0A4F4F9BD490A749D5437F821CF06DF1
21 CFR 54
https://www.govinfo.gov/content/pkg/CFR-2016-title21-vol1/pdf/CFR-2016-title21-vol1-part54.pdf
http://leaux.net/URLS/ConvertAPI Text Files/224B46B69ADACD4E50641100D3B7D139.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 / political affiliation
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p.000352: application or reclassification petition subject to this part that the applicant or FDA re- lies on to establish
p.000352: that the product is effective (including studies that show equivalence to an effective product) or any
p.000352: study in which a single investi- gator makes a significant contribution to the demonstration of safety.
p.000352: This would, in general, not include phase l tolerance studies or pharmacokinetic studies, most clinical
p.000352: pharmacology studies (unless they are critical to an efficacy determination), large open safety
p.000352: studies conducted at multiple sites, treatment protocols, and parallel track protocols. An applicant may con-
p.000352: sult with FDA as to which clinical studies constitute ‘‘covered clinical studies’’ for
p.000352: purposes of complying with financial disclosure requirements.
p.000352: (f) Significant payments of other sorts
p.000352: means payments made by the sponsor of a covered study to the investigator
p.000353: 353
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p.000353: § 54.3
p.000353: or the institution to support activities of the investigator that have a mone- tary value of more than
p.000353: $25,000, exclu- sive of the costs of conducting the clin- ical study or other clinical studies, (e.g., a
p.000353: grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or
p.000353: honoraria) during the time the clin- ical investigator is carrying out the study and for 1 year following the
p.000353: com- pletion of the study.
p.000353: (g) Applicant means the party who
p.000353: submits a marketing application to FDA for approval of a drug, device, or biologic product. The
p.000353: applicant is re- sponsible for submitting the appro- priate certification and disclosure
p.000353: statements required in this part.
p.000353: (h) Sponsor of the covered clinical study means the party supporting a par- ticular study at the time it was
p.000353: carried out.
p.000353: [63 FR 5250, Feb. 2, 1998, as amended at 63 FR
p.000353: 72181, Dec. 31, 1998]
p.000353: § 54.3 Scope.
p.000353: The requirements in this part apply to any applicant who submits a mar- keting application for a human
p.000353: drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for
p.000353: making the appropriate certification or disclosure statement where the applicant either contracted with one
p.000353: or more clinical investigators to conduct the studies or submitted studies conducted by others not under
p.000353: contract to the applicant.
p.000353: § 54.4 Certification and disclosure re- quirements.
p.000353: For purposes of this part, an appli- cant must submit a list of all clinical investigators who
p.000353: conducted covered clinical studies to determine whether the applicant’s product meets FDA’s marketing
p.000353: requirements, identifying those clinical investigators who are full-time or part-time employees of the
p.000353: sponsor of each covered study. The ap- plicant must also completely and accu- rately disclose or certify
p.000353: information concerning the financial interests of a clinical investigator who is not a full- time or
p.000353: part-time employee of the sponsor for each covered clinical study. Clinical investigators subject to inves-
p.000353: tigational new drug or investigational
p.000353: 21 CFR Ch. I (4–1–16 Edition)
p.000353: device exemption regulations must provide the sponsor of the study with sufficient accurate
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Health / Drug Usage
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p.000352: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000352: children in- volved as subjects are not wards.
p.000352: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000352: require appoint- ment of an advocate for each child who is a ward.
p.000352: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000352: guardian or in loco parentis.
p.000352: (2) One individual may serve as advo- cate for more than one child.
p.000352: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000352: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000352: investigation.
p.000352: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000352: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000352:
p.000352: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000352: Sec.
p.000352: 54.1 Purpose.
p.000352: 54.2 Definitions.
p.000352: 54.3 Scope.
p.000352: 54.4 Certification and disclosure require- ments.
p.000352: 352
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p.000352: Food and Drug Administration, HHS § 54.2
p.000352:
p.000352:
p.000352: 54.5 Agency evaluation of financial inter- ests.
p.000352: 54.6 Recordkeeping and record retention.
p.000352: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,
p.000352: 355, 360, 360c–360j, 371, 372, 373, 374, 375, 376,
p.000352: 379; 42 U.S.C. 262.
p.000352: SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth-
p.000352: erwise noted.
p.000352: § 54.1 Purpose.
p.000352: (a) The Food and Drug Administra- tion (FDA) evaluates clinical studies submitted in marketing
p.000352: applications, required by law, for new human drugs and biological products and marketing applications and
p.000352: reclassification peti- tions for medical devices.
p.000352: (b) The agency reviews data gen- erated in these clinical studies to de- termine whether the
p.000352: applications are approvable under the statutory re- quirements. FDA may consider clinical studies
p.000352: inadequate and the data inad- equate if, among other things, appro- priate steps have not been taken in the
p.000352: design, conduct, reporting, and anal- ysis of the studies to minimize bias. One potential source of
p.000352: bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study
p.000352: because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary
p.000352: in- terest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor
p.000352: of the covered study. This section and conforming regulations require an applicant whose submission
p.000352: relies in part on clinical data to disclose certain financial ar- rangements between sponsor(s) of the
p.000352: covered studies and the clinical inves- tigators and certain interests of the clinical investigators
p.000352: in the product under study or in the sponsor of the covered studies. FDA will use this in- formation,
p.000352: in conjunction with infor- mation about the design and purpose of the study, as well as information ob- tained
p.000352: through on-site inspections, in the agency’s assessment of the reli- ability of the data.
p.000352: § 54.2 Definitions.
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p.000352: a favor- able outcome than for an unfavorable
p.000352:
p.000352: outcome, such as compensation that is explicitly greater for a favorable result or compensation to the
p.000352: investigator in the form of an equity interest in the sponsor of a covered study or in the form of
p.000352: compensation tied to sales of the product, such as a royalty interest.
p.000352: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000352: stock options, or other financial interest whose value cannot be readily determined through reference
p.000352: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000352: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000352: is carrying out the study and for 1 year following comple- tion of the study.
p.000352: (c) Proprietary interest in the tested
p.000352: product means property or other finan- cial interest in the product including, but not limited to, a
p.000352: patent, trade- mark, copyright or licensing agree- ment.
p.000352: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000352: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000352: dependent child of the investigator.
p.000352: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000352: application or reclassification petition subject to this part that the applicant or FDA re- lies on to establish
p.000352: that the product is effective (including studies that show equivalence to an effective product) or any
p.000352: study in which a single investi- gator makes a significant contribution to the demonstration of safety.
p.000352: This would, in general, not include phase l tolerance studies or pharmacokinetic studies, most clinical
p.000352: pharmacology studies (unless they are critical to an efficacy determination), large open safety
p.000352: studies conducted at multiple sites, treatment protocols, and parallel track protocols. An applicant may con-
p.000352: sult with FDA as to which clinical studies constitute ‘‘covered clinical studies’’ for
p.000352: purposes of complying with financial disclosure requirements.
