Certificate of Confidentiality

Applicability

The National Institutes of Health provides a Certificate of Confidentiality automatically to research funded wholly or in part by the NIH for human research, including exempt research studies. As a result, upon award, the study is automatically issued a Certificate of Confidentiality from NIH and the NIH Policy for Issuing Certificates of Confidentiality applies to the study.

Disclosure Restrictions

As a recipient of the Certificate for this study, individuals shall not:

  • Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

  • Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

Disclosure is permitted only when:

  • Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;

  • Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

  • Made with the consent of the individual to whom the information, document, or biospecimen pertains; or

  • Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

Recipients of Certificates are required to ensure that any investigator or institution not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate issued by this Policy, understand they are also subject to the requirements of subsection 301(d) of the Public Health Service Act.  In accordance with NIHGPS Chapter 15.2.1, recipients are also responsible for ensuring that any subrecipient that receives funds to carry out part of the NIH award involving a copy of identifiable, sensitive information protected by a Certificate issued by this Policy understand they are also subject to subsection 301(d) of the Public Health Service Act.

Informed Consent

For studies in which informed consent is sought, NIH expects investigators to inform research participants of the protections and the limits to protections provided by a Certificate issued by this Policy.  Suggested language is available at: https://humansubjects.nih.gov/coc/suggested-consent-language

Length of Certificate of Confidentiality

If the NIH-funding will or has ended but the collection of new data from research participants will continue without NIH-funding you will need to apply for a CoC for continuity of protections using the CoC application system.

If the NIH funding will or has ended but the study has completed all enrollment and data collection, there is no need to extend the Certificate. Sensitive, identifiable research information maintained by investigators during any time a Certificate is in effect, is protected permanently.

Full Text

For the full text of the Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality policy (NOT-OD-17-109), please see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html

Special Considerations