Public Health Service Policy on Humane Care and Use of

Ofﬁce of Laboratory Animal Welfare

National Institutes of Health

U.S. Department of Health and Human Services

RKL 1, Suite 360, MSC 7982

6705 Rockledge Drive

Bethesda, MD 20892-7982

NIH Publication

No. 15-8013

U.S. Department of Health

and Human Services

National Institutes of Health

Ofﬁce of Laboratory Animal Welfare

Public Health Service Policy

on Humane Care and Use

of Laboratory Animals

Revised 2015

Public Health Service Policy

on Humane Care and Use

of Laboratory Animals

Preface

is 2015 reprint of the Public Health Service (PHS) Policy on Humane

Care and Use of Laboratory Animals (Policy) is available in both printed

and electronic formats. e electronic version may be found on the Oce of

Laboratory Animal Welfare (OLAW) website at OLAW.nih.gov and includes

hyperlinks to selected documents referred to in the text.

e 2015 reprint of the PHS Policy reects the following changes from the

2002 reprint: (1) On January 1, 2012, OLAW adopted the Guide for the

Care and Use of Laboratory Animals: Eighth Edition (Guide), an update of the

1996 Seventh Edition, released by the National Academy of Sciences Insti-

tute for Laboratory Animal Research (ILAR) in 2011. Institutions with PHS

Animal Welfare Assurances implemented the Eighth Edition of the Guide

during 2012. (2) On February 26, 2013, the American Veterinary Medical

Association (AVMA) Panel on Euthanasia released the AVMA Guidelines for

the Euthanasia of Animals: 2013 Edition (Guidelines). PHS Assured insti-

tutions implemented the 2013 AVMA Guidelines during the period from

March 1, 2013, to September 1, 2013. (3) e OLAW mail address has been

removed and electronic and fax contact information has been provided to

facilitate ecient communication and conserve resources. (4) Footnotes 2,

7, 9, 11, and 13 have been modied to require PHS Assured institutions to

comply with U.S. Department of Agriculture regulations that are applicable

to their programs. (5) A change in format, but not content, was made to

PHS Policy IV.B.3. (6) Grammatical corrections were made to reect current

writing standards.

is reprint includes the Health Research Extension Act of 1985, Public Law

99-158, “Animals in Research” (November 20, 1985), which provides the

statutory mandate for the PHS Policy. Also included in this reprint are the

U.S. Government Principles for the Utilization and Care of Vertebrate Ani-

mals Used in Testing, Research, and Training (Principles). e U.S. Principles

were promulgated in 1985 by the Interagency Research Animal Committee

and adopted by U.S. Government agencies that either develop requirements

for or sponsor procedures involving the use of vertebrate animals. e Princi-

ples were incorporated into the PHS Policy in 1986 and continue to provide

a framework for conducting research in accordance with the Policy.

OLAW, which has responsibility for the general administration and coordi-

nation of the Policy, provides specic guidance, instruction, and materials to

institutions that must comply with the Policy. For supplemental materials,

please contact OLAW at the National Institutes of Health at [email protected].

gov, or visit the OLAW website at OLAW.nih.gov.

Table of Contents

Health Research Extension Act of 1985, Public Law 99-158,

November 20, 1985, “Animals in Research” ...............................................1

U.S. Government Principles for the Utilization and Care of

Vertebrate Animals Used in Testing, Research, and Training ......................4

Public Health Service Policy on Humane Care and Use of

Laboratory Animals ................................................................................... 7

I. Introduction........................................................................................7

II. Applicability........................................................................................ 7

III. Denitions ......................................................................................... 8

IV. Implementation by Institutions ..........................................................9

A. Animal Welfare Assurance ............................................................ 9

B. Functions of the Institutional Animal Care

and Use Committee ................................................................... 12

C. Review of PHS-Conducted or Supported

Research Projects .......................................................................13

D. Information Required in Applications and

Proposals for Awards Submitted to the PHS ..............................16

E. Recordkeeping Requirements ..................................................... 17

F. Reporting Requirements ............................................................17

V. Implementation by the PHS .............................................................18

A. Responsibilities of the Oce of Laboratory

Animal Welfare .......................................................................... 18

B. Responsibilities of PHS Awarding Units ....................................19

C. Conduct of Special Reviews/Site Visits ....................................... 19

D. Waiver ........................................................................................ 19

“(A)

“(B)

(1)

“(A)

Health Research Extension Act of 1985

Public Law 99-158

November 20, 1985, “Animals in Research”

Sec. 495.