p.000352: (f) Significant payments of other sorts
p.000352: means payments made by the sponsor of a covered study to the investigator
p.000353: 353
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p.000353:
p.000353: § 54.3
p.000353: or the institution to support activities of the investigator that have a mone- tary value of more than
p.000353: $25,000, exclu- sive of the costs of conducting the clin- ical study or other clinical studies, (e.g., a
p.000353: grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or
p.000353: honoraria) during the time the clin- ical investigator is carrying out the study and for 1 year following the
p.000353: com- pletion of the study.
p.000353: (g) Applicant means the party who
p.000353: submits a marketing application to FDA for approval of a drug, device, or biologic product. The
p.000353: applicant is re- sponsible for submitting the appro- priate certification and disclosure
p.000353: statements required in this part.
p.000353: (h) Sponsor of the covered clinical study means the party supporting a par- ticular study at the time it was
p.000353: carried out.
p.000353: [63 FR 5250, Feb. 2, 1998, as amended at 63 FR
p.000353: 72181, Dec. 31, 1998]
p.000353: § 54.3 Scope.
p.000353: The requirements in this part apply to any applicant who submits a mar- keting application for a human
p.000353: drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for
p.000353: making the appropriate certification or disclosure statement where the applicant either contracted with one
p.000353: or more clinical investigators to conduct the studies or submitted studies conducted by others not under
p.000353: contract to the applicant.
p.000353: § 54.4 Certification and disclosure re- quirements.
p.000353: For purposes of this part, an appli- cant must submit a list of all clinical investigators who
p.000353: conducted covered clinical studies to determine whether the applicant’s product meets FDA’s marketing
p.000353: requirements, identifying those clinical investigators who are full-time or part-time employees of the
p.000353: sponsor of each covered study. The ap- plicant must also completely and accu- rately disclose or certify
p.000353: information concerning the financial interests of a clinical investigator who is not a full- time or
p.000353: part-time employee of the sponsor for each covered clinical study. Clinical investigators subject to inves-
p.000353: tigational new drug or investigational
p.000353: 21 CFR Ch. I (4–1–16 Edition)
p.000353: device exemption regulations must provide the sponsor of the study with sufficient accurate
p.000353: information needed to allow subsequent disclosure or cer- tification. The applicant is required to submit
p.000353: for each clinical investigator who participates in a covered study, ei- ther a certification that none of the fi-
p.000353: nancial arrangements described in § 54.2 exist, or disclose the nature of those arrangements to the agency. Where
p.000353: the applicant acts with due diligence to ob- tain the information required in this section but is unable to
p.000353: do so, the ap- plicant shall certify that despite the applicant’s due diligence in attempting to obtain the
p.000353: information, the appli- cant was unable to obtain the informa- tion and shall include the reason.
p.000353: (a) The applicant (of an application
p.000353: submitted under sections 505, 506, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic
p.000353: Act, or section 351 of the Public Health Service Act) that relies in whole or in part on clinical
p.000353: studies shall submit, for each clinical investigator who participated in a cov- ered clinical study, either
p.000353: a certifi- cation described in paragraph (a)(1) of this section or a disclosure statement described in
p.000353: paragraph (a)(3) of this section.
p.000353: (1) Certification: The applicant cov- ered by this section shall submit for all clinical investigators (as
p.000353: defined in
p.000353: § 54.2(d)), to whom the certification ap- plies, a completed Form FDA 3454 at- testing to the absence of
p.000353: financial in- terests and arrangements described in paragraph (a)(3) of this section. The form shall
p.000353: be dated and signed by the chief financial officer or other respon- sible corporate official or
p.000353: representa- tive.
p.000353: (2) If the certification covers less than all covered clinical data in the ap- plication, the applicant shall
p.000353: include in the certification a list of the studies covered by this certification.
p.000353: (3) Disclosure Statement: For any clinical investigator defined in § 54.2(d) for whom the applicant
p.000353: does not sub- mit the certification described in para- graph (a)(1) of this section, the appli- cant shall
p.000353: submit a completed Form FDA 3455 disclosing completely and ac- curately the following:
p.000353: (i) Any financial arrangement en- tered into between the sponsor of the
p.000354: 354
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p.000354:
p.000354:
p.000354: Food and Drug Administration, HHS § 54.6
p.000354:
p.000354:
p.000354: covered study and the clinical investi- gator involved in the conduct of a cov- ered clinical trial, whereby the
p.000354: value of the compensation to the clinical inves- tigator for conducting the study could be influenced by the
p.000354: outcome of the study;
p.000354: (ii) Any significant payments of other sorts from the sponsor of the cov- ered study, such as a grant to
p.000354: fund on- going research, compensation in the form of equipment, retainer for ongo- ing consultation, or
p.000354: honoraria;
p.000354: (iii) Any proprietary interest in the tested product held by any clinical in- vestigator involved in a
p.000354: study;
p.000354: (iv) Any significant equity interest in the sponsor of the covered study held by any clinical investigator
p.000354: involved in any clinical study; and
p.000354: (v) Any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements,
p.000354: interests, or payments.
p.000354: (b) The clinical investigator shall provide to the sponsor of the covered study sufficient accurate
p.000354: financial in- formation to allow the sponsor to sub- mit complete and accurate certifi- cation or
p.000354: disclosure statements as re- quired in paragraph (a) of this section. The investigator shall promptly update
p.000354: this information if any relevant changes occur in the course of the in- vestigation or for 1
p.000354: year following com- pletion of the study.
p.000354: (c) Refusal to file application. FDA
p.000354: may refuse to file any marketing appli- cation described in paragraph (a) of this section that does not
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p.000355: Subpart C—IRB Functions and Operations
p.000355: 56.108 IRB functions and operations.
p.000355: 56.109 IRB review of research.
p.000355: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000355: and for minor changes in approved research.
p.000355: 56.111 Criteria for IRB approval of research.
p.000355: 56.112 Review by institution.
p.000355: 56.113 Suspension or termination of IRB ap- proval of research.
p.000355: 56.114 Cooperative research.
p.000355: Subpart D—Records and Reports
p.000355: 56.115 IRB records.
p.000355:
p.000355: Subpart E—Administrative Actions for Noncompliance
p.000355: 56.120 Lesser administrative actions.
p.000355: 21 CFR Ch. I (4–1–16 Edition)
p.000355: 56.121 Disqualification of an IRB or an insti- tution.
p.000355: 56.122 Public disclosure of information re- garding revocation.
p.000355: 56.123 Reinstatement of an IRB or an insti- tution.
p.000355: 56.124 Actions alternative or additional to disqualification.
p.000355: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000355: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000355: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000355: 263b–263n.
p.000355: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000355: otherwise noted.
p.000355:
p.000355: Subpart A—General Provisions
p.000355: § 56.101 Scope.
p.000355: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000355: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000355: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000355: applications for research or mar- keting permits for products regulated by the Food and Drug
p.000355: Administration, including foods, including dietary sup- plements, that bear a nutrient content claim or a
p.000355: health claim, infant for- mulas, food and color additives, drugs for human use, medical devices
p.000355: for human use, biological products for human use, and electronic products. Compliance with this
p.000355: part is intended to protect the rights and welfare of human subjects involved in such inves- tigations.
p.000355: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000355: title 21, unless otherwise noted.
p.000355: [46 FR 8975, Jan. 27, 1981, as amended at 64
p.000355: FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
p.000355:
p.000355: § 56.102 Definitions.
p.000355: As used in this part:
p.000355: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040
p.000355: et seq., as amended (21 U.S.C. 321–392)).
p.000355: (b) Application for research or mar- keting permit includes:
p.000355: (1) A color additive petition, de- scribed in part 71.
