Abstract

The U.S. regulations for the protection of humans in biomedical and behavioral research were "born in scandal and reared in protectionism." This paper discusses the evolution of these regulations and the gaps that still persist in the ongoing effort to strike a balance between protecting vulnerable populations from research risks and providing all individuals and groups with an equal opportunity to benefit from research. In particular, this paper focuses on racial, social, and economic inequities in the selection of research participants; the exclusion and underrepresentation of the elderly in research, and controversies about U.S. clinical trials conducted in developing countries.