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OHRP Guidance – Certificates of Confidentiality

NOTE: THIS GUIDANCE REPLACES THE 9/1998 OHRP GUIDANCE: "Privacy Protection for Human Research Subjects, Certificates of Confidentiality" CLICK HERE. THIS GUIDANCE HAS BEEN UPDATED IN FORMAT, PROVIDES EMPHASIS ON LIMITATIONS OF THE CERTIFICATES OF CONFIDENTIALITY, AND PROVIDES LINKS TO RELEVANT MATERIALS ON THE NATIONAL INSTITUTES OF HEALTH (NIH) WEBSITE.

Office for Human Research Protections (OHRP)

Department of Health and Human Services (HHS)

Guidance on Certificates of Confidentiality

Date: February 25, 2003

Scope: The purpose of this document is to provide guidance about Certificates of Confidentiality and assistance in locating resources for obtaining a Certificate of Confidentiality to protect the privacy of research subjects.

Target Audience: Institutions, institutional review boards (IRBs), and investigators.

Background: The Public Health Service Act §301(d), 42 U.S.C. §241(d), "Protection of privacy of individuals who are research subjects," states:

The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.

The privacy of the research subjects referred to in §301(d) is protected through the issuance of Certificates of Confidentiality. These certificates of Confidentiality provide protection against compelled disclosure of identifying information about subjects enrolled in sensitive biomedical, behavioral, clinical, or other research. This protection is not limited to federally supported research.


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