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.
- The UCSF IRB requires submission of an application even if the study team believes its project constitutes Public Health Surveillance activities only and does not require IRB approval under the Common Rule.
- The primary reason for requiring an application is to determine whether the project involves components requiring IRB approval, and if so, to ensure they are adequately captured, reviewed and approved in accordance with current regulations. The IRB must also ensure that the project does not meet the definition of a clinical investigation as defined by the U.S. Food and Drug Administration (FDA). For example, if UCSF were to partner with a public health agency to engage in diagnostic testing using a test not granted an Emergency Use Authorization, 510(k) clearance, or other marketing approval by the FDA, the administration of the test would constitute a clinical investigation requiring IRB review. If any portion of the project involves a research component a separate application may be required.
- In addition, we require a submission in order to collect data on COVID-19 related Public Health Surveillance activities for general research enterprise reporting.
- Before you submit an application email Joanne Mickalian and Cheri Etter with a brief description of the scope of work. The HRPP will provide feedback on the submission process that best fits your activity.
(PDF - Updated 5/28/20)
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?
If your study has a specific requirement for written signed consent as the only acceptable form of consent for some or all of your participants, you must continue to obtain signed consent from subjects enrolled remotely.
DocuSign and REDCap are the only electronic platforms that UCSF currently permits researchers to use to obtain electronic consent and authorization during the Interim UCSF Policy. Other platforms should not be used for obtaining electronic signatures. However, if you have access to a different CFR Part 11 compliant platform for obtaining electronic consent that you wish to use, please contact the HRPP to discuss.
The U.S. Food and Drug Administration has made its recently developed ‘FDA MyStudies app’ available to investigators as a free platform to obtain informed consent for COVID-19 studies only. The IRB is working closely with IT Security and Privacy to review the software in hopes of making it an available option for eConsent in the near future. It is currently not available for UCSF, until further notice.
Q2a. Hasn’t DocuSign previously been allowed for eConsent?
UCSF has long allowed for the use of DocuSign for electronic consent and authorization signatures, with the advisement that it should not be used for FDA regulated studies due to the pending part 11 validation (see below).
During the public health emergency, we are allowing its use for all studies, including FDA-regulated trials, with the caveats and additional procedures (i.e., documentation requirements and risk mitigation measures) described below.
Q2b. Hasn’t REDCap previously been allowed for eConsent?
Yes, to a limited degree REDCap has been used for electronic consenting for a few, selected studies at UCSF, but not as the preferred platform at UCSF and not for FDA-regulated studies. During the public health emergency, we are allowing its use for all studies, including FDA-regulated trials, with the caveats and additional procedures (i.e., documentation requirements and risk mitigation measures) described below.
Note: There are additional requirements for VA research requiring signed consent and/or signed HIPAA authorization. Please contact the HRPP office for additional guidance if you are conducting research at a VA medical center and are contemplating use of eConsent. Currently neither DocuSign nor REDCap may be used.
If your study is FDA-regulated, please note:
- The UCSF versions of DocuSign and REDCap are not compliant with FDA regulations governing electronic records and electronic signatures as delineated in 21 CFR Part 11 (referred to as “Part 11”), because the implementation of these applications at UCSF has not been fully validated according to FDA standards.
- At this time, it is unknown whether the FDA will exercise enforcement discretion regarding the use of UCSF’s versions of DocuSign and REDCap to document consent during the COVID-19 public health emergency. However, HRPP deems it unlikely, given recent FDA guidance referenced below, and assuming adherence to proper remote consent procedures and documentation described below. UCSF is working to bring both these systems into compliance with Part 11, with REDCap likely to be completed first, with target completion date of mid-June.
- The Human Research Protection Program has prepared a memo to sponsors that may be shared with research sponsors to document our guidance on obtaining electronic consent and HIPAA authorization signatures during the COVID-19 public health emergency.
