The plight of the six volunteers who fell ill in a recent drug trial highlights the legal minefield of consent, writes Rosamund Rhodes-Kemp

The recent drug trial involving six male volunteers who suffered catastrophic injuries emphasises the urgent need for reform in the complex area of clinical trials, in terms of participation and consent, as well as compensation in the event of serious injury.


Such trials are vital to our understanding and treatment of all serious diseases and conditions, one or more of which are likely to affect all of us at some point. They must continue if diseases such as cancer are to be beaten.


We are fortunate in this country in that we have a vigorous system of regulation through various agencies and ethics committees. This ensures that clinical trials can only take place after careful consideration by external sources.


However, while I have no specific knowledge of the particular circumstances in the recent case, I am not convinced that volunteers generally are provided with enough information in a tangible form to enable them to give truly informed consent. The medical and legal language used is often highly complex and not easy for lay people to understand. Junior medical staff with little real knowledge of what the trial is about or the risk to the patient are usually left to provide oral explanations. Therefore, in some instances the risks may not be fully appreciated.


So what is the duty to warn in these cases? What recompense is there for patients injured through participation in clinical trials?


As so many clinical cases settle without judgments, it is difficult to find English case law on the point. In north America, there is an increasing number of claims arising from poor outcomes in clinical trials with a broad range of potential defendants being included in legal proceedings. The courts have been willing to find that a more onerous duty of consent applies and more than one defendant culpable.


Some recent US legal actions have alleged that the defendants failed to follow applicable laws, regulations, policies, procedures and/or guidelines, and if proved, liability follows.


It is unlikely that English courts would favour such a broad category of defendants, but cases such as the House of Lords decision in Chester v Afshar [2004] UKHL 41 suggest that the highest duty applies to warning patients of all known risks, especially if they entail serious injury.


While the men involved in the recent London tests were by all accounts young, fit and healthy, many who offer to participate in clinical trials are not. They are ill and extremely vulnerable, clutching at any possible help in the last stages of a terminal disease. To these volunteers, as to all who volunteer for clinical trials, we owe a huge debt, and their consent must be fully informed. This means that the explanation should be oral and written in clear English and offered by someone with the experience to be able to answer questions and advise further on any queries. There should always be a proper time to consider whether to participate or not. I have known of two cases where consent was obtained at the last minute with patients feeling pressurised into agreeing to take part.


Confidence in clinical trials will have suffered a huge blow as a result of recent events. It can be restored partly though the knowledge that such consequences are rare, and also by ensuring that the highest duty is exercised in obtaining fully informed consent. If there is a proved breach of duty, compen-sation will follow. But arguably in these cases where human volunteers are essential and all possible risks may not be known, there is a place for no fault compensation.


Rosamund Rhodes-Kemp is head of the healthcare department at London-based law firm Bolt Burdon Kemp