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Social / Access to Social Goods
Searching for indicator access:
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p.000354: (a) Financial records of clinical inves- tigators to be retained. An applicant who has submitted a marketing
p.000354: application containing covered clinical studies shall keep on file certain information pertaining to
p.000354: the financial interests of clinical investigators who conducted studies on which the application relies
p.000354: and who are not full or part-time em- ployees of the applicant, as follows:
p.000354: (1) Complete records showing any fi- nancial interest or arrangement as de- scribed in § 54.4(a)(3)(i)
p.000354: paid to such clinical investigators by the sponsor of the covered study.
p.000355: 355
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p.000355: Pt. 56
p.000355: (2) Complete records showing signifi- cant payments of other sorts, as de- scribed in § 54.4(a)(3)(ii),
p.000355: made by the sponsor of the covered clinical study to the clinical investigator.
p.000355: (3) Complete records showing any fi- nancial interests held by clinical inves- tigators as set forth in §
p.000355: 54.4(a)(3)(iii) and (a)(3)(iv).
p.000355: (b) Requirements for maintenance of clinical investigators’ financial records.
p.000355: (1) For any application submitted for a covered product, an applicant shall re- tain records as described in
p.000355: paragraph
p.000355: (a) of this section for 2 years after the date of approval of the application.
p.000355: (2) The person maintaining these records shall, upon request from any properly authorized officer or
p.000355: employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify
p.000355: these records.
p.000355:
p.000355: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000355: Subpart A—General Provisions
p.000355: Sec.
p.000355: 56.101 Scope.
p.000355: 56.102 Definitions.
p.000355: 56.103 Circumstances in which IRB review is required.
p.000355: 56.104 Exemptions from IRB requirement.
p.000355: 56.105 Waiver of IRB requirement.
p.000355: 56.106 Registration.
p.000355: Subpart B—Organization and Personnel
p.000355: 56.107 IRB membership.
p.000355: Subpart C—IRB Functions and Operations
p.000355: 56.108 IRB functions and operations.
p.000355: 56.109 IRB review of research.
p.000355: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000355: and for minor changes in approved research.
p.000355: 56.111 Criteria for IRB approval of research.
p.000355: 56.112 Review by institution.
p.000355: 56.113 Suspension or termination of IRB ap- proval of research.
p.000355: 56.114 Cooperative research.
p.000355: Subpart D—Records and Reports
p.000355: 56.115 IRB records.
p.000355:
p.000355: Subpart E—Administrative Actions for Noncompliance
p.000355: 56.120 Lesser administrative actions.
p.000355: 21 CFR Ch. I (4–1–16 Edition)
p.000355: 56.121 Disqualification of an IRB or an insti- tution.
p.000355: 56.122 Public disclosure of information re- garding revocation.
p.000355: 56.123 Reinstatement of an IRB or an insti- tution.
p.000355: 56.124 Actions alternative or additional to disqualification.
p.000355: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000355: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
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Social / Child
Searching for indicator child:
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p.000352: § 50.56
p.000352: IRB must take into account the ages, maturity, and psychological state of the children involved. This
p.000352: judgment may be made for all children to be in- volved in clinical investigations under a particular
p.000352: protocol, or for each child, as the IRB deems appropriate.
p.000352: (c) The assent of the children is not a necessary condition for proceeding with the clinical investigation
p.000352: if the IRB determines:
p.000352: (1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted,
p.000352: or
p.000352: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000352: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000352: in the context of the clinical investigation.
p.000352: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000352: requirement if it finds and documents that:
p.000352: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000352: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000352: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000352: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000352: participa- tion.
p.000352: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000352: the IRB must determine, in accordance with and to the extent that consent is required under part 50,
p.000352: that the permission of each child’s parents or guardian is granted.
p.000352: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000352: sufficient for clinical investigations to be con- ducted under § 50.51 or § 50.52.
p.000352: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000352: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000352: known, incompetent, or not reasonably available, or when only one parent has
p.000352:
p.000352: 21 CFR Ch. I (4–1–16 Edition)
p.000352: legal responsibility for the care and custody of the child.
p.000352: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000352: required by
p.000352: § 50.27.
p.000352: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000352: docu- mented.
p.000352: [66 FR 20598, Apr. 24, 2001, as amended at 78
p.000352: FR 12951, Feb. 26, 2013]
p.000352: § 50.56 Wards.
p.000352: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000352: clinical in- vestigations approved under § 50.53 or
p.000352: § 50.54 only if such clinical investiga- tions are:
p.000352: (1) Related to their status as wards; or
p.000352: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000352: children in- volved as subjects are not wards.
p.000352: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000352: require appoint- ment of an advocate for each child who is a ward.
p.000352: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000352: guardian or in loco parentis.
p.000352: (2) One individual may serve as advo- cate for more than one child.
p.000352: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000352: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000352: investigation.
p.000352: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000352: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000352:
p.000352: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000352: Sec.
p.000352: 54.1 Purpose.
p.000352: 54.2 Definitions.
p.000352: 54.3 Scope.
p.000352: 54.4 Certification and disclosure require- ments.
p.000352: 352
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352: Food and Drug Administration, HHS § 54.2
p.000352:
p.000352:
p.000352: 54.5 Agency evaluation of financial inter- ests.
p.000352: 54.6 Recordkeeping and record retention.
p.000352: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,
p.000352: 355, 360, 360c–360j, 371, 372, 373, 374, 375, 376,
p.000352: 379; 42 U.S.C. 262.
p.000352: SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth-
p.000352: erwise noted.
p.000352: § 54.1 Purpose.
p.000352: (a) The Food and Drug Administra- tion (FDA) evaluates clinical studies submitted in marketing
p.000352: applications, required by law, for new human drugs and biological products and marketing applications and
p.000352: reclassification peti- tions for medical devices.
p.000352: (b) The agency reviews data gen- erated in these clinical studies to de- termine whether the
p.000352: applications are approvable under the statutory re- quirements. FDA may consider clinical studies
...
p.000352: § 54.2 Definitions.
