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[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2017]

[CITE: = 21CFR56]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD = AND DRUG=20 ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES =
SUBCHAPTER A--GENERAL=20


PART 56	INSTITUTIONAL REVIEW = BOARDS

=20

Subpart=20 A--General Provisions

Sec. 56.101 Scope.

(a) This part contains the general standards for = the=20 composition, operation, and responsibility of an = Institutional=20 Review Board (IRB) that reviews clinical = investigations=20 regulated by the Food and Drug Administration under = sections=20 505(i) and 520(g) of the act, as well as clinical=20 investigations that support applications for research = or=20 marketing permits for products regulated by the Food = and Drug=20 Administration, including foods, including dietary=20 supplements, that bear a nutrient content claim or a = health=20 claim, infant formulas, food and color additives, = drugs for=20 human use, medical devices for human use, biological = products=20 for human use, and electronic products. Compliance = with this=20 part is intended to protect the rights and welfare of = human=20 subjects involved in such investigations.

(b) References in this part to regulatory sections = of the=20 Code of Federal Regulations are to chapter I of title = 21,=20 unless otherwise noted.

[46 FR 8975, Jan. 27, 1981, as amended at 64 FR = 399, Jan.=20 5, 1999; 66 FR 20599, Apr. 24, 2001]=20

Sec. 56.102 Definitions.

As used in this part:

(a) Act means the Federal Food, Drug, and = Cosmetic=20 Act, as amended (secs. 201-902, 52 Stat. 1040 et = seq.,=20 as amended (21 U.S.C. 321-392)).

(b) Application for research or marketing = permit=20 includes:

(1) A color additive petition, described in part = 71.

(2) Data and information regarding a substance = submitted as=20 part of the procedures for establishing that a = substance is=20 generally recognized as safe for a use which results = or may=20 reasonably be expected to result, directly or = indirectly, in=20 its becoming a component or otherwise affecting the=20 characteristics of any food, described in 170.35.

(3) A food additive petition, described in part = 171.

(4) Data and information regarding a food additive=20 submitted as part of the procedures regarding food = additives=20 permitted to be used on an interim basis pending = additional=20 study, described in 180.1.

(5) Data and information regarding a substance = submitted as=20 part of the procedures for establishing a tolerance = for=20 unavoidable contaminants in food and food-packaging = materials,=20 described in section 406 of the act.

(6) An investigational new drug application, = described in=20 part 312 of this chapter.

(7) A new drug application, described in part 314. =

(8) Data and information regarding the = bioavailability or=20 bioequivalence of drugs for human use submitted as = part of the=20 procedures for issuing, amending, or repealing a=20 bioequivalence requirement, described in part 320. =

(9) Data and information regarding an = over-the-counter drug=20 for human use submitted as part of the procedures for=20 classifying such drugs as generally recognized as safe = and=20 effective and not misbranded, described in part 330. =

(10) An application for a biologics license, = described in=20 part 601 of this chapter.

(11) Data and information regarding a biological = product=20 submitted as part of the procedures for determining = that=20 licensed biological products are safe and effective = and not=20 misbranded, as described in part 601 of this chapter. =

(12) An Application for an Investigational Device=20 Exemption, described in part 812.

(13) Data and information regarding a medical = device for=20 human use submitted as part of the procedures for = classifying=20 such devices, described in part 860.

(14) Data and information regarding a medical = device for=20 human use submitted as part of the procedures for=20 establishing, amending, or repealing a standard for = such=20 device, described in part 861.

(15) An application for premarket approval of a = medical=20 device for human use, described in section 515 of the = act.=20

(16) A product development protocol for a medical = device=20 for human use, described in section 515 of the act. =

(17) Data and information regarding an electronic = product=20 submitted as part of the procedures for establishing,=20 amending, or repealing a standard for such products, = described=20 in section 358 of the Public Health Service Act.

(18) Data and information regarding an electronic = product=20 submitted as part of the procedures for obtaining a = variance=20 from any electronic product performance standard, as = described=20 in 1010.4.

(19) Data and information regarding an electronic = product=20 submitted as part of the procedures for granting, = amending, or=20 extending an exemption from a radiation safety = performance=20 standard, as described in 1010.5.

(20) Data and information regarding an electronic = product=20 submitted as part of the procedures for obtaining an = exemption=20 from notification of a radiation safety defect or = failure of=20 compliance with a radiation safety performance = standard,=20 described in subpart D of part 1003.

