All prospective IRB Committee members are required to complete an initial two hour orientation session prior to serving on the IRB. The orientation session is conducted by the IRB Medical Director or IRB Chair and the Associate Director or designee. All new members are provided the following information and complete the CITI IRB member module in addition to those noted above:
- IRB Policy and Procedure Manual;
- DHHS regulations (45 CFR 46), FDA regulations (21 CFR 50 and 56);
- Belmont Report;
- Declaration of Helsinki;
- Nuremberg Code;
- University of Pittsburgh Conflict of Interest Policy;
- HIPAA Q&A;
- Institutional Review Board, Member Handbook;
- Relevant IRB Forms.
Observation of IRB Meeting
All new IRB Committee members are required to observe at least one IRB committee meeting prior to functioning as a voting member.
All new IRB Committee members will be trained by the Associate Director or designee in the use of the electronic submission system (OSIRIS). This training includes how to review electronic applications, post reviewer notes, and access checklists and other supporting documentation.
IRB members will receive, on an ongoing basis, continuing education related to human subject protection issues and requirements.
- Every month, the IRB Chair and Associate Director will identify a topic to be reviewed at each scheduled committee meeting. In order to ensure consistency with the information provided to the Committee members, the Associate Director or designee will make a presentation at the beginning of each meeting. The content will be recorded in the minutes for the meeting as well as the members present at the meeting
- In addition, IRB members are invited to educational presentations held throughout the year on topics related to the protection of human subjects.
- The IRB Chair, IRB Vice Chairs, Medical Director, and HRPO staff are routinely available to address any questions or concerns of the IRB members.
- IRB members are provided access to reference materials and research protocol files maintained within HRPO as such access may relate to their functions as an IRB member.
- Committee members are required to complete the refresher course available through CITI if their term exceeds four years.