What are considered "significant changes" that require a review of an amendment?

Significant changes that require a review of an amendment include alterations in study objectives, species involved, and other substantial modifications that could impact the research or the welfare of the animals involved. When the fundamental aims of a study are adjusted or when new species are introduced, this can alter the ethical considerations, regulatory compliance, and overall structure of the study.

Amendments that affect the core aspects of the research protocol necessitate a thorough review to ensure that all ethical guidelines and regulatory requirements are being met. This process helps to safeguard animal welfare and ensures that the research continues to comply with institutional policies and federal regulations. Changes in study objectives and species are critical because they can provide a completely different context and justification for the research, potentially influencing outcomes and the ethical implications involved in the work.