Office of Research COVID-19: Guidance related to studies involving human subjects (Updated April 2, 2020) - Office of Research
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COVID-19: Guidance related to studies involving human subjects (Updated April 2, 2020)

COVID-19: Guidance related to studies involving human subjects


Updated April 2, 2020
Released March 18, 2020

Due to the rapidly evolving concerns and risks related to the COVID-19 outbreak, the UC Davis Institutional Review Board (IRB) Administration is recommending that study investigators take specific actions to limit transmission of the virus by delaying or otherwise modifying non-essential interactions. In particular, the IRB Administration recommends that research involving immunocompromised or elderly at-risk participants, or research that involves group meetings or appointments, consider delaying or using alternative interactions via electronic means if possible. These modifications may be implemented prior to IRB approval when it is necessary to eliminate apparent immediate hazards to the subject (§46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4)).

In this section

DHHS Secretarial Declaration

The Secretary of DHHS has limited the ability of persons receiving drugs, biologics, and devices to cure, mitigate, treat, prevent, or diagnose COVID-19 to recover damages from manufacturers, distributors, program planners, providers, and sponsors (among others) related to the provision or use of such drugs, biologics, or devices. UCOP is currently developing template language to be included in consent documents for research that meets these criteria. More information will be posted here as it becomes available.

The Secretarial Declaration can be found here: https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf

Obtaining and Documenting Consent and HIPAA Authorization for Research

Note: The following guidance regarding waivers/alterations to the consent and HIPAA authorization processes (including the use of DocuSign for FDA-regulated studies) is only in effect while the campus has determined that any in-person contact for non-essential functions should be limited. When in-person activities are allowed to resume, while adhering to physical distancing and PPE requirements, the below waivers and alterations are no longer in force.  Keep in mind that in-person activities may be resumed and then halted due to infection surges so researchers should work with their department chairs to determine which studies are appropriate to resume and ensure that there are contingency plans in place should research need to quickly be halted.

  • Enrollment into studies that require in-person contact should be limited to research that has the potential of direct benefit that is critical to participant safety and in their best interest.
  • If research does not have the potential of direct benefit that is critical to participant safety, all interactions with participants should be remote. In-person interactions should temporarily halt until social distancing is no longer required.
  • A complete informed consent process must be conducted for participant enrollment, unless previously waived by the IRB. Acceptable remote methods of consent include mailing, emailing, and faxing of consent documents and telephone or video contact with potential research subjects.
  • The IRB has determined that is impracticable to obtain in-person signatures on consent forms when study visits are remote. If research has the potential of direct benefit that is critical to participant safety and enrollment requires a signed consent form, the IRB waives the requirement for signed consent. When this occurs, researchers should document that oral consent has been obtained and should make every attempt to obtain a signed consent document upon the cessation of social distancing requirements. This waiver is only in effect for studies which provide direct benefit to subjects.
  • When accessing, using or disclosing PHI a signed HIPAA authorization form is required. Acceptable remote methods of obtaining authorization include mailing, emailing, and faxing of HIPAA authorization forms.
  • The IRB has determined that it is impracticable to obtain in-person signatures on HIPAA authorization forms when study visits are remote. If research has the potential of direct benefit that is critical to participant safety and enrollment requires a signed HIPAA authorization form, the IRB waives the requirement for HIPAA authorization for research. Unlike research consent, oral authorization for HIPAA is not allowed. Researchers should document that the requirement of HIPAA authorization has been waived by the IRB due to the COIVD-19 pandemic and should make every attempt to obtain a signed authorization upon the cessation of social distancing requirements. This waiver is only in effect for studies which provide direct benefit to subjects.
  • You must use HIPAA compliant practices when emailing or faxing documents which may contain PHI when paired with a signature (e.g. diagnoses).
  • For FDA regulated research, you must ensure all electronic records are Part 11 compliant.

Use of DocuSign to Obtain E-Signatures

DocuSign is now available for use to capture e-signatures on informed consent and HIPAA Authorization forms.

  • The UC Davis licensed version of DocuSign is compliant with all requirements of FERPA, HIPAA, HRP-090 and HRP-091.
  • The UC Davis licensed version of DocuSign has not been evaluated for 21 CFR Part 11 compliance. However, limited use of DocuSign for FDA-regulated studies is being allowed by UC Davis Health only if the research offers potential direct benefit to subjects, and with additional documentation requirements as directed below.

How to access to DocuSign

UC Davis Campus Researchers – Instructions and training resources are available  here: http://kb.ucdavis.edu/?id=1432

 UC Davis Health Researchers – Submit an access request to the Service Now portal for each research team member who will utilize (i.e. send, sign, create form, etc.) DocuSign.

  • Training resources will be provided to users in response to their service request.
  • If you are seeking to use DocuSign for consent/Authorization of a COVID-19 related study, please indicate this in the access request.

