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2. Informed consent waivers in FDA-regulated research
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University of Michigan IRB Collaborative

3. 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
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4. 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 (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.
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5. 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
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6. 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
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U-MIC

7. Informed consent waivers in FDA-regulated research
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U-MIC

8. Thank you. Brian Seabolt IRBMED
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U-MIC