At one time it was accepted that the answers to these questions lay in the domains of science and medicine, and they would have been largely debated in those arenas. Today, biological and medical research have become a focus of public scrutiny. For each of the above questions, any public opinion poll would probably show a multitude of responses, including a healthy degree of uncertainty. Even among those questions for which a majority in the U.S. society can agree on the proper, moral response, organized vocal minorities can have considerable influence on how the debate is resolved.

There are many “publics” in any debate. In biomedical research decisions, the public can take the form of voters, taxpayers, special interest groups, community organizations, and patients. In the context of this report, the public refers to any group typically outside the process of biomedical research and its medical applications—that is, laypersons. When these groups have a say in what should and should not be allowed in biomedical research and practice, deciding what should be done involves listening, negotiating, advocating, judging, and implementing. This process of weighing alternatives is the process of decision making. When it is done in public, in the light of the competing values and interests of American pluralism, it is called policymaking. How the policy process is conducted has an effect on the outcome.

It is easy, with hindsight, to identify successful versus failed decisions. In the absence of outcomes, and when there is no precedent, as is often the case in biomedicine, predicting what is a correct decision becomes exceedingly difficult. Therefore, a useful strategy for examining decision making is to separate outcome from the quality of the decision process.

In recent years, numerous mechanisms have been established at the federal, state, and institutional levels to define, review, and regulate the application of biomedical advances and the content of biomedical research. In addition, various quantitative methods (e.g., use of indicators, cost-benefit and cost-effectiveness analyses, surveys of need, evaluation research, policy analysis, social experimentation) have been developed to help decision makers make better decisions. Some of these analytical methods and mechanisms have worked as intended; others have failed to produce desired results, and still others require more time before their adequacy can be judged.

The decision-making process is the focus of this report. Examining the way discourse proceeds among all affected parties in a policy debate may shed light on how the decision was made and could provide clues as to how similar decisions might best be debated in the future. It is not the purpose of this effort to judge whether the

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