700-5-Duties of IRB Members

Policy: Each IRB member’s primary duty is the protection of the rights and welfare of the individual human beings serving as the subjects of that research. The IRB member must understand that they are not serving on the IRB to expedite the approval of research, but to be a gatekeeper between the investigator and the research subjects. In order to fulfill their duties, IRB members are expected to be versed in regulations governing human subject protection and behavioral research ethics.

The IRB is an ad hoc Institutional Committee. As such, the IRB members serve USU as a whole, rather than a particular department. Therefore, regular IRB members and ad hoc consultants (see 700-8: Ad Hoc Consultant Reviewers, for policy regarding ad hoc consultants) must not allow their interest or that of their department to supersede their duty to protect the rights and welfare of research subjects. These members and ad hoc consultants must confirm on the IRB Reviewer Checklist they have no conflicts of interest before reviewing a submission.

IRB members must maintain the IRB’s reputation for being fair and impartial and invulnerable to pressure from the institution’s administration, faculty, staff, investigators, or any other professional and nonprofessional sources.

Unaffiliated members are expected to provide input regarding their knowledge of the local community and be willing to discuss issues from that perspective.

Nonscientific members are expected to provide input on areas germane to their knowledge, expertise and experience, professional and otherwise. Nonscientific members should advise the IRB if additional expertise in a nonscientific area is required to assess if the research proposal adequately protects the rights and welfare of subjects.

Scientific members are expected to contribute to the evaluation of a study on its scientific and statistical merits and standards of practice. These members may also advise the IRB in nonscientific areas to assess if the research proposal adequately protects the rights and welfare of subjects.

Ad hoc consultants are individuals with competence in special areas who are invited to assist in the review of issues that require expertise beyond or in addition to that of available IRB members; they are not voting members of the Institutional Review Board.

All IRB members, alternates, and ad hoc consultants sign a confidentiality agreement.

Procedures:

1. Duties of IRB Members
   1. IRB members must complete the required ethics and regulations training outlined in 700-7: IRB Training.
   2. IRB members and alternates sign a confidentiality agreement that is stored in the IRB Google Drive.
   3. IRB members should attend convened meetings and complete reviews using IRB Reviewer Checklists, as assigned. IRB members are expected to share input and participate in discussions at convened meetings.
   4. IRB members who are designated expedited reviewers will complete assigned reviews using IRB Checklists, as assigned.
   5. IRB members should communicate with the IRB Chair if they are unable to complete reviews, have conflicts of interest, or cannot attend a meeting. IRB members, alternates, and ad hoc consultants will communicate with the IRB Chair if they require additional information or guidance.
2. Duties of the IRB Chair
   1. In addition to the above responsibilities, the IRB Chair conducts meetings of the IRB.
   2. The IRB Chair or designee completes the pre-review of all submissions made to the IRB.
   3. The IRB Chair performs or assigns expedited reviews.
   4. The IRB Chair designates the board members qualified to conduct expedited reviews and assigns members as primary and secondary reviewers for agenda items at convened meetings.
      • Reviewers will be selected based on 1) IRB experience, research experience, and/or any life experiences or background applicable to human subject research, and 2) any other qualification the IRB Chair deems appropriate.
      • The designation of expedited reviewers is documented in writing and is maintained by the IRB Chair in the IRB Google Drive.
      • The designation of primary and secondary reviewers for convened meetings is noted on the meeting minutes.
   5. The IRB Chair may delegate their responsibilities as appropriate to other qualified individuals as appropriate to other qualified individual(s). Any such delegation of responsibility is documented in writing and maintained by the IRB Chair in the IRB Google Drive.

Purpose: This policy outlines the duties of IRB members, alternates, and ad hoc consultants.

Scope: This policy applies to USU IRB members, alternates, and ad hoc consultants.

Documents and Forms: