Is it ever ethical to do research on human subjects without their consent? The Nuremberg Code, written in the aftermath of the atrocities perpetrated by Nazi doctors, makes the voluntary consent of the human subject “absolutely essential”. Understandable as the desire for so absolute a barrier may be, it comes at a high cost, for it blocks research with the potential to help many children. Hence in 1964 the World Medical Association, in the Declaration of Helsinki, took a different stance, allowing research on human beings without the capacity to consent, if consent can be obtained from a legally authorised representative.
To decide when research with children is justifiable, we must take a stance somewhere on the spectrum between absolute protection of individual human rights and achieving the best consequences for all. In the debate between these two approaches, respect for human rights tends to win out. We have seen too many abuses committed in the name of the greater good to allow researchers, or ethics committees, to judge research by that standard alone, without some requirement to protect the
rights of the individual participant in research. Even utilitarians can accept that giving some weight to the rights of the individual will have better consequences in the long run. But just how is the best balance between individual rights and the general good to be struck?
The requirement to obtain consent from a parent or guardian gives rise to the further question of the basis on which the parent or guardian can properly consent. Adults motivated by an altruistic desire to benefit others may choose to participate in research that offers them no personal benefit—and perhaps imposes on them some risk or discomfort. They may even see their participation in this research project as something that makes their life more meaningful, and hence is in their interests, broadly understood. But can they ethically make the same choice for their child? Some who have written on this topic believe that if the research is going to inflict even very slight harm on the child—for example, the momentary pain the child experiences if it is necessary to take a blood sample—parents should allow their child
to participate only if the research is likely to produce a benefit for their child, not merely for other children.
This is the set of ethical issues philosopher and bioethicist David Wendler addresses in The Ethics of Pediatric Research. Despite the book’s textbook-like title, it is much more than a survey of the issues raised in the field. Wendler weaves all the useful information that a good textbook would have into an argument that defends an unusual
position on the ethics of research in children. The crux of this answer is Wendler’s attempt to broaden the notion of what can benefit a person so that it includes contributing to a valuable project. If that contention is defensible, we can justify the use of children in a wider range of research projects, without abandoning the principle that it is wrong to use children in research that will not benefit them.
Put so baldly, Wendler’s thesis may come across as philosophical sophistry. After all, while we might indeed think our life goes better if we know that we have contributed to something worthwhile, surely that is because we know that in choosing to contribute, we acted ethically, and that enhances our self-esteem and sense of satisfaction with what we have done. But if we were too young to make that choice and our parents made it for us, can that make us feel better about ourselves? Yes, says
Wendler. He contends that our intuitions on this point are clearer in the reverse case: our lives can be made worse if we contributed to something bad, even if we were too young to take moral responsibility for doing so. To persuade us to accept this claim he offers several examples, of which perhaps the strongest is his account of the life of
Irmgard Hunt, born in Germany in 1934 and who at the age of 3 years was walking in a park with her mother when they encountered Adolf Hitler and his entourage. The little blond, blue-eyed girl was soon being photographed sitting on Hitler’s lap. In a memoir published many years later, Hunt expresses concern that the photo may have been used for Nazi propaganda and, as Wendler interprets her comments, thinks that it would be worse for her if she had thereby, even passively, contributed to the
Nazi cause. If that worry is a reasonable one, then adults would be equally justified in thinking that it is good for them that they were able, at a similar age, to contribute to the development of a better treatment for a childhood disease.
But is Irmgard Hunt’s worry a reasonable one? Or is it evidence that the moral sensitivity appropriately felt in respect of acts for which we are morally responsible has spilled over into an area where it does not belong? I’m inclined to think that it may be the latter, and that the same is true of the intuition that our lives go better if, without any moral responsibility on our part, we contribute to a beneficial project.
Whether or not we accept Wendler’s broadening of the notion of benefit, there is a more straightforward way out of the original ethical dilemma: why should parents not be able to consent to the participation of their children in research that holds out the prospect of significant benefits to others, even if the research is not beneficial to the children? We may object to the idea of parents consenting to their children’s participation in research that causes them severe pain, or serious risk of long-term harm, but why should they not be able to consent when the research carries no more than a minimal risk of significant harm? On this test, for example, parents can consent to the involvement of their child in a well-designed study of an important medical question that involves drawing blood, despite the fact that doing so involves momentary pain and, in good medical practice, a risk of infection that is greater than zero, but still extremely small. And perhaps in exceptional circumstances, with stringent safeguards, parents could consent to the participation of their children in studies that involve more risk than merely drawing blood, where the harm to the child is still minor, the risk of significant harm is still extremely small, the potential benefits to others are great, and there is no other way of achieving those benefits. That is roughly what current regulations permit in the USA, and it seems ethically defensible.
In closing, I will raise a question in research ethics that is not discussed in Wendler’s book, but surely does raise a question about our different attitudes to distinct groups of vulnerable research subjects. Why are the standards for undertaking studies that, with the consent of the parents, inflict pain on human infants so much stricter than the standards for carrying out studies that inflict the same amount of pain on non-human animals? Animals are incapable of consent, and lack the protection of parents able to protect their interests. Yet even when the pain inflicted on a human infant is of brief duration and not so severe that it is plausible to believe it will have long-term psychological consequences, we take it much more seriously than we take the same kind of pain inflicted on a monkey, a dog, or a rat. Surely the badness of
pain does not depend on the species of the being who experiences it. In these cases, it is hard to see what could justify applying standards for research on animals that are lower than the standards used for research on young children.
In South Africa, non-therapeutic research on children requires ministerial approval.
The Lancet, Volume 377, Issue 9760, Pages 115 – 116, 8 January 2011
When is research on children ethical?
Peter Singer a
The Ethics of Pediatric Research, David Wendler
Oxford University Press, 2010
Pp. 348 US$49·95. ISBN-9780199730087