0A4F4F9BD490A749D5437F821CF06DF1
21 CFR 56
https://www.govinfo.gov/content/pkg/CFR-2010-title21-vol1/pdf/CFR-2010-title21-vol1-part56.pdf
http://leaux.net/URLS/ConvertAPI Text Files/E680345967D2B7A661DEB53BE58D6961.en.txt
Examining the file media/Synopses/E680345967D2B7A661DEB53BE58D6961.html:
This file was generated: 2020-07-14 04:42:51
| 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 / Criminal Convictions
Searching for indicator prisoners:
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p.000299: revised information must be sent to FDA either electroni- cally or in writing in accordance with
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
...
p.000302: following re- quirements are satisfied:
p.000302: (1) Risks to subjects are minimized:
p.000302: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000302: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
p.000302: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000302: the purposes of the research and the setting in which the research will be conducted and should be
p.000302: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000302: children, prisoners, pregnant women, handicapped, or mentally disabled per- sons, or economically or
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
...
Political / criminal
Searching for indicator criminal:
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p.000304: the parent institution is reinstated as provided in § 56.123.
p.000304:
p.000304: § 56.122 Public disclosure of informa- tion regarding revocation.
p.000304: A determination that the Food and Drug Administration has disqualified an institution and the
p.000304: administrative record regarding that determination are disclosable to the public under part 20.
p.000304:
p.000304: § 56.123 Reinstatement of an IRB or an institution.
p.000304: An IRB or an institution may be re- instated if the Commissioner deter- mines, upon an evaluation of a
p.000304: written submission from the IRB or institution that explains the corrective action that the institution
p.000304: or IRB plans to take, that the IRB or institution has provided adequate assurance that it will
p.000304: operate in compliance with the standards set forth in this part. Notifi- cation of reinstatement shall be
p.000304: pro- vided to all persons notified under
p.000304: § 56.121(c).
p.000304:
p.000304: § 56.124 Actions alternative or addi- tional to disqualification.
p.000304: Disqualification of an IRB or of an institution is independent of, and nei- ther in lieu of nor a
p.000304: precondition to, other proceedings or actions authorized by the act. The Food and Drug Admin- istration may, at
p.000304: any time, through the Department of Justice institute any appropriate judicial proceedings (civil or
p.000304: criminal) and any other appro- priate regulatory action, in addition to or in lieu of, and before, at the time of, or
p.000304: after, disqualification. The agency may also refer pertinent matters to an- other Federal, State, or local
p.000304: govern- ment agency for any action that that agency determines to be appropriate.
...
Political / political affiliation
Searching for indicator party:
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p.000301: (d) In cases where the documentation requirement is waived under paragraph (c)(1) of this section, the IRB may
p.000301: re- quire the investigator to provide sub- jects with a written statement regard- ing the research.
p.000301: (e) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000301: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000301: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000301: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000301: person or in writing. For investigations involving an exception to informed consent under
p.000301: § 50.24 of this chapter, an IRB shall
p.000301: promptly notify in writing the investi- gator and the sponsor of the research when an IRB determines that it
p.000301: cannot approve the research because it does not meet the criteria in the exception provided under § 50.24(a)
p.000301: of this chapter or because of other relevant ethical concerns. The written notification shall
p.000301: include a statement of the rea- sons for the IRB’s determination.
p.000301: (f) An IRB shall conduct continuing review of research covered by these regulations at intervals
p.000301: appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or
p.000301: have a third party ob- serve the consent process and the re- search.
p.000301: (g) An IRB shall provide in writing to the sponsor of research involving an exception to informed
p.000301: consent under
p.000301: § 50.24 of this chapter a copy of infor- mation that has been publicly disclosed under § 50.24(a)(7)(ii) and
p.000301: (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor
p.000301: promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor
p.000301: shall provide copies of the information disclosed to FDA.
p.000301: (h) When some or all of the subjects in a study are children, an IRB must determine that the research
p.000301: study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the
p.000301: research. When some or
p.000301: 21 CFR Ch. I (4–1–10 Edition)
p.000301: all of the subjects in a study that is on- going on April 30, 2001 are children, an IRB must conduct a
p.000301: review of the re- search to determine compliance with part 50, subpart D of this chapter, ei- ther at
p.000301: the time of continuing review or, at the discretion of the IRB, at an earlier date.
p.000301: [46 FR 8975, Jan. 27, 1981, as amended at 61
p.000301: FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24,
p.000301: 2001]
p.000301:
p.000301: § 56.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000299: research. All other information changes may be re- ported when the IRB renews its reg- istration. The
p.000299: revised information must be sent to FDA either electroni- cally or in writing in accordance with
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
...
p.000302: FR 28029, June 18, 1991]
p.000302:
p.000302: § 56.111 Criteria for IRB approval of research.
p.000302: (a) In order to approve research cov- ered by these regulations the IRB shall determine that all of the
p.000302: following re- quirements are satisfied:
p.000302: (1) Risks to subjects are minimized:
p.000302: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000302: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
p.000302: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000302: the purposes of the research and the setting in which the research will be conducted and should be
p.000302: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000302: children, prisoners, pregnant women, handicapped, or mentally disabled per- sons, or economically or
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000302: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000302: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000302: the Food and Drug Administration.
...
Health / Drug Usage
Searching for indicator drug:
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p.000296: 56.108 IRB functions and operations.
p.000296: 56.109 IRB review of research.
p.000296: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000296: and for minor changes in approved research.
p.000296: 56.111 Criteria for IRB approval of research.
p.000296: 56.112 Review by institution.
p.000296: 56.113 Suspension or termination of IRB ap- proval of research.
p.000296: 56.114 Cooperative research.
p.000296: Subpart D—Records and Reports
p.000296: 56.115 IRB records.
p.000296:
p.000296: Subpart E—Administrative Actions for Noncompliance
p.000296: 56.120 Lesser administrative actions.
p.000296: 56.121 Disqualification of an IRB or an insti- tution.
p.000296: 56.122 Public disclosure of information re- garding revocation.
p.000296: 56.123 Reinstatement of an IRB or an insti- tution.
p.000296:
p.000296: 21 CFR Ch. I (4–1–10 Edition)
p.000296: 56.124 Actions alternative or additional to disqualification.
p.000296: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000296: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000296: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000296: 263b–263n.
p.000296: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000296: otherwise noted.
p.000296:
p.000296: Subpart A—General Provisions
p.000296: § 56.101 Scope.
p.000296: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000296: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000296: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000296: applications for research or mar- keting permits for products regulated by the Food and Drug
p.000296: Administration, including foods, including dietary sup- plements, that bear a nutrient content claim or a
p.000296: health claim, infant for- mulas, food and color additives, drugs for human use, medical devices
p.000296: for human use, biological products for human use, and electronic products. Compliance with this
p.000296: part is intended to protect the rights and welfare of human subjects involved in such inves- tigations.
p.000296: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000296: title 21, unless otherwise noted.
p.000296: [46 FR 8975, Jan. 27, 1981, as amended at 64
p.000296: FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
p.000296:
p.000296: § 56.102 Definitions.
p.000296: As used in this part:
p.000296: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040
p.000296: et seq., as amended (21 U.S.C. 321–392)).
p.000296: (b) Application for research or mar- keting permit includes:
p.000296: (1) A color additive petition, de- scribed in part 71.
p.000296: (2) Data and information regarding a substance submitted as part of the pro- cedures for establishing that
p.000296: a sub- stance is generally recognized as safe for a use which results or may reason- ably be expected
p.000296: to result, directly or
p.000296: 296
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Food and Drug Administration, HHS § 56.102
p.000296:
p.000296:
p.000296: indirectly, in its becoming a compo- nent or otherwise affecting the charac- teristics of any food,
p.000296: described in
p.000296: § 170.35.
p.000296: (3) A food additive petition, described in part 171.
p.000296: (4) Data and information regarding a food additive submitted as part of the procedures regarding food
p.000296: additives permitted to be used on an interim basis pending additional study, de- scribed in §
p.000296: 180.1.
p.000296: (5) Data and information regarding a substance submitted as part of the pro- cedures for establishing a tolerance
p.000296: for unavoidable contaminants in food and food-packaging materials, described in section 406 of the act.
p.000296: (6) An investigational new drug appli- cation, described in part 312 of this chapter.
p.000296: (7) A new drug application, described in part 314.
p.000296: (8) Data and information regarding the bioavailability or bioequivalence of drugs for human use submitted
p.000296: as part of the procedures for issuing, amend- ing, or repealing a bioequivalence re- quirement, described in
p.000296: part 320.
p.000296: (9) Data and information regarding an over-the-counter drug for human use submitted as part of the
p.000296: procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described
p.000296: in part 330.
p.000296: (10) An application for a biologics li- cense, described in part 601 of this chapter.
p.000296: (11) Data and information regarding a biological product submitted as part of the procedures for determining that
p.000296: li- censed biological products are safe and effective and not misbranded, as de- scribed in part 601 of
p.000296: this chapter.
p.000296: (12) An Application for an Investiga- tional Device Exemption, described in part 812.
p.000296: (13) Data and information regarding a medical device for human use sub- mitted as part of the procedures
p.000296: for classifying such devices, described in part 860.
p.000296: (14) Data and information regarding a medical device for human use sub- mitted as part of the procedures for
p.000296: es- tablishing, amending, or repealing a standard for such device, described in part 861.
p.000296:
p.000296: (15) An application for premarket ap- proval of a medical device for human use, described in section 515 of the
p.000296: act.
p.000296: (16) A product development protocol for a medical device for human use, de- scribed in section 515 of the act.
p.000296: (17) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: establishing, amending, or repealing a standard for such products, described in section 358 of the Public
p.000296: Health Service Act.
p.000296: (18) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: obtaining a variance from any electronic product performance standard, as described in
p.000296: § 1010.4.
p.000296: (19) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: granting, amending, or extending an exemption from a radiation safety performance standard, as described in
p.000296: § 1010.5.
p.000296: (20) Data and information regarding an electronic product submitted as part of the procedures for obtaining
p.000296: an exemption from notification of a radi- ation safety defect or failure of compli- ance with a radiation
p.000296: safety perform- ance standard, described in subpart D of part 1003.
p.000296: (21) Data and information about a clinical study of an infant formula when submitted as part of
p.000296: an infant formula notification under section 412(c) of the Federal Food, Drug, and Cosmetic Act.
p.000296: (22) Data and information submitted in a petition for a nutrient content claim, described in § 101.69
p.000296: of this chap- ter, and for a health claim, described in
p.000296: § 101.70 of this chapter.
p.000296: (23) Data and information from inves- tigations involving children submitted in a new dietary ingredient
p.000296: notifica- tion, described in § 190.6 of this chapter.
p.000296: (c) Clinical investigation means any experiment that involves a test article and one or more human
p.000296: subjects, and that either must meet the require- ments for prior submission to the Food and Drug
p.000296: Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior sub-
p.000296: mission to the Food and Drug Adminis- tration under these sections of the act, but the results of which are intended to
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 56.103
p.000297: be later submitted to, or held for in- spection by, the Food and Drug Admin- istration as part of an application
p.000297: for a research or marketing permit. The term does not include experiments that must meet the provisions of
p.000297: part 58, re- garding nonclinical laboratory studies. The terms research, clinical research, clinical study,
p.000297: study, and clinical inves- tigation are deemed to be synonymous for purposes of this part.