(a) e Secretary, acting through the Director of NIH, shall establish guide-

lines for the following:

“(1) e proper care of animals to be used in biomedical and behavioral

research.

“(2) e proper treatment of animals while being used in such research.

Guidelines under this paragraph shall require—

the appropriate use of tranquilizers, analgesics, anesthetics, par-

alytics, and euthanasia for animals in such research; and

appropriate pre-surgical and post-surgical veterinary medical

and nursing care for animals in such research.

Such guidelines shall not be construed to prescribe methods of research.

“(3) e organization and operation of animal care committees in accor-

dance with subsection (b).

“(b) Guidelines of the Secretary under subsection (a)(3) shall require

animal care committees at each entity which conducts biomedical and

behavioral research with funds provided under this Act (including the

National Institutes of Health and the national research institutes) to

assure compliance with the guidelines established under subsection (a).

“(2) Each animal care committee shall be appointed by the chief execu-

tive ocer of the entity for which the committee is established, shall be

composed of not fewer than three members, and shall include at least

one individual who has no association with such entity and at least one

doctor of veterinary medicine.

“(3) Each animal care committee of a research entity shall—

review the care and treatment of animals in all animal study

areas and facilities of the research entity at least semiannually to eval-

uate compliance with applicable guidelines established under subsec-

tion (a) for appropriate animal care and treatment;

“(B)

“(C)

“(A)

“(B)

2 Health Research Extension Act of 1985

keep appropriate records of reviews conducted under subpara-

graph (A); and

for each review conducted under subparagraph (A), le with the

Director of NIH at least annually (i) a certication that the review

has been conducted, and (ii) reports of any violations of guidelines

established under subsection (a) or assurances required under para-

graph (1) which were observed in such review and which have con-

tinued after notice by the committee to the research entity involved

of the violations.

Reports led under subparagraph (C) shall include any minority views led

by members of the committee.

“(c) e Director of NIH shall require each applicant for a grant, contract,

or cooperative agreement involving research on animals which is adminis-

tered by the National Institutes of Health or any national research institute

to include in its application or contract proposal, submitted after the expira-

tion of the twelve-month period beginning on the date of enactment of this

section—

“(1) assurances satisfactory to the Director of NIH that—

the applicant meets the requirements of the guidelines estab-

lished under paragraphs (1) and (2) of subsection (a) and has an

animal care committee which meets the requirements of subsection

(b); and

scientists, animal technicians, and other personnel involved

with animal care, treatment, and use by the applicant have available

to them instruction or training in the humane practice of animal

maintenance and experimentation, and the concept, availability, and

use of research or testing methods that limit the use of animals or

limit animal distress; and

“(2)

a statement of the reasons for the use of animals in the research to be

conducted with funds provided under such grant or contract.

Notwithstanding subsection (a)(2) of section 553 of title 5, United States

Code, regulations under this subsection shall be promulgated in accordance

with the notice and comment requirements of such section.

“(d) If the Director of NIH determines that—

“(1)

the conditions of animal care, treatment, or use in an entity which is

receiving a grant, contract, or cooperative agreement involving research

on animals under this title do not meet applicable guidelines established

under subsection (a);

Public Law 99-158

“(2) the entity has been notied by the Director of NIH of such deter-

mination and has been given a reasonable opportunity to take corrective

action; and

“(3) no action has been taken by the entity to correct such conditions;

the Director of NIH shall suspend or revoke such grant or contract under

such conditions as the Director determines appropriate.

“(e) No guideline or regulation promulgated under subsection (a) or (c) may

require a research entity to disclose publicly trade secrets or commercial or

nancial information which is privileged or condential.”

U.S. Government Principles for the

Utilization and Care of Vertebrate Animals

Used in Testing, Research, and Training

e development of knowledge necessary for the improvement of the health

and well-being of humans as well as other animals requires in vivo experi-

mentation 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 con-

sidered; and whenever these agencies actually perform or sponsor such proce-

dures, the responsible Institutional Ocial shall ensure that these principles

are adhered to:

I. e transportation, care, and use of animals should be in accordance

with the Animal Welfare Act (7 U.S.C. 2131 et seq.) and other applica-

ble 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. e 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 scientic

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.

* For guidance throughout these Principles, the reader is referred to the Guide for the Care and Use of

Laboratory Animals prepared by the Institute for Laboratory Animal Research, National Academy of

Sciences.

5 U.S. Government Principles

VI. Animals that would otherwise suer 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. e 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 qualied 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.*

* Published in the Federal Register, May 20, 1985, Vol. 50, No. 97, by the Oce of Science and Technology

Policy [FR Doc. 85-12059].

Public Health Service Policy on Humane Care

and Use of Laboratory Animals

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 test-

ing activities (hereinafter referred to as “activities”) conducted or supported

by the PHS. e 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. is

Policy is intended to implement and supplement those Principles.

II. Applicability

is Policy is applicable to all PHS-conducted or supported activities involv-

ing 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 shall 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 aliated 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. is Policy does not aect applica-

ble state or local laws or regulations that 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 with other Federal statutes

and regulations relating to animals.

8 Denitions

III. Denitions

A. Animal – Any live, vertebrate animal used or intended for use in research,

research training, experimentation, or biological testing or for related pur-

poses.

B. Animal Facility – Any and all buildings, rooms, areas, enclosures, or vehi-

cles, including satellite facilities, used for animal connement, transport,

maintenance, breeding, or experiments inclusive of surgical manipulation. A

satellite facility is any containment outside of a core facility or centrally desig-

nated 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 reg-

ulations 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 – e documentation from an

institution assuring institutional compliance with this Policy.

E. Guide – Guide for the Care and Use of Laboratory Animals: Eighth Edition,

National Academy Press, 2011, Washington, D.C., or succeeding revised edi-

tions.

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 – e Public Health Service, or the PHS, includes

the Agency for Healthcare Research and Quality, 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).

9 PHS Policy on Humane Care and Use of Laboratory Animals

IV. Implementation by Institutions

A. Animal Welfare Assurance

No activity involving animals may be conducted or supported by the PHS until

the institution conducting the activity has provided a written Assurance accept-

able to the PHS, setting forth compliance with this Policy. Assurances shall be

submitted to the Oce of Laboratory Animal Welfare (OLAW), Oce of the

Director, National Institutes of Health (NIH).

e Assurance shall be signed

by the Institutional Ocial. OLAW will provide the institution with necessary

instructions and an example of an acceptable Assurance. All Assurances sub-

mitted to the PHS in accordance with this Policy will be evaluated by OLAW

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, OLAW may approve or disapprove the Assurance, or negotiate

an approvable Assurance with the institution. Approval of an Assurance will

be for a specied period of time (no longer than ve years) after which time

the institution must submit a new Assurance to OLAW. OLAW may limit the

period during which any particular approved Assurance shall remain eective

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.

1. Institutional Program for Animal Care and Use

e Assurance shall fully describe the institution’s program for the care

and use of animals in PHS-conducted or supported activities. e PHS

requires institutions to use the Guide for the Care and Use of Laboratory

Animals (Guide) as a basis for developing and implementing an institu-

tional program for activities involving animals.

e program description

must include the following:

a. a list of every branch and major component of the institution, as well as a

list of every branch and major component of any other institution,

which is to be included under the Assurance;

b. the lines of authority and responsibility for administering the program

and ensuring compliance with this Policy;

Assurances should be sent to OLAW, NIH, by e-mail to [email protected] or by fax to

301-451-5672.

is 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 applicable regulations (9 CFR,

Subchapter A) issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act.

e Guide may dier from USDA regulations in some respects. Compliance with applicable USDA

regulations is an absolute requirement of this Policy.

10 Implementation by Institutions

c. the qualications, authority, and responsibility of the veterinarian(s)

who will participate in the program and the percent of time each will

contribute to the program;

d. the membership list of the Institutional Animal Care and Use Com-

mittee(s) (IACUC) established in accordance with the requirements

set forth in IV.A.3. of this Policy;

e. the procedures that the IACUC will follow to fulll the requirements

set forth in this Policy;

f. the health program for personnel who work in laboratory animal

facilities or have frequent contact with animals;

g. a synopsis of training or instruction in the humane practice of

animal care and use, as well as training or instruction in research

or testing methods that minimize the number of animals required

to obtain valid results and minimize animal distress, oered to sci-

entists, animal technicians, and other personnel involved in animal

care, treatment, or use;

h. the gross square footage of each animal facility (including satellite

facilities), the species housed therein, and the average daily inven-

tory, by species, of animals in each facility; and

i. any other pertinent information requested by OLAW.

