Adequate preliminary animal research and reported data in pre-clinical trials for acute renal insufficiency: a historic example of scientific-ethical protocol from the 1940s

摘要

The subtle nature of ethical behavior in biomedical practice and clinical application predates formal NIH guidelines. The scientific community had already established standards by the 1940s for the use of animal research prior to the application of treatment to human patients. The example presented for consideration is drawn from the historic development of the first clinical kidney dialysis devices. The story is an example of how the medical research community viewed preliminary animal research as a necessary precursor to application of any new treatment to human patients. In an article written in 1949, 3 MD's criticized the efforts of leaders in the newly emerging area of kidney dialysis for acute renal insufficiency for failure to incorporate lengthy animal studies and for not reporting the high morbidity rate associated with kidney dialysis. This example provides insight to the foundations of modern animal models as a precursor to clinical trials. Further, this historic moment illustrates the tension between the dual forces of conservatism and advancement at work in the medical community.