p.000297: (d) Emergency use means the use of a test article on a human subject in a life-threatening situation in
p.000297: which no standard acceptable treatment is avail- able, and in which there is not suffi- cient time to obtain
p.000297: IRB approval.
p.000297: (e) Human subject means an indi- vidual who is or becomes a participant in research, either as a
p.000297: recipient of the test article or as a control. A subject may be either a healthy individual or a patient.
p.000297: (f) Institution means any public or private entity or agency (including Federal, State, and
p.000297: other agencies). The term facility as used in section 520(g) of the act is deemed to be syn-
p.000297: onymous with the term institution for purposes of this part.
p.000297: (g) Institutional Revie Board (IRB) means any board, committee, or other group formally designated by
p.000297: an insti- tution to review, to approve the initi- ation of, and to conduct periodic re- view of,
p.000297: biomedical research involving human subjects. The primary purpose of such review is to assure the protec-
p.000297: tion of the rights and welfare of the human subjects. The term has the same meaning as the
...
p.000297: (i) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000297: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000297: the performance of rou-
p.000297: 21 CFR Ch. I (4–1–10 Edition)
p.000297: tine physical or psychological exami- nations or tests.
p.000297: (j) Sponsor means a person or other entity that initiates a clinical inves- tigation, but that does
p.000297: not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving,
p.000297: a subject under the immediate direction of another indi- vidual. A person other than an indi- vidual
p.000297: (e.g., a corporation or agency) that uses one or more of its own em- ployees to conduct an
p.000297: investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees
p.000297: are considered to be investigators.
p.000297: (k) Sponsor-investigator means an in- dividual who both initiates and actu- ally conducts, alone or with
p.000297: others, a clinical investigation, i.e., under whose immediate direction the test article is administered or
p.000297: dispensed to, or used involving, a subject. The term does not include any person other than an indi- vidual,
p.000297: e.g., it does not include a cor- poration or agency. The obligations of a sponsor-investigator under this
p.000297: part include both those of a sponsor and those of an investigator.
p.000297: (l) Test article means any drug for human use, biological product for human use, medical
p.000297: device for human use, human food additive, color addi- tive, electronic product, or any other article
p.000297: subject to regulation under the act or under sections 351 or 354–360F of the Public Health Service Act.
p.000297: (m) IRB approval means the deter- mination of the IRB that the clinical investigation has been
p.000297: reviewed and may be conducted at an institution within the constraints set forth by the IRB and
p.000297: by other institutional and Federal requirements.
p.000297: [46 FR 8975, Jan. 27, 1981, as amended at 54
p.000297: FR 9038, Mar. 3, 1989; 56 FR 28028, June 18,
p.000297: 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct.
p.000297: 20, 1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599,
p.000297: Apr. 24, 2001; 74 FR 2368, Jan. 15, 2009]
p.000297:
p.000297: § 56.103 Circumstances in which IRB review is required.
p.000297: (a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for
p.000297: prior submission (as required in parts 312,
p.000298: 298
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298: Food and Drug Administration, HHS § 56.106
p.000298:
p.000298:
p.000298: 812, and 813) to the Food and Drug Ad- ministration shall not be initiated un- less that investigation
p.000298: has been re- viewed and approved by, and remains subject to continuing review by, an IRB meeting
p.000298: the requirements of this part.
p.000298: (b) Except as provided in §§ 56.104 and 56.105, the Food and Drug Administra- tion may decide not to consider in
p.000298: sup- port of an application for a research or marketing permit any data or informa- tion that has been derived
p.000298: from a clin- ical investigation that has not been ap- proved by, and that was not subject to initial and
p.000298: continuing review by, an IRB meeting the requirements of this part. The determination that a clinical
p.000298: investigation may not be considered in support of an application for a research or marketing permit does not,
p.000298: how- ever, relieve the applicant for such a permit of any obligation under any other applicable
p.000298: regulations to submit the results of the investigation to the Food and Drug Administration.
p.000298: (c) Compliance with these regula- tions will in no way render inapplicable pertinent Federal, State, or
p.000298: local laws or regulations.
p.000298: [46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27,
p.000298: 1981]
p.000298:
p.000298: § 56.104 Exemptions from IRB require- ment.
p.000298: The following categories of clinical investigations are exempt from the re- quirements of this part for IRB
p.000298: review:
p.000298: (a) Any investigation which com- menced before July 27, 1981 and was subject to requirements for
p.000298: IRB review under FDA regulations before that date, provided that the investigation remains subject
p.000298: to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
p.000298: (b) Any investigation commenced be-
p.000298: fore July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration
p.000298: regulations before that date.
p.000298: (c) Emergency use of a test article, provided that such emergency use is re- ported to the IRB within 5
p.000298: working days. Any subsequent use of the test article at the institution is subject to IRB review.
p.000298: (d) Taste and food quality evalua- tions and consumer acceptance studies,
p.000298:
p.000298: if wholesome foods without additives are consumed or if a food is consumed that contains a food
p.000298: ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or
p.000298: environmental contaminant at or below the level found to be safe, by the Food and Drug Administration
p.000298: or ap- proved by the Environmental Protec- tion Agency or the Food Safety and In- spection Service of the
p.000298: U.S. Depart- ment of Agriculture.
p.000298: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000298: FR 28028, June 18, 1991]
p.000298: § 56.105 Waiver of IRB requirement.
p.000298: On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any
p.000298: of the requirements contained in these regulations, including the require- ments for IRB review,
p.000298: for specific re- search activities or for classes of re- search activities, otherwise covered by these
p.000298: regulations.
p.000298:
p.000298: Subpart B—Organization and Personnel
p.000298: § 56.106 Registration.
p.000298: (a) Who must register? Each IRB in the United States that reviews clinical in- vestigations regulated by FDA
p.000298: under sections 505(i) or 520(g) of the act and each IRB in the United States that re- views clinical
p.000298: investigations that are intended to support applications for re- search or marketing permits for FDA- regulated
p.000298: products must register at a site maintained by the Department of Health and Human Services (HHS). (A
p.000298: research permit under section 505(i) of the act is usually known as an inves- tigational new drug
p.000298: application (IND), while a research permit under section 520(g) of the act is usually known as an investigational
p.000298: device exemption (IDE).) An individual authorized to act on the IRB’s behalf must submit the
p.000298: registration information. All other IRBs may register voluntarily.
p.000298: (b) What information must an IRB reg-
p.000298: ister? Each IRB must provide the fol- lowing information:
p.000298: (1) The name, mailing address, and street address (if different from the mailing address) of the
p.000298: institution op- erating the IRB and the name, mailing
p.000299: 299
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299: § 56.107
p.000299: address, phone number, facsimile num- ber, and electronic mail address of the senior officer of that
p.000299: institution who is responsible for overseeing activities performed by the IRB;
p.000299: (2) The IRB’s name, mailing address, street address (if different from the mailing address), phone
p.000299: number, fac- simile number, and electronic mail ad- dress; each IRB chairperson’s name, phone number,
p.000299: and electronic mail ad- dress; and the name, mailing address, phone number, facsimile number, and
p.000299: electronic mail address of the contact person providing the registration infor- mation.
p.000299: (3) The approximate number of active protocols involving FDA-regulated products reviewed. For purposes of
p.000299: this rule, an ‘‘active protocol’’ is any pro- tocol for which an IRB conducted an initial review or a
p.000299: continuing review at a convened meeting or under an expe- dited review procedure during the pre- ceding 12
p.000299: months; and
p.000299: (4) A description of the types of FDA- regulated products (such as biological products, color additives, food
p.000299: addi- tives, human drugs, or medical devices) involved in the protocols that the IRB reviews.
p.000299: (c) When must an IRB register? Each IRB must submit an initial registra- tion. The initial
p.000299: registration must occur before the IRB begins to review a clinical investigation described in paragraph
p.000299: (a) of this section. Each IRB must renew its registration every 3 years. IRB registration becomes effec-
p.000299: tive after review and acceptance by HHS.
p.000299: (d) Where can an IRB register? Each IRB may register electronically through
p.000299: http://ohrp.cit.nih.gov/efile. If an IRB lacks the ability to register elec- tronically, it must send its
p.000299: registration information, in writing, to the Good Clinical Practice Program (HF–34), Of- fice of Science
p.000299: and Health Coordina- tion, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
p.000299: (e) Ho does an IRB revise its registra- tion information? If an IRB’s contact or chair person
p.000299: information changes, the IRB must revise its registration infor- mation by submitting any changes in that
p.000299: information within 90 days of the change. An IRB’s decision to review new types of FDA-regulated
p.000299: products
p.000299: 21 CFR Ch. I (4–1–10 Edition)
p.000299: (such as a decision to review studies pertaining to food additives whereas the IRB previously
p.000299: reviewed studies pertaining to drug products), or to dis- continue reviewing clinical investiga- tions
p.000299: regulated by FDA is a change that must be reported within 30 days of the change. An IRB’s decision to
p.000299: dis- band is a change that must be reported within 30 days of permanent cessation of the IRB’s review of
p.000299: research. All other information changes may be re- ported when the IRB renews its reg- istration. The
p.000299: revised information must be sent to FDA either electroni- cally or in writing in accordance with
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000300: project in which the member has a conflicting interest, except to provide information re- quested by
p.000300: the IRB.
p.000300: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000300: in the review of complex issues which require expertise beyond or in addition to that available on the IRB.
p.000300: These individuals may not vote with the IRB.
p.000300: [46 FR 8975, Jan 27, 1981, as amended at 56 FR
p.000300: 28028, June 18, 1991; 56 FR 29756, June 28, 1991]
p.000300:
p.000300: Subpart C—IRB Functions and Operations
p.000300: § 56.108 IRB functions and operations.
p.000300: In order to fulfill the requirements of these regulations, each IRB shall:
p.000300: (a) Follow written procedures: (1) For conducting its initial and continuing review of research and for reporting
p.000300: its findings and actions to the investigator and the institution; (2) for determining which projects require
p.000300: review more often than annually and which projects need verification from sources other than the
p.000300: investigator that no material changes have occurred since previous IRB review; (3) for ensuring prompt re-
p.000300: porting to the IRB of changes in re- search activity; and (4) for ensuring that changes in approved
p.000300: research, dur- ing the period for which IRB approval has already been given, may not be ini- tiated without
p.000300: IRB review and ap- proval except where necessary to elimi- nate apparent immediate hazards to the human
p.000300: subjects.
p.000300: (b) Follow written procedures for en-
p.000300: suring prompt reporting to the IRB,
p.000300:
p.000300: appropriate institutional officials, and the Food and Drug Administration of:
p.000300: (1) Any unanticipated problems involv- ing risks to human subjects or others;
p.000300: (2) any instance of serious or con- tinuing noncompliance with these reg- ulations or the
p.000300: requirements or deter- minations of the IRB; or (3) any sus- pension or termination of IRB ap-
p.000300: proval.
p.000300: (c) Except when an expedited review procedure is used (see § 56.110), review proposed research at
p.000300: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000300: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000300: approved, it shall receive the approval of a ma- jority of those members present at the meeting.
p.000300: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000300: FR 28028, June 18, 1991; 67 FR 9585, Mar. 4,
p.000300: 2002]
p.000300:
p.000300: § 56.109 IRB review of research.
p.000300: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000300: approval), or dis- approve all research activities covered by these regulations.
p.000300: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000300: accordance with
p.000300: § 50.25. The IRB may require that infor- mation, in addition to that specifically mentioned in § 50.25, be
p.000300: given to the subjects when in the IRB’s judgment the information would meaningfully add to the
p.000300: protection of the rights and welfare of subjects.
