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August 9, 1991
TO: Deputy Assistant Secretary for Public Health Policy
FROM: Assistant Secretary for Health
SUBJECT: Certificates of Confidentiality -- Disease Reporting
This memorandum establishes policy for issuance of certificates of confidentiality under section 301 (d) of the Public Health Service Act when projects receiving them are subject to State laws requiring the reporting of communicable diseases to State and local health departments.
Certificates of confidentiality provide important protections for research subjects so that they will not be harmed as a result of their participation, and in so doing serve the valuable function of encouraging people to participate in research. Communicable disease reporting under State law is a basic feature of our societal mechanisms for protection of public health. It is important that certificates of confidentiality perform their protective function, while not thwarting the goals of communicable disease reporting.
The following policy is intended to accommodate both of these considerations.
This policy applies to issuance of certificates of confidentiality to projects that intend routinely to determine whether its subjects have communicable diseases and that are required to report them under State law.
1. In projects in which subjects are referred by treating physicians, a certificate will be issued only if the applicant provides written assurance that the project will accept individuals as subjects only if referring physicians assure the project that they have complied (and will continue to comply) with applicable State communicable disease reporting requirements with respect to the referred subjects.
In instances in which physicians conducting research also see their subjects in a clinical care, non-research, relationship, the protections of the certificate do not apply to the non-research relationship, and those physicians are the referring
physicians for the purposes of this policy.
2. In research projects covered by this policy to which the preceding paragraph does not apply (i.e., there is no referring physician), the applicant must describe in writing the agreement that the applicant has made with the health department to cooperate with the health department in ways that serve the purposes of communicable disease reporting requirements. That may include disclosure of identifiable information about subjects, or it may include other forms of cooperation not involving such disclosure.
In the absence of such an agreement, a certificate may be issued only if the applicant provides, in writing, justification setting out specific reasons, related to confidentiality requirements of the research, that preclude such cooperation. Authority to issue certificates in such circumstances is retained by the Assistant Secretary for Health.
3. Any disclosure of identifiable information about subjects must be in accord with the rules for protection of research subjects and any other legal limitation that may exist, and must be explained clearly to the subjects in advance.
I ask that you and your staff follow this policy in preparing certificates of confidentiality.
James O. Mason, M.D., Dr. P.H.
PHS Agency Heads
Chief Counsel, PHS