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

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

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

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."