Question

If a sponsor is notified by a IRB that research investigation intended to be conducted under the waived consent emergency research regulations cannot be approved, whom must the sponsor notify of this decision?

Answer 1

When an IRB disapproves research under waived consent regulations, the sponsor must notify the research team and potential participants, as well as relevant regulatory bodies and funding agencies.

Step-by-step explanation:

If a sponsor is notified by an Institutional Review Board (IRB) that the research investigation intended to be conducted under the waved consent emergency research regulations cannot be approved, the sponsor must then notify the research team and potential participants, if any have been contacted. Additionally, any regulatory bodies or funding agencies associated with the research may also need to be informed of the IRB's decision. It is critical that all parties involved are made aware of the disapproval as continued research without IRB approval would violate ethical and legal guidelines regarding human subject research.