Temporary Policy on Human Subjects Research-Related Visits

REVISED Temporary Policy on Human Subjects Research-Related Visits During COVID-19 Outbreak and Further Suspension of Non-Essential In-Person Clinical Research Study Activities

University of Utah – Office of the Vice President for Research Effective March 28, 2020 re. Non-COVID Trials

The Office of the Vice President for Research is providing guidance related to human subjects-related research visits.  This policy is being implemented to protect research participants, research personnel, and the larger University community from risk of infection from COVID-19, and to ensure continued access to clinical research that may provide essential therapies to participants.  This revision aligns with the VPR Guidance of Essential Research Activities During the COVID-19 Outbreak, dated March 23, 2020.

Beginning March 28, 2020, the REVISED Human Subjects Research-Related Temporary Policy will be in place until further notice for the University of Utah. 

1. Participant research visits must be performed remotely (i.e., by phone, Zoom, or other means) whenever possible.
2. If a research visit cannot be performed remotely, the principal investigator, in consultation with the participant’s clinical care provider, should determine if the visit is essential or not essential to the participant’s health and/or well-being.
   • Study teams should contact participants prior to any in-person visit to determine whether the subject has fever or respiratory symptoms. If this is the case, they should be directed to schedule screening for COVID testing and the research visit should be postponed.
3. Research visits that cannot be performed remotely and are essential to a participant's health and/or well-being may be performed in person. The visit should be accomplished outside University Hospital and Clinics in research compliant facilities if possible. Otherwise, participants should be made aware of how to access the University Hospital and Clinics facility for the visit, and provided with information about the current COVID-19 pandemic and how to reduce their risk of infection.
4. 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 guidance.
5. Enrollment of new patients on a clinical trial or other human subjects-related research should occur only if: 1) participation in the research is essential to a participant's health and/or well-being, as determined above; or 2) the enrollment and participant interactions can be conducted remotely for the duration of the COVID-19 outbreak.
6. There may be studies that are not essential to a participant’s health and/or well-being but have research-only procedures that can be performed at a participant’s clinical or surgical visits at usual care (i.e., extra blood draws, sample collection, data collection, etc.). Research-only procedures at usual care visits may be performed during the outbreak at the discretion of the treating physician and care team.  If the research-only procedures will impede or weaken protection of the participant, other patients, or the care team from COVID-19 exposure, the research-only procedures should not be performed. 
7. For necessary in-person visits we encourage visits to be relocated from University Hospitals and Clinics to research compliant space on campus. Please contact CCTS Nurse Manager Michelle Adams if you need assistance relocating your study activities from a clinical area of the UU Hospitals and Clinics to the Clinical Services Core of the CCTS, 421 Wakara Way.  If you have questions about continuing clinical research, please contact CCTS Clinical Trials Support. 

 

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