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
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
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
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: No competing interests