FDA In Brief: FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations

November 13, 2018

Media Inquiries

“Obtaining informed consent from those who volunteer to participate in research is a fundamentally important principle of human subject protection. The quality and integrity of clinical research is something the agency takes very seriously and the protection of research individuals is paramount. Over the years, we’ve received feedback from sponsors and investigators that they were not able to move forward in conducting important clinical investigations where there would be minimal risk as these trials involved situations where obtaining informed consent wasn’t possible, and the agency lacked the authority to permit a waiver of informed consent for that research. With the passage of the 21st Century Cures Act, the FDA’s authorities were changed, allowing greater flexibility. That’s why today, we’re proposing a change to our informed consent regulations in a way that maintains safeguards to protect study participants, while allowing important research to proceed where there is minimal risk to patients,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

Today, the U.S. Food and Drug Administration 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. 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 intends to withdraw its related 2017 guidance if this proposed rule becomes final. 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.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.