Composition of IRB
- Each IRB Committee will be comprised of at least five members, with varying background and expertise to provide complete and thorough review of research activities commonly conducted by the Institution.
- The membership of the IRB will be sufficiently qualified through the experience and expertise of its members and the diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human research subjects.
- Each IRB committee includes persons able to ascertain the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
- Each IRB committee includes both men and women.
- Each IRB committee includes members of more than one profession.
- Each IRB committee includes at least one member who represents the perspective of research participants.
- Each IRB committee includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas.
- Each IRB committee includes at least one member who is not otherwise affiliated with the University of Pittsburgh, UPMC, CHP, UPMC Cancer Centers, or Magee, and who is not part of the immediate family of a person with such affiliation (i.e., “unaffiliated member”).
- Regardless of the risk level associated with the protocol, research funded by the National Institute on Disability and Rehabilitation that purposefully requires inclusion of children with disabilities or individuals with mental disabilities will be reviewed by at least one individual who is primarily concerned with the welfare of these research subjects. This representative will have the appropriate scientific or scholarly expertise to serve in this capacity. If this is full board review, a member of the committee will serve in this capacity as a primary or secondary reviewer. In the absence of an appropriate reviewer, the IRB will identify a consultant to serve in this role. This will be documented in the minutes generated by the Full Board RRC. If the study meets an expedited review category, an appropriate consultant will review the protocol. This will be documented on the Documentation Form generated by the EERRC.
- When reviewing research that involves a vulnerable population, individuals knowledgeable about and experienced in working with these subjects will be present for the IRB Committee meeting or the review will be tabled.
The HRPO maintains an OHRP roster of trained alternates who may vote in place of an absent voting member. In addition, all active members listed on the OHRP rosters may be utilized as alternates for other active members as long as all applicable regulatory requirements and IRB policies are met. OHRP has been notified of this policy through correspondence sent on June 30, 2005.
- The alternate member will have similar expertise as the regular committee member for whom s/he is serving as a replacement (physician to physician; other scientific to other scientific; and non-scientific to non-scientific).
- The alternate member will assume all of the responsibilities of the committee member for whom s/he is serving as a replacement.
- Alternate members may attend IRB meetings without serving as a replacement for a regular committee member; however, in this capacity, the alternate member may not participate in any of the final approval decisions of the committee.
- IRB minutes will document if a member present at the meeting is an alternate as well as the IRB member for whom the alternate is substituting.
During initial review (at the time of meeting assignment, RRC review, vice chair review, or primary reviewer review) of a proposed research study, an IRB committee member or a HRPO staff member may determine that the current membership of the IRB does not include appropriate expertise to conduct an adequate study evaluation and may defer to another IRB committee or may invite individuals with competence in special areas to assist in the review.
- Consultants may be chosen from past IRB members or by contacting the department chair or division chief (or their designee) of the area from which the research is being submitted.
- Consultants will be provided with a copy of the IRB protocol and consent document as well as any attachments (investigator brochures, multicenter protocols, etc.) prior to the IRB meeting.
- Consultants are held to the same standards as regular members of the IRB Committee.
- Consultants may attend the meeting to participate in the review and discussion of the research study; however, s/he may not vote or count towards quorum.
- If the consultant is unable to attend the meeting, his/her written comments will be taken into consideration by the Committee during its review of the respective research protocol and will be documented in the IRB meeting minutes.
- During the review of a proposed research study, an IRB committee member may obtain consultations by directly contacting colleagues for information related to a research study. Before obtaining advice from a consultant in this manner, the IRB committee member should ensure that the colleague does not have a conflict of interest with the research study (Conflict of Interest Policies are addressed in Chapter 20).
Appointment of IRB Members
Appointments of voting IRB Committee members are made by the Institutional Official (IO). Recommendations for board members can be made to the IO by either the IRB Chair or Associate Director of Education based on the specific needs of the IRB Committee.
- The IRB Chair or his designee requests recommendations for faculty volunteers from the Division Chiefs and Department Chairs as needed based on considerations including, but not limited to, required committee composition, expertise and experience; knowledge of the individual’s interest; recommendations of institutional leadership; and/or investigators involved in research studies currently or previously approved by the IRB.
- The IRB Chair or his designee reviews the membership rosters and recommends appointment by the Institutional Official of potential non-scientific and/or non-affiliated members to the IRB based on considerations including, but not limited to: required committee composition, expertise and experience, knowledge of the individual’s interest; recommendations of current or past non-scientific and/or non-affiliated members; and individuals recruited from disease-related organizations or groups.
- The IRB Chair and membership coordinator will review each new member’s CV and demographic sheet for educational background, work history, as well as his/her current vocation to determine the member’s status (i.e., scientific versus non-scientific, affiliated vs. non-affiliated) on the IRB rosters. Refer to Chapter 21: Record Keeping and Retention.
Term of Service
Committee members are initially appointed to a term of three years. Committee members may be requested to accept reappointment to the IRB for an additional term of three years at the discretion of the Chair. At the end of the six year term, a determination will be made about an additional reappointment period. If a member declines full membership, s/he may be asked to become an alternate member. Reappointed members will be asked for an updated CV and demographic sheet.
Compensation of IRB Members
Affiliated IRB Committee members do not receive any direct monetary compensation for participation on the board. Unaffiliated IRB Committee members will be reimbursed at an amount not to exceed $50 per month to pay for internet access. Reimbursement payments will be issued quarterly.
University Policy 07-06-06 sets forth the conditions under which indemnification and legal defense may be available to faculty and staff. University Policy 07-06-07 sets forth the conditions under which indemnification and legal defense may be available to volunteers at the University. Indemnification may be afforded to the IRB members as set forth in these policies.
