[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.3]

[Page 279-281]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 50_PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  50.3  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended 
(secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321-392)).
    (b) Application for research or marketing permit includes:
    (1) A color additive petition, described in part 71.
    (2) A food additive petition, described in parts 171 and 571.
    (3) Data and information about a substance submitted as part of the 
procedures for establishing that the substance is generally recognized 
as safe for use that results or may reasonably be expected to result, 
directly or indirectly, in its becoming a component or otherwise 
affecting the characteristics of any food, described in Sec. Sec.  
170.30 and 570.30.
    (4) Data and information about a food additive submitted as part of 
the procedures for food additives permitted to be used on an interim 
basis pending additional study, described in Sec.  180.1.
    (5) Data and information about a substance submitted as part of the 
procedures for establishing a tolerance for unavoidable contaminants in 
food and food-packaging materials, described in section 406 of the act.
    (6) An investigational new drug application, described in part 312 
of this chapter.
    (7) A new drug application, described in part 314.
    (8) Data and information about the bioavailability or bioequivalence 
of drugs for human use submitted as part

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of the procedures for issuing, amending, or repealing a bioequivalence 
requirement, described in part 320.
    (9) Data and information about an over-the-counter drug for human 
use submitted as part of the procedures for classifying these drugs as 
generally recognized as safe and effective and not misbranded, described 
in part 330.
    (10) Data and information about a prescription drug for human use 
submitted as part of the procedures for classifying these drugs as 
generally recognized as safe and effective and not misbranded, described 
in this chapter.
    (11) [Reserved]
    (12) An application for a biologics license, described in part 601 
of this chapter.
    (13) Data and information about a biological product submitted as 
part of the procedures for determining that licensed biological products 
are safe and effective and not misbranded, described in part 601.
    (14) Data and information about an in vitro diagnostic product 
submitted as part of the procedures for establishing, amending, or 
repealing a standard for these products, described in part 809.
    (15) An Application for an Investigational Device Exemption, 
described in part 812.
    (16) Data and information about a medical device submitted as part 
of the procedures for classifying these devices, described in section 
513.
    (17) Data and information about a medical device submitted as part 
of the procedures for establishing, amending, or repealing a standard 
for these devices, described in section 514.
    (18) An application for premarket approval of a medical device, 
described in section 515.
    (19) A product development protocol for a medical device, described 
in section 515.
    (20) Data and information about an electronic product submitted as 
part of the procedures for establishing, amending, or repealing a 
standard for these products, described in section 358 of the Public 
Health Service Act.
    (21) Data and information about an electronic product submitted as 
part of the procedures for obtaining a variance from any electronic 
product performance standard, as described in Sec.  1010.4.
    (22) Data and information about an electronic product submitted as 
part of the procedures for granting, amending, or extending an exemption 
from a radiation safety performance standard, as described in Sec.  
1010.5.
    (23) Data and information about a clinical study of an infant 
formula when submitted as part of an infant formula notification under 
section 412(c) of the Federal Food, Drug, and Cosmetic Act.
    (24) Data and information submitted in a petition for a nutrient 
content claim, described in Sec.  101.69 of this chapter, or for a 
health claim, described in Sec.  101.70 of this chapter.
    (25) Data and information from investigations involving children 
submitted in a new dietary ingredient notification, described in Sec.  
190.6 of this chapter.
    (c) Clinical investigation means any experiment that involves a test 
article and one or more human subjects and that either is subject to 
requirements for prior submission to the Food and Drug Administration 
under section 505(i) or 520(g) of the act, or is not subject to 
requirements for prior submission to the Food and Drug Administration 
under these sections of the act, but the results of which are intended 
to be submitted later to, or held for inspection by, the Food and Drug 
Administration as part of an application for a research or marketing 
permit. The term does not include experiments that are subject to the 
provisions of part 58 of this chapter, regarding nonclinical laboratory 
studies.
    (d) Investigator means an individual who actually conducts a 
clinical investigation, i.e., under whose immediate direction the test 
article is administered or dispensed to, or used involving, a subject, 
or, in the event of an investigation conducted by a team of individuals, 
is the responsible leader of that team.
    (e) Sponsor means a person who initiates a clinical investigation, 
but who does not actually conduct the investigation, i.e., the test 
article is administered or dispensed to or used involving, a subject 
under the immediate direction of another individual. A person other than 
an individual (e.g., corporation or agency) that uses one or more

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of its own employees to conduct a clinical investigation it has 
initiated is considered to be a sponsor (not a sponsor-investigator), 
and the employees are considered to be investigators.
    (f) Sponsor-investigator means an individual who both initiates and 
actually conducts, alone or with others, a clinical investigation, i.e., 
under whose immediate direction the test article is administered or 
dispensed to, or used involving, a subject. The term does not include 
any person other than an individual, e.g., corporation or agency.
    (g) Human subject means an individual who is or becomes a 
participant in research, either as a recipient of the test article or as 
a control. A subject may be either a healthy human or a patient.
    (h) Institution means any public or private entity or agency 
(including Federal, State, and other agencies). The word facility as 
used in section 520(g) of the act is deemed to be synonymous with the 
term institution for purposes of this part.
    (i) Institutional review board (IRB) means any board, committee, or 
other group formally designated by an institution to review biomedical 
research involving humans as subjects, to approve the initiation of and 
conduct periodic review of such research. The term has the same meaning 
as the phrase institutional review committee as used in section 520(g) 
of the act.
    (j) Test article means any drug (including a biological product for 
human use), medical device for human use, human food additive, color 
additive, electronic product, or any other article subject to regulation 
under the act or under sections 351 and 354-360F of the Public Health 
Service Act (42 U.S.C. 262 and 263b-263n).
    (k) Minimal risk means that the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests.
    (l) Legally authorized representative means an individual or 
judicial or other body authorized under applicable law to consent on 
behalf of a prospective subject to the subject's particpation in the 
procedure(s) involved in the research.
    (m) Family member means any one of the following legally competent 
persons: Spouse; parents; children (including adopted children); 
brothers, sisters, and spouses of brothers and sisters; and any 
individual related by blood or affinity whose close association with the 
subject is the equivalent of a family relationship.
    (n) Assent means a child's affirmative agreement to participate in a 
clinical investigation. Mere failure to object may not, absent 
affirmative agreement, be construed as assent.
    (o) Children means persons who have not attained the legal age for 
consent to treatments or procedures involved in clinical investigations, 
under the applicable law of the jurisdiction in which the clinical 
investigation will be conducted.
    (p) Parent means a child's biological or adoptive parent.
    (q) Ward means a child who is placed in the legal custody of the 
State or other agency, institution, or entity, consistent with 
applicable Federal, State, or local law.
    (r) Permission means the agreement of parent(s) or guardian to the 
participation of their child or ward in a clinical investigation. 
Permission must be obtained in compliance with subpart B of this part 
and must include the elements of informed consent described in Sec.  
50.25.
    (s) Guardian means an individual who is authorized under applicable 
State or local law to consent on behalf of a child to general medical 
care when general medical care includes participation in research. For 
purposes of subpart D of this part, a guardian also means an individual 
who is authorized to consent on behalf of a child to participate in 
research.

[45 FR 36390, May 30, 1980, as amended at 46 FR 8950, Jan. 27, 1981; 54 
FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2, 
1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan. 5, 1999; 64 FR 56448, 
Oct. 20, 1999; 66 FR 20597, Apr. 24, 2001]

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