p.000352: For the purposes of this part:
p.000352: (a) Compensation affected by the out- come of clinical studies means compensa- tion that could be higher for
p.000352: a favor- able outcome than for an unfavorable
p.000352:
p.000352: outcome, such as compensation that is explicitly greater for a favorable result or compensation to the
p.000352: investigator in the form of an equity interest in the sponsor of a covered study or in the form of
p.000352: compensation tied to sales of the product, such as a royalty interest.
p.000352: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000352: stock options, or other financial interest whose value cannot be readily determined through reference
p.000352: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000352: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000352: is carrying out the study and for 1 year following comple- tion of the study.
p.000352: (c) Proprietary interest in the tested
p.000352: product means property or other finan- cial interest in the product including, but not limited to, a
p.000352: patent, trade- mark, copyright or licensing agree- ment.
p.000352: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000352: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000352: dependent child of the investigator.
p.000352: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000352: application or reclassification petition subject to this part that the applicant or FDA re- lies on to establish
p.000352: that the product is effective (including studies that show equivalence to an effective product) or any
p.000352: study in which a single investi- gator makes a significant contribution to the demonstration of safety.
p.000352: This would, in general, not include phase l tolerance studies or pharmacokinetic studies, most clinical
p.000352: pharmacology studies (unless they are critical to an efficacy determination), large open safety
p.000352: studies conducted at multiple sites, treatment protocols, and parallel track protocols. An applicant may con-
p.000352: sult with FDA as to which clinical studies constitute ‘‘covered clinical studies’’ for
p.000352: purposes of complying with financial disclosure requirements.
p.000352: (f) Significant payments of other sorts
p.000352: means payments made by the sponsor of a covered study to the investigator
p.000353: 353
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353: § 54.3
p.000353: or the institution to support activities of the investigator that have a mone- tary value of more than
p.000353: $25,000, exclu- sive of the costs of conducting the clin- ical study or other clinical studies, (e.g., a
p.000353: grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or
...
Searching for indicator children:
(return to top)
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352: § 50.56
p.000352: IRB must take into account the ages, maturity, and psychological state of the children involved. This
p.000352: judgment may be made for all children to be in- volved in clinical investigations under a particular
p.000352: protocol, or for each child, as the IRB deems appropriate.
p.000352: (c) The assent of the children is not a necessary condition for proceeding with the clinical investigation
p.000352: if the IRB determines:
p.000352: (1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted,
p.000352: or
p.000352: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000352: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000352: in the context of the clinical investigation.
p.000352: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000352: requirement if it finds and documents that:
p.000352: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000352: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000352: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000352: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000352: participa- tion.
p.000352: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000352: the IRB must determine, in accordance with and to the extent that consent is required under part 50,
p.000352: that the permission of each child’s parents or guardian is granted.
p.000352: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000352: sufficient for clinical investigations to be con- ducted under § 50.51 or § 50.52.
p.000352: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000352: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000352: known, incompetent, or not reasonably available, or when only one parent has
p.000352:
p.000352: 21 CFR Ch. I (4–1–16 Edition)
p.000352: legal responsibility for the care and custody of the child.
p.000352: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000352: required by
p.000352: § 50.27.
p.000352: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000352: docu- mented.
p.000352: [66 FR 20598, Apr. 24, 2001, as amended at 78
p.000352: FR 12951, Feb. 26, 2013]
p.000352: § 50.56 Wards.
p.000352: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000352: clinical in- vestigations approved under § 50.53 or
p.000352: § 50.54 only if such clinical investiga- tions are:
p.000352: (1) Related to their status as wards; or
p.000352: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000352: children in- volved as subjects are not wards.
p.000352: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000352: require appoint- ment of an advocate for each child who is a ward.
p.000352: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000352: guardian or in loco parentis.
p.000352: (2) One individual may serve as advo- cate for more than one child.
p.000352: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000352: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000352: investigation.
p.000352: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000352: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000352:
p.000352: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000352: Sec.
p.000352: 54.1 Purpose.
p.000352: 54.2 Definitions.
p.000352: 54.3 Scope.
p.000352: 54.4 Certification and disclosure require- ments.
p.000352: 352
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000355: 56.113 Suspension or termination of IRB ap- proval of research.
p.000355: 56.114 Cooperative research.
p.000355: Subpart D—Records and Reports
p.000355: 56.115 IRB records.
p.000355:
p.000355: Subpart E—Administrative Actions for Noncompliance
p.000355: 56.120 Lesser administrative actions.
p.000355: 21 CFR Ch. I (4–1–16 Edition)
p.000355: 56.121 Disqualification of an IRB or an insti- tution.
p.000355: 56.122 Public disclosure of information re- garding revocation.
p.000355: 56.123 Reinstatement of an IRB or an insti- tution.
p.000355: 56.124 Actions alternative or additional to disqualification.
p.000355: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000355: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000355: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000355: 263b–263n.
p.000355: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000355: otherwise noted.
p.000355:
p.000355: Subpart A—General Provisions
p.000355: § 56.101 Scope.
p.000355: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000355: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000355: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000355: applications for research or mar- keting permits for products regulated by the Food and Drug
p.000355: Administration, including foods, including dietary sup- plements, that bear a nutrient content claim or a
p.000355: health claim, infant for- mulas, food and color additives, drugs for human use, medical devices
p.000355: for human use, biological products for human use, and electronic products. Compliance with this
p.000355: part is intended to protect the rights and welfare of human subjects involved in such inves- tigations.
p.000355: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000355: title 21, unless otherwise noted.
p.000355: [46 FR 8975, Jan. 27, 1981, as amended at 64
p.000355: FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
p.000355:
p.000355: § 56.102 Definitions.
p.000355: As used in this part:
p.000355: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040
p.000355: et seq., as amended (21 U.S.C. 321–392)).
p.000355: (b) Application for research or mar- keting permit includes:
p.000355: (1) A color additive petition, de- scribed in part 71.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000352: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000352: stock options, or other financial interest whose value cannot be readily determined through reference
p.000352: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000352: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000352: is carrying out the study and for 1 year following comple- tion of the study.
p.000352: (c) Proprietary interest in the tested
p.000352: product means property or other finan- cial interest in the product including, but not limited to, a
p.000352: patent, trade- mark, copyright or licensing agree- ment.
p.000352: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000352: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000352: dependent child of the investigator.
p.000352: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000352: application or reclassification petition subject to this part that the applicant or FDA re- lies on to establish
p.000352: that the product is effective (including studies that show equivalence to an effective product) or any
p.000352: study in which a single investi- gator makes a significant contribution to the demonstration of safety.
p.000352: This would, in general, not include phase l tolerance studies or pharmacokinetic studies, most clinical
p.000352: pharmacology studies (unless they are critical to an efficacy determination), large open safety
p.000352: studies conducted at multiple sites, treatment protocols, and parallel track protocols. An applicant may con-
p.000352: sult with FDA as to which clinical studies constitute ‘‘covered clinical studies’’ for
p.000352: purposes of complying with financial disclosure requirements.
p.000352: (f) Significant payments of other sorts
p.000352: means payments made by the sponsor of a covered study to the investigator
p.000353: 353
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353: § 54.3
p.000353: or the institution to support activities of the investigator that have a mone- tary value of more than
p.000353: $25,000, exclu- sive of the costs of conducting the clin- ical study or other clinical studies, (e.g., a
p.000353: grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or
p.000353: honoraria) during the time the clin- ical investigator is carrying out the study and for 1 year following the
p.000353: com- pletion of the study.
p.000353: (g) Applicant means the party who
p.000353: submits a marketing application to FDA for approval of a drug, device, or biologic product. The
p.000353: applicant is re- sponsible for submitting the appro- priate certification and disclosure
p.000353: statements required in this part.