2. Institutional Status

Each institution must assure that its program and facilities are in one of

the following categories:

Category 1 – Accredited by the Association for Assessment and Accred-

itation of Laboratory Animal Care International (AAALAC). All of the

institution’s programs and facilities (including satellite facilities) for activ-

ities involving animals have been evaluated and accredited by AAALAC,

or another accrediting body recognized by the PHS.

All of the institu-

tion’s programs and facilities (including satellite facilities) for activities

involving animals have also been evaluated by the IACUC and will be

reevaluated by the IACUC at least once every six months, in accordance

with IV.B.1. and 2. of this Policy, and reports prepared in accordance

with IV.B.3. of this Policy.

e 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 are appropriate and humane in accordance with this Policy. However,

each institution may identify the committee by whatever name it chooses.

As of the 2015 revision of this Policy, the only accrediting body recognized by the PHS is AAALAC.

11 PHS Policy on Humane Care and Use of Laboratory Animals

Category 2 – Evaluated by the Institution. All of the institution’s pro-

grams and facilities (including satellite facilities) for activities involving

animals have been evaluated by the IACUC. ese programs and facili-

ties will be reevaluated by the IACUC at least once every six months, in

accordance with IV.B.1. and 2. of this Policy, and reports will be prepared

in accordance with IV.B.3. of this Policy. e most recent semiannual

report of the IACUC evaluation shall be submitted to OLAW with the

Assurance.

3. Institutional Animal Care and Use Committee

e Chief Executive Ocer shall appoint an IACUC, qualied

through the experience and expertise of its members to oversee the

institution’s animal program, facilities, and procedures.

b. e Assurance must include the names,

position titles, and creden-

tials of the IACUC chairperson and the members. e committee

shall consist of no fewer than ve members, and shall include at least:

(1) one Doctor of Veterinary Medicine, with training or experience

in laboratory animal science and medicine, who has direct or dele-

gated program authority and responsibility for activities involving

animals at the institution (see IV.A.1.c.);

(2) one practicing scientist experienced in research involving animals;

(3) one member whose primary concerns are in a nonscientic area

(e.g., ethicist, lawyer, and member of the clergy); and

(4) one individual who is not aliated with the institution in any

way other than as a member of the IACUC, and is not a member of

the immediate family of a person who is aliated with the institu-

tion.

c. An individual who meets the requirements of more than one of the

categories detailed in IV.A.3.b.(1)-(4) of this Policy may fulll more

than one requirement. However, no committee may consist of fewer

than ve members.

e Health Research Extension Act of 1985 requires the IACUC to be appointed by the Chief Executive

Ocer (CEO) of the entity for which the committee is established. OLAW considers the CEO to be the

highest operating ocial of the organization (such as the President of a University). If the CEO delegates

authority to appoint the IACUC then the delegation must be specic and in writing. e CEO may or

may not be the Institutional Ocial as dened by this Policy (see denition at III.G.).

Institutions may, at their discretion, represent the names of members other than the chairperson and

veterinarian with program authority (see IV.A.3.) by using numbers or other symbols in submissions to

OLAW. Sucient information for OLAW to determine that all appointees are appropriately qualied

must be provided. e identity of each member must be readily ascertainable by the institution and

available to authorized OLAW or other PHS representatives upon request.

12 Implementation by Institutions

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. review at least once every six months the institution’s program for

humane care and use of animals, using the Guide as a basis for eval-

uation;

2. inspect at least once every six months all of the institution’s animal

facilities (including satellite facilities) using the Guide as a basis for

evaluation;

3. prepare reports of the IACUC evaluations conducted as required by

IV.B.1. and 2. of this Policy, and submit the reports to the Institu-

tional Ocial;

(e reports must meet the following criteria:

a. e reports shall be updated at least once every six months upon

completion of the required semiannual evaluations.

b. e reports shall be maintained by the institution and made

available to OLAW upon request.

c. e reports must contain a description of the nature and extent

of the institution’s adherence to the Guide and this Policy and

must identify specically any departures from the provisions of

the Guide and this Policy, and must state the reasons for each

departure.

d. e reports must distinguish signicant deciencies from minor

deciencies. A signicant deciency is one that, consistent with

this Policy, and, in the judgment of the IACUC and the Insti-

tutional Ocial, is or may be a threat to the health or safety of

the animals. If program or facility deciencies are noted, the reports

must contain a reasonable and specic plan and schedule for cor-

recting each deciency.

e. If some or all of the institution’s facilities are accredited by

AAALAC or another accrediting body recognized by the PHS,

the report should identify those facilities as such.)

is 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 applicable regulations (9 CFR, Subchapter

A) issued by USDA under the Animal Welfare Act. e Guide may dier from USDA regulations in some

respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy.

e IACUC may, at its discretion, determine the best means of conducting an evaluation of the

institution’s programs and facilities. e IACUC may invite ad hoc consultants to assist in conducting

the evaluation. However, the IACUC remains responsible for the evaluation and report.

