Consent and randomized clinical trials: are there moral or design problems?

Abstract

The purpose of this paper is to examine whether randomized clinical trial (RCT) methods are necessarily morally problematic. If they are intrinsically problematic, then there may be a dilemma such that tragic choices might have to be made between this socially very useful method for making medical progress on the one hand, and patients' rights and welfare, or physicians' duties on the other. It is argued that the dilemma may be avoided if RCTs can sometimes be viewed as an honorable and cooperative venture between investigators and subjects. Another dilemma may take shape, however, if too few people are willing to cooperate to maintain the structural integrity of many important RCTs. Given their importance, does this method justify easing some of the consent requirements? It is argued that RCT methods are not so ideal that special consideration should be given to them regarding consent requirements. To examine the compatibility of current consent requirements and frequently used RCT schemas, seven RCT designs are discussed. It is found that some, but not all, RCTs, are intrinsically problematic but that sufficient reason has not been found to hold all RCT schemas as intrinsically morally troubling.