Back to: FDA CDER Overview: Certificates of Confidentiality
Presenter
Irene Rwakazina, PharmD, CCRP
Consumer Safety Officer
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Irene Rwakazina presents on Certificates of Confidentiality (COCs), documents issued by US federal agencies like the FDA to researchers engaged in biomedical, behavioral, clinical, or other research collecting identifiable sensitive information. The primary purpose of a COC is to protect the privacy of research participants by prohibiting the COC holder and anyone connected with the research from disclosing names or any information containing identifiable sensitive information to anyone not connected with the research. These protections are conferred by the PHS Act and the Cures Act, making the information immune from legal process and inadmissible as evidence in legal proceedings. Identifiable sensitive information is defined broadly to include any information about an individual collected in research that could be used for identification. While COCs offer strong protection, certain exceptions to disclosure exist, such as disclosures required by federal, state, or local laws, those necessary for medical treatment with consent, disclosures made with the individual’s consent, or for other compliant scientific research. COCs fall into two categories: mandatory, automatically issued for federally funded research, and discretionary, which may be requested for non-federally funded FDA-regulated research; both types offer identical legal protections. FDA has streamlined the process for requesting discretionary COCs.