Charles River Campus IRB
Policies and Procedures
Title: IRB Composition and IRB Member Roles and Responsibilities
Date: December 2, 2015
The purpose of this policy is to outline the composition of the IRB and to describe the roles and responsibilities of IRB members.
The Charles River Campus (Charles River Campus) IRB is established in accordance with federal regulations [45 CFR 46.107 and 21 CFR 56.107].
The CRC IRB meets the following criteria:
- The IRB has at least five members with varying backgrounds to promote complete and adequate review of research commonly conducted by the organization
- The IRB is not comprised of either all male or all female members
- The IRB is not comprised of members who represent only a single profession
- At least one member has primary concerns in scientific areas
- At least one member has primary concerns in nonscientific area
- At least one member is not otherwise affiliated with the organization and who is not part of the immediate family of a person who is affiliated with the organization
- At least one member represents the perspective of research participants
Individuals who are responsible for business development are prohibited from serving as members or ex-officio members on the IRB and from carrying out day-to-day operations of the review process.
Selection and Appointment
IRB Members (Regular members and Alternate members)
The IRB Chair and IRB Director are responsible for selecting members to serve on the IRB. The selection process is conducted in consultation with the Institutional Official, Deans, Department Chairs, and other IRB members.
The Institutional Official will appoint the IRB members. IRB members receive an appointment letter after their appointment is confirmed. The letter states the term of service. IRB members serve 3 year renewable terms. There are no term limits.
Members may resign at any time by submitting a letter of resignation to the IRB Chair and IRB Director. The IRB Chair may remove members from the committee if the member is not able to complete his/her responsibilities as an IRB member.
IRB Chair and Vice-Chair
The Institutional Official and IRB Director are responsible for selecting the IRB Chair and Vice- Chair. The selection process is conducted in consultation with Deans, Department Chairs, and other IRB members.
The Institutional Official will appoint the IRB Chair and Vice-Chair. The IRB Chair and Vice-Chair will receive an appointment letter after their appointment has been confirmed. There is no specified time limit for serving as an IRB Chair or Vice-Chair.
The IRB Chair or Vice-Chair may resign at any time by submitting a letter of resignation to the Institutional Official. The Institutional Official may remove the IRB Chair or Vice-Chair from the committee if he/she is not able to complete his/her responsibilities as an IRB Chair or Vice-Chair.
IRB Member Responsibilities
IRB members are responsible for:
- Attending monthly IRB meetings and participating in the review of research
- Completing human subjects research training
- Conducting and/or assisting with review of research by expedited procedures
- Serving on IRB sub-committees as needed
- Working with investigators to resolve issues related to IRB review
- Maintaining current knowledge of applicable regulations, laws, and institutional policies
- Participating in discussions of issues related to the review of human subjects research including policy development
IRB members should report any attempts of undue influence to the Institutional Official.
The responsibilities above apply to both regular members and alternate members.
In addition to assuming the responsibilities of an IRB member, the IRB Vice-Chair is responsible for:
- Supporting the IRB Chair
- Assuming the duties of the IRB Chair when the IRB Chair is not available or has conflict
In addition to assuming the responsibilities of an IRB member, the IRB Chair is responsible for:
- Providing leadership and guidance to the IRB
- Conducting convened IRB meeting
- Reviewing minor deviations and/or other events that qualify for review by expedited procedures
- Assisting with investigations/audits of investigators
- Reviewing and signing correspondence related to IRB determinations
- Ensuring that IRB members with a conflict of interest are not present for the discussion and vote on the research where he/she has a conflict
- Conducting review of IRB minutes
- Selecting new IRB members
- Assisting with the annual evaluation of the IRB
Alternate IRB members
Alternate members are appointed to serve as a substitute for a regular IRB member and/or to ensure that the IRB has the appropriate expertise to review research (e.g. prisoner representative, pharmacy representative, etc.).
The IRB roster indicates which regular member for which the alternate can substitute. When an alternate member substitutes for a regular IRB member, the alternate receives and reviews the same materials as the regular IRB members. The IRB minutes will document when and alternate member substitutes for a regular member.
If both a regular IRB member and his or her alternate(s) attend the same IRB meeting, the regular member is acting as the official voting member of the IRB for review of research protocols, unless the minutes clearly indicate otherwise. A designated alternate IRB member for a regular IRB member may substitute for the regular IRB member for an entire meeting or at any time during a meeting.
If the board does not have the appropriate expertise to review a research study, a consultant may be used to assist in the IRB review. Consultants may be used for exempt, expedited, and convened studies.
- The IRB Director or designee will determine if a consultant is needed. In addition, any member of the IRB may request the use of a consultant during the review process
- The IRB Director or designee will contact the consultant to determine if he/she is able to act as a consultant to the IRB
- The consultant will be asked to provide a written review. If determined to be necessary, the consultant will be asked to attend the meeting.
- If the consultant attends the meeting, the consultant does not count towards quorum and cannot vote.
- The use of consultants will be documented in the meeting minutes.
Evaluation of the IRB
Composition of the IRB
The composition of the IRB will be reviewed on an annual basis to ensure that the composition meets institutional and regulatory requirements. This review will be conducted by the IRB Chair and IRB Director in consultation with the Institutional Official.
IRB members are evaluated on an annual basis by the IRB Chair and IRB Director. IRB members receive a copy of their evaluation.
The IRB Vice-Chair is evaluated by the IRB Chair and IRB Director. The IRB Vice-Chair receives a copy of his/her evaluation.
The IRB Chair is evaluated by the Institutional Official in consultation with the IRB Director. The IRB Chairs receives a copy of his/her evaluation.
Title: IRB Composition and IRB Member Roles and Responsibilities
Author: Cynthia Monahan
Effective Date: June 18, 2014
Last Review/Update Date: December 2, 2015
Revision #: 2
Approved: Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance