[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR2a.7]



[Page 30-31]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 2a_PROTECTION OF IDENTITY_RESEARCH SUBJECTS--Table of Contents

 

Sec. 2a.7  Effect of Confidentiality Certificate.



    (a) A Confidentiality Certificate authorizes the withholding of the 

names and other identifying characteristics of



[[Page 31]]



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.

    (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.