Foreign Grants - Animal Welfare

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Foreign Grants - Animal Welfare

Animal Welfare

The NIH Office of Laboratory Animal Welfare (OLAW) oversees Public Health Service (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).

Applicability to Foreign Institutions

The PHS Policy states: "Institutions in foreign countries receiving PHS support for activities involving animals shall comply with this Policy, or provide evidence to the PHS that acceptable standards for the humane care and use of the animals in PHS-conducted or supported activities will be met."

Foreign Assurance

The PHS Policy requires that institutions have an OLAW-approved Animal Welfare Assurance before conducting activities involving live vertebrate animals. Institutions outside the U.S. that receive PHS funds directly through a grant or contract award will use the Animal Welfare Assurance for Foreign Institutions (Foreign Assurance). The Foreign Assurance also applies to institutions outside the U.S. that receive PHS funds indirectly (as a performance site through a primary institution).

Foreign 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 authorized institutional signing official

The Foreign Assurance commits the institution to:

Comply with the PHS Policy
Follow the International Guiding Principles for Biomedical Research Involving Animals developed by the Council for International Organizations of Medical Sciences (CIOMS)
Comply with all applicable laws, regulations and policies governing animal care and use for their country of jurisdiction

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.

Requirements

Foreign institutions may apply for a Foreign Assurance if either of the following conditions exist:

The institution has submitted a PHS grant application or contract proposal and has received notification from the funding component that the grant or contract will be awarded, or;
The institution is listed as a performance site on a PHS grant or contract, either foreign or domestic, AND award of the grant or contract is imminent.

IACUC approval is not required of foreign grantees; however, OLAW encourages foreign grantees to use the standards in the Guide for the Care and Use of Laboratory Animals (Guide). The Guide is recognized worldwide as a resource for laboratory animal research facilities.

When the grantee is a domestic institution and performance sites are foreign (i.e., domestic grant with a foreign component), PHS Policy requirements are applicable. Accordingly, the prime domestic grantee remains responsible for animal activity conducted at the foreign site and must provide verification of IACUC approval (i.e., certification that the activity as conducted at the foreign performance site is acceptable to the prime grantee). The prime grantee IACUC may accept, as its own, the approval of a foreign organization's IACUC; however, the prime grantee IACUC remains responsible for the review. Additionally, the foreign site must obtain a Foreign Assurance as described above.

Resources

For further guidance and contact information, please see the OLAW homepage at /grants/olaw/olaw.htm.

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