30. Responsibilities of IRB Members, Chair, and Co-Chair

Updated July 26, 2021

Responsibilities of IRB Members

Primary members attend IRB meetings as voting members. Alternative members attend IRB meetings as voting members only when replacing a specified Primary member; when the specified Primary member is present at the meeting, Alternative members attend as non-voting members.

In carrying out their duties, IRB chairs and members:

execute their responsibilities in accordance with University policies and applicable federal, state, and local and laws;
complete the required human research protection training;
complete an annual IRB Member Agreement and IRB Member Self-Evaluation Survey;
ensure that the criteria for IRB approval at 45 CFR 46.111 are met for all review assignments including expedited and full committee reviews;
when assigned as primary, secondary, or expedited reviewer, review and assess recruitment materials and procedures, and use of recruitment incentives when applicable to confirm the equitable selection of participants;
complete the relevant review worksheets when assigned as primary, secondary, or expedited reviewer for a project;
maintain confidentiality for all matters before the IRB, all expedited reviews, and IRB consultations;
comply with the University or Affiliate institution’s conflict of interest policy;
disclose conflict of interests for a project subject to IRB review at a convened meeting; refrain from the discussion except to provide information requested by the IRB, and leave the room during voting; and
when she/he/they has a conflict of interest for a project she/he/they has been asked to review by expedited procedures, disclose the conflict interests and decline the review.

In evaluating the risks and benefits of the study, IRB members have the additional responsibilities to:

consider the adequacy of inclusion/exclusion criteria to enroll individuals most likely to benefit from and least likely to be harmed by the research;
determine if the inclusion/exclusion criteria have an ethical basis;
verify the adequacy of the consent document for informing participants about the research, including risks and benefits; evaluate the clarity and appropriateness of the information in consent documents with consideration for the sample populations;
verify the consent documents are consistent with IRB protocols; verify that research studies have the resources necessary to protect participants, which includes:
- adequate time for the researchers to conduct and complete the research;
- adequate number of qualified staff;
- a process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions;
- adequate facilities;
- access to a population that will allow recruitment of the necessary number of participants;
- availability of medical or psychosocial resources that participants may need as a consequence of the research.

IRB members are expected to:

attend at least 50% of scheduled IRB meetings when a primary member;
notify Research Integrity staff in advance if there is a need to be absent from a scheduled meeting;
arrive promptly and stay at convened meetings until all committee business and training has been completed;
prepare for meetings by reviewing the complete package (including recruitment and consent materials) for all projects on the agenda for IRB meetings in which she/he/they is attending as a voting member;
complete all review checklists when assigned as the primary or secondary reviewer;
participate in IRB discussions of protocols; and

complete expedited reviews (including the relevant review worksheets) in a timely manner (within 10 business days of receipt). act as resources for researchers in the design of participant protection aspects of protocol development; and participate in training opportunities offered outside of IRB meetings. The IRB Community Member has the responsibility to bring the perspective of the volunteer research participant to the review process.

Additional IRB Member Responsibilities for Research Involving Sharing Data or Specimens

When University or Affiliate investigators plan to conduct non-exempt research that involves providing data/specimens to or obtaining data/specimens from an external entity, AND the dataset includes Protected Personally Identifiable Information or Protected Health Information (see the online Policy Manual Definitions), the Primary or expedited reviewer must confirm the following before approving the research:

The submission includes a fully executed research agreement that specifies the responsibilities of both the Data Provider and the Data Recipient.

The research agreement confirms that the Data Provider complied with Department of Health and Human Services (DHHS) requirements for informed consent as it relates to the use of the data/specimens as specified in the agreement.

IRB Member Training

In-House Orientation

All prospective IRB Committee members are required to complete an initial two hour orientation session prior to serving on the IRB. This training includes how to review electronic applications, post reviewer notes, and access checklists and other supporting documentation. All new members are provided the following information:

DHHS regulations (45 CFR 46)
IRB Policy and Procedure Manual;
FDA regulations (21 CFR 50 and 56);
Belmont Report;
University Conflict of Interest Policy;
HIPAA;
Relevant IRB Forms.

Observation of IRB Meeting

All new IRB Committee members are required to observe at least one IRB committee meeting prior to functioning as a voting member.

Continuing Education

IRB members will receive, on an ongoing basis, continuing education related to human research protection issues and requirements.