(21) Data and information about a clinical study of = an=20 infant formula when submitted as part of an infant = formula=20 notification under section 412(c) of the Federal Food, = Drug,=20 and Cosmetic Act.

(22) Data and information submitted in a petition = for a=20 nutrient content claim, described in 101.69 of this = chapter,=20 and for a health claim, described in 101.70 of this = chapter.=20

(23) Data and information from investigations = involving=20 children submitted in a new dietary ingredient = notification,=20 described in 190.6 of this chapter.

(c) Clinical investigation means any = experiment that=20 involves a test article and one or more human = subjects, and=20 that either must meet the requirements for prior = submission to=20 the Food and Drug Administration under section 505(i) = or=20 520(g) of the act, or need not meet the requirements = for prior=20 submission to the Food and Drug Administration under = these=20 sections of the act, but the results of which are = intended to=20 be later submitted to, or held for inspection by, the = Food and=20 Drug Administration as part of an application for a = research=20 or marketing permit. The term does not include = experiments=20 that must meet the provisions of part 58, regarding=20 nonclinical laboratory studies. The terms research, = clinical research, clinical study, study, and = clinical=20 investigation are deemed to be synonymous for = purposes of=20 this part.

(d) Emergency use means the use of a test = article on=20 a human subject in a life-threatening situation in = which no=20 standard acceptable treatment is available, and in = which there=20 is not sufficient time to obtain IRB approval.

(e) Human subject means an individual who is = or=20 becomes a participant in research, either as a = recipient of=20 the test article or as a control. A subject may be = either a=20 healthy individual or a patient.

(f) Institution means any public or private = entity=20 or agency (including Federal, State, and other = agencies). The=20 term facility as used in section 520(g) of the = act is=20 deemed to be synonymous with the term = institution for=20 purposes of this part.

(g) Institutional Review Board (IRB) means = any=20 board, committee, or other group formally designated = by an=20 institution to review, to approve the initiation of, = and to=20 conduct periodic review of, biomedical research = involving=20 human subjects. The primary purpose of such review is = to=20 assure the protection of the rights and welfare of the = human=20 subjects. The term has the same meaning as the phrase=20 institutional review committee as used in = section=20 520(g) of the act.

(h) Investigator means an individual who = actually=20 conducts a clinical investigation (i.e., under whose = immediate=20 direction the test article is administered or = dispensed to, or=20 used involving, a subject) or, in the event of an=20 investigation conducted by a team of individuals, is = the=20 responsible leader of that team.

(i) Minimal risk means that the probability = and=20 magnitude of harm or discomfort anticipated in the = research=20 are not greater in and of themselves than those = ordinarily=20 encountered in daily life or during the performance of = routine=20 physical or psychological examinations or tests.

(j) Sponsor means a person or other entity = that=20 initiates a clinical investigation, but that does not = actually=20 conduct the investigation, i.e., the test article is=20 administered or dispensed to, or used involving, a = subject=20 under the immediate direction of another individual. A = person=20 other than an individual (e.g., a corporation or = agency) that=20 uses one or more of its own employees to conduct an=20 investigation that it has initiated is considered to = be a=20 sponsor (not a sponsor-investigator), and the = employees are=20 considered to be investigators.

(k) Sponsor-investigator means an individual = who=20 both initiates and actually conducts, alone or with = others, a=20 clinical investigation, i.e., under whose immediate = direction=20 the test article is administered or dispensed to, or = used=20 involving, a subject. The term does not include any = person=20 other than an individual, e.g., it does not include a=20 corporation or agency. The obligations of a=20 sponsor-investigator under this part include both = those of a=20 sponsor and those of an investigator.

(l) Test article means any drug for human = use,=20 biological product for human use, medical device for = human=20 use, human food additive, color additive, electronic = product,=20 or any other article subject to regulation under the = act or=20 under sections 351 or 354-360F of the Public Health = Service=20 Act.

(m) IRB approval means the determination of = the IRB=20 that the clinical investigation has been reviewed and = may be=20 conducted at an institution within the constraints set = forth=20 by the IRB and by other institutional and Federal=20 requirements.

