The US Food and Drug Administration (FDA) on Monday, July 24 issued guidance detailing the circumstances to which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants, according to RAPS.
The guidance was released without public consultation and will therefore consider comments on the final version and revise the guidance as necessary.
“Over the years, FDA has received numerous inquiries from sponsors and investigators about conducting important minimal risk clinical inv
estigations for which obtaining informed consent was not practicable,”1 FDA says, also saying that many proposed studies not proceed because FDA could
not waive informed consent requirements.
Under the 2st Century Cures Act passed by Congress last year, FDA was granted the authority to waive or alter informed consent requirements for clinical studies that pose no more than minimal risk to subjects.
According to FDA, it is considered minimal risk when “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance or routine physical or psychological examinations or tests.”1
Before the Cures Act, exceptions from informed consent requirements were limited to life threatening situations or emergencies. In the guidance, FDA plans to revise its regulations on informed consent. Until then, the agency does not plan to object to IRBs approving consent procedures that do not include, or that alter, “some or all of the elements of informed consent.”1
According to RAPS, FDA “does not intent to object to an IRB waiving the requirements to obtain informed consent when the IRB finds:
- The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or102(i)) to the subjects;
- The waiver or alternation will not adversely affect the rights and welfare of the subjects;
- The clinical investigation could not practicably be carried out without the waiver or alternation; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.”1
In the future, FDA plans to withdraw the guidance once it promulgates regulations that allow for such waivers and alterations.
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