Compensation for subjects is fine as long as it doesn’t cross the line

When does inducement become coercion?

In November, national news outlets reported on Steve Rucker, a nurse at the National Institutes of Health and one of two people to receive an experimental vaccine for Ebola. He did it, he told reporters, because he knew how important vaccines were to areas of the world where medicines and expertise for treating diseases are hard to come by.

Unfortunately, sometimes clinical trials aren’t peopled with test subjects who volunteer out of the goodness of their hearts. Usually, there is some compensation involved. The problem is making sure the compensation isn’t so great that you coerce people into being part of a clinical trial.

At Duke University in Durham, NC, Debbie Brandon, RN, PhD, CCNS, director of the neonatal program and an assistant professor, says for some of the families who participate in her research, even offering a toy for a child on each visit could be considered coercive. "They may not have any toys for their child at all at home," she says. For some families, offering $35 — the amount Brandon’s most current study pays to cover parking, travel expenses, and lunch — seems like a lot.

"The compensation we give is minimal, and our IRB is very specific with us in limiting compensation to cover out-of-pocket expenses," says Brandon. She said she doesn’t know of any studies in the neonatal program that cover more than out-of-pocket expenses, and the total amount offered rarely reaches the $50 level.

That notion of limiting the amount of money given to study participants isn’t unique to Duke. A quick search of policies published on the Internet reveals similar concerns at organizations from the academic — the University of California for instance — to for-profit companies such as Pfizer.

When determining compensation amounts, there are two things to consider, says Wajeeh Bajwa, PhD, research subject advocate/regulatory consultant at Duke’s General Clinical Research Center. "First, look at the difficulty of the study and how much time is involved," he says. "If it takes eight hours or overnight, that’s much more of a hardship than something that takes an hour. Similarly, if a test involves one blood draw, that’s not as bad as one that requires a dozen of them. Compensation should reflect the level of difficulty of participation.

Bajwa adds that you shouldn’t just look at the impact of the particular day of the study on the participant, but on whether there are lasting effects. For instance, a sleep deprivation study may only take one day. But the next day is a total loss too, for the participant.

Second, you have to consider what costs the participant will incur, says Bajwa. "Will they have to pay for their own meals or will you provide them? Do they have to pay for parking? How much travel will they have to do to participate?"

What you shouldn’t consider are facts such as the going wage rate in your area, he warns. If you are keeping someone from work, you can’t try to compensate for that lost time because one participant might make $20,000 and another $100,000. How would you determine what to pay?

Sometimes, compensation is directly related to the budget of a protocol, Bajwa says. "If you have a budget of $2,000, and you want 200 patients, you have a problem if you want to offer them more than $10."

At Duke’s School of Nursing, Elizabeth E. Hill, RN, DNSc — an assistant professor, and director of the Clinical Research Management Program — is studying women who are or have been in abusive situations. "I always try to think about paying for child care, parking, and/or bus fare, and a small lunch," she says. Subjects can’t concentrate on what they are doing if they are hungry, and that’s often the case in the populations she works with, she says.

Usually, Hill pays an additional $50 for each assessment the participant attends, and says she would be uncomfortable paying up to $75 for each assessment. But that is dependent on whether she can build that amount into the grant. "I would be comfortable going up to $400 or $500 per subject on the research I do, depending on how much time they have to commit to the study, but I probably wouldn’t go much above that."

Participants in Hill’s studies are not told they won’t get paid until they complete the entire study. "I think that’s coercive and not really ethical, as they have given us their time whether they complete the study or not." In addition, if women complete an initial assessment, and Hill and her colleagues find they aren’t eligible for the study after all, they are still paid for the time they have committed, to include the child care, parking, and meal reimbursement.

She usually keeps some cash on hand to cover the reimbursement portions of the compensation as many of the participants can’t wait for a check to be cut and mailed to them.

Hill says she’s careful to make sure the dollar amounts are not so high that people would participate just for the money. Sometimes she offers products rather than money — gift certificates to local department or grocery stores or phone cards.

When she’s working with focus groups for studies, Hill tends to use door prizes and a meal. "That’s especially important if you pull people away from their dinner or lunch," she says. "It also helps them understand you are concerned about their comfort, and helps you to develop an interactive, social environment, which is important for focus groups."

Different for children?

Working with adults is one thing — money is probably the best compensation you can offer. But what about studies involving younger participants? Brandon says what to offer in protocols with children depends on the age of the children involved. For the pre-term infants with whom she works, money to cover costs the parents incur is appropriate. She also may offer a stuffed toy at the end of the study. Even for a child as old as 12 months, though, cooperation won’t likely improve with the promise of a toy. But for a 5-year-old, offering a toy at the end of participation can be an appropriate reward. Most of the studies in which older children participate involve developmental issues. In those cases, the toy provided usually is oriented to provide some developmental stimulation or intervention.

"The fact that our participants are little and very sick means that the families are often in a state of crisis," says Brandon. "That means we have to be especially careful that what we offer isn’t coercive in any way.

"You don’t want the amount to be coercive, but it has to be meaningful," Bajwa concludes. "There will always be arguments that we shouldn’t compensate people, that you should find people who are willing to do this for purely medical reasons."

The problem, he says, is that there are far too few people like Steve Rucker in the world who will roll up their sleeves to further medical knowledge. "If someone has a disease, they may be happy to participate in research on that illness," he notes. "But there probably not enough healthy participants who would do research without compensation."