[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

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.