0A4F4F9BD490A749D5437F821CF06DF1
21 CFR 50
https://www.govinfo.gov/content/pkg/CFR-2012-title21-vol1/pdf/CFR-2012-title21-vol1-part50.pdf
http://leaux.net/URLS/ConvertAPI Text Files/1C7FBEFE9F1A4B7895A456D6F0CCAFAB.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Indigenous
Searching for indicator native:
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p.000290: provided under paragraph (a) of this section or because of other relevant ethical con- cerns, the IRB must
p.000290: document its find- ings and provide these findings prompt- ly in writing to the clinical investi- gator and to
p.000290: the sponsor of the clinical investigation. The sponsor of the clin- ical investigation must promptly dis-
p.000290: close this information to FDA and to the sponsor’s clinical investigators who are participating or are asked
p.000290: to par- ticipate in this or a substantially equivalent clinical investigation of the sponsor, and to
p.000290: other IRB’s that have been, or are, asked to review this or a substantially equivalent investigation by
p.000290: that sponsor.
p.000290: [61 FR 51528, Oct. 2, 1996]
p.000290:
p.000290: § 50.25 Elements of informed consent.
p.000290: (a) Basic elements of informed consent. In seeking informed consent, the fol- lowing information shall be
p.000290: provided to each subject:
p.000290: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000290: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000290: and identification of any procedures which are experi- mental.
p.000290: (2) A description of any reasonably foreseeable risks or discomforts to the subject.
p.000290: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000290: research.
p.000290: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000290: might be advan- tageous to the subject.
p.000290: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000290: subject will be maintained and that notes the possi- bility that the Food and Drug Adminis- tration may inspect
p.000290: the records.
p.000290: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000290: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000290: consist of, or where further information may be ob- tained.
p.000290: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000290: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject.
p.000290: (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss
p.000290: of bene- fits to which the subject is otherwise entitled, and that the subject may dis- continue
p.000290: participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
p.000290: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000290: information shall also be provided to each subject:
p.000290: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000290: the embryo
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p.000291: § 50.27
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Political / political affiliation
Searching for indicator political:
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p.000288: ad- vance of using the investigational de- vice, the determinations of the investi- gator shall be made and,
p.000288: within 5 work- ing days after the use of the device, be reviewed and evaluated in writing by a physician who is not
p.000288: participating in the clinical investigation.
p.000288: (3) The investigator must submit the
p.000288: written certification of the determina- tions made by the investigator and an independent physician
p.000288: required in paragraph (e)(1) or (e)(2) of this section to the IRB and FDA within 5 working days after the
p.000288: use of the device.
p.000288: (4) An investigator must disclose the investigational status of the in vitro diagnostic device and what
p.000288: is known about the performance characteristics of the device in the report to the sub- ject’s health care
p.000288: provider and in any report to public health authorities. The investigator must provide the IRB with the
p.000288: information required in § 50.25 (ex- cept for the information described in
p.000288: § 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the
p.000288: subject’s legally authorized representative at the time the test results are provided to the sub- ject’s health
p.000288: care provider and public health authorities.
p.000288: (5) The IRB is responsible for ensur- ing the adequacy of the information re- quired in section 50.25 (except
p.000288: for the information described in § 50.25(a)(8)) and for ensuring that procedures are in place to provide
p.000288: this information to each subject or the subject’s legally au- thorized representative.
p.000288: (6) No State or political subdivision of a State may establish or continue in effect any law, rule,
p.000288: regulation or
p.000288:
p.000288: other requirement that informed con- sent be obtained before an investiga- tional in vitro diagnostic
p.000288: device may be used to identify chemical, biologi- cal, radiological, or nuclear agent in suspected
p.000288: terrorism events and other potential public health emergencies that is different from, or in addition to,
p.000288: the requirements of this regulation.
p.000288: [46 FR 8951, Jan. 27, 1981, as amended at 55
p.000288: FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999;
p.000288: 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7,
p.000288: 2006; 76 FR 36993, June 24, 2011]
p.000288:
p.000288: § 50.24 Exception from informed con- sent requirements for emergency research.
p.000288: (a) The IRB responsible for the re- view, approval, and continuing review of the clinical investigation
p.000288: described in this section may approve that inves- tigation without requiring that in- formed consent of all
p.000288: research subjects be obtained if the IRB (with the con- currence of a licensed physician who is a member of
p.000288: or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and
p.000288: documents each of the following:
p.000288: (1) The human subjects are in a life- threatening situation, available treat- ments are unproven or
p.000288: unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained
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Health / Drug Usage
Searching for indicator drug:
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p.000283:
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p.000283: Food and Drug Administration, HHS § 50.3
p.000283:
p.000283: PART 50—PROTECTION OF HUMAN SUBJECTS
p.000283: Subpart A—General Provisions
p.000283: Sec.
p.000283: 50.1 Scope.
p.000283: 50.3 Definitions.
p.000283: Subpart B—Informed Consent of Human Subjects
p.000283: 50.20 General requirements for informed consent.
p.000283: 50.23 Exception from general requirements.
p.000283: 50.24 Exception from informed consent re- quirements for emergency research.
p.000283: 50.25 Elements of informed consent.
p.000283: 50.27 Documentation of informed consent.
p.000283: Subpart C [Reserved]
p.000283: Subpart D—Additional Safeguards for Children in Clinical Investigations
p.000283: 50.50 IRB duties.
p.000283: 50.51 Clinical investigations not involving greater than minimal risk.
p.000283: 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of
p.000283: direct benefit to indi- vidual subjects.
p.000283: 50.53 Clinical investigations involving greater than minimal risk and no pros- pect of direct
p.000283: benefit to individual sub- jects, but likely to yield generalizable knowledge about the subjects’ disorder
p.000283: or condition.
p.000283: 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or
p.000283: alleviate a se- rious problem affecting the health or welfare of children.
p.000283: 50.55 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000283: 50.56 Wards.
p.000283: AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348,
p.000283: 350a, 350b, 352, 353, 355, 360, 360c–360f, 360h–
p.000283: 360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b–
p.000283: 263n.
p.000283: SOURCE: 45 FR 36390, May 30, 1980, unless
p.000283: otherwise noted.
p.000283:
p.000283: Subpart A—General Provisions
p.000283: § 50.1 Scope.
p.000283: (a) This part applies to all clinical in- vestigations regulated by the Food and Drug Administration under
p.000283: sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical
p.000283: investigations that support ap- plications for research or marketing
p.000283:
p.000283: permits for products regulated by the Food and Drug Administration, includ- ing foods, including dietary
p.000283: supple- ments, that bear a nutrient content claim or a health claim, infant for- mulas, food
p.000283: and color additives, drugs for human use, medical devices for human use, biological products
p.000283: for human use, and electronic products. Additional specific obligations and commitments of, and
p.000283: standards of con- duct for, persons who sponsor or mon- itor clinical investigations involving particular
p.000283: test articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is in-
p.000283: tended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug
p.000283: Adminis- tration pursuant to sections 403, 406,
p.000283: 409, 412, 413, 502, 503, 505, 510, 513–516,
p.000283: 518–520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sec- tions 351 and
p.000283: 354–360F of the Public Health Service Act.
p.000283: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000283: title 21, unless otherwise noted.
p.000283: [45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27,
p.000283: 1981, as amended at 63 FR 26697, May 13, 1998;
p.000283: 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24,
p.000283: 2001]
p.000283: § 50.3 Definitions.
p.000283: As used in this part:
p.000283: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040
p.000283: et seq. as amended (21 U.S.C. 321–392)).
p.000283: (b) Application for research or mar- keting permit includes:
p.000283: (1) A color additive petition, de- scribed in part 71.
p.000283: (2) A food additive petition, described in parts 171 and 571.
p.000283: (3) Data and information about a sub- stance submitted as part of the proce- dures for establishing that
p.000283: the sub- stance is generally recognized as safe for use that results or may reasonably be expected to
p.000283: result, directly or indi- rectly, in its becoming a component or otherwise affecting the characteristics of any
p.000283: food, described in §§ 170.30 and 570.30.
p.000283: (4) Data and information about a food
p.000283: additive submitted as part of the proce- dures for food additives permitted to be
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p.000283: § 50.3
p.000283: used on an interim basis pending addi- tional study, described in § 180.1.
p.000283: (5) Data and information about a sub- stance submitted as part of the proce- dures for establishing a
p.000283: tolerance for unavoidable contaminants in food and food-packaging materials, described in section 406 of the
p.000283: act.
p.000283: (6) An investigational new drug appli- cation, described in part 312 of this chapter.
p.000283: (7) A new drug application, described in part 314.
p.000283: (8) Data and information about the bioavailability or bioequivalence of drugs for human use submitted
p.000283: as part of the procedures for issuing, amend- ing, or repealing a bioequivalence re- quirement, described
p.000283: in part 320.
p.000283: (9) Data and information about an over-the-counter drug for human use submitted as part of the
p.000283: procedures for classifying these drugs as generally recognized as safe and effective and not misbranded,
p.000283: described in part 330.
p.000283: (10) Data and information about a prescription drug for human use sub- mitted as part of the
p.000283: procedures for classifying these drugs as generally recognized as safe and effective and not misbranded,
p.000283: described in this chapter.
p.000283: (11) [Reserved]
p.000283: (12) An application for a biologics li- cense, described in part 601 of this chapter.
p.000283: (13) Data and information about a bi- ological product submitted as part of the procedures for determining
p.000283: that li- censed biological products are safe and effective and not misbranded, described in part 601.
p.000283: (14) Data and information about an in vitro diagnostic product submitted as part of the procedures for
p.000283: establishing, amending, or repealing a standard for these products, described in part 809.
p.000283: (15) An Application for an Investiga- tional Device Exemption, described in part 812.
p.000283: (16) Data and information about a medical device submitted as part of the procedures for classifying
p.000283: these de- vices, described in section 513.
p.000283: (17) Data and information about a medical device submitted as part of the procedures for establishing,
p.000283: amending, or repealing a standard for these de- vices, described in section 514.
p.000283: 21 CFR Ch. I (4–1–12 Edition)
p.000283: (18) An application for premarket ap- proval of a medical device, described in section 515.
p.000283: (19) A product development protocol for a medical device, described in sec- tion 515.
p.000283: (20) Data and information about an electronic product submitted as part of the procedures for establishing, amend-
p.000283: ing, or repealing a standard for these products, described in section 358 of the Public Health Service Act.
p.000283: (21) Data and information about an electronic product submitted as part of the procedures for obtaining a variance
p.000283: from any electronic product perform- ance standard, as described in § 1010.4.
p.000283: (22) Data and information about an electronic product submitted as part of the procedures for granting,
p.000283: amending, or extending an exemption from a radi- ation safety performance standard, as described in § 1010.5.
p.000283: (23) Data and information about a clinical study of an infant formula when submitted as part of
p.000283: an infant formula notification under section 412(c) of the Federal Food, Drug, and Cosmetic Act.
p.000283: (24) Data and information submitted in a petition for a nutrient content claim, described in § 101.69
p.000283: of this chap- ter, or for a health claim, described in
p.000283: § 101.70 of this chapter.
p.000283: (25) Data and information from inves- tigations involving children submitted in a new dietary ingredient
p.000283: notifica- tion, described in § 190.6 of this chapter.
p.000283: (c) Clinical investigation means any experiment that involves a test article and one or more human
p.000283: subjects and that either is subject to requirements for prior submission to the Food and Drug
p.000283: Administration under section 505(i) or 520(g) of the act, or is not sub- ject to requirements for prior
p.000283: submis- sion to the Food and Drug Administra- tion under these sections of the act, but the results of which are
p.000283: intended to be submitted later to, or held for in- spection by, the Food and Drug Admin- istration as part of an
p.000283: application for a research or marketing permit. The term does not include experiments that are subject to
p.000283: the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.
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p.000284: Food and Drug Administration, HHS § 50.3
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p.000284: (d) Investigator means an individual who actually conducts a clinical inves- tigation, i.e., under whose
p.000284: immediate direction the test article is adminis- tered or dispensed to, or used involv- ing, a subject, or,
p.000284: in the event of an in- vestigation conducted by a team of in- dividuals, is the responsible leader of that
p.000284: team.
p.000284: (e) Sponsor means a person who initi- ates a clinical investigation, but who does not actually conduct the
p.000284: inves- tigation, i.e., the test article is admin- istered or dispensed to or used involv- ing, a subject under
p.000284: the immediate di- rection of another individual. A person other than an individual (e.g., corpora- tion or agency)
p.000284: that uses one or more of its own employees to conduct a clin- ical investigation it has initiated is
p.000284: considered to be a sponsor (not a spon- sor-investigator), and the employees are considered to be investigators.
p.000284: (f) Sponsor-investigator means an indi-
p.000284: vidual who both initiates and actually conducts, alone or with others, a clin- ical investigation, i.e.,
p.000284: under whose im- mediate direction the test article is ad- ministered or dispensed to, or used in- volving, a
p.000284: subject. The term does not include any person other than an indi- vidual, e.g., corporation or agency.
p.000284: (g) Human subject means an indi- vidual who is or becomes a participant in research, either as a
p.000284: recipient of the test article or as a control. A subject may be either a healthy human or a pa- tient.
p.000284: (h) Institution means any public or private entity or agency (including Federal, State, and
p.000284: other agencies). The word facility as used in section 520(g) of the act is deemed to be syn-
p.000284: onymous with the term institution for purposes of this part.
p.000284: (i) Institutional revie board (IRB) means any board, committee, or other group formally designated
p.000284: by an insti- tution to review biomedical research involving humans as subjects, to ap- prove the
p.000284: initiation of and conduct periodic review of such research. The term has the same meaning as the
p.000284: phrase institutional revie committee as used in section 520(g) of the act.
p.000284: (j) Test article means any drug (in- cluding a biological product for human use), medical device for
p.000284: human use, human food additive, color additive,
p.000284:
p.000284: electronic product, or any other article subject to regulation under the act or under sections 351 and
p.000284: 354–360F of the Public Health Service Act (42 U.S.C. 262 and 263b–263n).
p.000284: (k) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research
p.000284: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000284: performance of rou- tine physical or psychological exami- nations or tests.
p.000284: (l) Legally authorized representative means an individual or judicial or other body authorized under
p.000284: applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000284: particpation in the procedure(s) in- volved in the research.
p.000284: (m) Family member means any one of the following legally competent per- sons: Spouse; parents; children
p.000284: (includ- ing adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related
p.000284: by blood or af- finity whose close association with the subject is the equivalent of a family re- lationship.
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p.000285: article.
p.000285: (2) Informed consent cannot be ob- tained from the subject because of an inability to communicate with,
p.000285: or ob- tain legally effective consent from, the subject.
p.000285: (3) Time is not sufficient to obtain consent from the subject’s legal rep- resentative.
p.000285: (4) There is available no alternative method of approved or generally recog- nized therapy that provides an equal
p.000285: or greater likelihood of saving the life of the subject.
p.000285: (b) If immediate use of the test arti- cle is, in the investigator’s opinion, re- quired to preserve the
p.000285: life of the sub- ject, and time is not sufficient to ob- tain the independent determination re- quired in
p.000285: paragraph (a) of this section in advance of using the test article, the determinations of the clinical investi-
p.000285: gator shall be made and, within 5 work- ing days after the use of the article, be reviewed and evaluated in writing by
p.000285: a physician who is not participating in the clinical investigation.
p.000285: (c) The documentation required in
p.000285: paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after
p.000285: the use of the test article.
p.000285: (d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior consent requirement for the
p.000285: administration of an investigational new drug to a mem- ber of the armed forces in connection with the
p.000285: member’s participation in a particular military operation. The statute specifies that only the Presi-
p.000285: dent may waive informed consent in this connection and the President may grant such a waiver only if
p.000285: the Presi- dent determines in writing that obtain- ing consent: Is not feasible; is contrary to the best interests
p.000285: of the military member; or is not in the interests of national security. The statute further provides
p.000285: that in making a determina- tion to waive prior informed consent on the ground that it is not feasible or the
p.000285: ground that it is contrary to the best interests of the military members involved, the President shall
p.000285: apply the
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p.000286: Food and Drug Administration, HHS § 50.23
p.000286:
p.000286:
p.000286: standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior
p.000286: informed con- sent requirements of section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000286: 355(i)(4)). Before such a determination may be made that ob- taining informed consent from mili- tary
p.000286: personnel prior to the use of an in- vestigational drug (including an anti- biotic or biological product) in a
p.000286: spe- cific protocol under an investigational new drug application (IND) sponsored by the Department of
p.000286: Defense (DOD) and limited to specific military per- sonnel involved in a particular mili- tary
p.000286: operation is not feasible or is con- trary to the best interests of the mili- tary members involved the
p.000286: Secretary of Defense must first request such a de- termination from the President, and certify and document
p.000286: to the President that the following standards and cri- teria contained in paragraphs (d)(1) through
p.000286: (d)(4) of this section have been met.
p.000286: (i) The extent and strength of evi-
p.000286: dence of the safety and effectiveness of the investigational new drug in rela- tion to the medical risk that
p.000286: could be encountered during the military oper- ation supports the drug’s administra- tion under an IND.
p.000286: (ii) The military operation presents a substantial risk that military per- sonnel may be subject to a
p.000286: chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening
p.000286: injury or illness.
p.000286: (iii) There is no available satisfac- tory alternative therapeutic or preven- tive treatment in relation to
p.000286: the in- tended use of the investigational new drug.
p.000286: (iv) Conditioning use of the inves- tigational new drug on the voluntary participation of each
p.000286: member could significantly risk the safety and health of any individual member who would decline its use, the
p.000286: safety of other mili- tary personnel, and the accomplish- ment of the military mission.
p.000286: (v) A duly constituted institutional review board (IRB) established and op- erated in accordance with the
p.000286: require- ments of paragraphs (d)(2) and (d)(3) of this section, responsible for review of the study, has
p.000286: reviewed and approved the investigational new drug protocol
p.000286:
p.000286: and the administration of the inves- tigational new drug without informed consent. DOD’s request is
p.000286: to include the documentation required by
p.000286: § 56.115(a)(2) of this chapter.
p.000286: (vi) DOD has explained:
p.000286: (A) The context in which the inves- tigational drug will be administered, e.g., the setting or
p.000286: whether it will be self-administered or it will be adminis- tered by a health professional;
p.000286: (B) The nature of the disease or con- dition for which the preventive or therapeutic treatment is
p.000286: intended; and
p.000286: (C) To the extent there are existing data or information available, informa- tion on conditions that could
p.000286: alter the effects of the investigational drug.
p.000286: (vii) DOD’s recordkeeping system is capable of tracking and will be used to track the proposed treatment
p.000286: from supplier to the individual recipient.
p.000286: (viii) Each member involved in the military operation will be given, prior to the administration of the
p.000286: investiga- tional new drug, a specific written in- formation sheet (including information required by 10
p.000286: U.S.C. 1107(d)) con- cerning the investigational new drug, the risks and benefits of its use, poten- tial
p.000286: side effects, and other pertinent in- formation about the appropriate use of the product.
p.000286: (ix) Medical records of members in- volved in the military operation will accurately document the
p.000286: receipt by members of the notification required by paragraph (d)(1)(viii) of this section.
p.000286: (x) Medical records of members in- volved in the military operation will accurately document the
p.000286: receipt by members of any investigational new drugs in accordance with FDA regula- tions including part
p.000286: 312 of this chapter.
p.000286: (xi) DOD will provide adequate fol- lowup to assess whether there are bene- ficial or adverse health
p.000286: consequences that result from the use of the inves- tigational product.
p.000286: (xii) DOD is pursuing drug develop- ment, including a time line, and mar- keting approval with due
p.000286: diligence.
p.000286: (xiii) FDA has concluded that the in- vestigational new drug protocol may proceed subject to a decision by
p.000286: the President on the informed consent waiver request.
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p.000287: § 50.23
p.000287: (xiv) DOD will provide training to the appropriate medical personnel and po- tential recipients on the specific
p.000287: inves- tigational new drug to be administered prior to its use.
p.000287: (xv) DOD has stated and justified the time period for which the waiver is needed, not to exceed one
p.000287: year, unless separately renewed under these stand- ards and criteria.
p.000287: (xvi) DOD shall have a continuing ob- ligation to report to the FDA and to the President any changed
p.000287: cir- cumstances relating to these standards and criteria (including the time period referred to in
p.000287: paragraph (d)(1)(xv) of this section) or that otherwise might affect the determination to use an in-
p.000287: vestigational new drug without in- formed consent.
p.000287: (xvii) DOD is to provide public notice as soon as practicable and consistent with classification
p.000287: requirements through notice in the FEDERAL REG- ISTER describing each waiver of in- formed
p.000287: consent determination, a sum- mary of the most updated scientific in- formation on the products used, and
p.000287: other pertinent information.
p.000287: (xviii) Use of the investigational drug without informed consent otherwise conforms with applicable law.
p.000287: (2) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must
p.000287: include at least 3 nonaffiliated members who shall not be employees or officers of the Federal
p.000287: Government (other than for purposes of membership on the IRB) and shall be required to obtain any
p.000287: necessary security clearances. This IRB shall review the proposed IND pro- tocol at a convened meeting at
p.000287: which a majority of the members are present including at least one member whose primary concerns are in
p.000287: nonscientific areas and, if feasible, including a ma- jority of the nonaffiliated members. The
p.000287: information required by
p.000287: § 56.115(a)(2) of this chapter is to be pro-
p.000287: vided to the Secretary of Defense for further review.
p.000287: (3) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section,
p.000287: must review and approve:
p.000287: (i) The required information sheet;
p.000287: (ii) The adequacy of the plan to dis- seminate information, including dis-
p.000287: 21 CFR Ch. I (4–1–12 Edition)
p.000287: tribution of the information sheet to potential recipients, on the investiga- tional product (e.g., in
p.000287: forms other than written);
p.000287: (iii) The adequacy of the information and plans for its dissemination to health care providers, including
p.000287: poten- tial side effects, contraindications, po- tential interactions, and other perti- nent
p.000287: considerations; and
...
p.000287: (e)(1) Obtaining informed consent for investigational in vitro diagnostic de- vices used to identify
p.000287: chemical, bio- logical, radiological, or nuclear agents will be deemed feasible unless, before use of the
p.000287: test article, both the investi- gator (e.g., clinical laboratory director or other responsible individual) and
p.000287: a physician who is not otherwise partici- pating in the clinical investigation make the determinations and
p.000287: later cer- tify in writing all of the following:
p.000287: (i) The human subject is confronted by a life-threatening situation necessi- tating the use of the
p.000287: investigational in vitro diagnostic device to identify a chemical, biological, radiological, or nuclear
p.000287: agent that would suggest a ter- rorism event or other public health emergency.
p.000287: (ii) Informed consent cannot be ob- tained from the subject because:
p.000287: (A) There was no reasonable way for the person directing that the specimen be collected to know, at the
p.000287: time the specimen was collected, that there would be a need to use the investiga- tional in
p.000287: vitro diagnostic device on that subject’s specimen; and
p.000287: (B) Time is not sufficient to obtain consent from the subject without risk- ing the life of the subject.
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Food and Drug Administration, HHS § 50.24
p.000288:
p.000288:
p.000288: (iii) Time is not sufficient to obtain consent from the subject’s legally au- thorized representative.
p.000288: (iv) There is no cleared or approved available alternative method of diag- nosis, to identify the chemical,
p.000288: biologi- cal, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life
p.000288: of the subject.
p.000288: (2) If use of the investigational device is, in the opinion of the investigator (e.g., clinical laboratory
p.000288: director or other responsible person), required to preserve the life of the subject, and time is
p.000288: not sufficient to obtain the independent determination required in paragraph (e)(1) of this section in
p.000288: ad- vance of using the investigational de- vice, the determinations of the investi- gator shall be made and,
p.000288: within 5 work- ing days after the use of the device, be reviewed and evaluated in writing by a physician who is not
p.000288: participating in the clinical investigation.
p.000288: (3) The investigator must submit the
p.000288: written certification of the determina- tions made by the investigator and an independent physician
p.000288: required in paragraph (e)(1) or (e)(2) of this section to the IRB and FDA within 5 working days after the
p.000288: use of the device.
p.000288: (4) An investigator must disclose the investigational status of the in vitro diagnostic device and what
p.000288: is known about the performance characteristics of the device in the report to the sub- ject’s health care
...
p.000289: available to the IRB at the time of continuing review.
p.000289: (b) The IRB is responsible for ensur-
p.000289: ing that procedures are in place to in- form, at the earliest feasible oppor- tunity, each subject,
p.000289: or if the subject remains incapacitated, a legally au- thorized representative of the subject, or if
p.000289: such a representative is not rea- sonably available, a family member, of the subject’s inclusion in the
p.000289: clinical investigation, the details of the inves- tigation and other information con- tained in the
p.000289: informed consent docu- ment. The IRB shall also ensure that there is a procedure to inform the sub- ject, or if
p.000289: the subject remains incapaci- tated, a legally authorized representa- tive of the subject, or if such a
p.000289: rep- resentative is not reasonably available, a family member, that he or she may discontinue the subject’s
p.000289: participation at any time without penalty or loss of benefits to which the subject is other- wise
p.000289: entitled. If a legally authorized representative or family member is told about the clinical
p.000289: investigation and the subject’s condition improves,
p.000290: 290
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290: Food and Drug Administration, HHS § 50.25
p.000290:
p.000290:
p.000290: the subject is also to be informed as soon as feasible. If a subject is entered into a clinical
p.000290: investigation with waived consent and the subject dies be- fore a legally authorized representative or family member
p.000290: can be contacted, in- formation about the clinical investiga- tion is to be provided to the subject’s
p.000290: legally authorized representative or family member, if feasible.
p.000290: (c) The IRB determinations required
p.000290: by paragraph (a) of this section and the documentation required by paragraph
p.000290: (e) of this section are to be retained by the IRB for at least 3 years after com- pletion of the clinical
p.000290: investigation, and the records shall be accessible for inspection and copying by FDA in ac- cordance
p.000290: with § 56.115(b) of this chap- ter.
p.000290: (d) Protocols involving an exception to the informed consent requirement under this section must be
p.000290: performed under a separate investigational new drug application (IND) or investiga- tional device
p.000290: exemption (IDE) that clearly identifies such protocols as pro- tocols that may include subjects who are
p.000290: unable to consent. The submission of those protocols in a separate IND/ IDE is required even if an IND
p.000290: for the same drug product or an IDE for the same device already exists. Applica- tions for
p.000290: investigations under this sec- tion may not be submitted as amend- ments under §§ 312.30 or 812.35 of
p.000290: this chapter.
p.000290: (e) If an IRB determines that it can-
p.000290: not approve a clinical investigation be- cause the investigation does not meet the criteria in the exception
p.000290: provided under paragraph (a) of this section or because of other relevant ethical con- cerns, the IRB must
p.000290: document its find- ings and provide these findings prompt- ly in writing to the clinical investi- gator and to
p.000290: the sponsor of the clinical investigation. The sponsor of the clin- ical investigation must promptly dis-
p.000290: close this information to FDA and to the sponsor’s clinical investigators who are participating or are asked
p.000290: to par- ticipate in this or a substantially equivalent clinical investigation of the sponsor, and to
p.000290: other IRB’s that have been, or are, asked to review this or a substantially equivalent investigation by
p.000290: that sponsor.
p.000290: [61 FR 51528, Oct. 2, 1996]
p.000290:
p.000290: § 50.25 Elements of informed consent.
p.000290: (a) Basic elements of informed consent. In seeking informed consent, the fol- lowing information shall be
p.000290: provided to each subject:
p.000290: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000290: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000290: and identification of any procedures which are experi- mental.
p.000290: (2) A description of any reasonably foreseeable risks or discomforts to the subject.
p.000290: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000290: research.
p.000290: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000290: might be advan- tageous to the subject.
p.000290: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000290: subject will be maintained and that notes the possi- bility that the Food and Drug Adminis- tration may inspect
p.000290: the records.
p.000290: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000290: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000290: consist of, or where further information may be ob- tained.
p.000290: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000290: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject.
p.000290: (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss
p.000290: of bene- fits to which the subject is otherwise entitled, and that the subject may dis- continue
p.000290: participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
p.000290: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000290: information shall also be provided to each subject:
p.000290: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000290: the embryo
p.000291: 291
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291: § 50.27
p.000291: or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable.
p.000291: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
...
p.000291: before it is signed.
p.000291: (2) A short form written consent docu-
p.000291: ment stating that the elements of in- formed consent required by § 50.25 have been presented orally to
p.000291: the subject or the subject’s legally authorized rep- resentative. When this method is used, there
p.000291: shall be a witness to the oral presentation. Also, the IRB shall ap- prove a written summary of what
p.000291: is to be said to the subject or the represent- ative. Only the short form itself is to be signed by the
p.000291: subject or the rep- resentative. However, the witness shall sign both the short form and a copy of the
p.000291: summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the sum-
p.000291: mary shall be given to the subject or the representative in addition to a copy of the short form.
p.000291: [46 FR 8951, Jan. 27, 1981, as amended at 61
p.000291: FR 57280, Nov. 5, 1996]
p.000291:
p.000291: Subpart C [Reserved]
p.000291: Subpart D—Additional Safeguards for Children in Clinical Inves- tigations
p.000291: SOURCE: 66 FR 20598, Apr. 24, 2001, unless
p.000291: otherwise noted.
p.000291: § 50.50 IRB duties.
p.000291: In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each
p.000291: IRB must
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292: Food and Drug Administration, HHS § 50.54
p.000292:
p.000292:
p.000292: review clinical investigations involving children as subjects covered by this subpart D and approve only
p.000292: those clin- ical investigations that satisfy the cri- teria described in § 50.51, § 50.52, or
p.000292: § 50.53 and the conditions of all other applicable sections of this subpart D.
p.000292: § 50.51 Clinical investigations not in- volving greater than minimal risk.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no
p.000292: greater than minimal risk to children is presented may involve children as subjects only if the IRB finds
p.000292: and documents that adequate provisions are made for solic- iting the assent of the children and the permission of
p.000292: their parents or guard- ians as set forth in § 50.55.
p.000292: § 50.52 Clinical investigations involv- ing greater than minimal risk but presenting the prospect of
p.000292: direct benefit to individual subjects.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more
...
p.000293: care and custody of the child if consistent with State law.
p.000293: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000293: required by
p.000293: § 50.27.
p.000293: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000293: docu- mented.
p.000293: § 50.56 Wards.
p.000293: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000293: clinical in- vestigations approved under § 50.53 or
p.000293: § 50.54 only if such clinical investiga- tions are:
p.000293: (1) Related to their status as wards; or
p.000293: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000293: children in- volved as subjects are not wards.
p.000293: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000293: require appoint- ment of an advocate for each child who is a ward.
p.000293: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000293: guardian or in loco parentis.
p.000293: (2) One individual may serve as advo- cate for more than one child.
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Food and Drug Administration, HHS § 54.2
p.000294:
p.000294:
p.000294: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000294: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000294: investigation.
p.000294: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000294: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000294:
p.000294: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000294: Sec.
p.000294: 54.1 Purpose.
p.000294: 54.2 Definitions.
p.000294: 54.3 Scope.
p.000294: 54.4 Certification and disclosure require- ments.
p.000294: 54.5 Agency evaluation of financial inter- ests.
p.000294: 54.6 Recordkeeping and record retention.
p.000294: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,
p.000294: 355, 360, 360c–360j, 371, 372, 373, 374, 375, 376,
p.000294: 379; 42 U.S.C. 262.
p.000294: SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth-
p.000294: erwise noted.
p.000294: § 54.1 Purpose.
p.000294: (a) The Food and Drug Administra- tion (FDA) evaluates clinical studies submitted in marketing
p.000294: applications, required by law, for new human drugs and biological products and marketing applications and
p.000294: reclassification peti- tions for medical devices.
p.000294: (b) The agency reviews data gen- erated in these clinical studies to de- termine whether the
p.000294: applications are approvable under the statutory re- quirements. FDA may consider clinical studies
p.000294: inadequate and the data inad- equate if, among other things, appro- priate steps have not been taken in the
p.000294: design, conduct, reporting, and anal- ysis of the studies to minimize bias. One potential source of
p.000294: bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study
p.000294: because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary
p.000294: in- terest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor
p.000294: of the covered study. This section and conforming regulations require an applicant whose
p.000294:
p.000294: submission relies in part on clinical data to disclose certain financial ar- rangements between
p.000294: sponsor(s) of the covered studies and the clinical inves- tigators and certain interests of the
p.000294: clinical investigators in the product under study or in the sponsor of the covered studies. FDA will
p.000294: use this in- formation, in conjunction with infor- mation about the design and purpose of the study, as well
p.000294: as information ob- tained through on-site inspections, in the agency’s assessment of the reli- ability
p.000294: of the data.
...
p.000294: a favor- able outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a
p.000294: favorable result or compensation to the investigator in the form of an equity interest in the sponsor of
p.000294: a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.
p.000294: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000294: stock options, or other financial interest whose value cannot be readily determined through reference
p.000294: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000294: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000294: is carrying out the study and for 1 year following comple- tion of the study.
p.000294: (c) Proprietary interest in the tested product means property or other finan- cial interest in the
p.000294: product including, but not limited to, a patent, trade- mark, copyright or licensing agree- ment.
p.000294: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000294: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000294: dependent child of the investigator.
p.000294: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000294: application or reclassification petition subject to
...
Health / Motherhood/Family
Searching for indicator family:
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p.000284: onymous with the term institution for purposes of this part.
p.000284: (i) Institutional revie board (IRB) means any board, committee, or other group formally designated
p.000284: by an insti- tution to review biomedical research involving humans as subjects, to ap- prove the
p.000284: initiation of and conduct periodic review of such research. The term has the same meaning as the
p.000284: phrase institutional revie committee as used in section 520(g) of the act.
p.000284: (j) Test article means any drug (in- cluding a biological product for human use), medical device for
p.000284: human use, human food additive, color additive,
p.000284:
p.000284: electronic product, or any other article subject to regulation under the act or under sections 351 and
p.000284: 354–360F of the Public Health Service Act (42 U.S.C. 262 and 263b–263n).
p.000284: (k) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research
p.000284: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000284: performance of rou- tine physical or psychological exami- nations or tests.
p.000284: (l) Legally authorized representative means an individual or judicial or other body authorized under
p.000284: applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000284: particpation in the procedure(s) in- volved in the research.
p.000284: (m) Family member means any one of the following legally competent per- sons: Spouse; parents; children
p.000284: (includ- ing adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related
p.000284: by blood or af- finity whose close association with the subject is the equivalent of a family re- lationship.
p.000284: (n) Assent means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to
p.000284: object may not, absent affirmative agree- ment, be construed as assent.
p.000284: (o) Children means persons who have not attained the legal age for consent to treatments or procedures
p.000284: involved in clinical investigations, under the ap- plicable law of the jurisdiction in which the
p.000284: clinical investigation will be conducted.
p.000284: (p) Parent means a child’s biological or adoptive parent.
p.000284: (q) Ward means a child who is placed in the legal custody of the State or other agency, institution,
p.000284: or entity, consistent with applicable Federal, State, or local law.
p.000284: (r) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in a
p.000284: clinical investigation. Permission must be ob- tained in compliance with subpart B of this part and must
p.000284: include the ele- ments of informed consent described in
p.000284: § 50.25.
...
p.000289: medical con- dition of the potential class of subjects, the risks and benefits of standard ther- apy, if any, and
p.000289: what is known about the risks and benefits of the proposed intervention or activity.
p.000289: (4) The clinical investigation could not practicably be carried out without the waiver.
p.000289: (5) The proposed investigational plan defines the length of the potential therapeutic window based on
p.000289: scientific evidence, and the investigator has com- mitted to attempting to contact a le- gally authorized
p.000289: representative for each subject within that window of time and, if feasible, to asking the le-
p.000289: gally authorized representative con- tacted for consent within that window rather than proceeding
p.000289: without con- sent. The investigator will summarize efforts made to contact legally author- ized representatives
p.000289: and make this in- formation available to the IRB at the time of continuing review.
p.000289: (6) The IRB has reviewed and ap-
p.000289: proved informed consent procedures and an informed consent document consistent with § 50.25.
p.000289: These proce- dures and the informed consent docu- ment are to be used with subjects or their legally
p.000289: authorized representa- tives in situations where use of such procedures and documents is feasible. The
p.000289: IRB has reviewed and approved procedures and information to be used when providing an opportunity
p.000289: for a family member to object to a subject’s participation in the clinical investiga- tion consistent with
p.000289: paragraph (a)(7)(v) of this section.
p.000289: (7) Additional protections of the
p.000289: rights and welfare of the subjects will be provided, including, at least:
p.000289: (i) Consultation (including, where ap- propriate, consultation carried out by the IRB) with representatives
p.000289: of the communities in which the clinical in- vestigation will be conducted and from which the subjects will be
p.000289: drawn;
p.000289: 21 CFR Ch. I (4–1–12 Edition)
p.000289: (ii) Public disclosure to the commu- nities in which the clinical investiga- tion will be conducted and
p.000289: from which the subjects will be drawn, prior to ini- tiation of the clinical investigation, of plans for the
p.000289: investigation and its risks and expected benefits;
p.000289: (iii) Public disclosure of sufficient in- formation following completion of the clinical investigation to
p.000289: apprise the community and researchers of the study, including the demographic char- acteristics of the
p.000289: research population, and its results;
p.000289: (iv) Establishment of an independent data monitoring committee to exercise oversight of the clinical
p.000289: investigation; and
p.000289: (v) If obtaining informed consent is not feasible and a legally authorized representative is not
p.000289: reasonably avail- able, the investigator has committed, if feasible, to attempting to contact within the
p.000289: therapeutic window the sub- ject’s family member who is not a le- gally authorized representative, and
p.000289: asking whether he or she objects to the subject’s participation in the clinical investigation. The
p.000289: investigator will summarize efforts made to contact family members and make this infor- mation
p.000289: available to the IRB at the time of continuing review.
p.000289: (b) The IRB is responsible for ensur-
p.000289: ing that procedures are in place to in- form, at the earliest feasible oppor- tunity, each subject,
p.000289: or if the subject remains incapacitated, a legally au- thorized representative of the subject, or if
p.000289: such a representative is not rea- sonably available, a family member, of the subject’s inclusion in the
p.000289: clinical investigation, the details of the inves- tigation and other information con- tained in the
p.000289: informed consent docu- ment. The IRB shall also ensure that there is a procedure to inform the sub- ject, or if
p.000289: the subject remains incapaci- tated, a legally authorized representa- tive of the subject, or if such a
p.000289: rep- resentative is not reasonably available, a family member, that he or she may discontinue the subject’s
p.000289: participation at any time without penalty or loss of benefits to which the subject is other- wise
p.000289: entitled. If a legally authorized representative or family member is told about the clinical
p.000289: investigation and the subject’s condition improves,
p.000290: 290
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290: Food and Drug Administration, HHS § 50.25
p.000290:
p.000290:
p.000290: the subject is also to be informed as soon as feasible. If a subject is entered into a clinical
p.000290: investigation with waived consent and the subject dies be- fore a legally authorized representative or family member
p.000290: can be contacted, in- formation about the clinical investiga- tion is to be provided to the subject’s
p.000290: legally authorized representative or family member, if feasible.
p.000290: (c) The IRB determinations required
p.000290: by paragraph (a) of this section and the documentation required by paragraph
p.000290: (e) of this section are to be retained by the IRB for at least 3 years after com- pletion of the clinical
p.000290: investigation, and the records shall be accessible for inspection and copying by FDA in ac- cordance
p.000290: with § 56.115(b) of this chap- ter.
p.000290: (d) Protocols involving an exception to the informed consent requirement under this section must be
p.000290: performed under a separate investigational new drug application (IND) or investiga- tional device
p.000290: exemption (IDE) that clearly identifies such protocols as pro- tocols that may include subjects who are
p.000290: unable to consent. The submission of those protocols in a separate IND/ IDE is required even if an IND
p.000290: for the same drug product or an IDE for the same device already exists. Applica- tions for
p.000290: investigations under this sec- tion may not be submitted as amend- ments under §§ 312.30 or 812.35 of
p.000290: this chapter.
p.000290: (e) If an IRB determines that it can-
p.000290: not approve a clinical investigation be- cause the investigation does not meet the criteria in the exception
p.000290: provided under paragraph (a) of this section or because of other relevant ethical con- cerns, the IRB must
p.000290: document its find- ings and provide these findings prompt- ly in writing to the clinical investi- gator and to
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000286: spe- cific protocol under an investigational new drug application (IND) sponsored by the Department of
p.000286: Defense (DOD) and limited to specific military per- sonnel involved in a particular mili- tary
p.000286: operation is not feasible or is con- trary to the best interests of the mili- tary members involved the
p.000286: Secretary of Defense must first request such a de- termination from the President, and certify and document
p.000286: to the President that the following standards and cri- teria contained in paragraphs (d)(1) through
p.000286: (d)(4) of this section have been met.
p.000286: (i) The extent and strength of evi-
p.000286: dence of the safety and effectiveness of the investigational new drug in rela- tion to the medical risk that
p.000286: could be encountered during the military oper- ation supports the drug’s administra- tion under an IND.
p.000286: (ii) The military operation presents a substantial risk that military per- sonnel may be subject to a
p.000286: chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening
p.000286: injury or illness.
p.000286: (iii) There is no available satisfac- tory alternative therapeutic or preven- tive treatment in relation to
p.000286: the in- tended use of the investigational new drug.
p.000286: (iv) Conditioning use of the inves- tigational new drug on the voluntary participation of each
p.000286: member could significantly risk the safety and health of any individual member who would decline its use, the
p.000286: safety of other mili- tary personnel, and the accomplish- ment of the military mission.
p.000286: (v) A duly constituted institutional review board (IRB) established and op- erated in accordance with the
p.000286: require- ments of paragraphs (d)(2) and (d)(3) of this section, responsible for review of the study, has
p.000286: reviewed and approved the investigational new drug protocol
p.000286:
p.000286: and the administration of the inves- tigational new drug without informed consent. DOD’s request is
p.000286: to include the documentation required by
p.000286: § 56.115(a)(2) of this chapter.
p.000286: (vi) DOD has explained:
p.000286: (A) The context in which the inves- tigational drug will be administered, e.g., the setting or
p.000286: whether it will be self-administered or it will be adminis- tered by a health professional;
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000290: subject will be maintained and that notes the possi- bility that the Food and Drug Adminis- tration may inspect
p.000290: the records.
p.000290: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000290: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000290: consist of, or where further information may be ob- tained.
p.000290: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000290: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject.
p.000290: (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss
p.000290: of bene- fits to which the subject is otherwise entitled, and that the subject may dis- continue
p.000290: participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
p.000290: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000290: information shall also be provided to each subject:
p.000290: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000290: the embryo
p.000291: 291
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291: § 50.27
p.000291: or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable.
p.000291: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000291: investigator without regard to the subject’s con- sent.
p.000291: (3) Any additional costs to the sub- ject that may result from participation in the research.
p.000291: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000291: of participation by the subject.
p.000291: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000291: the subject’s willingness to continue par- ticipation will be provided to the sub- ject.
p.000291: (6) The approximate number of sub- jects involved in the study.
p.000291: (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the
p.000291: following statement shall be provided to each clinical trial subject in informed con- sent documents
p.000291: and processes. This will notify the clinical trial subject that clinical trial information has been or
p.000291: will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402
p.000291: of the Public Health Service Act. The state- ment is: ‘‘A description of this clinical trial will be
p.000291: available on http://
p.000291: .ClinicalTrials.gov, as required by
p.000291: U.S. Law. This Web site will not in- clude information that can identify you. At most, the Web site will
p.000291: include a summary of the results. You can search this Web site at any time.’’
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.000288: required in paragraph (e)(1) or (e)(2) of this section to the IRB and FDA within 5 working days after the
p.000288: use of the device.
p.000288: (4) An investigator must disclose the investigational status of the in vitro diagnostic device and what
p.000288: is known about the performance characteristics of the device in the report to the sub- ject’s health care
p.000288: provider and in any report to public health authorities. The investigator must provide the IRB with the
p.000288: information required in § 50.25 (ex- cept for the information described in
p.000288: § 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the
p.000288: subject’s legally authorized representative at the time the test results are provided to the sub- ject’s health
p.000288: care provider and public health authorities.
p.000288: (5) The IRB is responsible for ensur- ing the adequacy of the information re- quired in section 50.25 (except
p.000288: for the information described in § 50.25(a)(8)) and for ensuring that procedures are in place to provide
p.000288: this information to each subject or the subject’s legally au- thorized representative.
p.000288: (6) No State or political subdivision of a State may establish or continue in effect any law, rule,
p.000288: regulation or
p.000288:
p.000288: other requirement that informed con- sent be obtained before an investiga- tional in vitro diagnostic
p.000288: device may be used to identify chemical, biologi- cal, radiological, or nuclear agent in suspected
p.000288: terrorism events and other potential public health emergencies that is different from, or in addition to,
p.000288: the requirements of this regulation.
p.000288: [46 FR 8951, Jan. 27, 1981, as amended at 55
p.000288: FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999;
p.000288: 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7,
p.000288: 2006; 76 FR 36993, June 24, 2011]
p.000288:
p.000288: § 50.24 Exception from informed con- sent requirements for emergency research.
p.000288: (a) The IRB responsible for the re- view, approval, and continuing review of the clinical investigation
p.000288: described in this section may approve that inves- tigation without requiring that in- formed consent of all
p.000288: research subjects be obtained if the IRB (with the con- currence of a licensed physician who is a member of
p.000288: or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and
p.000288: documents each of the following:
p.000288: (1) The human subjects are in a life- threatening situation, available treat- ments are unproven or
p.000288: unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained
p.000288: through randomized placebo- controlled investigations, is necessary to determine the safety and effective-
p.000288: ness of particular interventions.
p.000288: (2) Obtaining informed consent is not feasible because:
p.000288: (i) The subjects will not be able to give their informed consent as a result of their medical condition;
...
Social / Age
Searching for indicator age:
(return to top)
p.000284: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000284: performance of rou- tine physical or psychological exami- nations or tests.
p.000284: (l) Legally authorized representative means an individual or judicial or other body authorized under
p.000284: applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000284: particpation in the procedure(s) in- volved in the research.
p.000284: (m) Family member means any one of the following legally competent per- sons: Spouse; parents; children
p.000284: (includ- ing adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related
p.000284: by blood or af- finity whose close association with the subject is the equivalent of a family re- lationship.
p.000284: (n) Assent means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to
p.000284: object may not, absent affirmative agree- ment, be construed as assent.
p.000284: (o) Children means persons who have not attained the legal age for consent to treatments or procedures
p.000284: involved in clinical investigations, under the ap- plicable law of the jurisdiction in which the
p.000284: clinical investigation will be conducted.
p.000284: (p) Parent means a child’s biological or adoptive parent.
p.000284: (q) Ward means a child who is placed in the legal custody of the State or other agency, institution,
p.000284: or entity, consistent with applicable Federal, State, or local law.
p.000284: (r) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in a
p.000284: clinical investigation. Permission must be ob- tained in compliance with subpart B of this part and must
p.000284: include the ele- ments of informed consent described in
p.000284: § 50.25.
p.000284: (s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000284: of a
p.000285: 285
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285: § 50.20
p.000285: child to general medical care when general medical care includes partici- pation in research. For
p.000285: purposes of sub- part D of this part, a guardian also means an individual who is authorized to
...
Social / Child
Searching for indicator child:
(return to top)
p.000284:
p.000284: electronic product, or any other article subject to regulation under the act or under sections 351 and
p.000284: 354–360F of the Public Health Service Act (42 U.S.C. 262 and 263b–263n).
p.000284: (k) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research
p.000284: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000284: performance of rou- tine physical or psychological exami- nations or tests.
p.000284: (l) Legally authorized representative means an individual or judicial or other body authorized under
p.000284: applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000284: particpation in the procedure(s) in- volved in the research.
p.000284: (m) Family member means any one of the following legally competent per- sons: Spouse; parents; children
p.000284: (includ- ing adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related
p.000284: by blood or af- finity whose close association with the subject is the equivalent of a family re- lationship.
p.000284: (n) Assent means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to
p.000284: object may not, absent affirmative agree- ment, be construed as assent.
p.000284: (o) Children means persons who have not attained the legal age for consent to treatments or procedures
p.000284: involved in clinical investigations, under the ap- plicable law of the jurisdiction in which the
p.000284: clinical investigation will be conducted.
p.000284: (p) Parent means a child’s biological or adoptive parent.
p.000284: (q) Ward means a child who is placed in the legal custody of the State or other agency, institution,
p.000284: or entity, consistent with applicable Federal, State, or local law.
p.000284: (r) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in a
p.000284: clinical investigation. Permission must be ob- tained in compliance with subpart B of this part and must
p.000284: include the ele- ments of informed consent described in
p.000284: § 50.25.
p.000284: (s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000284: of a
p.000285: 285
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285: § 50.20
p.000285: child to general medical care when general medical care includes partici- pation in research. For
p.000285: purposes of sub- part D of this part, a guardian also means an individual who is authorized to
p.000285: consent on behalf of a child to par- ticipate in research.
p.000285: [45 FR 36390, May 30, 1980, as amended at 46
p.000285: FR 8950, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989;
p.000285: 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2,
p.000285: 1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan.
p.000285: 5, 1999; 64 FR 56448, Oct. 20, 1999; 66 FR 20597,
p.000285: Apr. 24, 2001]
p.000285:
p.000285: Subpart B—Informed Consent of Human Subjects
p.000285: SOURCE: 46 FR 8951, Jan. 27, 1981, unless
p.000285: otherwise noted.
p.000285:
p.000285: § 50.20 General requirements for in- formed consent.
p.000285: Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a
p.000285: subject in research covered by these regulations unless the investigator has obtained the legally effective
p.000285: informed consent of the sub- ject or the subject’s legally authorized representative. An investigator
p.000285: shall seek such consent only under cir- cumstances that provide the prospec- tive subject or the
p.000285: representative suffi- cient opportunity to consider whether or not to participate and that minimize the possibility
p.000285: of coercion or undue in- fluence. The information that is given to the subject or the representative
p.000285: shall be in language understandable to the subject or the representative. No informed consent, whether oral
...
p.000293: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000293: parents or guardians as set forth in § 50.55.
p.000293: § 50.55 Requirements for permission by parents or guardians and for as- sent by children.
p.000293: (a) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that adequate provisions are made for soliciting the assent of the children when in
p.000293: the judgment of the IRB the children are capable of pro- viding assent.
p.000293: (b) In determining whether children are capable of providing assent, the IRB must take into account
p.000293: the ages, maturity, and psychological state of the children involved. This judgment may be made for
p.000293: all children to be in- volved in clinical investigations under a particular protocol, or for each child, as the
p.000293: IRB deems appropriate.
p.000293: (c) The assent of the children is not a necessary condition for proceeding with the clinical investigation
p.000293: if the IRB determines:
p.000293: (1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted,
p.000293: or
p.000293: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000293: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000293: in the context of the clinical investigation.
p.000293: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000293: requirement if it finds and documents that:
p.000293: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000293: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000293: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000293: 21 CFR Ch. I (4–1–12 Edition)
p.000293: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000293: participa- tion.
p.000293: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that the permission of each child’s parents or guardian is granted.
p.000293: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000293: sufficient, if consistent with State law, for clin- ical investigations to be conducted under § 50.51 or
p.000293: § 50.52.
p.000293: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000293: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000293: known, incompetent, or not reasonably available, or when only one parent has legal responsibility for the
p.000293: care and custody of the child if consistent with State law.
p.000293: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000293: required by
p.000293: § 50.27.
p.000293: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000293: docu- mented.
p.000293: § 50.56 Wards.
p.000293: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000293: clinical in- vestigations approved under § 50.53 or
p.000293: § 50.54 only if such clinical investiga- tions are:
p.000293: (1) Related to their status as wards; or
p.000293: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000293: children in- volved as subjects are not wards.
p.000293: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000293: require appoint- ment of an advocate for each child who is a ward.
p.000293: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000293: guardian or in loco parentis.
p.000293: (2) One individual may serve as advo- cate for more than one child.
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Food and Drug Administration, HHS § 54.2
p.000294:
p.000294:
p.000294: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000294: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000294: investigation.
p.000294: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000294: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000294:
p.000294: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000294: Sec.
p.000294: 54.1 Purpose.
p.000294: 54.2 Definitions.
p.000294: 54.3 Scope.
p.000294: 54.4 Certification and disclosure require- ments.
p.000294: 54.5 Agency evaluation of financial inter- ests.
p.000294: 54.6 Recordkeeping and record retention.
p.000294: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,
p.000294: 355, 360, 360c–360j, 371, 372, 373, 374, 375, 376,
p.000294: 379; 42 U.S.C. 262.
p.000294: SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth-
p.000294: erwise noted.
p.000294: § 54.1 Purpose.
p.000294: (a) The Food and Drug Administra- tion (FDA) evaluates clinical studies submitted in marketing
p.000294: applications, required by law, for new human drugs and biological products and marketing applications and
p.000294: reclassification peti- tions for medical devices.
p.000294: (b) The agency reviews data gen- erated in these clinical studies to de- termine whether the
p.000294: applications are approvable under the statutory re- quirements. FDA may consider clinical studies
p.000294: inadequate and the data inad- equate if, among other things, appro- priate steps have not been taken in the
p.000294: design, conduct, reporting, and anal- ysis of the studies to minimize bias. One potential source of
...
p.000294: of the data.
p.000294: § 54.2 Definitions.
p.000294: For the purposes of this part:
p.000294: (a) Compensation affected by the out- come of clinical studies means compensa- tion that could be higher for
p.000294: a favor- able outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a
p.000294: favorable result or compensation to the investigator in the form of an equity interest in the sponsor of
p.000294: a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.
p.000294: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000294: stock options, or other financial interest whose value cannot be readily determined through reference
p.000294: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000294: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000294: is carrying out the study and for 1 year following comple- tion of the study.
p.000294: (c) Proprietary interest in the tested product means property or other finan- cial interest in the
p.000294: product including, but not limited to, a patent, trade- mark, copyright or licensing agree- ment.
p.000294: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000294: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000294: dependent child of the investigator.
p.000294: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000294: application or reclassification petition subject to
...
Searching for indicator children:
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p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283: Food and Drug Administration, HHS § 50.3
p.000283:
p.000283: PART 50—PROTECTION OF HUMAN SUBJECTS
p.000283: Subpart A—General Provisions
p.000283: Sec.
p.000283: 50.1 Scope.
p.000283: 50.3 Definitions.
p.000283: Subpart B—Informed Consent of Human Subjects
p.000283: 50.20 General requirements for informed consent.
p.000283: 50.23 Exception from general requirements.
p.000283: 50.24 Exception from informed consent re- quirements for emergency research.
p.000283: 50.25 Elements of informed consent.
p.000283: 50.27 Documentation of informed consent.
p.000283: Subpart C [Reserved]
p.000283: Subpart D—Additional Safeguards for Children in Clinical Investigations
p.000283: 50.50 IRB duties.
p.000283: 50.51 Clinical investigations not involving greater than minimal risk.
p.000283: 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of
p.000283: direct benefit to indi- vidual subjects.
p.000283: 50.53 Clinical investigations involving greater than minimal risk and no pros- pect of direct
p.000283: benefit to individual sub- jects, but likely to yield generalizable knowledge about the subjects’ disorder
p.000283: or condition.
p.000283: 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or
p.000283: alleviate a se- rious problem affecting the health or welfare of children.
p.000283: 50.55 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000283: 50.56 Wards.
p.000283: AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348,
p.000283: 350a, 350b, 352, 353, 355, 360, 360c–360f, 360h–
p.000283: 360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b–
p.000283: 263n.
p.000283: SOURCE: 45 FR 36390, May 30, 1980, unless
p.000283: otherwise noted.
p.000283:
p.000283: Subpart A—General Provisions
p.000283: § 50.1 Scope.
p.000283: (a) This part applies to all clinical in- vestigations regulated by the Food and Drug Administration under
p.000283: sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical
p.000283: investigations that support ap- plications for research or marketing
p.000283:
p.000283: permits for products regulated by the Food and Drug Administration, includ- ing foods, including dietary
p.000283: supple- ments, that bear a nutrient content claim or a health claim, infant for- mulas, food
p.000283: and color additives, drugs for human use, medical devices for human use, biological products
p.000283: for human use, and electronic products. Additional specific obligations and commitments of, and
p.000283: standards of con- duct for, persons who sponsor or mon- itor clinical investigations involving particular
p.000283: test articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is in-
...
p.000283: amending, or repealing a standard for these de- vices, described in section 514.
p.000283: 21 CFR Ch. I (4–1–12 Edition)
p.000283: (18) An application for premarket ap- proval of a medical device, described in section 515.
p.000283: (19) A product development protocol for a medical device, described in sec- tion 515.
p.000283: (20) Data and information about an electronic product submitted as part of the procedures for establishing, amend-
p.000283: ing, or repealing a standard for these products, described in section 358 of the Public Health Service Act.
p.000283: (21) Data and information about an electronic product submitted as part of the procedures for obtaining a variance
p.000283: from any electronic product perform- ance standard, as described in § 1010.4.
p.000283: (22) Data and information about an electronic product submitted as part of the procedures for granting,
p.000283: amending, or extending an exemption from a radi- ation safety performance standard, as described in § 1010.5.
p.000283: (23) Data and information about a clinical study of an infant formula when submitted as part of
p.000283: an infant formula notification under section 412(c) of the Federal Food, Drug, and Cosmetic Act.
p.000283: (24) Data and information submitted in a petition for a nutrient content claim, described in § 101.69
p.000283: of this chap- ter, or for a health claim, described in
p.000283: § 101.70 of this chapter.
p.000283: (25) Data and information from inves- tigations involving children submitted in a new dietary ingredient
p.000283: notifica- tion, described in § 190.6 of this chapter.
p.000283: (c) Clinical investigation means any experiment that involves a test article and one or more human
p.000283: subjects and that either is subject to requirements for prior submission to the Food and Drug
p.000283: Administration under section 505(i) or 520(g) of the act, or is not sub- ject to requirements for prior
p.000283: submis- sion to the Food and Drug Administra- tion under these sections of the act, but the results of which are
p.000283: intended to be submitted later to, or held for in- spection by, the Food and Drug Admin- istration as part of an
p.000283: application for a research or marketing permit. The term does not include experiments that are subject to
p.000283: the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.
p.000284: 284
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284: Food and Drug Administration, HHS § 50.3
p.000284:
p.000284:
p.000284: (d) Investigator means an individual who actually conducts a clinical inves- tigation, i.e., under whose
p.000284: immediate direction the test article is adminis- tered or dispensed to, or used involv- ing, a subject, or,
p.000284: in the event of an in- vestigation conducted by a team of in- dividuals, is the responsible leader of that
p.000284: team.
...
p.000284: by an insti- tution to review biomedical research involving humans as subjects, to ap- prove the
p.000284: initiation of and conduct periodic review of such research. The term has the same meaning as the
p.000284: phrase institutional revie committee as used in section 520(g) of the act.
p.000284: (j) Test article means any drug (in- cluding a biological product for human use), medical device for
p.000284: human use, human food additive, color additive,
p.000284:
p.000284: electronic product, or any other article subject to regulation under the act or under sections 351 and
p.000284: 354–360F of the Public Health Service Act (42 U.S.C. 262 and 263b–263n).
p.000284: (k) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research
p.000284: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000284: performance of rou- tine physical or psychological exami- nations or tests.
p.000284: (l) Legally authorized representative means an individual or judicial or other body authorized under
p.000284: applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000284: particpation in the procedure(s) in- volved in the research.
p.000284: (m) Family member means any one of the following legally competent per- sons: Spouse; parents; children
p.000284: (includ- ing adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related
p.000284: by blood or af- finity whose close association with the subject is the equivalent of a family re- lationship.
p.000284: (n) Assent means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to
p.000284: object may not, absent affirmative agree- ment, be construed as assent.
p.000284: (o) Children means persons who have not attained the legal age for consent to treatments or procedures
p.000284: involved in clinical investigations, under the ap- plicable law of the jurisdiction in which the
p.000284: clinical investigation will be conducted.
p.000284: (p) Parent means a child’s biological or adoptive parent.
p.000284: (q) Ward means a child who is placed in the legal custody of the State or other agency, institution,
p.000284: or entity, consistent with applicable Federal, State, or local law.
p.000284: (r) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in a
p.000284: clinical investigation. Permission must be ob- tained in compliance with subpart B of this part and must
p.000284: include the ele- ments of informed consent described in
p.000284: § 50.25.
p.000284: (s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000284: of a
p.000285: 285
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285: § 50.20
...
p.000291: (1) A written consent document that embodies the elements of informed consent required by § 50.25.
p.000291: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but, in any
p.000291: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000291: before it is signed.
p.000291: (2) A short form written consent docu-
p.000291: ment stating that the elements of in- formed consent required by § 50.25 have been presented orally to
p.000291: the subject or the subject’s legally authorized rep- resentative. When this method is used, there
p.000291: shall be a witness to the oral presentation. Also, the IRB shall ap- prove a written summary of what
p.000291: is to be said to the subject or the represent- ative. Only the short form itself is to be signed by the
p.000291: subject or the rep- resentative. However, the witness shall sign both the short form and a copy of the
p.000291: summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the sum-
p.000291: mary shall be given to the subject or the representative in addition to a copy of the short form.
p.000291: [46 FR 8951, Jan. 27, 1981, as amended at 61
p.000291: FR 57280, Nov. 5, 1996]
p.000291:
p.000291: Subpart C [Reserved]
p.000291: Subpart D—Additional Safeguards for Children in Clinical Inves- tigations
p.000291: SOURCE: 66 FR 20598, Apr. 24, 2001, unless
p.000291: otherwise noted.
p.000291: § 50.50 IRB duties.
p.000291: In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each
p.000291: IRB must
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292: Food and Drug Administration, HHS § 50.54
p.000292:
p.000292:
p.000292: review clinical investigations involving children as subjects covered by this subpart D and approve only
p.000292: those clin- ical investigations that satisfy the cri- teria described in § 50.51, § 50.52, or
p.000292: § 50.53 and the conditions of all other applicable sections of this subpart D.
p.000292: § 50.51 Clinical investigations not in- volving greater than minimal risk.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no
p.000292: greater than minimal risk to children is presented may involve children as subjects only if the IRB finds
p.000292: and documents that adequate provisions are made for solic- iting the assent of the children and the permission of
p.000292: their parents or guard- ians as set forth in § 50.55.
p.000292: § 50.52 Clinical investigations involv- ing greater than minimal risk but presenting the prospect of
p.000292: direct benefit to individual subjects.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more
p.000292: than mini- mal risk to children is presented by an intervention or procedure that holds out the prospect of
p.000292: direct benefit for the individual subject, or by a moni- toring procedure that is likely to con- tribute
p.000292: to the subject’s well-being, may involve children as subjects only if the IRB finds and documents that:
p.000292: (a) The risk is justified by the antici-
p.000292: pated benefit to the subjects;
p.000292: (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000292: as that presented by available alternative approaches; and
p.000292: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292: § 50.53 Clinical investigations involv- ing greater than minimal risk and no prospect of direct benefit
p.000292: to in- dividual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more
p.000292: than mini- mal risk to children is presented by an intervention or procedure that does not hold out the prospect
p.000292: of direct benefit
p.000292:
p.000292: for the individual subject, or by a mon- itoring procedure that is not likely to contribute to the well-being of
p.000292: the sub- ject, may involve children as subjects only if the IRB finds and documents that:
p.000292: (a) The risk represents a minor in- crease over minimal risk;
p.000292: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000292: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000292: educational situations;
p.000292: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000292: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000292: condition; and
p.000292: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292:
p.000292: § 50.54 Clinical investigations not oth- erwise approvable that present an opportunity to understand, prevent,
p.000292: or alleviate a serious problem af- fecting the health or welfare of chil- dren.
p.000292: If an IRB does not believe that a clin- ical investigation within the scope de- scribed in §§ 50.1 and 56.101 of
p.000292: this chap- ter and involving children as subjects meets the requirements of § 50.51,
p.000292: § 50.52, or § 50.53, the clinical investiga- tion may proceed only if:
p.000292: (a) The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further
p.000292: the understanding, prevention, or allevi- ation of a serious problem affecting the health or welfare of
p.000292: children; and
p.000292: (b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent
p.000292: disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public
p.000292: review and comment, deter- mines either:
p.000292: (1) That the clinical investigation in fact satisfies the conditions of § 50.51,
p.000292: § 50.52, or § 50.53, as applicable, or
p.000292: (2) That the following conditions are met:
p.000292: (i) The clinical investigation presents a reasonable opportunity to further the
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 50.55
p.000293: understanding, prevention, or allevi- ation of a serious problem affecting the health or welfare of children;
p.000293: (ii) The clinical investigation will be conducted in accordance with sound ethical principles; and
p.000293: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000293: parents or guardians as set forth in § 50.55.
p.000293: § 50.55 Requirements for permission by parents or guardians and for as- sent by children.
p.000293: (a) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that adequate provisions are made for soliciting the assent of the children when in
p.000293: the judgment of the IRB the children are capable of pro- viding assent.
p.000293: (b) In determining whether children are capable of providing assent, the IRB must take into account
p.000293: the ages, maturity, and psychological state of the children involved. This judgment may be made for
p.000293: all children to be in- volved in clinical investigations under a particular protocol, or for each child, as the
p.000293: IRB deems appropriate.
p.000293: (c) The assent of the children is not a necessary condition for proceeding with the clinical investigation
p.000293: if the IRB determines:
p.000293: (1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted,
p.000293: or
p.000293: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000293: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000293: in the context of the clinical investigation.
p.000293: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000293: requirement if it finds and documents that:
p.000293: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000293: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000293: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000293: 21 CFR Ch. I (4–1–12 Edition)
p.000293: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000293: participa- tion.
p.000293: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that the permission of each child’s parents or guardian is granted.
p.000293: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000293: sufficient, if consistent with State law, for clin- ical investigations to be conducted under § 50.51 or
p.000293: § 50.52.
p.000293: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000293: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000293: known, incompetent, or not reasonably available, or when only one parent has legal responsibility for the
p.000293: care and custody of the child if consistent with State law.
p.000293: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000293: required by
p.000293: § 50.27.
p.000293: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000293: docu- mented.
p.000293: § 50.56 Wards.
p.000293: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000293: clinical in- vestigations approved under § 50.53 or
p.000293: § 50.54 only if such clinical investiga- tions are:
p.000293: (1) Related to their status as wards; or
p.000293: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000293: children in- volved as subjects are not wards.
p.000293: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000293: require appoint- ment of an advocate for each child who is a ward.
p.000293: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000293: guardian or in loco parentis.
p.000293: (2) One individual may serve as advo- cate for more than one child.
