Office of Laboratory Animal Welfare: Obtaining an Assurance
U.S. Department of Health & Human Services Logo
 
Grants and Funding
Grants Policy
Policy & Guidance
Compliance & Oversight
Research Involving Human Subjects
Office of Laboratory Animal Welfare (OLAW)
Animals in Research
Peer Review Policies & Practices
Intellectual Property Policy
Acknowledging NIH Funding
Invention Reporting (iEdison)
NIH Public Access
Research Integrity
Office of Laboratory Animal Welfare
Obtaining an Assurance

The following resources are provided to assist Public Health Service (PHS) awardee institutions in obtaining an Animal Welfare Assurance (Assurance).

Introduction

OLAW oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The PHS Policy, section IV.A., requires that:

“No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with the Policy.”

Criteria for Obtaining an Assurance

Institutions must have an Assurance on file with OLAW to receive PHS funding. If the institution does not have a valid Assurance, the funding component will ask OLAW to negotiate an Assurance before the grant, contract or cooperative agreement is awarded.

Sometimes an institution receives PHS funds and chooses to conduct the animal activities at a secondary institution(s). Activities subcontracted or subgranted to the secondary institution(s) are funded through a mechanism referred to as indirect funding. In this case, the secondary institution(s) must be named as a performance site by the prime awardee institution. After approving the performance site, the funding component will contact OLAW to negotiate an Assurance with the secondary institution(s).

OLAW assures PHS-funded animal activities. PHS funding components include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). OLAW does not oversee animal activities funded by the National Science Foundation (NSF), the Department of Defense (DoD), the U.S. Department of Agriculture (USDA), and non-profit or for-profit organizations. 

Process of Obtaining an Assurance

  • The PHS funding component notifies the institution of a pending grant or contract award (Notice of Award).
  • If the awardee institution does not already have an Assurance, the funding component notifies OLAW that an Assurance is required.
  • OLAW contacts the institution to negotiate an Assurance. Note: OLAW does not accept or process unsolicited applications.
  • The institution prepares an Assurance document and submits it to OLAW.
  • OLAW negotiates with the institution until the Assurance document meets the standards of the PHS Policy. Note: the institution may propose a program that exceeds the standards of the PHS Policy. After OLAW approves the Assurance document, the institution will be required to meet the standards they have proposed.
  • OLAW notifies the institution and funding component that an Assurance has been approved. The approval period will be for a specified time. Domestic Assurances are approved for a period of up to 4 years. Interinstitutional Assurances are approved for the life of the grant/contract up to 5 years. Foreign Assurances are approved for a period of up to 5 years.
  • Assured institutions are listed on the OLAW website under Fast Facts:

Three Types of Assurances

Domestic Assurance

The Domestic Assurance is required for U.S. institutions that receive PHS funds through a grant or contract award. Domestic Assurances are approved for a period of up to 4 years.

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)
    • a veterinarian with program authority and access to all animals

This Assurance is not to be used by:

  • Foreign institutions
  • Institutions that do not have their own animal care and use program
  • Institutions proposing to conduct an animal activity solely at a secondary institution(s)

Elements of the Assurance include:

  • 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

See also:

Interinstitutional Assurance

The Interinstitutional Assurance is required when the awardee institution does not have its own:

  • animal care and use program
  • facilities to house animals
  • IACUC; and
  • does not conduct animal research on-site.

The institution will perform the animal activity at a secondary Assured institution(s) named as the performance site.

Requirements of the Interinstitutional Assurance:

  • Statement of applicability and institutional responsibilities
  • Endorsement of awardee institution
  • Endorsement of Assured institution

Interinstitutional Assurances are approved for the life of the grant/contract up to 5 years.

See also, sample Interinstitutional Assurance.

Foreign Assurance

The Foreign Assurance is required for institutions outside the U.S. that receive PHS funds directly through a grant or contract award. The Foreign Assurance also applies to institutions outside the U.S. that receive PHS funds indirectly (named as a performance site by a primary awardee institution).

Foreign Assurances are approved for a period of up to 5 years. Foreign Assurances will be renewed only if the institution continues to receive PHS funds, either directly or indirectly.

The foreign institution must provide:

  • Components of the institution that will be covered by the Assurance
  • Commitment to the Council for International Organizations of Medical Sciences (CIOMS) International Guiding Principles for Biomedical Research Involving Animals and listing, in English, of all other applicable laws, regulations or policies governing animal care and use for the country of jurisdiction
  • Institutional endorsement

See also:

Assurance Renewal

The process for renewing an Assurance is similar to the process of obtaining a new Assurance. Your institution will receive a reminder letter prior to the expiration date with instructions for submitting a renewal. Note: Foreign Assurances will be renewed only if the institution continues to receive PHS funds, either directly or indirectly. OLAW requests institutions to submit the Domestic Assurance renewal document 4 months prior to the expiration date to allow time for review. It is important to submit the renewal documents promptly because the institution may not accept funds for animal activities unless the institution has a valid Assurance on file with OLAW (PHS Policy, section V.B.).

Report Program Changes

Changes that occur in an institution’s animal care and use program after the Assurance is approved but before it is renewed, should be described in the next annual report to OLAW. However, a change in the IO or IACUC chair should be forwarded to OLAW immediately because OLAW communicates with the institution through the IO and the IACUC chair.

Submit Assurance

Submit Assurance and program changes to OLAW by fax to 301-451-5672 or e-mail to olawdoa@mail.nih.gov.

Additional References

  • Animal Welfare Assurances - this section of the Topic Index provides additional guidance on Assurances found in Commentaries, Articles, FAQs, and NIH Guide Notices.
  • Writing a Good Assurance - this OLAW IACUC Staff Online Seminar, broadcast on June 9, 2011, discusses the parts of the Assurance and what is required in each section.
  • Sample Documents - sample Assurance documents and other sample documents can be found on this webpage.

Questions?

Telephone (301-496-7163) or e-mail (olawdoa@mail.nih.gov) the Division of Assurances for answers to your questions.

Division of Assurances

Phone: 301-496-7163
E-mail: olawdoa@mail.nih.gov
Fax: 301-451-5672

Mailing Address:

Division of Assurances
Office of Laboratory Animal Welfare
National Institutes of Health
Rockledge 1, Suite 360
6705 Rockledge Drive
Bethesda, MD 20892-7982

[20817 zip code for mail delivery service]



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.


This page last updated on January 11, 2012
Content Manager: olaw@od.nih.gov
Technical Issues: E-mail OER Webmaster

Social Media Links