The PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) mandates that an approved Animal Welfare Assurance must be on file with the Office of Laboratory Animal Welfare (OLAW) at the time of award for all grantee organizations receiving PHS support to conduct research using live vertebrate animals. The PHS Policy requires grantee organizations to establish appropriate policies and procedures to ensure the humane care and use of animals. The PHS Policy stipulates that the grantee organization, whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS supported research activities. This policy incorporates the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training and requires that institutions base their animal care and use programs on the Guide for the Care and Use of Laboratory Animals. This policy does not supersede state or local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply with the applicable regulations (9 CFR, Subchapter A) issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act, and other federal statutes and regulations relating to animals. These documents are available from the Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301) 496-7163 (http://grants.nih.gov/grants/olaw/olaw.htm).
The PHS Policy defines animal as any live vertebrate animal used or intended for use in research, research training, experimentation or biological testing or for related purposes. The generation of custom antibodies constitutes an activity involving vertebrate animals.
In addition to an OLAW-approved Animal Welfare Assurance, the grantee organization must provide verification that the IACUC has reviewed and approved the proposed activity. IACUC approval must have been granted within three years to be valid. IACUCs are not authorized to administratively extend approval beyond three years. Verification of IACUC approval is requested under Just-in-Time policy (prior to award) (see 1.7). Foreign grantees receiving direct support are not required to provide IACUC approval, but must have an approved Animal Welfare Assurance for Foreign Institutions (Foreign Assurance). See a sample Foreign Assurance at: http://grants.nih.gov/grants/olaw/sampledoc/foreign.htm.
Under consortium (subaward) agreements in which the grantee collaborates with one or more other organizations, the grantee, as the direct and primary recipient of NIH grant funds, is accountable for the performance of the project, the appropriate expenditure of grant funds by all parties, and all other obligations of the grantee as specified in the NIHGPS (See NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements). The animal welfare requirements that apply to grantees also apply to consortium participants and subprojects. The prime grantee is responsible for including these requirements in its agreements with collaborating organizations, and for ensuring that all sites engaged in research involving the use of live vertebrate animals have an approved Animal Welfare Assurance and that the activity has a valid IACUC approval.
If the prime grantee does not have an Animal Welfare Assurance and the animal work will be conducted at an institution with an Animal Welfare Assurance, the grantee must obtain an Inter-institutional Assurance from OLAW. When the grantee is a domestic institution and there is a foreign Project/Performance Site using animals, the grantee must ensure that the Project/Performance Site has an approved Animal Welfare Assurance and must provide verification of IACUC approval by the domestic grantee’s IACUC. This is to certify to NIH that the activity as conducted at the foreign Project/Performance Site is acceptable to the grantee organization. Foreign applicant organizations applying for PHS awards for activities involving vertebrate animals must comply with the Council for International Organizations of Medical Sciences’ International Guiding Principles for Biomedical Research Involving Laboratory Animals (http://cioms.ch/publications/guidelines/1985_texts_of_guidelines.htm) and all laws, regulations and policies governing the care and use of laboratory animals in the jurisdiction in which the research will be conducted.
For additional details regarding completion of the Vertebrate Animals Section of the Research Plan, see, NIH Guide Notice NOT-OD-10-027 and http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
2.3 Debarment and Suspension
Executive Order 12549, “Debarment and Suspension,” mandated development of a Government-wide debarment and suspension system for nonprocurement transactions with Federal agencies. Executive Order 12689 and Section 2455 of the Federal Acquisition Streamlining Act of 1994 further required Federal agencies to establish regulations for reciprocal Government-wide effect across procurement and nonprocurement debarment and suspension actions. This reciprocity rule is effective for any debarment, suspension or other Government-wide exclusion initiated on or after August 25, 1995.
DHHS regulations implementing Executive Orders 12549 and 12689 and Section 2455 of the Federal Acquisition Regulation are provided in 2 CFR 180 and 376, “Government-wide Debarment and Suspension (Nonprocurement).” Changes in this Government-wide requirement implement this as a term and condition of an award.
DHHS regulations implementing the Drug-Free Workplace Act of 1988 (Public Law 100-690, Title V, Subtitle D) are now provided in 45 CFR 82, “Government-wide Requirements for Drug-Free Workplace (Financial Assistance).” Changes in this Government-wide requirement (adopted in the November 26, 2003 Federal Register Notice) now implement this as a term and condition of an award.