...
p.000301: consent under
p.000301: § 50.24 of this chapter a copy of infor- mation that has been publicly disclosed under § 50.24(a)(7)(ii) and
p.000301: (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor
p.000301: promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor
p.000301: shall provide copies of the information disclosed to FDA.
p.000301: (h) When some or all of the subjects in a study are children, an IRB must determine that the research
p.000301: study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the
p.000301: research. When some or
p.000301: 21 CFR Ch. I (4–1–10 Edition)
p.000301: all of the subjects in a study that is on- going on April 30, 2001 are children, an IRB must conduct a
p.000301: review of the re- search to determine compliance with part 50, subpart D of this chapter, ei- ther at
p.000301: the time of continuing review or, at the discretion of the IRB, at an earlier date.
p.000301: [46 FR 8975, Jan. 27, 1981, as amended at 61
p.000301: FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24,
p.000301: 2001]
p.000301:
p.000301: § 56.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000301: minor changes in approved re- search.
p.000301: (a) The Food and Drug Administra- tion has established, and published in the FEDERAL REGISTER, a list
p.000301: of cat- egories of research that may be re- viewed by the IRB through an expe- dited review
p.000301: procedure. The list will be amended, as appropriate, through peri- odic republication in the FEDERAL REG- ISTER.
p.000301: (b) An IRB may use the expedited re- view procedure to review either or both of the following: (1) Some or all
p.000301: of the research appearing on the list and found by the reviewer(s) to involve no more than minimal
p.000301: risk, (2) minor changes in previously approved re- search during the period (of 1 year or
p.000301: less) for which approval is authorized. Under an expedited review procedure, the review may be carried
p.000301: out by the IRB chairperson or by one or more ex- perienced reviewers designated by the IRB chairperson
p.000301: from among the mem- bers of the IRB. In reviewing the re- search, the reviewers may exercise all of the
p.000301: authorities of the IRB except that the reviewers may not disapprove the research. A research activity may
p.000301: be disapproved only after review in ac- cordance with the nonexpedited review procedure set forth in §
p.000301: 56.108(c).
p.000301: (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of
p.000301: re- search proposals which have been ap- proved under the procedure.
p.000301: (d) The Food and Drug Administra- tion may restrict, suspend, or termi- nate an institution’s or IRB’s
p.000301: use of the expedited review procedure when
p.000302: 302
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302: Food and Drug Administration, HHS § 56.114
p.000302:
p.000302:
p.000302: necessary to protect the rights or wel- fare of subjects.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991]
p.000302:
p.000302: § 56.111 Criteria for IRB approval of research.
p.000302: (a) In order to approve research cov- ered by these regulations the IRB shall determine that all of the
p.000302: following re- quirements are satisfied:
p.000302: (1) Risks to subjects are minimized:
p.000302: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000302: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
...
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000302: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000302: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000302: the Food and Drug Administration.
p.000302: § 56.114 Cooperative research.
p.000302: In complying with these regulations, institutions involved in multi-institu- tional studies may use joint
p.000302: review, re- liance upon the review of another qualified IRB, or similar arrangements
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 56.115
p.000303: aimed at avoidance of duplication of ef- fort.
p.000303: Subpart D—Records and Reports
p.000303: § 56.115 IRB records.
p.000303: (a) An institution, or where appro- priate an IRB, shall prepare and main- tain adequate documentation
p.000303: of IRB activities, including the following:
p.000303: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000303: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000303: reports of injuries to sub- jects.
p.000303: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000303: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
p.000303: abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the
p.000303: discussion of controverted issues and their resolution.
p.000303: (3) Records of continuing review ac-
p.000303: tivities.
p.000303: (4) Copies of all correspondence be- tween the IRB and the investigators.
p.000303: (5) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications of
p.000303: experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s chief
p.000303: anticipated contributions to IRB deliberations; and any employ- ment or other relationship between each
p.000303: member and the institution; for example: full-time employee, part-time employee, a member of governing panel or
p.000303: board, stockholder, paid or unpaid consultant.
p.000303: (6) Written procedures for the IRB as
p.000303: required by § 56.108 (a) and (b).
p.000303: (7) Statements of significant new findings provided to subjects, as re- quired by § 50.25.
p.000303: (b) The records required by this regu- lation shall be retained for at least 3 years after completion of the
p.000303: research, and the records shall be accessible for inspection and copying by authorized representatives of
p.000303: the Food and Drug Administration at reasonable times and in a reasonable manner.
p.000303: (c) The Food and Drug Administra-
p.000303: tion may refuse to consider a clinical
p.000303: 21 CFR Ch. I (4–1–10 Edition)
p.000303: investigation in support of an applica- tion for a research or marketing per- mit if the institution or
p.000303: the IRB that reviewed the investigation refuses to allow an inspection under this section.
p.000303: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000303: FR 28029, June 18, 1991; 67 FR 9585, Mar. 4,
p.000303: 2002]
p.000303:
p.000303: Subpart E—Administrative Actions for Noncompliance
p.000303: § 56.120 Lesser administrative actions.
p.000303: (a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA
p.000303: investi- gator during an inspection, the inspec- tor will present an oral or written sum- mary of observations to
p.000303: an appropriate representative of the IRB. The Food and Drug Administration may subse- quently send a
p.000303: letter describing the noncompliance to the IRB and to the parent institution. The agency will re- quire
p.000303: that the IRB or the parent insti- tution respond to this letter within a time period specified by FDA
p.000303: and de- scribe the corrective actions that will be taken by the IRB, the institution, or both to achieve
p.000303: compliance with these regulations.
p.000303: (b) On the basis of the IRB’s or the
p.000303: institution’s response, FDA may sched- ule a reinspection to confirm the ade- quacy of corrective actions.
p.000303: In addi- tion, until the IRB or the parent insti- tution takes appropriate corrective ac- tion, the agency may:
p.000303: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the
p.000303: institution or reviewed by the IRB;
p.000303: (2) Direct that no new subjects be added to ongoing studies subject to this part;
p.000303: (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or
p.000303: (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human
p.000303: subjects, notify relevant State and Federal regu- latory agencies and other parties with a direct interest in the
p.000303: agency’s action of the deficiencies in the operation of the IRB.
p.000303: (c) The parent institution is pre- sumed to be responsible for the oper- ation of an IRB, and the Food
p.000303: and Drug
p.000304: 304
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304: Food and Drug Administration, HHS § 56.124
p.000304:
p.000304:
p.000304: Administration will ordinarily direct any administrative action under this subpart against the
p.000304: institution. How- ever, depending on the evidence of re- sponsibility for deficiencies, deter- mined
p.000304: during the investigation, the Food and Drug Administration may re- strict its administrative actions to the IRB
p.000304: or to a component of the parent institution determined to be respon- sible for formal designation of the
p.000304: IRB.
p.000304: § 56.121 Disqualification of an IRB or an institution.
p.000304: (a) Whenever the IRB or the institu- tion has failed to take adequate steps to correct the noncompliance
p.000304: stated in the letter sent by the agency under
p.000304: § 56.120(a), and the Commissioner of Food and Drugs determines that this noncompliance may justify
p.000304: the dis- qualification of the IRB or of the par- ent institution, the Commissioner will institute
p.000304: proceedings in accordance with the requirements for a regulatory hearing set forth in part 16.
p.000304: (b) The Commissioner may disqualify an IRB or the parent institution if the Commissioner determines that:
p.000304: (1) The IRB has refused or repeatedly failed to comply with any of the regu- lations set forth in this part, and
p.000304: (2) The noncompliance adversely af- fects the rights or welfare of the human subjects in a
p.000304: clinical investiga- tion.
p.000304: (c) If the Commissioner determines that disqualification is appropriate, the Commissioner will issue
p.000304: an order that explains the basis for the deter- mination and that prescribes any ac- tions to be taken
p.000304: with regard to ongo- ing clinical research conducted under the review of the IRB. The Food and Drug
p.000304: Administration will send notice of the disqualification to the IRB and the parent institution. Other
p.000304: parties with a direct interest, such as sponsors and clinical investigators, may also be sent a notice of the
p.000304: disqualification. In addition, the agency may elect to pub- lish a notice of its action in the FED- ERAL
p.000304: REGISTER.
p.000304: (d) The Food and Drug Administra-
p.000304: tion will not approve an application for a research permit for a clinical inves- tigation that is to be
p.000304: under the review of a disqualified IRB or that is to be conducted at a disqualified institution,
p.000304:
p.000304: and it may refuse to consider in sup- port of a marketing permit the data from a clinical investigation
p.000304: that was reviewed by a disqualified IRB as con- ducted at a disqualified institution, un- less the IRB or
p.000304: the parent institution is reinstated as provided in § 56.123.
p.000304:
p.000304: § 56.122 Public disclosure of informa- tion regarding revocation.
p.000304: A determination that the Food and Drug Administration has disqualified an institution and the
p.000304: administrative record regarding that determination are disclosable to the public under part 20.
p.000304:
p.000304: § 56.123 Reinstatement of an IRB or an institution.
p.000304: An IRB or an institution may be re- instated if the Commissioner deter- mines, upon an evaluation of a
p.000304: written submission from the IRB or institution that explains the corrective action that the institution
p.000304: or IRB plans to take, that the IRB or institution has provided adequate assurance that it will
p.000304: operate in compliance with the standards set forth in this part. Notifi- cation of reinstatement shall be
p.000304: pro- vided to all persons notified under
p.000304: § 56.121(c).
p.000304:
p.000304: § 56.124 Actions alternative or addi- tional to disqualification.
p.000304: Disqualification of an IRB or of an institution is independent of, and nei- ther in lieu of nor a
p.000304: precondition to, other proceedings or actions authorized by the act. The Food and Drug Admin- istration may, at
p.000304: any time, through the Department of Justice institute any appropriate judicial proceedings (civil or
p.000304: criminal) and any other appro- priate regulatory action, in addition to or in lieu of, and before, at the time of, or
p.000304: after, disqualification. The agency may also refer pertinent matters to an- other Federal, State, or local
p.000304: govern- ment agency for any action that that agency determines to be appropriate.
...
Searching for indicator influence:
(return to top)
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000302: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000302: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000302: the Food and Drug Administration.
p.000302: § 56.114 Cooperative research.
...
