The full-text of this policy is available at
http://grants.nih.gov/grants/olaw/references/phspol.htm
PREFACE
The development of knowledge necessary for the improvement of
the health and well-being of humans as well as other animals requires
in vivo experimentation with a wide variety of animal species.
Whenever U.S. Government agencies develop requirements for testing,
research, or training procedures involving the use of vertebrate
animals, the following principles shall be considered; and whenever
these agencies actually perform or sponsor such procedures, the
responsible Institutional Official shall ensure that these principles
are adhered to:
I. The transportation, care, and use of animals should be in accordance
with the Animal Welfare Act (7 U.S.C. 2131 et. seq.) and
other applicable Federal laws, guidelines, and policies.*
II. Procedures involving animals should be designed and performed
with due consideration of their relevance to human or animal health,
the advancement of knowledge, or the good of society.
III. The animals selected for a procedure should be of an appropriate
species and quality and the minimum number required to obtain
valid results. Methods such as mathematical models, computer simulation,
and in vitro biological systems should be considered.
IV. Proper use of animals, including the avoidance or minimization
of discomfort, distress, and pain when consistent with sound scientific
practices, is imperative. Unless the contrary is established,
investigators should consider that procedures that cause pain
or distress in human beings may cause pain or distress in other
animals.
V. Procedures with animals that may cause more than momentary
or slight pain or distress should be performed with appropriate
sedation, analgesia, or anesthesia. Surgical or other painful
procedures should not be performed on unanesthetized animals paralyzed
by chemical agents.
VI. Animals that would otherwise suffer severe or chronic pain
or distress that cannot be relieved should be painlessly killed
at the end of the procedure or, if appropriate, during the procedure.
VII. The living conditions of animals should be appropriate for
their species and contribute to their health and comfort. Normally,
the housing, feeding, and care of all animals used for biomedical
purposes must be directed by a veterinarian or other scientist
trained and experienced in the proper care, handling, and use
of the species being maintained or studied. In any case, veterinary
care shall be provided as indicated.
VIII. Investigators and other personnel shall be appropriately
qualified and experienced for conducting procedures on living
animals. Adequate arrangements shall be made for their in-service
training, including the proper and humane care and use of laboratory
animals.
IX. Where exceptions are required in relation to the provisions
of these Principles, the decisions should not rest with the investigators
directly concerned but should be made, with due regard to Principle
II, by an appropriate review group such as an institutional animal
care and use committee. Such exceptions should not be made solely
for the purposes of teaching or demonstration.
*For guidance throughout these Principles, the reader is referred
to the Guide for the Care and Use of Laboratory Animals prepared
by the Institute of Laboratory Animal Resources, National Academy
of Sciences.
I. INTRODUCTION
It is the Policy of the Public Health Service (PHS) to require
institutions to establish and maintain proper measures to ensure
the appropriate care and use of all animals involved in research,
research training, and biological testing activities (hereinafter
referred to as activities) conducted or supported by the PHS.
The PHS endorses the "U.S. Government Principles for the
Utilization and Care of Vertebrate Animals Used in Testing, Research,
and Training" developed by the Interagency Research Animal
Committee. This Policy is intended to implement and supplement
those Principles.
II. APPLICABILITY
This Policy is applicable to all PHS-conducted or supported activities
involving animals, whether the activities are performed at a PHS
agency, an awardee institution, or any other institution and conducted
in the United States, the Commonwealth of Puerto Rico, or any
territory or possession of the United States. Institutions in
foreign countries receiving PHS support for activities involving
animals shall comply with this Policy, or provide evidence to
the PHS that acceptable standards for the humane care and use
of the animals in PHS-conducted or supported activities will be
met. No PHS support for an activity involving animals will be
provided to an individual unless that individual is affiliated
with or sponsored by an institution which can and does assume
responsibility for compliance with this Policy, unless the individual
makes other arrangements with the PHS. This Policy does not affect
applicable state or local laws or regulations which impose more
stringent standards for the care and use of laboratory animals.
