[NAME OF INSTITUTION]
[Insert Assurance
number here if this is a renewal, e.g., A3000-01.
For new Assurances, a number will be assigned at approval.]
Animal Welfare Assurance for Domestic Institutions
I, [Insert
the name of Institutional Official] as named Institutional Official for
animal care and use at [Name of
Institution], provide assurance that this Institution will comply with the Public
Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy).
I.
Applicability of Assurance
This Assurance applies whenever this Institution conducts
the following activities: all research, research training, experimentation,
biological testing, and related activities involving live vertebrate animals
supported by the PHS. This Assurance covers only those facilities and
components listed below.
A. The following are branches and components over which this Institution
has legal authority, included are those that operate under a different name:
[List every branch and major component
covered by the Assurance.]
B. The following
are other institution(s), or branches and components of
another institution:
[List the names of other institutions, or
branches and components of other institutions. They must be recipients of PHS
funding or pending PHS award.]
[Note: only
those entities listed in this section will be entitled to use the Assurance
number for grant and contract submissions to PHS agencies.]
Recommended References:
o
Foreign
collaborations and performance sites
II.
Institutional Commitment
A. This Institution will comply with all applicable provisions of the Animal Welfare Act and
other Federal statutes and regulations relating to animals.
B. This Institution is guided by the "U.S.
Government Principles for the Utilization and Care of Vertebrate Animals Used
in Testing, Research, and Training."
C. This Institution acknowledges and accepts responsibility for the care
and use of animals involved in activities covered by this Assurance. As partial
fulfillment of this responsibility, this Institution will ensure that all
individuals involved in the care and use of laboratory animals understand their
individual and collective responsibilities for compliance with this Assurance, and
other applicable laws and regulations pertaining to animal care and use.
Recommended Reference:
o
Distribution of
Assurance within Institution
D. This Institution has established and will maintain a program for
activities involving animals according to the Guide for the Care and Use of Laboratory Animals (Guide).
Recommended Reference:
o
Use of the Guide
for the Care and Use of Agricultural Animals in Agricultural Research and
Teaching
E. This Institution agrees to ensure that all performance sites engaged in
activities involving live vertebrate animals under consortium (subaward) or
subcontract agreements have an Animal Welfare Assurance and that the activities
have Institutional Animal Care and Use Committee (IACUC) approval.
III. Institutional Program for Animal Care and Use
A. The lines of authority and responsibility for administering the program
and ensuring compliance with the PHS Policy are as follows:
[Insert or attach a description or organizational
chart for these components:
-
chief executive officer
-
Institutional Official
-
IACUC
-
veterinarian
-
animal facility management
Note: the description or chart must demonstrate the
direct reporting structure and lines of communication from the IACUC to the Institutional
Official and from the Veterinarian to the Institutional Official.]
Recommended References:
o
Effective
administrative organizations
o
Difference
between Chief Executive Officer and Institutional Official
B. The qualifications, authority, and percent of time contributed by the veterinarian(s)
who will participate in the program are as follows:
1) Name: [Enter veterinarian s name]
Qualifications
Degrees:
[Enter professional degrees and
certifications]
Training or experience in laboratory animal
medicine or in the use of the species at the institution:
[Briefly describe training or experience in
laboratory animal medicine or the species being used. Do not include or attach
a CV.]
Authority: Dr. [enter
veterinarian s name] has [specify
direct or delegated] program authority and responsibility for the
Institution s animal care and use program including access to all animals.
Time contributed to program:
[If full time, enter full time employee and
the percentage of time contributed to the animal care and use program.
If part time or if a consulting veterinarian is
used, enter the approximate number of hours per week or month and the
percentage of those hours contributed to the animal care and use program.]
[Note: if there is more than one veterinarian
associated with the program; provide the information below for each.
If only one veterinarian is associated with the program, describe
provisions in place for a back-up veterinarian.]
2) Name: [Enter veterinarian s name]
Qualifications
Degrees:
[Enter professional degrees and
certifications]
Training or experience in laboratory animal
medicine or in the use of the species at the institution:
[Briefly describe training or experience in
laboratory animal medicine or the species being used. Do not include or attach
a CV.]
