The question of the relationship of the making of value judgments in a typically ethical sense to the methods and procedures of science has been discussed in the literature at least to that point which e. e. cummings somewhere refers to as “The Mystical Moment of Dullness.” Nevertheless, albeit with some trepidation, I feel that something more may fruitfully be said on the subject.

: Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are socially (...) determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risks encountered and more attuned to the priorities of trial subjects. (shrink)

in Risk: Philosophical Perspectives ed Tim Lewens, Routledge.

Only ten to twelve percent of Americans would voluntarily live within a mile of a nuclear plant or hazardous waste facility. But industry spokespersons claim that such risk aversion represents ignorance and paranoia, and they lament that citizen protests have delayed valuable projects and increased their costs. Who is right? In _Risk and Rationality_, Kristin Shrader-Frechette argues that neither charges of irresponsible endangerment nor countercharges of scientific illiteracy frame the issues properly. She examines the debate over methodological norms for risk (...) evaluation and finds analysts arrayed in a spectrum. Points of view extend from cultural relativists who believe that any risk can be justified to naive positivists who believe that risk evaluation can be objective, neutral, and value free. Both camps, she argues, are wrong, because risk evaluation as a social process is rational and objective, even though all risk-evaluation rules are value-laden. Shrader-Frechette defends a middle position called "scientific proceduralism." She shows why extremist views are unreliable, reveals misconceptions underlying current risk-evaluation methods and strategies, and sketches the reforms needed to set hazard assessment and risk evaluation on a publicly defensible foundation. These reforms involve mathematical, economic, ethical, and legal procedures. They constitute a new paradigm for assessment when acceptance of public hazards is rational, recognizing that laypersons are often more rational in their evaluation of societal risks than either experts or governments have acknowledged. Such reforms would provide citizens with more influence in risk decisions and focus on mediating ethical conflicts, rather than seeking to impose the will of experts. Science, she argues, need not preclude democracy. (shrink)