September 2006

During the 1970s, Congress recognized that certain individuals would most likely not participate in research studies involving certain sensitive topics such as illegal activities unless measure were put into place to protect their privacy. A law was enacted allowing researchers to obtain Certificates of Confidentiality. The Certificate enabled the research to refuse to disclose names or other identifying characteristics even if asked to do so by a court or government agency. In essence, individuals who gave sensitive information to a researcher were protected and would not be identified or prosecuted as a result of participation in research.

Investigators who collect sensitive information should consider whether a Certificate of Confidentiality is appropriate in order to protect subject privacy. Applications for a Certificate of Confidentiality should be made to the agency responsible for the funding of the project. However, Certificates of Confidentiality are not limited to federally funded project. Researchers who conduct unfunded projects may apply for a Certificate of Confidentiality if the research is sensitive and protection is necessary to reach research objectives.

The Office for Human Research Protections (OHRP) defines as research sensitive if the collected information could have adverse consequences to participants such as damage to their financial status, employability, insurability, or reputation. The National Institutes of Health uses a nonexhaustive list of sensitive research activities that include:

• Genetic information
• Psychological well-being
• Sexual attitudes, preferences, or practices
• Substance abuse
• Other illegal behaviors

Certificates of Confidentiality do not apply to voluntary disclosure of identifying information by either a participant or investigator. In other words, if the study is covered by a Certificate of Confidentiality, the participant may voluntarily disclose information about himself or herself. The investigator may also voluntarily disclose information about abusive behaviors or a participant’s threat of violence to self or others. Information about the Certificate of Confidentiality is put into the Consent Form and should clearly outline any exceptions to the protection it offers.

Applications for a Certificate of Confidentiality must be made for a particular research project and are not transferable from one study to another. Additionally, if there are major changes in the protocol during the study, the issuing agency must be notified of the protocol amendment.

Certificates of Confidentiality can promote recruitment of participants into studies that collect sensitive information. The Certificates serve as protection for required disclosure of private, identifiable information against a valid subpoena from a court or administrative agency.

*Kaltman, S. P. and Isidor, J. M. (2006). Certificates of Confidentiality. In E. A. Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (pp. 311-312). Sudbury, MA: Jones and Bartlett.

Office for Human Research Protections (February, 2003). Guidance on Certificates of Confidentiality, http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm.