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
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
"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
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
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
"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,
"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
"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