CoCs for Research Not Funded by NIH

Scope Note

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.

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.
  • Will be conducted in accordance with 45 CFR 46 and relevant subparts, and all applicable federal, state, and local laws and regulations.

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
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 will issue a Certificate of Confidentiality only to single discrete individual studies*. CoC requests for research not funded by NIH are issued at the discretion of NIH and will not be issued for a research program (i.e., research that involves multiple projects, studies or protocols.)

NIH considers a CoC request to describe a research program when it includes activities involving more than one research project, protocol, study, or other multifaceted projects, including those with plans for future studies. Examples of a CoC request for which NIH would consider the description to be a research program include, but are not limited to:

  • a parent study with an individual sub-study or ancillary study;
  • the establishment and maintenance of a data or biospecimen repository and plans to conduct a study with those data and biospecimens.

Separate CoC requests for the individual studies within a research program may be submitted to NIH for consideration (e.g., a parent study; each of the individual sub -studies and ancillary studies; and each study that uses data or biospecimens from the repository). As noted above, CoC requests that include a research program will not be approved.

Note
For research not funded by NIH, CoC requests to cover the establishment and maintenance of a research repository will be considered if the request does not include the studies that will use the data and specimens in the repository. NIH will separately consider a request for a discretionary CoC for an individual research study that will use data or biospecimens from a repository. Requests for CoCs to cover individual studies utilizing the data and specimens in a repository must be submitted individually and will be considered on a study-by-study basis.

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 non-NIH funded research studies 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

Tip
*The regulations at Title 42 CFR Part 2a.6 limit issuance of Certificates of Confidentiality to single projects. See CoC FAQ G3 for further information.

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.

Note
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.

Note
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.

Note
*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.

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 at Requesting a Certificate of Confidentiality for Non-NIH Funded Research. page.

Request a Certificate 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.

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This page last updated on: August 13, 2024
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