V.
ADDITIONAL QUESTIONS ABOUT TRANSFERRING OVERSIGHT OF A
CLINICAL INVESTIGATION
Occasionally, during the course of its initial or continuing review of a transferred clinical
investigation or at other times during oversight transfer, an original or receiving IRB may have
44
21 CFR 56.108(a)(4). For drug/biologic studies, clinical investigators are responsible for securing IRB approval
under 21 CFR 312.66; for device studies, the sponsor is responsible under 21 CFR 812.35(a)(1) and (3).
45
21 CFR 56.110(b)(2).
46
See 21 CFR 56.103(a), 21 CFR 56.108(a)(4), and 21 CFR 56.110(b)(2). There is an exception to this general
requirement: changes necessary to eliminate apparent immediate hazards to human subjects may be initiated
without IRB review and approval, as described in 21 CFR 56.108(a)(4).
47
Ibid.
48
See 21 CFR 312.30, 21 CFR 312.31, 21 CFR 812.35, and 21 CFR 812.150(b)(5). For a discussion of the types of
changes in an IND study that require a new Form 1572, refer to Question 7 of FDA’s Guidance “Frequently Asked
Questions -- Statement of Investigator (Form FDA 1572),”available at
http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm214282.pdf
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