ABSTRACT
This chapter focuses on an area of research that has been marked by special problems, and it is tempting to think that it illustrates the need of vulnerable populations for special protections. Senator John Glenn was preparing a bill that would extend the central protections provided by the present regulations to all persons including those enrolled in privately sponsored studies. The National Bioethics Advisory agreed that everyone enrolled in research in this country should be afforded the basic protections of independent review and informed, voluntary consent. The advantages of Fletcher's recommendation to establish a National Office of Human Subjects Research are that it would give more visibility to human subjects protection and ensure that the agency was independent of the federal agencies that sponsor research. The disadvantages are primarily political: that in an era of “smaller government,” Congress would be unwilling to create a new agency and that such an agency once created would be vulnerable to pressure.
