Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while others (...) can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation. (shrink)

This study documents how people who inject drugs in rural Puerto Rico perceive payments for participating in HIV epidemiological studies. In-depth interviews were conducted among a subset of active PWID older than 18 years of age who had been previously enrolled in a much larger study. Findings suggest that financial compensation was the main motivation for initially enrolling in the parent study. Then, as trust in the researchers developed, participants came to perceive compensation as part of a reciprocal exchange in (...) which they assisted researchers by providing a trustful account of their experiences and researchers reciprocated with financial support. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

Supervised injectable opioid assisted treament prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize that it should be (...) considered in the context of inequities in access to siOAT as a medical treatment. Consequently, we suggest that bioethics literature on nonexploitation, which focuses on clinical research in low-income countries, is helpful due to locating ethical issues within systemic social conditions. Finally, we consider the implications of our argument for the ethics of clinical research on siOAT. (shrink)

In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent individuals are epistemologically (...) and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits (...) may constitute an undue inducement for some participants in middle-income countries, where economic challenges are prevalent. A case study is presented of a single participant in a cohort of 382 participants who used concealment, fabrication and deception to ensure eligibility for a post-trial access study of an unlicensed HIV prevention technology at potential risk to her health and that of her fetus. A root cause analysis revealed her desire to access HIV prevention during an unplanned pregnancy with a partner whose faithfulness was in question. Researchers should consider implementation of systems to efficiently identify similar cases without inconveniencing the majority of participants Trial registration number NCT01691768. (shrink)

Objectives: To determine the effects of risk and payment on subjects’ willingness to participate, and to examine how payment influences subjects’ potential behaviours and risk evaluations.Methods: A 3 × 3 , between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects. Payment (...) levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating.Results: Monetary payment had positive effects on respondents’ willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents’ potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents’ propensity to neglect to tell researchers about negative effects.Conclusions: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns—notably the potential for payments to diminish the integrity of a study’s findings. Future research is critical to make sound decisions about the payment of research subjects. (shrink)

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)

Monetary compensation given to study subjects in a clinical trial is an effective tool to increase overall study enrolment, nonetheless it may stimulate some participants to commit fraud and lie about their medical history.A survey-study in 684 Hispanic prospective subjects in Mexico and USA was conducted to evaluate if a high monetary compensation would encourage them to lie about their medical history. Almost half of the subjects considered participating in a clinical trial with no compensation. Younger male individuals were more (...) likely to consider committing fraud in order to receive a relatively high compensation. On the other hand, individuals with either low or high educational backgrounds, as those with higher income, were less likely to consider committing fraud. (shrink)

1. The opinions expressed are the author's own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, Department of Health and Human Services, or any of the authors affiliated organizations.