FDA Proposes Changes to Informed Consent Rules

Regulatory NewsRegulatory News | 13 November 2018 |  By 

The US Food and Drug Administration (FDA) on Tuesday proposed changes that would allow institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.
Under current FDA regulations, exceptions for obtaining informed consent can only be made in life-threatening situations or when conditions for emergency research are met. Outside those situations, FDA regulations require that subjects provide informed consent before they can participate in a clinical trial.
However, in Section 3024 of the 21st Century Cures Act, Congress expanded the exception to obtaining informed consent when there is minimal risk to participants to FDA-regulated studies.
In 2017, FDA issued guidance stating it would not object to IRBs waiving or altering informed consent in line with Cures. FDA now says it plans to withdraw that guidance if the newly proposed rule becomes final.
FDA is also seeking comment on the types of studies that would meet the criteria for minimal risk that investigators would request a waiver or alteration of informed consent from the IRB.
“To waive or alter informed consent under the proposal, the IRB would need to make findings that have been included in a Common Rule waiver provision for minimal risk research for decades,” FDA says, referring to provisions for waiver of informed consent for minimal risk research conducted or supported by other federal departments and agencies dating back to 1991.
Once final, FDA says the new rule will harmonize informed consent requirements for studies subject to its and the Department of Health and Human Services’ regulations.
In order to waive or alter informed consent requirements under the proposed rule, IRBs will need to determine and document the same four criteria as they would need to in order to waive or alter informed consent under the Common Rule:
  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waivers or alterations; and
  4. Whenever appropriate, the subjects will be provided with additional patient information after participation.
But FDA says it is not adding the fifth requirement that was added to the revised Common Rule set to take effect in January 2019 that allows a waiver or alteration of informed consent for research involving identifiable private information or identifiable biospecimens if the research “could not practicably be carried out without” without using identifiable information.
FDA, Federal Register Notice


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