Introduction

Few if any issues engender such passionate–often acrimonious–disagreement among clinicians, ethicists, statisticians, and representatives of patient groups as does the continuing debate about informed consent and clinical research trials. In the blue corner: clinicians and biostatisticians keen to “move the field forward,” so to speak, and answer as quickly as possible the research question currently under investigation. In the red corner … just about everyone else. Anyone left in the centre? Only the hapless referee, in this case the somewhat perplexed journal, whose editorial board–constantly hectored from both sides–somehow has to give all parties a decent airing and ensure fair play.

Those arguing in favour of fully informed consent as an inviolable rule (except, perhaps, in very special circumstances) often point out the essential, non-negotiable nature of a patient's right to autonomy and self determination. Quite rightly they remind clinicians that patients now wish to participate in decisions concerning their own management, to a far greater degree than ever before. Indeed, over the past decade, the move towards fully informed consent for all participants in clinical trials has become increasingly difficult to resist and is now formalised in various guidelines.1 However, neither lawyers, ethicists, nor medical scientists have so far agreed precisely what this term actually means–though it is generally held to imply a full declaration of the competing treatment options for any patient participating in a clinical research study, particularly one which involves randomisation between two or more treatment options. Together with the full description of treatments, there should be an explanation of the possible side effects of both new and standard therapies and a clear explanation that the “choice” of treatment is no choice at all–in the conventional sense–but is no more than a computerised flip of the coin.

Most clinicians recognise that the anxious patient sitting …