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2.2. Human Subject Research - Ethical and Legal Approaches for Compensation for Research Induced Injury in Taiwan

-Huei-Chih Niu, L.L.M., Ph.D
Assistant Professor, Institute of Law for Science and Technology, 
National Tsing Hua University, 101, Sec.2 Kuang-Fu Road,
HsinChu 30013, Taiwan, ROC
Project Investigator, the Core Project on ELSI Research sponsored
by National Science Council, Taiwan 2002
Email: hcniu@mx.nthu.edu.tw

1. Introduction

Pain, physical disability, or even death is sometimes heard when human subjects participate in biomedical research. However, even after a long history of debates, there is not yet a commonly accepted conclusion about the extent that research subjects who suffer physical injury as a result of their participation in experiment are entitled to financial or other assistance as would compensate equitably for any temporary or permanent impairment or disability.

With this in mind, the current paper is divided into three major parts to address the issues of compensating injured human subjects. The attempt of the first part is to briefly describe some background stories of the clinical trials. Recent tendencies of lawsuits targeting on research subjects' injuries will be also introduced. Part two turns to deal with various ethics, moral norms that aim to protect the human subjects in addition to offer a basis for compensatory justice. The third part tends to refer to the Civil Law of Taiwan and examine if all the injured human subjects can find a legal ground to bring action against the researchers under three cited circumstances. Finally, as the evolving biotechnology such as gene therapy may impose scientifically uncertain risks to the human subjects, the author seeks to examine whether the development of legal or ethical means should be parallel to the rapid innovation of the modern biotechnology to deal with the uncertain risks to human subjects, participating in the clinical trials of gene therapy.

2. Clinical Trials and Recent Tendency of Lawsuits Targeting Medical Research in USA

2.1 The Functions of Clinical Trials

It would be the beginnings of medicine itself when human subjects were used in medical experimentation. Clinical trials, in which new biotechnology and other medical products are tested on human subjects, are important to medical progress and improvement of public health. Because these researches are designed and managed to generate useful data or evidences for both the investigators and health authority to determine whether the medical innovations such as new biotech and other medical products are safe and efficacious enough for healthcare. Thus, clinical trials indeed are a learning process with two primacy functions: an operational function to discern whether the new product or process can efficiently provide anticipated benefits; and a safety function to identify the risks of the tested new technology or medicine, which may be latent and unknown at the outset, and to determine if these risks are manageable.[1]

Apart from the dual societal functions, in the light of remedying the human subjects' illnesses, research on human subjects is equally important. At least these people are direct beneficiaries. However, benefits as such may not always result. Instead, human subjects could be hurt as the result of the test. Especially when those people were the pioneers to the research of a new drug or technology, which are at their early stages such as the try-and-error test. Physical injury or death could also occur when experiments involve negligence, or sometimes even intention, of the investigators when operating the test.

2.2 Three Types of Lawsuits Targeting Medical Research in the USA

In the USA, lawsuits for genetic or medical research were hardly heard of before the death of one subject human, Jesse Gelsinger, in 1999. Mr. Gelsinger participated in a gene theory experiment as the 18th human subject, conducted by Dr James W. Wilson in University of Pennsylvania.[2] This 18-year-old young man had a relatively mild form of a rare metabolic disorder, which was manageable through diet and drug regimens. He voluntarily enrolled in the clinical trial to test the therapy for the benefit of others suffering from similar diseases related to liver function. However, he developed systemic blood clotting within the day of receiving the therapy. Following was the suffering of respiratory disease, liver and kidney failure, and he died on the day three. This tragedy ended up with a multimillion-dollar compensation to his family in one year later. This settlement, however, opens the door to other suits by focusing national attention on the flawed protections for study participants.[3]

Three types of allegations can be observed in the lawsuits following the Gelsinger case. First, physical injury or wrongful death claims are of course the major causes that lead to the lawsuits. For instance, a Philadelphia woman contends she lost complete control of her bowels as a result of an experiment at Graduate Hospital of Philadelphia. In addition, a Peabody woman seeks damages for the death of her husband during a gene therapy experiment at St. Elizabeth's Medical Center in Brighton.[4]

