OMB
Number 0925-0765
Expiration Date: 11/30/2022
Animal Welfare Assurance for Domestic Institutions
[Insert name of institution, e.g., Research University]
[Insert Assurance number(s) if this is a renewal, e.g., D16-00000 and/or A3000-01.
For new Assurances, a number will be assigned at approval.]
I, [Insert name of Institutional Official], as named Institutional Official for animal care and use at [Insert 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).
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, HHS (Department of Health and Human Services), and NSF (National Science Foundation). This Assurance covers only those facilities and components listed below.
[Note: only those entities listed in this section will be entitled to use the Assurance number for grant and contract submissions to PHS agencies.]
A. This Institution:
Name(s) of this Institution used in grant applications and contract proposals for awards:
[List every named entity covered by the Assurance.]
2) Branches and components over which this Institution has legal authority including those that operate under a different name:
[List every branch and major component covered by the Assurance; include any administrative descriptor, e.g., School of Public Health, School of Nursing, Division of Health Sciences.]
B. Institution(s) or branches and components of another institution:
[List the name and address of other institutions, or branches and components of other institutions – must be recipients of PHS funding or pending PHS award – or indicate NONE.]
Recommended References:
This Institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
This Institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
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:
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 References:
Use of the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. PHS Policy mandates that institutions use the Guide as a basis for developing and implementing a program for activities involving animals. The Guide (page 32) states that it “…applies to agricultural animals used in biomedical research, including those maintained in typical farm settings.” The Agricultural Guide may be used as a supplement to the Guide.
Nontraditional species guidelines may be used as a supplement to the Guide.
Applicability to animal research that is conducted in the field. Studies with the potential to impact the health or safety of personnel (Guide, page 18) or the animal’s environment may need Institutional Animal Care and Use Committee (IACUC) oversight, even if described as purely observational or behavioral. When capture, handling, confinement, transportation, anesthesia, euthanasia, or invasive procedures are involved, the IACUC must ensure that proposed studies are in accord with the Guide (page 32).
This Institution will ensure that methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, unless a deviation is justified for scientific reasons in writing by the investigator and reviewed and approved by the Institutional Animal Care and Use Committee (IACUC).
This Institution will 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 IACUC approval. Institutional collaborations will have a formal written understanding between participating institutions that address the responsibility for offsite animal care and use, animal ownership, and IACUC review and oversight.
Recommended Reference:
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
institutional 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:
The qualifications, authority, and percent of time contributed by the veterinarian(s) who participate in the program are listed below. For emergency veterinary care, the veterinarian has the authority, delegated by senior administration, the Institutional Official, and the IACUC, to treat the animal, remove it from the experiment, institute appropriate measures to relieve severe pain or distress or perform euthanasia if necessary.
Institutional veterinarian: [Enter institutional veterinarian’s name]
Qualifications:
Degrees: [Provide professional degrees and name of AVMA-accredited veterinary school attended (or indicate Educational Commission for Foreign Veterinary Graduates (ECFVG) or Program for the Assessment of Veterinary Education Equivalence (PAVE) certification and North American Veterinary Licensing Examination (NAVLE) pass date).]
Training or experience in laboratory animal medicine or in the use of the species at the Institution: [Briefly describe the veterinarian’s training or experience in laboratory animal science and medicine or with the species housed. Do not include or attach a CV.
Note: all veterinarians providing unsupervised care should satisfy the requirements of the definition of attending veterinarian as described by the USDA Animal Welfare Regulations: (1) graduated from a veterinary school accredited by the AVMA Council on Education; (2) certified by the AVMA ECFVG or PAVE and NAVLE pass date; or (3) received equivalent formal education as determined by the Administrator.]
Authority: Dr. [Insert 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.]
Other program veterinarians and back-up veterinarians: [Enter veterinarian’s name – complete this section for all other veterinarians providing unsupervised care.]
