All research participants should be screened for fever or other symptoms of COVID-19 and contact (in the last 14 days) with a person known or suspected to have COVID-19. This screening by research staff should happen prior to the research visit if possible, with repeat screening by research staff at the time of an in-person visit. Advise research participants that they will also be screened at entry point to the hospital campus per the standard for all visitors.All UTMC patient and visitor restrictions must be followed at all times.
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.
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 or IRB staff, 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.
The UTGSM in Knoxville is part of the UTHSC in Memphis.The Chair of the UTGSM IRB reports to the Dean of the GSM. The UTGSM IRB is an autonomous board, but is a part of the overall compliance program of the UTHSC.
The University of Tennessee Medical Center in Knoxville, an independent not-for-profit organization operated by UHS, has designated in its federal-wide assurance, the UTGSM IRB as an IRB of record, for review of research conducted by its physicians, staff or agents. In recognition of this affiliation, representatives from UHS are appointed to serve on the UTGSM IRB.
What is CITI? The Collaborative IRB Training Initiative (CITI) Program is a leading online training program maintained by the Biomedical Research Alliance of New York (BRANY). It offers curricula in human subjects research, animal research, and the responsible conduct of research.
Who has to take CITI? The training requirement applies to IRB members and to anyone conducting human subjects research activities at UTGSM. This includes anyone working directly with human subjects or with identifiable data or biological specimens for research purposes under UTGSM auspices. Investigators, research nurses, coordinators, students, technicians working with identifiable data, and faculty advisors all need to obtain CITI certification.
How do I log-in? If you are a first-time CITI user and you are an employee of the University, select Log in through my institution. Next, select University of Tennessee Health Science Center – Knoxville from the drop down list and log-in with your UT Net ID and password; this will allow your training to be entered into the human resources mandatory training database. If you are not an employee of the University and you do not have a UT Net ID, you will need to create an account following the online instructions. Remember that your password should consist of 8-50 characters and it is case sensitive.
Which CITI course do I have to take? You must take the course that is the most appropriate to your research activities. Investigators and all Key Study Personnel will take Group 3; Research Administrators, IRB Chairs, and IRB staff will take Group 1; IRB Members and Department Chairs will take Group 2 and Students, Residents and Fellows will take Group 4.
For how long is my certification effective? For IRB purposes, certification is good for three years for those conducting human subjects research at UTGSM. CITI offers refresher courses for recertification.
Need Assistance? If you need any assistance or have any questions regarding the CITI training, please contact Cindy Langley at 865-305-6892 or Jacque Van Audenhove at 865-305-9781.
iMedRIS (Integrated Medical Research Information System) is a web-base system designed to facilitate the on-line submission, review and tracking of human research studies submitted to the Graduate School of Medicine Institutional Review Board.
2021 Deadline and Meeting Dates
Federalwide Assurance (FWA) for Human Subject Protection
CITI-The Human Subjects Training Course (Select "University of Tennessee Health Science Center - Knoxville" as your institution)
Kimberly C Mason, PharmD
Jacque Van Audenhove, MS, CIP
Cindy Langley, RN, CIP
IRB Regulatory Specialist
The Institutional Review Board (IRB)
UTHSC Graduate School of Medicine
3rd Floor, U76
1924 Alcoa Highway
Knoxville, TN 37920
The University of Tennessee Graduate School of Medicine
1924 Alcoa Highway
Knoxville, Tennessee 37920 | 865-305-9290
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