Second, lawsuits point to dignitary harm. A 3.8 million settlement was made in 2000 for a drug study of poor women with high-risk pregnancies in the University of South Florida and Tampa General Hospital. As a matter of fact, none of the women or their babies suffered any physical harm. However, the women asserted they weren't told the drugs were experimental or that they could refuse to participate, and they said the consent form was far above their reading level. The other similar case focuses also on requirements that patients in experiments knowingly consent to the risks before agreeing to participate. Dolores Aderman contends she suffered emotional harm because the University of Pennsylvania gene therapy investigators didn't fully disclose the experiment's risks, including that a similar test made monkeys ill, or the university's investment in marketing gene therapy.[5] The significance of these two cases seem to overrule the "no harm no foul" principle in the biomedical research, and suggest that touching someone without their consent would violate their basic human dignity and is independently compensable.

The third ground for lawsuits over human subjects research targets inadequate oversight experiments of the ethics committees, such as alleged by the plaintiff in the above-mentioned Graduate Hospital of Philadelphia case. Although no review board member has ever been held liable by the courts for problems in an experiment due to the weak link in experiment safety, settlements from hospitals where the panels were included as defendants are however heard. As a result, some hospitals found the suits are making it more difficult to recruit investigators and citizens to take on the voluntary duties of a review board member.[6]

3. Major Ethical Principles for Protecting Human Subjects in Medical Experimentation and Biomedical Research

3.1 The Nuremberg Code and the Declaration of Helsinki

Not until the late nineteenth century, the use and safety of human subjects in biomedical research did not become one of the major ethical concerns in the Western society. French Professor Claude Bernard, for instance, wrote in 1865, "Physicians should never perform on a human an experiment that might be harmful to any extent, even though the resulting knowledge might be advantageous to science or to the health of others."[7] Almost 80 years latter, the legitimacy of research on human subjects became an international matter, followed by the famous Second World War Crimes Trial of the Nazi physicians.[8] In the very case, the trial court sought a historical framework of medical standards from which to judge the Nazi physicians and attempted to elucidate the scope of medical experimentation undertaken by the Nazi, and other physicians and scientists, during the Second Would War. Finally the court attempted to establish a set of principle of human experimentation that could serve as a code of research ethics. The Nuremberg Code was therefore made and consists of ten principles:[9]

  1. The voluntary consent of a human subject to experimentation is absolutely essential. The subject should have legal capacity to consent and sufficient knowledge and comprehension of the nature of the experiment and risks involved to make an informed and enlightened decision.
  2. The experiment should be designed to yield fruitful results for the good of society, unobtainable by other methods or means of study and not random and unnecessary in nature.
  3. Anticipated results of the experiment should justify its performance.
  4. The experiment should be conducted so as to avoid all unnecessary physical and mental suffering and injury.
  5. No experiment should be conducted where there is a priori reason to believe that death or disability will occur.
  6. The degree of risk to be taken should never exceed the humanitarian importance of the problem to be solved by the experiment.
  7. The experimental subject should be protected against even remote possibilities of injury, disability, or death.
  8. Only scientifically qualified persons should conduct the experiment.
  9. During the course of an experiment, a human subject should be free to end the experiment.
  10. During the course of an experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if there is reason to believe that continuation of the experiment is likely to result in injury, disability, or death to the subject.

The Nuremburg Code was not very influential to the development of subsequent ethical principles. In fact, efforts in worldwide tended to adopt ethical principles for research and experimentation to go beyond certain limitations of the Nuremburg Code. In 1954, the World Medical Association (WMA) established a set of ethical principles, including the ground for surrogate consent, which was not addressed in the Nuremburg Code, in the event a research subject was too ill to consent for him or herself. Then, it was the Declaration of Helsinki, issued in 1964 by the WMA, which treats clinical research occurring in conjunction with medical care and those with no therapeutic potential differently. The concept of a committee functioning to oversee the ethics and safety of proposed research involved human subject was first introduced in the 1975 revision of the Declaration of Helsinki. This Declaration is now one of the major international guidelines that are applied to evaluate the ethicality of human subject research.[10]

