In need of remedy: US policy for compensating injured research participants

Pike, Elizabeth R.

doi:10.1136/medethics-2012-100771

Cited by 9 publications

(5 citation statements)

References 10 publications

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“…With the no-fault system, when a research participant is injured during participation in the research, the research team only needs to establish that it is the participation in the research that has resulted in the injury ‘causality’ regardless of who was to blame or was responsible for the injury ‘fault’ 36. Despite a few challenges (like deciding what sort of injuries qualify for compensation and to what extent14), no-fault compensation is the model currently being advocated by some ethicists as probably the most equitable compensation policy, and argue that it should be adopted by the US government as a federal regulation 1 2 9. This system is enshrined in the ABPI guidelines and a lot of countries in Europe have a no-fault compensation policy as a legal requirement before approval of any clinical trial.…”

Section: Application Of the Traditional African Dispute Resolution Symentioning

confidence: 99%

“…These developments have included a growing consensus that participants with RRIs should not be left uncompensated 1. The realisation that the USA lacks a comprehensive system for managing RRIs (as reported by the US Presidential Commission for the Study of Bioethics), and the effects such deficiency may have on global research,2 3 as well as the introduction of new and controversial regulations for clinical trial-related injury and deaths in India, have created concern about the lack of a universal approach to guide regulatory bodies and ethics committees on how to deal with RRIs globally 4 5.…”

Section: Introductionmentioning

confidence: 99%

“…In 1991, the Association of British Pharmaceutical Industry (ABPI) issued a recommendation that researchers provide written assurance that in the event of an RRI, they will pay compensation to patient-volunteers according to some set guidelines 8. Additionally, the ABPI guidelines advocated that ‘compensation should be paid regardless of whether the patient is able to prove that the company has been negligent …’, a clause which forms the basis of no-fault compensation, a model advocated by some as probably the most equitable compensation policy 1 2 9 10. The same guidelines also stated that ‘… neither the fact that the adverse reaction causing the injury was foreseeable or predictable, nor was the fact that the patient freely consented (whether in writing or otherwise) to participate in the trial should exclude a patient from consideration for compensation’ 8.…”

Section: Introductionmentioning

confidence: 99%

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Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

2016

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Compensation for research-related injuries (RRIs) remains a challenge in the current environment of global collaborative biomedical research as exemplified by the continued reluctance of the US government, a major player in international biomedical research, to enact regulation for mandatory compensation for RRIs. This stance is in stark contrast to the mandatory compensation policies adopted by other democracies like the European Union (EU) countries. These positions taken by the USA and the EU create a nexus of confusion when research is exported to low-income and middle-income countries which have no laws guiding compensation for RRIs. In this paper, we begin by exploring the background to policies concerning RRIs, how they reflect on the traditional dispute resolution mechanisms in African societies, and how this compares with the no-fault compensation model. We then explore the underlying African ethical framework of Ubuntu in the sub-Saharan region, guiding traditional practices of dispute resolution and compensation, and how this framework can help to form the moral justification for no-fault compensation as the preferred compensation model for RRIs for African countries. Finally, we call upon countries in the African Union (AU), to adopt a no-fault policy for compensation of RRIs, and enact it into a regulatory requirement for insurance-based no-fault compensation for biomedical research, which will then be enforced by member states of the AU.

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Section: Application Of the Traditional African Dispute Resolution Symentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

2016

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“…Subjects who receive no compensation may suffer additional harms if they cannot pay for their medical treatment. [42–43]…”

Section: Unequal Treatment Of Human Research Subjectsmentioning

confidence: 99%

Unequal treatment of human research subjects

Resnik

2014

Med Health Care and Philos

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Unequal treatment of human research subjects is a significant ethical concern, because justice requires that equals be treated equally. If two research subjects are the same in the relevant respects, they should be treated equally. However, not all human subjects are the same in relevant respects: people differ with respect to age, health, gender, race, mental abilities, socioeconomic status, and other characteristics. Disputes sometimes arise concerning the issue of whether subjects are the same in relevant respects and should therefore be treated equally. Allegedly unequal treatment occurs when subjects are treated differently and there is a serious dispute about whether subjects are the same in relevant respects. Patently unequal treatment occurs when there is no significant dispute about whether subjects are the same in relevant respects and they are treated unequally. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, institutional review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Additional guidance may be necessary to minimize patently unequal treatment of research subjects.

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“…The moral argumentation for the compensation of research injury is premised on three ethical principles namely beneficence, justice and reciprocity [ 2 ]. The principle of beneficence dictates that the benefits of research should outweigh the risks.…”

Section: Introductionmentioning

confidence: 99%

Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa

Chingarande

Moodley

2018

BMC Med Ethics

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BackgroundCompensation 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 (BRICS).MethodsA systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007). 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 (MeSH) 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.ResultsThe 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.ConclusionsIt 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.

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In need of remedy: US policy for compensating injured research participants

Cited by 9 publications

References 10 publications

Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

Unequal treatment of human research subjects

Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa

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