FDA Proposed Rule – Alteration of Informed Consent for Minimal Risk Clinical Investigations

PUBLISHED: Nov 13, 2018
Relevant to: Critical Access Hospitals, Hospitals

The U.S. Food and Drug Administration (FDA) is proposing to amend its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants.

The proposed rule, if finalized, would allow the Institutional Review Board (IRB) responsible for the review and approval of the research to waive or alter certain elements of informed consent, or to waive the requirement to obtain informed consent entirely, under limited conditions. 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. According to the FDA, the Common Rule provision has provided appropriate safeguards to protect the rights, safety and welfare of individuals participating in certain minimal risk research for more than 25 years.

The FDA seeking comment on this proposed rule. The agency is also seeking input on the types of minimal risk clinical investigations for which sponsors, or investigators would anticipate requesting a waiver or alteration of informed consent from the IRB.

Follow the link below to review the proposed rule in its entirety and for comment submission instruction.

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