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  1. Home
  2. Policy & Compliance
  3. Human Subjects
  4. Certificates of Confidentiality
  5. Requesting a Certificate of Confidentiality For Non-NIH Funded Research

Requesting a Certificate of Confidentiality for non-NIH Funded Research

Investigators conducting non-NIH funded research can apply for a CoC through the NIH online CoC system. 

On this page:

Who Should Request a CoC?

Federally Funded Research- Is Your Funding Agency Listed Here?

Per the NIH CoC Policy, NIH recipients do NOT need to separately request a Certificate of Confidentiality for NIH-funded research.

Investigators whose research is funded by the Biomedical Advanced Research and Development Authority (BARDA ), Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), and Substance Abuse and Mental Health Services Administration (SAMHSA), or is under the authority of the Food and Drug Administration (FDA) should contact the CoC Coordinator at their funding agency for questions on how to obtain a CoC. Refer to our list of CoC Coordinator Contact Information

Note: NIH will not issue a CoC for Agency for Healthcare Research & Quality- (AHRQ Link to Non-U.S. Government Site - Click for Disclaimer) or Department of Justice- (DoJ Link to Non-U.S. Government Site - Click for Disclaimer) funded research.  Contact AHRQ and DoJ respectively, to obtain information about their privacy regulations.

Learn more about CoCs and select privacy regulations for non-NIH federally funded research.

Other Federally Funded Research or non-Federally Funded Research

Investigators whose research is not NIH-funded and is not funded by the above-listed agencies/departments should use the online NIH Certificate of Confidentiality System to request a CoC. 

To Request Non-NIH Funded CoCs

Access the online NIH Certificate of Confidentiality System to request new Certificates of Confidentiality (CoC).

NIH suggests that you review the Considerations for Issuing CoCs for Non-NIH Funded Research and the Limitations on Issuance of CoCs for Non-NIH Funded Research before you submit your CoC request.

Access NIH Certificate of Confidentiality System Link to Non-U.S. Government Site - Click for Disclaimer


The following information needs to be provided when requesting a CoC:

  1. Project details, including research title, start date, projected end date, and description.
  2. Institution and performance site (if applicable) details, including institution and performance site(s) names and addresses, and institutional official* name, email address, and phone number.
  3. Principal Investigator name, phone number, email address, degree, position.
  4. Key personnel names, degrees, and positions.
  5. Name(s) of drugs that will be administered, route of administration, and dosage.
  6. If applicable, a copy of the DEA certificate(s)/registration for studies in which a controlled substance will be administered.
     

*The authorized institutional official (IO) is the individual named by the requesting institution who is authorized to act for that institution and assumes on behalf of the institution the obligations imposed by the Certificate of Confidentiality as well as obligations imposed by Federal laws, regulations, and other requirements. In general, the institutional official is not the investigator or member of the research team. 
The institutional official has important responsibilities. The IO needs to have signature or other authority to assure that the institution will support and defend the authority of the Certificate against legal challenges. Please confirm that the appropriate person is named as the institutional official.

Note: The CoC system sends an auto-generated email to the institutional official listed on the CoC request with a hyperlink to the CoC request. The institutional official needs to review the CoC request information for accuracy and affirm the online Institutional Assurance Statement by checking each box and then submitting the CoC request. 
 
For information on requesting a CoC, see the CoC Online Help Link to Non-U.S. Government Site - Click for Disclaimer or the CoC User Guide Link to Non-U.S. Government Site - Click for Disclaimer (PDF).   

For technical difficulties with the CoC system, please contact the eRA Service Desk Link to Non-U.S. Government Site - Click for Disclaimer. See also our list of compatible browser versions Link to Non-U.S. Government Site - Click for Disclaimer.

For process or policy-related questions, contact the NIH CoC Coordinator 

Expiring Certificates

CoC protections remain in perpetuity for already collected or used information. A new CoC will need to be obtained to cover any new data collected from already enrolled participants or any new participants if the non-NIH funded research activity will extend beyond the expiration date on the Certificate or if data collection will continue after NIH funding ends. The investigator can submit a request for a new CoC through the Online CoC System Link to Non-U.S. Government Site - Click for Disclaimer. Note: NIH-issued CoCs for non-NIH funded research activities issued on or after January 12, 2021 do not have an expiration date.

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 Certificates current on April 15, 2020 by twelve months. View the NIH Notice for extending the expiration date of NIH-issued CoCs for non-NIH funded projects (PDF).

If the study has completed all enrollment and data collection, there is no need to request a new Certificate. Sensitive, identifiable research information that is collected or used when the Certificate is in effect, is permanently protected.

Significant Changes to Research

If there is a SIGNIFICANT change in a non-NIH funded research project after the Certificate has been issued, the investigator will need to request a new Certificate through the NIH online CoC system. Significant changes include a change in the primary institution where research will be conducted, a major change in the scope or direction of the research study, changes in the drugs that will be administered, and a change in the Principal Investigator.  For the purpose of the Certificate, minor changes, such as the addition of a new survey instrument or clinical test or adding a participating research site to a multisite study, are not considered a significant change, and do not require a new Certificate. 

Contact the NIH CoC Coordinator if there are changes in a research project and it is unclear if the changes are considered significant and need a new Certificate.

NIH-funding is Ending

When NIH funding ends, the study will no longer be deemed issued a CoC. While CoC protections remain in perpetuity for already collected or used information, a new CoC will need to be obtained to cover any new data collected from already enrolled participants or any new participants. See information on the process for requesting a new CoC. If the NIH funding will or has ended and the study has completed all enrollment and data collection, there is no need to request a new Certificate.

Please contact the NIH CoC Coordinator if you have additional questions.
 

This page last updated on: December 2, 2021

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