The University of Tennessee Graduate School of Medicine, Knoxville

As a result, and in the context of the rapidly evolving COVID-19 outbreak, the University of Tennessee Graduate School of Medicine Institutional Review Board has established this guidance related to human subjects research visits. This is being implemented to protect research participants and researchers from risk of infection with COVID-19 as well as to ensure ongoing access to research which may provide essential support and care to participants. This policy will be revised as needed, based on new information. It will also be available on the UT GSM website at: http://gsm.utmck.edu/irb/

Recommendation for Remote Visits

Whenever possible, research visits should be performed remotely (e.g., by phone, Zoom, Skype, Webex). Research activities not essential to patient care should be postponed or done remotely.

Non-Essential Research Visits

Research visits that cannot be performed remotely and are not essential to a participant's health and/or well-being should be postponed until further notice. Currently, the determination of whether or not a research visit is "essential to the health and/or well-being" of a participant is determined by the principal investigator of the research study, the participant, and the participant's care provider, and should be informed by current public health guidance regarding the COVID-19 outbreak.

Essential Research Visits

Research visits that cannot be performed remotely and are essential to a participant's health and/or well-being may be performed in person, with the following additional guidance:

• Participants should be provided with information regarding the current COVID-19 epidemic and how best to reduce their risk of infection. If possible, this information should be shared before the research visit. See the following CDC COVID-19 link for reference and materials: https://www.cdc.gov/coronavirus/2019-ncov/about/
• All research participants should be screened for fever, cough and flu-like symptoms by research staff prior to the research visit if possible, with repeat screening by research staff at the time of an in-person visit.

Enrollment of New Research Participants

Enrollment of new participants on a clinical trial or other human subject-related research should be allowed only if:

1. participation in the trial is essential to a participant's health and/or well-being, as determined as above; or
2. the enrollment and longitudinal participant management can be conducted remotely for the duration of the COVID-19 outbreak.

Study Sponsors

Principal investigators or their designees are asked to contact study sponsors to notify them of this guidance and make appropriate arrangements. All sponsor visits for clinical trials or other human subject-related research, whether for site qualification, site initiation, or monitoring visits, should be postponed whenever feasible. Consideration for remote monitoring should be based on study need and resource availability.

The University of Tennessee Graduate School of Medicine (UTGSM) and The University of Tennessee Medical Center (UTMC), as the region's only academic medical center, sponsors extensive research in both the clinical and laboratory settings. In that endeavor, we collaborate with the University of Tennessee, Knoxville (UTK), UT College of Veterinary Medicine, Oak Ridge National Laboratory (ORNL) and other research institutions to seek answers to complex medical problems. We train students, physicians and scientists to become the researchers of the future and approach health care with the curiosity that will lead to improvement in the lives of our patients.

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