30. Responsibilities of IRB Members, Chairs, and Vice Chairs
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.
IRB members must
- execute their responsibilities in accordance with University policies and applicable federal, state, and local and laws;
- complete the required human subjects protection training and HIPAA training, as applicable;
- complete an annual IRB Member Agreement and IRB Member Self-Evaluation Survey;
- ensure that the seven 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 has a conflict of interest for a project she/he 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 subjects about the research, including risks and benefits;
- evaluate the clarity and appropriateness of the information in consent documents with consideration for the sample populations; and
- verify the consent documents are consistent with IRB protocols.
IRB members are expected to
- attend at least 75% of scheduled IRB meetings when a primary member;
- notify RIO 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;
- review the complete package (including recruitment and consent materials) for all projects on the agenda for IRB meetings in which she/he is attending as a voting member;
- 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).
- may act as resources for researchers in the design of human subjects protection aspects of protocol development; and
- are encouraged to participate in training opportunities offered outside of IRB meetings.
Unaffiliated IRB members (i.e., IRB Community Members) have the particular responsibility of bringing the perspective of research participants 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 data-set 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 DHHS requirements for informed consent as it relates to the use of the data/specimens as specified in the agreement.
Additional Responsibilities of IRB Chairs and Vice Chairs
Chairs are voting members of the IRB and assume the aforementioned responsibilities of IRB Members. In addition to their responsibilities as voting IRB members, IRB Chairs and Vice Chairs oversee IRB meetings to ensure reviews and approvals comply with regulatory requirements, the Belmont Report, state laws, and University policy.
IRB Chairs and Vice Chairs are authorized to sign all documents relevant to the review and approval of human subject 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).
IRB Chairs and Vice Chairs may designate signature authority to qualified IRB members, the IRB 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 the RIO and the IRB.
IRB Chairs, 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/Vice Chair.
IRB Chairs and Vice Chairs oversee IRB meetings to ensure reviews and approvals comply with regulatory requirements, the Belmont Report, state laws, and University policy. During IRB meetings, Chairs and Vice Chairs
- 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, IRB Chairs and Vice Chairs
- may review investigator problem reports when referred by the QI Officer, to assess for possible noncompliance or unanticipated problem involving risks to participants or others and Full Committee Review;
- review QI Officer 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, IRB Chairs and Vice Chairs
- 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 RIO Director regarding IRB member performance and needs.
IRB Chairs and Vice Chairs work with the RIO Director to
- review IRB policy, documents (e.g., forms and worksheet), and correspondence; and
- provide consultation and guidance to RIO staff.