- Guideline from the American College of Laboratory Animal Medicine on Adequate Veterinary Care.
- Description of the responsibilities and qualifications of the veterinarian.
SAMPLE ANIMAL WELFARE ASSURANCE
In accordance with the PHS Policy for
Humane Care and Use of Laboratory Animals
This Animal Welfare Assurance (Assurance) sample document is provided to assist institutions with the development of an Assurance in accordance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy). Reviewing the entire document and reading the PHS Policy before beginning to write will facilitate the completion of your institution’s Assurance. Additional guidance, frequently asked questions (FAQs), and suggested references are available on the Office of Laboratory Animal Welfare (OLAW) website (http://grants.nih.gov/grants/olaw/olaw.htm).
This sample document should not be used by:
If one of these bullets describes your institution, please contact OLAW by email at olawdoa@mail.nih.gov for guidance.
If you are unsure as to whether your institution is required to submit an Assurance and OLAW has not contacted your institution, please consult with OLAW. Do not submit an unsolicited Assurance. Assurances that have not been requested by OLAW will not be processed.
This sample document supersedes all previous versions. It includes all required elements of an Assurance. Words that are italicized and in brackets [like this] indicate specific information the institution must provide about its animal care and use program. Notes to help in preparation of the document are in brackets [NOTE: like this] and should be deleted from the completed Assurance. Please strive for clear concise text in the document. Adherence to the sample document format will facilitate the institution’s preparation and OLAW’s review of the Assurance.
One or two page attachments are preferred and may be used to provide the following:
All other program elements are to be described in the text of the Assurance. Please do not send additional attachments, more comprehensive attachments, or include appendices, binders, or manuals. Due to OLAW’s use of electronic records, we will not accept these separate documents.
Submit completed Assurances
to:
Office of Laboratory Animal
Welfare/NIH
Division of Assurances
6705 Rockledge Drive
RKL1, Suite 360, MSC 7982
Bethesda, MD 20892-7982
(For express or
hand-delivered mail use ZIP 20817)
All questions concerning this sample are to be directed to the staff of the Division of Assurances at 301-496-7163, or email OLAW at: olawdoa@mail.nih.gov
[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
in accordance with the PHS Policy for
Humane Care and Use of Laboratory Animals
I, [Insert the name of Institutional Official] as named Institutional Official for animal care and use at [Name of Institution], hereinafter referred to as Institution, by means of this document, provide assurance that this Institution will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.
This Assurance is applicable to all research, research training, experimentation, biological testing, and related activities, hereinafter referred to as activities, involving live vertebrate animals supported by the Public Health Service (PHS) and conducted at this Institution, or at another institution as a consequence of the subgranting or subcontracting of a PHS‑conducted or -supported activity by this Institution.
"Institution" includes the following branches and major components of [Name of Institution]: [List every branch and major component covered by the Assurance.]
“Institution” also includes the following: [List the names of any other institution, or branch and components of any other institution, covered by the Assurance.]
[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:
- Antibody
production
- Avian embryos
- Foreign
collaborations and performance sites
- Non-PHS
funded activities
- Non-research
activities
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, as well as all other applicable laws and regulations pertaining to animal care and use.
Recommended Reference:
- Distribution of
Assurance within Institution
D. This Institution has established and will maintain a program for activities involving animals in accordance with the “Guide for the Care and Use of Laboratory Animals” (“Guide”).
III. INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE
A. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are as follows: [Insert or attach a description or a diagram of the reporting channels for the chief executive officer, the Institutional Official, the IACUC, the veterinarian, and animal facility management or indicate diagram is appended as an attachment. The description or diagram must demonstrate direct reporting from the IACUC to the Institutional Official, and from the veterinarian to the Institutional Official.]
Recommended References:
- Effective administrative
organizations
- 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:
Name: [Enter veterinarian’s name]
Qualifications:
Authority: Dr. [name] has [direct or delegated] program authority and responsibility for the Institution’s animal care and use program.
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 each veterinarian is present at the institution and the percentage of those hours he or she contributes to the animal care and use program.]
[NOTE: If there is more than one veterinarian associated with the program, please provide the information requested below for each. If only one veterinarian is associated with the program, describe provisions in place for a back-up veterinarian to ensure adequate veterinary care of research animals should that veterinarian not be available.]
Name: [Enter veterinarian’s name]
Qualifications:
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 each veterinarian is present at the institution and the percentage of those hours he or she contributes to the animal care and use program.]
Recommended References:
- Guideline
from the American College of Laboratory Animal Medicine on Adequate Veterinary
Care.
- Description
of the responsibilities and qualifications of the veterinarian.