All institutions are required to comply, as applicable, with the
Animal Welfare Act, and other Federal statutes and regulations
relating to animals.
III. DEFINITIONS
A. Animal
Any live, vertebrate animal used or intended for use in research,
research training, experimentation, or biological testing or for
related purposes.
B. Animal Facility
Any and all buildings, rooms, areas, enclosures, or vehicles,
including satellite facilities, used for animal confinement, transport,
maintenance, breeding, or experiments inclusive of surgical manipulation.
A satellite facility is any containment outside of a core facility
or centrally designated or managed area in which animals are housed
for more than 24 hours.
C. Animal Welfare Act
Public Law 89-544, 1966, as amended, (P.L. 91-579, P.L. 94-279
and P.L. 99-198) 7 U.S.C. 2131 et. seq. Implementing regulations
are published in the Code of Federal Regulations (CFR), Title
9, Chapter 1, Subchapter A, Parts 1, 2, and 3, and are administered
by the U.S. Department of Agriculture.
D. Animal Welfare Assurance or Assurance
The documentation from an institution assuring institutional compliance
with this Policy.
E. Guide
Guide for the Care and Use of Laboratory Animals, HHS,
NIH Pub. No. 86-23, 1985 edition or succeeding revised editions.
F. Institution
Any public or private organization, business, or agency (including
components of Federal, state, and local governments).
G. Institutional Official
An individual who signs, and has the authority to sign the institution's
Assurance, making a commitment on behalf of the institution that
the requirements of this Policy will be met.
H. Public Health Service
The Public Health Service or PHS currently includes the Agency
for Health Care Policy Research, the Centers for Disease Control
and Prevention, the Food and Drug Administration, the Health Resources
and Services Administration, the Indian Health Service, the National
Institutes of Health, and the Substance Abuse and Mental Health
Services Administration.
I. Quorum
A majority of the members of the Institutional Animal Care and
Use Committee (IACUC).
IV. IMPLEMENTATION BY INSTITUTIONS
No activity involving animals may be conducted or supported by
the PHS until the institution conducting the activity has provided
a written Assurance acceptable to the PHS, setting forth compliance
with this Policy. Assurances shall be submitted to the Office
for Protection from Research Risks (OPRR), Office of the Director,
National Institutes of Health.1 The Assurance shall
be typed on the institution's letterhead and signed by the Institutional
Official. OPRR will provide the institution with necessary instructions
and an example of an acceptable Assurance. All Assurances submitted
to the PHS in accordance with this Policy will be evaluated by
OPRR to determine the adequacy of the institution's proposed program
for the care and use of animals in PHS-conducted or supported
activities. On the basis of this evaluation OPRR may approve or
disapprove the Assurance, or negotiate an approvable Assurance
with the institution. Approval of an Assurance will be for a specified
period of time (no longer than five years) after which time the
institution must submit a new Assurance to OPRR. OPRR may limit
the period during which any particular approved Assurance shall
remain effective or otherwise condition, restrict, or withdraw
approval. Without an applicable PHS-approved Assurance no PHS-conducted
or supported activity involving animals at the institution will
be permitted to continue.
2. Institutional Status
Each institution must assure that its program and facilities
are in one of the following categories:
B. Functions of the Institutional
Animal Care and Use Committee
As an agent of the institution, the IACUC shall with respect
to PHS - conducted or supported activities:
1. In order to approve proposed research projects or proposed
significant changes in ongoing research projects, the IACUC shall
conduct a review of those components related to the care and use
of animals and determine that the proposed research projects are
in accordance with this Policy. In making this determination,
the IACUC shall confirm that the research project will be conducted
in accordance with the Animal Welfare Act insofar as it
applies to the research project, and that the research project
is consistent with the Guide unless acceptable justification
for a departure is presented.8 Further, the IACUC shall
determine that the research project conforms with the institution's
Assurance and meets the following requirements:
2. Prior to the review, each IACUC member shall be provided with
a list of proposed research projects to be reviewed. Written descriptions
of research projects that involve the care and use of animals
shall be available to all IACUC members, and any member of the
IACUC may obtain, upon request, full committee review of those
research projects. If full committee review is not requested,
at least one member of the IACUC, designated by the chairperson
and qualified to conduct the review, shall review those research
projects and have the authority to approve, require modifications
in (to secure approval) or request full committee review of those
research projects. If full committee review is requested, approval
of those research projects may be granted only after review at
a convened meeting of a quorum of the IACUC and with the approval
vote of a majority of the quorum present. No member may participate
in the IACUC review or approval of a research project in which
the member has a conflicting interest (e.g., is personally involved
in the project) except to provide information requested by the
IACUC; nor may a member who has a conflicting interest contribute
to the constitution of a quorum.