Responsibilities:
[Describe authority and responsibilities]
Time contributed to program:
[If full time, enter full time employee and
the percentage of time contributed to the animal care and use program.
If part time, enter the approximate number of hours
per week or month and the percentage of those hours contributed to the animal
care and use program.]
Recommended References:
o
ACLAM
Guidelines on Adequate Veterinary Care. (PDF)
o
Description
of the responsibilities and qualifications of the veterinarian.
C. The IACUC at this Institution is properly appointed according to PHS
Policy IV.A.3.a. and is qualified through the experience and expertise of its
members to oversee the Institution's animal care and use program and
facilities. The IACUC consists of at least 5 members, and its membership meets
the composition requirements of PHS Policy IV.A.3.b. Attached is a list of the
chairperson and members of the IACUC and their names, degrees, profession,
titles or specialties, and institutional affiliations.
[Complete the IACUC membership
table provided (see Part VIII.).
Note: for nonaffiliated
members, list specific position titles (e.g., banker, teacher, volunteer
fireman; not community member or retired )
Note: names of members,
other than the chairperson and veterinarian, may be represented by a number or
symbol.]
Recommended References:
o
ARENA/OLAW
IACUC Guidebook (PDF)
o
Consulting
veterinarian's affiliation with the Institution
o
Multiple
IACUC positions filled by the same individual
o
Reimbursement
of nonaffiliated member
o
Maintenance of
properly constituted IACUC
D. The IACUC will:
1) Review at least once every 6 months the Institution's program for humane
care and use of animals, using the Guide
as a basis for evaluation. The IACUC procedures for conducting semiannual
program reviews are as follows:
[Describe how the IACUC conducts the
semiannual program reviews. For example, who performs the reviews, what items are
included, where, when, and how those items are reviewed, and if a checklist is
used.]
2) Inspect at least once every 6 months all of the Institution's animal
facilities, including satellite facilities and animal surgical sites, using the
Guide as a basis for evaluation. The
IACUC procedures for conducting semiannual facility inspections are as
follows:
[Describe how the IACUC conducts the
semiannual facility inspections. For example, who performs the inspections,
what areas are inspected, and if a checklist is used.]
Recommended References:
o
Sample
Semiannual Program and Facility Review Checklist
o
Inspections
of laboratories and other animal sites
o
Inspections
of facilities housing animals for 12 hours
o
Sites/study
areas where animals are housed only sporadically or for less than 24 hours
3) Prepare reports of the IACUC evaluations according to PHS Policy IV.B.3.
and submit the reports to the Institutional Official. The IACUC procedures for
developing reports and submitting them to the Institutional Official are as
follows:
[Describe the following procedures:
-
How the IACUC develops, approves, and submits the semiannual reports of
the program review and facility inspection to the Institutional Official
-
How the IACUC identifies and approves departures from the PHS Policy and
the Guide
-
How the IACUC identifies and corrects deficiencies
Specify what is to be reported such as:
-
The institutions adherence to the PHS Policy and the Guide
-
IACUC-approved departures from the PHS Policy and the Guide and reason
for each departure
-
Identification of deficiencies and designation as either minor or
significant
-
Schedule and plan for correcting deficiencies
-
Minority views]
Recommended References:
o
Sample
format for the semiannual report to the Institutional Official
4) Review concerns involving the care and use of animals at the
Institution. The IACUC procedures for reviewing concerns are as follows:
[Describe the following:
-
Mechanisms that facilitate/enable individuals to report concerns
-
How the IACUC reviews reported concerns
-
How the IACUC reports concerns and relates findings and recommendations
to the Institutional Official]
5) Make written recommendations to the Institutional Official regarding any
aspect of the Institution's animal program, facilities, or personnel training.
The procedures for making recommendations to the Institutional Official are as
follows:
[Describe how the IACUC develops, approves,
and submits written recommendations to the Institutional Official regarding any
aspect of the Institution s animal care and use program, facilities, or
personnel training.]