C. The Institutional Animal Care and Use Committee (IACUC) at this Institution is properly appointed in accordance with the 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 five members, and its membership meets the composition requirements set forth in the PHS Policy, Section 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. [Insert or attach the sample IACUC table (provided).] [Note: Names of members, other than the chairperson and veterinarian, may be represented by a number or symbol in the attachment.]
Recommended References:
- ARENA/OLAW IACUC
Guidebook
- Consulting
veterinarian's affiliation with the Institution
- Membership
requirements
- Multiple
IACUC positions filled by the same individual
- Reimbursement
of nonaffiliated member
- Maintenance of
properly constituted IACUC
D. The IACUC will:
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 evaluation. The IACUC procedures for conducting semiannual program reviews are as follows: [Describe the procedures the IACUC uses to conduct the semiannual program reviews. For example, include who performs the reviews, what items are included, and where, when, and how those items are reviewed.]
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. The IACUC procedures for conducting semiannual facility inspections are as follows: [Describe the procedures the IACUC uses to conduct the semiannual facility inspections.]
Recommended References:
- Sample
Semiannual Program and Facility Review Checklist
- Inspections of
laboratories and other animal sites
- Inspections
of facilities housing animals for 12 hours
- Sites/study
areas where animals are housed only sporadically or for less than 24 hours
3. Prepare reports of the IACUC evaluations as set forth in the 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: 1) the procedures the IACUC uses to develop, approve, and submit the reports of its evaluations (program reviews and facility inspections) to the Institutional Official 2) how departures from the PHS Policy and the “Guide” are identified, designated, and reported; and 3) the process used to correct any deficiencies noted.]
Recommended References:
- Sample format
for the semiannual report to the Institutional Official
- Distinguishing
minor deficiencies from significant deficiencies and reporting deficiencies 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: 1) the mechanisms in place to facilitate/enable individuals to report concerns involving animal care and use; 2) the procedures the IACUC uses to review such reported concerns; and 3) the procedures the IACUC uses for reporting the concerns and related IACUC 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. In accord with the PHS Policy IV.C.1-3, the IACUC shall review and approve, require modifications in (to secure approval), or withhold approval of PHS-supported activities related to the care and use of animals. The IACUC procedures for protocol review are as follows: [Describe the procedures the IACUC uses to review, approve, require modifications in (to secure approval), and withhold approval of activities related to the care and use of animals. For example, include descriptions of all IACUC procedures from initial receipt of the written description of activity (protocol) through approval of the activity. The descriptions should include, but not necessarily be limited to, the following: receipt, pre-review or initial screening, notification of members, distribution, meetings and attendance requirements, methods of protocol review (full committee or designated member), conflicts of interest, and voting. Also include descriptions of any alternate processes or procedures for special or expedited reviews.]
Recommended References:
- Guidance
on use of telecommunications for IACUC meetings, NOT-OD-06-052.
- Methods of IACUC
review
- Correct Conduct
of Full Committee and Designated Member Protocol Review, Lab Animal, 2002: 31(9)
28-31
- Expedited
review
- Scientific
merit review
- Tracking the
number of animals used
- Use
of cold-blooded vertebrates
- 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 as set forth in the PHS Policy IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are as follows: [Describe how the IACUC handles proposed significant changes in previously approved activities involving the care and use of animals.] [Note: Review and approval of proposed significant changes must comply with the same requirements as review and approval of new protocols as set forth in the PHS Policy IV.C.]
Recommended Reference:
- 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 as set forth in the 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 Institutional Official of its decisions regarding protocol review.]
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 in accordance with the PHS Policy IV.C.1-4 at least once every three years. The IACUC procedures for conducting continuing reviews are as follows: [Describe the processes the IACUC uses for monitoring of ongoing activities and continuing review of previously approved protocols. Also include a description of the procedures the IACUC uses to conduct a complete review of continuing activities at least every three years.]
10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy IV.C.6. The IACUC procedures for suspending an ongoing activity are as follows: [Describe procedures used by the IACUC to suspend an ongoing activity, as well as procedures used by the Institutional Official to report an IACUC suspension to OLAW.]
