Number of UK patients offered participation in clinical trials will be boostedBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.a530 (Published 26 June 2008) Cite this as: BMJ 2008;336:1460
All rapid responses
The rousing call for more UK patients to take part in clinical trial research (BMJ 28 June, 1460) overlooks a vital point. People are unlikely to volunteer if they realise that they have no enforceable right to compensation should they suffer serious non-negligent injury in a trial. Professor Desmond Laurence has described and analysed this problem in detail. (1)
The Medicines for Human Use (Clinical Trial) Regulations 2004 set out the basis upon which Research Ethics Committees (REC) members shall arrive at their opinion, by imposing conditions and principles that apply to all clinical trials. They include: "The rights, safety, and well-being of the trial subjects are the most important considerations and shall prevail over the interests of science and society." These Statutory Regulations also state that the REC must consider "provision for indemnity or compensation in the event of injury or death attributable to the trial", and "any insurance or indemnity to cover the liability of the investigator or sponsor." Individual REC members, in deciding whether or not to allow a particular trial to proceed, have a personal duty to comply with these provisions. If they negligently fail to comply, then they are personally liable for any damage their negligence causes. But within the law they do have independence: the opinions of REC members cannot be dictated to them by any other person or body.
The Department of Health states that 'The following (or similar) should be included' in patient consent agreements: 'the [sponsor] will pay compensation for [non-negligent harm]. Any payment would be without legal commitment.' This term is however not straightforward, and it cannot lead to the informed consent which Sch 1 of the Statutory Regulations demands. For the clear legal commitment given in the first sentence ('will pay compensation') is undone by the legal sleight of hand of the second.
The DH has an ambiguous role in giving advice to RECs: its 'governance' is not legally binding, but the Statutory Regulations are. RECs must therefore look to themselves and the law, understanding that it is they who are responsible for protecting the vulnerable casualties of science, and that those who proffer advice have, themselves, conflicts of interest.
I believe that few RECs are aware of the onerous realities of their responsibilities. When they all clearly understand the law and act in accordance with it, we can wholeheartedly support the call for the widest possible participation in clinical trials.
1. Laurence DR. Guide, guide thyself: law and order in clinical research. Research Ethics Review 2008; 4 (2):69-72.
Competing interests: None declared
Competing interests: No competing interests