2015
DOI: 10.1093/jlb/lsv034
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Just compensation: a no-fault proposal for research-related injuries

Abstract: ABSTR ACTBiomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort… Show more

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Cited by 14 publications
(17 citation statements)
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“…For example, proposals to create a system of no-fault compensation for harm caused in both the research and clinical domains would reduce the differences. 40 Another option is to apply the fifth guideline and assure research participants that harm caused in the portions of the protocol that are both research and clinical care (such as incorporating genomic findings intended for clinical care use into the medical record) will be governed by the law of clinical care. This applies the decision rule in the fifth guideline as it avoids restricting the individual's access to the courts to adjudicate claimed harm.…”
Section: Liabilitymentioning
confidence: 99%
“…For example, proposals to create a system of no-fault compensation for harm caused in both the research and clinical domains would reduce the differences. 40 Another option is to apply the fifth guideline and assure research participants that harm caused in the portions of the protocol that are both research and clinical care (such as incorporating genomic findings intended for clinical care use into the medical record) will be governed by the law of clinical care. This applies the decision rule in the fifth guideline as it avoids restricting the individual's access to the courts to adjudicate claimed harm.…”
Section: Liabilitymentioning
confidence: 99%
“…These two aspects especially concern surgeons compared to clinicians, since they have a higher risk of medico-legal events 27 since they are involved in surgical procedures which, in most cases, are at high risk of errors due to their complexity and difficulty. Moreover, in support of the no-fault compensation system, the 1982 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical Behavioral Research stated that “a successful compensation system would treat like cases alike, make fair payment for the harm sought to be remedied, and disburse funds with maximum efficiency and minimum administrative cost” 28 .…”
Section: The No-fault Compensation Systemmentioning
confidence: 99%
“…12 There have been complaints that rules for compensation for clinical trial injuries are complicated, 13 there have been proposals for a simple compensation formula even in the US, where no compensation is provided by country's law. 14 Nominee and legal heir are two distinct parties. The Legal Dictionary defines a nominee as "a person or entity who is requested or named to act for another, such as an agent or trustee."…”
Section: Compensationmentioning
confidence: 99%