Risk-Benefit Analysis in Clinical Research Guidelines, Practices and a Utilitarian Interpretation

Abstract

This thesis explores several guidelines regarding risk-benefit analysis in clinical research, how some investigators apply these guidelines and concludes that lacunas in both guidance and practice can be observed. Risk-benefit analysis appears to be a difficult task in clinical research. Further, given its necessity for decision-making and its complexity in execution, this thesis explores how we must understand risk-benefit analysis. Because of its natural roots, a discussion is started to come to a utilitarian interpretation of risk-benefit analysis. Two modified features are articulated to meet the practice in clinical research. First, pain and pleasure from classical (hedonistic) utilitarianism are abandoned and replaced by Quality-Adjusted-Life-Years (QALYs). Second, a constraint on the maximum allowable risks is introduced in order to avoid participants from being sacrificed in experimentation. After having presented a most plausible version of a utilitarian interpretation of risk-benefit analysis, a substantial package of criticism remains. This criticism underpins the claim that risk-benefit analysis is a tool under development. If attention is given to some weak points of its procedure, risk-benefit analysis may support the balancing of potential harms and opportunities to some degree. However, it is undesirable to trust risk-benefit analysis as an indisputable calculation model commanding a decision in clinical experimentation by its own force.