In watching respiratory therapists recruit for two studies under way in her departments at both Mount Sinai Hospital and SickKids Hospital in Toronto, neonatologist Sharon Unger thought she saw a trend.
It appeared that respiratory therapists were talking to far more parents about entering their infants into the large, multi-center trial that rewarded recruiters for successfully enrolling subjects than for a similar study simultaneously being conducted by a research fellow who offered no incentives.
“There were so many approaching me about one over the other, it was obvious—but it was just an observation,” recalls Unger, who, as the attending physician, had to review each request by a respiratory therapist to discuss both trials with parents.
Studying the Studies
To figure out if her hunch was on the money, Unger decided to conduct some retrospective research. The larger study looked at what was already the standard of care: giving a particular common drug to newborns to stimulate them into breathing on their own just after a breathing tube was removed. The much-smaller neonatology fellow's study looked at using two different modes of ventilation just as the infant's breathing tube was taken out. Thus, the main eligibility criterion for the two studies was virtually the same: pre-term newborns poised to come off ventilation.
“Children could only be in one study and it was up to the 10 respiratory therapists to equally distribute the patients,” says Unger, who collected the log books for each study and subsequently poured over the approach rates. A close look proved that what Unger suspected was correct.
“The approach rate was much, much higher for the trial that had a lot of funding,” she confirmed. Respiratory therapists approached 43 parent sets about that trial, and only 12 regarding the other one. Distribution: not so equal. When asked, the respiratory therapists reported that they did not feel the financial incentives or lack thereof influenced their recruitment approach.
Approach vs. Consent
But there was a surprise: the consent rate was much higher for the smaller trial. Of the 12 parent sets who were approached, all enrolled their newborns. Of the 43 who were approached for the trial with some heft and money behind it, just 16—or 35 percent—consented.
Unger's paper , “Motivated by Money? How Financial Incentives Affect Clinical Study Recruitment,” was published in the Hastings Center journal "IRB: Ethics & Human Research." It joins only a very small group of studies on the ethics of paying researchers to recruit patients.
What accounted for the difference in recruiting rates? Unger theorizes that respiratory therapists who were being incentivized may have come off as too assertive and triggered parental distaste. Another possibility is that the therapists themselves might have acted with hesitancy due to what Unger calls “the white elephant in the room”—remuneration.
It wasn't cash. Respiratory therapists who successfully enrolled patients essentially earned points for themselves and coworkers to attend a professional conference at a ski resort in Utah.
The patients were unaware of any such incentives. Now—years later—it's becoming more standard among informed consent processes to reveal such incentives. It's also becoming more standard to offer incentives for the time spent recruiting rather than only for successful enrolling of subjects, says Unger, adding that that takes some of the pressure off both those recruiting and those being recruited.
“It's unethical to provide remuneration for positive recruitment, but at the same time, you can't expect people to use their coffee breaks to recruit,” says Unger. “There are huge pressures in medical research. In order to insure success, people do require payment for the time spent trying to recruit.”
Could the differences in recruiting success for these two trials have been due to the details of the research? Maybe. Unger wonders if some parents, upon learning the drug being studied had been the standard of care for 20 years, decided not to risk their children being assigned to the control group and potentially not receiving the standard of care.
It all remains murky, according to Unger, while the industry continues to try to work out the ethical issues as that the number of commercially sponsored trials is growing.
“There are no metrics, data or anything of that nature that has lead to a standard” for institutional review boards (IRBs) when considering the ethics of remuneration for positive recruiting within a prospective trial put before it for review, says Felix Gyi, an IRB industry veteran and CEO of Chesapeake Research Review in Columbia, MD. “There's a lot more that needs to be done in this area to help us understand whether patient recruiters are properly focused on the human protection element or not.”
The study's other authors include Karel O'Brian, staff neonatologist at Mount Sinai Hospital and SickKids Hospital; Leslie Wylie, manager of the Neonatal Neurodevelopment Follow-Up Program at the two hospitals; Shafagh Fallah, a statistician at Mount Sinai Hospital and University of Toronto; and Lee Heinrich, chief of anesthesiology at Southlake Regional Hospital.
—by Suz Redfearnd9A2t49mkex