Searching for indicator substance:
(return to top)
p.000296: applications for research or mar- keting permits for products regulated by the Food and Drug
p.000296: Administration, including foods, including dietary sup- plements, that bear a nutrient content claim or a
p.000296: health claim, infant for- mulas, food and color additives, drugs for human use, medical devices
p.000296: for human use, biological products for human use, and electronic products. Compliance with this
p.000296: part is intended to protect the rights and welfare of human subjects involved in such inves- tigations.
p.000296: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000296: title 21, unless otherwise noted.
p.000296: [46 FR 8975, Jan. 27, 1981, as amended at 64
p.000296: FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
p.000296:
p.000296: § 56.102 Definitions.
p.000296: As used in this part:
p.000296: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040
p.000296: et seq., as amended (21 U.S.C. 321–392)).
p.000296: (b) Application for research or mar- keting permit includes:
p.000296: (1) A color additive petition, de- scribed in part 71.
p.000296: (2) Data and information regarding a substance submitted as part of the pro- cedures for establishing that
p.000296: a sub- stance is generally recognized as safe for a use which results or may reason- ably be expected
p.000296: to result, directly or
p.000296: 296
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Food and Drug Administration, HHS § 56.102
p.000296:
p.000296:
p.000296: indirectly, in its becoming a compo- nent or otherwise affecting the charac- teristics of any food,
p.000296: described in
p.000296: § 170.35.
p.000296: (3) A food additive petition, described in part 171.
p.000296: (4) Data and information regarding a food additive submitted as part of the procedures regarding food
p.000296: additives permitted to be used on an interim basis pending additional study, de- scribed in §
p.000296: 180.1.
p.000296: (5) Data and information regarding a substance submitted as part of the pro- cedures for establishing a tolerance
p.000296: for unavoidable contaminants in food and food-packaging materials, described in section 406 of the act.
p.000296: (6) An investigational new drug appli- cation, described in part 312 of this chapter.
p.000296: (7) A new drug application, described in part 314.
p.000296: (8) Data and information regarding the bioavailability or bioequivalence of drugs for human use submitted
p.000296: as part of the procedures for issuing, amend- ing, or repealing a bioequivalence re- quirement, described in
p.000296: part 320.
p.000296: (9) Data and information regarding an over-the-counter drug for human use submitted as part of the
p.000296: procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described
p.000296: in part 330.
p.000296: (10) An application for a biologics li- cense, described in part 601 of this chapter.
p.000296: (11) Data and information regarding a biological product submitted as part of the procedures for determining that
p.000296: li- censed biological products are safe and effective and not misbranded, as de- scribed in part 601 of
p.000296: this chapter.
p.000296: (12) An Application for an Investiga- tional Device Exemption, described in part 812.
p.000296: (13) Data and information regarding a medical device for human use sub- mitted as part of the procedures
p.000296: for classifying such devices, described in part 860.
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000300: project in which the member has a conflicting interest, except to provide information re- quested by
p.000300: the IRB.
p.000300: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
...
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
p.000302: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000302: the purposes of the research and the setting in which the research will be conducted and should be
p.000302: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000302: children, prisoners, pregnant women, handicapped, or mentally disabled per- sons, or economically or
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
...
Searching for indicator mentally:
(return to top)
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000300: project in which the member has a conflicting interest, except to provide information re- quested by
p.000300: the IRB.
...
p.000302: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
p.000302: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000302: the purposes of the research and the setting in which the research will be conducted and should be
p.000302: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000302: children, prisoners, pregnant women, handicapped, or mentally disabled per- sons, or economically or
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000302: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000300: project in which the member has a conflicting interest, except to provide information re- quested by
p.000300: the IRB.
p.000300: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000300: in the review of complex issues which require expertise beyond or in addition to that available on the IRB.
p.000300: These individuals may not vote with the IRB.
p.000300: [46 FR 8975, Jan 27, 1981, as amended at 56 FR
p.000300: 28028, June 18, 1991; 56 FR 29756, June 28, 1991]
p.000300:
p.000300: Subpart C—IRB Functions and Operations
p.000300: § 56.108 IRB functions and operations.
p.000300: In order to fulfill the requirements of these regulations, each IRB shall:
p.000300: (a) Follow written procedures: (1) For conducting its initial and continuing review of research and for reporting
p.000300: its findings and actions to the investigator and the institution; (2) for determining which projects require
p.000300: review more often than annually and which projects need verification from sources other than the
p.000300: investigator that no material changes have occurred since previous IRB review; (3) for ensuring prompt re-
p.000300: porting to the IRB of changes in re- search activity; and (4) for ensuring that changes in approved
p.000300: research, dur- ing the period for which IRB approval has already been given, may not be ini- tiated without
p.000300: IRB review and ap- proval except where necessary to elimi- nate apparent immediate hazards to the human
p.000300: subjects.
p.000300: (b) Follow written procedures for en-
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
...
p.000302: following re- quirements are satisfied:
p.000302: (1) Risks to subjects are minimized:
p.000302: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000302: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
p.000302: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000302: the purposes of the research and the setting in which the research will be conducted and should be
p.000302: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000302: children, prisoners, pregnant women, handicapped, or mentally disabled per- sons, or economically or
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Pt. 56
p.000296: (3) Complete records showing any fi- nancial interests held by clinical inves- tigators as set forth in §
p.000296: 54.4(a)(3)(iii) and (a)(3)(iv).
p.000296: (b) Requirements for maintenance of clinical investigators’ financial records.
p.000296: (1) For any application submitted for a covered product, an applicant shall re- tain records as described in
p.000296: paragraph
p.000296: (a) of this section for 2 years after the date of approval of the application.
p.000296: (2) The person maintaining these records shall, upon request from any properly authorized officer or
p.000296: employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify
p.000296: these records.
p.000296:
p.000296: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000296: Subpart A—General Provisions
p.000296: Sec.
p.000296: 56.101 Scope.
p.000296: 56.102 Definitions.
p.000296: 56.103 Circumstances in which IRB review is required.
p.000296: 56.104 Exemptions from IRB requirement.
p.000296: 56.105 Waiver of IRB requirement.
p.000296: 56.106 Registration.
p.000296: Subpart B—Organization and Personnel
p.000296: 56.107 IRB membership.
p.000296: Subpart C—IRB Functions and Operations
p.000296: 56.108 IRB functions and operations.
p.000296: 56.109 IRB review of research.
p.000296: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000296: and for minor changes in approved research.
p.000296: 56.111 Criteria for IRB approval of research.
p.000296: 56.112 Review by institution.
p.000296: 56.113 Suspension or termination of IRB ap- proval of research.
p.000296: 56.114 Cooperative research.
p.000296: Subpart D—Records and Reports
p.000296: 56.115 IRB records.
p.000296:
p.000296: Subpart E—Administrative Actions for Noncompliance
p.000296: 56.120 Lesser administrative actions.
p.000296: 56.121 Disqualification of an IRB or an insti- tution.
p.000296: 56.122 Public disclosure of information re- garding revocation.
p.000296: 56.123 Reinstatement of an IRB or an insti- tution.
p.000296:
p.000296: 21 CFR Ch. I (4–1–10 Edition)
p.000296: 56.124 Actions alternative or additional to disqualification.
p.000296: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000296: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
...
Social / Child
Searching for indicator children:
(return to top)
p.000296: (17) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: establishing, amending, or repealing a standard for such products, described in section 358 of the Public
p.000296: Health Service Act.
p.000296: (18) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: obtaining a variance from any electronic product performance standard, as described in
p.000296: § 1010.4.
p.000296: (19) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: granting, amending, or extending an exemption from a radiation safety performance standard, as described in
p.000296: § 1010.5.
p.000296: (20) Data and information regarding an electronic product submitted as part of the procedures for obtaining
p.000296: an exemption from notification of a radi- ation safety defect or failure of compli- ance with a radiation
p.000296: safety perform- ance standard, described in subpart D of part 1003.
p.000296: (21) Data and information about a clinical study of an infant formula when submitted as part of
p.000296: an infant formula notification under section 412(c) of the Federal Food, Drug, and Cosmetic Act.
p.000296: (22) Data and information submitted in a petition for a nutrient content claim, described in § 101.69
p.000296: of this chap- ter, and for a health claim, described in
p.000296: § 101.70 of this chapter.
p.000296: (23) Data and information from inves- tigations involving children submitted in a new dietary ingredient
p.000296: notifica- tion, described in § 190.6 of this chapter.
p.000296: (c) Clinical investigation means any experiment that involves a test article and one or more human
p.000296: subjects, and that either must meet the require- ments for prior submission to the Food and Drug
p.000296: Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior sub-
p.000296: mission to the Food and Drug Adminis- tration under these sections of the act, but the results of which are intended to
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 56.103
p.000297: be later submitted to, or held for in- spection by, the Food and Drug Admin- istration as part of an application
p.000297: for a research or marketing permit. The term does not include experiments that must meet the provisions of
p.000297: part 58, re- garding nonclinical laboratory studies. The terms research, clinical research, clinical study,
p.000297: study, and clinical inves- tigation are deemed to be synonymous for purposes of this part.
p.000297: (d) Emergency use means the use of a test article on a human subject in a life-threatening situation in
p.000297: which no standard acceptable treatment is avail- able, and in which there is not suffi- cient time to obtain
p.000297: IRB approval.
p.000297: (e) Human subject means an indi- vidual who is or becomes a participant in research, either as a
...
p.000299: research. All other information changes may be re- ported when the IRB renews its reg- istration. The
p.000299: revised information must be sent to FDA either electroni- cally or in writing in accordance with
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
...
p.000301: § 50.24 of this chapter, an IRB shall
p.000301: promptly notify in writing the investi- gator and the sponsor of the research when an IRB determines that it
p.000301: cannot approve the research because it does not meet the criteria in the exception provided under § 50.24(a)
p.000301: of this chapter or because of other relevant ethical concerns. The written notification shall
p.000301: include a statement of the rea- sons for the IRB’s determination.
p.000301: (f) An IRB shall conduct continuing review of research covered by these regulations at intervals
p.000301: appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or
p.000301: have a third party ob- serve the consent process and the re- search.
p.000301: (g) An IRB shall provide in writing to the sponsor of research involving an exception to informed
p.000301: consent under
p.000301: § 50.24 of this chapter a copy of infor- mation that has been publicly disclosed under § 50.24(a)(7)(ii) and
p.000301: (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor
p.000301: promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor
p.000301: shall provide copies of the information disclosed to FDA.
p.000301: (h) When some or all of the subjects in a study are children, an IRB must determine that the research
p.000301: study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the
p.000301: research. When some or
p.000301: 21 CFR Ch. I (4–1–10 Edition)
p.000301: all of the subjects in a study that is on- going on April 30, 2001 are children, an IRB must conduct a
p.000301: review of the re- search to determine compliance with part 50, subpart D of this chapter, ei- ther at
p.000301: the time of continuing review or, at the discretion of the IRB, at an earlier date.
p.000301: [46 FR 8975, Jan. 27, 1981, as amended at 61
p.000301: FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24,
p.000301: 2001]
p.000301:
p.000301: § 56.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000301: minor changes in approved re- search.
p.000301: (a) The Food and Drug Administra- tion has established, and published in the FEDERAL REGISTER, a list
p.000301: of cat- egories of research that may be re- viewed by the IRB through an expe- dited review
p.000301: procedure. The list will be amended, as appropriate, through peri- odic republication in the FEDERAL REG- ISTER.
p.000301: (b) An IRB may use the expedited re- view procedure to review either or both of the following: (1) Some or all
p.000301: of the research appearing on the list and found by the reviewer(s) to involve no more than minimal
p.000301: risk, (2) minor changes in previously approved re- search during the period (of 1 year or
p.000301: less) for which approval is authorized. Under an expedited review procedure, the review may be carried
p.000301: out by the IRB chairperson or by one or more ex- perienced reviewers designated by the IRB chairperson
...
p.000302: (a) In order to approve research cov- ered by these regulations the IRB shall determine that all of the
p.000302: following re- quirements are satisfied:
p.000302: (1) Risks to subjects are minimized:
p.000302: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000302: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
p.000302: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000302: the purposes of the research and the setting in which the research will be conducted and should be
p.000302: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000302: children, prisoners, pregnant women, handicapped, or mentally disabled per- sons, or economically or
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000302: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000302: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000302: the Food and Drug Administration.
p.000302: § 56.114 Cooperative research.
p.000302: In complying with these regulations, institutions involved in multi-institu- tional studies may use joint
p.000302: review, re- liance upon the review of another qualified IRB, or similar arrangements
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 56.115
p.000303: aimed at avoidance of duplication of ef- fort.
