Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act…

The United States is a world leader in biomedical clinical research. America's existing human subject research regulations structure affords sizable protections for the ethical treatment of research volunteers. Early initiatives such as the Belmont Report were specific to federally funded research. Over the past several decades guidelines such as…

This year the world commemorates the beginning of the tragic USPHS syphilis experiments that occurred in Tuskegee, Alabama from 1932 to 1972. In light of this sobering anniversary, this article will briefly examine four studies: the already mentioned USPHS syphilis studies in Tuskegee, the Nazi Holocaust Experiments and the resulting Doctors'…

During the course of the last century, a number of historical instances of unethical human research have occurred, and risen to the forefront of the social imagination. The atrocities of the European and Pacific Holocausts, the tragic 1932-1972 United States Public Health Service Syphilis Studies at Tuskegee, concomitant with the 1946-48 unethical…

Voice of Experience advances the tradition of service of the "Journal of Research Administration" by fostering consideration of and reflection upon contemporary issues and concerns in research administration. VOE is a celebrated feature column in each edition of the Journal. In this article, the author presents a review of recent literature…