To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

Informed consent waivers in FDA-regulated research Developed by: U-MIC University of Michigan IRB Collaborative

Federal Food, Drug and Cosmetic (FD&C) Act Consent waivers in FDA-regulated research Federal Food, Drug and Cosmetic (FD&C) Act Formerly, FDA lacked statutory authority to permit consent waivers for minimal-risk clinical research in which obtaining consent was not practicable FD&C amendment (December 2016) provided FDA with authority to permit waivers of consent for minimal-risk research when specific criteria are met Developed by: U-MIC

FDA guidance—July 2017 Consent waivers in FDA-regulated research IRBs may now approve a consent procedure that omits/alters elements of consent listed at 21 CFR 50.25 waive the requirement to obtain consent when The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects; The waiver or alteration 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; and Whenever appropriate, the subjects will be provided with additional pertinent information after participation. criteria consistent with OHRP regulations FDA will revise its regulations to address waivers/alterations of consent. In the meantime, IRBs may grant waivers and alterations per guidance. Developed by: U-MIC

Before July 2017 Consent waivers in FDA-regulated research FDA permitted waivers/alterations of consent only in life-threatening situations for some emergency research for activities outside FDA’s definition of human subjects research e.g., recruitment for use of leftover specimens that are not individually identifiable Developed by: U-MIC

waivers of informed consent for minimal-risk research Consent waivers in FDA-regulated research waivers of informed consent for minimal-risk research facilitate research that may contribute to development of products to diagnose or treat diseases or conditions to address unmet medical needs more likely appropriate for research conducted in support of premarket submissions with human specimens collected for other purposes or obtained from specimen repositories rather than investigations with direct human interaction Developed by: U-MIC

Informed consent waivers in FDA-regulated research https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM566948.pdf Developed by: U-MIC

Thank you. Brian Seabolt IRBMED Developed by: U-MIC