3.2 The Belmont Report

It is also noteworthy that in the USA, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report to deal with biomedical research involved human subjects.[11] Three succinct but important principles are adopted in this Report and have considerable influence to the development of subsequent medical policies and regulations, and provide the basis for virtually all commentaries on the ethics of research involving human subjects. These principles are:[12]

Respect for persons

This principle incorporates at least two basic ethical convictions: First, that individuals should be treated as autonomous agents[13], and second, that persons with diminished autonomy and thus in need of protection are entitled to such protection.[14]

In the other words, the Belmont Report requires the investigators to treat individuals as autonomous and to protect those who are not autonomous. An autonomous person is "an individual capable of deliberation about personal goals and of acting under the direction of such deliberation."[15] Accordingly, the investigators must help the subjects to affirm their authority and enhance their capacity to be self-determining. The concept and process of informed consent,[16] full disclosure of information about a study to a research subject by an investigator so as to ensure the information has been fully understood by the subject and the decision of the subject's participation is made voluntarily, therefore is curial to this principle.

Beneficence and do no harm

Beneficence is linked to "do no harm", or stated in Latin as, "primum non nocere".[17] This is a very fundamental principle that firmly embedded in the ethical tradition of medicine.[18] This concept is based on the Hippocratic axiom "As to disease, make a habits or two things - to help, or at least to do no harm."[19] In striving to avoid restriction, the Report even attempts to refute the "do no harm" rule, and replace it with a qualitative balancing analysis:

"cAvoiding harm requires learning what is harmful; and in the process of obtaining this information, persons may be exposed to riskcLearning what will in fact benefit may require exposing persons to risk. The problem posed cis to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks."[20]

Apart from the requirement of "do no harm", the concept of beneficence involves also the other general rule, "maximize possible benefits and minimize possible harms."[21] This ethical standard requires that risks to research subjects are reasonable in relation to anticipated benefits, or can be justified by "the humanitarian importance of the problem to be solved by the experiment."[22] A good research design,[23] in addition to competent investigators are anticipated and necessary under the requirement of this principle.[24]

Justice

This very principle implied fairness in the distribution of both benefits and burdens of research[25] - especially that the "burdens" or risks of research are not borne only or merely by disadvantaged group (e.g. the poor, ethnic or racial minorities) when potential advantages of research stand to benefit all. It is obvious that the justice principle involves equitable subject selection.[26] Although it remains debatable in regards to what constitutes a fair sharing, and how to fairly select research subjects.[27]

3.3 Ethical Norms for Compensation for Research-induced Injury

For the purpose of the present paper, it is also important to note the ethical norm of compensation for research-induced injury. Little doubt should be put to suggest when one invites human beings to participate in activities that expose them to risk of injury, it is generally necessary to offer them in return something they find valuable. It may be true that in the extent of research involving human subjects, the most generally acceptable item of value that can be offered is a promise to pursue benefits either to the individual subjects or to other with whom they feel a bond of kinship.[28] However, in the case that someone participates in biomedical research and is physically injured as a consequence of the very experiment, financial assistance or compensation may be considered as another valuable item. To address this issue, in its International Ethical Guidelines for Biomedical Research Involving Human Subject, the Council for International Organization of Medical Sciences' (CIOMS) states in number 13: "Research subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate equitably for any temporary or permanent impairment or disability."[29] In addition, CIOMS notes in the commentary under its guideline number 13: "In some societies the right to compensation for accidental injury is not acknowledged. Therefore, when giving their informed consent to participate, research subjects should be told whether there is a provision for compensation in case of physical injury, and the circumstances in which they or their dependants would receive it."[30]

4. Legal Basis for Compensating Injured Human Subjects in Taiwan

4.1 Four Major distinctions for Human Subject Research Regarding Compensation

As suggested by Professor Ackerman, human subject research in regards to compensation issues can be classified into several groups on the basis of four major concerns.[31] Every group has a pair of instances. First of all, research injuries in some cases the subjects can posse legal means for securing redress. In other cases those who suffer injuries can refer to no legal resources. Second, therapeutic research procedures are performed in order to benefit the individual subjects, as well as to produce generalizable knowledge. Some researches are performed with no intention to benefit the subjects, but solely to produce generalizable knowledge. This distinction is crucial to disputes about the limits of the moral obligation to compensate injuries, the extent of the need for a program, and the practicality of any scheme for identifying compensable injuries. [32]

