Statutory Imposed Terms of Stress, Distress, Well-Being and Animal Welfare: Suggested Guidelines for Humane Endpoints in Animal Studies

Bad terminology is the enemy of good science. The US Congress passed the “Plain Writing Act of 2010” that required all federal agencies to use clear and concise language that the general public can understand and use. However, the Animal Welfare Act [1] and Good Laboratory Practice Guidelines [2] were written well before the enactment of the Plain Writing Act.The Study Director (SD) must strike a balance between the best interests of the client, contract research organization (CRO), veterinary staff, regulatory reviewers, as well as the animals in an effort to comply with guidance documents and regulations that are filled with poorly-defined terminology.Poorly chosen, legally ill-defined terms such as “well-being”, “welfare”, “distress”, and “anxiety” lead to confusion and discord during the nonclinical development of a drug.US civil courts have been struggling with these terms for years when defining damages in human personal injury cases; so it is not surprising the level of uncertainty that exists when applying these terms to animal research. Science is value-laden: it values ethical standards of conduct, objectively verifiable and legally defensible data, as well as clear and concise language in reporting the results. Three “seasoned” Study Directors with cumulative regulatory research history of >60 years and cumulative experiences on an Institutional Animal Care and Use Committee (IACUC) of > 20 years provide a view of the current research climate and propose some sound, legally-defensible processes in this balancing act required for drug development.