Law Commons^™

Symposium: Issues In Bioterrorism -Introduction, Jessica Wilen Berg

Faculty Publications

This issue of Health Matrix focuses on the legal issues involving bioterrorism.

Regulating Clinical Research: Informed Consent, Privacy, And Irbs, Sharona Hoffman

Faculty Publications

During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task.

Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical …