Mon 18 Apr 2005
Is it civic duty to be human guinea pigs?



WITHOUT experiments on human "guinea pigs", the development of new medicines to alleviate suffering and cure disease would scarcely be feasible.

However, the benefits of taking part in medical research have not always been clear to the public; scandals such as the infamous Tuskegee study - in which 399 African-American men were denied treatment for syphilis over a 40-year period - created an enduring legacy of suspicion and mistrust.

The medical profession has long accepted that the risks faced by research participants must be very carefully restricted, and balanced against the potential benefits. The Declaration of Helsinki, which has underpinned the ethical grounds of research since 1964, clearly states that "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."

But there are concerns that the desire to protect volunteers from potential harm is actually hampering research which could benefit the greater good. So should we all be obliged - or even compelled - to become human "guinea pigs"?

This controversial question has been raised by leading bioethicist Professor John Harris of the University of Manchester. Writing in the latest edition of the Journal of Medical Ethics, he suggests the public should be "morally obliged" to take part in research, in a similar way to wearing a seat belt or performing jury service.

Harris has called for the Declaration of Helsinki to be reviewed, arguing that research is becoming "impossibly difficult" to undertake, and that, in certain circumstances, a degree of compulsion is justified.

"The argument concerning the obligation to participate in research should be compelling for anyone who believes there is a moral obligation to help others, and/or a moral obligation to be just and do one's share," he writes. "Little can be said to those whose morality is so impoverished that they do not accept either of these two obligations."

Dr George Fernie , a member of the British Medical Association's medical ethics committee, agrees that the Declaration of Helsinki has made it more difficult for volunteers to be recruited by researchers. But he says that any degree of coercion, however slight, should be resisted in light of the profession's attempts to move away from a paternalistic approach to medical care.

"We don't have as large studies as we would like, and research is vital to ensure that people get the best possible medical care," he says. "But on a personal basis, and from the BMA's point of view, we don't want patients to be forced in any way to participate in research."

Dr Robert Carlson, a senior lecturer in medical ethics at the University of Edinburgh, says the "rehabilitation" of medical research is a legitimate area for public debate, but he too cautions against amending the Declaration of Helsinki in any way that implies research participation may be mandatory.

"John Harris's debate is aimed at society, broadly speaking," he says. "The Declaration of Helsinki, of which he is partially critical, is aimed at physicians and other participants in research involving human subjects specifically. Now you could say the participants include those human subjects, but primarily it is aimed at those involved in conducting medical research.

"It would be inappropriate for the Declaration of Helsinki, and thereby for physicians, to have in any way a position where they should imply to patients or others that somehow it's their duty to take part in research.

"That would be particularly inappropriate in the clinical setting, where there is often immense vulnerability and someone is looking to their healthcare providers for advice, for support and for appropriate treatment."

Carlson suggests that a mandatory obligation to participate in research would be incompatible with the ideal of achieving fully informed consent. "There is almost always a knowledge difference between researchers and participants with respect to the subject under research," he says. "Obviously the informed consent process aims to bridge that to a point where the potential participant is able to give genuine informed consent. But inevitably some degree of vulnerability persists.

"Society has to debate these things. But where it would be inappropriate is to somehow then say that those people who are in that relative position of power would then be able to use the lever of saying that it is your obligatory moral duty to participate in research."

The ramifications of obliging or compelling people to take part in studies or clinical trials against their wishes would also have significant ethical implications for those undertaking the research, adds Carlson.

"One problem with making some types of medical research mandatory is that it would have the potential for creating unwilling participants. To conduct research on an unwilling participant would run counter to the values and ethics of the healthcare professions.

"Then, a health researcher, faced with an unwilling individual 'mandated' to participate in research would have two choices.
"Either they would opt out of conducting the research on that person - a type of 'conscientious objection' - or they would go ahead, perhaps claiming they were 'only following orders', a phrase that has some very uncomfortable historical reverberations."