Certificate of Confidentiality

In order to collect sensitive information, researchers need to be able to ensure for themselves that identifiable research data will remain confidential and assure respondents that this is the case. However, neither legislatures nor courts have granted researchers an absolute privilege to protect the confidentiality of their research data. Despite this, there are several federal statutory mechanisms that can be helpful. In some cases researchers can obtain legal protection for the confidentiality of research data through a federally issued Certificate of Confidentiality as authorized by the Public Health Service Act § 301 (d), 42 U.S.C § 241(d):

Certificates of Confidentiality allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employ-ability, insurability, or reputation (such as drug use, sexual behavior, HIV status, mental illness).

Research need not be federally supported to be eligible for this privacy protection. Certificates of Confidentiality are issued by various Public Health Service component agencies, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health. Researchers are expected to inform subjects in the consent form about the Certificate of Confidentiality protections and the circumstances in which disclosures would be made to protect the subject and others from harm (such as suicidal intention, child abuse, elder abuse, intention to harm others) and certain types of federal audits.

There is very little legal precedent considering the scope of the protections afforded by Certificates of Confidentiality. However, in at least one case from 1973 (People v. Newman), a New York state court of appeals found that a certificate provided a substance abuse program with a proper basis for refusing to turn over the names of program participants.

There are other types of legal protection available for some federally funded research. The privacy of research subjects in Department of Justice-funded research is protected by statute—42 U.S.C. Section 3789g. Similarly, the privacy of research subjects in Agency for Health Care Quality and Research-funded research is protected by a statute 42 U.S.C. Section 299a-1(c) titled “limitation on use of certain information.” For these studies, Confidentiality Certificates are not appropriate. All researchers collecting sensitive data as part of projects under the jurisdiction of an institutional review board will need to work closely with their board and also may require legal counsel.

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