Updated on June 17, 2020: New guidance for Phase 2 Restart of Clinical Research for July 1-August 31 has been released.
Released on June 3, 2020 by Betsy Nugent, Chief Clinical Research Officer:
This document outlines SMPH-specific guidance related to restarting face to face human subjects research that supplements UW-Madison Office of the Vice Chancellor for Research and Graduate Education (OVCRGE) phase I research restart policies. Policies described here and in the OVCRGE guide supersede prior COVID-19 related compliance requirements.
All research that was approved through the prior SMPH essential research approval process may proceed without interruption as we transition to the new process.
Please note that while plans exist to reopen face-to-face research, the landscape remains uncertain and suspensions of face-to-face research interactions may be possible. Our concern is first and foremost for the safety of our research participants and our staff. Where there is potential to continue with remote interactions, those will remain preferable for the foreseeable future.
Additionally, the document “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” may provide further clarification for research teams engaged in FDA-regulated research activities on the need to focus on participant safety and strategies for remote conduct of study activities or appropriate delays in study activities.
The unique demands of the COVID-19 public health emergency as well as required flex-down time for both UW Health and SMPH employees will need to be considered as we phase in the reopening of clinical research.
Information for all researchers:
- Research participants should not be brought into clinical areas if not necessary for their own care/safety.
- Every effort should be made to continue with remote methods of research subject and sponsor interaction.
COVID-related human subjects research:
- As previously announced, all human subjects research related to COVID-19 is managed, prioritized and approved institutionally through a centralized process. If you have an interest in engaging in a COVID Related Research Protocol, please visit the link provided for information and the form to start the process: Institutional Approval for COVID-19 Human Subjects Research.
- General information about COVID-19 Clinical Trials and other general clinical trials updates can be found at www.clinicaltrials.wisc.edu
- The relatively limited number of COVID-19 cases at UW requires us to engage in studies that are most appropriate for our patient population and our institution, to ensure studies do not compete for the same patient population and to present the best opportunities for benefit to both patients and researchers.
- COVID-19 human subjects research is operationalized centrally and prioritized for start-up.
Guidance on resuming in-person human subjects research activities (not related to COVID-19)
- Phase 1: Clinical research with potential for early reopening (June 1-June 30, 2020)
- A limited number of previously enrolling clinical research protocols MAY be considered for reopening in the period between June 1 and June 30 as outlined in the OVCRGE guidelines if it meets the following criteria:
- Delay may lead to potential patient safety issues for existing participants that cannot be assessed remotely. For example, delay of exam for progression of disease that requires equipment only available on site or of safety labs/visit could create unnecessary risk to subjects, OR
- Research presents direct benefit to the patient/participant, OR
- Participation in research represents no greater risk to patients/subjects than that which the patients/subjects are already exposed. For example, if patients are already coming into the Emergency Department for treatment, then being part of a research study at that same location may not present greater provided participants remain in care areas for minimal additional time to be part of research activities.
Studies will be reviewed according to above criteria and the ability of the organization to adequately support the research. The review will account for study activities that may impact ancillary departments (lab, imaging, Pharmaceutical Research Center (PRC), CRU, etc.
If research is performed in a UW Health facility, the review process will also include review and approval by Infection Control and UW Health prior to approval.
For studies approved for early reopening:
- Research study activity that CANNOT be done remotely must have plans for appropriate protection of non-clinical staff and research participants must be in place including but not limited to:
- Minimal presence clinical areas
- Provision and use of appropriate PPE. PPE should be procured by filling out this form: https://shopuw.wisc.edu/eoc-ppe-request-form
- Appropriate physical distancing
- Guidance on initiating new in-person human subjects research activities (not related to COVID-19)
- New clinical trials that have not previously been opened to enrollment should be delayed until after June 30, 2020 UNLESS COVID-related.
- Many of the ancillary departments (Pharmaceutical Research Center (PRC), Lab, CRU etc.) that support critical components in new initiation of clinical trials may also be working in many other areas of research, including prioritized COVID-19 studies, so to ensure appropriate timelines and availability for support of new research protocols, please ensure that you have engaged with this department to ensure availability of resources prior to initiating new research studies.
- New clinical trials work may continue in the areas of regulatory activities, IRB submission, budget negotiations and contracting, remote training etc. however, enrollment in new trials should not begin until phase 2 of research reopening (after June 30, 2020). Please note that many pharmaceutical sponsors are also delaying new studies and prioritizing COVID studies. Continued discussions and updates with study sponsors are advised.
- New clinical trials should be submitted, along with studies coming out of suspension, for the phase in and prioritization of human subjects research for phase 2 of research reopening.
- In-person site initiation and site selection visits will not be allowed until further notice. Remote site selection and site initiation will remain preferred methods for the foreseeable future.
- Sponsor requests to resume on-site visits without meeting other criteria above is not an adequate reason for phase 1 restart.
- In person monitoring will not be allowed until further notice.
Information for Principal Investigators:
Process for consideration of reopening clinical research Phase 1 (June 1-June 30):
- The Principal Investigator (PI) initiates the request:
- Discuss your plans to restart your human subjects research activities with your department chair.
- Clear ancillary activities with relevant departments (e.g. lab, imaging, Pharmaceutical Research Center (PRC)) or CRU if appropriate.
- Document particular benefits or risk mitigation that the research study provides to participants as well as COVID-19 risk mitigation strategies.
- Upon approval by unit director, PI submits request via the Phase 1 approval form, which will be forwarded to the clinical research restart team.
- The clinical research restart team will review your request:
- To ensure that there is a clear and compelling rational to reopen research during Phase 1
- To confirm that there are adequate COVID-19 risk mitigation strategies in place.
- To determine if your research request includes UWHC facilities, it will also be reviewed by Infection Control and UW Health.
- To verify approval of the unit chair.
- To confirm that the research conforms to OVCRGE or SMPH guidelines.
- The request may be returned to the PI for revision if the proposed research does not adhere to criteria or if information is missing.
- If your request is approved, a message authorizing restart will be sent to you, your unit director, IRB, and the OVCRGE.
Information for chairs, division chiefs, and center directors:
Chairs, division chiefs, and center directors will be responsible for initial review of PI requests for reopening human subjects research and must first ensure that requests conform to OVCRGE and SMPH safety guidelines. Please be aware that only research that presents direct benefit to participants or addresses safety concerns will be reopened during Phase 1.
Studies that do not meet criteria for reopening in Phase 1 (June 1-June 30, 2020) will need to be prioritized for reopening in Phase 2 (after June 30, 2020.)
For human subject research that will open in Phase 2, SMPH will follow OVCRGE guidance about Phase 2 of research restart once it is announced.
Additional questions? Please email Betsy Nugent, Chief Clinical Research Officer at firstname.lastname@example.org for assistance.