Institutional Review Board (IRB) Membership
FWA#00005897/IRB#00000001
General Membership Policy
The NCI IRB membership meets the requirements as stated in 45 CFR 46.106, 21 CFR 56.107, and 45 CFR 812.62.
The NCI IRB Chair and members are appointed by the NIH Deputy Director for Intramural Research for one- to three-year renewable terms, following nomination by the Clinical Director in consultation with the Scientific Director. The Board currently has eleven members, two of whom are unaffiliated with the Public Health Service and whose primary interests are nonscientific. The Board also has a member with expertise as a statistician, a bioethicist from the Clinical Center Bioethics Department, and representatives from other Clinical Center Departments. The NCI IRB also utilizes ad hoc reviewers when additional or specialized expertise in protocol review would be of value to the Board in its deliberations. Ad hoc reviewers are not IRB members and do not vote on protocols.
Terms of Membership for IRB Members
The term of membership is one to three years, and each member will continue until they notify the Board that they wish to discontinue their IRB membership. Reappointment beyond three years may be made at the discretion of the Clinical/Scientific Directors and the IRB Chair.
Responsibilities of IRB Members
- To attend each meeting;
- To be prepared to discuss each agenda item;
- To consider the approval criteria offered in the regulations and the Belmont Report;
- To maintain confidentiality regarding any information contained in any review;
- To reveal any potential conflicts of interest;
- To provide the longest possible notice of inability to attend a meeting; and
- To be familiar with the IRB's operating procedures.
Selection of IRB Chair
The Chair of the IRB shall be selected from the membership of the IRB.
- The individual should have experience on an IRB of at least one year and be a member in good standing.
- The individual should have a thorough understanding of the regulations and policies of the IRB.
- The term of the Chair will be three years with reappointment beyond at the discretion of the Clinical and Scientific Directors.
- The individual should have sufficient time and resources at their disposal to perform the duties and responsibilities of the Chair.
The duties of the Chair include the following:
- Able to chair the scheduled IRB meetings.
- Able to meet with the IRB Coordinator on a regular basis.
- Available to research investigators to discuss IRB concerns.
- Available to provide emergency and/or administrative approval.
The candidates for IRB Chair will be nominated by the current Chair, the Clinical and Scientific Directors, and appointed by the NIH Deputy Director for Intramural Research.
Selection of IRB Deputy Chair
The IRB Chair and the Clinical and Scientific Directors may nominate candidates for Deputy IRB Chair to be appointed by the NIH Deputy Director for Intramural Research.
