COVID-19 Resources

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Please use the following links and resources: 

 
Helpful contact information
  • The IRB office is open during business hours, as usual, from Mondays-Fridays from 8:00am-5:00pm. Analysts have been encouraged 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 (Joanne.Mickalian@ucsf.edu) and Cheri Etter (Cheri.Etter@ucsf.edu), and include “COVID-19” in the subject line for COVID-19 related protocols.
 
 

 

IRB FAQs

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. Do I need to submit a modification form to the IRB and have it approved before changing an in-person visit to one conducted virtually or by remote means?

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.

Q2. 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?

If the approved procedures to be conducted at that visit can be done remotely without compromising the safety of the research participant, this would not require approval by the IRB. However, if there are procedures that can no longer be conducted because an in-person visit cannot occur AND those procedures impact the safety of the participant, this should be submitted to IRB for approval. 

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.

Q3. What changes do not need to be reported to the IRB within 10 working days?

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.

Q4. Are there any types of modifications that still need approval from the IRB prior to implementing the changes?

  
  • 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.

Q5. Do I need IRB approval to conduct consent remotely?

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.

Q6. Do I need IRB approval to communicate with research participants to inform them of a pause in recruitment or changes to study activities?

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.

Q7. 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.

Q8. 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.

Q9. 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.

Q10. My sponsor issued a protocol amendmend 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.

Q11. 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).

Q12. 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

Q13. 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.

Q14. 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.

Q15. 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.

Q16. 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.

Q17. 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.

Q18. 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.

Q19. 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.

Q20. 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.

Q21. 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.

Q22. 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.

Q23. Is there is a process for priority review of COVID-19 related protocols?

Yes. Please email Joanne Mickalian (Joanne.Mickalian@ucsf.edu) and Cheri Etter (Cheri.Etter@ucsf.edu), and include “COVID-19” in the subject line for COVID-19 related protocols.

Q24. I am preparing an IRB application for a COVID-19 study and I have IRB questions. Who should I speak to?

Please email Joanne Mickalian (Joanne.Mickalian@ucsf.edu) and Cheri Etter (Cheri.Etter@ucsf.edu), and include “COVID-19” and your IRB study # in the subject line for COVID-19 related protocols.

Q25. Is the IRB help desk still functioning?

Yes. The IRB help desk is available at (415) 476-1814 and IRB@ucsf.edu..