31. Roles and Responsibilities: IRB Members
In carrying out their duties, IRB chairs and members
- must execute their responsibilities in accordance with University policies and applicable federal, state, and local and laws;
- ensure that the seven criteria for IRB approval (§46.111) are met for all protocol review assignments including expedited reviews and reviews at convened meetings;
- must complete the required human subjects protection training and HIPAA training, as applicable;
- are encouraged to participate in training opportunities offered outside of IRB meetings;
- are expected to attend at least 75% of scheduled IRB meetings (according to panel assignment);
- 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;
- prepare for meetings and complete all review checklists when assigned as primary or secondary reviewer for specific protocols;
- are familiar with protocols on the agenda when attending as a voting member;
- participate in IRB discussions of protocols;
- complete expedited reviews review checklists in a timely manner (within 10 business days of receipt);
- may act as a resource for researchers in the design of human subjects protection aspects of protocol development;
- maintain confidentiality regarding reviewed protocols; and
- comply with University and IRB conflict of interest policy and procedures.
In evaluating the risks and benefits of the study, IRB chairs and 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.
The IRB Community Member has the particular responsibility of bringing the perspective of the volunteer research participant to the review process.