ABSTRACT
This chapter focuses on some ethical issues associated with the use of human experimentation to determine the risks and benefits of therapeutic and preventive interventions. No escape is imminent because the science and the ethics cannot be separated easily. In the context of human experimentation, traditional designs are probably uncontrolled case series and historical comparisons. Comparative studies are inherently stronger in evidential quality, principally because they permit discounting of maturational effects of the condition under study. As Alvan Feinstein and others have pointed out, virtually every aspect of the conduct of randomised clinical trials has been subject to ethical scrutiny. The ethical concerns about human involvement in therapeutic evaluation must be balanced against similar ethical concerns about widespread use of treatments of uncertain value and potential danger. The rights of children to benefit from new therapies should not be constrained by their exclusion from medical research.
