Reports to:

Charge:

Act as the certifying agency for the proposals it approves for East Tennessee State University and for the James H. Quillen Veterans Affairs Medical Center to the Office for Human Research Protections (OHRP), and to the Food and Drug Administration (FDA), and the Veterans Health Administration (VHA) Office of Research Oversight (ORO), in addition to other federal, state, or private agencies.

Ensure institutional compliance with federal, state, and local regulations and ordinances pertaining to the use of human subjects for the protocols it has approved.

Ensure compliance with the ETSU and the VAMC Federalwide Assurance (FWA) on file with OHRP.

Monitor ongoing research to ensure subject safety and quality improvement through regular and on-going site audits of approved Medical IRB research records and sites to confirm compliance with federal and institutional mandates and with protocols as approved by the convened Medical IRB.

Ensure that each individual involved in human subjects research in the James H. Quillen College of Medicine, the ETSU College of Pharmacy, the James H. Quillen Veterans Affairs Medical Center, and other Colleges or institutions operating under contractual agreement with ETSU has taken an IRB approved course, as appropriate,  in Good Clinical Practices, the ethical conduct of research involving human subjects and the privacy and confidentiality of protected health information, and has passed a post-course assessment(s) of her/his knowledge of the material presented in the course(s) prior to submitting a proposal for IRB review.

Ensure that each individual involved in human subject research in the James H. Quillen College of Medicine, the ETSU College of Pharmacy, or the James H. Quillen Veterans Affairs Medical Center maintains compliance education in the ethical conduct of research involving human subjects following initial certification (NOTE: Compliance Education policies may be different for VA employees). Should certification (initial or re-certification) expire, the investigator will have to retake the course in its entirety. The IRB, and/ or its administration, the Office for the Protection of Human Research Subjects (OPHRS), shall require written documentation of initial certification, or re-certification, as appropriate, prior to receiving any proposal for IRB review.

Frequency of Meetings:

Selection:

Among the voting members the following constituencies must be represented; men and women, behavioral and social scientists, non-scientists, an ethicist, and at least one member who is not affiliated with the institution or related to an affiliated member.

Alternates: