Please use the following links and resources:
- For latest updates: https://coronavirus.ucsf.edu/
- Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP) (Updated March 13, 2020)
- Per interim research policy, PIs or their designees should use this letter to communicate with sponsors (Updated March 13, 2020)
- COVID-19 Biospecimen Guidelines (Updated March 15, 2020)
- Frequently Asked Questions (FAQ) – UCSF Clinical Research Guidance (Issued 3/13/20; revised 3/17/20).
- Revised Interim UCSF Policy on Human Subjects-Related Research Visits at San Francisco Campuses during COVID-19 Outbreak. (Effective on March 16, 2020)
- Revised Guidance to Researchers Regarding Determination of "Essential to the health and/or well-being" for human subject research visits conducted in the ambulatory setting during the COVID-19 outbreak. (Updated March 16, 2020)
- UCSF Issues Escalated COVID-19 Policies and Guidance (Updated March 16, 2020)
Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (Updated March 16, 2020)
FDA Guidance on Emergency Use Authorizations (Updated March 21, 2020)
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The interim policy on human subjects-related research visits will require many studies to implement immediate changes in order to limit exposure to COVID-19. These policies apply only for the duration of the current public health emergency. Here are answers to some commonly asked questions about how this interim policy impacts IRB submissions:
No. Changes made for the specific purpose of minimizing or eliminating immediate hazards or protecting the life and well-being of research participants can be implemented prior to IRB approval. See FAQ #2 for information on submitting to the IRB after the changes are made.
When to submit changes to the IRB:
Submit an Incident Report form, ideally within 10 working days (weekends and holidays excluded) of implementing changes. However, the IRB recognizes that delayed reporting may occur during the COVID-19 outbreak.
Examples of changes requiring reporting include:
- Changes to procedures that impact the safety of the participant.
- Changing the timing or location of visits/procedures determined to be essential to the health and/or well-being of the participant. For changes to study visits deemed not essential to the health and/or well-being of the participant, see FAQ #3 below).
Note: After reviewing the Incident Report form, the IRB may ask you to modify your application and/or study materials.
See the UCSF reporting policy for more information. If you are unable to submit the Incident Report form within 10 days, you will be able to address this within the form.
The following changes do not need to be reported to the IRB via Incident Report form within 10 working days, but should be recorded by investigators and included in any subsequent modification or continuing review submission:
- Incorporating screening questions to identify potential exposure to COVID-19.
- Adding links to reputable websites for information about COVID-19 (UCSF, CDC, etc.) on the study website, where applicable.
- Postponing or cancelling non-essential study visits/procedures that do not impact participant safety. A note-to-file for the participant research chart that sufficiently documents the reason for the postponement/cancellation of the visit is acceptable for audit purposes. The distinction between essential and non-essential visits is left to the discretion of the PI and is further described in the UCSF interim policies on research.
- Changing visits that are not essential to the health and/or well-being of participants from in-person visits to virtual visits (e.g. use of digital technology as a substitute for in-person visits such as Zoom)
- Pausing recruitment
Of note, protocol violations are changes in the conduct of a IRB-approved research protocol that are under the investigator’s control and made without prior IRB approval and these must be reported in accordance with existing IRB/HRPP policies.
- All modifications not related to the UCSF interim policy (i.e. not related to immediately protecting participants from COVID-19 exposure) still need to be submitted to the IRB and approved prior to implementation, per usual.
- Any changes to inclusion/exclusion criteria, even if being changed in response to COVID-19, need IRB approval prior to being implemented.
- See FAQ #5 for another example.
If your study has a requirement for signed consent, you are allowed to obtain electronic informed consent without IRB approval. UCSF currently supports the use of DocuSign as a tool for electronic consent. Of note, if your study is FDA-regulated, the UCSF version of DocuSign is not compliant with the FDA’s data security rules at 21 CFR Part 11. At this time, it is unknown how the FDA will view the use of UCSF’s version of DocuSign during the COVID-19 public health crisis. Modification and IRB approval is required if you are currently approved to obtain signed consent but want to only get verbal consent for remote participants (i.e. no longer obtain a consent signature). In this case, submit a modification to the IRB in order to determine whether your study qualifies for a “waiver of signed consent.” The modification must receive IRB approval before you implement this change.
No. These messages to participants do not require IRB approval. In addition, messages about changes to study visits, like administering questionnaires over the phone or video conferencing, do not require IRB approval. Make a note to your study files to document these communications.
No. When changes necessary to eliminate apparent immediate hazards to participants are adopted prior to IRB review, no new consent is required unless the change fundamentally alters or negates what the participants initially consented to. Instead, participants should be informed of changes in the research study.
No. Research teams should carefully consider the risks of participants attending in-person study visits in light of the factors discussed in this document.
Not as it relates to risks of contracting COVID-19. However, any study changes adopted during the COVID-19 outbreak that may have resulted in increased risk to study participants should be reported as part of the continuing review.
Submit any sponsor notification that is related to subject safety (e.g. changes in study drug dispensation or treatment).
Yes. The Office of Research has developed “Guidance for Screening of Research Participants by Clinical Research Staff.” There are additional guidance documents available at the UCSF Coronavirus site and at https://infectioncontrol.ucsfmedicalcenter.org/coronavirus
No. The PI and research teams should follow applicable hospital or occupational health policies for managing and reporting COVID-19 infections.
Federal regulations from OHRP require the IRB to ensure that investigators promptly report "any unanticipated problems (UP) involving risk to subjects or others." The IRB/HRPP reviews the reports and determines whether they meet the institutional definition of a UP.
Yes. The FDA will need to be notified as soon as feasible.
No. The procedure for Emergency Use and Compassionate Use of Experimental Drugs and Devices currently remains the same during the COVID-19 outbreak.
Yes. All new studies are still being reviewed. If your study involves in-person contact, please note that procedures will either need to be performed remotely, or postponed, until the UCSF Interim Policy research restrictions are lifted. COVID-19 research studies are given review priority given the urgency of the evolving outbreak worldwide.
Yes. The IRB will continue to review and approve these submissions. If your study involves in-person contact, please note that procedures will either need to be performed remotely, or postponed, until the UCSF Interim Policy research restrictions are lifted.
Yes. IRB meetings and review agendas are proceeding as scheduled.
- The PI is available to maintain appropriate oversight.
- There are adequate supplies available including the treatment itself and all additional supplies to administer and monitor the study treatment.
- Procedures essential to the safety of subjects can be continued (labs, etc.)
- There are a sufficient number of trained study staff to support conduct of the study considering staff workloads and any requirement to work remotely or to cover other responsibilities at their health care facility or institution.
Yes.The Interim Policy and requirements regarding research restrictions applies to all research conducted in our UCSF locations in the City and County of San Francisco, regardless of the IRB that oversees the ethical and regulatory conduct of these studies. Continue to follow the IRB of Record’s reporting guidelines.
Yes. You should follow the requirements of the IRB that oversees your research regarding reporting changes and whether any reviews or approvals will be needed prior to resumption of study procedures.
Yes. The IRB help desk is available at (415) 476-1814 and IRB@ucsf.edu..