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)

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, (...) this article shows that decontextualized discussions of this putative moral obligation are problematic. (shrink)

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects (...) with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone. For 40 years, national advisory panels have concluded that this result is out of step with the Common Rule's otherwise protectionist promise. When the Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM) in 2011, suggesting potential changes to the Common Rule, the time seemed ripe to address research-related injuries. The ANPRM, however, makes no mention of compensation for research-related injuries, and the federal government once again seems poised to stop short of addressing what has arguably become the most longstanding, frequent, and consistent plea for regulatory reform of research: protections for injured subjects. This article asks why, despite decades of federal-level panels recommending no-fault compensation for research-related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees' articulation of multiple ethical principles – including humanitarianism, professional beneficence, and compensatory justice – results in incongruent obligations that favor different kinds of compensation systems. This outcome, which I call “moral gridlock,” makes it extremely difficult to determine what kind of compensation scheme to implement. Recognizing that each moral argument for compensation creates a slightly different trajectory is, however, an important first step in moving toward a more systematic approach to compensating injured research subjects. (shrink)

In early 2013, the Indian government introduced new rules governing the conduct of clinical trials involving human participants. Among other provisions, the law requires that sponsors of research compensate participants who are injured during the course of their research participation. This article examines the effects of India's compensation law and the efforts that policymakers in India have made to tailor the law since its passage. I use the legal concept of acoustic separation as a framework to explain and justify the (...) approach that India has taken in refining its regulation of research related injuries. I conclude that India's example may provide useful lessons for research sponsors and lawmakers in other regulatory states seeking to promote a well-regulated biomedical research industry. (shrink)

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of proposed research rest on (...) the presumption that the research enterprise owes subjects a duty of protection. (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)

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...) in recognition that there may be personal benefit from participation in some studies?The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (shrink)

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...) in recognition that there may be personal benefit from participation in some studies?The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (shrink)

Must treatment be provided to subjects who acquire HIV during the course of a prevention study? An analysis of ethical foundation, regulation, and recent argumentation provides no basis for the obligation. We outline an alternative approach to the problem based on moral negotiation.

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...) the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa. A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration. The search focused on three (...) main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis. The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees. It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence. (shrink)