May an IRB require that the sponsor of the study and/or the clinical investigator be identified on the studys consent document?
Yes. The FDA requirements for informed consent are the minimum basic elements of informed consent that must be presented to a research subject [21 CFR 50.25]. An IRB may require inclusion of any additional information which it considers important to a subject’s decision to participate in a research study [21 CFR 56.109(b)].
Related Questions
- The studys sponsor has sent me an Investigators Brochure (IB) that I need the IRB to acknowledge. What do I need to include when I send it to the IRB office?
- May an IRB require that the sponsor of the study and/or the clinical investigator be identified on the studys consent document?
- Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?