The third group concerns the reasons for which subjects participate in clinical research. Most subjects enter trials of therapeutic procedures to secure personal benefits, especially the opportunity to receive a new treatment that may be more efficacious or safe than existing therapies. On the other hand, subjects may participate in studies involving only nontherapeutic research procedures anticipate not medical benefit but an attractive payment. This group offers an important point of contention, i.e., whether personal sacrifice for the common good is a necessary condition for a valid claim against society for compensation of injuries. [33]

A final distinction concerns the difference between medical research that is undertaken at the behest of society and research not similarly sanctioned. Whether an obligation to compensate injuries should be limited to subjects in research sanctioned by the official agencies of society or should extend to all research that contributes to the common welfare is the important issue brought by the difference examples in this group. [34]

When no legal means is available for compensation, moral bases are applied to argue the society has an obligation to establish a compensation program so as to improve the overall cost-benefit ratio of biomedical research, and to justly distribute the benefits and burdens. However, it is also suggested that such a moral approach would have several serious shortcomings. For instance, it is argued some advantages claimed by moral approach in fact solely depend on unproven factual assumptions. Thus the availability of compensation would not necessarily encourage participation in research by persons who might demur in the absence of protection against personal loss.[35] Correct or not, it remains to be observed. As a legal issue, the following part of present paper will explore merely the legal regime of Taiwan to deal with compensation issues in the first group of research subjects' injury.

4.2 Brief Introduction to Taiwan's Major National Guidance for Human Subjects Protection

In the national level, Taiwan's human subject research is subject to several medical related laws, regulations and practice guidelines. Defined by the Medical Care Act 1986, article 7: "human experiment means any experimental study involving humans for testing new medical techniques, new drugs, and new medical devices." Three major characteristics can be observed. First, only teaching hospitals can conduct biomedical research involving human subjects.[36] By far, there are 129 teaching hospitals in Taiwan. Second, before undertaking such clinical trials, teaching hospitals must propose "research protocols" to the Review Board of Department of Health (DOH) for the approval of clinical trials.[37] Third, a consent form shall be obtained from the human subject, informed of the full consequences of this research by the investigators before the clinical trial is undertaken.[38]

Apart from the Medical Care Act 1986, other medical laws, regulations and guidelines provide further detailed requirements or standards for using human subject research for special purposes. The Pharmaceutical Act (1993), for instance, requires investigational new drugs (IND) to receive clinical trials for testing their safety and therapeutic efficacy prior to the DOH approval.[39] Other important rules include but are not limited to: Guideline for Good Clinical Practice, adopting principles for medical institutes and protecting trial subjects;[40] Guideline for Clinical Trial on New Medical Techniques, setting new medical procedures for clinical trial;[41] Guideline for Clinical Trial on Gene Therapy, establishing safety monitoring system on the research protocol of gene therapy proposed by the qualified hospitals.[42]

Before a research protocol is proposed to the Review Board of the DOH, it must be oversight and approved by a hospital IRB as an institutional level of surveillance. The first Institutional Review Board (IRB) was established in 1986 according to the Medical Care Act 1986, article 73. Until 2001, 25 IRBs and ethics Committees are registered, working for improving medical system and overseeing research protocols. In 1997, medical society decided to set up an IRB on a joint level. As a result, the Joint IRB (JIRB) established, which has 18 members, who are representatives from 5 major medical centers and NHRI, and one third of them are laypersons. The JIRB is now the major IRB in Taiwan and nearly 40 hospitals have authorized JIRB and endorsed its review results.

All these rules aim to build up a process or mechanism to ensure the safety of the human subjects participating the researches. However, no remedy in regard to compensation when the participants are injured seems to be offered in these medical rules. The civil law perhaps is the only legal ground that the suffering subjects can rely on to bring claim for compensation against the research institutions.

