Changes to Certificates of Confidentiality (CoC)

  • All Certificates of Confidentiality (CoC)s issued in the past or in the future, must comply with the new requirements of subsection 301(d) of the Public Health Service Act as amended, especially the new disclosure requirements and restrictions.
    • The new disclosure requirements prohibit disclosure of the name of research subjects or any identifiable research information, document, or biospecimen to anyone not connected with the research except under very specific circumstances including:
    • if required by other Federal, State, or local laws, such as for reporting of communicable diseases
    • if the subject consents;
    • Or for the purposes of scientific research that is compliant with human subjects regulations
  • For studies in which informed consent is sought, CDC expects investigators to inform research participants of the new protections and the limits to protections provided by a CoC. CoCs will now automatically cover any CDC-funded project collecting or using identifiable, sensitive information that was new or on-going as of December 13, 2016
    • The CoC will apply as a term and condition of award
    • There will be no physical certificate issued
  • Automatic coverage of a CoC means that institutions and investigators do not need to apply for a CoC. However, institutions and investigators are responsible for determining whether research they conduct is subject to subsection 301(d) of the Public Health Service Act.

Where can I learn more?

Have a CoC Question?

Contact the Privacy and Confidentiality Unit

Page last reviewed: November 20, 2018
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