[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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