Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 8, Aug., 2022

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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.

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Excerpt from pg. 3 … IRBs and Assessment of Benefit-Risk Ratios (#7)

We continue this month with more advice for IRBs in the especially useful FDA guidance titled “Benefit-Risk Assessment for New Drug and Biological Products.”

Why do we say “especially useful?” For two reasons.

First, assessing benefits vs. risks is at the core of what IRBs do. The range of possible benefits/risks for human research subjects is as extensive as the number of different research disciplines themselves.

In other words, said range is immense. Hence, any such guidance will assist IRBs in the challenges of their day-to-day protocol reviews.

Second, this particular guidance emphasizes a relatively recent phenomenon in human subjects research; namely, relying more than in the past on reports from the subjects themselves.