On May 27, 2020, the Office of the Vice Chancellor for Research and Graduate Education (OVCRGE) distributed a plan for the phased reopening of campus operations over the course of the coming months. Based on the OVCRGE reopening framework, the School of Medicine and Public Health (SMPH) partnered with UW Health to design a process tailored to the onsite conduct of human subjects research. The scope, time-frame and approval process for each phase are outlined below.
- Virtual study visits and remote capture of human subjects research data is preferred and should continue to be maximized
- All dates are tentative and subject to change based on the availability of new COVID-19 information, a virus resurgence, or changes in institutional capacity. Therefore, all on-site human subjects research activities should have a contingency plan for the orderly reduction or cessation of on-campus activity.
March 15 – May 31
During Phase 0, all onsite human subjects research activity was suspended.
Under limited circumstances, School of Medicine and Public Health (SMPH) Deans and Directors were permitted to grant exceptions for the continuation of onsite human subjects research deemed essential.
Examples of “essential” research include:
- Therapeutic trials of a drug or device
- Studies critical to the health and safety of the research participant, and
- COVID-19 clinical research.
June 1 – June 30
During the first phase of limited re-expansion, only human subjects research which presents a direct benefit to participants or addresses safety will be considered for re-initiation of on-site or face-to-face research activities.
July 1 – August 30
During the second phase, School of Medicine & Public Health (SMPH) departments, units and centers will identify and prioritize studies to be considered for resumption of onsite activities or new initiation. Requests will be reviewed by a committee charged with assessing safety, institutional capacity, and overall priority.
Each department (or operational unit) should:
- Review the SMPH-specific guidance for Phase 2 Restart of Clinical Research
- Complete the Prioritization Spreadsheet (updated 6-19-20) and submit to Rochelle Rannow.
Requests received by June 25, 2020 will be notified of decisions prior to July 1, 2020. Requests received after June 25th will be reviewed on a rolling basis.
To Be Determined