Recommended References:
- Model for
Performing Continuing Review of Research Activities, Contemporary Topics,
1996:35(5)53-56
- Frequency of
review
- Annual review
(USDA) vs. triennial review (PHS)
E. The occupational health and safety program for personnel working in laboratory animal facilities or have frequent contact with animals is as follows: [Describe the Institution’s occupational health and safety (OH&S) program for personnel involved in the care and use of animals. The description should be based on the relevant topics listed in the “Guide” for the Care and Use of Laboratory Animals, such as:
Some examples of other relevant topics might include, but not necessarily be limited to, the following: personnel covered, measures to alleviate identified risks, required vaccinations, occupational health and safety training, handling of hazardous agents, and reporting and treating 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 Cercopithecine herpesvirus 1 (Herpes B)).] [NOTE: Please provide a succinct description of the Institution’s occupational health and safety program in this section of the Assurance. Do not reference and/or send attachments.]
Recommended References:
- Institute of Laboratory Animal
Resources Occupational Health and Safety in the Care and Use of Research
Animals, 1997.
- Employee
health issues
F. The total gross number of square feet in each animal facility (including each satellite facility), the species of animals housed therein and the average daily inventory of animals, by species, in each facility is provided in the attached Facility and Species Inventory table. [Please attach the Facilities and Species Inventory sample table, provided.] [Note: Institutions may identify animal areas in any manner, e.g., initials, ID number, etc. in this attachment.]
G. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows: [Provide a synopsis of training or instruction to ensure that people caring for or using laboratory animals are trained and qualified to do so. Describe training or instruction in the humane practice of animal care and use, including 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 how the IACUC members are provided orientation, background materials, resources, and/or training.] [NOTE: Do not reference and/or send attachments.]
Recommended References:
- Training in the
Laboratory Animal Science Community: Strategies to Support Adult Learning.
2007: ILAR Journal 48(2) 75-89.
- Employee
training programs
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 six months and will be re-evaluated by the IACUC at least once every six months thereafter, in accord with the PHS Policy IV.B.1-2. Reports have been and will continue to be prepared in accord with the 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 “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.
[NOTE: From the following two paragraphs, retain one paragraph that is applicable and delete the one that is not applicable.]
This Institution is Category
One (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 ***
This Institution is Category
Two (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. [Please attach the most recent semi-annual program
review and facility inspection report.]
Recommended Reference:
- Sample format
for the semiannual report to the Institutional Official
A. This Institution will maintain for at least three years:
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 three 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.
A. This Institution’s reporting period is [insert “January 1 – December 31”, or another 12 month reporting period]. The IACUC, through the Institutional Official, will submit an annual report to OLAW on [insert “January 31” or the last day of the month following the end of the reporting period] of each year. The report will include:
Recommended Reference:
- Reporting of
modifications to facilities/programs in annual report to OLAW
Recommended References:
- Sample annual report
to OLAW
- 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:
Recommended References:
- Guidance
on prompt reporting, NOT-OD-05-034
- OLAW and APHIS: Common
Areas of Noncompliance, Lab Animal, 2000: 29(5)32-37 (PDF - 65 KB)
- Reporting
sanctions to non-PHS funded activities
- Guidance
on allowable costs, NOT-OD-07-044
C. Reports filed under
sections VI.A. and VI.B. of this document shall include any minority views
filed by members of the IACUC.
VII. INSTITUTIONAL ENDORSEMENT AND PHS APPROVAL
A. Authorized Institutional Official
Name:
Title:
Name of Institution:
Address: [street address, city, state, zip code]
Phone:
Fax:
E-mail:
Signature:
Date:
B. PHS Approving Official
Name:
Title:
Address:
Phone:
Fax:
E-mail:
Signature:
Date:
C. Effective Date of Assurance:
D. Expiration Date of Assurance:
MEMBERSHIP OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEEDATE:
NAME OF INSTITUTION:
ASSURANCE NUMBER:
Chairperson Name, Title, and Degree/Credentials |
Business Address, Phone, Fax, and Email of Chairperson |
Name*: |
Address*: |
Title*: |
Degree/credentials*: |
Phone*: |
Fax*: |
Email*: |
Name of Member/Code** |
Degree/Credentials |
Position Title |
PHS Policy |
*This information is mandatory.
**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.
***PHS Policy Requirements - identify which IACUC members meet the four criteria below:
Notes:
OTHER KEY CONTACTS (OPTIONAL)
If there are other individuals within the Institution who may be contacted regarding this Assurance, please provide information below.
Name:
Title:
Phone & Fax:
E-mail:
Name:
Title:
Phone & Fax:
E-mail:
FACILITY AND SPECIES INVENTORY
DATE:
NAME OF INSTITUTION:
ASSURANCE NUMBER:
Laboratory, Unit, or Building* |
Gross Square Feet (including service areas) |
Species Housed in Unit (use complete common names) |
Approx. Average Daily Inventory |
*Institutions may identify animal areas in any manner, e.g., initials, ID number, etc. However, the name and location must be provided to OLAW upon request.