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000353: information needed to allow subsequent disclosure or cer- tification. The applicant is required to submit
p.000353: for each clinical investigator who participates in a covered study, ei- ther a certification that none of the fi-
p.000353: nancial arrangements described in § 54.2 exist, or disclose the nature of those arrangements to the agency. Where
p.000353: the applicant acts with due diligence to ob- tain the information required in this section but is unable to
p.000353: do so, the ap- plicant shall certify that despite the applicant’s due diligence in attempting to obtain the
p.000353: information, the appli- cant was unable to obtain the informa- tion and shall include the reason.
p.000353: (a) The applicant (of an application
p.000353: submitted under sections 505, 506, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic
p.000353: Act, or section 351 of the Public Health Service Act) that relies in whole or in part on clinical
p.000353: studies shall submit, for each clinical investigator who participated in a cov- ered clinical study, either
p.000353: a certifi- cation described in paragraph (a)(1) of this section or a disclosure statement described in
p.000353: paragraph (a)(3) of this section.
p.000353: (1) Certification: The applicant cov- ered by this section shall submit for all clinical investigators (as
p.000353: defined in
p.000353: § 54.2(d)), to whom the certification ap- plies, a completed Form FDA 3454 at- testing to the absence of
p.000353: financial in- terests and arrangements described in paragraph (a)(3) of this section. The form shall
p.000353: be dated and signed by the chief financial officer or other respon- sible corporate official or
p.000353: representa- tive.
p.000353: (2) If the certification covers less than all covered clinical data in the ap- plication, the applicant shall
p.000353: include in the certification a list of the studies covered by this certification.
p.000353: (3) Disclosure Statement: For any clinical investigator defined in § 54.2(d) for whom the applicant
p.000353: does not sub- mit the certification described in para- graph (a)(1) of this section, the appli- cant shall
p.000353: submit a completed Form FDA 3455 disclosing completely and ac- curately the following:
p.000353: (i) Any financial arrangement en- tered into between the sponsor of the
p.000354: 354
p.000354:
p.000354:
p.000354:
p.000354:
p.000354:
p.000354:
p.000354:
p.000354: Food and Drug Administration, HHS § 54.6
p.000354:
p.000354:
p.000354: covered study and the clinical investi- gator involved in the conduct of a cov- ered clinical trial, whereby the
p.000354: value of the compensation to the clinical inves- tigator for conducting the study could be influenced by the
p.000354: outcome of the study;
p.000354: (ii) Any significant payments of other sorts from the sponsor of the cov- ered study, such as a grant to
p.000354: fund on- going research, compensation in the form of equipment, retainer for ongo- ing consultation, or
p.000354: honoraria;
p.000354: (iii) Any proprietary interest in the tested product held by any clinical in- vestigator involved in a
p.000354: study;
p.000354: (iv) Any significant equity interest in the sponsor of the covered study held by any clinical investigator
p.000354: involved in any clinical study; and
...
p.000354: (4) Refusing to treat the covered clin- ical study as providing data that can be the basis for an agency action.
p.000354: § 54.6 Recordkeeping and record re- tention.
p.000354: (a) Financial records of clinical inves- tigators to be retained. An applicant who has submitted a marketing
p.000354: application containing covered clinical studies shall keep on file certain information pertaining to
p.000354: the financial interests of clinical investigators who conducted studies on which the application relies
p.000354: and who are not full or part-time em- ployees of the applicant, as follows:
p.000354: (1) Complete records showing any fi- nancial interest or arrangement as de- scribed in § 54.4(a)(3)(i)
p.000354: paid to such clinical investigators by the sponsor of the covered study.
p.000355: 355
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355: Pt. 56
p.000355: (2) Complete records showing signifi- cant payments of other sorts, as de- scribed in § 54.4(a)(3)(ii),
p.000355: made by the sponsor of the covered clinical study to the clinical investigator.
p.000355: (3) Complete records showing any fi- nancial interests held by clinical inves- tigators as set forth in §
p.000355: 54.4(a)(3)(iii) and (a)(3)(iv).
p.000355: (b) Requirements for maintenance of clinical investigators’ financial records.
p.000355: (1) For any application submitted for a covered product, an applicant shall re- tain records as described in
p.000355: paragraph
p.000355: (a) of this section for 2 years after the date of approval of the application.
p.000355: (2) The person maintaining these records shall, upon request from any properly authorized officer or
p.000355: employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify
p.000355: these records.
p.000355:
p.000355: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000355: Subpart A—General Provisions
p.000355: Sec.
p.000355: 56.101 Scope.
p.000355: 56.102 Definitions.
p.000355: 56.103 Circumstances in which IRB review is required.
p.000355: 56.104 Exemptions from IRB requirement.
p.000355: 56.105 Waiver of IRB requirement.
p.000355: 56.106 Registration.
p.000355: Subpart B—Organization and Personnel
p.000355: 56.107 IRB membership.
p.000355: Subpart C—IRB Functions and Operations
p.000355: 56.108 IRB functions and operations.
p.000355: 56.109 IRB review of research.
p.000355: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000355: and for minor changes in approved research.
p.000355: 56.111 Criteria for IRB approval of research.
p.000355: 56.112 Review by institution.
p.000355: 56.113 Suspension or termination of IRB ap- proval of research.
p.000355: 56.114 Cooperative research.
p.000355: Subpart D—Records and Reports
p.000355: 56.115 IRB records.
p.000355:
p.000355: Subpart E—Administrative Actions for Noncompliance
p.000355: 56.120 Lesser administrative actions.
p.000355: 21 CFR Ch. I (4–1–16 Edition)
p.000355: 56.121 Disqualification of an IRB or an insti- tution.
p.000355: 56.122 Public disclosure of information re- garding revocation.
p.000355: 56.123 Reinstatement of an IRB or an insti- tution.
p.000355: 56.124 Actions alternative or additional to disqualification.
p.000355: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000352: covered studies and the clinical inves- tigators and certain interests of the clinical investigators
p.000352: in the product under study or in the sponsor of the covered studies. FDA will use this in- formation,
p.000352: in conjunction with infor- mation about the design and purpose of the study, as well as information ob- tained
p.000352: through on-site inspections, in the agency’s assessment of the reli- ability of the data.
p.000352: § 54.2 Definitions.
