Vol. 38, No. 11, November, 2023

Back Issues

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.

Click to Subscribe

Excerpt from pg. 3 … IRBs Have New Consent Procedures to Review (#2)

As we introduced in last month’s lead article, the FDA has issued an extensive new guidance for IRBs and others on informed consent. Titled “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors,” the final guidance adds new advice for the research compliance community.

In addition to the section on human subject “coercion and undue influence” that we presented before, we now focus on FDA’s guidance for IRB reviews of possible financial relationships and related factors.

The clinical investigator should consider whether information related to financial relationships or interests should be provided to subjects.

Clinical investigators should consider the potential effects that a financial relationship might have on the clinical investigation or on interactions with subjects“…