Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 37, No. 7, July, 2022
Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.
IRBs and FDA’s Advice on How To Cope with COVID-19 (#12)
We continue this month with more advice for IRBs and researchers from the FDA regarding clinical trial changes due to COVID.
These recommendations continue to be issued by FDA. We are presenting them in the chronological order established by the agency.
We resume our coverage where FDA advises us how to obtain informed consent from hospitalized patients when COVID infection keeps the researchers from entering the patient’s room to collect the usual signed consent form.
In such cases, FDA describes two methods for obtaining said signed consents, as follows:
“Method 1: A photograph of the signed informed consent document can be transmitted to the trial staff
1. An unsigned consent form is provided to the patient by a person who has entered the room (“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency — Guidance for Industry, Investigators, and Institutional Review Boards,”…