[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2002]
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.

    (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.