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# Update Informed Consent Guidance: AdvaMed
- URL: https://www.fdaweb.com/update-informed-consent-guidance-advamed/
- Published: 2024-05-01T12:00:00.000Z
- Updated: 2026-09-14T14:29:45.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5156897

AdvaMed says FDA should update its draft guidance on key information and facilitating understanding in informed consent “to be clear about what levels of reimbursement, compensation, and recruitment incentives are problematic for medical device studies.” The association’s comment [letter](https://downloads.regulations.gov/FDA-2022-D-2997-0042/attachment%5F1.pdf?ref=fdaweb.com) also suggests that HHS modernize its human subject protection guidance, especially on payments to human subjects, and develop an Office of Inspector General safe harbor for financial assistance in clinical trials.