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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
ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 56

INSTITUTIONAL REVIEW BOARDS

Subpart
A--General Provisions

Sec. 56.101 Scope.

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

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

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

Sec. 56.102 Definitions.

As used in this part:

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

(b) Application for research or marketing permit
includes:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sec. 56.103 Circumstances in which IRB review is required.

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

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

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

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

Sec. 56.104 Exemptions from IRB requirement.

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

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

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

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

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

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

Sec. 56.105 Waiver of IRB requirement.

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

Subpart
B--Organization and Personnel

Sec. 56.106 Registration.

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

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

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

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

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

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

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

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

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

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

Sec. 56.107 IRB membership.

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

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

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

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

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

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

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

Subpart
C--IRB Functions and Operations

Sec. 56.108 IRB functions and operations.

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

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

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

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

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

Sec. 56.109 IRB review of research.

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

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

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

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

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

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

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

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

(g) An IRB shall provide in writing to the sponsor of
research involving an exception to informed consent under
50.24 of this chapter a copy of information that has been
publicly disclosed under 50.24(a)(7)(ii) and (a)(7)(iii) of
this chapter. The IRB shall provide this information to the
sponsor promptly so that the sponsor is aware that such
disclosure has occurred. Upon receipt, the sponsor shall
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
compliance with part 50, subpart D of this chapter, at the
time of its initial review of the research. When some or all
of the subjects in a study that was ongoing on April 30, 2001,
are children, an IRB must conduct a review of the research to
determine compliance with part 50, subpart D of this chapter,
either at the time of continuing review or, at the discretion
of the IRB, at an earlier date.

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

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

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

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

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

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

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

Sec. 56.111 Criteria for IRB approval of research.

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

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

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

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

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

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

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

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

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

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

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

Sec. 56.112 Review by institution.

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

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

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

Sec. 56.114 Cooperative research.

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

Subpart
D--Records and Reports

Sec. 56.115 IRB records.

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

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

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

(3) Records of continuing review activities.

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

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

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

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

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

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

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

Subpart
E--Administrative Actions for Noncompliance

Sec. 56.120 Lesser administrative actions.

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

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

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

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

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

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

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

Sec. 56.121 Disqualification of an IRB or an institution.

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

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

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

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

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

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

Sec. 56.122 Public disclosure of information regarding
revocation.

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

Sec. 56.123 Reinstatement of an IRB or an institution.

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

Sec. 56.124 Actions alternative or additional to
disqualification.

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

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

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