6) Review and approve, require modifications in (to secure approval), or
withhold approval of PHS-supported activities related to the care and use of
animals according to PHS Policy IV.C.1-3. The IACUC procedures for protocol
review are as follows:
[Describe how the IACUC conducts protocol
review, from initial receipt of the protocol through approval of the activity.
Include details such as:
- How protocols are received
- The pre-review or initial
screening process, if one is used
- How members are notified
- How materials are distributed
to members
- How meetings are conducted
- The methods of protocol
review (full committee and/or designated member), including a description of
the process and possible outcomes
- How conflicts of interest
are handled
- The voting process
- Also, include descriptions
of any alternate processes or procedures for special or expedited reviews]
Recommended References:
o
Guidance
on use of telecommunications for IACUC meetings
o
Use
of designated member review subsequent to full committee review
o
Correct
Conduct of Full Committee and Designated Member Protocol Review
o
Tracking
the number of animals used
o
Use
of cold-blooded vertebrates
o
Quorum
and attendance of nonaffiliated member and veterinarian
7) Review and approve, require modifications in (to secure approval), or
withhold approval of proposed significant changes regarding the use of animals
in ongoing activities according to PHS Policy IV.C. The IACUC procedures for
reviewing proposed significant changes in ongoing research projects are as
follows:
[Describe how the IACUC reviews proposed
significant changes in previously approved activities.
Note: review and approval of proposed significant
changes must comply with the same requirements as review and approval of new
protocols under PHS Policy IV.C.]
Recommended Reference:
o
Significant
changes to approved protocols
8) 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 according to PHS
Policy IV.C.4. The IACUC procedures to notify investigators and the Institution
of its decisions regarding protocol review are as follows:
[Describe how the IACUC notifies
investigators and the IO of its decisions regarding protocol review.
Describe what happens if the IACUC withholds
approval.]
9) Conduct continuing review of each previously approved, ongoing activity
covered by PHS Policy at appropriate intervals as determined by the IACUC,
including a complete review at least once every 3 years according to PHS Policy
IV.C.1.-5. The IACUC procedures for conducting continuing reviews are as
follows:
[Describe how the IACUC monitors ongoing
activities (postapproval monitoring).
Describe how the IACUC conducts a complete review
of previously approved protocols at least every 3 years.
Describe the annual review process for USDA covered
species, if applicable.]
Recommended References:
o
Model
for Performing Continuing Review of Research Activities
o
Annual
review (USDA) vs. triennial review (PHS)
10) Be authorized to suspend an activity involving animals according to PHS
Policy IV.C.6. The IACUC procedures for suspending an ongoing activity are as
follows:
[Describe how the IACUC suspends an ongoing
activity.
Describe how the IO reports an IACUC suspension to
OLAW.]
E. The risk-based occupational health and safety program for personnel
working in laboratory animal facilities and personnel who have frequent contact
with animals is as follows:
[Describe the Institution s occupational
health and safety program for personnel involved in the care and use of animals.
Refer to the following relevant topics listed in the Guide:
-
Control and prevention strategies
-
Hazard identification and risk assessment
-
Facilities, equipment, and monitoring
-
Personnel training
-
Personal hygiene
-
Animal experimentation involving hazards
-
Personal protection
-
Medical evaluation and preventive medicine for personnel (including
immunizations, vaccinations, and procedures for reporting and treating bites,
scratches, and injuries.)
-
Where appropriate, describe special precautions for personnel working
with nonhuman primates (e.g., tuberculosis screening, training and procedures
for bites and scratches, and education regarding Macacine herpesvirus 1,
formerly Cercopithecine herpesvirus 1 (Herpes B)).
Note: do not reference or send attachments.]
Recommended References:
o
Occupational
Health and Safety Programs
F. The total gross number of square feet in each animal facility (including
each satellite facility), the species of animals housed there and the average
daily inventory of animals, by species, in each facility is provided in the
attached Facility and Species Inventory table.
[Complete the Facility and Species Inventory table
provided (see Part X.).
Note: list common names for animal species, e.g., mouse, rat, rhesus, baboon, zebrafish, African
clawed frog.
Note: animal areas (buildings/rooms) may be represented
by a number or symbol in this submission to OLAW.]
