faculty affiliated with the institution representing diverse academic disciplines that typically engage in research with human participants; (2) Nonscientist faculty affiliated with the institution; (3) Community representatives with no formal institutional affiliation whose role is to represent the interests of the community and to bring an independent perspective; and (4) If the IRB typically reviews research with prisoners, community representatives who have the sole responsibility to ensure that rights of prisoners are protected (for example, a public defender or a representative of a prisoner advocacy group). Nonscientist members bring an important perspective to the IRB review process, as they may advocate the views of potential research participants more effectively than may scientist members (e.g., Porter, 1987; Porter, 1986).

IRBs are locally administered

The administrative staff for the IRB at many institutions consists of paid professionals who write operating procedures, handle correspondence with relevant federal agencies, process applications for review, request periodic progress reports from researchers, conduct training for researchers and IRB members, and generally provide support services needed for the oversight of research at the local, institutional level. Researchers should be aware that the IRB, not the professional staff, makes final decisions regarding a research project that has been submitted for consideration. Thus, the IRB and the professional staff have differing roles and responsibilities, and their relationship with researchers will therefore differ.

Conflict potential among IRBs, administrators, and investigators

Increased scrutiny of human participant research has intensified pressures on IRBs, administrators, and investigators. Intense pressure can lead to increased potential for conflict. Anecdotal evidence suggests that possibility of conflict with IRBs and IRB administrators may be high for some behavioral scientists (e.g., Oakes, 2002; Council, Smith, Kaster-Bundgaard, & Gladue, 1999). These scientists cite the minimal risks associated with their research methods, such as questionnaires, item recall, or stimulus response. For these investigators, IRB review may be seen as a hindrance that adds little to research participant protection (e.g., Brinthaupt, 2002; Schmidt & Meara, 1996). Further, the administrative burdens of investigator training, IRB submission, and follow-up reporting may impose seemingly overwhelming demands on already over-extended faculty.

IRBs, IRB administrators, and investigators can and should work collaboratively to reduce conflict potential. For example, IRBs can use the latitude provided in federal regulations to maximize participant protections while minimizing investigators’ regulatory burden. IRB administrators can tailor training and review procedures to meet investigator and IRB needs. Investigators can work with IRB members to communicate research-related issues and to understand and address mandated IRB processes and procedures and specific IRB concerns. In sum, IRB members, IRB administrators, and investigators each play a role in protecting research participants within an institutional framework that removes impediments to quality research while ensuring compliance with applicable regulations. The purpose of this paper is to suggest specific strategies that investigators, IRB members, and IRB administrators can use to avoid conflict and facilitate human research participant protection and high quality research.

IRBs, IRB administrators, and investigators: A collaboration

In this section, we propose strategies that emphasize a collaborative relationship among the IRB, IRB administrators, and investigators, and that involve responsibilities for each group. We begin by describing the most salient responsibilities for IRB members and IRB administrators, and then elaborate the responsibilities of investigators. We contend that when these groups understand and face these responsibilities collaboratively, conflict will be minimized and safe, ethical, high quality research will flourish.

Responsibilities of IRBs

Individual IRB members and the IRB as a group have a variety of essential responsibilities that can be challenging. Delineating these challenges may help IRBs understand their role in facilitating safe and ethical research and help administrators and investigators appreciate the knowledge and thought that goes into IRB deliberations. IRB responsibilities include knowing and applying the rules, and maintaining open communication with administrators and researchers.

Knowing the rules

IRB members are most effective when they are conversant with the federal rules and regulations, as well as the underlying ethical principles that govern the conduct of research with human participants. Effective IRB members are also familiar with their own institutional policies and procedures, all of which affect deliberations and decisions regarding proposed research. Furthermore, effective IRB members are acquainted with the current guidance from federal regulatory agencies and emerging human research protection issues unique to behavioral, social, and/or biomedical research.

Knowing the rules is particularly important for IRBs faced with a research proposal outside their area of collective expertise; the regulations provide for a solution to this understandable challenge. The notion that every IRB has the expertise to review every proposal may be untenable in today’s environment: the average number of IRB members at major research universities is 16, and these IRB members review an average of 297 research proposals each year (some review over 1000; Hayes et al., 1995). Many research institutions handle this issue by using multiple IRBs, (e.g., one focusing on biomedical and another on behavioral research; Hayes et al., 1995). As many IRB members are aware, federal regulations make clear that an IRB must have the “. . . professional competence necessary to review specific research activities . . .”, and that an IRB may invite input from “. . . individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB” [45 CFR 46.107 (a) and (f)]. Thus, the regulations suggest that an effective IRB recognizes the research areas in which it is strong, and, when reviewing proposals from other areas, invites input from individuals with relevant expertise.

The regulations make clear that respect for an IRB’s advice and counsel is likely promoted when review is based on collective experience and expertise. A complete knowledge of federal rules and institutional policies, and the ability to operationalize this knowledge when reviewing research protocols is essential for an IRB to be successful and respected. Equally important is an appreciation that most rules are open to interpretation, and can change with experience (e.g., Rosnow, 1997). Thus, effective IRB members are able to appreciate and learn from differing viewpoints within and outside IRB meetings. We suggest that openness to differing viewpoints, the ability to adapt standards based on these viewpoints, and a willingness to apply viewpoints and standards while maximizing participant protection within a research context are components of a successful collaboration.

