What is the approval requirement for research involving animals under U.S. federal regulations?

The requirement for research involving animals under U.S. federal regulations is that the protocol must be approved by the Institutional Animal Care and Use Committee (IACUC) before the project can begin. This is crucial because the IACUC’s primary role is to ensure the ethical and humane treatment of animals in research. They assess the proposed research protocol to ensure that it complies with all applicable federal laws and regulations, including considerations of animal welfare and the ethical justification for the use of animals in research.

The requirement for prior approval serves to protect both the animals used in research and the research integrity. Without this approval, researchers may not have fully considered the potential impacts of their studies on animal welfare, and thus the validity and ethical foundation of their research could be compromised. Ensuring that IACUC review occurs before the commencement of the project underscores the importance of oversight in promoting responsible conduct in research involving animals.