[46 FR 8975, Jan. 27, 1981, as amended at 54 FR = 9038, Mar.=20 3, 1989; 56 FR 28028, June 18, 1991; 64 FR 399, Jan. = 5, 1999;=20 64 FR 56448, Oct. 20, 1999; 65 FR 52302, Aug. 29, = 2000; 66 FR=20 20599, Apr. 24, 2001; 74 FR 2368, Jan. 15, 2009]=20

Sec. 56.103 Circumstances in which IRB review is = required.=20

(a) Except as provided in 56.104 and 56.105, any = clinical=20 investigation which must meet the requirements for = prior=20 submission (as required in parts 312, 812, and 813) to = the=20 Food and Drug Administration shall not be initiated = unless=20 that investigation has been reviewed and approved by, = and=20 remains subject to continuing review by, an IRB = meeting the=20 requirements of this part.

(b) Except as provided in 56.104 and 56.105, the = Food and=20 Drug Administration may decide not to consider in = support of=20 an application for a research or marketing permit any = data or=20 information that has been derived from a clinical=20 investigation that has not been approved by, and that = was not=20 subject to initial and continuing review by, an IRB = meeting=20 the requirements of this part. The determination that = a=20 clinical investigation may not be considered in = support of an=20 application for a research or marketing permit does = not,=20 however, relieve the applicant for such a permit of = any=20 obligation under any other applicable regulations to = submit=20 the results of the investigation to the Food and Drug=20 Administration.

(c) Compliance with these regulations will in no = way render=20 inapplicable pertinent Federal, State, or local laws = or=20 regulations.

[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, = 1981]=20

Sec. 56.104 Exemptions from IRB requirement.=20

The following categories of clinical investigations = are=20 exempt from the requirements of this part for IRB = review:

(a) Any investigation which commenced before July = 27, 1981=20 and was subject to requirements for IRB review under = FDA=20 regulations before that date, provided that the = investigation=20 remains subject to review of an IRB which meets the = FDA=20 requirements in effect before July 27, 1981.

(b) Any investigation commenced before July 27, = 1981 and=20 was not otherwise subject to requirements for IRB = review under=20 Food and Drug Administration regulations before that = date.=20

(c) Emergency use of a test article, provided that = such=20 emergency use is reported to the IRB within 5 working = days.=20 Any subsequent use of the test article at the = institution is=20 subject to IRB review.

(d) Taste and food quality evaluations and consumer = acceptance studies, if wholesome foods without = additives are=20 consumed or if a food is consumed that contains a food = ingredient at or below the level and for a use found = to be=20 safe, or agricultural, chemical, or environmental = contaminant=20 at or below the level found to be safe, by the Food = and Drug=20 Administration or approved by the Environmental = Protection=20 Agency or the Food Safety and Inspection Service of = the U.S.=20 Department of Agriculture.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR = 28028, June=20 18, 1991]

Sec. 56.105 Waiver of IRB requirement.=20

On the application of a sponsor or = sponsor-investigator,=20 the Food and Drug Administration may waive any of the=20 requirements contained in these regulations, including = the=20 requirements for IRB review, for specific research = activities=20 or for classes of research activities, otherwise = covered by=20 these regulations. =

Subpart=20 B--Organization and Personnel

Sec. 56.106 Registration.

(a) Who must register? Each IRB in the = United States=20 that reviews clinical investigations regulated by FDA = under=20 sections 505(i) or 520(g) of the act and each IRB in = the=20 United States that reviews clinical investigations = that are=20 intended to support applications for research or = marketing=20 permits for FDA-regulated products must register at a = site=20 maintained by the Department of Health and Human = Services=20 (HHS). (A research permit under section 505(i) of the = act is=20 usually known as an investigational new drug = application=20 (IND), while a research permit under section 520(g) of = the act=20 is usually known as an investigational device = exemption=20 (IDE).) An individual authorized to act on the IRB's = behalf=20 must submit the registration information. All other = IRBs may=20 register voluntarily.

(b) What information must an IRB register? = Each IRB=20 must provide the following information:

(1) The name, mailing address, and street address = (if=20 different from the mailing address) of the institution = operating the IRB and the name, mailing address, phone = number,=20 facsimile number, and electronic mail address of the = senior=20 officer of that institution who is responsible for = overseeing=20 activities performed by the IRB;

(2) The IRB's name, mailing address, street address = (if=20 different from the mailing address), phone number, = facsimile=20 number, and electronic mail address; each IRB = chairperson's=20 name, phone number, and electronic mail address; and = the name,=20 mailing address, phone number, facsimile number, and=20 electronic mail address of the contact person = providing the=20 registration information.

