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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
Update: FDA has now extended the comment period for this proposed rule to February 13, 2019.

FDA recently announced a proposal to add an exception to the agency’s informed consent requirements. Under the proposed rule, FDA will allow Institutional Review Boards (IRBs) to waive or alter informed consent for clinical trials that present only minimal risk to the subjects. This proposal is similar to the policy set forth in FDA’s guidance document on the same topic, which we have written on previously.

As observed by FDA, prior to the 21st Century Cures Act, the agency lacked the statutory authority to permit clinical investigation informed consent waivers except for emergency research or in life-threatening situations. The proposed rule would allow IRBs to waive or alter informed consent if they find and document that

  • the research 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 research could not practicably be carried out without the waivers or alterations; and
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

FDA’s proposed rule is generally consistent with the “Common Rule,” which governs the protection of human subjects involved in federally funded research. At this time, however, without explanation, FDA is not proposing to adopt an additional fifth factor that was added to the Common Rule and has a general compliance date of January 21, 2019. This fifth factor requires that, for research using identifiable private information or identifiable biospecimens, the IRB must determine that the research could not practicably be carried out using the information or specimens in an unidentifiable format. Even with this omission, FDA has stated that, since some clinical research is subject to both FDA’s human subject regulations and the Common Rule, it anticipates that alignment of a waiver exception under both frameworks will reduce confusion and the burden created by the need to comply with differing requirements.

Overall, FDA’s proposed rule is a positive step for medical research, as it codifies the agency’s nonbinding guidance on informed consent waivers and should facilitate the conduct of valuable research. However, as we have previously discussed, this rule does not provide researchers with carte blanc permission to conduct such research, as IRB’s must agree with the waiver or alteration. There may also be applicable state law requirements and, for existing data and biospecimens, researchers will need to consider whether prior subject informed consent restricts future uses of the data and specimens. FDA’s proposed regulations do not speak to these issues. FDA is seeking comments on its proposed rule by February 13, 2019.