LAWS RELATED TO THE PROTECTION OF HUMAN SUBJECTS

FDA REGULATIONS
IRBs

[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56]

[Page 294-302]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 56--INSTITUTIONAL REVIEW BOARDS

Subpart A--General Provisions

Sec.
56.101 Scope.
56.102 Definitions.
56.103 Circumstances in which IRB review is required.
56.104 Exemptions from IRB requirement.
56.105 Waiver of IRB requirement.

Subpart B--Organization and Personnel

56.107 IRB membership.

Subpart C--IRB Functions and Operations

56.108 IRB functions and operations.
56.109 IRB review of research.
56.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
56.111 Criteria for IRB approval of research.
56.112 Review by institution.
56.113 Suspension or termination of IRB approval of research.
56.114 Cooperative research.

Subpart D--Records and Reports

56.115 IRB records.

Subpart E--Administrative Actions for Noncompliance

56.120 Lesser administrative actions.
56.121 Disqualification of an IRB or an institution.
56.122 Public disclosure of information regarding revocation.
56.123 Reinstatement of an IRB or an institution.
56.124 Actions alternative or additional to disqualification.

Authority: 21 U.S.C. 321, 346, 346a, 348, 351, 352, 353, 355, 360,
360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-
263n.

Source: 46 FR 8975, Jan. 27, 1981, unless otherwise noted.

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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 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]

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)).

[[Page 295]]

(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 Sec. 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 Sec. 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 parts 812 and 813.
(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 Sec. 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
Sec. 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.
(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.

[[Page 296]]

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]

Sec. 56.103 Circumstances in which IRB review is required.

(a) Except as provided in Secs. 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 Secs. 56.104 and 56.105, the Food and Drug
Administration may decide not to consider in support of an application
for a research or

[[Page 297]]

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.

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Subpart B--Organization and Personnel

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 or professional conduct
and practice. The IRB shall therefore include persons knowledgeable in
these areas. If an IRB regularly reviews research that involves a
vulnerable catgory 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

[[Page 298]]

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]

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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
Sec. 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.

(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control
number 0910-0130)

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

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 Sec. 50.25. The IRB may
require that information, in addition to that specifically mentioned in
Sec. 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 Sec. 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

[[Page 299]]

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 Sec. 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 Sec. 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 Sec. 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 Sec. 50.24 of this
chapter a copy of information that has been publicly disclosed under
Sec. 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.

[46 FR 8975, Jan. 27, 1981, as amended at 61 FR 51529, Oct. 2, 1996]

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 Sec. 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

[[Page 300]]

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 Sec. 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.

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

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.

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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,

[[Page 301]]

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 Sec. 56.108 (a)
and (b).
(7) Statements of significant new findings provided to subjects, as
required by Sec. 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.

(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control
number 0910-0130)

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

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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:
(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;
(3) Terminate ongoing studies subject to this part when doing so
would not endanger the subjects; or
(4) When the apparent noncompliance creates a significant threat to
the rights and welfare of human subjects, 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.
(c) 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

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institution determined to be responsible for formal designation of the
IRB.

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 Sec. 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 Sec. 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 Sec. 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.

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Last updated: 16 June 2009
First published: 2 February 2005
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