HRPP policies & procedures manual
202: Duties of IRB members
The purpose of this policy is to define the duties required of IRB members.
Each IRB member’s primary duty is the protection of the rights and welfare of the individuals who are serving as the subjects of research. The IRB member must understand that he or she is not serving on the IRB to expedite the approval of research, but to be a gatekeeper between the PI and research subjects. In order to fulfill their duties, IRB members are expected to be versed in regulations governing human subjects protection, biomedical and behavioral research ethics, and the policies of WSU relevant to human subject protection. The IRB must be, and perceived to be, fair and impartial, immune from pressure either by the institution’s administration, the investigators whose protocols are brought before it, or other professional or nonprofessional sources.
3. Specific policies
3.1 General duties of IRB members
- Attend all meetings for which they are scheduled; inform the IRB coordinator of all expected absences as early as possible in order to provide sufficient time to assign protocols to an alternate and ensure a quorum.
- Review all materials related to each item on the agenda in order to participate fully in the discussion and review of each proposed protocol.
- Treat the research protocols and supporting data confidentially.
- Expedited reviews: Submit review determinations for each expedited submission assigned to them within 3-5 business days of receipt.
3.2 Specific duties
Regular and alternate members
- Nonaffiliated members: Nonaffiliated members are expected to provide input regarding their knowledge about the local community and be willing to discuss issues and research from that perspective.
- Nonscientific members: Nonscientific members are expected to provide input on areas relevant to their knowledge, expertise and experience; professional and otherwise.
- Scientific members: Scientific members are expected to contribute to the evaluation of a study on its scientific and statistical merits and standards of practice. These members should also be able to advise the IRB if additional expertise in a scientific area is required to assess if a protocol adequately protects the rights and welfare of subjects.
- Chairpersons: The chair directs the IRB meetings in accordance with Institutional, state and federal requirements. The chair works closely with IRB members, the ORA director, the IRB coordinator, the institutional official, and investigators, to ensure the rights and welfare of research subjects are protected. The chair has the authority to sign for the IRB and conducts all IRB meetings. The chair helps the ORA director to designate the reviewers for expedited and full-board applications and may delegate in writing the ability to assign reviewers to the IRB coordinator and others in the ORA.
Such requests shall be in writing, signed by the chair, and for a period not to exceed one year. The chair also designates the IRB coordinator(s) to send official letters, e-mail approval notifications and some IRB related correspondence on behalf of the chair.
The chair carries broad responsibilities and an obligation to:
- Ensure proper conduct and review of all IRB applications.
- Participate in pre-IRB planning meetings with the ORA to ensure optimal review procedures, assignment of duties, and preparation of convened meeting agendas.
- Assist in investigating and resolving complaints, unanticipated events, and adverse events.
- Assist in communications with federal agencies.
- Assist in communicating with faculty and Institutional administration regarding IRB resources and functionality.
- Assist in orienting new members to the board; also delegate the responsibility to ORA staff as needed.
Primary, secondary and tertiary reviewers
In addition to the duties described in sections 3.1 and 3.2, regular members will be expected to act as the primary reviewers for their assigned studies at convened meetings. Secondary and tertiary reviewers will also be assigned. The primary reviewer presents his or her findings resulting from review of the application materials and provides an assessment of the soundness and safety of the protocol and recommends specific actions to the IRB. He or she leads the IRB discussion of the study. The secondary reviewer adds to the discussion, as necessary or serves as the discussion leader in the unexpected absence of the primary reviewer. The third reviewer follows the second.
When reviewing a study, if the IRB reviewing member has issues or questions for the PI to address, the reviewing member will relay the questions to the IRB coordinator, who will then communicate to the PI. All communications with the PI will go through the ORA.
Members (when not assigned as reviewers)
All members attending the convened IRB meeting will receive all submission materials via Sharepoint. When a member is not assigned as a primary, secondary, or tertiary reviewer, the member will review the study materials thoroughly enough to provide input into the discussion. All IRB members attending convened meetings are expected to contribute to the committee discussion including those about other members’ assigned protocols.
4. Applicable regulations and guidelines
6. Procedures employed to implement this policy & assignment of responsibility
|ORA director, IRB|
|Maintain up-to-date descriptions of member responsibilities. Answer
questions from IRB members as needed.
Ensure that members are carrying out their expected functions and that
there is adequate staff support to ensure that members are able to
function as documented.
As needed, make recommendations to the chairperson regarding
changes to descriptions, staffing, meeting schedules, and other factors
that affect members' ability to perform their roles.