Responsibilities/Actions of IRB
Composition of the IRB and Appointment of Members:
Federal regulations require that the IRB must be composed of at least five members (45 CFR 46.107). The University IRB shall be composed of at least eight (8) members. Representation will include members whose primary concerns are in scientific areas, such that social and behavioral sciences, education, business, and biomedical sciences are represented. The IRB should have at least one member whose primary concerns are in non-scientific areas, and a community representative who is not otherwise affiliated with the University nor a member of the immediate family of a University employee. At least one member (or alternate) must be able to act as an advocate for “vulnerable populations”, by virtue of experience and education. At least one member shall have expertise in both qualitative and quantitative research methods. In addition, the membership shall include men and women, as well as representation of racial and ethnic minority groups reflective of the composition of the University, when at all possible. All IRB members and alternates shall serve three-year terms, which are staggered, and they may be reappointed for consecutive terms.
If a member goes on sabbatical or other leave for a semester, then an alternate will take his or her place from the college they represent. If a member or alternate leaves the University or goes on leave for one year or more, then the Provost and the Institutional Official, in concert with the IRB Chair, will appoint a replacement for the period of leave or for the remainder of the member or alternate’s term, whichever is applicable.
The IRB Chairperson will be appointed by the Institutional Official. He or she will serve a three-year term with each year being a renewable contract between the individual and the Institutional Official, and he or she may be reappointed for consecutive terms. If either the IRB Chair takes a sabbatical, other leave of absence, or leaves the University, the Institutional Official shall recommend a replacement to the remainder of the IRB. The IRB members will then vote for or against this nominee, with a simple majority being needed for ratification. Once ratified, the new Chair will serve during the previous Chair’s absence.
In conjunction with the Office of the Provost, Director of Sponsored Programs and IRB Research Compliance Officer and others, the IRB Chair promotes a culture consistent with the objectives of SVSU Institutional Review Board for the Protection of Human Research Subjects (IRB), with special emphasis on the respect for and protection of individuals participating in research at the University. In promoting such a culture, the Chair is directly responsible for overseeing the protection of research participants by ensuring the proper review, approval, disapproval or determination of exemption from further review of research protocol submissions to the IRB.
Responsibilities of the Institutional Review Board Chair
- Preside over meetings of the fully convened IRB and ensure that the IRB carries out its duly authorized responsibilities as required by federal regulations, ethical principles, state laws and University policy.
- Review and approve protocol submissions that qualify for expedited review pursuant to federal regulations, ethical principles, state laws and University policies, or delegate such authority to a qualified and experienced IRB member to conduct such review and approval.
- Ensure that membership of the IRB is recruited, appointed and oriented such that the IRB is duly qualified to fulfill its obligations to review, require modifications to, approve (or disapprove) research protocols that represent the breadth of research submitted to the IRB by SVSU researchers.
- Serve as a liaison between the SVSU IRB and the University research community to promote communication and understanding of the concerns of the IRB and the SVSU research community.
- Ensure that reports related to safety, noncompliance, unanticipated problems in research and adverse events are reviewed, attended to and reported pursuant to federal regulations, state laws and University policy.
- Respond to local and federal investigations relating to protocols and actions, as required.
- In conjunction with the Office of the Provost, Director of Sponsored Programs and IRB Research Compliance Officer, and others as appropriate, develop and revise Research and IRB policies, procedures and guidelines to stay current with societal thinking, regulatory changes and national best practice standards.
- Annual Report – Liaison to Provost
Each IRB member is appointed by the Provost and typically serves a three-year term of service. IRB member responsibilities include all of the following:
- Attending IRB meetings and actively participating in the review of research, unless arrangements have been made for the alternate’s attendance
- Completing initial training in human subjects protection for IRB members prior to voting on any research, with continuing education every three years and as provided
- Understanding and applying the principles of the Belmont Report and the federal regulations related to the protection of human subjects
- Providing timely written comments on research undergoing IRB review, when required
- Annually completing and providing a copy of the SVSU Financial Conflict of Interest Screening/Disclosure Form and disclosing any potential conflicts prior to IRB review of the research for which a conflict may exist
- Maintaining confidentiality of IRB-related information in accordance with the terms and conditions of the SVSU’s IRB Member Confidentiality Agreement
- Maintaining a current knowledge of and assuring compliance with relevant regulations, laws, and policies related to the protection of human subjects
- Working with investigators to resolve matters relating to research approval and participating in educational efforts for investigators, research staff, and new IRB members
- Participating in the discussion of issues affecting the human research protection program and contributing to policy development, as appropriate
- Reviewing and approving research by expedited procedures, when designated by the IRB Chair to perform this review.
Federal regulations allow organizations to appoint an alternate(s) to substitute for an IRB member(s) who is/are unable to attend so that IRB business may move forward in a timely manner. Alternates are appointed by the same process and for the same length of time as IRB members.
- IRB alternates function as regular board members when they are in attendance. An alternate may substitute for the primary IRB member for an entire meeting or at any time during a meeting. Alternates and IRB members have equal responsibilities in terms of required education, service and time commitments, and participation.
- Each alternate member is paired with one or more regular members with comparable experience and expertise, as possible. The IRB roster identifies the primary member(s) for whom each alternate may substitute. Minimally, alternates and members are paired by scientific “class,” as physician scientists (when applicable), other scientists, and non-scientists. The IRB roster will identify the member(s) for whom each alternate can substitute.
- When an alternate substitutes for a regular IRB member, the alternate receives and reviews the same materials that the regular member received (or would have received), and IRB minutes document that an alternate replaced a primary member.
For research that requires expertise beyond or in addition to that available on the IRBs, or involves a vulnerable population where no IRB member knowledgeable about or experienced in working with these participants will be present at the meeting, one of the following will occur:
IRB Chair/Staff/Member may identify the need for review by a consultant during the screening of a protocol submission. The IRB Protocol Reviewer will work with the IRB Administrative Staff and IRB Chair to invite an individual with the necessary expertise to serve as a consultant and assist the IRB in its review.
- The primary reviewers or IRB membership may identify the need for a consultant during their review. The primary reviewer(s) will work with the IRB Chair and the IRB Administrative Staff to invite an individual with the necessary expertise to serve as a consultant and assist the IRB in its review.
- Consultants with potential conflicts of interest may not provide information to the IRB. Conflicts will be identified as described by SVSU policy.
- The use of a consultant and the result of the consultant’s review will be shared with the IRB by either having the consultant attend and present to the convened IRB or by having the consultant provide a written report to the IRB.
- If the consultant presents at a convened meeting, the IRB minutes will document key information provided by the consultant. The consultant will not vote with the IRB.
- If the consultant provides a written report, the report will be included in the protocol records.