Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 36, No. 9, September, 2021
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.
Excerpt from pg. 3 … IRBs, COVID, and Experiments With Drugs and Biologics (#2)
“As we introduced in last month’s HRR, a new FDA guidance on the ongoing COVID-19 pandemic contains useful information for researchers and IRBs. With emphases on trial design and resultant human subject safety, the new guidance is titled “COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.”
“The guidance primarily focuses on the design, conduct, and statistical considerations of master protocols intended to generate or contribute to substantial evidence of effectiveness and adequate characterization of safety of drugs for the treatment or prevention of COVID-19.
However, the principles in the guidance may also apply to master protocols generating proof of concept or dose-ranging data for drugs to treat or prevent COVID-19” (guidance, May, 2021, p. 3; on the Web at https://www.fda.gov/media/148739/download).“