FDA believes that there should be some flexibility in how
sponsors or applicants comply with 21 CFR 312.120(b)(9). The sponsor
or applicant may follow ICH E6 or ICH E3, providing a sample or model
informed consent form that describes any incentives provided (section
4.8.10 of ICH E6 and appendix 16.1.3 of ICH E3), to satisfy 21 CFR
312.120(b)(9). Alternatively, a sponsor or applicant may satisfy this
requirement by submitting a brief narrative description of any incentives
provided to subjects who participate in the study.
