given a placebo in the absence of consent is deceived and research ethics committees will, rightly, decline to agree to this. (But see Lewis et al. 2002, p. 71)
The question of compensation for accidental (physical) injury due to participation in research is a vexed one. Plainly there are substantial differences between the position of healthy volunteers (whether or not they are paid) and that of patients who may benefit and, in some cases, who may be prepared to accept even serious risk for the chance of gain. There is no simple answer. But the topic must always be addressed in any research carrying risk, including the risk of withholding known effective treatment.
The CIOMS/WHO guidelines4 state:
Research subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependents are entitled to material compensation. The right to compensation may not be waived.
Therefore, when giving their informed consent to participate, research subjects should be told whether there is provision for compensation in case of physical injury, and the circumstances in which they or their dependants would receive it.
Healthy volunteers are usually paid to take part in a clinical trial. The rationale is that they will not benefit from treatment received and should be compensated for discomfort and inconvenience. There is a fine dividing line between this and a financial inducement, but it is unlikely that more than a small minority of healthy volunteer studies would now take place without a 'fee for service' provision. It is all the more important that the sums involved are commensurate with the invasiveness of the investigations and the length of the studies. The monies should be declared and agreed by the ethics committee.
Patients are not paid to take part in clinical trials, though 'out of pocket' expenses are frequently met.
There is an intuitive abreaction by physicians to pay patients (compared with healthy volunteers), because they feel the accusation of inducement or persuasion could be levelled at them, and because they assuage any feeling of taking advantage of the doctor-patient relationship by the hope that the medicines under test may be of benefit to the individual. This is not an entirely comfortable position.
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