CURRENT REGULATORY GUIDELINES REQUIRE the ethical review committee to consider one question when evaluating payment: Is the payment to the participant undue or coercive? Although this is a seemingly simple question, determining appropriate payment involves a series of complex issues. There is limited empirical knowledge to assist with this determination and little consensus on which elements of a study should be considered in making these decisions. For example, should the culture of the study population or the potential risks and benefits of the research be considered in the selection of appropriate payment? Following a review of national and international guidelines, the concerns and benefits of paying research participants are presented, and prior ethical debate is outlined. The current research literature on the practice of paying participants and the impact of payment on participants and study integrity are reviewed. Finally, given continued debate with limited data to help determine best practices, a research agenda is proposed to assist in the development of an empirical basis to aid investigators and ethical review committees in making appropriate decisions about payment to research participants.
The principle that payment to participants should not be undue or coercive is the consensus of international and national guidelines and ethical debates; however, what this means in practice is unclear. This study determined the attitudes and practices of IRB chairpersons and investigators regarding participant payment. One thousand six hundred investigators and 1900 IRB chairpersons received an invitation to participate in a web-based survey. Four hundred and fifty-five investigators (28.3%) and 395 IRB chairpersons (18.6%) responded. The survey was designed to gather considerations that govern payment determination and practical application of these considerations in hypothetical case studies. The survey asked best answer, multiple choice, and open text questions. Short hypothetical case scenarios where presented, and participants were asked to rate factors in the study that might impact payment and then determine their recommended payment. A predictive model was developed for each case to determine factors which affected payment. Although compensation was the primary reason given to justify payment by both investigators and IRB chairpersons, the cases suggested that, in practice, payment is often guided by incentive, as shown by the impact of anticipated difficulty recruiting, inconvenience, and risk in determining payment. Payment models varied by type of study. Ranges for recommended payments by both groups for different types of procedures and studies are presented.
Losartan, the first AT1 receptor blocker (ARB), was FDA approved 15 years ago. During those years, researchers and clinicians have developed a growing base of knowledge on the benefits of losartan, particularly for hypertension and renal disease. These benefits include decreasing proteinuria, slowing the progression of diabetic nephropathy, controlling hypertension, and decreasing stroke risk in patients with left ventricular hypertrophy. Although many of the benefits of losartan represent a class effect for ARBs, losartan has pharmacokinetic and pharmacodynamic characteristics and effects that are unique and are not a class effect. For example, a shorter duration of action is seen with this first ARB compared with other more recently approved ARBs. Losartan also has a uricosuric effect not seen in other ARBs and attenuates platelet aggregation, which is not seen or is seen to a lesser extent with the other ARBs. This review presents the physiological effects of losartan on the kidney and discusses relevant clinical outcomes.
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