Federal Regulations and How They Impact on Research

Abstract

Federal regulations govern all areas of both preclinical and clinical research. These rules, proposed and currently enacted, serve to provide guidelines to the investigator for the proper conduct and ultimate acceptance by the federal agencies. It is necessary that all persons involved in research be knowledgeable of the requirements to avoid problems with data acceptance. For the investigator and local institution, this translates into continued financial support. In regard to the pharmaceutical industry, acceptance of data would allow earlier marketing of a new product.