(6) Determining whether the consent form needs to be revised.
The informed consent document is required to contain “[a]n explanation of whom to contact for
answers to pertinent questions about the research and research subjects’ rights, and whom to
contact in the event of a research-related injury to the subject.”
35
Therefore, when a change in
IRB oversight results in changes in the contact information regarding subject rights and/or whom
to contact in the event of research-related injury, the new contact information must be provided
32
Ibid.
33
For further information about reporting of suspensions or terminations of IRB approval, refer to FDA’s guidance
on “IRB Continuing Review after Clinical Investigation Approval,” available at:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf
.
34
We note that, the device regulations place this responsibility on investigators. However, IRBs may nonetheless
also choose to inform sponsors of a termination or suspension and the reasons for doing so. 21 CFR 812.150(a)(2).
35
21 CFR 50.25(a)(7).
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