[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.2]

[Page 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.2  Definitions.

    (a) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (b) Person means any individual, corporation, government, or 
governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    (c) Research means systematic study directed toward new or fuller 
knowledge and understanding of the subject studied. The term includes, 
but is not limited to, behavioral science studies, surveys, evaluations, 
and clinical investigations.
    (d) Drug has the meaning given that term by section 201(g)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
    (e) Controlled drug means a drug which is included in schedule I, 
II, III, IV, or V of part B of the Controlled Substances Act (21 U.S.C. 
811-812).
    (f) Administer refers to the direct application of a drug to the 
body of a human research subject, whether such application be by 
injection, inhalation, ingestion, or any other means, by (1) a qualified 
person engaged in research (or, in his or her presence, by his or her 
authorized agent), or (2) a research subject in accordance with 
instructions of a qualified person engaged in research, whether or not 
in the presence of a qualified person engaged in research.
    (g) Identifying characteristics refers to the name, address, any 
identifying number, fingerprints, voiceprints, photographs or any other 
item or combination of data about a research subject which could 
reasonably lead directly or indirectly by reference to other information 
to identification of that research subject.
    (h) Psychoactive drug means, in addition to alcohol, any drug which 
has as its principal action an effect on thought, mood, or behavior.