[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56]

                        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.


    (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]




Subpart A--General Provisions

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 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.
    (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 Sec. 101.69 of this chapter, and for a 
health claim, described in Sec. 101.70 of this chapter.
    (23) Data and information from investigations involving children 
submitted in a new dietary ingredient notification, described in 
Sec. 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]




Subpart A--General Provisions

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 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]




Subpart A--General Provisions

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]




Subpart A--General Provisions

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. 56.107 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 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]




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.

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




Subpart C--IRB Functions and Operations

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 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.
    (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 is 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]




Subpart C--IRB Functions and Operations

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]




Subpart C--IRB Functions and Operations

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 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.
    (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]




Subpart C--IRB Functions and Operations

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.




Subpart C--IRB Functions and Operations

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.




Subpart C--IRB Functions and Operations

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 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.

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




Subpart E--Administrative Actions for Noncompliance

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.




Subpart E--Administrative Actions for Noncompliance

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.




Subpart E--Administrative Actions for Noncompliance

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).




Subpart E--Administrative Actions for Noncompliance

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.