On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations that pose, at most, a minimal risk to human subject participants. The rule implements a provision of the 21st Century Cures Act, enacted in 2016, which allows the FDA to promulgate regulations that simplify and assist the public in complying with regulations governing clinical trials.
If finalized, the Proposed Rule allows an Institutional Review Board (IRB) to waive or alter informed consent requirements for FDA-regulated studies if the IRB determines and documents that:
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the research poses no more than minimal risk to the subjects;
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the waiver or alteration will not adversely affect the rights and welfare of the subjects;
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the research could not practicably be carried out without the waiver or alteration; and
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whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Comments on the proposed rule are due by January 14, 2019. The FDA is also seeking input on the types of minimal risk investigations for which sponsors or investigators would anticipate requesting a waiver or alteration of informed consent from the IRB.
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