Protection of Human Research Subjects (PDF)

Regulations on human subjects research have evolved over a 20-year period and now provide a formal set of requirements for the conduct of federally sponsored studies. Over time, government regulations, like taboos in primitive societies, develop a life of their own, seemingly dissociated from their origins and justifica­ tions. When the investigator suffers the burdens of trying to comply with com­ plex rules, it is easy for him or her to lapse into a frustration that can be eased by being informed or reminded of why the rules were created in the first place and what they were designed to accomplish. Dennis Maloney's work provides a handy historical record of the processes by which the regulations were created and modified. He also recounts his own experience with research at Boys Town and provides instructions on how to cope with the system. It is difficult to find in one place the current status and appropriate citations for regulations as well as the contacts and know-how to obtain more information on the subject. In this respect, by providing a history and guide to interpretation and compliance, "Protection of Human Subjects" is a reference of importance and utility to the investigator entering into or working in the field of biomedical or behavioral research involving human subjects.