Applying the rules

The federal regulations that govern IRBs provide a foundation on which an IRB can build and adapt its policies. IRBs interested in working collaboratively to facilitate safe, ethical, high quality research are cognizant of the latitude provided by the regulations. For example, under certain conditions, IRBs may waive written documentation of informed consent or particular elements of the consent document, and can also approve studies that use deception, or approve the use of financial incentives for participation, as illustrated in published psychological studies (e.g., Tiedens & Fragale, 2003; Phillips, Douthitt, & Hyland, 2001; Gire & Eissenberg, 2000). In essence, IRBs are obligated to interpret regulations in a manner consistent with the local environment, understanding that local environments differ substantially from each other and even differ across time. These differences mean that the application of regulations is not done automatically or mechanically, but is guided by thoughtful consideration of the spirit or purpose of the regulation as it relates to a specific research project.

Maintaining open communication

An effective IRB engages in open and collegial exchange of information with investigators. Communication between investigators and the board as a whole, and/or between investigators and individual board members serving as reviewers, are consistent with federal regulations and should be encouraged. When possible, an investigator can be given the opportunity to address sources of confusion before the meeting at which his/her protocol will be reviewed. Because some concerns may be raised and clarified during the IRB meeting, steps can be taken to ensure that investigators are available to answer questions (e.g., by contacting the researcher by phone during the meeting or having the researcher physically present to answer questions during the meeting). Time permitting, the IRB may wish to invite a researcher to attend a meeting to present his/her research, or to discuss a particularly challenging issue. There may be practical limitations to these approaches because the entire board needs to have sufficient time to review revised documents before the meeting, but this type of communication may ultimately save time and resources for all involved, by reducing the length of the review process. Moreover, it serves to build a positive and collaborative relationship between IRBs and researchers.

IRB members and the IRB as a whole are challenged by the need to keep abreast of federal and state regulations governing the conduct of human participant research and current guidance from federal regulatory agencies, apply regulations and guidelines fairly and practically, and maintain open lines of communication with IRB administrators and investigators. IRBs, IRB administrators, and investigators may work best as a team whose overall goal is to facilitate safe and ethical research with the greatest possible benefit and the least possible risk.

Responsibilities of IRB administrators

IRB administrators are generally the public face of the IRB, and interact with IRBs, researchers, and members of the general public, including the research participants, the press, and other influential groups. As such, IRB administrators might work best by maintaining a service orientation, facilitating timely, thorough, and complete reviews, providing clear and relevant protocol submission forms, communicating effectively with researchers, and also making available a variety of training opportunities for IRB members and research teams.

Maintaining a service orientation

Put simply, the IRB administrative staff has an obligation to be helpful to investigators, without whom it would have no raison d’être. Being helpful to investigators is entirely consistent with an IRB administrator’s primary responsibility to ensure the rights and welfare of human participants. Research participants are protected most effectively when IRB staff, IRB members, and researchers work together to ensure their safe and ethical treatment. Being helpful includes ensuring that information regarding the process of obtaining IRB approval is contained in the written policies and procedures governing the operation of the local IRB, and that this information is readily available to investigators. This information, which should also outline investigator obligations and responsibilities, can be made available on a web site and/or distributed as a printed reference guide. Templates, checklists, and tip sheets can be provided to assist investigators in completing paperwork for submission. IRB administrators (and members) can provide telephone, email, and personal consultations with investigators. Information regarding investigator responsibilities also can be disseminated through the approval letters sent to investigators. Thus, the professional staff could help the researchers understand and navigate the application process, thereby helping them comply with pertinent regulatory requirements.

Facilitating timely, thorough, and complete review

Timely review is a key issue for psychologists (e.g., Liddle & Brazelton, 1996) and IRB administrators are in an excellent position to ensure that research applications are processed in a timely manner. For example, administrators may set goals for processing and review such that research protocols submitted for IRB review are processed (i.e., logged in and sent to a reviewer) within one week, and protocols are reviewed within five weeks of submission (three weeks for protocols that qualify for exempt or expedited status). Review goals may differ across institutions, but IRB administrators may be able to guide, evaluate, and reinforce timeliness in the review process.

Timeliness may be a particularly salient issue for psychological researchers who conduct research with undergraduate students. For example, a study involving students as research participants submitted in August, but not approved until mid-November, delays data collection until mid-January (because of holidays, final exams, etc.). This situation is detrimental to the productivity of an established researcher, but worse for a student gathering data for a thesis or dissertation, or a junior faculty member who undergoes periodic evaluation.

The relevance of timely review has been highlighted in empirical studies of psychology faculty-IRB interactions. For example, a study of faculty at several research institutions showed that quick IRB review of proposals was the most commonly reported strength of an IRB, and slow review the most common complaint (Liddle & Brazelton, 1996; see also Ferraro et al., 1999). Interestingly, 23% of investigators who reported noncompliance with IRB policies indicated the reason was time: “I was in a hurry and could not afford the delay” (Liddle & Brazelton, 1996; p. 5). Investigators’ failure to comply with institutional policies and/or federal regulations can lead, in extreme cases, to suspension of all human participant research at the institution (Oakes, 2002). IRB administrators interested in identifying and reducing the influence of factors associated with noncompliance may want to work with investigators and IRB members to make sure that protocols are processed in a timely manner.

They may ask investigators to identify protocols that qualify for expedited review, so that a single qualified reviewer can review (and, where applicable, approve) the study, rather than waiting for the full board. Behavioral research is often a prime candidate for expedited review; although the federal regulations should be consulted to ensure that the study meets the criteria (see Federal Register, Volume 63, p. 60, 364 or Office for Human Research Protections, “ Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure ”). IRB administrators have an outstanding opportunity to ensure that research proposals are reviewed by IRB members with the most relevant expertise. Thus, administrators may want to make sure that IRB members selected to review behavioral science or biomedical protocols are familiar with the relevant issues. Just as a cognitive scientist may not be the most appropriate reviewer for a trial investigating the efficacy of a novel surgical procedure, so a surgeon may not be the most appropriate for a cognitive science protocol. As noted, federal regulations encourage reviews by individuals with the appropriate expertise, even if those individuals are not regular members of the IRB.

