When is an inducement 'undue'? Is a payment ever coercive?
Can payments invalidate informed consent?
From a bioethical perspective, payments to research participants are complicated, an expert says.
"Partly because a lot of people are used to how clinical medicine works, the idea of paying people to participate in clinical studies, particularly when they involve risk, makes people very uncomfortable," says Neal Dickert, PhD, MD, a resident at Johns Hopkins Hospital in Baltimore, MD.
"That's the fundamental issue," Dickert says.
Other ethical concerns involve the notion that segments of the population who are economically disadvantaged and, perhaps, vulnerable, are more likely than others to be attracted by offers of money, he says.
"The fundamental issue of paying people to be involved in research, that it might be harmful leads to significant worry about preying on people's vulnerability," Dickert explains.
Dickert has published research on payment policies for study participants, and he and co-investigators have found that phase I studies often are well-designed with regard to participant payments.1,2
"We found from talking to chief executive officers at drug companies that phase I units often have the most well-worked-out and defined payment schedules," Dickert says.
Here are the three main reasons why payments to participants are a significant issue to clinical research professionals:
1. Is a payment too much?
"Paying people too much money might invalidate their ability to give informed consent," Dickert suggests. "Like deer in the headlights, they might pay too much attention to the money and not enough to the risk."
2. Will it force a bad decision?
Another argument is that payments for research participation discourage potential participants from thinking carefully about the risks and benefits, Dickert says.
"Making money hijacks their judgment, and they might make bad decisions," he explains. "These are the kinds of arguments people advance."
There are no data to support this argument, but it has not been studied well, he adds.
"People take money into account all the time in making lots of different decisions, and we don't normally say they're unable to make those decisions because money is involved," Dickert says.
3. Is payment coercive?
People in the research community experience great discomfort around the idea of paying people to participate in clinical trials, Dickert says.
"The subset of arguments about payments is that it invalidates consent," he explains.
However, the word "coercive" should not be applied to clinical research, Dickert says.
"One thing I've tried to argue over the years is that a payment for research participation cannot be considered coercive because coercion involves the presence of a threat," he says. "If someone mugs you and puts a gun to your head and says, 'If you don't give me your money I'm going to shoot you,' that's coercive."
But asking people to participate in clinical research is not the same as making a threat, Dickert says.
"No one is threatening to make you worse off if you don't do what they offer," he says. "If you were offered $1 million to participate in a research study, and you say, 'No,' then there's no harm that comes to you."
On the other hand, this doesn't mean that all offers of payment for participation are okay, Dickert says.
"It's a semantic decision, but I think it's important that we be straight when we say what we mean by coercion," he says. "In general, coercion is defined by the presence of harm if one doesn't do what the person wants them to do."
The more proper term is "undue inducements," Dickert notes.
"That, more properly, is the concern that most people have," he says. "It's a concern that is hard for people to define."
Research regulations and guidance documents provide lots of different ways to think about how to define undue inducement.
"There are so many different concepts of what undue inducement might be that there's little in the way of clear guidance out there," Dickert says.
From an ethical standpoint, there is nothing inherently wrong with providing inducements to research participation, he says. One study found no evidence that commonly used payment levels represent undue inducement.3
"There are inducements all around us, such as whether we take a job we like or shop at a sale at a store," Dickert says. "All those things are designed to induce us to do things we might not necessarily do, but we don't say they're bad."
Likewise, inducements in research are not problematic.
"An inducement could be anything as simple as offering to pay for a person's parking because the person might not participate if he has to pay for his own parking," Dickert explains. "But we don't think there's anything wrong with that."
Concern over undue inducement is properly raised in settings where large amounts of some compensation are involved and where the research might cause some people to have significant value-based objections or concerns, Dickert says.
For example, suppose there's a clinical trial studying different ways of delivering blood transfusions, and the participant pool is composed of people who are Jehovah's Witnesses, who clearly object to blood transfusions, Dickert says.
"Most of us would think there's something wrong with going to this population to say, 'How much do we have to offer you to get you to participate in this study?'" he adds. "The problem with this is you're using large amounts of money to overcome important values that people hold."
Another concern is when participants are paid large amounts of money in studies that fall toward the risky end of the approvable spectrum, Dickert notes.
Dickert's own research has shown that the dollar amounts research participants are paid vary widely, and the variation is unexplained.1
One study showed that 11 IRBs approved 467 study protocols that paid participants from $5 to $2,000 with an overall median of $155. These payments were described in the consent forms 94.4% of the time.1
The variation occurred even among the same study at multiple sites and among similar studies.1
The findings suggest that there is little logic to the amount of money research participants are paid.
By the same token, the amount of money it would take to induce someone to become involved in a study they otherwise might avoid also varies.
"The worry becomes greater when you're offering money to overcome certain concerns about risks," Dickert adds.
References
- Grady C, Dickert N, Jawetz T, et al. An analysis of U.S. practices of paying research participants. Contemp Clin Trials 2005;26:365-375.
- Dickert N, Grady C. What's the price of a research subject? Approaches to payment for research participation. N Engl J Med 1999;341:198-203.
- Halpern SD, Karlawish JHT, Casarett D, et al. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Arch Intern Med 2004;164:801-803.
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