IRB Member Review Responsibilities and Guidance
IRB Meeting Agenda
Meeting Agendas
The HRPP staff finalizes the agenda at least three weeks before the upcoming meeting. You will be notified by email when the agenda is finalized, and a copy of the agenda will be attached to the email. You can access an electronic copy of the agenda and all of the submissions on it by going to the “Meeting Agenda” section in OneAegis.
The full committee meeting agenda may include the following types of submissions:
- initial submissions (new studies),
- continuing reviews for full committee studies,
- modifications of approved studies, and
- post-approval events that require a full committee determinations.
The agenda also will include the review of the last month’s minutes, miscellaneous items for discussion, and education.
There will be an attachment of expedited studies that were approved the month before. These submissions are listed for reporting purposes only and will not be discussed at the IRB meeting, unless the members have questions or comments.
Reviewer Assignments
You will receive an email notification and see a “Reviewer Assignment” task in OneAegis for each of your reviewer assignments.
The IRB Administrator does his best to assign studies according to member interests and expertise. However, to balance the number of reviews, members may be assigned to review studies not within their immediate area of expertise. In addition, a member may find a study of particular interest and decide to comment. If members notice they are not being assigned the type of studies they are particularly interested in, they should let the Administrator know.
Leading Meeting Discussions
At the meeting, submissions generally are discussed in the order in which they appear on the meeting agendas. Each study will be assigned as a Primary Reviewer and a Secondary Reviewer, and sometimes a consultant or advocate. However, all members in attendance at the IRB meeting are expected have read and made notes on all studies so that he or she can follow and contribute to the discussion.
The number of assigned reviewers depends on the type of submission, and the roles of the reviewers vary, as described below.
In IRB meetings, the focus should be on ethical and regulatory issues that directly impact the study’s approval status. Minor issues — those that do not rise to the level of affecting risk/benefit, informed consent, participant safety, or regulatory compliance — should not occupy meeting time but will be included in the determination letter or reviewer notes. These issues are often called "editorial comments" or "non-substantive suggestions."
Some examples of minor issues include:
Typos, grammar, formatting errors
- Spelling or punctuation mistakes in consent documents or protocol text.
Inconsistent terminology or phrasing
- Referring to “subjects” in some places and “participants” in others.
Non-substantive inconsistencies
- Minor discrepancies between the protocol and consent form that don’t affect comprehension (e.g., saying “you will complete 3 surveys” in one place and “you will complete two surveys” in another).
Inclusion of unnecessary information
- Redundant content in the consent form that doesn’t affect understanding or length significantly.
Slight consent readability issues
- Consent form reads at a 9th grade level instead of 8th grade, but overall is understandable.
Minor stylistic suggestions
- Suggestions for rewording a sentence to sound smoother or more participant-friendly, but not essential for comprehension.
Clarification of non-impactful procedural steps
- "Consider explaining how long the online survey will take." (if not critical to risk or understanding)
Initial Submissions Full Board Studies and Tabled or Returned Studies
First Reviewer:  The first reviewer presents a brief overview of the study so the other members will be able to have a sense of the subject population, purpose, and design of the study. This presentation should be no more than a minute or so and should not go into great detail. Then the reviewer should:
- Present your assessment based on the criteria for approval in the order of the application and associated documents: recruiting materials, consent form, instruments and other supporting documents.
- Follow with the most salient concerns or comments about the study protocol with a focus on the risk/benefit ratio, other risks and/or procedures to minimize risks.
The discussion should be limited to questions, problems, or concerns with: 
- Subject selection,
- Informed consent documents,
- Data safety monitoring provisions,
- Protection of privacy and confidentiality, and/or
- Adequate protections of vulnerable populations.
- Subject selection,
Initiate discussion about:
- Any needed clarifications, justifications and/or additional information in the protocol,
- Requested revisions and/or stipulations in the protocol;
- Major problems or concerns with consent documents.
- NOTE: Minor issues are noted as comments within OneAegis and need not be discussed Staff will include in letters as appropriate.
- NOTE: Easily correctable consent form should list be listed in the Reviewer’s Checklist (see below) or member notes rather than discussed at the meeting.
- Any needed clarifications, justifications and/or additional information in the protocol,
Second Reviewer: The second reviewer may either concur with the first reviewer or make additional comments or raise additional concerns. The second reviewer is also back up for the first reviewer if the first reviewer has to cancel unexpectedly. Thus, the second reviewer should be prepared to present the protocol.
