Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden sharing; (3) fair opportunity; and (4) fair distribution of (...) third-party risks. We first map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly. (shrink)

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)

Does the content of a physically dangerous job affect the moral permissibility of hiring for that job? To what extent may employers consider costs in choosing workplace safety measures? Drawing on Kantian ethical theory, this article defends two strong ethical standards of workplace safety. First, the content of a hazardous job does indeed affect the moral permissibility of offering it. Unless employees need hazard pay to meet basic needs, it is permissible to offer a dangerous job only if prospective employees (...) have a reason other than hazard pay to choose this job instead of safer alternatives. Second, employers typically cannot justify omitting expensive safety measures by paying employees more, even if employees prefer higher pay to greater safety. Employers offering dangerous jobs must meet these two standards to avoid treating their employees merely as means. (shrink)

A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting research subjects in underserved communities from exploitation and evaluates the effectiveness of those mechanisms as responses (...) to exploitation worries. It goes on to highlight where the conceptual frameworks relied upon by research ethicists must be improved if we are to fully understand the nature of the moral claims and obligations that arise in research conducted in underserved communities. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

The U.S. Code of Federal Regulations governing federally funded research on human subjects assumes that harmful research is sometimes morally justifiable because the beneficiaries of that research share a particular vulnerability with its subjects. In this article, I argue against this assumption, which occurs in every subpart of the Code of Federal Regulations that deals with specific vulnerable populations . I argue that shared vulnerability is no exception to the general principle that harming one person in order to benefit another (...) is no more justifiable if the two people have traits in common. Further, shared vulnerability is not a reasonable proxy for any morally relevant desideratum of research, in particular the desire to benefit the worst off, the desire to avoid exploitation, and the desire to use vulnerable populations in research only when necessary. (shrink)

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)

The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well as non-participants with (...) one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies, and that medical care of industry-sponsored research trials is better than their usual medical care. The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study. The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation. Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants. (shrink)

Rapid growth in structural and functional brain research has led to increasing ethical discussion of what to do about incidental findings within the brains of healthy neuroimaging research participants that have potential health importance, but which are beyond the original aims of the study. This dilemma has been widely debated with respect to general neuroimaging research but has attracted little attention in the context of neuromarketing studies. In this paper, I argue that neuromarketing researchers owe participants the same ethical obligations (...) as other neuroimaging researchers. The financial resources available to neuromarketing firms and the social value of neuromarketing studies should command greater attention to the elucidation and management of incidental findings. However, this needs to be balanced against finite resources available within most public health systems. (shrink)

It has long been taken for granted that clinical research involving human subjects is ethical only if it holds out the prospect of producing socially valuable knowledge. Recently, this social value requirement has come under scrutiny, with prominent ethicists arguing that the social value requirement cannot be substantiated as an ethical limit on clinical research, and others attempting to offer new support. In this paper, I argue that both criticisms and existing defenses of the social value requirement are predicated on (...) what I call the “transactional model of stakeholder obligations”. I go on to problematize this framework, and to introduce an alternative framework for conceptualizing ethical obligations within clinical research. In defending this framework, which I call the “basic structure model of stakeholder obligations”, I also demonstrate how it provides a stronger grounding for the social value requirement that is not vulnerable to critiques grounded in the transactional model. (shrink)

The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry _significant_ foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would (...) be a bad deal for participants, and the research is considered justifiable because of the promise of significant potential social benefit. I argue that there is an ethical tension inherent in risky FIH research and that researchers should fairly compensate risky FIH trial participants. This does not make the risk–benefit outcome more favorable for participants; rather, it amounts to a collective reckoning with the ethical tension inherent in the research. (shrink)