informed consent

Proposed Rule Will Supplant FDA Informed Consent Guidance When Finalized

The FDA is proposing a rule, as announced in the Federal Register (FR) (here), to provide for relaxing the provisions of informed consent under specific circumstances.  The history of the change is explained in the FR notice.  The FDA notes that the Cures Act has provided it with the statutory basis to support the proposed regulation, although it has been operating under the general provisions outlined in the proposed rule for some time now.

The FR notice states that “[S]ubsequent to the Cures Act amendment to the FD&C Act, FDA issued a guidance document for immediate implementation, entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects”.  This guidance informed sponsors, investigators, and IRBs that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations…. FDA intends to withdraw the guidance after regulations to implement section 3024 of the Cures Act become effective.”

The rule, when finalized, will track the same provisions outlined in the guidance, and will permit the IRB to approve informed consent that “does not include or alters some of the elements of informed consent” in the applicable regulations, or will permit it to waive informed consent requirements under the following four conditions:

  • the clinical investigation involves no more than minimal risk to the subjects;
  • the waiver or alteration of informed consent 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 of informed consent; and
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The Agency further notes that this proposed rule does not impact other such rules that relate to informed consent when a patient has a life-threatening condition and cannot give consent.  The rule provides further guidance on the waiver or revision provisions of informed consent and the duties and authority of IRBs, so read it carefully.  The FDA does not intend to take action if the IRB follows the above-cited guidance until the proposed rule is finalized.