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Who largely handles the administrative safeguards in a facility?

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Final answer:

Administrative safeguards in facilities utilizing animals for research are managed by the Institutional Animal Care and Use Committee (IACUC), while for research involving human participants, the Institutional Review Board (IRB) is responsible. The Office of Regulatory Affairs (ORA) oversees inspections and regulatory compliance for the FDA.

Step-by-step explanation:

In facilities that use animals for research and receive federal funding, the Institutional Animal Care and Use Committee (IACUC) is primarily responsible for handling administrative safeguards. This committee, mandated to follow the National Institutes of Health (NIH) guidelines, includes researchers, administrators, a veterinarian, and at least one member who is a concerned citizen with no ties to the institution. The IACUC conducts regular inspections of laboratories and reviews protocols to ensure compliance. For studies involving human participants, the Institutional Review Board (IRB) fulfills a similar role, making sure that research protocols adhere to established ethical guidelines and regulations.

Moreover, within the broader scope of facilities, the Office of Regulatory Affairs (ORA) functions as the 'eyes and ears' of the Food and Drug Administration (FDA), carrying out inspections and investigations related to consumer safety. The ORA enforces regulations across a wide array of products, including medical devices and pharmaceuticals.

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