NMU's Compliance Database - Northern Michigan University

A Compliance Attestation for Animal Welfare Assurance is a formal contract and institutional commitment between a research institution and the federal government that's required by U.S. funding agencies (like the PHS, NSF, or NASA) ensuring that any research, testing, or training involving live vertebrate animals complies with the Animal Welfare Act and ethical care standards. It outlines and commits the institution to proper standards for the humane care and use of live vertebrate animals in research. 

Core Components

• Institutional Responsibility: The organization accepts full accountability for animal care, health, and compliance.
• Oversight Committee: Requires an active Institutional Animal Care and Use Committee (IACUC) to review protocols.
• Veterinary Authority: A designated attending veterinarian must have direct program authority and access to all animals.
• Guiding Standards: Operations must follow the Guide for the Care and Use of Laboratory Animals.

Key Requirements

• Valid Assurance Number: Filed and approved via the NIH Office of Laboratory Animal Welfare (OLAW).
• Annual Reporting: Institutions must submit yearly updates on program changes or protocol modifications.
• Subaward Verification: Prime recipients must ensure all subcontractors also hold active animal welfare assurances

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.
 

REFERENCES:

• Animal Welfare Act Quick Reference Guides
• Requirements for Annual Report to OLAW
• Animal Welfare Audit and Certification Programs
• Domestic Assurance Sample Document