(3) The approximate number of active protocols = involving=20 FDA-regulated products reviewed. For purposes of this = rule, an=20 "active protocol" is any protocol for which an IRB = conducted=20 an initial review or a continuing review at a convened = meeting=20 or under an expedited review procedure during the = preceding 12=20 months; and

(4) A description of the types of FDA-regulated = products=20 (such as biological products, color additives, food = additives,=20 human drugs, or medical devices) involved in the = protocols=20 that the IRB reviews.

(c) When must an IRB register? Each IRB must = submit=20 an initial registration. The initial registration must = occur=20 before the IRB begins to review a clinical = investigation=20 described in paragraph (a) of this section. Each IRB = must=20 renew its registration every 3 years. IRB registration = becomes=20 effective after review and acceptance by HHS.

(d) Where can an IRB register? Each IRB may = register=20 electronically through = http://ohrp.cit.nih.gov/efile.=20 If an IRB lacks the ability to register = electronically, it=20 must send its registration information, in writing, to = the=20 Office of Good Clinical Practice, Office of Special = Medical=20 Programs, Food and Drug Administration, 10903 New = Hampshire=20 Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993. =

(e) How does an IRB revise its registration=20 information? If an IRB's contact or chair person=20 information changes, the IRB must revise its = registration=20 information by submitting any changes in that = information=20 within 90 days of the change. An IRB's decision to = review new=20 types of FDA-regulated products (such as a decision to = review=20 studies pertaining to food additives whereas the IRB=20 previously reviewed studies pertaining to drug = products), or=20 to discontinue reviewing clinical investigations = regulated by=20 FDA is a change that must be reported within 30 days = of the=20 change. An IRB's decision to disband is a change that = must be=20 reported within 30 days of permanent cessation of the = IRB's=20 review of research. All other information changes may = be=20 reported when the IRB renews its registration. The = revised=20 information must be sent to FDA either electronically = or in=20 writing in accordance with paragraph (d) of this = section.

[74 FR 2368, Jan. 15, 2009, as amended at 78 FR = 16401, Mar.=20 15, 2013]

Sec. 56.107 IRB membership. =

(a) Each IRB shall have at least five members, with = varying=20 backgrounds to promote complete and adequate review of = research activities commonly conducted by the = institution. The=20 IRB shall be sufficiently qualified through the = experience and=20 expertise of its members, and the diversity of the = members,=20 including consideration of race, gender, cultural = backgrounds,=20 and sensitivity to such issues as community attitudes, = to=20 promote respect for its advice and counsel in = safeguarding the=20 rights and welfare of human subjects. In addition to=20 possessing the professional competence necessary to = review the=20 specific research activities, the IRB shall be able to = ascertain the acceptability of proposed research in = terms of=20 institutional commitments and regulations, applicable = law, and=20 standards of professional conduct and practice. * * * = The IRB=20 shall therefore include persons knowledgeable in these = areas.=20 If an IRB regularly reviews research that involves a=20 vulnerable category of subjects, such as children, = prisoners,=20 pregnant women, or handicapped or mentally disabled = persons,=20 consideration shall be given to the inclusion of one = or more=20 individuals who are knowledgeable about and = experienced in=20 working with those subjects.

(b) Every nondiscriminatory effort will be made to = ensure=20 that no IRB consists entirely of men or entirely of = women,=20 including the instituton's consideration of qualified = persons=20 of both sexes, so long as no selection is made to the = IRB on=20 the basis of gender. No IRB may consist entirely of = members of=20 one profession.

(c) Each IRB shall include at least one member = whose=20 primary concerns are in the scientific area and at = least one=20 member whose primary concerns are in nonscientific = areas.

(d) Each IRB shall include at least one member who = is not=20 otherwise affiliated with the institution and who is = not part=20 of the immediate family of a person who is affiliated = with the=20 institution.

(e) No IRB may have a member participate in the = IRB's=20 initial or continuing review of any project in which = the=20 member has a conflicting interest, except to provide=20 information requested by the IRB.