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Food and Drug Administration, HHS § 54.2
p.000294:
p.000294:
p.000294: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000294: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000294: investigation.
p.000294: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000294: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000294:
p.000294: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000294: Sec.
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Social / Fetus/Neonate
Searching for indicator fetus:
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p.000290: might be advan- tageous to the subject.
p.000290: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000290: subject will be maintained and that notes the possi- bility that the Food and Drug Adminis- tration may inspect
p.000290: the records.
p.000290: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000290: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000290: consist of, or where further information may be ob- tained.
p.000290: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000290: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject.
p.000290: (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss
p.000290: of bene- fits to which the subject is otherwise entitled, and that the subject may dis- continue
p.000290: participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
p.000290: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000290: information shall also be provided to each subject:
p.000290: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000290: the embryo
p.000291: 291
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291: § 50.27
p.000291: or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable.
p.000291: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000291: investigator without regard to the subject’s con- sent.
p.000291: (3) Any additional costs to the sub- ject that may result from participation in the research.
p.000291: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000291: of participation by the subject.
p.000291: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000291: the subject’s willingness to continue par- ticipation will be provided to the sub- ject.
p.000291: (6) The approximate number of sub- jects involved in the study.
p.000291: (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the
p.000291: following statement shall be provided to each clinical trial subject in informed con- sent documents
p.000291: and processes. This will notify the clinical trial subject that clinical trial information has been or
p.000291: will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402
p.000291: of the Public Health Service Act. The state- ment is: ‘‘A description of this clinical trial will be
p.000291: available on http://
p.000291: .ClinicalTrials.gov, as required by
p.000291: U.S. Law. This Web site will not in- clude information that can identify you. At most, the Web site will
...
Social / Infant
Searching for indicator infant:
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p.000283: benefit to individual sub- jects, but likely to yield generalizable knowledge about the subjects’ disorder
p.000283: or condition.
p.000283: 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or
p.000283: alleviate a se- rious problem affecting the health or welfare of children.
p.000283: 50.55 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000283: 50.56 Wards.
p.000283: AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348,
p.000283: 350a, 350b, 352, 353, 355, 360, 360c–360f, 360h–
p.000283: 360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b–
p.000283: 263n.
p.000283: SOURCE: 45 FR 36390, May 30, 1980, unless
p.000283: otherwise noted.
p.000283:
p.000283: Subpart A—General Provisions
p.000283: § 50.1 Scope.
p.000283: (a) This part applies to all clinical in- vestigations regulated by the Food and Drug Administration under
p.000283: sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical
p.000283: investigations that support ap- plications for research or marketing
p.000283:
p.000283: permits for products regulated by the Food and Drug Administration, includ- ing foods, including dietary
p.000283: supple- ments, that bear a nutrient content claim or a health claim, infant for- mulas, food
p.000283: and color additives, drugs for human use, medical devices for human use, biological products
p.000283: for human use, and electronic products. Additional specific obligations and commitments of, and
p.000283: standards of con- duct for, persons who sponsor or mon- itor clinical investigations involving particular
p.000283: test articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is in-
p.000283: tended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug
p.000283: Adminis- tration pursuant to sections 403, 406,
p.000283: 409, 412, 413, 502, 503, 505, 510, 513–516,
p.000283: 518–520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sec- tions 351 and
p.000283: 354–360F of the Public Health Service Act.
p.000283: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000283: title 21, unless otherwise noted.
p.000283: [45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27,
p.000283: 1981, as amended at 63 FR 26697, May 13, 1998;
p.000283: 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24,
p.000283: 2001]
p.000283: § 50.3 Definitions.
p.000283: As used in this part:
p.000283: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040
p.000283: et seq. as amended (21 U.S.C. 321–392)).
p.000283: (b) Application for research or mar- keting permit includes:
...
p.000283: (14) Data and information about an in vitro diagnostic product submitted as part of the procedures for
p.000283: establishing, amending, or repealing a standard for these products, described in part 809.
p.000283: (15) An Application for an Investiga- tional Device Exemption, described in part 812.
p.000283: (16) Data and information about a medical device submitted as part of the procedures for classifying
p.000283: these de- vices, described in section 513.
p.000283: (17) Data and information about a medical device submitted as part of the procedures for establishing,
p.000283: amending, or repealing a standard for these de- vices, described in section 514.
p.000283: 21 CFR Ch. I (4–1–12 Edition)
p.000283: (18) An application for premarket ap- proval of a medical device, described in section 515.
p.000283: (19) A product development protocol for a medical device, described in sec- tion 515.
p.000283: (20) Data and information about an electronic product submitted as part of the procedures for establishing, amend-
p.000283: ing, or repealing a standard for these products, described in section 358 of the Public Health Service Act.
p.000283: (21) Data and information about an electronic product submitted as part of the procedures for obtaining a variance
p.000283: from any electronic product perform- ance standard, as described in § 1010.4.
p.000283: (22) Data and information about an electronic product submitted as part of the procedures for granting,
p.000283: amending, or extending an exemption from a radi- ation safety performance standard, as described in § 1010.5.
p.000283: (23) Data and information about a clinical study of an infant formula when submitted as part of
p.000283: an infant formula notification under section 412(c) of the Federal Food, Drug, and Cosmetic Act.
p.000283: (24) Data and information submitted in a petition for a nutrient content claim, described in § 101.69
p.000283: of this chap- ter, or for a health claim, described in
p.000283: § 101.70 of this chapter.
p.000283: (25) Data and information from inves- tigations involving children submitted in a new dietary ingredient
p.000283: notifica- tion, described in § 190.6 of this chapter.
p.000283: (c) Clinical investigation means any experiment that involves a test article and one or more human
p.000283: subjects and that either is subject to requirements for prior submission to the Food and Drug
p.000283: Administration under section 505(i) or 520(g) of the act, or is not sub- ject to requirements for prior
p.000283: submis- sion to the Food and Drug Administra- tion under these sections of the act, but the results of which are
p.000283: intended to be submitted later to, or held for in- spection by, the Food and Drug Admin- istration as part of an
p.000283: application for a research or marketing permit. The term does not include experiments that are subject to
p.000283: the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.
p.000284: 284
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284: Food and Drug Administration, HHS § 50.3
p.000284:
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000285: consent on behalf of a child to par- ticipate in research.
p.000285: [45 FR 36390, May 30, 1980, as amended at 46
p.000285: FR 8950, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989;
p.000285: 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2,
p.000285: 1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan.
p.000285: 5, 1999; 64 FR 56448, Oct. 20, 1999; 66 FR 20597,
p.000285: Apr. 24, 2001]
p.000285:
p.000285: Subpart B—Informed Consent of Human Subjects
p.000285: SOURCE: 46 FR 8951, Jan. 27, 1981, unless
p.000285: otherwise noted.
p.000285:
p.000285: § 50.20 General requirements for in- formed consent.
p.000285: Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a
p.000285: subject in research covered by these regulations unless the investigator has obtained the legally effective
p.000285: informed consent of the sub- ject or the subject’s legally authorized representative. An investigator
p.000285: shall seek such consent only under cir- cumstances that provide the prospec- tive subject or the
p.000285: representative suffi- cient opportunity to consider whether or not to participate and that minimize the possibility
p.000285: of coercion or undue in- fluence. The information that is given to the subject or the representative
p.000285: shall be in language understandable to the subject or the representative. No informed consent, whether oral
p.000285: or writ- ten, may include any exculpatory lan- guage through which the subject or the representative is made to
p.000285: waive or ap- pear to waive any of the subject’s legal rights, or releases or appears to release the investigator,
p.000285: the sponsor, the insti- tution, or its agents from liability for negligence.
p.000285: [46 FR 8951, Jan. 27, 1981, as amended at 64
p.000285: FR 10942, Mar. 8, 1999]
p.000285:
p.000285: § 50.23 Exception from general re- quirements.
p.000285: (a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except
p.000285: as pro- vided in paragraph (b) of this section), both the investigator and a physician
p.000285: 21 CFR Ch. I (4–1–12 Edition)
p.000285: who is not otherwise participating in the clinical investigation certify in writing all of the following:
p.000285: (1) The human subject is confronted by a life-threatening situation necessi- tating the use of the test
p.000285: article.
p.000285: (2) Informed consent cannot be ob- tained from the subject because of an inability to communicate with,
p.000285: or ob- tain legally effective consent from, the subject.
p.000285: (3) Time is not sufficient to obtain consent from the subject’s legal rep- resentative.
p.000285: (4) There is available no alternative method of approved or generally recog- nized therapy that provides an equal
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000294: sponsor(s) of the covered studies and the clinical inves- tigators and certain interests of the
p.000294: clinical investigators in the product under study or in the sponsor of the covered studies. FDA will
p.000294: use this in- formation, in conjunction with infor- mation about the design and purpose of the study, as well
p.000294: as information ob- tained through on-site inspections, in the agency’s assessment of the reli- ability
p.000294: of the data.
p.000294: § 54.2 Definitions.
p.000294: For the purposes of this part:
p.000294: (a) Compensation affected by the out- come of clinical studies means compensa- tion that could be higher for
p.000294: a favor- able outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a
p.000294: favorable result or compensation to the investigator in the form of an equity interest in the sponsor of
p.000294: a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.
p.000294: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000294: stock options, or other financial interest whose value cannot be readily determined through reference
p.000294: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000294: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000294: is carrying out the study and for 1 year following comple- tion of the study.
p.000294: (c) Proprietary interest in the tested product means property or other finan- cial interest in the
p.000294: product including, but not limited to, a patent, trade- mark, copyright or licensing agree- ment.
p.000294: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000294: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000294: dependent child of the investigator.
p.000294: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000294: application or reclassification petition subject to
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000285: or ob- tain legally effective consent from, the subject.
p.000285: (3) Time is not sufficient to obtain consent from the subject’s legal rep- resentative.
p.000285: (4) There is available no alternative method of approved or generally recog- nized therapy that provides an equal
p.000285: or greater likelihood of saving the life of the subject.
p.000285: (b) If immediate use of the test arti- cle is, in the investigator’s opinion, re- quired to preserve the
p.000285: life of the sub- ject, and time is not sufficient to ob- tain the independent determination re- quired in
p.000285: paragraph (a) of this section in advance of using the test article, the determinations of the clinical investi-
p.000285: gator shall be made and, within 5 work- ing days after the use of the article, be reviewed and evaluated in writing by
p.000285: a physician who is not participating in the clinical investigation.
p.000285: (c) The documentation required in
p.000285: paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after
p.000285: the use of the test article.
p.000285: (d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior consent requirement for the
p.000285: administration of an investigational new drug to a mem- ber of the armed forces in connection with the
p.000285: member’s participation in a particular military operation. The statute specifies that only the Presi-
p.000285: dent may waive informed consent in this connection and the President may grant such a waiver only if
p.000285: the Presi- dent determines in writing that obtain- ing consent: Is not feasible; is contrary to the best interests
p.000285: of the military member; or is not in the interests of national security. The statute further provides
p.000285: that in making a determina- tion to waive prior informed consent on the ground that it is not feasible or the
p.000285: ground that it is contrary to the best interests of the military members involved, the President shall
p.000285: apply the
p.000286: 286
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286: Food and Drug Administration, HHS § 50.23
p.000286:
p.000286:
p.000286: standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior
p.000286: informed con- sent requirements of section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000286: 355(i)(4)). Before such a determination may be made that ob- taining informed consent from mili- tary
p.000286: personnel prior to the use of an in- vestigational drug (including an anti- biotic or biological product) in a
p.000286: spe- cific protocol under an investigational new drug application (IND) sponsored by the Department of
p.000286: Defense (DOD) and limited to specific military per- sonnel involved in a particular mili- tary
p.000286: operation is not feasible or is con- trary to the best interests of the mili- tary members involved the
p.000286: Secretary of Defense must first request such a de- termination from the President, and certify and document
p.000286: to the President that the following standards and cri- teria contained in paragraphs (d)(1) through
p.000286: (d)(4) of this section have been met.
p.000286: (i) The extent and strength of evi-
p.000286: dence of the safety and effectiveness of the investigational new drug in rela- tion to the medical risk that
p.000286: could be encountered during the military oper- ation supports the drug’s administra- tion under an IND.
p.000286: (ii) The military operation presents a substantial risk that military per- sonnel may be subject to a
p.000286: chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening
p.000286: injury or illness.
p.000286: (iii) There is no available satisfac- tory alternative therapeutic or preven- tive treatment in relation to
p.000286: the in- tended use of the investigational new drug.
p.000286: (iv) Conditioning use of the inves- tigational new drug on the voluntary participation of each
p.000286: member could significantly risk the safety and health of any individual member who would decline its use, the
p.000286: safety of other mili- tary personnel, and the accomplish- ment of the military mission.
p.000286: (v) A duly constituted institutional review board (IRB) established and op- erated in accordance with the
p.000286: require- ments of paragraphs (d)(2) and (d)(3) of this section, responsible for review of the study, has
p.000286: reviewed and approved the investigational new drug protocol
p.000286:
p.000286: and the administration of the inves- tigational new drug without informed consent. DOD’s request is
p.000286: to include the documentation required by
p.000286: § 56.115(a)(2) of this chapter.
p.000286: (vi) DOD has explained:
p.000286: (A) The context in which the inves- tigational drug will be administered, e.g., the setting or
p.000286: whether it will be self-administered or it will be adminis- tered by a health professional;
p.000286: (B) The nature of the disease or con- dition for which the preventive or therapeutic treatment is
p.000286: intended; and
p.000286: (C) To the extent there are existing data or information available, informa- tion on conditions that could
p.000286: alter the effects of the investigational drug.
p.000286: (vii) DOD’s recordkeeping system is capable of tracking and will be used to track the proposed treatment
p.000286: from supplier to the individual recipient.
p.000286: (viii) Each member involved in the military operation will be given, prior to the administration of the
p.000286: investiga- tional new drug, a specific written in- formation sheet (including information required by 10
p.000286: U.S.C. 1107(d)) con- cerning the investigational new drug, the risks and benefits of its use, poten- tial
p.000286: side effects, and other pertinent in- formation about the appropriate use of the product.
p.000286: (ix) Medical records of members in- volved in the military operation will accurately document the
p.000286: receipt by members of the notification required by paragraph (d)(1)(viii) of this section.
p.000286: (x) Medical records of members in- volved in the military operation will accurately document the
p.000286: receipt by members of any investigational new drugs in accordance with FDA regula- tions including part
p.000286: 312 of this chapter.
