The IRB office is open during business hours, as usual, from Mondays-Fridays from 8:00am - 5:00 pm. Analysts have been encourage to work from home and are responding to emails and calls. Contact information for analysts can be found here. Click here to find the analyst assigned to a particular submission.
There is a process for priority review of COVID-19 related protocols. Please email Joanne Mickalian ([email protected]) and Cheri Etter ([email protected]), and include "COVID-19" in the subject line for COVID-19 related protocols. More information about submitting COVID-19 Protocols can be found here.
For information about priority IRB review of COVID-19 studies and instructions on submitting COVID-19 studies to the IRB (new studies and modifications), click here. The IRB has some specific requirements for these applications and consent forms, so please read the page thoroughly before submitting any COVID-19 research.
(PDF - Updated 4/22/20)
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:
Q1. If changes necessary for protecting research participants from COVID-19 are made in accordance with interim policies, what should we submit to the IRB, and when?
Please see the table below. You can also provide your sponsor with a memo regarding what changes do/do not require prior IRB approval.
Changes that do not increase risks to subjects
Changes that may increase risks to subjects
Changes that require IRB approval before implementation
Prior IRB approval required?
When to submit
At the time of your next necessary modification or continuing review.
Tip: Make notes to your study files to document the changes.
Within 10 business days of implementing changes. Note: the IRB recognizes that delayed reporting may occur during the COVID-19 outbreak.
Tip: 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.
Before the changes are implemented
What iRIS form to use
Note: In this form, you can indicate that you are reporting a research-related incident, not a protocol violation.
Changing visits that are not essential to the health and/or well-being of participants from in-person visits to remote/virtual visits.
Incorporating screening questions to identify potential exposure to COVID-19.
Adding links to reputable websites for information about COVID-19 (UCSF, CDC, etc.) to the study website.
Postponing or cancelling non-essential study visits/procedures that do not impact participant safety. Add a note-to-file for the participant research chart that sufficiently documents the reason for the postponement or cancellation of the visit.
Moving from in-person to remote consent and HIPAA authorization. Note: If your study has a requirement for signed consent, you must still collect signatures remotely.
Pausing/suspending recruitment and enrollment.
Elimination of safety-related procedures that can no longer be conducted because an in-person visit cannot occur, such as critical safety labs or a scan to monitor disease progression.
Changing the timing or location of visits/procedures determined to be essential to the health and/or well-being of the participant, such as a significantly out of window safety lab, as determined by the PI.
Changes to inclusion/exclusion criteria, even if being changed in response to COVID-19.
Changing from signed consent to verbal or implied consent (e.g., no longer obtaining wet or electronic signatures)
All changes not related to the UCSF interim policy (i.e. not related to immediately protecting participants from COVID-19 exposure)
Note: You do not need IRB approval to communicate with research participants to inform them of a pause in recruitment or changes to study activities. Make a note to your study files to document these communications.
Q2. How can I obtain signed consent electronically?
UCSF currently supports the use of DocuSign as a tool for electronic signed 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.
Note: DocuSign cannot be used for VA research studies which require signed consent and/or signed HIPAA authorization.
Q3. Do participants need to be re-consented to reflect changes to study activities?
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.
Q4. Should consent forms be revised to include the risk of contracting COVID-19 at the hospital or during a study visit?
No. Research teams should carefully consider the risks of participants attending in-person study visits in light of the factors discussed in this document.
Q5. Do I need to report the risk of contracting COVID-19 at time of continuing review in response to the questions "Since the last continuing (or initial) review, have the risks to subjects changed?"
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.
Q6. My sponsor issued a protocol amendment to include COVID-19 information. Should I submit this to the IRB?
Yes. Submit updated sponsor protocols/sponsor protocol amendments via the iRIS modification form as you normally would.
Q7. My sponsor issued a Sponsor Notification Letter. Should I submit this to the IRB?
Submit any sponsor notification that is related to subject safety (e.g. changes in study drug dispensation or treatment)
Q8. Are there institutional guidelines for clinical research staff to screen for COVID-19 before and during in-person visits?