All Members: All members are expected read all studies in order to contribute to the discussion.
Human Subject Advocate: An advocate is required in IRB meetings only in specific, federally defined circumstances, particularly for certain vulnerable populations. When an advocate is required:
1. Children (Subpart D of 45 CFR 46)
- Required for research involving wards of the state if the research is greater than minimal risk and not related to their status as wards.
- In this case, the IRB must appoint an advocate for each child who is a ward.
The advocate must:
- Have the background and experience to act in the best interests of the child.
- Not be associated in any way (except as the advocate) with the research, the investigator(s), or the guardian organization.
2. Prisoners (Subpart C of 45 CFR 46)
- A prisoner representative is required whenever the IRB reviews research involving prisoners.
The representative must:
- Be a member of the IRB or be invited for the meeting.
- Have appropriate background and experience to represent the interests of prisoners.
- Be present for quorum and approval for any protocol involving prisoners.
Full Committee Major Modifications, Continuing Reviews (Renewals), and Post-Approval Events
First Reviewer: The first reviewer does not need to present an overview of the study, though he or she could provide a very brief summary of changes (not the details, unless they are a matter of safety). The discussion should begin with if and how the risks and benefits of the study have changed. Comments or concerns should be addressed, first with respect to the protocol and study status, then the consent form. Confirm regulatory determinations.
**Unless serious oversights occurred at initial review, avoid asking for changes in design or the consent unless related to changes in the actual study.
Second Reviewer: The second reviewer may either concur with the first review or presents his or her additional comments or questions.
All Members: All members should be familiar enough with the materials in order to follow and contribute to the discussion.
Chair and IRB Administrator
Chair: Although the chair is rarely assigned as a primary reviewer, he or she reviews all the studies and may comment on studies as well.
IRB Administrator: The IRB Administrator is a full voting member of the committee and actively participates in the review and discussion of research submissions. The Administrator brings expertise in federal regulations, institutional policies, and standard operating procedures (SOPs), and is responsible for ensuring the consistent application of these requirements across all studies reviewed by the IRB.
IRB Coordinator: The IRB Coordinator supports the operational and logistical aspects of the IRB meeting, including preparation of materials, scheduling, and documentation. The Coordinator is not a member of the committee and does not participate in deliberations or decision-making.
Expedited Review
Studies in which all procedures are no more than minimal risk and which fit into one of the nine expedited review categories may be reviewed using the expedited process.
Expedited Initial Reviews
The IRB Administrator assigns expedited studies to one to two committee members for expedited review with similar expertise or interests described in the study.
The expedited review process for these types of studies is as follows:
- Expedited review assignments will appear in the member’s task list just as full board reviews do. The reviewer also will receive an e-mail notification from the OneAegis system.
- Members are asked to complete these reviews within 10 business days. If a more rapid turnaround is needed, staff will check with the reviewer before assigning.
Subcommittee: Reviewing Responses
After the IRB meeting, the IRB staff will edit comments if necessary and forward the committee’s comments to the investigator. Unless the response needs to be returned to the full committee for re-review, a subcommittee (usually the assigned primary and secondary reviewers) will review the response or forward the response to a Chair, Vice Chair, or a member who raised concerns or has particular expertise to decide if the response is sufficient. This will be done using Internal Routing in OneAegis. If the response is adequate, the reviewer should inform the staff by stating that the investigator has addressed all stipulations. If additional changes are needed, the reviewer should include that information in the notes.
Member Review Tools
The Office of Human Research Protections (OHRP) offers comprehensive suite of educational resources designed to support IRB members in their review responsibilities. These resources include articles, pre-recorded webinars, instructional videos, and official guidance documents. IRB members are encouraged to utilize these tools to enhance their understanding of human research protections and stay informed about current regulatory expectations and best practices.
Access these resources directly through the OHRP Website
Completing a Review in OneAegis
Timing: To ensure timely processing and discussion of protocols, please adhere to the following review deadlines:
- Full Board Reviews: Submit your completed review no later than one day prior to the scheduled IRB meeting.
- Expedited Reviews: Complete your review within 10 business days of receiving the assignment.
Formatting Comments: When writing comments for investigators, please:
- Be specific: Reference the exact location in the submission (e.g., "second paragraph, third sentence" or "Section 4.2, Study Procedures").
- Be sure that the comment pertains to the section where you want the PI to change or clarify.
- Be directive: Clearly state what the investigator needs to revise, clarify, or provide.