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000296: 56.113 Suspension or termination of IRB ap- proval of research.
p.000296: 56.114 Cooperative research.
p.000296: Subpart D—Records and Reports
p.000296: 56.115 IRB records.
p.000296:
p.000296: Subpart E—Administrative Actions for Noncompliance
p.000296: 56.120 Lesser administrative actions.
p.000296: 56.121 Disqualification of an IRB or an insti- tution.
p.000296: 56.122 Public disclosure of information re- garding revocation.
p.000296: 56.123 Reinstatement of an IRB or an insti- tution.
p.000296:
p.000296: 21 CFR Ch. I (4–1–10 Edition)
p.000296: 56.124 Actions alternative or additional to disqualification.
p.000296: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000296: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000296: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000296: 263b–263n.
p.000296: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000296: otherwise noted.
p.000296:
p.000296: Subpart A—General Provisions
p.000296: § 56.101 Scope.
p.000296: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000296: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000296: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000296: applications for research or mar- keting permits for products regulated by the Food and Drug
p.000296: Administration, including foods, including dietary sup- plements, that bear a nutrient content claim or a
p.000296: health claim, infant for- mulas, food and color additives, drugs for human use, medical devices
p.000296: for human use, biological products for human use, and electronic products. Compliance with this
p.000296: part is intended to protect the rights and welfare of human subjects involved in such inves- tigations.
p.000296: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000296: title 21, unless otherwise noted.
p.000296: [46 FR 8975, Jan. 27, 1981, as amended at 64
p.000296: FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
p.000296:
p.000296: § 56.102 Definitions.
p.000296: As used in this part:
p.000296: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040
p.000296: et seq., as amended (21 U.S.C. 321–392)).
p.000296: (b) Application for research or mar- keting permit includes:
p.000296: (1) A color additive petition, de- scribed in part 71.
p.000296: (2) Data and information regarding a substance submitted as part of the pro- cedures for establishing that
p.000296: a sub- stance is generally recognized as safe for a use which results or may reason- ably be expected
p.000296: to result, directly or
p.000296: 296
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Food and Drug Administration, HHS § 56.102
p.000296:
p.000296:
...
p.000296: for classifying such devices, described in part 860.
p.000296: (14) Data and information regarding a medical device for human use sub- mitted as part of the procedures for
p.000296: es- tablishing, amending, or repealing a standard for such device, described in part 861.
p.000296:
p.000296: (15) An application for premarket ap- proval of a medical device for human use, described in section 515 of the
p.000296: act.
p.000296: (16) A product development protocol for a medical device for human use, de- scribed in section 515 of the act.
p.000296: (17) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: establishing, amending, or repealing a standard for such products, described in section 358 of the Public
p.000296: Health Service Act.
p.000296: (18) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: obtaining a variance from any electronic product performance standard, as described in
p.000296: § 1010.4.
p.000296: (19) Data and information regarding an electronic product submitted as part of the procedures for
p.000296: granting, amending, or extending an exemption from a radiation safety performance standard, as described in
p.000296: § 1010.5.
p.000296: (20) Data and information regarding an electronic product submitted as part of the procedures for obtaining
p.000296: an exemption from notification of a radi- ation safety defect or failure of compli- ance with a radiation
p.000296: safety perform- ance standard, described in subpart D of part 1003.
p.000296: (21) Data and information about a clinical study of an infant formula when submitted as part of
p.000296: an infant formula notification under section 412(c) of the Federal Food, Drug, and Cosmetic Act.
p.000296: (22) Data and information submitted in a petition for a nutrient content claim, described in § 101.69
p.000296: of this chap- ter, and for a health claim, described in
p.000296: § 101.70 of this chapter.
p.000296: (23) Data and information from inves- tigations involving children submitted in a new dietary ingredient
p.000296: notifica- tion, described in § 190.6 of this chapter.
p.000296: (c) Clinical investigation means any experiment that involves a test article and one or more human
p.000296: subjects, and that either must meet the require- ments for prior submission to the Food and Drug
p.000296: Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior sub-
p.000296: mission to the Food and Drug Adminis- tration under these sections of the act, but the results of which are intended to
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 56.103
p.000297: be later submitted to, or held for in- spection by, the Food and Drug Admin- istration as part of an application
p.000297: for a research or marketing permit. The term does not include experiments that must meet the provisions of
p.000297: part 58, re- garding nonclinical laboratory studies. The terms research, clinical research, clinical study,
p.000297: study, and clinical inves- tigation are deemed to be synonymous for purposes of this part.
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Pt. 56
p.000296: (3) Complete records showing any fi- nancial interests held by clinical inves- tigators as set forth in §
p.000296: 54.4(a)(3)(iii) and (a)(3)(iv).
p.000296: (b) Requirements for maintenance of clinical investigators’ financial records.
p.000296: (1) For any application submitted for a covered product, an applicant shall re- tain records as described in
p.000296: paragraph
p.000296: (a) of this section for 2 years after the date of approval of the application.
p.000296: (2) The person maintaining these records shall, upon request from any properly authorized officer or
p.000296: employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify
p.000296: these records.
p.000296:
p.000296: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000296: Subpart A—General Provisions
p.000296: Sec.
p.000296: 56.101 Scope.
p.000296: 56.102 Definitions.
p.000296: 56.103 Circumstances in which IRB review is required.
p.000296: 56.104 Exemptions from IRB requirement.
p.000296: 56.105 Waiver of IRB requirement.
p.000296: 56.106 Registration.
p.000296: Subpart B—Organization and Personnel
p.000296: 56.107 IRB membership.
p.000296: Subpart C—IRB Functions and Operations
p.000296: 56.108 IRB functions and operations.
p.000296: 56.109 IRB review of research.
p.000296: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000296: and for minor changes in approved research.
p.000296: 56.111 Criteria for IRB approval of research.
p.000296: 56.112 Review by institution.
p.000296: 56.113 Suspension or termination of IRB ap- proval of research.
p.000296: 56.114 Cooperative research.
p.000296: Subpart D—Records and Reports
p.000296: 56.115 IRB records.
p.000296:
p.000296: Subpart E—Administrative Actions for Noncompliance
p.000296: 56.120 Lesser administrative actions.
p.000296: 56.121 Disqualification of an IRB or an insti- tution.
p.000296: 56.122 Public disclosure of information re- garding revocation.
p.000296: 56.123 Reinstatement of an IRB or an insti- tution.
p.000296:
p.000296: 21 CFR Ch. I (4–1–10 Edition)
p.000296: 56.124 Actions alternative or additional to disqualification.
p.000296: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
...
p.000298: for specific re- search activities or for classes of re- search activities, otherwise covered by these
p.000298: regulations.
p.000298:
p.000298: Subpart B—Organization and Personnel
p.000298: § 56.106 Registration.
p.000298: (a) Who must register? Each IRB in the United States that reviews clinical in- vestigations regulated by FDA
p.000298: under sections 505(i) or 520(g) of the act and each IRB in the United States that re- views clinical
p.000298: investigations that are intended to support applications for re- search or marketing permits for FDA- regulated
p.000298: products must register at a site maintained by the Department of Health and Human Services (HHS). (A
p.000298: research permit under section 505(i) of the act is usually known as an inves- tigational new drug
p.000298: application (IND), while a research permit under section 520(g) of the act is usually known as an investigational
p.000298: device exemption (IDE).) An individual authorized to act on the IRB’s behalf must submit the
p.000298: registration information. All other IRBs may register voluntarily.
p.000298: (b) What information must an IRB reg-
p.000298: ister? Each IRB must provide the fol- lowing information:
p.000298: (1) The name, mailing address, and street address (if different from the mailing address) of the
p.000298: institution op- erating the IRB and the name, mailing
p.000299: 299
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299: § 56.107
p.000299: address, phone number, facsimile num- ber, and electronic mail address of the senior officer of that
p.000299: institution who is responsible for overseeing activities performed by the IRB;
p.000299: (2) The IRB’s name, mailing address, street address (if different from the mailing address), phone
p.000299: number, fac- simile number, and electronic mail ad- dress; each IRB chairperson’s name, phone number,
p.000299: and electronic mail ad- dress; and the name, mailing address, phone number, facsimile number, and
p.000299: electronic mail address of the contact person providing the registration infor- mation.
p.000299: (3) The approximate number of active protocols involving FDA-regulated products reviewed. For purposes of
p.000299: this rule, an ‘‘active protocol’’ is any pro- tocol for which an IRB conducted an initial review or a
p.000299: continuing review at a convened meeting or under an expe- dited review procedure during the pre- ceding 12
p.000299: months; and
p.000299: (4) A description of the types of FDA- regulated products (such as biological products, color additives, food
p.000299: addi- tives, human drugs, or medical devices) involved in the protocols that the IRB reviews.
p.000299: (c) When must an IRB register? Each IRB must submit an initial registra- tion. The initial
p.000299: registration must occur before the IRB begins to review a clinical investigation described in paragraph
p.000299: (a) of this section. Each IRB must renew its registration every 3 years. IRB registration becomes effec-
p.000299: tive after review and acceptance by HHS.
p.000299: (d) Where can an IRB register? Each IRB may register electronically through
p.000299: http://ohrp.cit.nih.gov/efile. If an IRB lacks the ability to register elec- tronically, it must send its
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000299: (e) Ho does an IRB revise its registra- tion information? If an IRB’s contact or chair person
p.000299: information changes, the IRB must revise its registration infor- mation by submitting any changes in that
p.000299: information within 90 days of the change. An IRB’s decision to review new types of FDA-regulated
p.000299: products
p.000299: 21 CFR Ch. I (4–1–10 Edition)
p.000299: (such as a decision to review studies pertaining to food additives whereas the IRB previously
p.000299: reviewed studies pertaining to drug products), or to dis- continue reviewing clinical investiga- tions
p.000299: regulated by FDA is a change that must be reported within 30 days of the change. An IRB’s decision to
p.000299: dis- band is a change that must be reported within 30 days of permanent cessation of the IRB’s review of
p.000299: research. All other information changes may be re- ported when the IRB renews its reg- istration. The
p.000299: revised information must be sent to FDA either electroni- cally or in writing in accordance with
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000303: § 56.120 Lesser administrative actions.
