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Ethics and paediatric research

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In medical research on human subjects, considerations related to the well being of the human subject should take precedence over the interests of science and society. World Medical Association (WMA), Helsinki Declaration, 2000. People with parental responsibility…cannot agree to any intervention contrary to the child’s best interests. British Medical Association (BMA), 2004. A research procedure which is not intended directly to benefit the child subject is not necessarily either unethical or illegal. Royal College of Paediatrics and Child Health (RCPCH), 2000. We believe that research in which children are submitted to more than minimal risk with only slight, uncertain or no benefit to themselves deserves serious ethical consideration. RCPCH, 2000. When there is ethical and scientific justification to conduct research with individuals incapable of giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for the individual subject should be no more likely and not greater than the risk attached to routine medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an overriding scientific or medical rationale for such increases and when an ethical review committee has approved them. Council for International Organizations of Medical Sciences (CIOMS), 2002.

In discussing the ethics of research involving children incapable of giving informed consent, S D Edwards and M McNamee (

) examine the guidance offered by the BMA, the RCPCH, and the CIOMS in the light of the WMA Helsinki Declaration; they regard the latter as the reference standard. In support of the WMA they quote Kant; you should:

…always treat humanity, whether in your own person or in the person of any other, never simply as a means, but always at the same time as an end.

They conclude that the BMA, RCPCH, and CIOMS statements are incompatible with the WMA declaration and too permissive.

They take the BMA to task for stating that an intervention should not be contrary to the child’s best interests; it should, they say, be in the child’s best interests. They point to a change in the RCPCH guidelines for research not beneficial to the individual child; such research involving (for instance) venepuncture was initially considered unethical but now only “deserves serious ethical consideration”. The CIOMS guideline clearly allows research procedures that involve a low degree of risk. Edwards and McNamee question the possibility of therapeutic research (research of direct benefit to the participant). If, as they seem inclined to accept, all research is non-therapeutic and any discomfort or risk is counter to the individual’s well being, then it follows that all clinical research falls foul of either the WMA (the well being of the subject) or Kant (means to an end). They insist, however, that they have “refrained from advancing this radical claim”. [The extract from Kant seems to deny the possibility of any valid consent for non-therapeutic research since it is using people as “a means to an end”; but it seems doubtful that Kant was thinking of research on children (or any other kind of research) when he wrote it. (It also seems to rule out any form of altruism.)] They call upon the BMA, the RCPCH, and the CIOMS to square their views with those of the WMA.

Edwards and McNamee begin their article by listing reasons why research on young children is desirable; they then stop barely short of calling it unethical. Something’s got to give. Are the views of the WMA and the other three bodies as incompatible as these authors imply? It seems to me that they are not. What, after all, are “considerations relating to the well being of the human subject” and does “take precedence over” necessarily mean preclude?

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