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Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies

This guidance describes FDA's implementation of provisions related to Certificates of Confidentiality (CoC) for protecting privacy of human research subjects from whom identifiable, sensitive information is collected. It focuses on discretionary CoCs for non-federally funded research involving FDA-regulated products, explaining how to request them and the associated statutory responsibilities.

  1. Evaluate if your research requires a CoC by assessing:
    • If you collect identifiable, sensitive information
    • If you are a sponsor/sponsor-investigator
    • If research involves FDA-regulated products
    • If you have adequate confidentiality protection measures
  2. If CoC is needed:
    • Prepare request letter with required descriptive information
    • Include all necessary assurances regarding confidentiality protection
    • Submit electronically to appropriate FDA Center
  3. Implement processes to:
    • Protect identifiable information in perpetuity
    • Control information sharing with other entities
    • Handle permitted disclosures appropriately
    • Maintain documentation of CoC compliance
  4. Review and update privacy protection procedures to enhance confidentiality safeguards
  5. Train relevant staff on CoC requirements and responsibilities

Key Considerations

Cybersecurity

  • Must have sufficient research measures to protect confidentiality of identifiable, sensitive information
  • All copies of identifiable, sensitive information must be protected in perpetuity

Other considerations

  • 21 CFR §50.3: Protection of Human Subjects
  • 21 CFR §56.102: Institutional Review Boards
  • 42 U.S.C. §241(d): Public Health Service Act provisions on Certificates of Confidentiality

Original guidance

  • Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies
  • HTML / PDF
  • Issue date: 2020-11-13
  • Last changed date: 2024-10-01
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Good Clinical Practice (GCP), Dietary Supplements, Drugs, Animal & Veterinary, Biologics, Research, Cosmetics
  • ReguVirta summary file ID: 2b121db17b5cacef2633b6fc3c56f3a4
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