(f) An IRB may, in its discretion, invite = individuals with=20 competence in special areas to assist in the review of = complex=20 issues which require expertise beyond or in addition = to that=20 available on the IRB. These individuals may not vote = with the=20 IRB.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR = 28028, June=20 18, 1991; 56 FR 29756, June 28, 1991; 78 FR 16401, = Mar. 15,=20 2013]

Subpart=20 C--IRB Functions and Operations

Sec. 56.108 IRB functions and operations.=20

In order to fulfill the requirements of these = regulations,=20 each IRB shall:

(a) Follow written procedures: (1) For conducting = its=20 initial and continuing review of research and for = reporting=20 its findings and actions to the investigator and the=20 institution; (2) for determining which projects = require review=20 more often than annually and which projects need = verification=20 from sources other than the investigator that no = material=20 changes have occurred since previous IRB review; (3) = for=20 ensuring prompt reporting to the IRB of changes in = research=20 activity; and (4) for ensuring that changes in = approved=20 research, during the period for which IRB approval has = already=20 been given, may not be initiated without IRB review = and=20 approval except where necessary to eliminate apparent=20 immediate hazards to the human subjects.

(b) Follow written procedures for ensuring prompt = reporting=20 to the IRB, appropriate institutional officials, and = the Food=20 and Drug Administration of: (1) Any unanticipated = problems=20 involving risks to human subjects or others; (2) any = instance=20 of serious or continuing noncompliance with these = regulations=20 or the requirements or determinations of the IRB; or = (3) any=20 suspension or termination of IRB approval.

(c) Except when an expedited review procedure is = used (see=20 56.110), review proposed research at convened meetings = at=20 which a majority of the members of the IRB are = present,=20 including at least one member whose primary concerns = are in=20 nonscientific areas. In order for the research to be = approved,=20 it shall receive the approval of a majority of those = members=20 present at the meeting.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR = 28028, June=20 18, 1991; 67 FR 9585, Mar. 4, 2002]=20

Sec. 56.109 IRB review of research. =

(a) An IRB shall review and have authority to = approve,=20 require modifications in (to secure approval), or = disapprove=20 all research activities covered by these regulations. =

(b) An IRB shall require that information given to = subjects=20 as part of informed consent is in accordance with = 50.25. The=20 IRB may require that information, in addition to that=20 specifically mentioned in 50.25, be given to the = subjects when=20 in the IRB's judgment the information would = meaningfully add=20 to the protection of the rights and welfare of = subjects.

(c) An IRB shall require documentation of informed = consent=20 in accordance with 50.27 of this chapter, except as = follows:=20

(1) The IRB may, for some or all subjects, waive = the=20 requirement that the subject, or the subject's legally = authorized representative, sign a written consent form = if it=20 finds that the research presents no more than minimal = risk of=20 harm to subjects and involves no procedures for which = written=20 consent is normally required outside the research = context; or=20

(2) The IRB may, for some or all subjects, find = that the=20 requirements in 50.24 of this chapter for an exception = from=20 informed consent for emergency research are met.

(d) In cases where the documentation requirement is = waived=20 under paragraph (c)(1) of this section, the IRB may = require=20 the investigator to provide subjects with a written = statement=20 regarding the research.

(e) An IRB shall notify investigators and the = institution=20 in writing of its decision to approve or disapprove = the=20 proposed research activity, or of modifications = required to=20 secure IRB approval of the research activity. If the = IRB=20 decides to disapprove a research activity, it shall = include in=20 its written notification a statement of the reasons = for its=20 decision and give the investigator an opportunity to = respond=20 in person or in writing. For investigations involving = an=20 exception to informed consent under 50.24 of this = chapter, an=20 IRB shall promptly notify in writing the investigator = and the=20 sponsor of the research when an IRB determines that it = cannot=20 approve the research because it does not meet the = criteria in=20 the exception provided under 50.24(a) of this chapter = or=20 because of other relevant ethical concerns. The = written=20 notification shall include a statement of the reasons = for the=20 IRB's determination.

(f) An IRB shall conduct continuing review of = research=20 covered by these regulations at intervals appropriate = to the=20 degree of risk, but not less than once per year, and = shall=20 have authority to observe or have a third party = observe the=20 consent process and the research.

(g) An IRB shall provide in writing to the sponsor = of=20 research involving an exception to informed consent = under=20 50.24 of this chapter a copy of information that has = been=20 publicly disclosed under 50.24(a)(7)(ii) and = (a)(7)(iii) of=20 this chapter. The IRB shall provide this information = to the=20 sponsor promptly so that the sponsor is aware that = such=20 disclosure has occurred. Upon receipt, the sponsor = shall=20 provide copies of the information disclosed to FDA. =

(h) When some or all of the subjects in a study are = children, an IRB must determine that the research = study is in=20 compliance with part 50, subpart D of this chapter, at = the=20 time of its initial review of the research. When some = or all=20 of the subjects in a study that was ongoing on April = 30, 2001,=20 are children, an IRB must conduct a review of the = research to=20 determine compliance with part 50, subpart D of this = chapter,=20 either at the time of continuing review or, at the = discretion=20 of the IRB, at an earlier date.

