(a) A Confidentiality Certificate authorizes the withholding of the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate while the Certificate is in effect. The authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of the research. Persons so authorized may not, at any time, be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify the research subjects encompassed by the Certificate, except in those circumstances specified in paragraph (b) of this section.

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(b) A Confidentiality Certificate granted under this part does not authorize any person to refuse to reveal the name or other identifying characteristics of any research subject in the following circumstances:

(1) The subject (or, if he or she is legally incompetent, his or her guardian) consents, in writing, to the disclosure of such information,

(2) Authorized personnel of DHHS request such information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors and their employees or agents carrying out such a project. (See 45 CFR 5.71 for confidentiality standards imposed on such DHHS personnel), or

(3) Release of such information is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301) or the regulations promulgated thereunder (title 21, Code of Federal Regulations).

(c) Neither a Confidentiality Certificate nor the regulations of this part govern the voluntary disclosure of identifying characteristics of research subjects.