Regulating the Market in Human Research Participants

I n the past couple of years, several investigations by the Offi ce of the Inspector General (OIG) of the US Department of Health and Human Services (DHHS) have drawn attention to the use of recruitment incentives in research. In 2003, Toronto's Globe and Mail reported that the pharmaceutical company Biovail became the subject of an investigation because it paid $1,000 per patient to American physicians who managed to renew prescriptions of its new drug Cardizem LA for at least 11 patients. The company argued that the payments were a reward for data gathering for post-marketing research [1]. Less successful physicians received only $250 per patient. In 2005, the OIG started an inquiry into payments made by Advanced Neuromodulation Systems to physicians who implanted a pain-management device in their patients for a fi ve-day trial [2]. According to the Wall Street Journal , those who managed to implant the device in at least fi ve of their patients received $1,000 for " data collection and management of the trial process. " Although the OIG has not yet released results of either investigation, it previously documented in 2000 other examples of troubling practices in a special report on the use of recruitment incentives [3]. Among them were an Internet advertisement by a family medical practice, highlighting their ability to quickly recruit patients for drug trials and post-marketing studies using two full-time research coordinators and their computerized patient database; and an industry article on recruiting patients into studies, recommending that researchers secure " an endorsement by your well-respected newspaper reporter or TV news anchor " to generate " more phone calls needed to fi ll studies. " These examples have to be understood in the context of the pervasive commercialization of medical research. General concerns relating to commercialization have received considerable attention. The practice of paying research participants has also been extensively debated [4–8] but remains inadequately regulated [9]. Much less attention has been paid, however, to issues surrounding " fi nder's fees " and other recruitment incentives issued to physicians for successfully referring patients to clinical trials investigators. This article aims to partly fi ll this void. The increasing prevalence of recruitment incentives is directly related to growing competition between research sponsors. More pharmaceutical clinical trials are being undertaken than ever before. US statistics indicate industry investment of increasing magnitude in clinical trials. As of 1999, more than 450 heart, cancer, …