Frequently Asked Questions

Does FDA prohibit direct communication between sponsors and IRBs?

No items found.
IRB: General

It is important that a formal line of communication be established between the clinical investigator and the IRB. Clinical investigators should report adverse events directly to the responsible IRB and should send progress reports directly to that IRB. However, FDA does not prohibit direct communication between the sponsor and the IRB and recognizes that doing so could result in more efficient resolution of some problems.

FDA does require direct communication between the sponsors and the IRBs for certain studies of medical devices and when the 21 CFR 50.24 informed consent waiver has been invoked. Sponsors and IRBs are required to communicate directly for medical device studies.