3. The IACUC may invite consultants to assist in the review of
complex issues. Consultants may not approve or withhold approval
of an activity or vote with the IACUC unless they are also members
of the IACUC.
4. The IACUC shall notify investigators and the institution in
writing of its decision to approve or withhold approval of those
activities related to the care and use of animals, or of modifications
required to secure IACUC approval. If the IACUC decides to withhold
approval of an 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.
5. The IACUC shall conduct continuing review of each previously
approved, ongoing activity covered by this Policy at appropriate
intervals as determined by the IACUC, including a complete review
in accordance with IV.C.1.-4. at least once every three years.
6. The IACUC may suspend an activity that it previously approved
if it determines that the activity is not being conducted in accordance
with applicable provisions of the Animal Welfare Act, the
Guide the institution's Assurance, or IV.C.1.a.-g.
of this Policy.10 The IACUC may suspend an activity
only after review of the matter at a convened meeting of a quorum
of the IACUC and with the suspension vote of a majority of the
quorum present.
7.If the IACUC suspends an activity involving animals, the Institutional
Official in consultation with the IACUC shall review the reasons
for suspension, take appropriate corrective action, and report
that action with a full explanation to OPRR.
8.Applications and proposals that have been approved by the IACUC
may be subject to further appropriate review and approval by officials
of the institution. However, those officials may not approve an
activity involving the care and use of animals if it has not been
approved by the IACUC.
D. Information Required
in Applications-Proposals for Awards Submitted to PHS
1. All Institutions
Applications and proposals (competing and non-competing) for awards submitted to PHS that involve the care and use of animals shall contain the following information:
2. Institutions That Have an Approved Assurance
Applications or proposals (competing and non-competing) covered
by this Policy from institutions which have an approved Assurance
on file with OPRR shall include verification of approval (including
the date of the most recent approval) by the IACUC of those components
related to the care and use of animals. For competing applications
or proposals only, such verification may be filed at a time not
to exceed 60 days after the receipt deadline date. If verification
of IACUC approval is submitted subsequent to the submission of
the application or proposal, the verification shall state the
modifications, if any, required by the IACUC. The verification
shall be signed by an individual authorized by the institution,
but need not be signed by the Institutional Official.
3. Institutions That Do Not Have an Approved Assurance
For applications and proposals covered by this Policy from institutions that do not have an approved Assurance on file with OPRR, the signature of the official signing for the applicant organization shall constitute a declaration that the institution will submit an Assurance when requested by OPRR. Upon such request, the institution shall prepare the Assurance as instructed by OPRR and in accordance with IV.A. of this Policy. The authorized IACUC shall review those components of the application or proposal as required by IV.C. of this Policy. Upon IACUC approval of those components of the application or proposal the institution shall submit the Assurance to OPRR.
1. The awardee institution shall maintain:
1. At least once every 12 months, the IACUC, through the Institutional
Official, shall report in writing to OPRR:
4. Reports filed under IV.F. of this Policy shall include any minority views filed by members of the IACUC.
A. Responsibilities of the Office for Protection from Research Risks (OPRR)
OPRR is responsible for the general administration and coordination
of this Policy and will:
B. Responsibilities of PHS
Awarding Units
PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OPRR, and the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. If any one of these institutions does not have an approved Assurance on file with OPRR, the awarding unit will ask OPRR to negotiate an Assurance with the institution(s) before an award is made. No award shall be made until all required Assurances have been submitted by the institution(s), been approved by OPRR, and the institution(s) have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals.
