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The Domestic Assurance is required for U.S. institutions that conduct live, vertebrate animal work onsite for PHS, NSF, or NASA-funded or supported animal activities.
Domestic Assurance
The Domestic Assurance is required for U.S. institutions that conduct live, vertebrate animal work onsite for PHS, NSF, or NASA-funded or supported animal activities. Domestic Assurances are approved for a period of up to 4 years and will be renewed only if the institution continues to conduct live, vertebrate animal work onsite for PHS, NSF, or NASA-funded or supported animal activities.
Domestic Assurances are negotiated with institutions that:
- Control their own animal facilities
- Conduct animal research on-site
- Have an animal care and use program with an Institutional Official (IO), an Institutional Animal Care and Use Committee (IACUC), and a veterinarian with program authority and access to all animals
This Assurance form is not to be used by foreign institutions, institutions that do not have their own animal care and use program, or institutions proposing to conduct an animal activity solely at one or more secondary institutions.
Basic Elements of the Assurance
The following are the basic tenets that should be addressed in every Assurance. The Assurance form provides prompts for each of these areas.
- Facilities and components of the institution that will be covered by the Assurance
- Institutional commitment to the Animal Welfare Act, the U.S. Government Principles and the Guide for the Care and Use of Laboratory Animals
- Description of program for animal care and use
- Program evaluation and accreditation
- Recordkeeping
- Reporting to OLAW
- Institutional endorsement
- Membership of the IACUC
- Facility and species inventory
Format, Submission, and Reporting
Writing Your Assurance Document
Institutions that meet the criteria for a Domestic Assurance must download and use the Domestic Assurance form to describe their program of animal care and use. Specific instructions, information, and recommended references are provided in the italicized text and should be deleted from the final document. Submissions should be clear and concise, should utilize the section headings, and retain the numbering and format included on the form.
One or two page attachments can be used to provide the following:
- Organizational structure for the animal care and use program
- IACUC membership roster
- Facility and Species inventory
Category 1 institutions that are accredited by AAALAC International have the option to incorporate portions of the Program Description in applicable parts of the Domestic Assurance document as described in Using AAALAC Program Description Sections in the OLAW Domestic Assurance.
Category 2 institutions (those not accredited by AAALAC International) must provide the most recent Semiannual Report to the IO with the completed Assurance. The Semiannual Report to the IO may be provided as a separate file and should include all PHS Policy-required components as described in PHS Policy IV.B.3.c-e and Section III.D.3. of the Assurance document. OLAW highly recommends the use of the sample document Semiannual Report to the IO.
Tips to Facilitate Review
Here are some helpful tips to help speed up the review process. However, this list is not intended to provide an exhaustive overview of all possible revision requests; as every institution is unique, always follow the guidance of your Assurance reviewer.
Tip 02: Review the PHS Policy and OLAW FAQs While Drafting Your Assurance
Tip 03: Account for Everyone
Tip 04: Ensure that the Assurance Reflects Your Unique Program
Tip 05: Completely But Succinctly Describe Your Program
Tip 06: Update the IACUC Roster, Key Contacts, and Facility Inventory
Tip 07: Respond Promptly
Using AAALAC Program Description Sections in the OLAW Domestic Assurance
Institutions have the option to incorporate the following AAALAC PD sections into their Assurance:
For the Assurance Part III.D.9. Describe how the IACUC monitors ongoing activities (post-approval monitoring).
AAALAC PD Section 2.I.B.2. Post-Approval Monitoring:
e. Describe any other monitoring mechanisms or procedures used to facilitate ongoing protocol assessment and compliance, if applicable (PD pg. 19).
For the Assurance Part III.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.]
AAALAC PD Section 2.I.A.2.b. Occupational Health and Safety of Personnel:
ii.1) a) Describe who receives personal medical evaluation as a component of individual risk assessment (PD pg. 8).
ii.1) d) Describe safety considerations for individuals with incidental exposure to animal care and use (e.g., contractors; PD pg. 8).
ii.1) e) Describe general features of the medical evaluation and preventive medicine programs within the context of work duties including: pre-employment/pre-assignment health evaluation, medical evaluations, diagnostic tests (e.g., for tuberculosis), precautions for working with potentially hazardous species, and immunization programs (PD pg. 8).
ii.2) Describe general educational program(s) to inform personnel about: allergies, zoonoses, personal hygiene, physical injuries in animal facilities, or species used (e.g., nonhuman primates). Include in the description a summary of the topics covered, including entities responsible for providing the training (PD pg. 9).
ii.3) a) List routine personal protective equipment and work clothing provided and/or required for animal care personnel, research, and technical staff (PD pg. 9).
ii.3) c) Describe provisions and expected practices for washing hands, showering, and changing clothes (PD pg. 9).
ii.3) d) Describe policies regarding eating, drinking, and smoking in animal facilities (PD pg. 10).
For the Assurance Part III.G. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use.
AAALAC PD Section 2.I.A.2.a. Training, Education, and Continuing Educational Opportunities:
ii. 2) For Animal Care Personnel, summarize training and continuing education opportunities provided (PD pg. 5). [There is no requirement to include animal care personnel certification levels, type, and experience in the Assurance document.]
iii.1) a) For the Research Team, briefly describe the content of any required training (PD pg. 6).
iii.1) c) For the Research Team, describe continuing education opportunities offered (PD pg. 6).
AAALAC PD, Section 2.I.B.1. The Role of the IACUC:
a. iii. Describe the orientation, training, and continuing education opportunities for IACUC members (PD pg. 14).
Submitting Your Assurance Document
After your institution has received a request from OLAW to submit an Assurance, send your completed document via e-mail to [email protected]
Institutions should not submit an Assurance unless requested to do so by OLAW. OLAW will not process unsolicited applications. If your institution has received confirmation that proposed animal activities will be funded by the PHS, NSF, or NASA AND have not been contacted by OLAW, you may submit an inquiry by e-mail to [email protected]. Include the award number, name of the prime awardee institution (recipient), and contact information of the funding component (e.g., grants or contracts specialist) in the e-mail.
Reporting Changes and the Annual Report
Changes that occur in an institution’s animal care and use program after the Assurance is approved should be described in the next Annual Report to OLAW. However, a change in the IO, IACUC Chair, or Assurance Contacts should be forwarded to OLAW immediately because OLAW communicates with the institution through these individuals.
The annual reporting period is the federal fiscal year, October 1 to September 30, with the annual report due on or before December 1 (but no earlier than September 30)
See Annual Report Instructions
Assured Institutions Look Up Tool
Find out if your institution has an approved Domestic or Foreign Assurance using our Assured Institutions Look Up Tool.