Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (shrink)

This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: the categorization of increasingly risky interventions as minimal risk in a variety of protocols; the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; research on asymptomatic at risk children; and the inclusion of children and adolescents in placebo-controlled trials for participants of (...) all ages without performing subgroup analysis. While embracing the imperative to include children in research is an encouraging step towards providing the pediatric population with effective medical care and finally eradicating the therapeutic orphan, we must ensure that this research does not become overly permissive. (shrink)

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

Purpose Academic scholars have leveraged crowd work platforms such as Amazon Mechanical Turk for human subjects research for almost two decades. However, few scholars have reflected or questioned this mode of academic research. This paper aims to examine three fundamental problems of crowd work and elaborates on their lasting effects on impacting the validity and quality of human subjects research on crowd work. Design/methodology/approach` A critical analysis is conducted on the characteristics of crowd work, and three fundamental problems of crowd (...) work since its origin were identified, namely, the position of “Human-as-a-service,” the confusion of terminology and crowd work platforms’ abdication of responsibilities. Findings This paper explains that the three identified fundamental problems of crowd work render at least two lasting problems in crowd work-based research: first, the negligence of the teleological difference between crowd work and academic research; second, the ontological schism between scholars and institutional review boards (IRBs) in their ethical concerns and practices. Originality/value This paper critiques the foundation of crowd work-based research that has become growingly popular, extolled and taken for granted. Such a critique is deficient in literature and may seem a bit peculiar. However, we hold that it is time to take research ethics seriously in crowd work because we need to introspect and question ourselves as scholars: What is our motive or ethical stance in using crowd work for human subjects research? Is it for advancing scientific knowledge, promoting crowd workers’ welfare, or predominantly for benefiting ourselves from the fast, cheap and “good” data via crowd work? (shrink)

Both international and federal regulations exist to ensure that scientists perform research on human subjects in an environment free of coercion and in which the benefits of the research are commensurate with the risks involved. Ensuring that these conditions hold is difficult, and perhaps even more so when protocols include the issue of monetary compensation of research subjects. The morality of paying human research subjects has been hotly debated for over 40 years, and the grounds for this debate have ranged (...) from discussion of legal rights, economic rights, philosophical principles of vulnerability and altruism to bioethical concepts of consent, best-interest determination, and justice theory. However, the thought surrounding these issues has evolved over time, and the way we think about the role of the human research subject today is markedly different than the way we thought in the past. Society first thought of the research subject as an altruist, necessarily giving of his time to benefit society as a whole. As time progressed, many suggested that the subject should not need to sacrifice himself for research: if something goes wrong, someone should compensate the subject for injuries. The concept of redress evolved into a system in which subjects were offered money as an inducement to participate in research, sometimes merely to offset the monetary costs of participation, but sometimes even to mitigate the risks of the study. This article examines ethical and legal conversations regarding compensation from the 1960s through today, examining theories of the ethics of compensation both comparatively and critically. In conclusion, we put forward an ethical framework for treating paid research subjects, with an attempt to use this framework as a means of resolving some of the more difficult problems with paying human subjects in research. (shrink)

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how Lilly was able (...) to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”. (shrink)

This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers several practical problems (...) related to changing the amount of payment, including determining whether there is enough money in the budget to offer additional payments to subjects who have already enrolled, ascertaining how difficult it will be to re-contact subjects, and developing a plan of action for responding to subjects who find out they are receiving less money and demand an explanation. (shrink)

As the demand for human eggs for stem cell research increases, debate about appropriate standards for recruitment and compensation of women intensifies. In the majority of cases, the source of eggs for research is women undergoing fertility treatment requiring ovarian stimulation and egg retrieval. The principle of "just participant selection" requires that research subjects be selected from the population that stands to benefit from the research. Based on this principle, infertile women should be actively recruited to donate eggs for fertility-related (...) research only. It is unethical to exclusively or predominantly recruit infertile women to donate eggs for stem cell research that concerns general medical conditions. It is preferable to recruit women from the general population to donate eggs for such research, and these women should be viewed as healthy volunteers. To avoid exploitation, these donors should receive compensation for both the direct and indirect costs associated with their donation. (shrink)

ABSTRACTThis paper begins with the assumption that it is morally problematic when people in need are offered money in exchange for research participation if the amount offered is unfair. Such offers are called ‘coercive’, and the degree of coerciveness is determined by the offer's potential to cause exploitation and its irresistibility. Depending on what view we take on the possibility to compensate for the sacrifices made by research participants, a wish to avoid ‘coercive offers’ leads to policy recommendations concerning payment (...) for participation. For sacrifices considered compensable, we ought to offer either no payment or payment at a level deemed fair, while for sacrifices deemed incompensable, we always ought to offer no payment because as compensation appears and increases, so too does coercion. This article provides a model for thinking of the way in which degrees of exploitativeness, irresistibility, and coerciveness interact with the size of the reward for compensable and incompensable cases. T... (shrink)

Lowering compensation to research subjects to protect them from “undue inducement” is a misguided attempt to shoehorn a concern about exploitation into the framework of autonomy. We suggest that oversight bodies should be less concerned about undue influence than about exploitation of subjects. Avoiding exploitation in human subjects research requires not only increasing compensation, but enhancing the dignity of research participation.