[46 FR 8975, Jan. 27, 1981, as amended at 61 FR = 51529, Oct.=20 2, 1996; 66 FR 20599, Apr. 24, 2001; 78 FR 12951, Feb. = 26,=20 2013]

Sec. 56.110 Expedited review procedures for certain = kinds=20 of research involving no more than minimal risk, and = for minor=20 changes in approved research. =

(a) The Food and Drug Administration has = established, and=20 published in the Federal Register, a list of = categories of=20 research that may be reviewed by the IRB through an = expedited=20 review procedure. The list will be amended, as = appropriate,=20 through periodic republication in the Federal = Register.

(b) An IRB may use the expedited review procedure = to review=20 either or both of the following: (1) Some or all of = the=20 research appearing on the list and found by the = reviewer(s) to=20 involve no more than minimal risk, (2) minor changes = in=20 previously approved research during the period (of 1 = year or=20 less) for which approval is authorized. Under an = expedited=20 review procedure, the review may be carried out by the = IRB=20 chairperson or by one or more experienced reviewers = designated=20 by the IRB chairperson from among the members of the = IRB. In=20 reviewing the research, the reviewers may exercise all = of the=20 authorities of the IRB except that the reviewers may = not=20 disapprove the research. A research activity may be=20 disapproved only after review in accordance with the=20 nonexpedited review procedure set forth in 56.108(c). =

(c) Each IRB which uses an expedited review = procedure shall=20 adopt a method for keeping all members advised of = research=20 proposals which have been approved under the = procedure.

(d) The Food and Drug Administration may restrict, = suspend,=20 or terminate an institution's or IRB's use of the = expedited=20 review procedure when necessary to protect the rights = or=20 welfare of subjects.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR = 28029, June=20 18, 1991]

Sec. 56.111 Criteria for IRB approval of research.=20

(a) In order to approve research covered by these=20 regulations the IRB shall determine that all of the = following=20 requirements are satisfied:

(1) Risks to subjects are minimized: (i) By using=20 procedures which are consistent with sound research = design and=20 which do not unnecessarily expose subjects to risk, = and (ii)=20 whenever appropriate, by using procedures already = being=20 performed on the subjects for diagnostic or treatment=20 purposes.

(2) Risks to subjects are reasonable in relation to = anticipated benefits, if any, to subjects, and the = importance=20 of the knowledge that may be expected to result. In = evaluating=20 risks and benefits, the IRB should consider only those = risks=20 and benefits that may result from the research (as=20 distinguished from risks and benefits of therapies = that=20 subjects would receive even if not participating in = the=20 research). The IRB should not consider possible = long-range=20 effects of applying knowledge gained in the research = (for=20 example, the possible effects of the research on = public=20 policy) as among those research risks that fall within = the=20 purview of its responsibility.

(3) Selection of subjects is equitable. In making = this=20 assessment the IRB should take into account the = purposes of=20 the research and the setting in which the research = will be=20 conducted and should be particularly cognizant of the = special=20 problems of research involving vulnerable populations, = such as=20 children, prisoners, pregnant women, handicapped, or = mentally=20 disabled persons, or economically or educationally=20 disadvantaged persons.

(4) Informed consent will be sought from each = prospective=20 subject or the subject's legally authorized = representative, in=20 accordance with and to the extent required by part 50. =

(5) Informed consent will be appropriately = documented, in=20 accordance with and to the extent required by 50.27. =

(6) Where appropriate, the research plan makes = adequate=20 provision for monitoring the data collected to ensure = the=20 safety of subjects.

(7) Where appropriate, there are adequate = provisions to=20 protect the privacy of subjects and to maintain the=20 confidentiality of data.

