[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.1]



[Page 26-27]

 

                         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.1  Applicability.









Sec.

2a.1 Applicability.

2a.2 Definitions.

2a.3 Application; coordination.

2a.4 Contents of application; in general.

2a.5 Contents of application; research projects in which drugs will be 

          administered.

2a.6 Issuance of Confidentiality Certificates; single project 

          limitation.

2a.7 Effect of Confidentiality Certificate.

2a.8 Termination.



    Authority: Sec. 3(a), Pub. L. 91-513 as amended by sec. 122(b), Pub. 

L. 93-282; 84 Stat. 1241 (42 U.S.C. 242a(a)), as amended by 88 Stat. 

132.



    Source: 44 FR 20384, Apr. 4, l979, unless otherwise noted.





    (a) Section 303(a) of the Public Health Service Act (42 U.S.C. 

242a(a)) provides that ``[t]he Secretary [of Health and Human Services] 

may authorize persons engaged in 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.'' The regulations in this part establish procedures 

under which any person engaged in research on mental health including 

research on the use and effect of alcohol and other psychoactive drugs 

(whether or not the research is federally funded) may, subject to the 

exceptions set forth in paragraph (b) of this section, apply for such an 

authorization of confidentiality.

    (b) These regulations do not apply to:

    (1) Authorizations of confidentiality for research requiring an 

Investigational New Drug exemption under section 505(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or to approved new 

drugs, such as methadone, requiring continuation of long-



[[Page 27]]



term studies, records, and reports. Attention is called to 21 CFR 

291.505(g) relating to authorizations of confidentiality for patient 

records maintained by methadone treatment programs.

    (2) Authorizations of confidentiality for research which are related 

to law enforcement activities or otherwise within the purview of the 

Attorney General's authority to issue authorizations of confidentiality 

pursuant to section 502(c) of the Controlled Substances Act (21 U.S.C. 

872(c)) and 21 CFR 1316.21.

    (c) The Secretary's regulations on confidentiality of alcohol and 

drug abuse patient records (42 CFR part 2) and the regulations of this 

part may, in some instances, concurrently cover the same transaction. As 

explained in 42 CFR 2.24 and 2.24-1, 42 CFR part 2 restricts voluntary 

disclosures of information from applicable patient records while a 

Confidentiality Certificate issued pursuant to the regulations of this 

part protects a person engaged in applicable research from being 

compelled to disclose identifying characteristics of individuals who are 

the subject of such research.