p.000286: (xi) DOD will provide adequate fol- lowup to assess whether there are bene- ficial or adverse health
p.000286: consequences that result from the use of the inves- tigational product.
p.000286: (xii) DOD is pursuing drug develop- ment, including a time line, and mar- keting approval with due
p.000286: diligence.
p.000286: (xiii) FDA has concluded that the in- vestigational new drug protocol may proceed subject to a decision by
p.000286: the President on the informed consent waiver request.
p.000287: 287
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287: § 50.23
p.000287: (xiv) DOD will provide training to the appropriate medical personnel and po- tential recipients on the specific
p.000287: inves- tigational new drug to be administered prior to its use.
p.000287: (xv) DOD has stated and justified the time period for which the waiver is needed, not to exceed one
p.000287: year, unless separately renewed under these stand- ards and criteria.
p.000287: (xvi) DOD shall have a continuing ob- ligation to report to the FDA and to the President any changed
p.000287: cir- cumstances relating to these standards and criteria (including the time period referred to in
p.000287: paragraph (d)(1)(xv) of this section) or that otherwise might affect the determination to use an in-
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000288: described in this section may approve that inves- tigation without requiring that in- formed consent of all
p.000288: research subjects be obtained if the IRB (with the con- currence of a licensed physician who is a member of
p.000288: or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and
p.000288: documents each of the following:
p.000288: (1) The human subjects are in a life- threatening situation, available treat- ments are unproven or
p.000288: unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained
p.000288: through randomized placebo- controlled investigations, is necessary to determine the safety and effective-
p.000288: ness of particular interventions.
p.000288: (2) Obtaining informed consent is not feasible because:
p.000288: (i) The subjects will not be able to give their informed consent as a result of their medical condition;
p.000288: (ii) The intervention under investiga- tion must be administered before con- sent from the subjects’ legally
p.000288: author- ized representatives is feasible; and
p.000288: (iii) There is no reasonable way to identify prospectively the individuals likely to become eligible
p.000288: for participa- tion in the clinical investigation.
p.000288: (3) Participation in the research holds out the prospect of direct benefit to the subjects because:
p.000288: (i) Subjects are facing a life-threat- ening situation that necessitates inter- vention;
p.000289: 289
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289: § 50.24
p.000289: (ii) Appropriate animal and other preclinical studies have been con- ducted, and the
p.000289: information derived from those studies and related evidence support the potential for the interven- tion to
p.000289: provide a direct benefit to the individual subjects; and
p.000289: (iii) Risks associated with the inves- tigation are reasonable in relation to what is known about the
p.000289: medical con- dition of the potential class of subjects, the risks and benefits of standard ther- apy, if any, and
p.000289: what is known about the risks and benefits of the proposed intervention or activity.
p.000289: (4) The clinical investigation could not practicably be carried out without the waiver.
p.000289: (5) The proposed investigational plan defines the length of the potential therapeutic window based on
p.000289: scientific evidence, and the investigator has com- mitted to attempting to contact a le- gally authorized
p.000289: representative for each subject within that window of time and, if feasible, to asking the le-
p.000289: gally authorized representative con- tacted for consent within that window rather than proceeding
p.000289: without con- sent. The investigator will summarize efforts made to contact legally author- ized representatives
p.000289: and make this in- formation available to the IRB at the time of continuing review.
p.000289: (6) The IRB has reviewed and ap-
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000292: (a) The risk is justified by the antici-
p.000292: pated benefit to the subjects;
p.000292: (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000292: as that presented by available alternative approaches; and
p.000292: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292: § 50.53 Clinical investigations involv- ing greater than minimal risk and no prospect of direct benefit
p.000292: to in- dividual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more
p.000292: than mini- mal risk to children is presented by an intervention or procedure that does not hold out the prospect
p.000292: of direct benefit
p.000292:
p.000292: for the individual subject, or by a mon- itoring procedure that is not likely to contribute to the well-being of
p.000292: the sub- ject, may involve children as subjects only if the IRB finds and documents that:
p.000292: (a) The risk represents a minor in- crease over minimal risk;
p.000292: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000292: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000292: educational situations;
p.000292: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000292: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000292: condition; and
p.000292: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292:
p.000292: § 50.54 Clinical investigations not oth- erwise approvable that present an opportunity to understand, prevent,
p.000292: or alleviate a serious problem af- fecting the health or welfare of chil- dren.
p.000292: If an IRB does not believe that a clin- ical investigation within the scope de- scribed in §§ 50.1 and 56.101 of
p.000292: this chap- ter and involving children as subjects meets the requirements of § 50.51,
p.000292: § 50.52, or § 50.53, the clinical investiga- tion may proceed only if:
p.000292: (a) The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further
...
Social / education
Searching for indicator education:
(return to top)
p.000292: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000292: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000292: condition; and
p.000292: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292:
p.000292: § 50.54 Clinical investigations not oth- erwise approvable that present an opportunity to understand, prevent,
p.000292: or alleviate a serious problem af- fecting the health or welfare of chil- dren.
p.000292: If an IRB does not believe that a clin- ical investigation within the scope de- scribed in §§ 50.1 and 56.101 of
p.000292: this chap- ter and involving children as subjects meets the requirements of § 50.51,
p.000292: § 50.52, or § 50.53, the clinical investiga- tion may proceed only if:
p.000292: (a) The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further
p.000292: the understanding, prevention, or allevi- ation of a serious problem affecting the health or welfare of
p.000292: children; and
p.000292: (b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent
p.000292: disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public
p.000292: review and comment, deter- mines either:
p.000292: (1) That the clinical investigation in fact satisfies the conditions of § 50.51,
p.000292: § 50.52, or § 50.53, as applicable, or
p.000292: (2) That the following conditions are met:
p.000292: (i) The clinical investigation presents a reasonable opportunity to further the
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 50.55
p.000293: understanding, prevention, or allevi- ation of a serious problem affecting the health or welfare of children;
p.000293: (ii) The clinical investigation will be conducted in accordance with sound ethical principles; and
p.000293: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000293: parents or guardians as set forth in § 50.55.
p.000293: § 50.55 Requirements for permission by parents or guardians and for as- sent by children.
p.000293: (a) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that adequate provisions are made for soliciting the assent of the children when in
p.000293: the judgment of the IRB the children are capable of pro- viding assent.
...
Searching for indicator educational:
(return to top)
p.000292: as that presented by available alternative approaches; and
p.000292: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292: § 50.53 Clinical investigations involv- ing greater than minimal risk and no prospect of direct benefit
p.000292: to in- dividual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more
p.000292: than mini- mal risk to children is presented by an intervention or procedure that does not hold out the prospect
p.000292: of direct benefit
p.000292:
p.000292: for the individual subject, or by a mon- itoring procedure that is not likely to contribute to the well-being of
p.000292: the sub- ject, may involve children as subjects only if the IRB finds and documents that:
p.000292: (a) The risk represents a minor in- crease over minimal risk;
p.000292: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000292: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000292: educational situations;
p.000292: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000292: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000292: condition; and
p.000292: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292:
p.000292: § 50.54 Clinical investigations not oth- erwise approvable that present an opportunity to understand, prevent,
p.000292: or alleviate a serious problem af- fecting the health or welfare of chil- dren.
p.000292: If an IRB does not believe that a clin- ical investigation within the scope de- scribed in §§ 50.1 and 56.101 of
p.000292: this chap- ter and involving children as subjects meets the requirements of § 50.51,
p.000292: § 50.52, or § 50.53, the clinical investiga- tion may proceed only if:
p.000292: (a) The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further
p.000292: the understanding, prevention, or allevi- ation of a serious problem affecting the health or welfare of
p.000292: children; and
p.000292: (b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent
...
Social / employees
Searching for indicator employees:
(return to top)
p.000283: Administration under section 505(i) or 520(g) of the act, or is not sub- ject to requirements for prior
p.000283: submis- sion to the Food and Drug Administra- tion under these sections of the act, but the results of which are
p.000283: intended to be submitted later to, or held for in- spection by, the Food and Drug Admin- istration as part of an
p.000283: application for a research or marketing permit. The term does not include experiments that are subject to
p.000283: the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.
p.000284: 284
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284: Food and Drug Administration, HHS § 50.3
p.000284:
p.000284:
p.000284: (d) Investigator means an individual who actually conducts a clinical inves- tigation, i.e., under whose
p.000284: immediate direction the test article is adminis- tered or dispensed to, or used involv- ing, a subject, or,
p.000284: in the event of an in- vestigation conducted by a team of in- dividuals, is the responsible leader of that
p.000284: team.
p.000284: (e) Sponsor means a person who initi- ates a clinical investigation, but who does not actually conduct the
p.000284: inves- tigation, i.e., the test article is admin- istered or dispensed to or used involv- ing, a subject under
p.000284: the immediate di- rection of another individual. A person other than an individual (e.g., corpora- tion or agency)
p.000284: that uses one or more of its own employees to conduct a clin- ical investigation it has initiated is
p.000284: considered to be a sponsor (not a spon- sor-investigator), and the employees are considered to be investigators.
p.000284: (f) Sponsor-investigator means an indi-
p.000284: vidual who both initiates and actually conducts, alone or with others, a clin- ical investigation, i.e.,
p.000284: under whose im- mediate direction the test article is ad- ministered or dispensed to, or used in- volving, a
p.000284: subject. The term does not include any person other than an indi- vidual, e.g., corporation or agency.
p.000284: (g) Human subject means an indi- vidual who is or becomes a participant in research, either as a
p.000284: recipient of the test article or as a control. A subject may be either a healthy human or a pa- tient.
p.000284: (h) Institution means any public or private entity or agency (including Federal, State, and
p.000284: other agencies). The word facility as used in section 520(g) of the act is deemed to be syn-
p.000284: onymous with the term institution for purposes of this part.
p.000284: (i) Institutional revie board (IRB) means any board, committee, or other group formally designated
p.000284: by an insti- tution to review biomedical research involving humans as subjects, to ap- prove the
p.000284: initiation of and conduct periodic review of such research. The term has the same meaning as the
p.000284: phrase institutional revie committee as used in section 520(g) of the act.
p.000284: (j) Test article means any drug (in- cluding a biological product for human use), medical device for
p.000284: human use, human food additive, color additive,
p.000284:
p.000284: electronic product, or any other article subject to regulation under the act or under sections 351 and
...
p.000287: inves- tigational new drug to be administered prior to its use.
p.000287: (xv) DOD has stated and justified the time period for which the waiver is needed, not to exceed one
p.000287: year, unless separately renewed under these stand- ards and criteria.
p.000287: (xvi) DOD shall have a continuing ob- ligation to report to the FDA and to the President any changed
p.000287: cir- cumstances relating to these standards and criteria (including the time period referred to in
p.000287: paragraph (d)(1)(xv) of this section) or that otherwise might affect the determination to use an in-
p.000287: vestigational new drug without in- formed consent.
p.000287: (xvii) DOD is to provide public notice as soon as practicable and consistent with classification
p.000287: requirements through notice in the FEDERAL REG- ISTER describing each waiver of in- formed
p.000287: consent determination, a sum- mary of the most updated scientific in- formation on the products used, and
p.000287: other pertinent information.
p.000287: (xviii) Use of the investigational drug without informed consent otherwise conforms with applicable law.
p.000287: (2) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must
p.000287: include at least 3 nonaffiliated members who shall not be employees or officers of the Federal
p.000287: Government (other than for purposes of membership on the IRB) and shall be required to obtain any
p.000287: necessary security clearances. This IRB shall review the proposed IND pro- tocol at a convened meeting at
p.000287: which a majority of the members are present including at least one member whose primary concerns are in
p.000287: nonscientific areas and, if feasible, including a ma- jority of the nonaffiliated members. The
p.000287: information required by
p.000287: § 56.115(a)(2) of this chapter is to be pro-
p.000287: vided to the Secretary of Defense for further review.
p.000287: (3) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section,
p.000287: must review and approve:
p.000287: (i) The required information sheet;
p.000287: (ii) The adequacy of the plan to dis- seminate information, including dis-
p.000287: 21 CFR Ch. I (4–1–12 Edition)
p.000287: tribution of the information sheet to potential recipients, on the investiga- tional product (e.g., in
p.000287: forms other than written);
p.000287: (iii) The adequacy of the information and plans for its dissemination to health care providers, including
p.000287: poten- tial side effects, contraindications, po- tential interactions, and other perti- nent
p.000287: considerations; and
p.000287: (iv) An informed consent form as re- quired by part 50 of this chapter, in those circumstances in which
p.000287: DOD de- termines that informed consent may be obtained from some or all personnel in- volved.
...
Social / parents
Searching for indicator parent:
(return to top)
p.000284: (l) Legally authorized representative means an individual or judicial or other body authorized under
p.000284: applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000284: particpation in the procedure(s) in- volved in the research.
p.000284: (m) Family member means any one of the following legally competent per- sons: Spouse; parents; children
p.000284: (includ- ing adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related
p.000284: by blood or af- finity whose close association with the subject is the equivalent of a family re- lationship.
p.000284: (n) Assent means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to
p.000284: object may not, absent affirmative agree- ment, be construed as assent.
p.000284: (o) Children means persons who have not attained the legal age for consent to treatments or procedures
p.000284: involved in clinical investigations, under the ap- plicable law of the jurisdiction in which the
p.000284: clinical investigation will be conducted.
p.000284: (p) Parent means a child’s biological or adoptive parent.
p.000284: (q) Ward means a child who is placed in the legal custody of the State or other agency, institution,
p.000284: or entity, consistent with applicable Federal, State, or local law.
p.000284: (r) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in a
p.000284: clinical investigation. Permission must be ob- tained in compliance with subpart B of this part and must
p.000284: include the ele- ments of informed consent described in
p.000284: § 50.25.
p.000284: (s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000284: of a
p.000285: 285
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285: § 50.20
p.000285: child to general medical care when general medical care includes partici- pation in research. For
p.000285: purposes of sub- part D of this part, a guardian also means an individual who is authorized to
p.000285: consent on behalf of a child to par- ticipate in research.
p.000285: [45 FR 36390, May 30, 1980, as amended at 46
p.000285: FR 8950, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989;
p.000285: 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2,
p.000285: 1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan.
p.000285: 5, 1999; 64 FR 56448, Oct. 20, 1999; 66 FR 20597,
p.000285: Apr. 24, 2001]
p.000285:
p.000285: Subpart B—Informed Consent of Human Subjects
p.000285: SOURCE: 46 FR 8951, Jan. 27, 1981, unless
p.000285: otherwise noted.
p.000285:
p.000285: § 50.20 General requirements for in- formed consent.
...
p.000293: or
p.000293: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000293: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000293: in the context of the clinical investigation.
p.000293: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000293: requirement if it finds and documents that:
p.000293: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000293: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000293: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000293: 21 CFR Ch. I (4–1–12 Edition)
p.000293: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000293: participa- tion.
p.000293: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that the permission of each child’s parents or guardian is granted.
p.000293: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000293: sufficient, if consistent with State law, for clin- ical investigations to be conducted under § 50.51 or
p.000293: § 50.52.
p.000293: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000293: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000293: known, incompetent, or not reasonably available, or when only one parent has legal responsibility for the
p.000293: care and custody of the child if consistent with State law.
p.000293: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000293: required by
p.000293: § 50.27.
p.000293: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000293: docu- mented.
p.000293: § 50.56 Wards.
p.000293: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000293: clinical in- vestigations approved under § 50.53 or
p.000293: § 50.54 only if such clinical investiga- tions are:
p.000293: (1) Related to their status as wards; or
p.000293: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000293: children in- volved as subjects are not wards.
p.000293: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000293: require appoint- ment of an advocate for each child who is a ward.
p.000293: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000293: guardian or in loco parentis.
p.000293: (2) One individual may serve as advo- cate for more than one child.
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
...
