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NIH Policy on Certificates of Confidentiality Background Information

This page provides background information on NIH issued Certificates of Confidentiality.

On this page:

Synopsis of 2017 NIH Policy Changes

Effective October 1, 2017, NIH updated its Policy for issuing Certificates of Confidentiality (Certificates or CoCs) for NIH-funded and conducted research. This update implemented Section 2012 of the 21st Century Cures Act, P.L. 114-255, which states that the Secretary, HHS shall issue Certificates of Confidentiality to persons engaged in biomedical, behavioral, clinical or other research, in which identifiable, sensitive information is collected.  These Certificates protect the privacy of participants by limiting the disclosure of identifiable, sensitive information.

21st Century Cures Act

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, established new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.  Specifically, the amended authority requires the Secretary to issue to investigators or institutions engaged in biomedical, behavioral, clinical, or other research in which identifiable, sensitive information is collected, a Certificate to protect the privacy of individuals who are subjects of such research, if the research is funded wholly or in part by the Federal Government. The authority also specifies the prohibitions on disclosure of the names of participants or any information, documents, or biospecimens that contain identifiable, sensitive information collected or used in research by an investigator or institution with a Certificate. 
If the research is not federally funded, the Secretary may issue a Certificate to an investigator or institution engaged in such research, upon application.

NIH Transition to New CoC System

In March 2020, NIH retired its former CoC system and onboarded a new CoC system. View the NIH Notice of Transition to New CoC System for Non-NIH Funded Research, NOT-OD-20-075.  (February 28, 2020)