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.
Q9. Do I need to report to the IRB if a study participants or member of the research team tests positive for COVID-19?
No. The PI and research teams should follow applicable hospital or occupational health policies for managing and reporting COVID-19 infections.
Q10. Do I need to report to the IRB if a participant is hospitalized or dies due to COVID-19?
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.
Q11. I am conducting FDA-regulated research for which I am the sponsor of an IND or IDE. Do I need to notify the FDA if I pause my study?
Yes. The FDA will need to be notified as soon as feasible.
Q12. Has the process for single patient emergency use been changed?
No. The procedure for Emergency Use and Compassionate Use of Experimental Drugs and Devices currently remains the same during the COVID-19 outbreak.
Q13. Is the IRB still reviewing new studies that aren't COVID-19 related?
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.
Q14. Will the IRB continue to accept and review Modifications, Continuing Reviews, and other reporting forms?
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.
Q15. My new study is assigned to an upcoming IRB meeting, will it still be reviewed?
Yes. IRB meetings and review agendas are proceeding as scheduled.
Q16. I am the Lead PI on a study where UCSF IRB serves as the central IRB for external research sites. Do these requirements apply to the external sites?
It depends. The requirements apply to research conducted at UCSF locations in the City and County of San Francisco and are based on the situation in the Bay Area. External research sites may have different requirements based on the local situation. As the IRB of Record for research conducted at the external research site, we require the UCSF Lead PI to assess whether the study can continue under the following conditions:
- 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.
Q17. My research study is reviewed by an external IRB. Do the UCSF restrictions apply to my study?
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.
Q18. Enrollment has been paused for my study due to COVID-19. How should I let the IRB know?
How to report an enrollment pause:
- If your study requires annual renewal (i.e. study has an IRB expiration date): Report the enrollment pause in the Continuing Review form, at the time of your next continuing review.
- If your study does not require annual renewal (i.e. no IRB expiration date): You do not need to report the enrollment pause to the IRB.
How NOT to report an enrollment pause:
- Please do NOT submit a Modification form, Protocol Violation/Incident Report, or Reporting Form to the IRB to report a pause in enrollment due to COVID-19. This aligns with FDA guidance.
Q19. I am pausing recruitment and/or study procedures on a project REVIEWED BY AN EXTERNAL IRB, should I notify that IRB?
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.
Q20. Is there is a process for priority review of COVID-19 related protocols?
Q21. I am preparing an IRB application for a COVID-19 study and I have IRB questions. Who should I speak to?
Q22. Is the IRB help desk still functioning?
Yes. The IRB help desk is available at (415) 476-1814 and [email protected].
The HRPP has created a memo that researchers can share with sponsors detailing IRB reporting requirements for protocol deviations made in response to COVID-19 and in response to the Revised Interim UCSF Policy on Human Subjects-Related Research Visits at San Francisco Campuses during COVID-19 Outbreak. This memo was developed in response to requests from the UCSF research community in collaboration with the COVID-19 task force. Download the memo here.
- For latest updates: https://coronavirus.ucsf.edu/
- Frequently Asked Questions (FAQ) – UCSF Clinical Research Guidance (Issued 3/13/20; revised 3/31/20)
- Revised Interim UCSF Policy on Human Subjects-Related Research Visits at San Francisco Campuses during COVID-19 Outbreak. (Effective on 3/16/20)
- 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 3/16/20)
- UCSF Issues Escalated COVID-19 Policies and Guidance (Updated 3/16/20)
- Per interim research policy, PIs or their designees should use this letter to communicate with sponsors (Updated 3/13/20)
- COVID-19 Biospecimen Guidelines (Updated 3/15/20)
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards (Updated 5/11/20)
- FDA Guidance on Emergency Use Authorizations (Updated 5/13/20)
- FDA Investigational COVID-19 Convalescent Plasma - Emergency INDs: Frequently Asked Questions (3/26/20)
- Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff (Updated 5/11/20)
- COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (Updated 5/11/20)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (Updated 5/11/20)
- Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (Updated 3/16/20)