Compensation for Injured Research Subjects
Date Issued
2007
Date
2007
Author(s)
Lin, Hung-Hsiang
DOI
zh-TW
Abstract
In England and the United States , litigation involving human clinical research trials has escalated rapidly in the past few years. These lawsuits raise many important questions, such as what should be the tort basis for compensating injured research subjects, and whether courts understand the differences between research injuries and ordinary medical malpractice, or how courts deal with human research trials. All of these questions are worthy of discussion.
However, since there is no such litigation in Taiwan , we have no idea how courts in Taiwan will deal with these issues. Thus, from the study of the liability and compensation for injures arising from human clinical research , this Article offers some ground-level observations and reflections that , it is hoped , may be of use to people in clinical research who might one day find themselves in a similar position .
Chapter I of this Article illustrates the incentives for writing and methodologies.
Chapter II of this Article will review general trends in this emerging litigation in England and the United States , showing that courts have not yet formulated an adequate theoretical basis for addressing the distinctive issues of research. On one hand, many courts regard research-related injuries as simply a genre of medical malpractice—an error that misunderstands the fundamental difference between research and ordinary practice. On the other hand, the relatively few courts that do clearly distinguish between research and medical practice have commonly made the mistake of placing research injuries into the realm of ordinary negligence—thereby failing to appreciate that researchers have far greater duties of care toward their subjects than the routine prudence that ordinary citizens owe fellow citizens.
After exploring courts’ confusion, this Article will lay some conceptual groundwork, discussing fundamental differences between research and ordinary medical practice. The pivotal distinction does not lie in the allegedly greater level of uncertainty characterizing research, but rather in its very different focus. Whereas ordinary medical treatment and even innovative treatment aspire to benefit the individual patient, research aims to gain generalizable knowledge, typically via protocols that, by the very essence of medical science, cannot aim to promote the benefit of any particular research subject. Research can thus subordinate the individual to a broader goal.
Chapter III will review the available causes of action in England and the United States for addressing injuries that arise through human clinical research , showing that familiar causes of action may require adaptation before they can be appropriately applied to the research context. When research injuries are pursued as negligence torts, a major shift must be recognized. Such as duty of care, injury, and causation.
Overall the part of this Article argues that, if familiar medical malpractice doctrines are applied uncritically to research injuries the dangers are, in the first place, that research participants may sometimes be left without appropriate remedy for their injuries. Reciprocally, investigators, sponsors, and others conducting research may be subjected to inappropriate or unfair standards of liability. Thus, this Article argues that human clinical trials need tort doctrines specifically adapted to the research setting.
Chapter IV explores some of the legal and ethical issues in compensating subjects for research-related injuries and describes some of the policies adopted by different institutions. One view is that sponsors and institutions are obligated to compensate injured subjects, particularly in trials with commercial sponsors and regardless of who may be to blame or whether the participants were paid. The contrary view is that routine compensation is not required because subjects are made aware of the risks through the informed-consent process, understand them, and voluntarily agree to participate.
Generally speaking, in the United States, despite decades of discussion and recommendations by national commissions, sponsors and institutions are not required to provide either free medical care or compensation, although some do. In contrast, many European countries mandate the provision of clinical-trials insurance, through which subjects are often covered regardless of fault.
Chapter V will discuss the contract and tort liability of human research in Taiwan, By analyzing how courts will apply legal doctrine in dealing with human clinical trials in the future, basing on the law system and presently judgements of similar cases .
Chapter VI discusses the insurance policy and no-fault compensation for research-related injuries in Taiwan .
Chapter VII compares the possible points of view of Taiwan’s courts on human research trials with foreign cases addressing the distinctive issues of research in chapter III .
As the energy and financing behind human clinical trials increase, litigation will assuredly increase alongside. Courts will need considerable guidance to understand that, just as clinical research differs from ordinary medical practice, research litigation differs importantly from ordinary medical malpractice litigation. Tort doctrines simply do not fit the realities of research and, if they are applied thoughtlessly in this emerging body of cases, the danger is great that research participants will be left without appropriate compensation for very real injuries, and reciprocally that investigators may be subjected to unfair standards of liability. Courts need to recognize clinical research as a distinct area of medical activity and to attune tort doctrines specifically to its nuances.
Subjects
人體試驗
臨床試驗
受試者保護
告知後同意
契約責任
侵權責任
自主決定權
無過失補償
human research
clinical research
Declaration of Helsinki
compensation
research-related injuries
human research trials
informed consent
Type
thesis
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