G. The training or instruction available to scientists, animal technicians,
and other personnel involved in animal care, treatment, or use is as follows:
[Describe training or instruction provided to
people caring for or using laboratory animals in the proper and humane animal
care and use.
Describe training or instruction on research or
testing methods that minimize the number of animals required to obtain valid
results and limit animal pain and distress.
Describe training or orientation provided to the
IACUC members, including background materials and resources.
Note: do not reference or send attachments.]
Recommended References:
o
Training
in the Laboratory Animal Science Community: Strategies to Support Adult
Learning, 2007 
IV.
Institutional Program Evaluation and Accreditation
All of this Institution's programs and facilities
(including satellite facilities) for activities involving animals have been
evaluated by the IACUC within the past 6 months and will be reevaluated by the
IACUC at least once every 6 months according to PHS Policy IV.B.1.-2. Reports have
been and will continue to be prepared according to PHS Policy IV.B.3. All IACUC
semiannual reports will include a description of the nature and extent of this
Institution's adherence to the PHS Policy and the Guide. Any departures from the Guide
will be identified specifically and reasons for each departure will be stated.
Reports will distinguish significant deficiencies from minor deficiencies.
Where program or facility deficiencies are noted, reports will contain a
reasonable and specific plan and schedule for correcting each deficiency. Semiannual
reports of the IACUC s evaluations will be submitted to the Institutional
Official. Semiannual reports of IACUC evaluations will be maintained by this
Institution and made available to the OLAW upon request.
[From the following two paragraphs, retain the
one that is applicable and delete the one that is not applicable.]
(1) This Institution is Category 1 accredited by the Association for Assessment and Accreditation of
Laboratory Animal Care International (AAALAC) . As noted above, reports of the IACUC s semiannual
evaluations (program reviews and facility inspections) will be made available
upon request.
*** OR ***
(2) This Institution is Category 2 not accredited by
the Association for Assessment and
Accreditation of Laboratory Animal Care International (AAALAC) . As noted above, reports of the IACUC s semiannual
evaluations (program reviews and facility inspections) will be made available
upon request. The report of the most recent evaluations (program review and facility
inspection) is attached.
[For Category 2 only, attach
the most recent semiannual program review and facility inspection report.]
Recommended Reference:
o
Sample
semiannual report to the Institutional Official
V.
Recordkeeping Requirements
A. This Institution will maintain for at least 3 years:
1.
A copy of this Assurance and any modifications made
to it, as approved by the PHS
2.
Minutes of IACUC meetings, including records of
attendance, activities of the committee, and committee deliberations
3.
Records of applications, proposals, and proposed
significant changes in the care and use of animals and whether IACUC approval
was granted or withheld
4.
Records of semiannual IACUC reports and recommendations
(including minority views) as forwarded to the Institutional Official, [Insert name or title of the Institutional
Official signing the Assurance].
5.
Records of accrediting body determinations
B. This Institution will maintain records that relate directly to
applications, proposals, and proposed changes in ongoing activities reviewed
and approved by the IACUC for the duration of the activity and for an
additional 3 years after completion of the activity.
C. All records shall be accessible for inspection and copying by authorized
OLAW or other PHS representatives at reasonable times and in a reasonable
manner.
VI.
Reporting Requirements
A. The Institutional reporting period is the calendar year (January 1
December 31). The IACUC, through the Institutional Official, will submit an
annual report to OLAW by January 31 of each year. The annual report will
include:
1.
Any change in the accreditation status of the
Institution (e.g., if the Institution obtains accreditation by AAALAC or AAALAC
accreditation is revoked)
2.
Any change in the description of the Institution's
program for animal care and use as described in this Assurance
3.
Any change in the IACUC membership
4.
Notification of the dates that the IACUC conducted
its semiannual evaluations of the Institution's program and facilities
(including satellite facilities) and submitted the evaluations to the
Institutional Official, [Insert name or
title of the Institutional Official signing the Assurance].
5.
Any minority views filed by members of the IACUC
[Note: if there are no changes to report,
provide written notification that there are no changes.]
