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The Food and Drug Administration (FDA) recently released updated guidance on conducting clinical trials of medical products during the COVID-19 pandemic. The new version of the guidelines includes a question-and-answer (Q&A) section that clarifies some emergency changes affecting human research protection policies and procedures.
“The first guidance that was issued by the FDA was giving folks a good deal of latitude in the changes they needed to make in response to COVID,” says James Riddle, MCSE, CIP, CPIA, CRQM, vice president of institutional services with Advarra in Columbia, MD. “This updated guidance provides more concrete examples of how FDA viewed flexibility.”
“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” updated July 2, is intended for industry, investigators, and IRBs. The Q&A section provides good examples of the flexibility the FDA had in mind with the original guidance, Riddle explains.
The updated guidance explains how to obtain informed consent when the researcher and participant cannot be together. It clarifies how to obtain informed consent from a quarantined hospital patient. It also provides information on how to handle situations where a prospective trial participant can receive an informed consent document electronically, but cannot sign it electronically or print it for signature.
“The FDA is not saying to not get consent, but they’re giving people flexibility on how to document informed consent,” Riddle explains.
For example, question 10 and its answer are as follows:
• “How do I obtain signed informed consent from a hospitalized patient who is in isolation when a COVID-19 infection control policy prevents us from entering the patient’s room to collect a signed informed consent form?”
• Answer: “FDA regulations generally require that the informed consent of a trial participant (in this case, a hospitalized patient) be documented by the use of a written consent document that typically includes the elements of informed consent, as described in 21 CFR 50.25, and that has been approved by the IRB and signed and dated by the trial participant or their legally authorized representative at the time of consent (21 CFR 50.27(a)). When feasible, we recommend a traditional method of obtaining and documenting informed consent using a signed paper copy of the consent form, or use of electronic informed consent. If neither of these approaches are possible, the following procedures would be considered to satisfy FDA’s informed consent documentation requirement.” (The guidance is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency?utm_campaign=Updated%20Q%26A%20COVID%20%207.6.2020&utm_medium=email&utm_source=Eloqua.)
“The updated guidance makes it very clear the FDA expects electronic consent to comply with regulations,” Riddle adds. “While I see FDA encouraging the use of electronic consent, I don’t see a relaxation of standards relative to e-consent.”
The revised guidance and Q&A do not change the FDA’s original guidance, but it provides more details.
“It says, ‘We understand this is hard, and we know you need to make changes and deviate from existing protocol, so go ahead in the interest of patient safety, but document what you did,’” Riddle says.
The underlying message is the FDA wants IRBs and sites to document everything. Include documentation of these changes in the research record with explanations about how the changes affect data integrity. “They’ll look for records of why changes were made for each individual patient or participant,” Riddle says. “The other underlying message I take away from the guidance is to remind people that the guidance is directed for during the pandemic.”
When the pandemic ends, it is likely the FDA’s flexibility also will end, Riddle says.
“FDA doesn’t come out and say that in the guidance, but there are quite a few spots where it indicates ‘during the pandemic’ and ‘in response to the pandemic,’ which suggests it will come to an end,” he adds. “You should document what you did, and keep in mind the guidance is designed for flexibility during the pandemic.”
For questions on clinical trial conduct during the COVID-19 pandemic, please email the FDA at: Clinicaltrialconduct-COVID19@fda.hhs.gov.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Reviewer Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, reports she is on the speakers bureau for AORN and Ethicon USA and is a consultant for Mobile Instrument Service and Repair.