[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1316.23]

[Page 150-151]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES--Table of Contents
 
       Subpart B--Protection of Researchers and Research Subjects
 
Sec. 1316.23  Confidentiality of identity of research subjects.

    (a) Any person conducting a bona fide research project directly 
related to the enforcement of the laws under the jurisdiction of the 
Attorney General concerning drugs or other substances which are or may 
be subject to control under the Controlled Substances Act (84 Stat. 
1242; 21 U.S.C. 801) who intends to maintain the confidentiality of the 
identity of those persons who are the subjects of such research may 
petition the Administrator of the Drug Enforcement Administration for a 
grant of confidentiality: Providing, That:
    (1) The Attorney General is authorized to carry out such research 
under the provisions of Section 502(a) (2-6) of the Controlled 
Substances Act of 1970 (21 U.S.C. 872(a) (2-6)); and the research is 
being conducted with funds provided in whole or part by the Department 
of Justice; or
    (2) The research is of a nature that the Attorney General would be 
authorized to carry out under the provisions of Section 502(a) (2-6) of 
the Controlled Substances Act (21 U.S.C. 872(a) (2-6), and is being 
conducted with funds provided from sources outside the Department of 
Justice.
    (b) All petitions for Grants of Confidentiality shall be addressed 
to the Administrator, Drug Enforcement Administration, Washington, DC 
20537, and shall contain the following:
    (1) A statement as to whether the research protocol requires the 
manufacture, production, import, export, distribution, dispensing, 
administration, or possession of controlled substances, and if so the 
researcher's registration number or a statement that an application for 
such registration has been submitted to DEA;
    (2) The location of the research project;
    (3) The qualifications of the principal investigator;
    (4) A general description of the research or a copy of the research 
protocol;
    (5) The source of funding for the research project;

[[Page 151]]

    (6) A statement as to the risks posed to the research subjects by 
the research procedures and what protection will be afforded to the 
research subjects;
    (7) A statement as to the risks posed to society in general by the 
research procedures and what measures will be taken to protect the 
interests of society;
    (8) A specific request to withhold the names and/or any other 
identifying characteristics of the research subjects; and
    (9) Statements establishing that a grant of confidentiality is 
necessary to the successful completion of the research project.
    (c) The grant of confidentiality of identity of research subjects 
shall consist of a letter issued by the Administrator, which shall 
include:
    (1) The researcher's name and address.
    (2) The researcher's registration number, if applicable.
    (3) The title and purpose of the research.
    (4) The location of the research project.
    (5) An authorization for all persons engaged in the research to 
withhold the names and identifying characteristics of persons who are 
the subjects of such research, stating that persons who obtain this 
authorization may not be compelled in any Federal, State, or local 
civil, criminal, administrative, legislative, or other proceeding to 
identify the subjects of such research for which this authorization was 
obtained.
    (6) The limits of this authorization, if any.
    (7) A statement to the effect that the grant of confidentiality of 
identity of research subjects shall be perpetual but shall pertain only 
to the subjects of the research described in the research protocol, the 
description of the research submitted to DEA, or as otherwise 
established by DEA.
    (d) Within 30 days of the date of completion of the research 
project, the researcher shall so notify the Administrator. The 
Administrator shall issue another letter including the information 
required in paragraph (c) of this section and stating the starting and 
finishing dates of the research for which the confidentiality of 
identity of research subjects was granted; upon receipt of this letter, 
the research shall return the original letter of exemption.

[42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, 
as amended at 62 FR 13970, Mar. 24, 1997]