Compensation for non-negligent harm in trials remains shakyBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7539.489-b (Published 23 February 2006) Cite this as: BMJ 2006;332:489
EDITOR—Last year in the BMJ I showed that a patient's agreement to take part in a clinical trial is a legal contract which consumer law requires to be expressed in plain language.1 2 In a letter to me on behalf of the chief medical officer (for which I am grateful), the Department of Health has now agreed that where there are contracts between patients and trials sponsors, consumer law is applicable.
I had cited words in my article as not being plain language that the Department of Health's Central Office for Research Ethics Committees (COREC)3 was advocating for use in information to potential patient volunteers for clinical trials. The words were: “Broadly speaking… the sponsor, without legal commitment, should compensate you [for non-negligent harm], without you having to prove that it is at fault” (my italics).4
The Department of Health told me that it was always open to suggestions for improvement and would ask COREC to review whether the words could leave a lay person in any doubt that there is no automatic right to compensation.
On 22 November 2005 the Department of Health and COREC published replacement words: “[the sponsor] will pay compensation for [non-negligent harm]. Any payment would be without legal commitment (please ask if you wish for more information on this)” (my italic).5 Clearly these new words also are not plain language: the certainty of compensation given in the first sentence is negated by the legal jiggery-pokery of the second.
Unforeseen risks are inherent in medical research. In clinical trials patients will inevitably sometimes suffer serious non-negligent harm (for which the courts will not award compensation when there is no prior legally binding commitment to compensate).
As a matter of law, the Department of Health and COREC may not recruit patients for trials by concealing the fact that present compensation arrangements for non-negligent harm are flimsy and unreliable. The Office of Fair Trading has legal powers to ask a court for an injunction to prevent such misrepresentation.2 The department should now obey the law. If it simply will not, then the Office of Fair Trading should now enforce the law.
Competing interests None declared.