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
- Limitations on Issuance of CoCs for Non-NIH Funded Research
- Research Funded by Non-NIH HHS-Agencies and Other Federal Departments and Agencies
- Non-Federally Funded and Unfunded Research
- Request a Certificates of Confidentiality
- NIH Announcement: Automatic Certificate Extension Related to the COVID-19 Public Health Emergency
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:
- Collecting or using identifiable, sensitive information,
- On a topic that is within the NIH mission or HHS health-related research mission, and
- Research information that is collected, used, or stored in the US.
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
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.
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.
- 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.
Please direct CoC questions to the NIH Office of Extramural Research: NIH-CoC-Coordinator@mail.nih.gov