UPDATED FDA Guidance on Conduct of Clinical Trials During COVID-19 Pandemic

March 30, 2020

• The FDA has updated its guidance on informed consent during the COVID-19 Pandemic.  In summary, the following consent processes and documentation is described:
  • Use electronic methods of obtaining consent where technology is available.
  • If in-person communication with a patient in isolation is not feasible or safe, the investigator/designee arranges for a copy of the consent form to be provided to the patient and also arranges a three-way call or video conference with the patient and an impartial witness (not a member of the study team). The consent process should then be conducted in standard fashion, with verbal confirmation that the patient would like to participate in the trial. The patient must still sign and date the consent document in their possession.
  • If the signed informed consent document cannot be collected from the patient’s location and included in the study records because of COVID-19 transmission concerns, the FDA considers the following two options acceptable:
    1. A written attestation by the impartial witness and the investigator/designee that the patient verbally agreed to participate. The witness and investigator ALSO sign a separate copy of the consent form. These documents are kept in the research record as documentation of consent.
       OR
    2. A photograph of the signed informed consent document, accompanied by a written attestation by the investigator/designee that states how that photograph was obtained. The witness and investigator ALSO sign a copy of the consent form.  These documents are kept in the research record as documentation of consent.
  • If a Legally Authorized Representative is providing consent on behalf of a patient, the usual regulatory methods for obtaining a signed consent document remain in place.

  In order for a witness to sign the consent document and make their written attestation, use the COVID-19 Witness Signature & Attestation Page available on the IRB website (no IRB amendment required).

  In order for the investigator/designee to make their written attestation, use the COVID-19 Person Obtaining Consent AttestationPage available on the IRB website (no IRB amendment required).

  The IRB now provides a Research Consent Process Worksheet – Obtaining Signed Consent During the COVID-19 Pandemic, which can be used by study teams to document that appropriate processes and documentation have occurred.

 VA Update

March 20, 2020

• For studies at the VA, per the VA Office of Research Development: If you initiate a temporary hold on VA research, it must be reported to the IRB within 10 business days and a note to file should be placed in the Investigator’s study records. Please submit notice of these holds to the University of Utah IRB via a Report of Information in ERICA.

 Guidance Related to Human Subject-Related Research Visits and FDA Guidance on Conduct of Clinical Trials During COVID-19 Pandemic

March 18, 2020

• The amendment and deviation instructions from March 12 (below) are still in place in tandem with the University’s Temporary Policy on Human Subjects Research Related Visits During COVID-19.
• The FDA has released new guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic.

 UU IRB & Research Preparations for COVID-19

March 12, 2020

The University of Utah IRB is heeding current guidelines from University leaders in response to the COVID-19 outbreak. This email is to provide the research community with information regarding the review and conduct of human subject research during this time.

 The University of Utah IRB will be fully operational.

There will be no reduced IRB review or consultation services. There may be periods of time that the IRB staff are expected to work remotely to support social isolation efforts. Though it may not be possible for the IRB staff to meet with study teams in person, phone and web conferencing will be functional for all IRB staff members. The IRB staff will be unable to answer direct phone calls while working remotely; however, all IRB staff will receive voicemails and can return calls or respond to emails.

 Researchers need to prepare their studies for possible interruptions or complications in conducting procedures.

Because of public and institutional self-isolation efforts, as well as possible quarantine of exposed individuals, it may be necessary to alter your research plans in order to keep study team members and research participants safe. Please make the following considerations for each active study.

1. Additional clinical services, testing, and screening related to COVID-19 that need to be performed for research participants do not need IRB approval prior to initiation. Such procedures would be considered usual care outside of the research context.
2. Consider whether your study or parts of your study should be placed on hold during this time. This hold may be for all research procedures. Perhaps placing a hold on enrollment, study visits, data collection, or data analysis separately is reasonable.  It is recognized that discontinuing a participant’s care during this time may not be safe or may dramatically jeopardize the results of the project. The decision to place a hold on your study needs to be made on a study by study basis, likely in consultation with your department leadership to ensure department and participant needs are met. You are not required to report study holds to the IRB; however, you must document them in your research records and report them to sponsors as necessary. 
3. Any changes to your protocol or the conduct of your research procedures still require an amendment with the IRB.  The IRB does not pre-approve deviations from protocol outside of the amendment process.
4. There may be an urgency to deviate from the protocol or the conduct of research procedures before an amendment can be approved by the IRB.  Some deviations will be minor. Some may have major effects on the welfare of participants and/or study validity. All deviations must be reported according to the IRB’s reporting policy.The IRB acknowledges that the COVID-19 outbreak and isolation/quarantine requirements may result in deviations that are intended to eliminate apparent immediate hazard to a research participant. The IRB recognizes that some deviations pose little to no threat to participant safety or scientific integrity. For example, when the subject misses a clinic visit and the only available re-schedule date is outside the study visit window, though no study procedures or medication doses are missed. In this case, the subject may not incur possible harm from a missed dose or missed procedures meant to maintain or evaluate the subject’s safety and welfare.  As such, reporting is left to the discretion of the investigator within the context of the IRB’s reporting policy.Though a deviation may not pose a conceivable threat or possible harm, it may represent possible continuing non-compliance if an amendment is not pursued with the IRB.  All deviations must be documented in the research record, regardless of whether they meet the IRB’s reporting criteria.
5. The IRB supports the use of home visits and phone calls for participant data collection and monitoring, so long as no procedures would be performed that are unsafe in this setting. Home visits and phone calls need to be conducted by a member of the study team that is approved in the IRB application. Your IRB application should be amended to include these methods if you choose to use them.
6. Do not store electronic research data on unsecure devices in order to work remotely. The IRB encourages the use of University-approved cloud services and VPN access while working at home instead of storing data directly on your devices. Do not take home physical research records or data (paper consent forms, case report forms, questionnaires/surveys, etc.).  All physical records must continue to be stored in IRB-approved, secure locations.