Project Categories

Translating Research Into Health Benefits: Returning Research Results & Incidental Findings

Award Year: 2011 Investigator: Susan Wolf
Tremendous debate surrounds the question of whether researchers have a duty to offer research participants incidental findings (IFs) or individual research results (IRRs) of potential health importance that are discovered in the course of conducting the research. When neuroscience researchers obtain an MRI scan of the brain, they risk stumbling upon a brain tumor or other IF of potential life-and-death significance.

Human Subjects Protection as Regulation: A Comparative, Empirical View

Award Year: 2001 Investigator: Scott Burris, Zita Lazzarini
Since 1991, most of the studies conducted on human subjects in U.S. research institutions have been regulated by the Department of Health and Human Services under Title 45, Part 46 of the Code of Federal Regulations, known as The Common Rule. Although the goal of protecting human research subjects is unquestionably valid, it is not clear that the regulatory approach codified in The Common Rule is the most sensible or effective option.

Human Experimentation and Public Policy

Award Year: 2000 Investigator: Sydney Halpern
Controversy surrounding federally mandated oversight of human-subjects research has redoubled in recent years as news of regulatory problems receive increased public attention. Advocates continue to call for reform and changes, yet neither scholarship nor public discourse has offered much insight into the sources of recurrent controversies. Dr.

Social Equity, Group Identity, and the Medical Management of Difference

Award Year: 1997 Investigator: Steven Epstein
Federal policy changes, which include greater numbers of women and racial minorities in government-funded clinical trials, were designed to improve the health of these groups. Dr. Epstein explores the origins and consequences of incorporating gender and race variables into the design and evaluation of NIH-funded clinical trials and in trials of new drugs submitted for FDA approval.