p.000303: (a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA
p.000303: investi- gator during an inspection, the inspec- tor will present an oral or written sum- mary of observations to
p.000303: an appropriate representative of the IRB. The Food and Drug Administration may subse- quently send a
p.000303: letter describing the noncompliance to the IRB and to the parent institution. The agency will re- quire
p.000303: that the IRB or the parent insti- tution respond to this letter within a time period specified by FDA
p.000303: and de- scribe the corrective actions that will be taken by the IRB, the institution, or both to achieve
p.000303: compliance with these regulations.
p.000303: (b) On the basis of the IRB’s or the
p.000303: institution’s response, FDA may sched- ule a reinspection to confirm the ade- quacy of corrective actions.
p.000303: In addi- tion, until the IRB or the parent insti- tution takes appropriate corrective ac- tion, the agency may:
p.000303: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the
p.000303: institution or reviewed by the IRB;
p.000303: (2) Direct that no new subjects be added to ongoing studies subject to this part;
p.000303: (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or
p.000303: (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human
p.000303: subjects, notify relevant State and Federal regu- latory agencies and other parties with a direct interest in the
p.000303: agency’s action of the deficiencies in the operation of the IRB.
p.000303: (c) The parent institution is pre- sumed to be responsible for the oper- ation of an IRB, and the Food
p.000303: and Drug
p.000304: 304
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304: Food and Drug Administration, HHS § 56.124
p.000304:
p.000304:
p.000304: Administration will ordinarily direct any administrative action under this subpart against the
p.000304: institution. How- ever, depending on the evidence of re- sponsibility for deficiencies, deter- mined
p.000304: during the investigation, the Food and Drug Administration may re- strict its administrative actions to the IRB
p.000304: or to a component of the parent institution determined to be respon- sible for formal designation of the
p.000304: IRB.
p.000304: § 56.121 Disqualification of an IRB or an institution.
p.000304: (a) Whenever the IRB or the institu- tion has failed to take adequate steps to correct the noncompliance
p.000304: stated in the letter sent by the agency under
p.000304: § 56.120(a), and the Commissioner of Food and Drugs determines that this noncompliance may justify
...
Social / Women
Searching for indicator women:
(return to top)
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000300: project in which the member has a conflicting interest, except to provide information re- quested by
p.000300: the IRB.
p.000300: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000300: in the review of complex issues which require expertise beyond or in addition to that available on the IRB.
p.000300: These individuals may not vote with the IRB.
p.000300: [46 FR 8975, Jan 27, 1981, as amended at 56 FR
p.000300: 28028, June 18, 1991; 56 FR 29756, June 28, 1991]
p.000300:
p.000300: Subpart C—IRB Functions and Operations
p.000300: § 56.108 IRB functions and operations.
...
p.000302: (1) Risks to subjects are minimized:
p.000302: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000302: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000302: on the subjects for di- agnostic or treatment purposes.
p.000302: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000302: importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should
p.000302: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000302: benefits of therapies that subjects would receive even if not par- ticipating in the research).
p.000302: The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example,
p.000302: the possible effects of the research on public policy) as among those research risks that fall within the purview
p.000302: of its responsi- bility.
p.000302: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000302: the purposes of the research and the setting in which the research will be conducted and should be
p.000302: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000302: children, prisoners, pregnant women, handicapped, or mentally disabled per- sons, or economically or
p.000302: educationally disadvantaged persons.
p.000302: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000302: representa- tive, in accordance with and to the ex- tent required by part 50.
p.000302: (5) Informed consent will be appro- priately documented, in accordance with and to the extent
p.000302: required by
p.000302: § 50.27.
p.000302:
p.000302: (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected
p.000302: to en- sure the safety of subjects.
p.000302: (7) Where appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000302: con- fidentiality of data.
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Pt. 56
p.000296: (3) Complete records showing any fi- nancial interests held by clinical inves- tigators as set forth in §
p.000296: 54.4(a)(3)(iii) and (a)(3)(iv).
p.000296: (b) Requirements for maintenance of clinical investigators’ financial records.
p.000296: (1) For any application submitted for a covered product, an applicant shall re- tain records as described in
p.000296: paragraph
p.000296: (a) of this section for 2 years after the date of approval of the application.
p.000296: (2) The person maintaining these records shall, upon request from any properly authorized officer or
p.000296: employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify
p.000296: these records.
p.000296:
p.000296: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000296: Subpart A—General Provisions
p.000296: Sec.
p.000296: 56.101 Scope.
p.000296: 56.102 Definitions.
p.000296: 56.103 Circumstances in which IRB review is required.
p.000296: 56.104 Exemptions from IRB requirement.
p.000296: 56.105 Waiver of IRB requirement.
p.000296: 56.106 Registration.
p.000296: Subpart B—Organization and Personnel
p.000296: 56.107 IRB membership.
p.000296: Subpart C—IRB Functions and Operations
p.000296: 56.108 IRB functions and operations.
p.000296: 56.109 IRB review of research.
p.000296: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000296: and for minor changes in approved research.
p.000296: 56.111 Criteria for IRB approval of research.
p.000296: 56.112 Review by institution.
p.000296: 56.113 Suspension or termination of IRB ap- proval of research.
p.000296: 56.114 Cooperative research.
p.000296: Subpart D—Records and Reports
p.000296: 56.115 IRB records.
p.000296:
p.000296: Subpart E—Administrative Actions for Noncompliance
p.000296: 56.120 Lesser administrative actions.
p.000296: 56.121 Disqualification of an IRB or an insti- tution.
p.000296: 56.122 Public disclosure of information re- garding revocation.
p.000296: 56.123 Reinstatement of an IRB or an insti- tution.
p.000296:
p.000296: 21 CFR Ch. I (4–1–10 Edition)
p.000296: 56.124 Actions alternative or additional to disqualification.
p.000296: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000296: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000296: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000296: 263b–263n.
p.000296: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000296: otherwise noted.
p.000296:
p.000296: Subpart A—General Provisions
p.000296: § 56.101 Scope.
p.000296: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000296: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000296: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000296: applications for research or mar- keting permits for products regulated by the Food and Drug
...
p.000301: (g) An IRB shall provide in writing to the sponsor of research involving an exception to informed
p.000301: consent under
p.000301: § 50.24 of this chapter a copy of infor- mation that has been publicly disclosed under § 50.24(a)(7)(ii) and
p.000301: (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor
p.000301: promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor
p.000301: shall provide copies of the information disclosed to FDA.
p.000301: (h) When some or all of the subjects in a study are children, an IRB must determine that the research
p.000301: study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the
p.000301: research. When some or
p.000301: 21 CFR Ch. I (4–1–10 Edition)
p.000301: all of the subjects in a study that is on- going on April 30, 2001 are children, an IRB must conduct a
p.000301: review of the re- search to determine compliance with part 50, subpart D of this chapter, ei- ther at
p.000301: the time of continuing review or, at the discretion of the IRB, at an earlier date.
p.000301: [46 FR 8975, Jan. 27, 1981, as amended at 61
p.000301: FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24,
p.000301: 2001]
p.000301:
p.000301: § 56.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000301: minor changes in approved re- search.
p.000301: (a) The Food and Drug Administra- tion has established, and published in the FEDERAL REGISTER, a list
p.000301: of cat- egories of research that may be re- viewed by the IRB through an expe- dited review
p.000301: procedure. The list will be amended, as appropriate, through peri- odic republication in the FEDERAL REG- ISTER.
p.000301: (b) An IRB may use the expedited re- view procedure to review either or both of the following: (1) Some or all
p.000301: of the research appearing on the list and found by the reviewer(s) to involve no more than minimal
p.000301: risk, (2) minor changes in previously approved re- search during the period (of 1 year or
p.000301: less) for which approval is authorized. Under an expedited review procedure, the review may be carried
p.000301: out by the IRB chairperson or by one or more ex- perienced reviewers designated by the IRB chairperson
p.000301: from among the mem- bers of the IRB. In reviewing the re- search, the reviewers may exercise all of the
p.000301: authorities of the IRB except that the reviewers may not disapprove the research. A research activity may
p.000301: be disapproved only after review in ac- cordance with the nonexpedited review procedure set forth in §
p.000301: 56.108(c).
p.000301: (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of
p.000301: re- search proposals which have been ap- proved under the procedure.
p.000301: (d) The Food and Drug Administra- tion may restrict, suspend, or termi- nate an institution’s or IRB’s
p.000301: use of the expedited review procedure when
p.000302: 302
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302: Food and Drug Administration, HHS § 56.114
p.000302:
p.000302:
p.000302: necessary to protect the rights or wel- fare of subjects.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991]
p.000302:
p.000302: § 56.111 Criteria for IRB approval of research.
p.000302: (a) In order to approve research cov- ered by these regulations the IRB shall determine that all of the
...
Social / employees
Searching for indicator employees:
(return to top)
p.000297: tion of the rights and welfare of the human subjects. The term has the same meaning as the
p.000297: phrase institu- tional revie committee as used in sec- tion 520(g) of the act.
p.000297: (h) Investigator means an individual who actually conducts a clinical inves- tigation (i.e., under whose
p.000297: immediate direction the test article is adminis- tered or dispensed to, or used involv- ing, a subject) or,
p.000297: in the event of an in- vestigation conducted by a team of in- dividuals, is the responsible leader of that
p.000297: team.
p.000297: (i) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000297: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000297: the performance of rou-
p.000297: 21 CFR Ch. I (4–1–10 Edition)
p.000297: tine physical or psychological exami- nations or tests.
p.000297: (j) Sponsor means a person or other entity that initiates a clinical inves- tigation, but that does
p.000297: not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving,
p.000297: a subject under the immediate direction of another indi- vidual. A person other than an indi- vidual
p.000297: (e.g., a corporation or agency) that uses one or more of its own em- ployees to conduct an
p.000297: investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees
p.000297: are considered to be investigators.
p.000297: (k) Sponsor-investigator means an in- dividual who both initiates and actu- ally conducts, alone or with
p.000297: others, a clinical investigation, i.e., under whose immediate direction the test article is administered or
p.000297: dispensed to, or used involving, a subject. The term does not include any person other than an indi- vidual,
p.000297: e.g., it does not include a cor- poration or agency. The obligations of a sponsor-investigator under this
p.000297: part include both those of a sponsor and those of an investigator.
p.000297: (l) Test article means any drug for human use, biological product for human use, medical
p.000297: device for human use, human food additive, color addi- tive, electronic product, or any other article
p.000297: subject to regulation under the act or under sections 351 or 354–360F of the Public Health Service Act.
p.000297: (m) IRB approval means the deter- mination of the IRB that the clinical investigation has been
p.000297: reviewed and may be conducted at an institution within the constraints set forth by the IRB and
p.000297: by other institutional and Federal requirements.
p.000297: [46 FR 8975, Jan. 27, 1981, as amended at 54
p.000297: FR 9038, Mar. 3, 1989; 56 FR 28028, June 18,
p.000297: 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct.
p.000297: 20, 1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599,
p.000297: Apr. 24, 2001; 74 FR 2368, Jan. 15, 2009]
p.000297:
p.000297: § 56.103 Circumstances in which IRB review is required.
p.000297: (a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for
...
Social / gender
Searching for indicator gender:
(return to top)
p.000299: (e) Ho does an IRB revise its registra- tion information? If an IRB’s contact or chair person
p.000299: information changes, the IRB must revise its registration infor- mation by submitting any changes in that
p.000299: information within 90 days of the change. An IRB’s decision to review new types of FDA-regulated
p.000299: products
p.000299: 21 CFR Ch. I (4–1–10 Edition)
p.000299: (such as a decision to review studies pertaining to food additives whereas the IRB previously
p.000299: reviewed studies pertaining to drug products), or to dis- continue reviewing clinical investiga- tions
p.000299: regulated by FDA is a change that must be reported within 30 days of the change. An IRB’s decision to
p.000299: dis- band is a change that must be reported within 30 days of permanent cessation of the IRB’s review of
p.000299: research. All other information changes may be re- ported when the IRB renews its reg- istration. The
p.000299: revised information must be sent to FDA either electroni- cally or in writing in accordance with
p.000299: paragraph (d) of this section.
p.000299: [74 FR 2368, Jan. 15, 2009]
p.000299: § 56.107 IRB membership.
p.000299: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000299: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000299: qualified through the experience and expertise of its members, and the diversity of the members,
p.000299: including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as commu- nity
p.000299: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000299: sub- jects. In addition to possessing the pro- fessional competence necessary to re- view the specific
p.000299: research activities, the IRB shall be able to ascertain the acceptability of proposed research in
p.000299: terms of institutional commitments and regulations, applicable law, and standards or professional
p.000299: conduct and practice. The IRB shall therefore in- clude persons knowledgeable in these areas. If an IRB
p.000299: regularly reviews re- search that involves a vulnerable cat- egory of subjects, such as children,
p.000299: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000299: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000299: with those subjects.
p.000299: (b) Every nondiscriminatory effort
p.000299: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000299: instituton’s con- sideration of qualified persons of both sexes, so long as no selection is made
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Food and Drug Administration, HHS § 56.109
p.000300:
p.000300:
p.000300: to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000300: (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at
p.000300: least one member whose primary concerns are in nonscientific areas.
p.000300: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000300: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000300: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000300: project in which the member has a conflicting interest, except to provide information re- quested by
p.000300: the IRB.
p.000300: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000300: in the review of complex issues which require expertise beyond or in addition to that available on the IRB.
p.000300: These individuals may not vote with the IRB.
p.000300: [46 FR 8975, Jan 27, 1981, as amended at 56 FR
p.000300: 28028, June 18, 1991; 56 FR 29756, June 28, 1991]
p.000300:
p.000300: Subpart C—IRB Functions and Operations
p.000300: § 56.108 IRB functions and operations.
p.000300: In order to fulfill the requirements of these regulations, each IRB shall:
p.000300: (a) Follow written procedures: (1) For conducting its initial and continuing review of research and for reporting
p.000300: its findings and actions to the investigator and the institution; (2) for determining which projects require
p.000300: review more often than annually and which projects need verification from sources other than the
...
Social / parents
Searching for indicator parent:
(return to top)
p.000303: (6) Written procedures for the IRB as
p.000303: required by § 56.108 (a) and (b).
p.000303: (7) Statements of significant new findings provided to subjects, as re- quired by § 50.25.
p.000303: (b) The records required by this regu- lation shall be retained for at least 3 years after completion of the
p.000303: research, and the records shall be accessible for inspection and copying by authorized representatives of
p.000303: the Food and Drug Administration at reasonable times and in a reasonable manner.
p.000303: (c) The Food and Drug Administra-
p.000303: tion may refuse to consider a clinical
p.000303: 21 CFR Ch. I (4–1–10 Edition)
p.000303: investigation in support of an applica- tion for a research or marketing per- mit if the institution or
p.000303: the IRB that reviewed the investigation refuses to allow an inspection under this section.
p.000303: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000303: FR 28029, June 18, 1991; 67 FR 9585, Mar. 4,
p.000303: 2002]
p.000303:
p.000303: Subpart E—Administrative Actions for Noncompliance
p.000303: § 56.120 Lesser administrative actions.
p.000303: (a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA
p.000303: investi- gator during an inspection, the inspec- tor will present an oral or written sum- mary of observations to
p.000303: an appropriate representative of the IRB. The Food and Drug Administration may subse- quently send a
p.000303: letter describing the noncompliance to the IRB and to the parent institution. The agency will re- quire
p.000303: that the IRB or the parent insti- tution respond to this letter within a time period specified by FDA
p.000303: and de- scribe the corrective actions that will be taken by the IRB, the institution, or both to achieve
p.000303: compliance with these regulations.
p.000303: (b) On the basis of the IRB’s or the
p.000303: institution’s response, FDA may sched- ule a reinspection to confirm the ade- quacy of corrective actions.
p.000303: In addi- tion, until the IRB or the parent insti- tution takes appropriate corrective ac- tion, the agency may:
p.000303: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the
p.000303: institution or reviewed by the IRB;
p.000303: (2) Direct that no new subjects be added to ongoing studies subject to this part;
p.000303: (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or
p.000303: (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human
p.000303: subjects, notify relevant State and Federal regu- latory agencies and other parties with a direct interest in the
p.000303: agency’s action of the deficiencies in the operation of the IRB.
p.000303: (c) The parent institution is pre- sumed to be responsible for the oper- ation of an IRB, and the Food
p.000303: and Drug
p.000304: 304
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304: Food and Drug Administration, HHS § 56.124
p.000304:
p.000304:
p.000304: Administration will ordinarily direct any administrative action under this subpart against the
p.000304: institution. How- ever, depending on the evidence of re- sponsibility for deficiencies, deter- mined
p.000304: during the investigation, the Food and Drug Administration may re- strict its administrative actions to the IRB
p.000304: or to a component of the parent institution determined to be respon- sible for formal designation of the
p.000304: IRB.
p.000304: § 56.121 Disqualification of an IRB or an institution.
p.000304: (a) Whenever the IRB or the institu- tion has failed to take adequate steps to correct the noncompliance
p.000304: stated in the letter sent by the agency under
p.000304: § 56.120(a), and the Commissioner of Food and Drugs determines that this noncompliance may justify
p.000304: the dis- qualification of the IRB or of the par- ent institution, the Commissioner will institute
p.000304: proceedings in accordance with the requirements for a regulatory hearing set forth in part 16.
p.000304: (b) The Commissioner may disqualify an IRB or the parent institution if the Commissioner determines that:
p.000304: (1) The IRB has refused or repeatedly failed to comply with any of the regu- lations set forth in this part, and
p.000304: (2) The noncompliance adversely af- fects the rights or welfare of the human subjects in a
p.000304: clinical investiga- tion.
p.000304: (c) If the Commissioner determines that disqualification is appropriate, the Commissioner will issue
p.000304: an order that explains the basis for the deter- mination and that prescribes any ac- tions to be taken
p.000304: with regard to ongo- ing clinical research conducted under the review of the IRB. The Food and Drug
p.000304: Administration will send notice of the disqualification to the IRB and the parent institution. Other
p.000304: parties with a direct interest, such as sponsors and clinical investigators, may also be sent a notice of the
p.000304: disqualification. In addition, the agency may elect to pub- lish a notice of its action in the FED- ERAL
p.000304: REGISTER.
p.000304: (d) The Food and Drug Administra-
p.000304: tion will not approve an application for a research permit for a clinical inves- tigation that is to be
p.000304: under the review of a disqualified IRB or that is to be conducted at a disqualified institution,
p.000304:
p.000304: and it may refuse to consider in sup- port of a marketing permit the data from a clinical investigation
p.000304: that was reviewed by a disqualified IRB as con- ducted at a disqualified institution, un- less the IRB or
p.000304: the parent institution is reinstated as provided in § 56.123.
p.000304:
p.000304: § 56.122 Public disclosure of informa- tion regarding revocation.
p.000304: A determination that the Food and Drug Administration has disqualified an institution and the
p.000304: administrative record regarding that determination are disclosable to the public under part 20.
p.000304:
p.000304: § 56.123 Reinstatement of an IRB or an institution.
p.000304: An IRB or an institution may be re- instated if the Commissioner deter- mines, upon an evaluation of a
p.000304: written submission from the IRB or institution that explains the corrective action that the institution
p.000304: or IRB plans to take, that the IRB or institution has provided adequate assurance that it will
p.000304: operate in compliance with the standards set forth in this part. Notifi- cation of reinstatement shall be
p.000304: pro- vided to all persons notified under
p.000304: § 56.121(c).
p.000304:
p.000304: § 56.124 Actions alternative or addi- tional to disqualification.
p.000304: Disqualification of an IRB or of an institution is independent of, and nei- ther in lieu of nor a
p.000304: precondition to, other proceedings or actions authorized by the act. The Food and Drug Admin- istration may, at
p.000304: any time, through the Department of Justice institute any appropriate judicial proceedings (civil or
p.000304: criminal) and any other appro- priate regulatory action, in addition to or in lieu of, and before, at the time of, or
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000296: (22) Data and information submitted in a petition for a nutrient content claim, described in § 101.69
p.000296: of this chap- ter, and for a health claim, described in
p.000296: § 101.70 of this chapter.
p.000296: (23) Data and information from inves- tigations involving children submitted in a new dietary ingredient
p.000296: notifica- tion, described in § 190.6 of this chapter.
p.000296: (c) Clinical investigation means any experiment that involves a test article and one or more human
p.000296: subjects, and that either must meet the require- ments for prior submission to the Food and Drug
p.000296: Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior sub-
p.000296: mission to the Food and Drug Adminis- tration under these sections of the act, but the results of which are intended to
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 56.103
p.000297: be later submitted to, or held for in- spection by, the Food and Drug Admin- istration as part of an application
p.000297: for a research or marketing permit. The term does not include experiments that must meet the provisions of
p.000297: part 58, re- garding nonclinical laboratory studies. The terms research, clinical research, clinical study,
p.000297: study, and clinical inves- tigation are deemed to be synonymous for purposes of this part.
p.000297: (d) Emergency use means the use of a test article on a human subject in a life-threatening situation in
p.000297: which no standard acceptable treatment is avail- able, and in which there is not suffi- cient time to obtain
p.000297: IRB approval.
p.000297: (e) Human subject means an indi- vidual who is or becomes a participant in research, either as a
p.000297: recipient of the test article or as a control. A subject may be either a healthy individual or a patient.
p.000297: (f) Institution means any public or private entity or agency (including Federal, State, and
p.000297: other agencies). The term facility as used in section 520(g) of the act is deemed to be syn-
p.000297: onymous with the term institution for purposes of this part.
p.000297: (g) Institutional Revie Board (IRB) means any board, committee, or other group formally designated by
p.000297: an insti- tution to review, to approve the initi- ation of, and to conduct periodic re- view of,
p.000297: biomedical research involving human subjects. The primary purpose of such review is to assure the protec-
p.000297: tion of the rights and welfare of the human subjects. The term has the same meaning as the
p.000297: phrase institu- tional revie committee as used in sec- tion 520(g) of the act.
p.000297: (h) Investigator means an individual who actually conducts a clinical inves- tigation (i.e., under whose
p.000297: immediate direction the test article is adminis- tered or dispensed to, or used involv- ing, a subject) or,
p.000297: in the event of an in- vestigation conducted by a team of in- dividuals, is the responsible leader of that
p.000297: team.
