New FDA Guidance Effective Immediately

New FDA Guidance Effective Immediately

On July 24, 2017, the FDA announced that, effectively immediately, it will now permit IRBs to waive or alter informed consent for minimal risk*  clinical investigations, so long as the IRB determines and documents that the following criteria are satisfied:
● The clinical investigation involves no more than minimal risk* to the subjects;
● The waiver or alteration will not adversely affect the rights and welfare of the subjects;
● The clinical investigation could not practicably be carried out without the waiver or alteration; and
● Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

As these criteria are identical to the consent waiver criteria in the Common Rule (which doesn’t cover FDA) this is an important step in harmonization across federal agencies. Affected applications are expected to include certain registries, observational
studies, and studies using existing data and specimens.

The guidance can be accessed here.

* Minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in theresearch are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological
examinations or tests.”

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