Administrators can also encourage IRB members to provide complete, accurate and timely reviews, provide guidance on the regulations to IRB members as necessary to facilitate their review, and alert institutional officials if individual IRB member are having difficulty meeting their obligations to the university community. Institutional officials have the authority to remove IRB members who are not able to provide thorough, informed, and timely reviews.

Providing clear and relevant protocol submission forms

Clear, well-organized, and relevant IRB application forms are likely to elicit the most complete information from researchers. Eliciting complete information may sometimes necessitate different forms for different types of research. The information necessary for biomedical research protocols may be irrelevant for nonbiomedical research, and vice versa. Thus, IRB administrators might construct application forms that extract appropriate information regarding research objectives, methodologies, and outcome measures (Sieber & Baliyot, 1992). Where applicable, these forms might also ask investigators to indicate the type of review requested (exempt, expedited, or full board) and to provide a clear reason for their request. Forms that elicit relevant information may better allow IRB administrators help IRB members conduct comprehensive reviews and assess the criteria necessary for issuing IRB approval in a timely fashion.

Communicating effectively with investigators

In order to make IRB procedures and requirements transparent to researchers, IRB administrators may want establish clear communication procedures. Ideally, there should be a variety of mechanisms through which researchers can access information about federal regulations, institutional policies and guidance, protocol submission and review procedures, IRB meeting dates and deadlines, research-related issues of local and national importance (e.g., proposed rule changes on the federal level), federal or institutional educational requirements and opportunities, and whom to contact for information or assistance. At some institutions, this type of communication involves diverse media, including web site updates, a newsletter column, and accessible IRB staff (Council et al., 1999).

Accessible staff can be an important component of IRB administration, and staff provide an opportunity for real dialogue between researchers and IRB administrators not possible through electronic communication. This dialogue might take place at both the individual and group levels. Open communication with individual researchers or research teams may be important for new researchers, researchers tackling particularly challenging issues, or researchers seeking to understand IRB requirements or submission and review processes.

For example, a challenge encountered by some scientists involves the requirement to obtain and document participants’ informed consent (45 CFR 46.116 & 117). Sometimes research objectives are more consistent with verbal consent procedures, or enrolling children without parental permission. Disapproval of these requests suggests an opportunity for better communication between researchers and IRB. Researchers may be unaware that the regulations include specific provisions for IRBs to approve requests to alter or waive informed consent requirements.

For example, IRBs may waive the requirement to document in writing a participant’s consent under certain conditions, if the signed consent document would represent a significant risk to participants. 2 Similarly, an IRB may waive the requirement to obtain signed consent if the research poses little risk and written consent would not be required if the project did not involve research. 3 Thus, IRB administrators are in a position to advise investigators about the conditions necessary to obtain a waiver of the requirement to obtain written consent, and where appropriate, to make recommendations about how best to deal with the issue.

The provisions for waiving parental permission for research involving children often prove more challenging for researchers than do those regarding the documentation of consent. For example, in seeking guidance concerning a waiver of parental consent, a researcher might suggest a “passive consent” process. The IRB administrator processing the proposal might, however, note that “passive consent” is not a part of current regulations. In this situation, the administrator might provide the researcher with the applicable regulatory information and suggest seeking a waiver of parental permission that includes a procedure through which parents can opt their child out of the research. 4 This approach provides important information to the researcher about what is permissible within the regulatory framework, and puts the researcher in a better position to determine the best approach. Moreover, this approach allows the administrator to be a partner in problem-solving, where the shared goal is facilitating research while protecting research participants and complying with applicable regulations.

In addition to communication with individual researchers, group dialog is also important as it can allow for dissemination of new information by IRB administrators that may be of interest to a more general audience, and it also allow researchers to raise general concerns or challenges that they may be facing. Reaching out to a more general audience may be done through campus forums, campus town meetings, or by inviting an administrator to a departmental meeting, seminar, or other group gathering that is devoted to IRB issues. This dialog is important for dissemination of new information by IRB administrators, and for allowing researchers to discuss general concerns or challenges that they face. Reaching out to a general audience may be done through campus forums, campus town meetings, or by inviting an administrator to a departmental meeting, seminar, or other group gathering devoted to IRB issues. This dialogue also allows for sharing information and perspectives between IRB administrators and researchers. Researchers usually do not understand the IRB process or requirements as well as IRB administrators do, whereas IRB administrators may not understand all the practical research-related issues, such as sampling, design, etc. Facilitating dialogue allows both parties to appreciate and understand the other’s concerns.

Providing training opportunities for IRB members and investigators

Training is critical to reduce conflict and improve the working relationships among investigators, IRBs, and IRB administrators. Investigators who understand the ethical foundations of the federal regulations, the federal and state regulations governing human participant research, and the procedures used by their local IRB are less likely to see IRB decisions as inconsistent or arbitrary. In addition, investigators who understand the parameters within which IRBs operate can be more effective in presenting their research to the IRB, thereby minimizing difficulties in getting research approved. In turn, IRBs that are well grounded in the ethical foundations of the federal regulations and have a thorough understanding of the regulations may be more likely to use the latitude inherent in the regulations to tailor their review to the risks associated with a particular project. IRBs also may be more efficient and effective in their reviews if they understand clearly the scientific methodology and associated risks posed by certain research activities.