Qualifications:
Degrees: [Provide professional degrees and name of AVMA-accredited veterinary school attended (or indicate ECFVG or PAVE certification and NAVLE pass date).]
Training or experience in laboratory animal medicine or in the use of the species at the Institution: [Briefly describe the veterinarian’s training or experience in laboratory animal science and medicine or with the species housed. Do not include or attach a CV.
Note: all veterinarians providing unsupervised care should satisfy the requirements of the definition of attending veterinarian as described by the USDA Animal Welfare Regulations: (1) graduated from a veterinary school accredited by the AVMA Council on Education; (2) certified by the AVMA ECFVG or PAVE and NAVLE pass date; or (3) received equivalent formal education as determined by the Administrator.]
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.]
Responsible individual: [If the institutional veterinarian listed above is a part-time veterinarian, then enter the name and title of the individual with assigned responsibility for daily animal care and use and facility management.]
Recommended References:
Program for the Assessment of Veterinary Education Equivalence (PAVE)
USDA Animal Welfare Regulations, Title 9, Chapter 1, Subchapter A, Part 1.1 Definitions.
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, professions, titles or specialties, and institutional affiliations.
[Complete the IACUC membership table provided (see Part VIII.).
Note: for nonaffiliated members, list specific position titles or occupational background (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:
The IACUC will:
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 or other aid is used.]
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 or other aid is used.]
Recommended References:
Prepare reports of the IACUC evaluations according to PHS Policy IV.B.3. and submit the reports to the Institutional Official. Reports are signed by a majority of members as required by USDA Animal Welfare Regulations (§2.31(c)(3)), if applicable. 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 Institution’s 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 and responsible individual
Minority views]
Recommended References:
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 and how displayed (e.g., posting in the facility, posting on institutional websites)
How the IACUC reviews reported concerns
How the IACUC reports concerns and relates findings and recommendations to the Institutional Official
Mechanism for anonymity
Compliance with whistleblower policies and nondiscrimination against the concerned/reporting party
Protection from reprisals]
Recommended Reference:
Guide, pages 23-24
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.]
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.
To approve proposed research projects the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed projects are in accordance with the PHS Policy. The IACUC shall determine that the research project conforms with the Institution’s Assurance and meets the following requirements:
Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
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 justified for scientific reasons in writing by the investigator.
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.
The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The 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.
Medical care for animals will be available and provided as necessary by a qualified veterinarian.
Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.
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:
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:
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 Institutional Official of its decisions regarding protocol review.
Describe what happens if the IACUC withholds approval.]
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:
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 Institutional Official reports an IACUC suspension to OLAW.]
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 all 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 and ongoing process for identification and 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:
Guide, pages 17-23
Occupational Health and Safety in the Care and Use of Research Animals, 1997
OLAW Online Seminar: “Occupational Health and Safety Programs”
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.]
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 practice of animal care and use.
Describe training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal pain and distress.
Describe training or orientation, and ongoing training opportunities provided to the IACUC members, including background materials and resources.
Describe how the IACUC evaluates the effectiveness of the training program.
Describe continuing education programs to reinforce training and provide updates to reflect changing technology.
Note: do not reference or send attachments.]
Recommended References:
Guide, pages 15-17
Training in the Laboratory Animal Science Community: Strategies to Support Adult Learning, 2007
I, [Insert name of Institutional Official], as named Institutional Official assure that the animal program has a facilities disaster plan that defines the actions necessary to prevent animal pain, distress, and death due to loss of systems including those that control ventilation, cooling, heating, and provision of potable water. The plan includes provisions to:
preserve animals that are necessary for critical research activities or irreplaceable;
humanely euthanize animals that cannot be relocated or protected from the disaster;
identify and train essential personnel in advance;
ensure that emergency contact information is accessible to security and emergency personnel;
ensure that emergency procedures are posted; and
consider the safety of personnel and animals.
Recommended Reference:
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 OLAW upon request.
