INFORMATION SHEETS
Guidance for Institutional Review Boards and Clinical Investigators
1998 Update
Appendix B
21 CFR Part 50 - Protection of Human Subjects Subpart A General Provisions
50.1 Scope.
50.3 Definitions.
Subpart B Informed Consent of Human Subjects
50.20 General requirements for informed consent.
50.21 Effective date.
50.23 Exception from general requirements.
50.24 Exception from informed consent requirements for emergency research 50.25 Elements of informed consent.
50.27 Documentation of informed consent.
[Source: 45 FR 36390, May 30, 1980, unless otherwise noted.]
Subpart A - General Provisions
ß 50.1 Scope.
(a) This part applies to all clinical investigations regulated by the Food and
Drug Administration under sections 505(i) 507(d), and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including 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., 21 CFR 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 406, 409, 502, 503, 505,
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506, 507, 510, 513-516, 518 520, 706, 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.
[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981]
ß 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 ßß 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 ß 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 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) Data and information about an antibiotic drug submitted as part of the procedures for issuing, amending or repealing regulations for these drugs, described in ß 314.300 of this chapter.
(12) An application for a biological product license, described in part 601.
(13) Data and information about a biological product submitted as part of the Page 2 of 13
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 ß 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 ß 1010.5.
(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), 507(d), 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 Page 3 of 13
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 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 participation in the procedure(s) involved in the research.
(m) Family member means any one of the following legally competent persons: Spouse; parents; childr
en (including adopted children); brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.
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[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 51497, Oct. 2, 1996;
62 FR 39440, July 23, 1997]
Subpart B - Informed Consent of Human Subjects
Source: 46 FR 8951, Jan. 27, 1981, unless otherwise noted.
Sec. 50.20 General requirements for informed consent.
Except as provided in Secs. 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the
representative
sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release
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the investigator, the sponsor, the institution, or its agents from liability for negligence.
[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999] Sec. 50.23 Exception from general requirements.
(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in
writing
all of the following:
(1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.
(2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.
(3) Time is not sufficient to obtain consent from the subject's legal representative.
(4) There is available no alternative method of approved or
generally recognized therapy that provides an equal or greater
likelihood of saving the life of the subject.
(b) If immediate use of the test article is, in the investigator's Page 5 of 13
opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in
paragraph
(a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.
(c) The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.
(d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation. The statute specifies that only the President may waive informed consent in this connection and the President may grant such a waiver only if the President determines in writing that obtaining consent: Is not feasible; is contrary to the best interests of the military member; or is not in the interests of national security. The statute further provides that in making a determination to waive prior informed consent on the ground that it is not feasible or the ground that it is contrary to the best interests of the military members involved, the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the pr
ior informed consent requirements of section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C.
355(i)(4)). Before such a determination may be made that obtaining informed consent from military personnel prior to the use of an investigational drug (including an antibiotic or biological product) in a specific protocol under an investigational new drug application (IND) sponsored by the Department of Defense (DOD) and limited to specific military personnel involved in a particular military operation is not feasible or is contrary to the best interests of the military members involved the Secretary of Defense must first request such a
determination from the President, and certify and document to the President that the following standards and criteria contained in paragraphs (d)(1) through (d)(4) of this section have been met.
(i) The extent and strength of evidence of the safety and effectiveness of the investigational new drug in relation to the
medical
risk that could be encountered during the military operation supports the drug's administration under an IND.
(ii) The military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear,
or
other exposure likely to produce death or serious or life-threatening injury or illness.
(iii) There is no available satisfactory alternative therapeutic
or
preventive treatment in relation to the intended use of the investigational new drug.
(iv) Conditioning use of the investigational new drug on the voluntary
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