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What is a Certificate of Confidentiality?

IN situations where the Investigator requires protection of research of a sensitive nature, the principal investigator can apply to the Department of Health and Human Services to protect this information.  This allows a researcher to protect the privacy of research subjects by withholding from all persons not connected with the research team the names and other identifying information relating to research subjects. The protection will be granted only when the research is of a sensitive nature where the protection is judged necessary to achieve the research objectives. Examples include research relating to sexual attitudes, preferences, or practices, the use of alcohol, drugs, or other addictive products, pertaining to illegal conduct or to an individual’s psychological well being or mental health, genetic information, information that, if released, could be damaging to an individual’s financial standing, employability, or reputation, and information that would normally be recorded in a patient’s medical record that, if released, could lead to social stigmatization or discrimination. Researchers may receive a Certificate of Confidentiality regardless of funding source. Researchers who receive a certificate may not be compelled by Federal, State, or local legal processes or subpoenas to disclose information that they process as a consequence of the research.

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