The notion that IRB policies and procedures develop over time suggests that IRB member training is an ongoing process. IRB administrators can take the lead in providing ongoing training opportunities. Periodical publications such as “Human Research Report: Protecting Researchers and Research Subjects” and “IRB: Ethics in Human Research” can be provided to IRB members. Brief training sessions conducted by IRB staff can be held during IRB meetings, and institutions may bring in outside trainers (e.g. a researcher who is also an IRB member at another institution) for extended training sessions. IRB administrators can encourage the use of consultants who provide a dual function (i.e., provide guidance on review of particular research activities and contribute to the general knowledge of IRB members). Broadcast emails to IRB members can be used to disseminate important guidance in a timely manner. Administrators might also encourage IRB members to attend regional and national meetings geared to human subject protection issues. IRB administrators can work with institutional officials to identify funds for IRB members to attend meetings or to bring in outside trainers.

IRB administrators should also support ongoing training opportunities for investigators. Administrators can request that their libraries carry publications geared to human research participant protection issues. A web site with links to current guidance from OHRP and FDA, upcoming regional and national meetings, etc. should be available. In addition, joint workshops for investigators, IRB members, and IRB administrators can be held. These joint workshops may be particularly informative when these groups are all struggling with current interpretation of issues (e.g., third party consent) by federal regulatory agencies.

IRB administrators are the interface between IRB members and investigators who seek IRB approval for their human participant research. Thus, these professional staff members are a critical part of the collaboration that we propose. When IRB administrators adopt a service orientation, and when IRB members and investigators work with IRB administrators to improve IRB services, research participants, researchers, and the research enterprise can benefit.

Responsibilities of investigators

Like IRB members and administrators, investigators who conduct research with human participants face many important challenges, and these challenges may increase along with increased regulatory oversight and public scrutiny of this work. The collaboration proposed here is a way to meet critical challenges, while maintaining and demonstrating a commitment to safe and ethical research. The investigators’ role in the collaboration involves valuing research as a privilege, knowing the rules, appreciating comprehensive IRB review, planning ahead, and joining the process.

Valuing the privilege of conducting research

Investigators should remember that conducting research is a privilege (see Oakes, 2002). The opportunity to conduct research is formally granted by some combination of the researcher’s institution (governmental or nongovernmental), the federal government, and, where applicable, the funding agency. That this opportunity is a privilege and not a right is made most clear when the privilege is revoked, as it has been at several universities over the last 5 years (Oakes, 2002). Perhaps more important, research participants themselves endow the investigator with the privilege of conducting research. Regardless of the risks of a particular research study, participants put their trust in the principal investigator and his/her staff. This trust must be protected, through the application of basic ethical principles, including respect for persons, beneficence, and justice (OPRR, 1979). Along with their federally- and/or institutionally-mandated roles, IRBs and IRB administrators are the formal bodies that speak for and protect the rights of research participants. In an important sense, when investigators collaborate with IRBs and IRB administrators, they are working with their participants to ensure the integrity of the research enterprise, and the ability of the investigator to exercise the privilege of conducting research.

Investigators benefit when they are familiar with the institutional policies and regulations that govern research with human participants. At most institutions this information is included in investigator manuals, which may be disseminated within the institution’s research community, as printed copies and/or as web-based documents. A working knowledge of applicable policies and regulations enables investigators to better understand whether the proposed research activities meet the federal regulatory definitions of “research” and “human subjects.” Although not all research falls under the authority of the IRB, most institutions require any research activity that meets both definitions contained in the Common Rule be submitted to the IRB for review. Thus, wide dissemination of basic regulatory information may ensure that investigators submit protocols for review prior to starting a research study. Furthermore, such knowledge equips the researcher to prepare more complete research protocols for IRB review, further facilitating the review process.

Investigators also benefit when they have a firm understanding of federal regulations governing human participant research and IRB review. Specifically, investigators may be able to save a great deal of time and effort if they understand the difference between exempt, expedited, and full board review, and know when to request which type (see Oakes, 2002 for an excellent summary). Of particular note for behavioral scientists, research that involves only “minimal risk” to participants likely qualifies for expedited review. Expedited review saves time for investigators and the IRB as a group, because a single member can approve (but not disapprove) a proposal. If an IRB does not make use of the expedited review process, an informed investigator might discuss with the IRB administrator the value to the IRB of providing this important service. Similarly, informed investigators can discuss with IRB administrators the value of ensuring that IRB membership includes expertise relevant to the review of particular research proposals, and the possibility of obtaining reviews from non-IRB members whenever necessary. These and other issues can be discussed in terms of improving IRB efficiency (e.g., expedited review of minimal risk protocols means more time for the full board to review nonminimal risk protocols; outside reviewers with specific expertise help the IRB gauge risk and anticipated benefit accurately). Thus, informed investigators can be seen as partners in improving IRB procedures as well as research participant protections.

Investigators might also benefit from understanding current thinking among IRBs and federal regulatory agencies regarding behavioral and social science issues. For example, investigators might be encouraged to attend regional or national conferences geared to human research participant protection issues, because these conferences cover issues and concerns germane to behavioral and social science research.

