The University of Tennessee Graduate School of Medicine, Knoxville


The Institutional Review Board

The Institutional Review Board

The University of Tennessee Health Sciences Center (UTHSC) including the UT Graduate School of Medicine (UTGSM) has provided a guarantee Federal Wide Assurance (FWA) to the Office for Human Research Protection (OHRP) in the Department of Health and Human Services (HHS) that it will follow procedures which will assure the protection of all human subjects participating in research projects. The guarantee applies to all human subjects research conducted by anyone on premises owned, or leased by the UTGSM, and to research conducted anywhere by faculty, students, staff or others acting as representatives of the University.

In order to comply with this assurance, the UTGSM has established an institutional committee competent to review research projects that involve human subjects. Under the provisions of the HHS Regulations for Protection of Human Subjects (45 CFR 46) and similar FDA Regulations (21 CFR 50 and 56), this committee has been designated as the Institutional Review Board (IRB) and consists of representatives from the UTGSM and surrounding community. Because of the special relationship between the UTGSM and University Health System (UHS) , a private not for profit entity which operates the University of Tennessee Medical Center (UTMC) in Knoxville, representatives from that organization are included as members of the IRB as well.

The primary function of the IRB is to assist the investigator in the protection of the rights and welfare of human subjects. It is necessary for others who are independent of the research to share the responsibility for determining the standards for ethical conduct of research involving human subjects. Investigators however, carry primary responsibility for assuring that research protocols are planned, and conducted in an ethical manner and consistent with standards established by the IRB.

Before a human subjects research project can be initiated, it must first be reviewed and approved by the IRB and then conducted in full compliance with Federal Regulations. There can be no exceptions to this requirement, since violations may result in serious repercussions for the institution and the investigator.

The information provided is to assist UTGSM investigators in the preparation and submission of research proposals for review by the IRB, and to provide guidance during the conduct of human subject research. The guidelines, which serve as the official governance document for human subject research at the UTGSM reflect both the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (The Belmont Report) and the Federal Regulations (45 CFR 46, 21 CFR 50 and 56) which regulate human subject research.

All research involving human subjects must undergo IRB review and approval prior to initiation of the research. The type of IRB review performed depends on the classification of the research as a) full Board review, b) expedited review, or c) exempt from review. It is important to note that investigators may request a specific classification of review; however, the final decision is determined by the Board. If investigators are unsure of the method to follow, they are encouraged to discuss their proposed protocol with the IRB chair, early in the process and thus, facilitate their preparation and the eventual review.

Nothing in the IRB guidelines and/or the Federal Regulations governing human subject research is intended to limit the authority of a physician or other health care provider from providing emergency medical care to the extent the individual is permitted to do under applicable Federal, State, or local law.

Organization

The UTGSM in Knoxville is a part of the UTHSC in Memphis. Therefore, the Chancellor of the UTHSC, as CEO, makes all appointments to the IRB. The chairman of the UTGSM IRB reports to the Dean of the GSM, and to the chairperson of the parent IRB in Memphis. The UTGSM IRB is an autonomous board, but is a part of the overall compliance program of the UTHSC. The chairperson in Memphis is responsible for communicating to the Chancellor and to regulatory agencies all issues pertinent to the protection of human participants and compliance with guidelines.

Affiliation(s)

The UTMC in Knoxville, an independent not-for-profit organization operated by UHS, has designated in its federal-wide assurance the UTGSM IRB for review of federally supported research conducted by its physicians, staff or agents. In recognition of this affiliation, representatives from UHS are appointed to serve on the UTGSM IRB to insure competency of review.

Bioethics Training

Consistent with the University's commitment to the ethical conduct of research, investigators governed by these regulations are required to complete an on-line instructional program covering issues which affect the ethics of research involving human subjects. Completion of the course is documented by an on-line multiple-choice test. A passing grade of 80 is required for certification of course completion.

No proposed research will be reviewed by the IRB unless the investigator submits certification of completion of the program. Investigator, co-investigators, coordinators, or people conducting consent must take the course. The IRB will be notified of successful completion. Members of the IRB are also expected to take the on-line course and submit certification of satisfactory completion.

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