C. Conduct of Special Reviews/Site
Visits
Each awardee institution is subject to review at any time by PHS staff and advisors, which may include a site visit, in order to assess the adequacy or accuracy of the institution's compliance or expressed compliance with this Policy.
Institutions may request a waiver of a provision or provisions
of this Policy by submitting a request to OPRR. No waiver will
be granted unless sufficient justification is provided and the
waiver is approved in writing by OPRR.
Footnote 1:
Assurances should be sent to the Division of Animal Welfare,
Office for Protection from Research Risks, National Institutes
of Health, 6100 Executive Boulevard, MSC 7507, Suite 3B01, Rockville,
Maryland 20892-7507. The address for express or hand-delivered
mail is Division of Animal Welfare, Office for Protection from
Research Risks, National Institutes of Health, 6100 Executive
Boulevard, Suite 3B01, Rockville, Maryland 20852.
Footnote 2:
This Policy requires that Assured institutions base their programs
of animal care and use on the Guide for the Care and Use of
Laboratory Animals and that they comply with the regulations
(9 CFR, Subchapter A) issued by the U.S. Department of Agriculture
(USDA) under the Animal Welfare Act. The Guide may differ
from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
Footnote 3:
The name Institutional Animal Care and Use Committee (IACUC) as
used in this Policy is intended as a generic term for a committee
whose function is to ensure that the care and use of animals in
PHS-conducted or supported activities is appropriate and humane
in accordance with this Policy. However, each institution may
identify the committee by whatever name it chooses.
Footnote 4:
As of the 1996 reprint of this Policy, the only accrediting body
recognized by PHS is the American Association for Accreditation
of Laboratory Animal Care (AAALAC)
Footnote 5:
The Health Research Extension Act of 1985 requires the
IACUC to be appointed by the chief executive officer (CEO) of
the entity for which the committee is established. OPRR considers
the CEO to be the highest operating official of the organization
(such as the President of a University). If the CEO delegates
authority to appoint the IACUC then the delegation must be specific
and in writing. The CEO may or may not be the Institutional Official
as defined by this Policy (see definition at III.G.).
Footnote 6:
This Policy requires that Assured institutions base their programs
of animal care and use on the Guide for the Care and Use of
Laboratory Animals and that they comply with the regulations
(9 CFR, Subchapter A) issued by the U.S. Department of Agriculture
(USDA) under the Animal Welfare Act. The Guide may differ
from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
Footnote 7:
The Institutional Animal Care and Use Committee (IACUC) may, at
its discretion, determine the best means of conducting an evaluation
of the institution's programs and facilities. The IACUC may invite
ad hoc consultants to assist in conducting the evaluation. However,
the IACUC remains responsible for the evaluation and report.
Footnote 8:
This Policy requires that Assured institutions base their programs
of animal care and use on the Guide for the Care and Use of
Laboratory Animals and that they comply with the regulations
(9 CFR, Subchapter A) issued by the U.S. Department of Agriculture
(USDA) under the Animal Welfare Act. The Guide may differ
from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
Footnote 9:
Journal of the American Veterinary Medical Association (JAVMA),
1993, Vol. 202, No. 2, pp. 229-249, or succeeding revised editions.
Footnote 10:
This Policy requires that Assured institutions base their programs
of animal care and use on the Guide for the Care and Use of
Laboratory Animals and that they comply with the regulations
(9 CFR, Subchapter A) issued by the U.S. Department of Agriculture
(USDA) under the Animal Welfare Act. The Guide may differ
from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
Footnote 11:
This Policy requires that Assured institutions base their programs
of animal care and use on the Guide for the Care and Use of
Laboratory Animals and that they comply with the regulations
(9 CFR, Subchapter A) issued by the U.S. Department of Agriculture
(USDA) under the Animal Welfare Act. The Guide may differ
from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
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Last updated February 22, 2001