What is a Certificate of Confidentiality?
      A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant.

What kind of research is eligible for a Certificate?
      Any research project that collects personally identifiable, sensitive information and that has been approved by an IRB is eligible for a Certificate. NIH or federal funding is not a prerequisite for a Certificate.

What is meant by sensitive information?
      Sensitive information includes (but is not limited to) information relating to sexual attitudes, preferences, or practices; information relating to the use of alcohol, drugs, or other addictive products; information pertaining to illegal conduct; information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination; information pertaining to an individual's psychological well-being or mental health; and genetic information or tissue samples.

Who may apply for a Certificate of Confidentiality?
      Any person engaged in research in which sensitive information is gathered from human research participants (or any person who intends to engage in such research) may apply for a Certificate of Confidentiality.

Is NIH required to give all who apply a Certificate of Confidentiality?
      No. No project is entitled to a Certificate; its issuance is discretionary.

How long does a Certificate's protection last?
      Individuals who participate as research subjects (i.e., about whom the investigator maintains identifying information) in the specified research project during any time the Certificate is in effect are protected permanently.

What is the researcher's responsibility to participants regarding a Certificate of Confidentiality?
      When a researcher obtains a Certificate of Confidentiality, the subjects must be told about protections afforded by the Certificate and any exceptions to those protections unless a research subject is no longer actively participating in the project so amendment of the informed consent would be impractical. This information should be included in the informed consent form. In addition, researchers may not represent the Certificate as an endorsement of the research project by the DHHS or use it in a coercive manner when recruiting subjects.

When should I apply for a Certificate?
      Generally, an application for a Certificate of Confidentiality is submitted after the Institutional Review Board (IRB) responsible for its review approves the research project (because IRB approval or approval conditioned upon issuance of a Certificate of Confidentiality is a prerequisite for issuance of a Certificate). Since the informed consent form should include language describing the Certificate and any voluntary disclosures specified by the investigator, the Applicant could tell the IRB that they are applying for a Certificate of Confidentiality and have included appropriate language in the informed consent form. Applications for Certificates should be submitted at least three months prior to the date on which enrollment of research subjects is expected to begin.

Whom do I contact to apply for a Certificate of Confidentiality?
      If NIH funds the research project for which you would like a Certificate, you may apply through the funding Institute. However, even if your research is not supported with NIH funding, you may apply for a Certificate through the NIH Institute or Center (IC) funding research in a scientific area similar to your project. Contact information is available on the NIH web site (see link below).

Complied by Joe Brown using the NIH web site information. For additional information, go to the NIH web site.

Last updated on  December 23, 2005
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