...
p.000298: sup- port of an application for a research or marketing permit any data or informa- tion that has been derived
p.000298: from a clin- ical investigation that has not been ap- proved by, and that was not subject to initial and
p.000298: continuing review by, an IRB meeting the requirements of this part. The determination that a clinical
p.000298: investigation may not be considered in support of an application for a research or marketing permit does not,
p.000298: how- ever, relieve the applicant for such a permit of any obligation under any other applicable
p.000298: regulations to submit the results of the investigation to the Food and Drug Administration.
p.000298: (c) Compliance with these regula- tions will in no way render inapplicable pertinent Federal, State, or
p.000298: local laws or regulations.
p.000298: [46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27,
p.000298: 1981]
p.000298:
p.000298: § 56.104 Exemptions from IRB require- ment.
p.000298: The following categories of clinical investigations are exempt from the re- quirements of this part for IRB
p.000298: review:
p.000298: (a) Any investigation which com- menced before July 27, 1981 and was subject to requirements for
p.000298: IRB review under FDA regulations before that date, provided that the investigation remains subject
p.000298: to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
p.000298: (b) Any investigation commenced be-
p.000298: fore July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration
p.000298: regulations before that date.
p.000298: (c) Emergency use of a test article, provided that such emergency use is re- ported to the IRB within 5
p.000298: working days. Any subsequent use of the test article at the institution is subject to IRB review.
p.000298: (d) Taste and food quality evalua- tions and consumer acceptance studies,
p.000298:
p.000298: if wholesome foods without additives are consumed or if a food is consumed that contains a food
p.000298: ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or
p.000298: environmental contaminant at or below the level found to be safe, by the Food and Drug Administration
p.000298: or ap- proved by the Environmental Protec- tion Agency or the Food Safety and In- spection Service of the
p.000298: U.S. Depart- ment of Agriculture.
p.000298: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000298: FR 28028, June 18, 1991]
p.000298: § 56.105 Waiver of IRB requirement.
p.000298: On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any
p.000298: of the requirements contained in these regulations, including the require- ments for IRB review,
p.000298: for specific re- search activities or for classes of re- search activities, otherwise covered by these
p.000298: regulations.
p.000298:
p.000298: Subpart B—Organization and Personnel
p.000298: § 56.106 Registration.
p.000298: (a) Who must register? Each IRB in the United States that reviews clinical in- vestigations regulated by FDA
p.000298: under sections 505(i) or 520(g) of the act and each IRB in the United States that re- views clinical
...
p.000300: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000300: accordance with
p.000300: § 50.25. The IRB may require that infor- mation, in addition to that specifically mentioned in § 50.25, be
p.000300: given to the subjects when in the IRB’s judgment the information would meaningfully add to the
p.000300: protection of the rights and welfare of subjects.
p.000300: (c) An IRB shall require documenta- tion of informed consent in accordance with § 50.27 of this chapter,
p.000300: except as follows:
p.000300: (1) The IRB may, for some or all sub- jects, waive the requirement that the subject, or the subject’s legally
p.000300: author- ized representative, sign a written con- sent form if it finds that the research presents no more
p.000300: than minimal risk of harm to subjects and involves no proce- dures for which written consent is nor- mally
p.000300: required outside the research context; or
p.000300: (2) The IRB may, for some or all sub- jects, find that the requirements in
p.000300: § 50.24 of this chapter for an exception
p.000301: 301
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301: § 56.110
p.000301: from informed consent for emergency research are met.
p.000301: (d) In cases where the documentation requirement is waived under paragraph (c)(1) of this section, the IRB may
p.000301: re- quire the investigator to provide sub- jects with a written statement regard- ing the research.
p.000301: (e) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000301: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000301: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000301: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000301: person or in writing. For investigations involving an exception to informed consent under
p.000301: § 50.24 of this chapter, an IRB shall
p.000301: promptly notify in writing the investi- gator and the sponsor of the research when an IRB determines that it
p.000301: cannot approve the research because it does not meet the criteria in the exception provided under § 50.24(a)
p.000301: of this chapter or because of other relevant ethical concerns. The written notification shall
p.000301: include a statement of the rea- sons for the IRB’s determination.
p.000301: (f) An IRB shall conduct continuing review of research covered by these regulations at intervals
p.000301: appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000296: these records.
p.000296:
p.000296: PART 56—INSTITUTIONAL REVIEW BOARDS
p.000296: Subpart A—General Provisions
p.000296: Sec.
p.000296: 56.101 Scope.
p.000296: 56.102 Definitions.
p.000296: 56.103 Circumstances in which IRB review is required.
p.000296: 56.104 Exemptions from IRB requirement.
p.000296: 56.105 Waiver of IRB requirement.
p.000296: 56.106 Registration.
p.000296: Subpart B—Organization and Personnel
p.000296: 56.107 IRB membership.
p.000296: Subpart C—IRB Functions and Operations
p.000296: 56.108 IRB functions and operations.
p.000296: 56.109 IRB review of research.
p.000296: 56.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000296: and for minor changes in approved research.
p.000296: 56.111 Criteria for IRB approval of research.
p.000296: 56.112 Review by institution.
p.000296: 56.113 Suspension or termination of IRB ap- proval of research.
p.000296: 56.114 Cooperative research.
p.000296: Subpart D—Records and Reports
p.000296: 56.115 IRB records.
p.000296:
p.000296: Subpart E—Administrative Actions for Noncompliance
p.000296: 56.120 Lesser administrative actions.
p.000296: 56.121 Disqualification of an IRB or an insti- tution.
p.000296: 56.122 Public disclosure of information re- garding revocation.
p.000296: 56.123 Reinstatement of an IRB or an insti- tution.
p.000296:
p.000296: 21 CFR Ch. I (4–1–10 Edition)
p.000296: 56.124 Actions alternative or additional to disqualification.
p.000296: AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
p.000296: 350a, 350b, 351, 352, 353, 355, 360, 360c–360f,
p.000296: 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,
p.000296: 263b–263n.
p.000296: SOURCE: 46 FR 8975, Jan. 27, 1981, unless
p.000296: otherwise noted.
p.000296:
p.000296: Subpart A—General Provisions
p.000296: § 56.101 Scope.
p.000296: (a) This part contains the general standards for the composition, oper- ation, and responsibility
p.000296: of an Institu- tional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug
p.000296: Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that sup- port
p.000296: applications for research or mar- keting permits for products regulated by the Food and Drug
p.000296: Administration, including foods, including dietary sup- plements, that bear a nutrient content claim or a
p.000296: health claim, infant for- mulas, food and color additives, drugs for human use, medical devices
p.000296: for human use, biological products for human use, and electronic products. Compliance with this
p.000296: part is intended to protect the rights and welfare of human subjects involved in such inves- tigations.
p.000296: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000296: title 21, unless otherwise noted.
p.000296: [46 FR 8975, Jan. 27, 1981, as amended at 64
p.000296: FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
...
p.000301: (d) In cases where the documentation requirement is waived under paragraph (c)(1) of this section, the IRB may
p.000301: re- quire the investigator to provide sub- jects with a written statement regard- ing the research.
p.000301: (e) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000301: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000301: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000301: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000301: person or in writing. For investigations involving an exception to informed consent under
p.000301: § 50.24 of this chapter, an IRB shall
p.000301: promptly notify in writing the investi- gator and the sponsor of the research when an IRB determines that it
p.000301: cannot approve the research because it does not meet the criteria in the exception provided under § 50.24(a)
p.000301: of this chapter or because of other relevant ethical concerns. The written notification shall
p.000301: include a statement of the rea- sons for the IRB’s determination.
p.000301: (f) An IRB shall conduct continuing review of research covered by these regulations at intervals
p.000301: appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or
p.000301: have a third party ob- serve the consent process and the re- search.
p.000301: (g) An IRB shall provide in writing to the sponsor of research involving an exception to informed
p.000301: consent under
p.000301: § 50.24 of this chapter a copy of infor- mation that has been publicly disclosed under § 50.24(a)(7)(ii) and
p.000301: (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor
p.000301: promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor
p.000301: shall provide copies of the information disclosed to FDA.
p.000301: (h) When some or all of the subjects in a study are children, an IRB must determine that the research
p.000301: study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the
p.000301: research. When some or
p.000301: 21 CFR Ch. I (4–1–10 Edition)
p.000301: all of the subjects in a study that is on- going on April 30, 2001 are children, an IRB must conduct a
p.000301: review of the re- search to determine compliance with part 50, subpart D of this chapter, ei- ther at
p.000301: the time of continuing review or, at the discretion of the IRB, at an earlier date.
p.000301: [46 FR 8975, Jan. 27, 1981, as amended at 61
p.000301: FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24,
p.000301: 2001]
p.000301:
...
p.000302: (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or
p.000302: mentally dis- abled persons, or economically or edu- cationally disadvantaged persons, are likely to be
p.000302: vulnerable to coercion or undue influence additional safeguards have been included in the study to pro- tect
p.000302: the rights and welfare of these subjects.
p.000302: (c) In order to approve research in which some or all of the subjects are children, an IRB must
p.000302: determine that all research is in compliance with part 50, subpart D of this chapter.
p.000302: [46 FR 8975, Jan. 27, 1981, as amended at 56
p.000302: FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
p.000302: 2001]
p.000302: § 56.112 Review by institution.
p.000302: Research covered by these regula- tions that has been approved by an IRB may be subject to further
p.000302: appropriate review and approval or disapproval by officials of the institution. However, those officials
p.000302: may not approve the re- search if it has not been approved by an IRB.
p.000302: § 56.113 Suspension or termination of IRB approval of research.
p.000302: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000302: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000302: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000302: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000302: the Food and Drug Administration.
p.000302: § 56.114 Cooperative research.
p.000302: In complying with these regulations, institutions involved in multi-institu- tional studies may use joint
p.000302: review, re- liance upon the review of another qualified IRB, or similar arrangements
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 56.115
p.000303: aimed at avoidance of duplication of ef- fort.
p.000303: Subpart D—Records and Reports
p.000303: § 56.115 IRB records.
p.000303: (a) An institution, or where appro- priate an IRB, shall prepare and main- tain adequate documentation
p.000303: of IRB activities, including the following:
p.000303: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000303: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000303: reports of injuries to sub- jects.
p.000303: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000303: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| children | Child |
| criminal | criminal |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| gender | gender |
| infant | Infant |
| influence | Drug Usage |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| officer | Police Officer |
| parent | parents |
| party | political affiliation |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| race | Racial Minority |
| substance | Drug Usage |
| threat | Threat of Stigma |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| disabled | ['mentally'] |
| drug | ['influence', 'substance'] |
| influence | ['drug', 'substance'] |
| mentally | ['disabled'] |
| substance | ['drug', 'influence'] |
Trigger Words
capacity
coercion
consent
cultural
harm
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input