(b) When some or all of the subjects, such as = children,=20 prisoners, pregnant women, handicapped, or mentally = disabled=20 persons, or economically or educationally = disadvantaged=20 persons, are likely to be vulnerable to coercion or = undue=20 influence additional safeguards have been included in = the=20 study to protect the rights and welfare of these = subjects.=20

(c) In order to approve research in which some or = all of=20 the subjects are children, an IRB must determine that = all=20 research is in compliance with part 50, subpart D of = this=20 chapter.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR = 28029, June=20 18, 1991; 66 FR 20599, Apr. 24, 2001]=20

Sec. 56.112 Review by institution. =

Research covered by these regulations that has been = approved by an IRB may be subject to further = appropriate=20 review and approval or disapproval by officials of the = institution. However, those officials may not approve = the=20 research if it has not been approved by an IRB.=20

Sec. 56.113 Suspension or termination of IRB = approval of=20 research.

An IRB shall have authority to suspend or terminate = approval of research that is not being conducted in = accordance=20 with the IRB's requirements or that has been = associated with=20 unexpected serious harm to subjects. Any suspension or = termination of approval shall include a statement of = the=20 reasons for the IRB's action and shall be reported = promptly to=20 the investigator, appropriate institutional officials, = and the=20 Food and Drug Administration. =

Sec. 56.114 Cooperative research. =

In complying with these regulations, institutions = involved=20 in multi-institutional studies may use joint review, = reliance=20 upon the review of another qualified IRB, or similar=20 arrangements aimed at avoidance of duplication of = effort.=20

Subpart=20 D--Records and Reports

Sec. 56.115 IRB records.

(a) An institution, or where appropriate an IRB, = shall=20 prepare and maintain adequate documentation of IRB = activities,=20 including the following:

(1) Copies of all research proposals reviewed, = scientific=20 evaluations, if any, that accompany the proposals, = approved=20 sample consent documents, progress reports submitted = by=20 investigators, and reports of injuries to subjects. =

(2) Minutes of IRB meetings which shall be in = sufficient=20 detail to show attendance at the meetings; actions = taken by=20 the IRB; the vote on these actions including the = number of=20 members voting for, against, and abstaining; the basis = for=20 requiring changes in or disapproving research; and a = written=20 summary of the discussion of controverted issues and = their=20 resolution.

(3) Records of continuing review activities.

(4) Copies of all correspondence between the IRB = and the=20 investigators.

(5) A list of IRB members identified by name; = earned=20 degrees; representative capacity; indications of = experience=20 such as board certifications, licenses, etc., = sufficient to=20 describe each member's chief anticipated contributions = to IRB=20 deliberations; and any employment or other = relationship=20 between each member and the institution; for example:=20 full-time employee, part-time employee, a member of = governing=20 panel or board, stockholder, paid or unpaid = consultant.

(6) Written procedures for the IRB as required by = 56.108=20 (a) and (b).

(7) Statements of significant new findings provided = to=20 subjects, as required by 50.25.

(b) The records required by this regulation shall = be=20 retained for at least 3 years after completion of the=20 research, and the records shall be accessible for = inspection=20 and copying by authorized representatives of the Food = and Drug=20 Administration at reasonable times and in a reasonable = manner.=20

(c) The Food and Drug Administration may refuse to = consider=20 a clinical investigation in support of an application = for a=20 research or marketing permit if the institution or the = IRB=20 that reviewed the investigation refuses to allow an = inspection=20 under this section.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR = 28029, June=20 18, 1991; 67 FR 9585, Mar. 4, 2002]=20

Subpart=20 E--Administrative Actions for Noncompliance =

Sec. 56.120 Lesser administrative actions.=20

(a) If apparent noncompliance with these = regulations in the=20 operation of an IRB is observed by an FDA investigator = during=20 an inspection, the inspector will present an oral or = written=20 summary of observations to an appropriate = representative of=20 the IRB. The Food and Drug Administration may = subsequently=20 send a letter describing the noncompliance to the IRB = and to=20 the parent institution. The agency will require that = the IRB=20 or the parent institution respond to this letter = within a time=20 period specified by FDA and describe the corrective = actions=20 that will be taken by the IRB, the institution, or = both to=20 achieve compliance with these regulations.

(b) On the basis of the IRB's or the institution's=20 response, FDA may schedule a reinspection to confirm = the=20 adequacy of corrective actions. In addition, until the = IRB or=20 the parent institution takes appropriate corrective = action,=20 the Agency may require the IRB to:

(1) Withhold approval of new studies subject to the = requirements of this part that are conducted at the=20 institution or reviewed by the IRB;

(2) Direct that no new subjects be added to ongoing = studies=20 subject to this part; or

(3) Terminate ongoing studies subject to this part = when=20 doing so would not endanger the subjects.