13 PHS Policy on Humane Care and Use of Laboratory Animals

4. review concerns involving the care and use of animals at the institu-

tion;

5. make recommendations to the Institutional Ocial regarding any

aspect of the institution’s animal program, facilities, or personnel

training;

6. review and approve, require modications in (to secure approval), or

withhold approval of those components of PHS-conducted or sup-

ported activities related to the care and use of animals as specied in

IV.C. of this Policy;

7. review and approve, require modications in (to secure approval),

or withhold approval of proposed signicant changes regarding the

use of animals in ongoing activities; and

8. be authorized to suspend an activity involving animals in accordance

with the specications set forth in IV.C.6. of this Policy.

C. Review of PHS-Conducted or Supported Research Projects

1. In order to approve proposed research projects or proposed signi-

cant 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

conrm that the research project will be conducted in accordance

with the Animal Welfare Act insofar as it applies to the research proj-

ect, and that the research project is consistent with the Guide unless

acceptable justication for a departure is presented.

Further, the

IACUC shall determine that the research project conforms with the

institution’s Assurance and meets the following requirements:

a. Procedures with animals will avoid or minimize discomfort, dis-

tress, and pain to the animals, consistent with sound research

design.

b. Procedures that may cause more than momentary or slight pain

or distress to the animals will be performed with appropriate

sedation, analgesia, or anesthesia, unless the procedure is justi-

ed for scientic reasons in writing by the investigator.

is 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 applicable regulations (9 CFR,

Subchapter A) issued by USDA under the Animal Welfare Act. e Guide may dier from USDA

regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement

of this Policy.

14 Implementation by Institutions

c. Animals that would otherwise experience severe or chronic pain

or distress that cannot be relieved will be painlessly killed at the

end of the procedure or, if appropriate, during the procedure.

d. e living conditions of animals will be appropriate for their

species and contribute to their health and comfort. e housing,

feeding, and nonmedical care of the animals will 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.

e. Medical care for animals will be available and provided as neces-

sary by a qualied veterinarian.

f. Personnel conducting procedures on the species being main-

tained or studied will be appropriately qualied and trained in

those procedures.

g. Methods of euthanasia used will be consistent with the recom-

mendations of the American Veterinary Medical Association

(AVMA) Panel on Euthanasia, unless a deviation is justied for

scientic reasons in writing by the investigator.

2. Prior to the review, each IACUC member shall be provided with a

list of proposed research projects to be reviewed. Written descrip-

tions 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 qual-

ied to conduct the review, shall review those research projects and

have the authority to approve, require modications in (to secure

approval), or request full committee review of those research proj-

ects. 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

conicting interest (e.g., is personally involved in the project) except

to provide information requested by the IACUC; nor may a member

who has a conicting interest contribute to the constitution of a

quorum.

AVMA Guidelines for the Euthanasia of Animals: 2013 Edition or succeeding revised editions. Available

at https://www.avma.org/KB/Policies/Documents/euthanasia.pdf.

15 PHS Policy on Humane Care and Use of Laboratory Animals

3. e IACUC may invite consultants to assist with the review of com-

plex 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. e 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 modications required to

secure IACUC approval. If the IACUC decides to withhold approval

of an activity, it shall include in its written notication a statement of

the reasons for its decision and give the investigator an opportunity

to respond in person or in writing.

5. e 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. e IACUC may suspend an activity which 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.

e 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 Institu-

tional Ocial in consultation with the IACUC shall review the rea-

sons for suspension, take appropriate corrective action, and report

that action with a full explanation to OLAW.

8. Applications and proposals that have been approved by the IACUC

may be subject to further appropriate review and approval by ocials

of the institution. However, those ocials may not approve an activ-

ity involving the care and use of animals if it has not been approved

by the IACUC.

is 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 applicable regulations (9 CFR,

Subchapter A) issued by USDA under the Animal Welfare Act. e Guide may dier from USDA

regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement

of this Policy.