Appreciating comprehensive IRB review

As many investigators realize, comprehensive IRB review of a proposed research project can be a source of valuable feedback. IRB review of issues related to the rights and safety of participants is often appreciated, but investigators may become uncomfortable when IRBs consider issues related to research design, experimental method, or statistical analysis (e.g., Ferraro, Szigeti, Dawes, & Pan, 1999; Liddle & Brazelton, 1996). However, IRBs must always weigh the potential benefits of a study against the potential costs to the participants; and investigators would likely agree that there is little benefit to a project with a flawed research design, inappropriate experimental method, and/or improper data analysis plan. If investigators appreciate that design, method, and analysis can influence project benefit, then they can also appreciate why IRB are required to review these important issues when determining risk/benefit ratio(see, for example, Schmidt & Meara, 1996; Hayes et al., 1995). If a flawed project has no potential benefits, even minimal risks (such as emotional discomfort or breach of confidentiality) might tilt the ratio unfavorably (Schmidt & Meara, 1996). In such cases, the IRB might ask an investigator to clarify the appropriateness of the proposed design, method, and/or analysis plan, or to revisit these issues in a protocol revision. Such suggestions are part of the IRB review process (a majority of IRBs report that they review methodology; Hayes et al., 1995), just as they are commonplace in the review of grant applications and journal submissions.

Planning ahead

The proposed collaboration maintains that one of the primary responsibilities of IRB administrators is to be helpful to all investigators. Researchers too have a role to play in ensuring the success of this collaboration. One way that researchers can fulfill their obligations is by ensuring that their research time frame includes the time needed for thorough IRB review. Advance planning allows the researcher to prepare his/her protocol for efficient review, (e.g., by affording researchers time to consult with IRB administrators and/or members about protocol specifics prior to submission), and also allows the IRB to process the application more efficiently (Schmidt & Meara, 1996). Thus, recognizing the time and resource constraints under which most IRBs function, and planning accordingly, reduces the burden and increases the benefit for both IRB and researcher.

Joining the process

The best way to help an IRB become responsive to the research needs of a particular discipline is for researchers in that discipline to become involved in the review process. Active researchers have an obligation to serve on local IRBs, and researchers should remember that IRB service is an excellent method of peer (and self) education (Gillespie, 1999). Many faculty may consider IRB service onerous, and suggest that their schedules are already full with departmental and other university service. These same ideas may occur to current IRB members as they review the protocols of their faculty colleagues. However, as more researchers join the process, they contribute to a decreased workload for individual IRB members.

There are also other ways to participate in IRB review, which include volunteering as an alternate or ad hoc reviewer, partnering with IRB administrators to host educational sessions, helping to review and improve IRB forms and procedures, and working with the IRB to find creative solutions to common challenges faced by behavioral/ social science researchers.

The increased public scrutiny of human participant research impacts all parties involved in the research enterprise. Accordingly, the proposed collaboration includes responsibilities for each party in order to facilitate research and protect rights and welfare of research participants. Researcher responsibilities include understanding the review process and having a realistic timetable, knowing the relevant federal policies and regulations, and becoming involved in local research oversight. Active participation by behavioral researchers in the review process is perhaps the most effective way to make the system responsive to the needs and circumstances unique to behavioral and social science research.

Responsibilities of institutional officials and administration

In addition to improving the working relationship among IRBs, IRB administrators, and researchers, there is also a need for other institutional officials to recognize and attend to the needs of social and behavioral science researchers. When an institution focuses on biomedical sciences, enlightening the administration regarding regulatory issues or concerns pertaining to behavioral research may seem challenging. Meeting this challenge can bring enhanced support to the IRB, greater responsiveness from IRB administrators, and can facilitate the work of behavioral researchers in the institution.

One important goal for social and behavioral scientists involves gaining access to individuals with authority for their institutions’ research programs. Investigators can identify appropriate institutional officials through a variety of mechanisms, depending on the type of institution. For an institution of higher education, research is overseen primarily by a Vice President or Vice Provost for Research, who serve typically as the signatory Institutional Official, but there may be others who also serve in this role. Often, each College also has an Associate Dean for Research or similar position. Hospital and medical facilities, such as the Veterans Affairs, typically have a different hierarchy but have individuals who oversee research conducted at the facility. Identifying the people who serve in these positions and establishing channels of communication with them can help bring greater appreciation of the needs of behavioral scientists. This greater appreciation is best gained when a researcher presents challenges in a constructive and positive manner, along with proposed solutions for meeting the challenges. Concerns that are presented with a clearly formulated and practical means of addressing them are often well received.

While IRBs are autonomous, there is considerable latitude with regard to a number of local policies regarding IRB issues. For example, institutional administration can influence IRB member tenure, application review forms, submission policies and deadlines. Because these issues involve the regulation of research, it is important that institutional administrators continually seek feedback from the diverse spectrum of researchers affected by them. Formal administrative mechanisms for ensuring researcher input into these processes may include establishment of an executive or advisory committee of researchers and systematic, periodic “customer satisfaction” surveys of the research community. If feedback is solicited and acted upon, institutional officials can facilitate a positive relationship among IRBs, IRB administrators, and researchers. They may also enhance the level of researcher participation in the process, and ultimately improve protections afforded to human research participants.

IRBs represent the federal government and the local agencies involved in reviewing research and are responsible for protecting the rights and welfare of research participants at a particular institution. IRB administrators are responsible for organizing and maintaining the activities of the IRB and can serve an oversight role for IRB members and for investigators. Researchers are obligated to perform safe and ethical research and to minimize the risks and maximize the benefits of their science. These responsibilities and obligations can be met most effectively when IRBs, administrators, and researchers work collaboratively. At times, behavioral/psychological scientists may feel left out of the IRB process, or neglected by IRB administrators. When this feeling arises, it may be an indicator that greater collaboration is necessary. We hope that researchers will use the suggestions presented here to develop or enhance collaborative relationships with their IRB and IRB administrators. Perhaps more importantly, we hope that behavioral/psychological researchers will work to reduce conflict within the IRB process, secure in the knowledge that regardless of scientific discipline or role in the research process, the goal of all involved in the research enterprise is the same—to promote knowledge, to expand our understanding of each other and the issues that we face together, and to provide the best protection possible for those willing individuals who volunteer their time and trust to serve as research participants.