- Use professional, concise language that can be directly copied into correspondence by IRB staff.
- Ensure that all comments relate to a criterion for approval, SOP, policy, or law.
Example Comment Format:
- Section 3.1, Recruitment Methods: Please clarify how potential participants will be identified and approached. Specify whether any protected populations are involved and how privacy will be maintained during recruitment.
- Consent Form, Page 2, Risks Section: Revise the language to more clearly describe the potential risks of blood draws, including the likelihood and severity of discomfort or bruising.
- Second paragraph, third sentence: Please define the term "routine monitoring" and explain how it differs from standard clinical care.
Click here to view Instructions on IRB Board Member Review
Conflict of Interest (COI)
To uphold the integrity and credibility of the research review process, all IRB members and expert consultants—regardless of voting status—must avoid both actual and perceived conflicts of interest in connection with any study under review. This includes, but is not limited to, significant financial interests or personal relationships that could compromise impartiality.
A conflict of interest in research arises when financial, professional, or personal considerations may unduly influence, or appear to influence, an IRB member’s judgment in reviewing or evaluating a research protocol. The presence of a conflict is determined by the nature of the situation, not the character or intent of the individual.
The purpose of this policy is to ensure that no conflicting interest interferes with an IRB member’s responsibility to protect the rights and welfare of research participants or undermines the credibility of the IRB’s decisions. Members are expected to disclose any potential conflicts and recuse themselves from deliberation and voting when appropriate. In the meeting the member/expert with a reported COI will be placed in a virtual waiting room during deliberations and voting and will not count towards quorum.
Conflict of Interest Considerations for IRB Members and Consultants
Before participating in the review, discussion, or vote on any research protocol, IRB members and consultants must evaluate whether any personal, professional, or financial interests could compromise—or appear to compromise—their objectivity.
Required Recusal
If you answer “yes” to any of the following questions, you must recuse yourself from reviewing, discussing, or voting on the protocol:
1. Are you listed as an investigator or part of the research team on the protocol?
2. Are you a direct supervisor of the investigator or serving as the faculty sponsor for the protocol director?
3. Do you have a close personal relationship with an investigator (e.g., spouse, child, domestic partner, significant other)?
4. Do you or a close family member (spouse, child, domestic partner, significant other) have a significant financial interest in the drug, device, assay, or product being studied?
5. Are you an executive or board member of the organization sponsoring the research?
Situational Considerations
Affirmative responses to the following questions do not automatically require recusal but should prompt careful reflection. If you believe your objectivity may be affected, you are expected to follow the conflict of interest policy and recuse yourself as appropriate:
6. Do you have a competing interest with the protocol under review (e.g., professional rivalry, intellectual property concerns)?
7. Do you have other concerns that, in your judgment, may impair your impartiality (e.g., strong personal beliefs about the research topic or methodology)?
Procedures for Protocol Review and Attendance at the IRB Meeting
Please be aware of the following procedures as part of your membership or consulting responsibilities:
- Please inform the IRB Administrator at the beginning of your service of any existing conflicts of interest, as discussed above. The Administrator will track these conflicts and not assign you studies to review if you have indicated you would have a conflict of interest.
- If at any time during the period of IRB service new conflicts of interest arise, please alert the IRB Administrator. You should not participate in the review of a study for which you have a significant financial interest. If you indicate at any point during your service of any significant financial interests, the IRB Administrator will not assign you as a reviewer on the study. If you are inadvertently assigned, please notify the Administrator immediately so that the study may be reassigned.
- You may answer questions about the study and then will be placed in a virtual wait room during deliberations and voting.
- The IRB member will not be counted as part of the quorum for the protocol. If quorum is not present as a result of this absence, then the IRB may not take further action or vote on this protocol. It will have to be re-reviewed at a meeting for which there is quorum.
Member Appointment
Appointments: Members are nominated by various sources including but not limited to the Department Chairs, Associate Deans for Research, the HRPP Associate Director, and Unit Directors. Members are chosen to represent the types of research being reviewed by each IRB.
Appointments are typically for three years and renewable by mutual agreement, depending on the needs of the IRBs and departmental and college needs. The Associate Vice Chancellor for Ethics and Compliance gives final approval to an appointment or the decision to rotate a member off the IRB.
Member Evaluations: The HRPP will conduct annual member evaluations in order to provide feedback to members on the quality of their reviews. These metrics will be reported to department chairs and associate deans for research for annual stewardship evaluations.