Searching for indicator parents:
(return to top)
p.000284: by an insti- tution to review biomedical research involving humans as subjects, to ap- prove the
p.000284: initiation of and conduct periodic review of such research. The term has the same meaning as the
p.000284: phrase institutional revie committee as used in section 520(g) of the act.
p.000284: (j) Test article means any drug (in- cluding a biological product for human use), medical device for
p.000284: human use, human food additive, color additive,
p.000284:
p.000284: electronic product, or any other article subject to regulation under the act or under sections 351 and
p.000284: 354–360F of the Public Health Service Act (42 U.S.C. 262 and 263b–263n).
p.000284: (k) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research
p.000284: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000284: performance of rou- tine physical or psychological exami- nations or tests.
p.000284: (l) Legally authorized representative means an individual or judicial or other body authorized under
p.000284: applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000284: particpation in the procedure(s) in- volved in the research.
p.000284: (m) Family member means any one of the following legally competent per- sons: Spouse; parents; children
p.000284: (includ- ing adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related
p.000284: by blood or af- finity whose close association with the subject is the equivalent of a family re- lationship.
p.000284: (n) Assent means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to
p.000284: object may not, absent affirmative agree- ment, be construed as assent.
p.000284: (o) Children means persons who have not attained the legal age for consent to treatments or procedures
p.000284: involved in clinical investigations, under the ap- plicable law of the jurisdiction in which the
p.000284: clinical investigation will be conducted.
p.000284: (p) Parent means a child’s biological or adoptive parent.
p.000284: (q) Ward means a child who is placed in the legal custody of the State or other agency, institution,
p.000284: or entity, consistent with applicable Federal, State, or local law.
...
p.000291: Subpart D—Additional Safeguards for Children in Clinical Inves- tigations
p.000291: SOURCE: 66 FR 20598, Apr. 24, 2001, unless
p.000291: otherwise noted.
p.000291: § 50.50 IRB duties.
p.000291: In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each
p.000291: IRB must
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292: Food and Drug Administration, HHS § 50.54
p.000292:
p.000292:
p.000292: review clinical investigations involving children as subjects covered by this subpart D and approve only
p.000292: those clin- ical investigations that satisfy the cri- teria described in § 50.51, § 50.52, or
p.000292: § 50.53 and the conditions of all other applicable sections of this subpart D.
p.000292: § 50.51 Clinical investigations not in- volving greater than minimal risk.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no
p.000292: greater than minimal risk to children is presented may involve children as subjects only if the IRB finds
p.000292: and documents that adequate provisions are made for solic- iting the assent of the children and the permission of
p.000292: their parents or guard- ians as set forth in § 50.55.
p.000292: § 50.52 Clinical investigations involv- ing greater than minimal risk but presenting the prospect of
p.000292: direct benefit to individual subjects.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more
p.000292: than mini- mal risk to children is presented by an intervention or procedure that holds out the prospect of
p.000292: direct benefit for the individual subject, or by a moni- toring procedure that is likely to con- tribute
p.000292: to the subject’s well-being, may involve children as subjects only if the IRB finds and documents that:
p.000292: (a) The risk is justified by the antici-
p.000292: pated benefit to the subjects;
p.000292: (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000292: as that presented by available alternative approaches; and
p.000292: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292: § 50.53 Clinical investigations involv- ing greater than minimal risk and no prospect of direct benefit
p.000292: to in- dividual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition.
p.000292: Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more
p.000292: than mini- mal risk to children is presented by an intervention or procedure that does not hold out the prospect
p.000292: of direct benefit
p.000292:
p.000292: for the individual subject, or by a mon- itoring procedure that is not likely to contribute to the well-being of
p.000292: the sub- ject, may involve children as subjects only if the IRB finds and documents that:
p.000292: (a) The risk represents a minor in- crease over minimal risk;
p.000292: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000292: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000292: educational situations;
p.000292: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000292: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000292: condition; and
p.000292: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000292: parents or guardians as set forth in § 50.55.
p.000292:
p.000292: § 50.54 Clinical investigations not oth- erwise approvable that present an opportunity to understand, prevent,
p.000292: or alleviate a serious problem af- fecting the health or welfare of chil- dren.
p.000292: If an IRB does not believe that a clin- ical investigation within the scope de- scribed in §§ 50.1 and 56.101 of
p.000292: this chap- ter and involving children as subjects meets the requirements of § 50.51,
p.000292: § 50.52, or § 50.53, the clinical investiga- tion may proceed only if:
p.000292: (a) The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further
p.000292: the understanding, prevention, or allevi- ation of a serious problem affecting the health or welfare of
p.000292: children; and
p.000292: (b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent
p.000292: disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public
p.000292: review and comment, deter- mines either:
p.000292: (1) That the clinical investigation in fact satisfies the conditions of § 50.51,
p.000292: § 50.52, or § 50.53, as applicable, or
p.000292: (2) That the following conditions are met:
p.000292: (i) The clinical investigation presents a reasonable opportunity to further the
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 50.55
p.000293: understanding, prevention, or allevi- ation of a serious problem affecting the health or welfare of children;
p.000293: (ii) The clinical investigation will be conducted in accordance with sound ethical principles; and
p.000293: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000293: parents or guardians as set forth in § 50.55.
p.000293: § 50.55 Requirements for permission by parents or guardians and for as- sent by children.
p.000293: (a) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that adequate provisions are made for soliciting the assent of the children when in
p.000293: the judgment of the IRB the children are capable of pro- viding assent.
p.000293: (b) In determining whether children are capable of providing assent, the IRB must take into account
p.000293: the ages, maturity, and psychological state of the children involved. This judgment may be made for
p.000293: all children to be in- volved in clinical investigations under a particular protocol, or for each child, as the
p.000293: IRB deems appropriate.
p.000293: (c) The assent of the children is not a necessary condition for proceeding with the clinical investigation
p.000293: if the IRB determines:
p.000293: (1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted,
p.000293: or
p.000293: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000293: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000293: in the context of the clinical investigation.
p.000293: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000293: requirement if it finds and documents that:
p.000293: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000293: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000293: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000293: 21 CFR Ch. I (4–1–12 Edition)
p.000293: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000293: participa- tion.
p.000293: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000293: the IRB must determine that the permission of each child’s parents or guardian is granted.
p.000293: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000293: sufficient, if consistent with State law, for clin- ical investigations to be conducted under § 50.51 or
p.000293: § 50.52.
p.000293: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000293: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000293: known, incompetent, or not reasonably available, or when only one parent has legal responsibility for the
p.000293: care and custody of the child if consistent with State law.
p.000293: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000293: required by
p.000293: § 50.27.
p.000293: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000293: docu- mented.
p.000293: § 50.56 Wards.
p.000293: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000293: clinical in- vestigations approved under § 50.53 or
p.000293: § 50.54 only if such clinical investiga- tions are:
p.000293: (1) Related to their status as wards; or
p.000293: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000293: children in- volved as subjects are not wards.
p.000293: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000293: require appoint- ment of an advocate for each child who is a ward.
p.000293: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000293: guardian or in loco parentis.
p.000293: (2) One individual may serve as advo- cate for more than one child.
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Food and Drug Administration, HHS § 54.2
p.000294:
p.000294:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000285: or writ- ten, may include any exculpatory lan- guage through which the subject or the representative is made to
p.000285: waive or ap- pear to waive any of the subject’s legal rights, or releases or appears to release the investigator,
p.000285: the sponsor, the insti- tution, or its agents from liability for negligence.
p.000285: [46 FR 8951, Jan. 27, 1981, as amended at 64
p.000285: FR 10942, Mar. 8, 1999]
p.000285:
p.000285: § 50.23 Exception from general re- quirements.
p.000285: (a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except
p.000285: as pro- vided in paragraph (b) of this section), both the investigator and a physician
p.000285: 21 CFR Ch. I (4–1–12 Edition)
p.000285: who is not otherwise participating in the clinical investigation certify in writing all of the following:
p.000285: (1) The human subject is confronted by a life-threatening situation necessi- tating the use of the test
p.000285: article.
p.000285: (2) Informed consent cannot be ob- tained from the subject because of an inability to communicate with,
p.000285: or ob- tain legally effective consent from, the subject.
p.000285: (3) Time is not sufficient to obtain consent from the subject’s legal rep- resentative.
p.000285: (4) There is available no alternative method of approved or generally recog- nized therapy that provides an equal
p.000285: or greater likelihood of saving the life of the subject.
p.000285: (b) If immediate use of the test arti- cle is, in the investigator’s opinion, re- quired to preserve the
p.000285: life of the sub- ject, and time is not sufficient to ob- tain the independent determination re- quired in
p.000285: paragraph (a) of this section in advance of using the test article, the determinations of the clinical investi-
p.000285: gator shall be made and, within 5 work- ing days after the use of the article, be reviewed and evaluated in writing by
p.000285: a physician who is not participating in the clinical investigation.
p.000285: (c) The documentation required in
p.000285: paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after
p.000285: the use of the test article.
p.000285: (d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior consent requirement for the
p.000285: administration of an investigational new drug to a mem- ber of the armed forces in connection with the
p.000285: member’s participation in a particular military operation. The statute specifies that only the Presi-
p.000285: dent may waive informed consent in this connection and the President may grant such a waiver only if
p.000285: the Presi- dent determines in writing that obtain- ing consent: Is not feasible; is contrary to the best interests
p.000285: of the military member; or is not in the interests of national security. The statute further provides
...
p.000287: investigational in vitro diagnostic device to identify a chemical, biological, radiological, or nuclear
p.000287: agent that would suggest a ter- rorism event or other public health emergency.
p.000287: (ii) Informed consent cannot be ob- tained from the subject because:
p.000287: (A) There was no reasonable way for the person directing that the specimen be collected to know, at the
p.000287: time the specimen was collected, that there would be a need to use the investiga- tional in
p.000287: vitro diagnostic device on that subject’s specimen; and
p.000287: (B) Time is not sufficient to obtain consent from the subject without risk- ing the life of the subject.
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Food and Drug Administration, HHS § 50.24
p.000288:
p.000288:
p.000288: (iii) Time is not sufficient to obtain consent from the subject’s legally au- thorized representative.
p.000288: (iv) There is no cleared or approved available alternative method of diag- nosis, to identify the chemical,
p.000288: biologi- cal, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life
p.000288: of the subject.
p.000288: (2) If use of the investigational device is, in the opinion of the investigator (e.g., clinical laboratory
p.000288: director or other responsible person), required to preserve the life of the subject, and time is
p.000288: not sufficient to obtain the independent determination required in paragraph (e)(1) of this section in
p.000288: ad- vance of using the investigational de- vice, the determinations of the investi- gator shall be made and,
p.000288: within 5 work- ing days after the use of the device, be reviewed and evaluated in writing by a physician who is not
p.000288: participating in the clinical investigation.
p.000288: (3) The investigator must submit the
p.000288: written certification of the determina- tions made by the investigator and an independent physician
p.000288: required in paragraph (e)(1) or (e)(2) of this section to the IRB and FDA within 5 working days after the
p.000288: use of the device.
p.000288: (4) An investigator must disclose the investigational status of the in vitro diagnostic device and what
p.000288: is known about the performance characteristics of the device in the report to the sub- ject’s health care
p.000288: provider and in any report to public health authorities. The investigator must provide the IRB with the
p.000288: information required in § 50.25 (ex- cept for the information described in
p.000288: § 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the
p.000288: subject’s legally authorized representative at the time the test results are provided to the sub- ject’s health
p.000288: care provider and public health authorities.
p.000288: (5) The IRB is responsible for ensur- ing the adequacy of the information re- quired in section 50.25 (except
...
General/Other / Dependent
Searching for indicator dependent:
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p.000294: of the data.
p.000294: § 54.2 Definitions.
p.000294: For the purposes of this part:
p.000294: (a) Compensation affected by the out- come of clinical studies means compensa- tion that could be higher for
p.000294: a favor- able outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a
p.000294: favorable result or compensation to the investigator in the form of an equity interest in the sponsor of
p.000294: a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.
p.000294: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000294: stock options, or other financial interest whose value cannot be readily determined through reference
p.000294: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000294: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000294: is carrying out the study and for 1 year following comple- tion of the study.
p.000294: (c) Proprietary interest in the tested product means property or other finan- cial interest in the
p.000294: product including, but not limited to, a patent, trade- mark, copyright or licensing agree- ment.
p.000294: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000294: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000294: dependent child of the investigator.
p.000294: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000294: application or reclassification petition subject to
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000289: 21 CFR Ch. I (4–1–12 Edition)
p.000289: (ii) Public disclosure to the commu- nities in which the clinical investiga- tion will be conducted and
p.000289: from which the subjects will be drawn, prior to ini- tiation of the clinical investigation, of plans for the
p.000289: investigation and its risks and expected benefits;
p.000289: (iii) Public disclosure of sufficient in- formation following completion of the clinical investigation to
p.000289: apprise the community and researchers of the study, including the demographic char- acteristics of the
p.000289: research population, and its results;
p.000289: (iv) Establishment of an independent data monitoring committee to exercise oversight of the clinical
p.000289: investigation; and
p.000289: (v) If obtaining informed consent is not feasible and a legally authorized representative is not
p.000289: reasonably avail- able, the investigator has committed, if feasible, to attempting to contact within the
p.000289: therapeutic window the sub- ject’s family member who is not a le- gally authorized representative, and
p.000289: asking whether he or she objects to the subject’s participation in the clinical investigation. The
p.000289: investigator will summarize efforts made to contact family members and make this infor- mation
p.000289: available to the IRB at the time of continuing review.
p.000289: (b) The IRB is responsible for ensur-
p.000289: ing that procedures are in place to in- form, at the earliest feasible oppor- tunity, each subject,
p.000289: or if the subject remains incapacitated, a legally au- thorized representative of the subject, or if
p.000289: such a representative is not rea- sonably available, a family member, of the subject’s inclusion in the
p.000289: clinical investigation, the details of the inves- tigation and other information con- tained in the
p.000289: informed consent docu- ment. The IRB shall also ensure that there is a procedure to inform the sub- ject, or if
p.000289: the subject remains incapaci- tated, a legally authorized representa- tive of the subject, or if such a
p.000289: rep- resentative is not reasonably available, a family member, that he or she may discontinue the subject’s
p.000289: participation at any time without penalty or loss of benefits to which the subject is other- wise
p.000289: entitled. If a legally authorized representative or family member is told about the clinical
p.000289: investigation and the subject’s condition improves,
p.000290: 290
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290: Food and Drug Administration, HHS § 50.25
p.000290:
p.000290:
p.000290: the subject is also to be informed as soon as feasible. If a subject is entered into a clinical
p.000290: investigation with waived consent and the subject dies be- fore a legally authorized representative or family member
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283: Food and Drug Administration, HHS § 50.3
p.000283:
p.000283: PART 50—PROTECTION OF HUMAN SUBJECTS
p.000283: Subpart A—General Provisions
p.000283: Sec.
p.000283: 50.1 Scope.
p.000283: 50.3 Definitions.
p.000283: Subpart B—Informed Consent of Human Subjects
p.000283: 50.20 General requirements for informed consent.
p.000283: 50.23 Exception from general requirements.
p.000283: 50.24 Exception from informed consent re- quirements for emergency research.
p.000283: 50.25 Elements of informed consent.
p.000283: 50.27 Documentation of informed consent.
p.000283: Subpart C [Reserved]
p.000283: Subpart D—Additional Safeguards for Children in Clinical Investigations
p.000283: 50.50 IRB duties.
p.000283: 50.51 Clinical investigations not involving greater than minimal risk.
p.000283: 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of
p.000283: direct benefit to indi- vidual subjects.
p.000283: 50.53 Clinical investigations involving greater than minimal risk and no pros- pect of direct
p.000283: benefit to individual sub- jects, but likely to yield generalizable knowledge about the subjects’ disorder
p.000283: or condition.
p.000283: 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or
p.000283: alleviate a se- rious problem affecting the health or welfare of children.
p.000283: 50.55 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000283: 50.56 Wards.
p.000283: AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348,
p.000283: 350a, 350b, 352, 353, 355, 360, 360c–360f, 360h–
p.000283: 360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b–
p.000283: 263n.
...
p.000287: poten- tial side effects, contraindications, po- tential interactions, and other perti- nent
p.000287: considerations; and
p.000287: (iv) An informed consent form as re- quired by part 50 of this chapter, in those circumstances in which
p.000287: DOD de- termines that informed consent may be obtained from some or all personnel in- volved.
p.000287: (4) DOD is to submit to FDA sum- maries of institutional review board meetings at which the proposed
p.000287: pro- tocol has been reviewed.
p.000287: (5) Nothing in these criteria or stand- ards is intended to preempt or limit FDA’s and DOD’s authority or
p.000287: obliga- tions under applicable statutes and regulations.
p.000287: (e)(1) Obtaining informed consent for investigational in vitro diagnostic de- vices used to identify
p.000287: chemical, bio- logical, radiological, or nuclear agents will be deemed feasible unless, before use of the
p.000287: test article, both the investi- gator (e.g., clinical laboratory director or other responsible individual) and
p.000287: a physician who is not otherwise partici- pating in the clinical investigation make the determinations and
p.000287: later cer- tify in writing all of the following:
p.000287: (i) The human subject is confronted by a life-threatening situation necessi- tating the use of the
p.000287: investigational in vitro diagnostic device to identify a chemical, biological, radiological, or nuclear
p.000287: agent that would suggest a ter- rorism event or other public health emergency.
p.000287: (ii) Informed consent cannot be ob- tained from the subject because:
p.000287: (A) There was no reasonable way for the person directing that the specimen be collected to know, at the
p.000287: time the specimen was collected, that there would be a need to use the investiga- tional in
p.000287: vitro diagnostic device on that subject’s specimen; and
p.000287: (B) Time is not sufficient to obtain consent from the subject without risk- ing the life of the subject.
