[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

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.