eCFR — Code of Federal Regulations
ELECTRONIC CODE OF FEDERAL REGULATIONS
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ent as of May 21, 2020
Title 21 → Chapter I → Subchapter A → Part 50
Title 21: Food and Drugs
PART 50—PROTECTION OF HUMAN SUBJECTS
Contents
Subpart A—General Provisions
§50.1 Scope.
§50.3 Definitions.
Subpart B—Informed Consent of Human Subjects
§ XXXXXXXXXXGeneral requirements for informed consent.
§ XXXXXXXXXXException from general requirements.
§ XXXXXXXXXXException from informed consent requirements for emergency research.
§ XXXXXXXXXXElements of informed consent.
§ XXXXXXXXXXDocumentation of informed consent.
Subpart C [Reserved]
Subpart D—Additional Safeguards for Children in Clinical Investigations
§ XXXXXXXXXXIRB duties.
§ XXXXXXXXXXClinical investigations not involving greater than minimal risk.
§ XXXXXXXXXXClinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual
subjects.
§ XXXXXXXXXXClinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but
likely to yield generalizable knowledge about the subjects' disorder or condition.
§ XXXXXXXXXXClinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a
serious problem affecting the health or welfare of children.
§ XXXXXXXXXXRequirements for permission by parents or guardians and for assent by children.
§ XXXXXXXXXXWards.
AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
263b-263n.
SOURCE: 45 FR 36390, May 30, 1980, unless otherwise noted.
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Subpart A—General Provisions
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§50.1 Scope.
(a) This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and
520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research o
marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements,
that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical
devices for human use, biological products for human use, and electronic products. Additional specific obligations and
commitments of, and standards of conduct for, persons who sponsor or monitor clinical investigations involving particular test
articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is intended to protect the rights
and safety of subjects involved in investigations filed with the Food and Drug Administration pursuant to sections 403, 406, 409,
412, 413, 502, 503, 505, 510, XXXXXXXXXX, XXXXXXXXXX, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351
and 354-360F of the Public Health Service Act.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless
otherwise noted.
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[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 66 FR
20597, Apr. 24, 2001]
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§50.3 Definitions.
As used in this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs XXXXXXXXXX, 52 Stat. 1040 et seq. as amended
(21 U.S.C XXXXXXXXXX)).
(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 §§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 §180.1.
(5) Data and information about a substance submitted as part of the procedures for establishing a tolerance fo
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 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 mis
anded, 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 mis
anded, 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
iological products are safe and effective and not mis
anded, 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, o
epealing 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, o
epealing 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 §1010.4.
(22) Data and information about an electronic product submitted as part of the procedures for granting, amending, o
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extending an exemption from a radiation safety performance standard, as described in §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 §101.69 of this chapter, or for a
health claim, described in §101.70 of this chapter.
(25) Data and information from investigations involving children submitted in a new dietary ingredient notification, described
in §190.6 of this chapter.
(c) Clinical investigation means any experiment that involves a test article and one or more human subjects and that eithe
is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, o
is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the
esults 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 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
eview biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such
esearch. 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 greate
in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical o
psychological examinations or tests.
(l) Legally authorized representative means an