American Psychological Association. (2002). Ethical principles of psychologists and code of conduct. American Psychologist , 57 (12), 1060–1073.

Beh, H. G. (2002). The role of Institutional Review Boards in protecting human subjects: Are we really ready to fix a broken system? Law and Psychology Review , 26 (Spring 2002), 1–47.

Brinthaupt, T. M. (2002). Teaching research ethics: Illustrating the nature of the researcher-IRB relationship. Teaching of Psychology , 29 , 243–245.

Council, J. R., Smith, E. J. H., Kaster-Bundgaard, J., & Gladue, B. A. (1999). Interactions concerning risky research: Investigators rate their IRBs (and vice versa). In G, Chastain & R. E. Landrum (Eds.), Protecting human subjects: Departmental subject pools and Institutional Review Boards . (pp 183–198). American Psychological Association.

Ferraro, F. R., Szigeti, E., Dawes, K. J., & Pan, S. (1999). A survey regarding the University of North Dakota institutional review board: Data, attitudes, and perceptions. The Journal of Psychology , 133 , 272–276.

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• Sub-part A, of Title 45 Code of Federal Regulations, Part 46 (45 CFR 46), which specifies the basic Department of Health and Human Services policy for the protection of human research participants, was also adopted by 14 other federal agencies, the Central Intelligence Agency, and the Office of Science and Technology Policy and is usually referred to as The Common Rule.
• See HHS regulations at 45 CFR 46.117(c)(1): the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
• See HHS regulations at 45 CFR 46.117(c)(2): the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
• Such a procedure is clearly permissible for research that meets the conditions specified at 45 CFR 46.116(d).

Related Resources

• Printable version (PDF, 144KB)
• Recommendations of the 2007 APA Presidential Task Force on Institutional Review boards and Psychological Science (PDF, 36KB)

Related Pages

• How to be a wise consumer of psychological research
• Links to psychological research data sets

Contact APA

As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.

The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.

ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.

Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).

eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).

Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.

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U-M HRPP Operations Manual References

IRB approval criteria: Part 3, Section III, C 6

Regulated/not regulated research: Part 4, Section V  

Exempt research policy: Part 4, Section VI

Using the U-M IRB System

IRB staff and board members have access to the IRB application and posted correspondence via the eResearch Regulatory Management (eRRM) system.  The system facilitates the IRB review process by:

• Providing regulatory checklists that guide IRB staff review
• Routing submissions to ancillary committees (e.g., COI-UMOR), as applicable
• Re-routing submissions to a different U-M IRB, if applicable

IRB-HSBS Turnaround Times

"Turnaround" is the estimated time it takes to complete the IRB review and determination process.

Full-board :  4 - 8 weeks

Expedited :  2 - 4 weeks

Exempt :  < 1 week

The U-M Institutional Review Boards (IRBs) fulfill their goals to protect human research participants and support the design and conduct of sound research by reviewing and approving IRB submissions for new applications, amendments, and continuing reviews.

All projects that meet the definition of research with human subjects ( 45 CFR 46.102 ) must be reviewed and approved by an IRB, or receive an exempt determination,  prior  to beginning the research.  The IRB staff initially screens submissions to determine the completeness and the appropriate type of review.  Submissions may be returned to the study team for changes before the review type is assigned.  The review type may be reassessed at any time during the review process.

Types of IRB Review

The basic types of IRB Review are: Comprehensive , Exempt , and Not Regulated .  The type of IRB review and the associated review process (e.g., full board , expedited , limited IRB review , system-generated ) are determined by the:

• Level of risk to research participants
• Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
• Sensitivity of the research questions or complexity of the research design
• Involvement of vulnerable populations as research participants
• Use of identifiable information or indentifiable biospecimens
• Applicability of one or more of the criteria for exempt or expedited review

Research Requiring Comprehensive IRB Review

The IRB may conduct either an  expedited or full board review for IRB-regulated research proposed in the  Interaction/Intervention or   Secondary Use   application types  to ensure:

• Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits
• The subject selection is equitable
• Privacy and confidentiality are protected
• Informed consent processes meet federal regulatory and U-M requirements 

Full Board Review

Federal regulations and institutional policy require a review by the IRB Full Board for applications where the research involves  more than minimal risk  to human subjects, does not meet the criteria for one of the categories of expedited review , or has been referred to the committee by an expedited reviewer or the Chair.  Regardless of risk level, IRB-HSBS may require full board review when the research involves: 

• Vulnerable populations, particularly prisoners
• Sensitive topics, including illegal behaviors which may require an NIH  Certificate of Confidentiality  (CoC) to protect subject data from compelled disclosure
• Research involving genetic/genomic analyses
• A complex research design requiring the expertise of multiple board members to evaluate

The IRB posts submission deadlines for upcoming IRB meeting dates. If an application is “board ready”, meaning that it contains all of the information and materials necessary for the full board to conduct its review, the application will be assigned to the next IRB meeting date (see Related Information to the right for schedule links), except where the agenda is already full or a reviewer with the necessary expertise is not available for that meeting. IRB staff assign submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission.

IRB Full Board Determinations 

Approved : the application is approved as submitted.  The approval date is the date of the IRB review.

Approved with Contingencies : the application is approved, contingent on submission of specified changes to the protocol, informed consent document(s) and/or other supporting materials.  Final approval status is granted when the IRB has reviewed and approved all requested changes. The date of the "approved with contingencies" determination is deemed the date of approval.

