The role of litigation in human research accountability.

This essay examines and analyzes the recent and dramatic series of personal injury lawsuits instituted against those individuals and institutions that conduct and monitor human research. It discusses the social engineering functions of tort litigation, outlines the legal elements and viability of lawsuits against those who conduct and monitor human research, and evaluates and predicts what role tort litigation will play in fulfilling the goals of accountability in the context of human research and human research regulation. In general, tort law engenders two forms of accountability: retrospective and prospective. Retrospective accountability is backward looking, focusing on harms that have already occurred, their culprits, and the reimbursement of individuals for their injuries. Prospective accountability is forward looking in that it encourages actors and institutions to fulfill responsibilities toward individuals in order that harm does not occur, or at least that the risk of harm is decreased. This article argues that research litigation is not, and will probably never become, an effective means of ensuring retrospective accountability in regard to research injuries and ethical violations. Paradoxically though, the current wave of research litigation may serve an important and even key role in encouraging and ensuring prospective accountability.