The NIH is committed to the compassionate and humane treatment of animals used in NIH research. Studies involving animal research are essential to the incremental advancements of knowledge resulting in better human and animal health. With this commitment to advancing science goes a commitment to ensure animal activities are conducted according to federal regulations and NIH grants policy. In January 2007, NIH issued NOT-OD-07-044 to remind the community that costs for grant activities involving animals cannot be charged to grants or contracts when terms and conditions are not met. The Notice explains that costs for activities with live vertebrate animals may not be charged to NIH unless the institution holds a valid Animal Welfare Assurance and the proposed animal study has been reviewed and approved by the institution’s Institutional Animal Care and Use Committee (IACUC).
What constitutes a valid Assurance?
An Animal Welfare Assurance is an agreement between an institution that receives Public Health Service (PHS) funds and the PHS that the institution will operate its animal program in compliance with the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy). Animal Welfare Assurances are valid after they are reviewed and approved by OLAW and remain valid for a set period, depending on the type of Assurance.
What does IACUC approval mean?
Before conducting an experiment using live vertebrate animals, a PHS-funded investigator must prepare a detailed proposal explaining the reason for the experiment, describing the experimental design and addressing issues of humane care and use of the animal research subjects. This proposal is submitted to the IACUC, which carefully reviews the proposal before granting approval for the research to proceed. IACUC approval can be granted for a period of up to three years. There are several ways that an investigator can fail to have a valid IACUC approval: (1) an initial failure to obtain IACUC approval, (2) working after the IACUC approval expires, or (3) continuing research after the IACUC has suspended the approval for cause.
The NIH has already taken a number of actions since the issuance of NOT-OD-07-044. The Office of Laboratory Animal Welfare (OLAW) has recommended that awardee institutions contact the NIH Institute or Center that funded the research regarding repayment of funds on 51 occasions. The OLAW has also referred 33 institutions to the Notice for educational purposes and has directed 11 institutions to report a suspension of animal activities to the NIH funding component. The financial aspects involved in recovering grant monies rest with the funding Institute or Center. The Office of Policy for Extramural Research Administration and OLAW provide guidance regarding the NIH Grants Policy Statement and PHS Policy.
OLAW provides a variety of educational opportunities to help institutions ensure animal activities are conducted according to federal regulations and NIH grants policy, including the two new on-line seminar series for Institutional Officials and IACUC Staff that are highlighted later in this issue of the Nexus.
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