Policy on Humane Care and use of Laboratory Animals Sample Clauses

Policy on Humane Care and use of Laboratory Animals. Before award and then with the annual progress report, the Contractor must submit to BARDA a copy of the current Institutional Animal Care and Use Committees (IACUC) documentation of continuing review and approval and the Office of Laboratory Animal Welfare (OLAW) federal wide assurance number for the institution or site. If other institutions are involved in the research (e.g., a multicenter trial or study), each institution’s IACUC must review and approve the protocol. They must also provide BARDA initial and annual documentation of continuing review and approval and federal wide assurance number. The Contractor must ensure that the application, as well as all protocols, are reviewed by the performing institution’s IACUC. To help ensure the safety of animals used in BARDA-funded studies, the Contractor must provide BARDA copies of documents related to all major changes in the status of ongoing protocols, including the following: • All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid. • All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if applicable). • Termination or temporary suspension of the study(ies) for regulatory issues. • Termination or temporary suspension of the protocol. • Any change that is made in the specific IACUC approval for the indicated study(ies). • Any other problems or issues that could affect the scientific integrity of the study(ies), i.e., fraud, misrepresentation, misappropriation of funds, etc. Contractor must notify BARDA of any of the above changes within five (5) working days from the time the Contractor becomes aware of such changes by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IACUC and a copy of any responses from the IACUC. If a non-clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
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Policy on Humane Care and use of Laboratory Animals. 2. Investigators are responsible for checking their breeding colonies frequently and recording the date of birth (DOB) for new pups.
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