Dear Sir,
I am writing to highlight a possible consequence of human volunteer research on an individual's ability to pursue compensation for injury or harm through civil litigation.
An epidemiological study was conducted to investigate an alleged association between chemical exposure and ill health. Although the link between the two had a high level of anecdotal support there was no accepted scientific evidence either for the association or, indeed, for a clearly defined pattern of ill health. The study outcome was inconclusive but a number of volunteers were identified who clearly had abnormal clinical findings for which there was no obvious underlying cause. The research team provided feedback to the individual volunteers and, where abnormalities had been detected, advised them to consult with their General Practitioner.
The question which has subsequently arisen is whether this feedback might have triggered, or might be interpreted as having triggered, the time clock of three years that individuals have to lodge a claim for compensation, once they have due grounds for considering that a compensation claim is warranted.
The legal position is unclear and has (to our knowledge) never been tested in the courts. The issue that 'clinical' feedback to research participants, might have set the clock ticking needs to be considered because section 14 of the Limitation Act 1980 defines the date of knowledge effectively as the time the person knew or ought to have known (having taken any reasonable step open to him by way of further enquiry) that he had suffered a significant injury1. The fact that the feedback did not constitute a diagnosis is considered irrelevant, particularly having regard to the context of the study itself. The advice to individuals to consult their GP's is a reasonable step for a person to take and, therefore, those who do not consult their GP could accordingly be fixed with constructive knowledge; those who consult their GP and are told not to worry are 'off the hook'.
Clearly this has implications for research participants and for the communication between research teams and their volunteers. Researchers are not under any legal obligation to provide advice on the implications of research feedback and so the question is whether, in this case, they have a moral/ethical obligation to inform subjects of the implications of attending, or not attending, their GP to further discuss the study outcomes in relation to their health. This in turn would seem to put an onus on the GP but it also raises questions in relation to the information provided to volunteers at recruitment, in respect of their being able to make fully informed decisions, and in relation to the communication between the researcher and the GP, in respect of test result interpretation.
We are interested in any comment on the issues raised and whether any other RECs have considered these implications of study result feedback.
Yours faithfully
1 * Section 14(3) provides that "knowledge includes knowledge which he might reasonably have been expected to acquire -
(a) ........................... or
(b) from facts ascertainable by him with the help of medical or other appropriate expert advice which it is reasonable for him to seek;
but a person shall not be fixed under this subsection with knowledge of a fact ascertainable only with the help of expert advice so long as he has taken all reasonable steps to obtain (and, where appropriate, to act on) that advice."