Guidance for all studies using DocuSign

Security – For security reasons, research subjects or their legally authorized representative (LAR) should not use publicly available devices for e-signing informed consents and HIPAA Authorization forms. The subject or LAR should utilize a privately-owned device to which they have regular access and use.

IRB Approval Not Required – At this time it is not necessary to submit a prospective modification to the IRB requesting to use DocuSign for obtaining signed consent and HIPAA authorization. If the study’s approved Initial Review Application and/or research protocol specifically state that consent will be obtained in-person, create a note to file in the study record and update the study documents at the next necessary modification.

Additional Guidance for studies subject to Part 11 (research involving drugs, biological, and devices regulated by FDA) using DocuSign

 

Limited Use – The use of the current UC Davis licensed version of DocuSign for FDA-regulated studies is only approved for use until further notice and may be subject to further FDA Guidance.

Documentation Requirements – In addition to existing documentation requirements, use of DocuSign for a FDA-regulated research study requires the following information be expressly noted in the research file:

  • Need – Document the need to obtain remote consent during the COVID-19 public health emergency.
  • Verification of Identity – When using DocuSign, research personnel must ensure there is a standard process to verify the identity of the individual who signs the documents. Document both verification of identity and the process. See more information here.
  • Informed Consent Conversation – Document that the informed consent conversation occurred, the method by which it occurred (e.g. telephone call, telehealth encounter), and the subject’s understanding of the information presented to them.
  • Verification of Signature – A participant/LAR will often e-sign the ICF and/or HIPAA Authorization during the informed consent conversation. When this occurs, it should be noted in the file.  In the event the documents are signed by the participant or LAR after the informed consent conversation ended, the researcher must conduct a follow-up conversation with the participant or LAR. After providing an opportunity to ask questions, verify and document the following:
    • Confirm that the individual who engaged in the informed consent conversation signed the DocuSign forms; and
    • Confirm that the consent and Authorization remain in effect.

Additional Considerations for FDA-regulated studies

  • Please discuss the use of DocuSign with your sponsor(s) of FDA-regulated studies prior to implementing use of DocuSign. The UC Davis licensed version of DocuSign has not been evaluated for 21 CFR Part 11 compliance. However, limited use of DocuSign for FDA-regulated studies is being allowed by UC Davis Health until further notice.
  • Prior to beginning the electronic consent process, researchers and their teams should review the joint FDA/OHRP guidance on using electronic consent in FDA-regulated research:  Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers.
  • Re-consent – When research activities are allowed to resume in person for FDA-regulated studies which have documented informed consent through DocuSign, subjects who have signed consent forms using DocuSign and continue to have in-person visits with the study staff must be re-consented using normal consent documentation methods. If a subject who had previously documented consent using DocuSign has since discontinued, completed the study, or does not require further in-person visits, they will not need to be re-consented.

Study Visits

There are many telework tools available to UC Davis researchers. Each research team should ensure they are appropriately safeguarding research participants’ privacy and the confidentiality of the research data. Options to consider for remote visits:

  • For research participants who also have MyChart, schedule a video visit.
  • Hold remote interviews or group meetings via Zoom or WebEx.
  • Transition questionnaires and surveys to an online format such as Qualtrics or RedCap.

Reporting Requirements

  • Changes necessary to eliminate apparent immediate hazards to research subjects (e.g., to limit exposure to COVID-19) may be implemented prior to IRB approval in accordance with §46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4).  Because these events are outside of the control of the research team, they are considered minor deviations. For research that is not FDA-regulated, there is no requirement to report these changes to the IRB, unless reporting is required by the sponsor.
  • The FDA has issued specific guidance for the conduct of clinical trials during the COVID-19 pandemic. To comply with the guidance, investigators conducting FDA-regulated research should record changes to the research related to the COVID-19 pandemic in the Project Event Summary Table and submit them to the IRB at continuing review.

Please do not delay or otherwise modify interventions that are in the subject’s best interest. Patients with any acute respiratory complaints should not be triaged by their research physicians but should seek initial care through their PCP. For more information or if you have questions please contact the IRB at [email protected]or (916) 703-9158.

Subscribe to the IRB-Info Listserv to receive updates from the UC Davis IRB Administration.

Resources for Researchers

Updated March 20, 2020: UCDMC Script for Research Related Visits During the Coronavirus Outbreak, March 17, 2020 version replaced with March 18, 2020 version. Removed text regarding telephone and video contact with research subjects for HIPAA Authorization. FDA Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Reporting Requirements section added.

Updated March 26, 2020: Use of DocuSign to Obtain E-Signatures section added.

Updated March 30, 2020: DHHS Secretarial Declaration section added, link to UCDH Guidance for Video for Clinical Research added.

Updated April 2, 2020: DHHS Secretarial Declaration section revised to state template language for consent documents is being developed by UCOP. 

 

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