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Note, CoCs for NIH-funded studies (i.e., deemed issued CoCs) are not affected.
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
Limitations on Issuance of CoCs for Non-NIH Funded Research
Research Programs
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.
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
Certain Participant Populations
As previously noted, issuance of a CoC for research that is not funded by NIH is at the discretion of NIH. NIH will not issue a discretionary CoC for non-NIH funded research when the research includes certain participant populations: sex offenders, child abusers, elder abusers, minor attracted persons, domestic/intimate partner abusers, and perpetrators of homicide. NIH limits issuance of CoCs for research involving these participant populations to NIH-funded studies, all of which must follow the terms and conditions of the award. NIH funded studies with these populations are deemed issued a CoC under the NIH Policy for Issuing Certificates of Confidentiality. The list above may be updated in the future at NIH discretion.
NIH will consider CoC requests for non-NIH funded research involving victims or family members of these populations that otherwise meet requirements.
Certain Research Topics
Issuance of CoCs to non-NIH funded studies is at NIH's discretion. NIH generally limits issuance of discretionary CoCs to research topics that are consistent with agency priorities.
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.
Note
Note
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.
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 (PDF).