Responsibilities of IRB Members
General Responsibilities of all IRB Members include:
- Reviewing research study proposals and evaluating them from the perspective of the regulatory criteria for approval addressed under 45 CFR 46.111, 21 CFR 56.111 (if applicable); and any other relevant ethical, scientific or compliance considerations;
- Reviewing informed consent documents and evaluating them from the perspective of addressing the required and additional elements of informed consent addressed under 45 CFR 46.116, 21 CFR 50.20 (if applicable) and any other relevant ethical or compliance considerations;
- Attending at least 70% of IRB meetings in person, unless exigent circumstances prevent such attendance on an occasional basis; reporting promptly at the designated time that the meeting convenes; and remaining in attendance at the meeting until the full agenda has been addressed;
- Participating in IRB deliberations concerning issues inherent to proposed research studies and related informed consent documents, and making recommendations for reducing risk and improving the informed consent process and otherwise for improving human subject protections;
- Voting for full approval, approval subject to modification(s), reconsideration, or disapproval of the human subject research as outlined in Chapter 12;
- Evaluating the risk level (i.e., minimal or greater than minimal) of the proposed research. In performing this evaluation, IRB members will use the following absolute definition for "minimal risk" at 45 CFR 46.102(i) unless the research is directed at prisoner-subjects:
"Minimal risk means that 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 (i.e., of the general population) or during the performance of routine physical or psychological examinations or tests."
- Deciding, for research studies of greater than minimal risk, if IRB continuing review of the research is warranted on a more frequent basis than the requisite annual review. In making this determination, IRB members will follow the procedure outlined in Chapter 12;
- Deciding, for research studies involving greater than minimal risk, complexity, or conflict-of-interest concerns, if the informed consent process and/or other aspects of the research study should be audited by the Education and Compliance Office of the University of Pittsburgh’s RCCO;
- Deciding, for research studies involving an unapproved device, if the device and its proposed use constitute a non-significant or significant risk to research subjects;
- Deciding, for research studies subject to IRB continuation approval, if verification is required from sources other than the investigator that no material changes have occurred since previous IRB review using the criteria outlined in Chapter 12;.
- Recommending improvements to IRB policies and procedures so as to enhance the IRB review process and/or human subject protections;
- Informing the IRB Chair or an IRB Vice Chair of human subject research noncompliance problems or ethical issues of which they become aware;
- Conforming, at all times, their behavior to be within legal and ethical principles accepted by the IRB; including, but not limited to, maintaining confidentiality/non-disclosure of human subject research submitted for IRB review and approval, and good faith participation in IRB deliberations without appearance of discrimination or conflict-of-interest.
Responsibilities of IRB Members Designated Reviewers
In addition to the responsibilities outlined above, responsibilities of those assigned as reviewers include:
- Providing written evaluations of the research protocol and informed consent document(s) to the IRB Office staff either on paper or through the OSIRIS system in advance of the IRB meeting;
- Utilizing the IRB Reviewer Checklist as a guide when reviewing protocol submissions;
- Basing their review and approval decisions for industry-sponsored clinical trials on the information presented in the sponsor’s clinical protocol and investigator’s brochure and IRB research application;
- Ensuring that for federally-supported research requiring full board IRB review that the IRB research application is essentially consistent with the corresponding federal grant application.
The IRB membership roster will include the following information and will be used to determine relevant expertise in making protocol assignments at convened meetings:
- Names of members;
- Earned degrees;
- Representative capacities;
- Scientific/nonscientific status
- Affiliation status (whether the IRB member or an immediate family member of the IRB member is affiliated with the organization)Indications of experience sufficient to describe each IRB member’s chief anticipated contributions;
- Employment or other relationship between each IRB member and the organization;
- Alternate members including the primary members or class of primary members for whom each alternate can substitute.
The IRB Membership Coordinator is responsible for submitting an updated membership roster to OHRP at the beginning of each month or more often based on necessity. The IRB Membership Rosters are posted on the IRB website at Committees.
Evaluation of Committee Members
The IRB Chair, Vice Chairs and senior HRPO staff meet monthly to discuss the conduct of IRB Committee meetings and the performance of IRB membership.
- New IRB members will meet with the Vice Chair within six months of their first IRB committee meeting. The Vice Chair will identify any areas for improvement, including, but not limited to understanding of IRB responsibility and function, OSIRIS proficiency, meeting participation and overall performance of IRB reviews.
- Committee member performance is discussed monthly 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 Vice Chair or Chair will address these with the individual committee member and then provide necessary guidance materials or educational sessions.The performance of committee members is discussed with respect to their awareness and understanding of relevant ethical issues, regulations, and institutional policies. If concerns are identified, the IRB Chair and/or Vice Chairs will address these with the individual committee member and then provide necessary guidance materials or educational sessions.
- HRPO coordinators will interact with the Vice Chair to provide feedback on member performances. If concerns are identified, the IRB Chair and/or Vice Chairs will address these with the individual committee member and then provide necessary guidance materials or educational sessions.
- Attendance of the members will be monitored by the Associate Director of Education. Any issues that arise related to non-attendance will be discussed with the IRB Chair to determine whether action is necessary. Attendance reports will be sent to the members’ responsible department chairs or center/institute director at their request.
- 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 Vice Chair and/or IRB Chair.
Resignation and Termination of IRB Members
Resignation of IRB membership status, based on the wishes of the IRB member, will be submitted, in writing, to the Institutional Official and copied to the IRB Chair and, where applicable, the member’s department chair or center/institute director.
IRB Membership status may be terminated by the IRB Chair due to failure to attend and/or otherwise actively participate in IRB functions. Termination of any individual from IRB membership will be reported to the Institutional Official to include a written justification for the termination.