The unending saga of legal controls over scientific misconduct: a clash of cultures needing resolution.

Jesse A. Goldner^ INTRODUCTION There are a remarkable number of similarities between science and the law. Each discipline sets as a gold standard a search for precision. For example, scientists utilize the scientific method-a specific set of principles and procedures designed to aid them in a systematic pursuit of knowledge. Following the scientific method involves the recognition and formulation of a problem, the collection of data through observation and possibly experimentation, the formulation of a hypothesis and the testing and confirmation of the hypothesis formulated.l The law, in turn, seeks its form of precision through the careful use of words, as in finely crafted statutes or regulations and contractual language that seek to eliminate the possibility of vagueness or confusion. Each discipline utilizes an approach or methodology that strives to minimize or eliminate the possibility of error and to arrive at a form of "truth" that it recognizes as being maximal within the confines of the rules it has established, be they rules of scientific method or legal rules of evidence. At the same time, however, there is a notable clash of cultures between the disciplines of law and science, and nowhere is this clash more evident than in the lengthy-but still very current-battle over appropriate definitions, rules and procedures concerning legal controls over scientific misconduct. For well over a decade, this dispute has been played out, in large measure, through rulemaking and agency adjudication within the federal regulatory process, as well as in the political arenas of congressional hearings, statutory mandates and claims of key roles for selfappointed monitors of scientific integrity. The ultimate penalty on a finding of research misconduct is debarment from participation in federal grants and contracts,2 but the long-term implications for the professional reputation and careers of those disciplined may be even more significant.3 Currently, the scientific and legal communities are awaiting action by the Secretary of the Department of Health and Human Services (DHHS) on a series of proposed regulatory changes based on a study mandated by congressional action.4 This issue is critical for approximately 200,000 researchers supported by Public Health Service (PHS) grants-researchers who "want the government to leave them alone but also want it to protect them against false or frivolous accusations of misconduct."5 The general trend over the past decade has been away from a primarily scientist-run process toward one in which lawyers have played an increasingly crucial role.6 This Article reviews the history of government responses to scientific misconduct and lays out the current regulatory mechanisms for its monitoring and control. The Article then details a number of the cases and incidents that have demonstrated significant dissatisfaction-on the part of scientists, their attorneys, government regulators and elected officials-with some of current regulatory approaches. After describing proposed alterations to the current regulations, this Article evaluates the proposed changes in light of the various investigations of alleged instances of scientific misconduct that have has transpired to date. It concludes by suggesting that the movement toward a more legalistic approach in dealing with allegations of scientific misconduct is appropriate. II. HISTORY Prior to the 1980s, allegations of scientific misconduct apparently were handled by the institutions in which the cases arose, either on an ad-hoc basis or through review processes established by the institutions themselves.7 The incentive for action lay both in the institutions' desire to maintain the integrity of their research programs and in their concern that failure to do so could jeopardize funding for such programs. Ultimately, even absent the more particularized government process described below, control of scientific misbehavior is intimately connected with the supervision of federal research project funding. …