The payment of human subjects is an area where Institutional Review Boards have wide discretion. Although the “Common Rule” requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation cautions that high payments for risky research “may induce a needy participant to take a risk that they normally would prefer not to take.” (...) For research under its purview, the Food and Drug Administration guidance provides that “[a]dvertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.” One might read the FDA guidance to permit the advertisement for human subjects to state the specific amount of payment, as long as it is not emphasized. (shrink)

Psychology departments often require undergraduates to participate in faculty and graduate research as part of their course or face a penalty. Involuntary participant pools in which students are compulsorily enrolled are objectively coercive. Students have less autonomy than other research participants because they face a costly alternative task or the penalties that accompany failure to meet a course requirement if they choose not to participate. By contrast, other research participants are free to refuse consent without cost or penalty. Some researchers (...) claim that the educational value of participation justifies the requirement. They treat coercion as a cost that can be outweighed by the benefits to students. This paper argues that such an approach is flawed because coercion is not like other costs and that educational value is inherently low relative to personal study or classroom time. The unethical nature of involuntary participation is best demonstrated with an opportunity cost analysis. This shows that students are forced to sacrifice higher value alternatives that they have paid to do and undertake a lower value activity that principally benefits others. Faculty have a conflict of interest as they are the beneficiaries of student coercion in their role as researchers and responsible for student achievement in their role as teachers. Voluntary participant pools can resolve this conflict but at the cost of reducing the supply of participants. A change in departmental research conduct is required to restore the autonomy of students who are competent adults and not legitimate subjects of paternalism when it comes to research participation. (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)

Volume 19, Issue 9, September 2019, Page 64-66.

In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set of—more or less well-justified—ethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. It argues that researchers have aprima faciemoral obligation to offer payment to research subjects, which stems from the principle (...) of social beneficence. This principle constitutes an ethical “spine” of the practice. Other ethical principles of research ethics (respect for autonomy, individual beneficence, and justice/fairness) make up an ethical “skeleton” of morally sound payment schemes by providing additional moral reasons for offering participants (1) recompense for reasonable expenses; and (2a) remuneration conceptualized as a reward for their valuable contribution, provided (i) it meets standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive (i.e., it does not constitute undue inducement for participation or retention, and does not encourage deceptive behaviors); or (2b) remuneration conceptualized as a market-driven price, provided (i) it is necessary and designed to help the study achieve its social and scientific goals, (ii) it does not reinforce wider social injustices and inequalities; (iii) it meets the requirement of non-exploitation; and (iv) it is not overly attractive. The principle of justice provides a strong ethical reason for not offering recompenses for lost wages (or loss of other reasonably expected profits). (shrink)

Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, (...) coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment. (shrink)

Volume 19, Issue 9, September 2019, Page 1-4.

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.

Volume 19, Issue 9, September 2019, Page 66-68.

Volume 19, Issue 9, September 2019, Page 5-7.

The practice of paying prisoners to for their participation in research has long been debated, and the controversy is reflected in the differing policies in the U.S. prison systems. Empirical study of financial payments to inmates who enroll in research has focused on whether this practice is coercive. In this study, we examined whether monetary incentives have the potential to be unduly influential among fifty HIV‐positive prisoners. The majority of prisoners surveyed believed that inmates should receive some compensation for their (...) involvement in research and disagreed with statements suggesting that the offer of payment constitutes undue influence. However, a sense of potentially being susceptible to undue influence was significantly higher among participants who had spent a longer time in prison and had less education. Overall, our findings suggest that most prisoners feel that they would be able to make a decision about research enrollment that is not solely based on an offer of monetary payment. (shrink)

Given that the concept of coercion remains a central concern for bioethics, Quigley's (Monash Bioethics Rev 32:141–158, 2014) recent article provides a helpful analysis of its frequent misapplication in debates over the use of ‘nudges’. In this commentary I present a generally sympathetic response to Quigley’s argument while also raising several issues that are important for the larger debates about nudges and coercion. I focus on several closely related topics, including the definition of coercion, the role of empirical research, and (...) the normative concerns at the core of these disputes. I suggest that while a degree of precision is certainly required when deploying the relevant concepts, perhaps informed by empirical data, we need to continue to push these debates towards more pressing normative considerations. (shrink)

We examine the ethical, social, and regulatory barriers that may hinder research on therapeutic potential of certain controversial controlled substances like marijuana, heroin, or ketamine. Hazards for individuals and society and potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of these substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may, however, limit research on their considerable therapeutic potential. We review (...) the surprisingly sparse literature and address the particular ethical concerns pertinent to research with illicit and addictive substances, such as undue inducement, informed consent, therapeutic misconception, and risk to participants, researchers, and institutions. We consider the perspectives of key research stakeholders and explore whether they may be infected with bias. We conclude by proposing an empirical research agenda to provide an evidentiary basis for ethical reasoning. (shrink)

ABSTRACTThe provision of gifts and payments for healthy volunteer subjects remains an important topic in global health research ethics. This paper provides empirical insights into theoretical debat...

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)