Human Subjects 

A Certificate of Confidentiality (CoC) protects the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research, such as from forced disclosure through court orders and subpoenas, except when the subject consents or in a few other specific situations.

Research is automatically covered by a CoC whenever the study is funded in whole or in part by the NIH and involves identifiable, sensitive information.

The term “identifiable, sensitive information” means information about an individual that is gathered or used during biomedical, behavioral, clinical, or other research, where the following may occur:

  • 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 identity of an individual.

Examples of research automatically covered by a CoC include:

  • Biomedical, behavioral, clinical or other research, including exempt research, except where the information obtained is recorded in such a manner that human participants cannot be identified or the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participants.
  • The collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual.
  • The generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human participants can be identified or the identity of the human participants can readily be ascertained.
  • Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.

Researchers may also apply for a CoC for non-federally funded research. Any principal investigator (PI) considering obtaining a CoC should initiate the CoC process with NIH concurrently with submittal to the IRB.

The NIH maintains a CoC information kiosk, and PIs interested in a CoC should visit the kiosk to evaluate whether their project is eligible. If eligible, the PI next must contact the UNLV Office of Research Integrity – Human Subjects to coordinate submission of the CoC application and obtain signature of the Institutional Official. The PI must indicate on the IRB Protocol Proposal Form that they will be pursuing a CoC on the project. Once IRB approval is obtained, the PI may submit a request for a CoC. The project may not be initiated until after the CoC is received.

When research is covered by a CoC, researchers:

  • May 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
  • May not 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.
  • May disclose information 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 participants in research.

When research is covered by a CoC, researchers must inform participants (for example, in the consent document) of the protections and limitations of certificates of confidentiality:

  • For studies that were previously issued a Certificate, and participants were notified of the protections provided by that Certificate, NIH does not expect participants to be notified that the protections afforded by the Certificate have changed, although IRBs may determine whether it is appropriate to inform participants.
  • If part of the study cohort was recruited prior to issuance of the Certificate, but are no longer actively participating in the study, NIH does not expect participants consented prior to the change in authority, or prior to the issuance of a Certificate, to be notified that the protections afforded by the Certificate have changed, or that participants who were previously consented to be re-contacted to be informed of the Certificate, although IRBs may determine whether it is appropriate to inform participants.

Researchers conducting NIH-supported research covered by a CoC must ensure that if identifiable, sensitive information is provided to other researchers or organizations, regardless of whether or not the research is federally funded, the other researcher or organization must comply with applicable requirements when research is covered by a CoC.

Researchers conducting research covered by a CoC, even if the research is not federally funded, must ensure that if identifiable, sensitive information is provided to other researchers or organizations, the other researcher or organization must comply with applicable requirements when research is covered by a CoC.