continue: The burden associated with 21 CFR § 50.25 (Elements of
Informed Consent) and 21 CFR § 50.27 (Documentation of Informed
Consent) is limited to the burden of development and approval by an
institutional review board (IRB) of a site-specific informed
consent document, and the documentation of informed consent. OMB
does not grant approval for the content of individual consent forms
that are reviewed and approved by IRBs and subsequently presented
to research participants.
Inventory as of this Action
36 Months From Approved
This information collection request
addresses limited collections of information not currently approved
under an OMB control number for institutional review boards (IRBs)
and clinical investigators involved with human subject research
regulated by the Food and Drug Administration (FDA). IRBs are
required to review for approval FDA-regulated research activities.
Clinical investigators are required to obtain informed consent from
research subjects participating in FDA-regulated clinical trials.
These limited collections of information help protect the rights,
safety, and welfare of human subjects who participate in research
actitivies within FDA's jurisdiction.
FDA estimates that the total
annual burden hours have decreased from 243,070 to 104,695, due
primarily to a reduction in the estimated number of respondents
because of more accurate information about the number of IRBs that
review research involving FDA-regulated products. Based on the
number of active IRBs in OHRP’s registration system that indicate
they review FDA-regulated research, the number of respondents has
been reduced from 6,000 to 2,520.