p.000352: For the purposes of this part:
p.000352: (a) Compensation affected by the out- come of clinical studies means compensa- tion that could be higher for
p.000352: a favor- able outcome than for an unfavorable
p.000352:
p.000352: outcome, such as compensation that is explicitly greater for a favorable result or compensation to the
p.000352: investigator in the form of an equity interest in the sponsor of a covered study or in the form of
p.000352: compensation tied to sales of the product, such as a royalty interest.
p.000352: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000352: stock options, or other financial interest whose value cannot be readily determined through reference
p.000352: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000352: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000352: is carrying out the study and for 1 year following comple- tion of the study.
p.000352: (c) Proprietary interest in the tested
p.000352: product means property or other finan- cial interest in the product including, but not limited to, a
p.000352: patent, trade- mark, copyright or licensing agree- ment.
p.000352: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000352: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000352: dependent child of the investigator.
p.000352: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000352: application or reclassification petition subject to this part that the applicant or FDA re- lies on to establish
p.000352: that the product is effective (including studies that show equivalence to an effective product) or any
p.000352: study in which a single investi- gator makes a significant contribution to the demonstration of safety.
p.000352: This would, in general, not include phase l tolerance studies or pharmacokinetic studies, most clinical
p.000352: pharmacology studies (unless they are critical to an efficacy determination), large open safety
p.000352: studies conducted at multiple sites, treatment protocols, and parallel track protocols. An applicant may con-
p.000352: sult with FDA as to which clinical studies constitute ‘‘covered clinical studies’’ for
p.000352: purposes of complying with financial disclosure requirements.
p.000352: (f) Significant payments of other sorts
p.000352: means payments made by the sponsor of a covered study to the investigator
p.000353: 353
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000355: made by the sponsor of the covered clinical study to the clinical investigator.
p.000355: (3) Complete records showing any fi- nancial interests held by clinical inves- tigators as set forth in §
p.000355: 54.4(a)(3)(iii) and (a)(3)(iv).
p.000355: (b) Requirements for maintenance of clinical investigators’ financial records.
p.000355: (1) For any application submitted for a covered product, an applicant shall re- tain records as described in
p.000355: paragraph
p.000355: (a) of this section for 2 years after the date of approval of the application.
p.000355: (2) The person maintaining these records shall, upon request from any properly authorized officer or
p.000355: employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify
p.000355: these records.
p.000355:
p.000355: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000355: Subpart A—General Provisions
p.000355: Sec.
p.000355: 56.101 Scope.
p.000355: 56.102 Definitions.
p.000355: 56.103 Circumstances in which IRB review is required.
p.000355: 56.104 Exemptions from IRB requirement.
p.000355: 56.105 Waiver of IRB requirement.
p.000355: 56.106 Registration.
p.000355: Subpart B—Organization and Personnel
p.000355: 56.107 IRB membership.
p.000355: Subpart C—IRB Functions and Operations
p.000355: 56.108 IRB functions and operations.
p.000355: 56.109 IRB review of research.
p.000355: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000355: and for minor changes in approved research.
p.000355: 56.111 Criteria for IRB approval of research.
p.000355: 56.112 Review by institution.
p.000355: 56.113 Suspension or termination of IRB ap- proval of research.
p.000355: 56.114 Cooperative research.
p.000355: Subpart D—Records and Reports
p.000355: 56.115 IRB records.
p.000355:
p.000355: Subpart E—Administrative Actions for Noncompliance
p.000355: 56.120 Lesser administrative actions.
p.000355: 21 CFR Ch. I (4–1–16 Edition)
p.000355: 56.121 Disqualification of an IRB or an insti- tution.
p.000355: 56.122 Public disclosure of information re- garding revocation.
p.000355: 56.123 Reinstatement of an IRB or an insti- tution.
p.000355: 56.124 Actions alternative or additional to disqualification.
p.000355: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000355: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000355: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000355: 263b–263n.
p.000355: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000355: otherwise noted.
p.000355:
p.000355: Subpart A—General Provisions
p.000355: § 56.101 Scope.
p.000355: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000355: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000355: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000355: applications for research or mar- keting permits for products regulated by the Food and Drug
...
Social / employees
Searching for indicator employees:
(return to top)
p.000353: com- pletion of the study.
p.000353: (g) Applicant means the party who
p.000353: submits a marketing application to FDA for approval of a drug, device, or biologic product. The
p.000353: applicant is re- sponsible for submitting the appro- priate certification and disclosure
p.000353: statements required in this part.
p.000353: (h) Sponsor of the covered clinical study means the party supporting a par- ticular study at the time it was
p.000353: carried out.
p.000353: [63 FR 5250, Feb. 2, 1998, as amended at 63 FR
p.000353: 72181, Dec. 31, 1998]
p.000353: § 54.3 Scope.
p.000353: The requirements in this part apply to any applicant who submits a mar- keting application for a human
p.000353: drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for
p.000353: making the appropriate certification or disclosure statement where the applicant either contracted with one
p.000353: or more clinical investigators to conduct the studies or submitted studies conducted by others not under
p.000353: contract to the applicant.
p.000353: § 54.4 Certification and disclosure re- quirements.
p.000353: For purposes of this part, an appli- cant must submit a list of all clinical investigators who
p.000353: conducted covered clinical studies to determine whether the applicant’s product meets FDA’s marketing
p.000353: requirements, identifying those clinical investigators who are full-time or part-time employees of the
p.000353: sponsor of each covered study. The ap- plicant must also completely and accu- rately disclose or certify
p.000353: information concerning the financial interests of a clinical investigator who is not a full- time or
p.000353: part-time employee of the sponsor for each covered clinical study. Clinical investigators subject to inves-
p.000353: tigational new drug or investigational
p.000353: 21 CFR Ch. I (4–1–16 Edition)
p.000353: device exemption regulations must provide the sponsor of the study with sufficient accurate
p.000353: information needed to allow subsequent disclosure or cer- tification. The applicant is required to submit
p.000353: for each clinical investigator who participates in a covered study, ei- ther a certification that none of the fi-
p.000353: nancial arrangements described in § 54.2 exist, or disclose the nature of those arrangements to the agency. Where
p.000353: the applicant acts with due diligence to ob- tain the information required in this section but is unable to
p.000353: do so, the ap- plicant shall certify that despite the applicant’s due diligence in attempting to obtain the
p.000353: information, the appli- cant was unable to obtain the informa- tion and shall include the reason.
p.000353: (a) The applicant (of an application
p.000353: submitted under sections 505, 506, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic
p.000353: Act, or section 351 of the Public Health Service Act) that relies in whole or in part on clinical
p.000353: studies shall submit, for each clinical investigator who participated in a cov- ered clinical study, either
...
