• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Sets New Certificate of Confidentiality Application Process for Nonfederal Trials

FDA Sets New Certificate of Confidentiality Application Process for Nonfederal Trials

November 23, 2020

Sponsors of nonfederally funded clinical trials can request a certificate of confidentiality (CoC) that protects them from being compelled to disclose participants’ private information, according to a final FDA guidance released last week.

A CoC specifically prohibits an investigator or sponsor from releasing a participant’s identifiable, sensitive information — including biospecimens — to anyone not connected to the trial so that they cannot be compelled to disclose the information in any kind of legal proceeding or litigation.

However, it does not protect investigators or sponsors from any federal, state or local laws already on the books that require disclosure. The CoC also does not apply to information that is necessary for a participant’s medical treatment, released with the consent of the participant or used for the purposes of other scientific research conducted under federal human research subject protections.

While federally funded trials are required to have a CoC, trials not sponsored by a federal agency are not, but they may apply for one if they are conducting research regulated by the FDA, says the guidance.

Other entities involved in a trial, such as CROs or academic institutions, are also bound by CoCs, but the FDA recommends that only sponsors or sponsor-investigators submit requests for them to avoid duplicate requests.

The final guidance includes the same provisions as the draft released in November 2019 with the exception of two points suggested in public comments on the draft: clarification of the definition of “identifiable, sensitive information” and an additional paragraph noting that it is within a trial’s IRB authority to require a CoC as a condition of approval.

Read the final guidance at https://bit.ly/3pMzqLX.

Upcoming Events

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • Resources-360x240.png

    Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

  • FocusinRed-360x240.png

    Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

  • VaccinewithNeedle-360x240.png

    2021 Vaccine Industry Will Continue to be Dominated by COVID-19 Trials, Experts Say

  • Dominate-360x240.png

    COVID-19, Oncology, CNS and Infectious Disease Trials Will Dominate in 2021, Survey Predicts

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing