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Institutional Review Board

Human Research Protections (HRP)

 

FDA Clinical Trial Guidance Updated


Version July 30, 2020

 

The FDA has updated its Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. This information, along with other pertinent federal guidance is available on the Office of Research – Research Continuity webpage. The guidance also includes 24 questions and answers (containing nonbinding recommendations) to help researchers apply the guidance in real circumstances. 

 

The following may be of interest to our clinical researchers:

Question 10:

How do I obtain a 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?

Question 12:

How can informed consent be obtained and documented from a prospective trial participant (or legally authorized representative) when they cannot print and sign a paper copy of the consent form provided electronically by the investigator/designee, they cannot electronically sign the informed consent form, and providing a paper copy of the consent form via mail/courier is not feasible within the time frame for enrollment into the clinical trial?

Question 20:

We are instituting trial participant visits remotely through video conferencing. Are there recommendations regarding best practices?