http://bmj.com/cgi/content/full/325/7368/796/c
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 Collections under
which this article appears: Research
and publication ethics |
Roger Dobson Abergavenny
Gift vouchers, book tokens, videos, and savings bonds instead of cash could be used as payments for children who have taken part in clinical trials.
An 11 point plan designed to deal with ethical concerns over payments made to children and their parents also proposes that any payments should be small, or deferred, and directed at the child.
The US ethicists who have outlined the plan in a new report say that a rigid ban on payments may be counterproductive.
"An alternative approach, advocated by the European Union, is to ban all payments that might act as incentives, eliminating the possibility that incentive payments might distort parents’ or children’s decision making. Although banning all incentive payments beyond reimbursement and compensation is ethically defensible, doing so runs the risk of impeding socially valuable paediatric research," say the authors, from the Department of Clinical Bioethics at the National Institutes of Health (Journal of Pediatrics 2002;141:166-71).
The report says that because children cannot give consent, someone else, usually their parents, must decide whether to enrol them in research. It says the central concern is whether it is ethical for investigators to offer incentive payments on top of appropriate reimbursement and compensation payments.
"Offers of payment raise ethical concerns because they have the potential to distort parents’ decision-making. The opportunity for financial gain may lead parents to agree to research enrolment they otherwise would have opposed as contrary to their children’s interests. Some payments may unwittingly distort parents’ decision-making. Research enrolment decisions are inherently complex, and the offer of payment may lead parents to unconsciously inflate the benefits and/or minimise the risks of their children’s research participation," say the authors.
The report cites data from a US clinical trials listing service showing that nearly 25% of paediatric trials offer payment, with amounts ranging from $25 (£16; €26) to each child in a study of influenza treatment to $1500 to families for the time and travel involved in a study of psoriasis treatment.
On methods of payment the report says, "Avoid lump sum payments. Large lump payments, such as $2000, are more enticing than equivalent, pro-rated payments, such as $40 per weekly clinic visit."
It says that deferred payments should be considered, because large lump sums—even when based on time spent participating—may distort parents’ and children’s decision making: "For protocols that offer large sums, deferred payment mechanisms, such as savings bonds for the child, might be appropriate."
It also urges consideration of non-cash payments: "Parents often exercise control over their children’s assets. To minimise parents’ access to children’s payments, gift certificates redeemable at children’s stores or the choice of an age-appropriate gift, such as a book, video, or movie pass, could be offered in lieu of money."
The recommendations can be found at
www2.us.elsevierhealth.com
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