(c) When the apparent noncompliance creates a = significant=20 threat to the rights and welfare of human subjects, = FDA may=20 notify relevant State and Federal regulatory agencies = and=20 other parties with a direct interest in the Agency's = action of=20 the deficiencies in the operation of the IRB.

(d) The parent institution is presumed to be = responsible=20 for the operation of an IRB, and the Food and Drug=20 Administration will ordinarily direct any = administrative=20 action under this subpart against the institution. = However,=20 depending on the evidence of responsibility for = deficiencies,=20 determined during the investigation, the Food and Drug = Administration may restrict its administrative actions = to the=20 IRB or to a component of the parent institution = determined to=20 be responsible for formal designation of the IRB.

[46 FR 8975, Jan. 27, 1981, as amended at 81 FR = 19035, Apr.=20 4, 2016]

Sec. 56.121 Disqualification of an IRB or an = institution.=20

(a) Whenever the IRB or the institution has failed = to take=20 adequate steps to correct the noncompliance stated in = the=20 letter sent by the agency under 56.120(a), and the=20 Commissioner of Food and Drugs determines that this=20 noncompliance may justify the disqualification of the = IRB or=20 of the parent institution, the Commissioner will = institute=20 proceedings in accordance with the requirements for a=20 regulatory hearing set forth in part 16.

(b) The Commissioner may disqualify an IRB or the = parent=20 institution if the Commissioner determines that:

(1) The IRB has refused or repeatedly failed to = comply with=20 any of the regulations set forth in this part, and =

(2) The noncompliance adversely affects the rights = or=20 welfare of the human subjects in a clinical = investigation.=20

(c) If the Commissioner determines that = disqualification is=20 appropriate, the Commissioner will issue an order that = explains the basis for the determination and that = prescribes=20 any actions to be taken with regard to ongoing = clinical=20 research conducted under the review of the IRB. The = Food and=20 Drug Administration will send notice of the = disqualification=20 to the IRB and the parent institution. Other parties = with a=20 direct interest, such as sponsors and clinical = investigators,=20 may also be sent a notice of the disqualification. In=20 addition, the agency may elect to publish a notice of = its=20 action in the Federal Register.

(d) The Food and Drug Administration will not = approve an=20 application for a research permit for a clinical = investigation=20 that is to be under the review of a disqualified IRB = or that=20 is to be conducted at a disqualified institution, and = it may=20 refuse to consider in support of a marketing permit = the data=20 from a clinical investigation that was reviewed by a=20 disqualified IRB as conducted at a disqualified = institution,=20 unless the IRB or the parent institution is reinstated = as=20 provided in 56.123. =

Sec. 56.122 Public disclosure of information = regarding=20 revocation.

A determination that the Food and Drug = Administration has=20 disqualified an institution and the administrative = record=20 regarding that determination are disclosable to the = public=20 under part 20. =

Sec. 56.123 Reinstatement of an IRB or an = institution.=20

An IRB or an institution may be reinstated if the=20 Commissioner determines, upon an evaluation of a = written=20 submission from the IRB or institution that explains = the=20 corrective action that the institution or IRB plans to = take,=20 that the IRB or institution has provided adequate = assurance=20 that it will operate in compliance with the standards = set=20 forth in this part. Notification of reinstatement = shall be=20 provided to all persons notified under 56.121(c).=20

Sec. 56.124 Actions alternative or additional to=20 disqualification.

Disqualification of an IRB or of an institution is=20 independent of, and neither in lieu of nor a = precondition to,=20 other proceedings or actions authorized by the act. = The Food=20 and Drug Administration may, at any time, through the=20 Department of Justice institute any appropriate = judicial=20 proceedings (civil or criminal) and any other = appropriate=20 regulatory action, in addition to or in lieu of, and = before,=20 at the time of, or after, disqualification. The agency = may=20 also refer pertinent matters to another Federal, = State, or=20 local government agency for any action that that = agency=20 determines to be appropriate. =

Authority:=20 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, = 353, 355,=20 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, = 381; 42=20 U.S.C. 216, 241, 262.
Source: 46 FR = 8975, Jan.=20 27, 1981, unless otherwise noted.=20

CFR - Code of Federal = Regulations Title=20 21

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