Recommended References:
o Reporting of
modifications to facilities/programs in annual report to OLAW
o Sample annual report
to OLAW
o Annual reporting
requirements
B. The IACUC, through the Institutional Official, will promptly provide
OLAW with a full explanation of the circumstances and actions taken with
respect to:
1.
Any serious or continuing noncompliance with the
PHS Policy
2.
Any serious deviations from the provisions of the Guide
3.
Any suspension of an activity by the IACUC
Recommended References:
o
Guidance
on prompt reporting, NOT-OD-05-034
o
OLAW and
APHIS: Common Areas of Noncompliance, Lab Animal, 2000: 29(5)32-37 (PDF -
65 KB)
o
Reporting
sanctions to non-PHS funded activities
o
Guidance
on allowable costs, NOT-OD-07-044
C. Reports filed under VI.A. and VI.B. above should include any minority
views filed by members of the IACUC.
VII. Institutional Endorsement and PHS Approval
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A. Authorized
Institutional Official |
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Address: (street,
city, state, country, postal code) |
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Phone: |
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E-mail:
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Acting
officially in an authorized capacity on behalf of this Institution and with
an understanding of the Institution s responsibilities under this Assurance,
I assure the humane care and use of animals as specified above. |
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Signature: |
Date: |
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B. PHS Approving Official (to be completed by OLAW) |
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Name/Title: Office of Laboratory
Animal Welfare (OLAW) National Institutes of
Health 6705 Rockledge Drive RKL1, Suite 360, MSC
7982 Bethesda, MD USA
20892-7982 (FedEx Zip Code 20817) Phone: +1
(301) 496-7163 Fax: +1 (301)
915-9465 |
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Signature: |
Date: |
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Assurance
Number: |
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Effective Date: |
Expiration Date: |
VIII. Membership of the IACUC
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Date: |
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Assurance Number: |
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IACUC Chairperson |
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Name*: |
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Title*: |
Degree/Credentials*: |
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Address*: (street, city, state, zip code) |
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E-mail*: |
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Phone*: |
Fax*: |
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IACUC Roster |
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Name of Member/ Code** |
Degree/ Credentials |
Position Title*** |
PHS Policy Membership
Requirements**** |
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* This
information is mandatory. |
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** Names of
members, other than the chairperson and veterinarian, may be represented by a
number or symbol in this submission to OLAW. Sufficient information to
determine that all appointees are appropriately qualified must be provided
and the identity of each member must be readily ascertainable by the
institution and available to authorized OLAW or other PHS representatives
upon request. |
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*** List specific
position titles for all members, including nonaffiliated (e.g., banker,
teacher, volunteer fireman; not community member or retired ). |
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**** PHS Policy Membership
Requirements: |
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Veterinarian |
veterinarian with training or
experience in laboratory animal science and medicine or in the use of the
species at the institution, who has direct or delegated program authority and
responsibility for activities involving animals at the institution. |
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Scientist |
practicing scientist experienced in
research involving animals. |
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Nonscientist |
member whose primary concerns are in
a nonscientific area (e.g., ethicist, lawyer, member of the clergy). |
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Nonaffiliated |
individual who is not affiliated 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 affiliated with the
institution. This member is expected to represent general
community interests in the proper care and use of animals and should not be a
laboratory animal user. A consulting veterinarian may not be considered
nonaffiliated. |
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[Note: all members must be appointed by the
CEO (or individual with specific written delegation to appoint members) and
must be voting members. Non-voting members and alternate members must be so
identified.] |
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IX.
Other Key Contacts (optional)
If there are other individuals within the
Institution who may be contacted regarding this Assurance, please provide
information below.
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Contact #1 |
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Title: |
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Phone: |
E-mail:
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Contact #2 |
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Phone: |
E-mail:
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X.
Facility and Species Inventory
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Date: |
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Institution: |
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Assurance Number: |
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Laboratory, Unit, or
Building* |
Gross Square Feet [include service areas] |
Species Housed [use common names, e.g., mouse, rat,
rhesus, baboon, zebrafish, African clawed frog] |
Approximate Average
Daily Inventory |
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*Institutions may identify animal areas (buildings/rooms) by a number or
symbol in this submission to OLAW. However, the name and location must be
provided to OLAW upon request.