VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

6.2. Duties of the Chairperson The duties of the IRB Chair include those assigned above as well as the following:

• Meet with the Provost on a regular basis to discuss reviews and potential problems. • Provide emergency and/or administrative approval. • Keep abreast of all changes in regulations governing human subject research and keep the IRB informed of any such changes. • Serve as a resource person for PIs conducting or contemplating conducting human subject research. • Work with IRB administration to determine review level and reviewer assignments. • Nominate IRB members for appointment or re-appointment to the Provost. • Work with IRB administration if necessary to review progress or closure reports from the PIs as specified at the time of approval. • If deemed necessary, perform post-approval visits to observe any phase of a research project that involves human subjects. • Suspend part or all of an approved research project that is not being conducted in accordance with the approved protocol and requirements or that has shown to cause serious harm to the subjects. • Develop and maintain training programs for IRB members and PIs who use human subjects. • Certify that PIs have completed the training program and are qualified to conduct human subjects research. • Receive all applications for research involving human subjects. Assign each application a unique number to serve as the identifier of that project throughout its existence and in the records of the IRB. • Determine whether all required documents are included and filled out correctly in the applications. If documents are missing or incomplete, return the application to the PI for revision. • Along with the Chair, determine the level of risk and review of each application. • Schedule a time and place for IRB meetings. • Develop an agenda for each meeting and distribute application packets/meeting materials to members in a timely fashion. • Record complete minutes of each IRB meeting, including discussion and requests for modification of each application. Minutes also include the recording of votes on each action taken by the IRB, including abstentions. The total number of votes must equal the number of members present. • Maintain all records of the IRB in accordance with VCOM and OHRP requirements (see Section 8 Record Keeping ).

6.3. Duties of the IRB Coordinator

VCOM Institutional Review Board Policies and Procedures

Page 13 of 40