Subpart A -- General Provisions
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 Action for Noncompliance
56.120 Lesser administrative actions
56.121Disqualification 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
Subpart A -- General Provisions
§ 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), 507(d), 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
§ 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:
- A color additive petition, described in part 71.
- 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.
- A food additive petition, described in part 171.
- 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.
- 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.
- An investigational new drug application, described in part 312 of this chapter.
- A new drug application, described in part 314.
- 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.
- 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.
- Data and information regarding an antibiotic drug submitted as part of the procedures for issuing, amending, or repealing regulations for such drugs, described in § 314.300 of this chapter.
- An application for a biological product license, described in part 601.
- 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.
- An Application for an Investigational Device Exemption, described in parts 812 and 813.
- Data and information regarding a medical device for human use submitted as part of the procedures for classifying such devices, described in part 860.
- 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.
- An application for premarket approval of a medical device for human use, described in section 515 of the act.
- A product development protocol for a medical device for human use, described in section 515 of the act.
- 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.
- 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.
- 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.
- 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), 507(d), 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981, as amended at 54 FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, 1991]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
Subpart B -- Organization and Personnel
§ 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 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 institution’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.
HISTORY:
[46 FR 8975, Jan 27, 1981, as amended at 56 FR 28028, June 18, 1991; 56 FR 29756, June 28, 1991]
Subpart C -- IRB Functions and Operations
§ 56.108 IRB functions and operations.
In order to fulfill the requirements of these regulations, each IRB
shall:
(a) Follow written procedures:
- For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
- 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;
- for ensuring prompt reporting to the IRB of changes in research activity; and
- 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:
- Any unanticipated problems involving risks to human subjects or others;
- any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or
- 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.
(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control number
0910-0130).
HISTORY:
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991]
§ 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:
- 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
- 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981; 61 FR 51498, 51529, Oct. 2, 1996]
§
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:
- Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
- 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991]
§ 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:
- Risks to subjects are minimized:
- By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
- whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- 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.
- 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.
- 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.
- Informed consent will be appropriately documented, in accordance
with and to the extent required by
§
50.27.
- Where appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects.
- 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
Subpart D -- Records and Reports
§ 56.115 IRB records.
(a) An institution, or where appropriate an IRB, shall prepare
and maintain adequate documentation of IRB activities, including the following:
- 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.
- 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.
- Records of continuing review activities.
- Copies of all correspondence between the IRB and the investigators.
- 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.
- Written procedures for the IRB as required by §
56.108 (a) and (b).
- 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.
(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control number
0910-0130).
HISTORY:
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991]
Subpart E -- Administrative Action for Noncompliance
§ 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:
- Withhold approval of new studies subject to the requirements of
this part that are conducted at the institution or reviewed by the IRB;
- Direct that no new subjects be added to ongoing studies subject
to this part;
- Terminate ongoing studies subject to this part when doing so would
not endanger the subjects; or
- 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 institution determined to be responsible for formal designation
of the IRB.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
§ 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:
- The IRB has refused or repeatedly failed to comply with any of
the regulations set forth in this part, and
- 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
§ 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).
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
§ 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.
HISTORY:
[46 FR 8975, Jan. 27, 1981.]
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