Institutional Review Board Medical Campus

Reports to:

ETSU President and to the VA Director as established in the Memorandum of Understanding (MOU)

Charge:

Review all proposals involving research on human subjects submitted by faculty, staff and students from the James H. Quillen College of Medicine, the ETSU College of Pharmacy, and the James H. Quillen Veterans Affairs Medical Center, and from other Colleges or institutions operating under contractual agreement with ETSU where warranted by the content of the study and requested by either the principal investigator or Chair of the ETSU Campus IRB.  This responsibility includes considering the level of risk to the individuals involved as it relates to the overall benefit of the protocol as presented, determining that participants have been given "informed consent," and resolving that the proposed research is consistent with the moral and ethical precepts of the institution.

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:

The Board meets at least monthly.

Selection:

Members are nominated by the Senior Vice President for Academics/Interim Provost, Vice President for Clinical Affairs, and by the Associate Chief of Staff for Research from the Veterans Affairs Medical Center Office of Research & Development.

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:

A pool of alternates may be selected by the Board upon the approval of the Senior Vice President for Academics/Interim Provost, Vice President for Clincal Affairs, and by the VAMC Director.  They have full voting authority (in the absence of the regular member) and are designated to replace regular members at meetings to which the latter cannot attend.  Alternates are appointed for three year terms, as are regular members, and are encouraged to attend the meetings so as to gain from their experience in serving on the IRB.  Alternates may be recommended by the Chair, with concurrence of the regular membership, for election to vacant, unexpired terms and full three year terms for which they qualify on the regular committee.