Social / parents
Searching for indicator parent:
(return to top)
p.000352: or
p.000352: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000352: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000352: in the context of the clinical investigation.
p.000352: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000352: requirement if it finds and documents that:
p.000352: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000352: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000352: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000352: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000352: participa- tion.
p.000352: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000352: the IRB must determine, in accordance with and to the extent that consent is required under part 50,
p.000352: that the permission of each child’s parents or guardian is granted.
p.000352: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000352: sufficient for clinical investigations to be con- ducted under § 50.51 or § 50.52.
p.000352: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000352: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000352: known, incompetent, or not reasonably available, or when only one parent has
p.000352:
p.000352: 21 CFR Ch. I (4–1–16 Edition)
p.000352: legal responsibility for the care and custody of the child.
p.000352: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000352: required by
p.000352: § 50.27.
p.000352: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000352: docu- mented.
p.000352: [66 FR 20598, Apr. 24, 2001, as amended at 78
p.000352: FR 12951, Feb. 26, 2013]
p.000352: § 50.56 Wards.
p.000352: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000352: clinical in- vestigations approved under § 50.53 or
p.000352: § 50.54 only if such clinical investiga- tions are:
p.000352: (1) Related to their status as wards; or
p.000352: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000352: children in- volved as subjects are not wards.
p.000352: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000352: require appoint- ment of an advocate for each child who is a ward.
p.000352: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000352: guardian or in loco parentis.
...
Searching for indicator parents:
(return to top)
p.000352: if the IRB determines:
p.000352: (1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted,
p.000352: or
p.000352: (2) That the intervention or proce- dure involved in the clinical investiga- tion holds out a prospect of
p.000352: direct ben- efit that is important to the health or well-being of the children and is avail- able only
p.000352: in the context of the clinical investigation.
p.000352: (d) Even where the IRB determines that the subjects are capable of assent- ing, the IRB may still waive the assent
p.000352: requirement if it finds and documents that:
p.000352: (1) The clinical investigation in- volves no more than minimal risk to the subjects;
p.000352: (2) The waiver will not adversely af- fect the rights and welfare of the sub- jects;
p.000352: (3) The clinical investigation could not practicably be carried out without the waiver; and
p.000352: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000352: participa- tion.
p.000352: (e) In addition to the determinations required under other applicable sec- tions of this subpart D,
p.000352: the IRB must determine, in accordance with and to the extent that consent is required under part 50,
p.000352: that the permission of each child’s parents or guardian is granted.
p.000352: (1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is
p.000352: sufficient for clinical investigations to be con- ducted under § 50.51 or § 50.52.
p.000352: (2) Where clinical investigations are covered by § 50.53 or § 50.54 and permis- sion is to be
p.000352: obtained from parents, both parents must give their permis- sion unless one parent is deceased, un-
p.000352: known, incompetent, or not reasonably available, or when only one parent has
p.000352:
p.000352: 21 CFR Ch. I (4–1–16 Edition)
p.000352: legal responsibility for the care and custody of the child.
p.000352: (f) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000352: required by
p.000352: § 50.27.
p.000352: (g) When the IRB determines that as- sent is required, it must also determine whether and how assent must be
p.000352: docu- mented.
p.000352: [66 FR 20598, Apr. 24, 2001, as amended at 78
p.000352: FR 12951, Feb. 26, 2013]
p.000352: § 50.56 Wards.
p.000352: (a) Children who are wards of the State or any other agency, institution, or entity can be included in
p.000352: clinical in- vestigations approved under § 50.53 or
p.000352: § 50.54 only if such clinical investiga- tions are:
p.000352: (1) Related to their status as wards; or
p.000352: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of
p.000352: children in- volved as subjects are not wards.
p.000352: (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must
p.000352: require appoint- ment of an advocate for each child who is a ward.
p.000352: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000352: guardian or in loco parentis.
p.000352: (2) One individual may serve as advo- cate for more than one child.
p.000352: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000352: § 54.2 Definitions.
p.000352: For the purposes of this part:
p.000352: (a) Compensation affected by the out- come of clinical studies means compensa- tion that could be higher for
p.000352: a favor- able outcome than for an unfavorable
p.000352:
p.000352: outcome, such as compensation that is explicitly greater for a favorable result or compensation to the
p.000352: investigator in the form of an equity interest in the sponsor of a covered study or in the form of
p.000352: compensation tied to sales of the product, such as a royalty interest.
p.000352: (b) Significant equity interest in the sponsor of a covered study means any ownership interest,
p.000352: stock options, or other financial interest whose value cannot be readily determined through reference
p.000352: to public prices (generally, interests in a nonpublicly traded cor- poration), or any equity interest
p.000352: in a publicly traded corporation that ex- ceeds $50,000 during the time the clin- ical investigator
p.000352: is carrying out the study and for 1 year following comple- tion of the study.
p.000352: (c) Proprietary interest in the tested
p.000352: product means property or other finan- cial interest in the product including, but not limited to, a
p.000352: patent, trade- mark, copyright or licensing agree- ment.
p.000352: (d) Clinical investigator means only a listed or identified investigator or sub- investigator who is directly
p.000352: involved in the treatment or evaluation of re- search subjects. The term also includes the spouse and each
p.000352: dependent child of the investigator.
p.000352: (e) Covered clinical study means any study of a drug or device in humans submitted in a marketing
p.000352: application or reclassification petition subject to this part that the applicant or FDA re- lies on to establish
p.000352: that the product is effective (including studies that show equivalence to an effective product) or any
p.000352: study in which a single investi- gator makes a significant contribution to the demonstration of safety.
p.000352: This would, in general, not include phase l tolerance studies or pharmacokinetic studies, most clinical
p.000352: pharmacology studies (unless they are critical to an efficacy determination), large open safety
p.000352: studies conducted at multiple sites, treatment protocols, and parallel track protocols. An applicant may con-
p.000352: sult with FDA as to which clinical studies constitute ‘‘covered clinical studies’’ for
p.000352: purposes of complying with financial disclosure requirements.
p.000352: (f) Significant payments of other sorts
p.000352: means payments made by the sponsor of a covered study to the investigator
p.000353: 353
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353:
p.000353: § 54.3
p.000353: or the institution to support activities of the investigator that have a mone- tary value of more than
p.000353: $25,000, exclu- sive of the costs of conducting the clin- ical study or other clinical studies, (e.g., a
p.000353: grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000352: require appoint- ment of an advocate for each child who is a ward.
p.000352: (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as
p.000352: guardian or in loco parentis.
p.000352: (2) One individual may serve as advo- cate for more than one child.
p.000352: (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to
p.000352: act in, the best interest of the child for the duration of the child’s participation in the clinical
p.000352: investigation.
p.000352: (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the
p.000352: IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
p.000352:
p.000352: PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
p.000352: Sec.
p.000352: 54.1 Purpose.
p.000352: 54.2 Definitions.
p.000352: 54.3 Scope.
p.000352: 54.4 Certification and disclosure require- ments.
p.000352: 352
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352:
p.000352: Food and Drug Administration, HHS § 54.2
p.000352:
p.000352:
p.000352: 54.5 Agency evaluation of financial inter- ests.
