Back to: FDA CDER Overview: Certificates of Confidentiality
Presenter
Kelly M. K. Nolen, PhD
Senior Pharmacologist
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Kelly M. K. Nolen’s presentation details how to request Discretionary Certificates of Confidentiality (COCs) from FDA CDER for non-federally funded research involving FDA-regulated products. A COC is a document that prohibits researchers from disclosing identifiable sensitive information about human subject research participants in federal, state, or local legal proceedings, which serves to protect participant privacy. Unlike mandatory COCs automatically issued for federally funded studies, discretionary COCs are specifically requested for eligible research. FDA issues these for studies involving products subject to their jurisdiction. It is recommended that sponsors or sponsor investigators or their authorized representatives submit the requests. A requester must be involved in human subject research collecting identifiable sensitive information, be a sponsor/sponsor investigator or authorized representative, the research must involve an FDA-regulated product under FDA authority, and the requester’s measures must adequately protect confidentiality. Requests should include descriptive study information and specific assurances confirming compliance with statutory requirements. FDA CDER aims to review requests within 60 days. Upon issuance, the COC recipient must uphold the assurances to protect identifiable sensitive information. Certain exceptions to the disclosure prohibition exist, including disclosures required by law, for medical treatment with consent, or with the individual’s consent.