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Certificate of Confidentiality for CDC Funded Research

Section 301(d) of the Public Health Service (PHS) Act, as amended by Section 2012 of the 21st Century Cures Act, P.L. 114-255 (42 U.S.C. 241(d)), states that the Secretary shall issue Certificates of Confidentiality (Certificates) to persons engaged in biomedical, behavioral, clinical, or other research activities in which identifiable, sensitive information is collected. In furtherance of this provision, CDC supported research commenced or ongoing after December 13, 2016 and in which identifiable, sensitive information is collected, as defined by Section 301(d), is deemed issued a Certificate and therefore required to protect the privacy of individuals who are subjects of such research in accordance with Section 301(d) of the PHS Act.

Institutions and investigators are responsible for determining whether research they conduct is subject to subsection 301(d) of the PHS Act. Certificates issued in this manner will not be issued as a separate document, but will be issued by application of a term and condition to awards.

This applies to CDC funded:

  • Grants
  • Cooperative Agreements
  • Contracts
  • CDC’s own intramural research

See additional requirements regarding Certificates: https://www.cdc.gov/grants/additionalrequirements/ar-36.html

Have a CoC Question?

Please contact the Privacy and Confidentiality Unit at CDCCOC@cdc.gov

  • Page last reviewed: October 11, 2017
  • Page last updated: January 7, 2016
  • Content source:
    • Office of the Associate Director for Science
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