Action Deferred : the IRB needs additional information from the investigator before the IRB can make all of the determinations found at 45 CFR 46.111  necessary to approve the study. The principal investigator must submit the requested additional information before the IRB will consider the application for further review.

Disapproved :  the protocol does not provide adequate protection to human participants, and it is unlikely that it can be modified to provide such protection. The IRB notifies the principal investigator of the disapproval in writing, including a statement of the reasons for its decision, and provides the opportunity for the investigator to respond to the IRB in person or in writing.

Tabled :  the IRB full board did not have time to review the application at the convened board meeting. The application is placed on the agenda for the next convened meeting.

Expedited Review

Federal regulations ( 45 CFR 46.110 ) authorize the use of an expedited review process for:

• Minimal risk  human research that meets one or more of the OHRP  Expedited Review Categories   
• Minor  changes to research  previously approved by the full board

Applications qualifying for expedited review are assigned to an expediting reviewer, an experienced IRB member appointed to the role by the IRB Chair.  The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise), including in cases of disapproval.  Only the full board has the authority to disapprove a study.  Most studies that qualify for the expedited review process do not require annual Continuing Review .

IRB Expedited Review Determinations

In addition to the  Approved  and  Approved with Contingencies  determinations ( described above ) reviewer may issue a Changes Requested  determination, when substantial changes to the application and/or materials are required before the expediting reviewer can approve the study. 

Exempt Research Review

Per university policy, investigators must submit an IRB application for determination of exemption before research begins. Applications are routed for exempt review through the Interaction/Intervention application or the Secondary Use application types.  IRB-HSBS recommends using the Brief Protocol for Exempt Research Projects (download) to provide an overview of you exempt project or as a data entry guide when completing the IRB application.

Projects that meet the criteria for a  federal exemption category  (45 CFR 46.104) or for a  U-M exemption #5  may be granted a  determination of exemption  by the IRB, or where applicable, through the system-generated review process.  The review determination, whether conducted by the IRB or system-generated, is limited in scope to the information necessary to determine if the proposed exemption applies.  The IRB does not review informed consent documentation or recruitment materials for proposed exempt studies.  Exemptions may be granted by the IRB Chair, expedited reviewers, or (in most cases) qualified IRB staff members.

Projects receiving an exempt determination are not subject to the Continuing Review process .  Amendments are required only if the changes to the project would alter the exemption criteria.  An exempt determination does not lessen the researcher's ethical obligations to participants as articulated in the Belmont Report or to the codes of conduct for specific disciplines.

Limited IRB Review

The Common Rule provides a Limited IRB Review process, which is a required expedited review of recruitment and consent materials as well as plans to maintain participant privacy and data confidentiality for exempt 2 and 3 projects that collect or use sensitive and identifiable data .  An exempt determination is issued once the expediting reviewer confirms that these protections are acceptable.

Not Regulated Review

Not all research-related activities that involve people, their data, or their biospecimens are covered by the regulations governing human research. However, investigators may wish to submit a brief eResearch IRB application for a formal “not regulated” determination for funding or publication purposes; or, the investigator may be able to issue a system-generated determination letter without submission to the IRB.

Submission to the IRB is not required for the following activities:

• Case studies
• Class activities
• Journalism/documentary activities
• Oral history
• Quality assurance and quality improvement activities
• Research on organizations
• Research using deidentified data or biospecimens
• Research using publicly available data sets

Some categories require IRB review for the purpose of assessing compliance with HIPAA or other regulations. These include:

• Research involving existing information or biospecimens that have been coded before the researcher receives them, but identifiers exist
• Research involving deceased individuals only
• Pre-review of clinical data sets preparatory to research
• Standard public health surveillance or prevention activities

For a complete list of not regulated research activities, see the HRPP Operations Manual, Part 4 .

If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:

1.  Is it research?

Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge   ~ Federal definition,  45 CFR 46.102 (l)

• Activities such as the  practice  of public health, medicine, counseling, or social work are not research. 
• Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.

2.  Does the research involve human subjects?

Human subjects research is a project that involves a living individual about whom the investigator (whether student or professional) (i) obtains information or biospecimens through interaction/intervention with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses studies, analyzes, or generates identifiable private information or indentifable biospecimens.  ~  Federal definition  45 CFR 46.102 (e)(1) 

3.  Is the university engaged in the conduct of the research?​​

The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities.  See OHRP's Guidance on Engagement of Institutions for more information and examples.

• Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.  
• If you answer "no" to any of these questions, you may have other obligations than IRB review.  See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.

IRB Health Sciences and Behavioral Sciences Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

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Graduate and Undergraduate Students

Checklist for submitting a student research proposal:

• Review your research proposal with your faculty advisor
• Obtain faculty advisor’s approval using the Faculty Approval of Student Research form
• Scan the completed form and save an electronic copy to attach to your proposal
• Be prepared to also attach the following: IRB training certificate, informed consent documentation and any researcher-created instruments
• Submit your proposal online

Note: we have been having some intermittent issues with the submission form. Please craft your responses in a separate document that you save for your own records; then copy/paste your answers into the form to submit. If you do not receive an email of your submission within one hour, please contact the EMU Help Desk .

EMU Faculty and Non-Student Researchers External to EMU

Checklist for submitting a research proposal:

• Be prepared to attach the following: IRB training certificate, informed consent documentation and any researcher-created instruments

EMU Classroom Research Projects

Checklist for faculty submitting a classroom research proposal:

• Prepare a list of the projects to be completed by the students in your class.
• Complete the Faculty Assurance Form .
• Send both documents as email attachments to the IRB .