Every month, the Director will identify a topic to be reviewed at each scheduled committee meeting. To ensure consistency with the information provided to the Committee members, the Director or designee will make a presentation at each meeting. The content will be recorded in the minutes for the meeting as well as the members present at the meeting.
In addition, IRB members are invited to educational presentations held throughout the year on topics related to the protection of human subjects.
The IRB Chair, IRB Co-Chair, Director, and Research Integrity staff are routinely available to address any questions or concerns of the IRB members.
IRB members are provided access to reference materials and research protocol files
Committee members are required to complete PRIM&R's Ethical Research Online Course.

Evaluation of Committee Members

Each member will be given an annual letter that describes performance as satisfactory or requiring attention. The letter will include metrics on attendance and volume of IRB assignments for the member. Self evaluations will be distributed annually to members and members will have the opportunity to meet informally with the IRB Chair.

Attendance of the members will be monitored by the Director or designee. Any issues that arise related to non-attendance will be discussed with the IRB Chair to determine whether action is necessary.

Committee member performance is discussed quarterly with respect to awareness and understanding of relevant ethical issues, regulations, and institutional policies. The performance of the members will also be assessed by evaluating quality of performed reviews to ensure they are timely, comprehensive, and well-informed. If concerns are identified, the IRB Chair will address these with the individual committee member and then provide necessary guidance materials or educational sessions.

IRB Membership status may be terminated by the IRB Chair due to failure to attend and/or otherwise actively participate in IRB functions.

Additional Responsibilities of the IRB Chair and Co-Chair

The Chair and Co-Chair are voting members of the IRB and assumes the aforementioned responsibilities of IRB Members. In addition to their responsibilities as a voting IRB member, the IRB Chair and Co-Chair oversee IRB meetings to ensure reviews and approvals consider with regulatory requirements, the Belmont Report, state laws, and University policy.

The IRB Chair and Co-Chair are authorized to sign all documents relevant to the review and approval of human research projects (e.g., waivers of HIPAA authorization) and documents submitted for post-approval monitoring (e.g., safety reports that are not unanticipated problems; acknowledgement of and notifications from external IRBs), except IRB Institutional Agreements, which are signed by the Institutional Official or designee).

The IRB Chair and Co-Chair may designate signature authority to qualified IRB members, the Research Integrity Director, and IRB staff who are voting members of the IRB as appropriate. In all cases individuals sign their own name. NOTE: Electronic signatures procured via IRBNet require access through secure login procedures and are therefore considered valid by Research Integrity and the IRB.

IRB Chair, through annual “Designation of Authority” letters (or more frequently as required by rapid turnover of IRB members or other circumstances) identify members who are qualified to complete reviews using expedited procedures and members who may serve in the absence of the Chair/Co-Chair.

The IRB Chair and Co-Chair oversee IRB meetings to ensure reviews and approvals comply with regulatory requirements, the Belmont Report, state laws, and University policy. During IRB meetings, The Chair and Co-Chair:

remind members who have a conflict of interest to leave the room during deliberation and voting;
ensure ample time is allowed for discussion for each study;
ensure the criteria for IRB approval and other relevant requirements (e.g., consent waivers/alterations, waivers of signed consent, determinations for vulnerable populations) are met before projects/packages are approved; and
ensure a determination is made and voting takes place for each action item on the agenda.

For reportable events, the IRB Chair and Co-Chair:

may review investigator problem reports when referred by the Research Compliance Officer (RCO), to assess for possible noncompliance or unanticipated problem involving risks to participants or others and Full Committee Review;
review RCO reports of initial allegations of serious and/or continuing noncompliance to determine whether to refer the incident for Full Committee Review;

With respect to their relationships with other members, the IRB Chair and Co-Chair:

evaluate their IRB members at least once a year by reviewing and providing feedback to members based on observation and completed IRB Member Self-Evaluation Surveys;
provide guidance to IRB members during and outside of meetings as appropriate; and
consult with the Research Integrity Director regarding IRB member performance and needs.

The IRB Chair and Co-Chair work with the Research Integrity Director to:

review IRB policy, documents (e.g., forms and worksheet), and correspondence; and
provide consultation and guidance to Research Integrity staff.
receive training and support respective to the duties and functions of the position.
the conduct of IRB Committee meetings and the performance of IRB membership