CONSIDER the following scenario. Researchers from a biotech company want to
enlist a family with a rare genetic mutation for a study into dementia. They
strongly believe that they can identify one of the genes involved in the disease
in this family, and if they do the company stands to make a large amount of
money. The researchers aim to persuade the family to take part in the study by
offering each member $10,000. All they would have to do is give some
saliva samples.
In many countries today such a scenario is inconceivable. Researchers
are not allowed to offer significant sums of money to participants in a medical
trial, even for low-risk experiments. Offering money is considered 鈥渦ndue
inducement鈥� that could interfere with a volunteer鈥檚 judgement on whether to take
part, and turn the relationship between scientist and subject into a commercial,
unethical one.
Such standards are rigorously enforced. One ethics committee in Australia
nearly rejected a proposal to pay intravenous drug addicts the equivalent of
just 10 US dollars for completing an anonymous questionnaire about their
behaviour for a study on the spread of hepatitis C.
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But there is another way of looking at it. Pharmaceuticals and biotech
companies carry out trials because they hope eventually to make substantial
profits from the results. The researchers also benefit financially and through
the advancement of their careers. Meanwhile, the participants in a trial barely
benefit at all. Indeed they could be said to be exploited in the interests of
industry and biomedicine. Surely it is only fair that they share in the
rewards?
Publicly funded research is more complicated, as participants may be acting
in the public interest. But my main argument applies equally to commercial and
non-commercial trials: researchers should be allowed to pay volunteers, and to
pay them well, even for high-risk research.
Now compare the hypothetical dementia trial mentioned above with a real
example in which a patient is invited to take part in a study into genetic
predisposition to glaucoma. If she agrees, the patient will have access to a new
genetic test for glaucoma that is not available outside the study. The cost of
this test is a few hundred dollars. Benefits in kind like this are permissible,
and many volunteers receive them. They are not considered undue inducements, yet
money is.
This is paternalistic and nonsensical. It would be far more respectful to
volunteers if researchers could offer them the choice.
The issue becomes most acute when applied to high-risk research. Ethics
committees argue that in these cases money may make people go against their
鈥渂etter judgement鈥� and take risks that they would not ordinarily take. However,
not paying volunteers who take part in high-risk research makes an even greater
mockery of the system. For example, a researcher wishes to recruit healthy,
unemployed men at a local labour exchange for a study into the effects of new
anti-hypertensive medications. The volunteers would have a catheter to measure
pressure in the heart. This can cause life-threatening complications, such as
abnormal heart rhythms, haemorrhaging or a rupture of the pulmonary artery. The
risk of death is between 1 in 2000 and 1 in 5000 and is clearly stated on the
consent form, yet all the researcher can offer the volunteers is a mere
$100 for their trouble.
In many cases such as this the financial reward is the only thing that makes
it worthwhile for a volunteer to take the risk. But why should that bother
ethics committees? We make such decisions every day. Do we always make them
against our better judgement?
Consider a couple with two young children who are contemplating buying a new
car. They find one for $30,000, but if they spend an extra $10,000
they could get one with significantly better safety features such as air bags
and an anti-lock braking system. The safer car has been shown to reduce the risk
of death by 1 in 2000 a year. But the couple decides to buy the cheaper car and
spend the extra $10,000 on a family holiday abroad.
Similarly, an unemployed man sees an advertisement for a construction
worker鈥檚 job. At the interview, the employer tells him the job involves working
on high scaffolding and that the risk of dying on the site is between 1 in 2000
and 1 in 5000 higher per year than working at ground level. In compensation for
this he will receive an extra $10,000 a year. He takes the job.
Could you say that the couple with children or the unemployed construction
worker made unsound judgements? In both cases they are being paid for taking on
a greater risk of death. There appears nothing objectionable in their decisions,
yet participants in medical trials are not even allowed to make the choice.
Why should they be treated as a special case? Life is all about taking
considered risks. If $10,000 is the going rate for taking on a 1 in 2000
increased risk of dying then researchers should be allowed to offer volunteers
the going rate. Indeed, there is no reason why they shouldn鈥檛 be allowed to
offer ten times the going rate. Competent, rational people are quite able to
weigh up the risks and benefits for themselves. I have never understood the
suggestion that offering money restricts people鈥檚 freedom to choose.
The crucial things are to ensure that the risk involved is reasonable
compared with the benefits it will offer the participant and society, and that
the participants are fully informed and that they give their consent freely. If
the risks balance the benefits鈥攆or example, if the right heart catheter
study is likely to save the lives of heart-disease patients in the
future鈥攁nd the participants know all the risks and are free to make their
choice, then what does it matter how much they are paid?
When people go to war voluntarily to risk their lives for their country, they
are hailed as heroes. If we allow people to die for their country, it seems to
me we should allow them to risk death or injury for the chance to improve the
quality of their lives or their children鈥檚 lives or for anything else they
value. We should allow them to make that choice in any field. Why should war be
more acceptable than medical research?