- Please study these guidance documents about remote & electronic consent of FDA-regulated research:
- Use of Electronic Informed Consent in Clinical Investigations-Questions and Answers (Dec 2016)
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (March 2020, updated May 14, 2020) - Specifically, see Q10 in the “Questions and Answers” appendix
- Signature of the Person Obtaining Consent: The person who has oriented and obtained consent must sign and date the consent document after the participant has signed. Electronic platforms (DocuSign and REDCap) may be used to first route the document to the participant for signature then route to the person obtaining consent. This process may be followed for non-electronic consent processes as well such as mail-in or fax consenting procedures.
- Copies: You must provide a copy of the consent to the participant via mail, secure email or secured fax.
- Identification: Researchers are advised to make a record of the additional steps they take to remotely verify the identity of the person signing study documentation (i.e., by asking security questions or viewing some form of official identification). Also document that use of electronic consent at a remote visit is in compliance with the Interim UCSF Policy.
- Questions: If researchers will not be available via live chat, video conferencing or telephone (see suggestions in “Risk Mitigation,” below) at the time when the participant is asked to sign their consent and authorization forms, the participant must be provided with information about how to contact the study team with questions about the research and their rights as a participant.
- Confidentiality: Researchers must advise participants against the use of public computers when completing consent and HIPAA forms electronically.
In using virtual tools, including electronic consenting, UCSF researchers are strongly advised to adopt as many of the following risk mitigation measures as possible to protect research participants and the University:
- Use of video calls to permit better assessment of participant comprehension, answer questions, and verify identity; if video calls are not possible due to technology limitations, phone calls are preferred to communicating exclusively via email with participants. To ensure that patients are approached in a consistent fashion, a standard process should be used1 that will accomplish the following:
- Identification of who is on the call
- Review of the informed consent with the patient by the investigator (or their designee) and response to any questions the patient may have
- Presence of an impartial witness to the consent process (Note: The HRPP strongly advises, but does not require, the use of a witness). If an impartial witness is involved, obtain confirmation by the witness that the patient’s questions have been answered.
- Confirmation by the investigator that the patient is willing to participate in the trial and sign the informed consent document while the witness is listening on the phone
- Verbal confirmation by the patient that they agree to participate in the trial and that they have signed and dated the informed consent document that is in their possession
- Note: Verbal confirmation alone does not constitute written documentation/eSignature (see below for more information on verbal consent).
- Include additional fields in the signature section that more closely approximate Part 11 requirements (the form should already include fields for the participant’s signature and date of signature):
- Time of signature (time stamp)
- Typed/printed name of signer (in addition to signed name)
- Reason for signing (for example: “I agree to participate in the study and authorize use of my health information”)
- Sponsors and clinical investigators should document how restrictions related to COVID-19 led to the changes in study conduct, the duration of those changes, and indicate which trial participants were impacted and how those trial participants were impacted. For example: “In response to the COVID-19 public health emergency, the University of California San Francisco has issued an Interim Policy on Human Subjects-Related Research Visits outlining the conduct and location of research visits. For the safety of research participants and investigators, the vast majority of consenting procedures are taking place remotely. Remote consenting was implemented on [date] and impacts all participants after that date. The policy is in place until further notice from the UCSF Office of Research.”
- Verbal consent means that the individual obtaining consent reads/explains a verbal version of a consent form (i.e., an information sheet or a script), and subjects give their verbal consent in place of written consent to participate (i.e., there is no “wet ink” or electronic signature).
- If you are currently approved to obtain signed consent but want to obtain verbal consent only from participants remotely (i.e., no longer obtain a written signature), modification and prior IRB approval is required (see “Scenario C” in FAQ #1, above). 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.
For guidance regarding when a waiver of signed consent is allowed click here.
DocuSign and REDCap can be used for studies requiring HIPAA Authorization for the use of PHI (except for VA studies unless additional requirements can be met). Refer to https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html
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 two memos that researchers can share with sponsors:
- IRB Reporting Requirements Memo: This memo details 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.
- Obtaining Electronic Consent Signatures Memo: This memo describes the IRB’s guidance on obtaining electronic consent and HIPAA authorization signatures during the COVID-19 public health emergency.
- 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)
- Use of Electronic Informed Consent: Questions and Answers (Updated 12/2016)
- Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (Updated 3/16/20)