人體試驗之賠償與補償

Abstract

人體試驗在人類醫學進步中佔有重要地位，且台灣實施人體試驗之數量也將 增加，一旦受試者在人體試驗過程中遭受傷害時，如何請求損害賠償及法院如何處理人體試驗訴訟之問題，勢必成為不可忽視之問題。本文主要探討人體試驗中受害受試者之損害賠償與補償，並探求人體試驗究竟為醫療之一部份，或是在本質上與醫療行為相異？法院對於人體試驗所生傷害，究竟應適用一般過失原則或醫療過失原則？又法院在審理人體試驗訴訟時，是否可直接適用傳統侵權原則，或應隨著人體試驗的特殊性而加以調整適用？這些都仍有待釐清。 雖然我國目前並無人體試驗受試者受害而求償之訴訟例子，目前法院對於人體試驗之處理方法也尚未明確。但由於人體試驗最早源於英美，相關訴訟及賠償制度在英美已有相當程度之發展，探求英美學說及實務見解，將有助於了解上述問題。因此本文首先觀察英美法上法院對人體試驗之看法，檢視法院是否將人體試驗與醫療行為區分，若有區分，其理由為何？以及區分之後，法院對於人體試驗訴訟有無發展出特別的法律原則。 本文第一章將說明研究目的與動機、研究方法、研究範圍及研究架構等。 第二章將觀察英美法院早期之人體試驗訴訟案例，藉此了解法院是否區分人體試驗與醫療行為? 是否在人體試驗訴訟中適用不同的法律原則？或僅把人體訴訟當作一般醫療行為，而依照醫療訴訟之模式處理？最後再提出分析與檢討。 第三章則說明在人體試驗訴訟中，法院不能直接適用傳統醫療過失訴訟的法律原則。且法院在適用類似法律原則時，應考量人體試驗的特殊性而加以調整。接著論述侵權行為法律原則在人體試驗訴訟中的特殊調整與改變，並分別從注意義務、告知同意原則、因果關係、損害等，觀察法院基於人體試驗目的本質與醫療行為不同之考量，在訴訟中發展出的特殊見解。 首先在注意義務方面，將論述人體試驗中研究者對受試者之注意義務來源及義務內容，且該注意義務異於醫療行為中醫生對病人基於醫病關係之注意義務。關於告知同意部分，則探討人體試驗的說明義務的範圍與標準，是否與常規醫療中的範圍與標準相同？人體試驗之特殊性是否產生更嚴格的說明標準？又如果有特殊說明標準，其標準內容為何？法院實務對此又有何看法？至於因果關係方面，將討論主觀標準說與客觀標準說對人體於試驗訴訟的影響，以及在人體試驗訴訟判斷因果關係時，應採取何種標準。而關於傷害方面，將討論是否在傳統侵權訴訟之外，在人體試驗領域中承認特殊的傷害類型。 第四章說明侵權行為不足作為受試者請求賠償之主要和唯一方法，故英美人體試驗中受害受試者除了侵權行為之外，還有契約補償與無過失補償等救濟方式。並介紹受試者無過失補償制度之肯定理由與否定理由，及歐美各國對人體試驗受試者之補償制度。 第五章分析台灣現行法律架構之下，首先討論受試者可能主張之契約責任；次就侵權責任，從注意義務、因果關係、損害、告知義務等方面，嘗試推導出法院對於將來人體試驗訴訟可能之處理方法與觀點。 第六章說明在我國目前法制下，對人體試驗中無過失傷害之處理，並從無過失補償制度及藥物臨床試驗責任保險二方面觀察。 第七章將英美法院在人體試驗訴訟發展之調整特殊見解，與台灣法院將來可能對人體試驗訴訟之處理相互比較，分析我國與外國之作法有何不同或相同之處。 最後基於以上人體試驗賠償補償責任之探討，嘗試提出心得與建議，以供我國將來處理人體試驗訴訟時之參考。

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.