16 Implementation by Institutions

D. Information Required in Applications and Proposals for Awards

Submitted to the PHS

1. All Institutions

Applications and proposals (competing and noncompeting) for awards

submitted to the PHS that involve the care and use of animals shall con-

tain the following information:

a. identication of the species and approximate number of animals to

be used;

b. rationale for involving animals, and for the appropriateness of the

species and numbers used;

c. a complete description of the proposed use of the animals;

d. a description of procedures designed to assure that discomfort and

injury to animals will be limited to that which is unavoidable in

the conduct of scientically valuable research, and that analgesic,

anesthetic, and tranquilizing drugs will be used where indicated and

appropriate to minimize discomfort and pain to animals; and

e. a description of any euthanasia method to be used.

Noncompeting applications and contract proposals for other than full

and open competitions need not repeat the information required by

IV.D.1.a.-e. if the information was complete in the last competing appli-

cation or proposal and there are no signicant changes to that informa-

tion. However, the application or proposal must contain a statement to

that eect. If there are signicant changes in the information, then the

application or proposal must specically identify them and state the rea-

sons for the changes.

2. Institutions at Have an Approved Assurance

Applications or proposals (competing and noncompeting) covered by

this Policy from institutions that have an approved Assurance on le

with OLAW shall include verication 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 verication may be led at any time prior to award unless

specically required earlier by the funding component. If verication of

IACUC approval is submitted subsequent to the submission of the appli-

cation or proposal, the verication shall state the modications, if any,

required by the IACUC. e verication shall be signed by an individual

authorized by the institution, but need not be signed by the Institutional

Ocial.

17 PHS Policy on Humane Care and Use of Laboratory Animals

3. Institutions at Do Not Have an Approved Assurance

For applications and proposals covered by this Policy from institutions

that do not have an approved Assurance on le with OLAW, the signa-

ture of the ocial signing for the applicant organization shall constitute a

declaration that the institution will submit an Assurance when requested

by OLAW. Upon such request, the institution shall prepare the Assur-

ance as instructed by OLAW and in accordance with IV.A. of this Policy.

e 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 OLAW.

E. Recordkeeping Requirements

1. e awardee institution shall maintain:

a. a copy of the Assurance that has been approved by the PHS;

b. minutes of IACUC meetings, including records of attendance,

activities of the committee, and committee deliberations;

c. records of applications, proposals, and proposed signicant

changes in the care and use of animals and whether IACUC

approval was given or withheld;

d. records of semiannual IACUC reports and recommendations

(including minority views) as forwarded to the Institutional

Ocial; and

e. records of accrediting body determinations.

2. All records shall be maintained for at least three years; records that

relate directly to applications, proposals, and proposed signicant

changes in ongoing activities reviewed and approved by the IACUC

shall be maintained for the duration of the activity and for an addi-

tional three years after completion of the activity. All records shall be

accessible for inspection and copying by authorized OLAW or other

PHS representatives at reasonable times and in a reasonable manner.

F. Reporting Requirements

1. At least once every 12 months, the IACUC, through the Institu-

tional Ocial, shall report in writing to OLAW:

a. any change in the institution’s program or facilities that would

place the institution in a dierent category than specied in its

Assurance (see IV.A.2. of this Policy);

18 Implementation by Institutions

b. any change in the description of the institution’s program for

animal care and use as required by IV.A.1.a.-i. of this Policy;

c. any changes in the IACUC membership;

and

d. notice of the dates that the IACUC conducted its semiannual

evaluations of the institution’s program and facilities and sub-

mitted the evaluations to the Institutional Ocial.

2. At least once every 12 months, the IACUC, at an institution which

has no changes to report as specied in IV.F.1.a.-c. of this Policy,

shall report to OLAW in writing, through the Institutional Ocial,

that there are no changes and shall inform OLAW of the dates of the

required IACUC evaluations and submissions to the Institutional

Ocial.

3. e IACUC, through the Institutional Ocial, shall promptly pro-

vide OLAW with a full explanation of the circumstances and actions

taken with respect to:

a. any serious or continuing noncompliance with this Policy;

b. any serious deviation from the provisions of the Guide;

c. any suspension of an activity by the IACUC.

4. Reports led under IV.F. of this Policy shall include any minority

views led by members of the IACUC.

V. Implementation by the PHS

A. Responsibilities of the Oce of Laboratory Animal Welfare

OLAW is responsible for the general administration and coordination of this

Policy and will:

1. request and negotiate, approve or disapprove, and, as necessary,

restrict or withdraw approval of Assurances;

Institutions may, at their discretion, represent the names of the members other than the chairperson and