FDA to Modify Informed Consent Rules, Seeks Feedback

November 16, 2018

On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations, informed consent must be provided by subjects before participating in a trial. The only exceptions under current FDA regulation is if the subject is in a life threatening situation or if the situation requires emergency research. If finalized, the proposed rule would allow the Institutional Review Board (IRB) to waive these requirements under limited conditions for certain minimal risk clinical investigations.

Modifications to Informed Consent Rules & the Role of the 21st Century Cures Act

The intention of the proposed rule is to become a statutory change to the 21st Century Cures Act (Cures Act). The Cures Act, which was signed into law on December 13, 2016, amended certain provisions of the FD&C Act and increased FDA’s authority in a number of areas. As such, sections 520(g)(3) and 505(i)(4) of the FD&C Act as amended by section 3024 of the Cures Act provides FDA with the authority to allow such exceptions from informed consent requirements.

For the IRB to approve a waiver or alteration of informed consent, “the proposed rule would require an IRB to find and document four criteria that are consistent with the ‘Federal Policy for the Protection of Human Subjects’ (the Common Rule) (56 FR 28001, June 18, 1991).” The following are the four criteria:

  1. The clinical investigation involves no more than minimal risk to the subjects
  2. The waiver or alteration of informed consent will not adversely affect the rights and welfare of the subjects
  3. The clinical investigation could not practicably be carried out without the waiver or alteration of informed consent
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation

For over 25 years, the Common Rule provision has protected individuals who participate in minimal risk research. In July 2017, the Common Rule was revised with new terminology and regulatory provisions. The revision also added a fifth criterion regarding the identification of private information or identifiable biospecimens. However, the FDA is proposing to only adopt the original four criteria as included in the 1991 version.

Benefits of the Proposed Changes

The Common Rule was implemented to create a uniform body of regulations across the Federal department and agencies, and to promote uniformity, understanding, and compliance with human subject protections. The proposed amendment would streamline healthcare advances from minimal risk clinical investigations by reducing the burden to comply with different requirements.

In a recent statement from the FDA, Scott Gottlieb, MD, Commissioner of the FDA stated that “this change would facilitate the conduct of certain minimal risk clinical investigations that may be important to addressing significant public health needs without compromising the rights, safety, or welfare of human subjects.”

If the proposed rule is finalized, FDA’s 2017 guidance document, entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects,” stating that there would be no objection to IRBs waiving informed consent, will be withdrawn. FDA is requesting questions, concerns, and comments regarding the type of studies that would meet the criteria for minimal risk. These comments can be submitted in written or electronic format and must be received by January 14, 2019.

For more information regarding FDA’s proposed modifications to its regulations for informed consent for minimal risk clinical investigations, view the Agency’s full proposed rule.

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