UTC’s overarching priority throughout the course of the pandemic is the safety of faculty, staff, students, and visitors. This includes participants in research conducted under the auspices of the university. Accordingly, research involving in-person interactions between researchers and participants currently remains suspended unless the IRB and Vice Chancellor for Research have approved an exception. The restriction applies to all research that requires in-person interactions, regardless of whether a study qualifies—previously or in the future—for an exemption from ongoing IRB oversight.
Exceptions will only be considered under the following circumstances:
- The research has the potential to provide 1) an immediate, life-saving benefit to participants, 2) direct benefits to participants with conditions that are otherwise untreatable, or 3) beneficial information about COVID-19 that will be provided to the Hamilton County Health Department or Tennessee Department of Health. Protocols should be optimized to minimize risk.
- The research achieves the following three safety goals:
- No potential spread of the virus attributable to research activities in on-campus or off-campus settings.
- No potential spread of the virus from the campus environment to the local community.
- No potential spread of the virus from the local community to campus.
If you believe your research qualifies for an exception, complete and submit Form P: Pandemic Risk Evaluation – Research Requiring In-Person Interactions. You are also encouraged to contact the IRB at [email protected] if you have questions about the exception process.
If you have a previously approved project that can be modified to eliminate in-person contact between researchers and participants, please submit Form B: Application for Changes. Upon review and approval by the IRB, you may resume your project. Additional guidance regarding the use of remote communication methods during the informed consent and data collection phases of a study is provided below.
Studies that cannot eliminate in-person contact with participants will need to be optimized to reduce COVID-19 transmission risks. Although they will continue to be suspended while community transmission risk is high, some studies may be approved to resume as COVID-19 transmission risks decline in the community. If there are procedures in your study that require in-person interaction with participants, please review Form P: Pandemic Risk Evaluation to familiarize yourself with factors that will be considered. If you are able to modify your protocol to reduce (but not eliminate) in-person contact, submit Form B and Form P, and the IRB will review and provide further guidance.