p.000352: 54.6 Recordkeeping and record retention.
p.000352: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,
p.000352: 355, 360, 360c–360j, 371, 372, 373, 374, 375, 376,
p.000352: 379; 42 U.S.C. 262.
p.000352: SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth-
p.000352: erwise noted.
p.000352: § 54.1 Purpose.
p.000352: (a) The Food and Drug Administra- tion (FDA) evaluates clinical studies submitted in marketing
p.000352: applications, required by law, for new human drugs and biological products and marketing applications and
p.000352: reclassification peti- tions for medical devices.
p.000352: (b) The agency reviews data gen- erated in these clinical studies to de- termine whether the
p.000352: applications are approvable under the statutory re- quirements. FDA may consider clinical studies
p.000352: inadequate and the data inad- equate if, among other things, appro- priate steps have not been taken in the
p.000352: design, conduct, reporting, and anal- ysis of the studies to minimize bias. One potential source of
p.000352: bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study
p.000352: because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary
p.000352: in- terest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor
p.000352: of the covered study. This section and conforming regulations require an applicant whose submission
p.000352: relies in part on clinical data to disclose certain financial ar- rangements between sponsor(s) of the
p.000352: covered studies and the clinical inves- tigators and certain interests of the clinical investigators
...
p.000355: these records.
p.000355:
p.000355: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000355: Subpart A—General Provisions
p.000355: Sec.
p.000355: 56.101 Scope.
p.000355: 56.102 Definitions.
p.000355: 56.103 Circumstances in which IRB review is required.
p.000355: 56.104 Exemptions from IRB requirement.
p.000355: 56.105 Waiver of IRB requirement.
p.000355: 56.106 Registration.
p.000355: Subpart B—Organization and Personnel
p.000355: 56.107 IRB membership.
p.000355: Subpart C—IRB Functions and Operations
p.000355: 56.108 IRB functions and operations.
p.000355: 56.109 IRB review of research.
p.000355: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000355: and for minor changes in approved research.
p.000355: 56.111 Criteria for IRB approval of research.
p.000355: 56.112 Review by institution.
p.000355: 56.113 Suspension or termination of IRB ap- proval of research.
p.000355: 56.114 Cooperative research.
p.000355: Subpart D—Records and Reports
p.000355: 56.115 IRB records.
p.000355:
p.000355: Subpart E—Administrative Actions for Noncompliance
p.000355: 56.120 Lesser administrative actions.
p.000355: 21 CFR Ch. I (4–1–16 Edition)
p.000355: 56.121 Disqualification of an IRB or an insti- tution.
p.000355: 56.122 Public disclosure of information re- garding revocation.
p.000355: 56.123 Reinstatement of an IRB or an insti- tution.
p.000355: 56.124 Actions alternative or additional to disqualification.
p.000355: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000355: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000355: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000355: 263b–263n.
p.000355: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000355: otherwise noted.
p.000355:
p.000355: Subpart A—General Provisions
p.000355: § 56.101 Scope.
p.000355: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000355: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000355: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000355: applications for research or mar- keting permits for products regulated by the Food and Drug
p.000355: Administration, including foods, including dietary sup- plements, that bear a nutrient content claim or a
p.000355: health claim, infant for- mulas, food and color additives, drugs for human use, medical devices
p.000355: for human use, biological products for human use, and electronic products. Compliance with this
p.000355: part is intended to protect the rights and welfare of human subjects involved in such inves- tigations.
p.000355: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000355: title 21, unless otherwise noted.
p.000355: [46 FR 8975, Jan. 27, 1981, as amended at 64
p.000355: FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
...
Orphaned Trigger Words
p.000354: this information if any relevant changes occur in the course of the in- vestigation or for 1
p.000354: year following com- pletion of the study.
p.000354: (c) Refusal to file application. FDA
p.000354: may refuse to file any marketing appli- cation described in paragraph (a) of this section that does not
p.000354: contain the information required by this section or a certification by the applicant that the applicant has
p.000354: acted with due dili- gence to obtain the information but was unable to do so and stating the
p.000354: reason.
p.000354: [63 FR 5250, Feb. 2, 1998; 63 FR 35134, June 29,
p.000354: 1998, as amended at 64 FR 399, Jan. 5, 1999]
p.000354:
p.000354: § 54.5 Agency evaluation of financial interests.
p.000354: (a) Evaluation of disclosure statement. FDA will evaluate the information dis- closed under § 54.4(a)(2) about each
p.000354: cov- ered clinical study in an application to determine the impact of any disclosed financial interests on the
p.000354: reliability of the study. FDA may consider both the size and nature of a disclosed financial
p.000354:
p.000354: interest (including the potential in- crease in the value of the interest if the product is approved)
p.000354: and steps that have been taken to minimize the po- tential for bias.
p.000354: (b) Effect of study design. In assessing the potential of an investigator’s finan- cial interests to bias a
p.000354: study, FDA will take into account the design and pur- pose of the study. Study designs that utilize such
p.000354: approaches as multiple in- vestigators (most of whom do not have a disclosable interest), blinding, objec- tive
p.000354: endpoints, or measurement of endpoints by someone other than the investigator may adequately
p.000354: protect against any bias created by a disclosable financial interest.
p.000354: (c) Agency actions to ensure reliability of data. If FDA determines that the fi- nancial interests of
p.000354: any clinical inves- tigator raise a serious question about the integrity of the data, FDA will take
p.000354: any action it deems necessary to ensure the reliability of the data in-
p.000354: cluding:
p.000354: (1) Initiating agency audits of the data derived from the clinical investi- gator in question;
p.000354: (2) Requesting that the applicant submit further analyses of data, e.g., to evaluate the effect of the
p.000354: clinical in- vestigator’s data on overall study out- come;
p.000354: (3) Requesting that the applicant conduct additional independent studies to confirm the results of
p.000354: the ques- tioned study; and
p.000354: (4) Refusing to treat the covered clin- ical study as providing data that can be the basis for an agency action.
p.000354: § 54.6 Recordkeeping and record re- tention.
p.000354: (a) Financial records of clinical inves- tigators to be retained. An applicant who has submitted a marketing
p.000354: application containing covered clinical studies shall keep on file certain information pertaining to
p.000354: the financial interests of clinical investigators who conducted studies on which the application relies
p.000354: and who are not full or part-time em- ployees of the applicant, as follows:
p.000354: (1) Complete records showing any fi- nancial interest or arrangement as de- scribed in § 54.4(a)(3)(i)
p.000354: paid to such clinical investigators by the sponsor of the covered study.
p.000355: 355
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355:
p.000355: Pt. 56
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| dependent | Dependent |
| drug | Drug Usage |
| employees | employees |
| infant | Infant |
| minor | Youth/Minors |
| officer | Police Officer |
| parent | parents |
| parents | parents |
| party | political affiliation |
| property | Property Ownership |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| parent | ['parents'] |
| parents | ['parent'] |
Trigger Words
consent
protect
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input