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IRB Approval at the University of North Texas

Certification required for human subjects.

IRB stands for Institutional Review Board, and at UNT the IRB is part of the  Office of Research and Innovation , located in Hurley Admin. Building, Room 210. The board is composed of UNT faculty and staff who apply federal regulations in the review of research involving humans. Your research plan may require review and approval if the plan includes human subjects. The IRB guides you through the process on the IRB Homepage  and the IRB Guidelines page . Contact IRB or talk to your faculty advisor if you have questions.

Before starting a research study with humans, all investigators and other involved staff must go through federal training online. Each person must submit a certificate of completion to the IRB office. Check the UNT IRB webpage for the currently accepted training programs.

Need help? Then use the library's  Ask Us service. Get help from real people face-to-face, by phone, or by email.

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• REDCap - An Overview

REDCap- An Overview

Research Electronic Data Capture (REDCap) is a data collection tool for building surveys and databases. It was implemented to assist principal investigators, students, compliance and research administration staff with administering sponsored programs. In this training session, participants will learn how to create a survey using REDCap. You will be given an overview of the software and how to navigate through the different features and functions of the software when participating in research at UB. 

Prerequisites

You'll benefit by learning to.

• Explore all of the different features and functions of REDCap software
• Navigate the software to build a survey

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Principal Investigators and Study Team Members

Training Materials

Register for qualtrics- an overview.

Tracie Groves Training Programs Coordinator UB Commons, Suite 114 Email:  [email protected] Phone: 716-829-6650

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Tracie Groves Traing Programs Coordinator UB Commons, Suite 114 Email:  [email protected] Phone: 716-829-6650

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• Events Calendar

Elevate your fall fellowship proposal through RIO's Writing & Peer Editing Program, starting July 16

Elevate your fall fellowship proposal through rio's writing & peer editing program, starting july 16.

The Research and Innovation Office (RIO) announces the launch of the fourth annual Fall Fellowships Writing & Peer Editing Program: ACLS, NHC, Fulbright and More , facilitated by RIO Proposal Writer/Editor Donna Axel. Faculty are encouraged to attend a brief 30-minute kickoff   on Tuesday, July 16 at either 10 a.m. or 4 p.m. to determine if the program is right for them. 

The virtual program is designed to assist faculty in submitting a proposal to one of the many fellowships with a fall deadline—including the American Council of Learned Societies (ACLS) , National Humanities Center (NHC) , Stanford (SHC) , Guggenheim , Fulbright and more. In the process, participants will also learn how to reuse, repurpose and recycle proposals at a later date or for other opportunities. 

From July through September, program participants will draft proposals and participate in a peer editing workshop to hone the narrative portion of fellowship applications typically due in September and November.

Learn More about the Fall Fellowships Writing & Peer Editing Program

  Bonus session

September 10 Faculty Panel: Fellowship Writing Success Stories

Three CU Boulder faculty members will share their success stories—and their processes—for applying for fellowships:

• Ashleigh Lawrence-Sanders (History) , awarded the American Council of Learned Societies Fellowship (2023)
• Elspeth Dusinberre (Classics) , awarded the Guggenheim Fellowship (2023)
• Emmanuel David (Women & Gender Studies) , awarded the National Humanities Center Fellowship (2022)

Program overview

• Attend a Kickoff on Tuesday, July 16  to determine if the program is appropriate for your needs.  Register for 10 a.m. Kickoff   Register for 4 p.m. Kickoff  
• Attend one of the “Categories & Requirements” sessions  taking place on Thursday, July 25  to review specific fellowship opportunities.  Register for 10 a.m. Session   Register for 4 p.m. Session  
• Meet 1-on-1 with Donna  and/or send her your draft one to two weeks prior to submitting your draft for the peer review workshop.
• Prepare a draft narrative  for review by committed colleagues one week in advance of your peer review workshop. 
• Peer review 1–4 of your colleagues’ proposals  in advance of the Peer Editing Workshop.
• Participate in at least one peer review workshop  (Aug.–Sept., TBD by faculty).
• Optional : As part of participating in this program, and on a first-come-first-served basis, Donna Axel offers to review your draft after you have incorporated any suggestions from the peer-review process.
• Optional : Attend the panel event where faculty share their success stories on Sept. 10.  Register Here

  I couldn’t have managed the fellowship application process last year without the help of the fellowship writing program. I benefited enormously from Donna’s expert and valuable suggestions at every step of the way; she helped me improve my various proposals, re-craft them for different fellowships, and also think about additional programs to which I might apply for funding. The peer editing program was also incredibly helpful and resulted not only in much better proposals but also in real friendships with colleagues across campus. Donna’s guidance in writing proposals geared toward readers outside my field has also helped me think more critically and productively about how best to craft public presentations that are compelling to a broader audience. The work I was fortunate enough to do with Donna and the fellowship writing program has improved my entire professional being and career trajectory." 

— Elspeth Dusinberre , Professor, Classics; Selected as a Guggenheim Fellow 2023-2024.

  My participation in RIO’s peer editing fellowship program made a world of difference for me as I prepared my external fellowship applications. I received useful and concrete feedback from the other faculty members in the program, and Donna Axel really helped me shape my proposal with her comments and suggestions. I’ve used my application for several fellowship programs and have worked with Donna to tailor the prose for different funding opportunities. I feel like my application writing skills and my understanding of the entire grant application process have improved immensely thanks to Donna’s expert advice and close attention to detail.”

— Emmanuel David , Associate Professor, Women & Gender Studies; Selected as a National Humanities Center Fellow 2022-2023.

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