[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR2.21]

[Page 17]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 2--CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS--Table of Contents
 
                      Subpart B--General Provisions
 
Sec. 2.21  Relationship to Federal statutes protecting research subjects against compulsory disclosure of their identity.

    (a) Research privilege description. There may be concurrent coverage 
of patient identifying information by these regulations and by 
administrative action taken under: Section 303(a) of the Public Health 
Service Act (42 U.S.C. 242a(a) and the implementing regulations at 42 
CFR part 2a); or section 502(c) of the Controlled Substances Act (21 
U.S.C. 872(c) and the implementing regulations at 21 CFR 1316.21). These 
``research privilege'' statutes confer on the Secretary of Health and 
Human Services and on the Attorney General, respectively, the power to 
authorize researchers conducting certain types of research to withhold 
from all persons not connected with the research the names and other 
identifying information concerning individuals who are the subjects of 
the research.
    (b) Effect of concurrent coverage. These regulations restrict the 
disclosure and use of information about patients, while administrative 
action taken under the research privilege statutes and implementing 
regulations protects a person engaged in applicable research from being 
compelled to disclose any identifying characteristics of the individuals 
who are the subjects of that research. The issuance under subpart E of 
these regulations of a court order authorizing a disclosure of 
information about a patient does not affect an exercise of authority 
under these research privilege statutes. However, the research privilage 
granted under 21 CFR 291.505(g) to treatment programs using methadone 
for maintenance treatment does not protect from compulsory disclosure 
any imformation which is permitted to be disclosed under those 
regulations. Thus, if a court order entered in accordance with subpart E 
of these regulations authorizes a methadone maintenance treatment 
program to disclose certain information about its patients, that program 
may not invoke the research privilege under 21 CFR 291.505(g) as a 
defense to a subpoena for that information.