Exemption Determinations
Occasionally investigators need a formal IRB determination that research
is exempt under 45 CFR 46.101(b) for the purpose of obtaining federal
funding, or for meeting the submission requirements of medical journals.
WIRB will provide formal exemption determinations for research under
45 CFR 46.101(b) for a fee. However, WIRB will not provide exemption
determinations from the FDA regulations (21 CFR Parts 50, 56, 312 and 812)
as the definitions of "clinical investigation" and "marketing application"
are difficult to interpret, and because the FDA exemptions involve the
sponsor's intent as to whether or not to submit data to FDA, which WIRB
cannot independently determine.
WIRB recommends use of its "Request for Exemption Determination" form available
on the download forms page.
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