[From the following two paragraphs, retain the one that is applicable and delete the one that is not applicable.]
[***OR ***]
Recommended Reference:
This Institution will maintain for at least 3 years:
A copy of this Assurance and any modifications made to it, as approved by the PHS
Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations
Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was granted or withheld
Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to [Insert name or title of Institutional Official]
Records of accrediting body determinations (i.e., AAALAC accreditation).
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.
All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.
The institutional reporting period is the federal fiscal year (October 1 – September 30). The IACUC, through the Institutional Official, will submit an annual report to OLAW after September 30, but on or before December 1 of each year. The annual report will include:
Any change in the accreditation status of the Institution (e.g., if the Institution obtains accreditation by AAALAC or AAALAC accreditation is revoked)
Any change in the description of the Institution's program for animal care and use as described in this Assurance
Any change in the IACUC membership
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 Institutional Official]
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:
The IACUC, through the Institutional Official, will promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:
Any serious or continuing noncompliance with the PHS Policy
Any serious deviations from the provisions of the Guide
Any suspension of an activity by the IACUC
Recommended References:
Reports filed under VI.A. and VI.B. above will include any minority views filed by members of the IACUC.
A. Authorized Institutional Official |
|
Name: |
|
Title: |
Degree/Credentials: |
Name of Institution: |
|
Address: [street, city, state, zip code]
|
|
Phone: |
Fax: |
E-mail: |
|
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. |
|
Signature:
|
Date:
|
B. PHS Approving Official [to be completed by OLAW] |
|
Name/Title: Office of Laboratory Animal Welfare (OLAW) National Institutes of Health Bethesda, Maryland Phone: +1 (301) 496-7163 Fax: +1 (301) 451-5672 |
|
Signature:
|
Date: |
Assurance Number: |
|
Effective Date: |
Expiration Date: |
Date: |
|
||||
Name of Institution: |
|
||||
Assurance Number: |
|
||||
IACUC Contact Information* |
|||||
Address: [street, city, state, zip code]
|
|||||
E-mail: |
|||||
Phone: |
Fax: |
||||
IACUC Chairperson |
|||||
Name: |
|||||
Title: |
Degree/Credentials: |
||||
PHS Policy Membership Requirements****: |
|||||
IACUC Roster |
|
||||
Name of Member/ Code** |
Degree/ Credentials |
Position Title/ Occupational Background*** |
PHS Policy Membership Requirements**** |
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
* This information is mandatory. Provide the contact information of the office or individual responsible for IACUC business. This contact information may be released under the Federal Freedom of Information Act, if requested.
|
|
** 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.
|
|
*** List specific position titles for all members, including nonaffiliated (e.g., banker, teacher, volunteer fireman; not “community member” or “retired”).
|
|
**** PHS Policy Membership Requirements: |
|
Veterinarian |
veterinarian as defined in Part III.B. 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. |
Scientist |
practicing scientist experienced in research involving animals. |
Nonscientist |
member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy). |
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 or former user. A consulting veterinarian may not be considered nonaffiliated. |
[Note: all members must be appointed by the Chief Executive Officer (or individual with specific written delegation to appoint members) and must be voting members. Non-voting members and alternate members must be so identified.] |
|
If there are other individuals within the institution who may be contacted regarding this Assurance, please provide information below.
Contact #1 |
|
Name: |
|
Title: |
|
Phone: |
E-mail: |
Contact #2 |
|
Name: |
|
Title: |
|
Phone: |
E-mail: |
Date: |
|||
Name of Institution: |
|||
Assurance Number: |
|||
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* 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.
Statement of Burden
Public reporting burden for this collection of information is estimated to vary from 26 to 30 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0765). Do not return the completed form to this address.
Domestic
Assurance v02/05/2020
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Domestic Assurance sample document |
| Author | NIH/OD/OER/OLAW |
| File Modified | 0000-00-00 |
| File Created | 2021-01-14 |