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CoCs for Research Not Funded by NIH

Eligibility for an NIH-issued CoC may depend on the type of funding that is supporting the research. Issuance of a CoC for research that is not funded by NIH is at the discretion of NIH. Note there are no costs or fees to request or be issued a discretionary CoC from NIH.

On this page:

Considerations for Issuing CoCs for Non-NIH Funded Research

The NIH will consider requests for Certificates of Confidentiality for specific research projects that are not funded by NIH. These considerations include if the research project is: 

42 U.S. Code §241(d) defines identifiable, sensitive information as information that is about an individual and that is gathered or used during the course of research where the following may occur:

  • Through which an individual is identified; or
  • For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identify of an individual.

Research in which identifiable, sensitive information is collected or used includes research that: 

  • Meets the definition of human subjects’ research, including exempt research in which participants can be identified; 
  • Is collecting or using human biospecimens that are identifiable or that have even a small risk of being identifiable; 
  • Involves the generation or use of individual level human genomic data; or
  • Involves any other information that might identify a person 
Note that the law focuses on the identifiability of the information, and not on the sensitivity of the information.

Limitations on Issuance of CoCs for Non-NIH Funded Research

For research not funded by NIH, NIH limits issuance of a Certificate of Confidentiality to single projects or individual studies. CoC requests for research not funded by NIH that involve multiple projects, studies or protocols, or that include a research program will not be approved. NOTE:  For research not funded by NIH, CoC requests for the establishment and maintenance of a data or biospecimen repository that include plans to conduct studies and projects with those data and/or biospecimens are considered research programs and will not be approved.  NIH will consider CoC requests for research not funded by NIH for an individual study that will use data or biospecimens from a repository. 

NIH also limits to NIH-funded studies—which are bound by the terms and conditions of their award—issuance of a Certificate of Confidentiality for the establishment and maintenance of research repositories where the main source of the data and/or biospecimens was originally obtained for clinical care or other purposes, rather than research purposes. CoC requests for research not funded by NIH (e.g., discretionary CoCs) for repositories where the main source of the data and/or biospecimens was originally obtained for clinical care or other purposes will not be approved. 
For information about protections for NIH-funded research, see our CoCs for NIH-funded Research page.

Research Funded by Non-NIH, HHS-Agencies and Other Federal Departments and Agencies

Several non-NIH, HHS agencies issue Certificates of Confidentiality (CoCs), including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), and Substance Abuse and Mental Health Services Administration (SAMHSA).

Investigators whose research is funded by BARDA*, CDC, HRSA, IHS, or SAMHSA should contact the Certificate Coordinators at their funding agency to determine how to obtain a CoC. Investigators whose research is operating under an IND or IDE and is under the authority of the FDA should contact the FDA Certificate Coordinators at the relevant Center. See a list of non-NIH HHS Agencies CoC Coordinators and Contact information.

Investigators whose research is funded by an HHS agency, other than NIH, BARDA, CDC, FDA, HRSA, IHS, or SAMHSA, or a non-HHS Federal Department or Agency may request a Certificate of Confidentiality for specific research projects that collect or use identifiable, sensitive information through the online NIH CoC system.

Notes:

  • The Agency for Healthcare Research & Quality (AHRQ) has its own privacy regulations which may apply; NIH will not issue a CoC for projects covered by AHRQ’s regulations. Contact AHRQ for further information about their privacy regulations.
  • The Department of Justice (DoJ) has its own confidentiality and privacy regulations for DoJ-funded research. NIH will not issue a CoC for DoJ-funded projects. Contact the DoJ for additional information about their confidentiality and privacy regulations.
  • *Investigators whose research is funded or sponsored by BARDA through an award that was issued prior to July 17, 2023, may continue to request a CoC for specific research projects that collect or use identifiable, sensitive information through the online NIH CoC system.

For more information, see these related CoC FAQs.

Non-Federally Funded or Unfunded Research

Investigators conducting research that is not federally funded in which identifiable, sensitive information is collected or used, may request a Certificate of Confidentiality (CoC) from NIH. Learn how on our Requesting A Certificate of Confidentiality page. 

For more information, see these related CoC FAQs.

Request a Certificates of Confidentiality

All CoC requests are processed through our online CoC system.

Get Started: Request a Certificate of Confidentiality
 

NIH Announcement: Automatic Certificate Extension Related to the COVID-19 Public Health Emergency

In April 2020 and in response to research delays associated with the COVID-19 Public Health Emergency, NIH automatically extended the Certificate expiration date for non-NIH funded studies with NIH-issued Certificates current on April 15, 2020 by twelve months. View the NIH announcement for extending the expiration date of NIH-issued CoCs for non-NIH funded projects .

For more information, see this CoC FAQ.

CoC Questions 

Please direct CoC questions to the NIH Office of Extramural Research: NIH-CoC-Coordinator@mail.nih.gov 

 

This page last updated on: January 24, 2023

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