While the guidance was released without a public consultation on a draft version, FDA says it will 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 investigations for which obtaining informed consent was not practicable," FDA writes, adding that many of these proposed studies did not proceed because FDA lacked the authority to waive informed consent requirements.
But, under the 21st Century Cures Act passed by Congress last year, FDA gained that authority for clinical studies that pose no more than minimal risk to the subjects, similar to existing provisions under the Common Rule.
FDA says it considers risk to be minimal 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."
Prior to the Cures act, FDA regulations only allowed for exceptions from informed consent requirements in life-threatening situations or for emergency research.
In the guidance, FDA says it plans to revise its regulations on informed consent to allow for waivers or alterations for minimal risk clinical investigations.
Until then, the agency says it does not plan to object to institutional review boards (IRBs) approving consent procedures that do not include, or that alter, "some or all of the elements of informed consent."
Additionally, FDA says it does not intend to object to an IRB waiving the requirement 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) or 56.102(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.
Going forward, FDA says it will withdraw the guidance once it promulgates regulations that allow for such waivers or alterations.