Guidance on Certificates of Confidentiality
NOTE: THIS GUIDANCE HAS BEEN REPLACED BY OHRP’S FEBRUARY 25, 2003, GUIDANCE ENTITLED, “GUIDANCE ON CERTIFICATES OF CONFIDENTIALITY. CLICK HERE FOR THE FEBRUARY 25, 2003 GUIDANCE.
- Statutory Basis for Protection. Protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is provided by the Public Health Service Act §301(d), 42 U.S.C. §241(d):
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.
- History. Product of drug wars of 1970s; need to collect information on extent of illegal drug use, motivation, etc.; legal hazards to individuals of collecting such data. Solution was legal protection against disclosure of subject information in research on "use and effect of drugs" to be granted by Secretary of Health, Education and Welfare. (Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, §3(a)).
The 1974 Amendment expanded the protection to cover "mental health, including research on the use and effect of alcohol and other psychoactive drugs" (Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Amendments of 1974, Pub. L. No. 93-282, §122(b)).
The 1988 Amendment expanded the protection to health research generally (current text). (Health Omnibus Programs Extension of 1988, Pub. L. No. 100-607, §163).
- Court Consideration. Upheld by New York Court of Appeals (highest court in State) against challenge based on argument that law was implicitly repealed by later drug abuse patient confidentiality statute. U.S. Supreme Court declined to hear case. (People v. Newman, 32 N.Y.2d 379, 298 N.E.2d 651, 345 N.Y.S.2d 502 (1973), cert. denied, 414 U.S. 1163 (1973)).
- Current Administration. Protection given in form of certificate of confidentiality issued upon application for a particular project. Federal funding is not a prerequisite.
Protection can be granted only to research (i.e., a systematic investigation designed to develop or contribute to generalizable knowledge). 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. Research can be considered sensitive if it involves the collection of information in any of the following categories:
- 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 could reasonable by damaging to an individuals financial standing, employability, or reputation within the community;
- Information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
- Information pertaining to an individual's psychological well being or mental health.
- Genetic information.
- Voluntary Disclosure. The Confidentiality Certificate does not govern the voluntary disclosure of identifying characteristics of research subjects but only protects subjects from compelled disclosure of identifying characteristics. Researchers, therefore, are not prevented from the voluntary disclosure of matters such as child abuse or a subject's threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this.
- Exceptions. There are also limited exceptions to confidentiality (audit, FDA, subject request) and there are special policies on communicable disease reporting (Memorandum, "Certificates of Confidentiality - Disease Reporting", Assistant Secretary for Health James 0. Mason, Aug. 9, 1991, found in OPRR Institutional Review Board Guidebook at A5-45 (1993)).
- Regulations and Policies. For certificates for drug abuse, alcohol abuse, and mental health research, regulation at 42 CFR part 2a, applies. For other research, certificates are subject to administrative guidance. Certificate issuance formerly administered by Assistant Secretary for Health of U.S. Department of Health and Human Services, now devolved to agencies. Administrative arrangements now being designed.