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Food and Drug Administration, HHS § 50.24
p.000288:
p.000288:
p.000288: (iii) Time is not sufficient to obtain consent from the subject’s legally au- thorized representative.
p.000288: (iv) There is no cleared or approved available alternative method of diag- nosis, to identify the chemical,
p.000288: biologi- cal, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life
p.000288: of the subject.
p.000288: (2) If use of the investigational device is, in the opinion of the investigator (e.g., clinical laboratory
p.000288: director or other responsible person), required to preserve the life of the subject, and time is
p.000288: not sufficient to obtain the independent determination required in paragraph (e)(1) of this section in
...
p.000288: information required in § 50.25 (ex- cept for the information described in
p.000288: § 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the
p.000288: subject’s legally authorized representative at the time the test results are provided to the sub- ject’s health
p.000288: care provider and public health authorities.
p.000288: (5) The IRB is responsible for ensur- ing the adequacy of the information re- quired in section 50.25 (except
p.000288: for the information described in § 50.25(a)(8)) and for ensuring that procedures are in place to provide
p.000288: this information to each subject or the subject’s legally au- thorized representative.
p.000288: (6) No State or political subdivision of a State may establish or continue in effect any law, rule,
p.000288: regulation or
p.000288:
p.000288: other requirement that informed con- sent be obtained before an investiga- tional in vitro diagnostic
p.000288: device may be used to identify chemical, biologi- cal, radiological, or nuclear agent in suspected
p.000288: terrorism events and other potential public health emergencies that is different from, or in addition to,
p.000288: the requirements of this regulation.
p.000288: [46 FR 8951, Jan. 27, 1981, as amended at 55
p.000288: FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999;
p.000288: 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7,
p.000288: 2006; 76 FR 36993, June 24, 2011]
p.000288:
p.000288: § 50.24 Exception from informed con- sent requirements for emergency research.
p.000288: (a) The IRB responsible for the re- view, approval, and continuing review of the clinical investigation
p.000288: described in this section may approve that inves- tigation without requiring that in- formed consent of all
p.000288: research subjects be obtained if the IRB (with the con- currence of a licensed physician who is a member of
p.000288: or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and
p.000288: documents each of the following:
p.000288: (1) The human subjects are in a life- threatening situation, available treat- ments are unproven or
p.000288: unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained
p.000288: through randomized placebo- controlled investigations, is necessary to determine the safety and effective-
p.000288: ness of particular interventions.
p.000288: (2) Obtaining informed consent is not feasible because:
p.000288: (i) The subjects will not be able to give their informed consent as a result of their medical condition;
p.000288: (ii) The intervention under investiga- tion must be administered before con- sent from the subjects’ legally
p.000288: author- ized representatives is feasible; and
p.000288: (iii) There is no reasonable way to identify prospectively the individuals likely to become eligible
p.000288: for participa- tion in the clinical investigation.
p.000288: (3) Participation in the research holds out the prospect of direct benefit to the subjects because:
...
p.000291: the subject’s willingness to continue par- ticipation will be provided to the sub- ject.
p.000291: (6) The approximate number of sub- jects involved in the study.
p.000291: (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the
p.000291: following statement shall be provided to each clinical trial subject in informed con- sent documents
p.000291: and processes. This will notify the clinical trial subject that clinical trial information has been or
p.000291: will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402
p.000291: of the Public Health Service Act. The state- ment is: ‘‘A description of this clinical trial will be
p.000291: available on http://
p.000291: .ClinicalTrials.gov, as required by
p.000291: U.S. Law. This Web site will not in- clude information that can identify you. At most, the Web site will
p.000291: include a summary of the results. You can search this Web site at any time.’’
p.000291: (d) The informed consent require- ments in these regulations are not in- tended to preempt any
p.000291: applicable Fed- eral, State, or local laws which require additional information to be disclosed for informed
p.000291: consent to be legally ef- fective.
p.000291: (e) Nothing in these regulations is in- tended to limit the authority of a phy- sician to provide emergency
p.000291: medical care to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law.
p.000291: [46 FR 8951, Jan. 27, 1981, as amended at 76
p.000291: FR 270, Jan. 4, 2011]
p.000291: 21 CFR Ch. I (4–1–12 Edition)
p.000291:
p.000291: § 50.27 Documentation of informed consent.
p.000291: (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written
p.000291: consent form approved by the IRB and signed and dated by the subject or the subject’s le- gally authorized
p.000291: representative at the time of consent. A copy shall be given to the person signing the form.
p.000291: (b) Except as provided in § 56.109(c), the consent form may be either of the following:
p.000291: (1) A written consent document that embodies the elements of informed consent required by § 50.25.
p.000291: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but, in any
p.000291: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000291: before it is signed.
p.000291: (2) A short form written consent docu-
p.000291: ment stating that the elements of in- formed consent required by § 50.25 have been presented orally to
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000283: 50.23 Exception from general requirements.
p.000283: 50.24 Exception from informed consent re- quirements for emergency research.
p.000283: 50.25 Elements of informed consent.
p.000283: 50.27 Documentation of informed consent.
p.000283: Subpart C [Reserved]
p.000283: Subpart D—Additional Safeguards for Children in Clinical Investigations
p.000283: 50.50 IRB duties.
p.000283: 50.51 Clinical investigations not involving greater than minimal risk.
p.000283: 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of
p.000283: direct benefit to indi- vidual subjects.
p.000283: 50.53 Clinical investigations involving greater than minimal risk and no pros- pect of direct
p.000283: benefit to individual sub- jects, but likely to yield generalizable knowledge about the subjects’ disorder
p.000283: or condition.
p.000283: 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or
p.000283: alleviate a se- rious problem affecting the health or welfare of children.
p.000283: 50.55 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000283: 50.56 Wards.
p.000283: AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348,
p.000283: 350a, 350b, 352, 353, 355, 360, 360c–360f, 360h–
p.000283: 360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b–
p.000283: 263n.
p.000283: SOURCE: 45 FR 36390, May 30, 1980, unless
p.000283: otherwise noted.
p.000283:
p.000283: Subpart A—General Provisions
p.000283: § 50.1 Scope.
p.000283: (a) This part applies to all clinical in- vestigations regulated by the Food and Drug Administration under
p.000283: sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical
p.000283: investigations that support ap- plications for research or marketing
p.000283:
p.000283: permits for products regulated by the Food and Drug Administration, includ- ing foods, including dietary
p.000283: supple- ments, that bear a nutrient content claim or a health claim, infant for- mulas, food
p.000283: and color additives, drugs for human use, medical devices for human use, biological products
p.000283: for human use, and electronic products. Additional specific obligations and commitments of, and
p.000283: standards of con- duct for, persons who sponsor or mon- itor clinical investigations involving particular
p.000283: test articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is in-
p.000283: tended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug
...
p.000287: which a majority of the members are present including at least one member whose primary concerns are in
p.000287: nonscientific areas and, if feasible, including a ma- jority of the nonaffiliated members. The
p.000287: information required by
p.000287: § 56.115(a)(2) of this chapter is to be pro-
p.000287: vided to the Secretary of Defense for further review.
p.000287: (3) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section,
p.000287: must review and approve:
p.000287: (i) The required information sheet;
p.000287: (ii) The adequacy of the plan to dis- seminate information, including dis-
p.000287: 21 CFR Ch. I (4–1–12 Edition)
p.000287: tribution of the information sheet to potential recipients, on the investiga- tional product (e.g., in
p.000287: forms other than written);
p.000287: (iii) The adequacy of the information and plans for its dissemination to health care providers, including
p.000287: poten- tial side effects, contraindications, po- tential interactions, and other perti- nent
p.000287: considerations; and
p.000287: (iv) An informed consent form as re- quired by part 50 of this chapter, in those circumstances in which
p.000287: DOD de- termines that informed consent may be obtained from some or all personnel in- volved.
p.000287: (4) DOD is to submit to FDA sum- maries of institutional review board meetings at which the proposed
p.000287: pro- tocol has been reviewed.
p.000287: (5) Nothing in these criteria or stand- ards is intended to preempt or limit FDA’s and DOD’s authority or
p.000287: obliga- tions under applicable statutes and regulations.
p.000287: (e)(1) Obtaining informed consent for investigational in vitro diagnostic de- vices used to identify
p.000287: chemical, bio- logical, radiological, or nuclear agents will be deemed feasible unless, before use of the
p.000287: test article, both the investi- gator (e.g., clinical laboratory director or other responsible individual) and
p.000287: a physician who is not otherwise partici- pating in the clinical investigation make the determinations and
p.000287: later cer- tify in writing all of the following:
p.000287: (i) The human subject is confronted by a life-threatening situation necessi- tating the use of the
p.000287: investigational in vitro diagnostic device to identify a chemical, biological, radiological, or nuclear
p.000287: agent that would suggest a ter- rorism event or other public health emergency.
p.000287: (ii) Informed consent cannot be ob- tained from the subject because:
p.000287: (A) There was no reasonable way for the person directing that the specimen be collected to know, at the
p.000287: time the specimen was collected, that there would be a need to use the investiga- tional in
p.000287: vitro diagnostic device on that subject’s specimen; and
p.000287: (B) Time is not sufficient to obtain consent from the subject without risk- ing the life of the subject.
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
...
p.000291: of participation by the subject.
p.000291: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000291: the subject’s willingness to continue par- ticipation will be provided to the sub- ject.
p.000291: (6) The approximate number of sub- jects involved in the study.
p.000291: (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the
p.000291: following statement shall be provided to each clinical trial subject in informed con- sent documents
p.000291: and processes. This will notify the clinical trial subject that clinical trial information has been or
p.000291: will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402
p.000291: of the Public Health Service Act. The state- ment is: ‘‘A description of this clinical trial will be
p.000291: available on http://
p.000291: .ClinicalTrials.gov, as required by
p.000291: U.S. Law. This Web site will not in- clude information that can identify you. At most, the Web site will
p.000291: include a summary of the results. You can search this Web site at any time.’’
p.000291: (d) The informed consent require- ments in these regulations are not in- tended to preempt any
p.000291: applicable Fed- eral, State, or local laws which require additional information to be disclosed for informed
p.000291: consent to be legally ef- fective.
p.000291: (e) Nothing in these regulations is in- tended to limit the authority of a phy- sician to provide emergency
p.000291: medical care to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law.
p.000291: [46 FR 8951, Jan. 27, 1981, as amended at 76
p.000291: FR 270, Jan. 4, 2011]
p.000291: 21 CFR Ch. I (4–1–12 Edition)
p.000291:
p.000291: § 50.27 Documentation of informed consent.
p.000291: (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written
p.000291: consent form approved by the IRB and signed and dated by the subject or the subject’s le- gally authorized
p.000291: representative at the time of consent. A copy shall be given to the person signing the form.
p.000291: (b) Except as provided in § 56.109(c), the consent form may be either of the following:
p.000291: (1) A written consent document that embodies the elements of informed consent required by § 50.25.
p.000291: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but, in any
p.000291: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000291: before it is signed.
p.000291: (2) A short form written consent docu-
...
p.000293: require appoint- ment of an advocate for each child who is a ward.
p.000293: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000293: guardian or in loco parentis.
p.000293: (2) One individual may serve as advo- cate for more than one child.
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Food and Drug Administration, HHS § 54.2
p.000294:
p.000294:
p.000294: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000294: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000294: investigation.
p.000294: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000294: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000294:
p.000294: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000294: Sec.
p.000294: 54.1 Purpose.
p.000294: 54.2 Definitions.
p.000294: 54.3 Scope.
p.000294: 54.4 Certification and disclosure require- ments.
p.000294: 54.5 Agency evaluation of financial inter- ests.
p.000294: 54.6 Recordkeeping and record retention.
p.000294: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,
p.000294: 355, 360, 360c–360j, 371, 372, 373, 374, 375, 376,
p.000294: 379; 42 U.S.C. 262.
p.000294: SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth-
p.000294: erwise noted.
p.000294: § 54.1 Purpose.
p.000294: (a) The Food and Drug Administra- tion (FDA) evaluates clinical studies submitted in marketing
p.000294: applications, required by law, for new human drugs and biological products and marketing applications and
p.000294: reclassification peti- tions for medical devices.
p.000294: (b) The agency reviews data gen- erated in these clinical studies to de- termine whether the
p.000294: applications are approvable under the statutory re- quirements. FDA may consider clinical studies
p.000294: inadequate and the data inad- equate if, among other things, appro- priate steps have not been taken in the
p.000294: design, conduct, reporting, and anal- ysis of the studies to minimize bias. One potential source of
p.000294: bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study
p.000294: because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary
p.000294: in- terest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor
p.000294: of the covered study. This section and conforming regulations require an applicant whose
p.000294:
p.000294: submission relies in part on clinical data to disclose certain financial ar- rangements between
p.000294: sponsor(s) of the covered studies and the clinical inves- tigators and certain interests of the
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000288: regulation or
p.000288:
p.000288: other requirement that informed con- sent be obtained before an investiga- tional in vitro diagnostic
p.000288: device may be used to identify chemical, biologi- cal, radiological, or nuclear agent in suspected
p.000288: terrorism events and other potential public health emergencies that is different from, or in addition to,
p.000288: the requirements of this regulation.
p.000288: [46 FR 8951, Jan. 27, 1981, as amended at 55
p.000288: FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999;
p.000288: 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7,
p.000288: 2006; 76 FR 36993, June 24, 2011]
p.000288:
p.000288: § 50.24 Exception from informed con- sent requirements for emergency research.
p.000288: (a) The IRB responsible for the re- view, approval, and continuing review of the clinical investigation
p.000288: described in this section may approve that inves- tigation without requiring that in- formed consent of all
p.000288: research subjects be obtained if the IRB (with the con- currence of a licensed physician who is a member of
p.000288: or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and
p.000288: documents each of the following:
p.000288: (1) The human subjects are in a life- threatening situation, available treat- ments are unproven or
p.000288: unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained
p.000288: through randomized placebo- controlled investigations, is necessary to determine the safety and effective-
p.000288: ness of particular interventions.
p.000288: (2) Obtaining informed consent is not feasible because:
p.000288: (i) The subjects will not be able to give their informed consent as a result of their medical condition;
p.000288: (ii) The intervention under investiga- tion must be administered before con- sent from the subjects’ legally
p.000288: author- ized representatives is feasible; and
p.000288: (iii) There is no reasonable way to identify prospectively the individuals likely to become eligible
p.000288: for participa- tion in the clinical investigation.
p.000288: (3) Participation in the research holds out the prospect of direct benefit to the subjects because:
p.000288: (i) Subjects are facing a life-threat- ening situation that necessitates inter- vention;
p.000289: 289
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289: § 50.24
p.000289: (ii) Appropriate animal and other preclinical studies have been con- ducted, and the
p.000289: information derived from those studies and related evidence support the potential for the interven- tion to
p.000289: provide a direct benefit to the individual subjects; and
p.000289: (iii) Risks associated with the inves- tigation are reasonable in relation to what is known about the
p.000289: medical con- dition of the potential class of subjects, the risks and benefits of standard ther- apy, if any, and
p.000289: what is known about the risks and benefits of the proposed intervention or activity.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| dependent | Dependent |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| illness | Physically Disabled |
| incapacitated | Incapacitated |
| infant | Infant |
| language | Linguistic Proficiency |
| military | Soldier |
| minor | Youth/Minors |
| native | Indigenous |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| placebo | participants in a control group |
| political | political affiliation |
| pregnant | Pregnant |
| property | Property Ownership |
| threat | Threat of Stigma |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| education | ['educational'] |
| educational | ['education'] |
| parent | ['parents'] |
| parents | ['parent'] |
Trigger Words
coercion
consent
ethics
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input