Most of the scientific methods relating to human drug testing are undergoing orderly change. Animal testing of toxicity, evaluation of human therapeutic effects, statistical analysis, monitoring of improvement in disease, and design of human studies have changed in progressive steps that appeared slow and appropriate to those who lived through these changes but are dramatic when the changes are looked at in brief review. All of these changes result in better standards of laboratory and human testing such that what was commonplace and accepted even ten years ago is no longer up to the standard of today. Regulations, on the other hand, have usually changed abruptly in response to one or more seminal issues arising from abuse of the public. This introductory chapter will trace the development of the ethical and regulatory concepts that have influenced and controlled current research practices to provide a framework that the new investigator or research administrator may find useful in interpreting this work.
KeywordsInterstate Commerce United States Public Health Service Federal Regulatory Agency Current Research Practice Traditional Health Care System
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