4.3 Legal Means for Injured Subjects in Taiwan

As above mentioned, injury to the human subjects may occur as a result of researcher negligence when subjects have not been adequately informed of the risks involved or when due care has not been exercised in protecting them from risks. It may also be a result beyond the predictability on the basis of the present science and technology. In the former instances, injured persons may bring civil suits for damages against investigators. However, to explore the remedy for the latter cases would be a rather complicate and difficult task.

4.3.1 Remedies for Human Subjects Suffering Physical Harm

Article 184 of the Civil Law in Taiwan offers the major governing rules to address wrongful acts and charges civil liability to the actors/ debtors. Three types of wrongful acts are subject to this provision and the actors are liable for compensating the damages. First instance happens when a person intentionally or by his own fault wrongfully injures the rights of another.[43] This provision applies also to the situation that the injury is done intentionally in a manner contrary to not law but the rules of good morals.[44] Third, article 184 deems a person to be liable for his wrongful act when he infringes a statutory provision enacted for protection of others. In such a circumstance, this person is presumed to have committed a fault.[45]

It would be little doubt that article 184 applies to the medical cases the physical injury to the human subjects occurred as a result of researcher negligence. However, what constitutes the wrongful act would be clarified at the first place due to different types of faults refer to different part of this provision. Regardless how difficult it would be to prove the investigators' negligence or lack of exercising due care in protecting the subjects, provided evidences existed firmly to illustrate the casual linkage between the physical harm and the mistakes or careless of the investigators, it is a wrongful act. The human subject whose physical right is injured can rely on the first half of paragraph one of Article 184 to demand compensation for his physical suffering. Moreover, the compensation is not limited to the amount spending on recovering the physical harm. If the wrongful injury makes the human subject's earning capacity lost or decreased, or makes an increase of the subject's necessities arises, the investigator would be bound to make compensation to the injured subject for further damage arising there from.[46] In the case of injury to the body or health, the Civil Law authorizes the injured subjects to claim a reasonable compensation in money for damage, as is not purely pecuniary loss.[47] Furthermore, according to article 188 of the Civil Law, the employer is jointly liable to make compensation for any damage, which the employee wrongfully causes to the rights of another person in performance of his duties. Thus the injured human subjects are entitled to claim compensation from both the in charged investigators and the conducting research institutions, i.e. the teaching hospital.

Different types of wrongful acts happen when the researchers or institutions fail to follow the requirements or processes as set in the Medical Care Act 1986 or other medical rules. For instance, when a clinical trial is operated with no approval or permission of the IRB or Review Board of the DOH,[48] or is conducted by a not teaching hospital,[49] it is subject to the second paragraph of Article 184 of the Civil Law, infringing a statutory provision enacted for the protection of others. If the intention of the undertaking institution to perform a wrongful act is proved, the injured human subjects can refer also to the first half of paragraph one of the same provisions.

Similarly, in the case the injury occurred, and human subjects have not been adequately informed of the risks involved, the injured subjects can have recourse to both the first half of paragraph one, and the second paragraph of article 184. However, when referring to the first half of paragraph one of article 184, the short of informed consent is due to the intention or the negligence of the investigators must be distinguished.

Resorting to medical contract is another ground for compensation. Article 227 of the Civil Law states the debtor is liable for the damage of the counterparty when he fails to conduct the requirements as set in the contract among between. Accordingly, the researchers who fail to protect the safety of the human subjects as a result of not exercising due care requested in the contents of the medical contract is responsible to compensate the injured subject.

4.3.2 Remedies for Human Subjects Suffering Emotional Harm

A claim for compensation occurs also in the circumstances that no actual physical harm is induced by the clinical trials, but the human subjects declare suffering emotional harm. As was mentioned above, in the University of South Florida and Tampa General Hospital case, the dignitary harm may be the consequence of the investigators' negligence, e.g. not to fully disclose information, especially those in respect to experiment's risks, to the human subjects. In addition, according to preliminary results of a new study, informed consent forms now in use may confuse people participating in gene therapy research experiments about what they can expect from the experimental procedure. It is due to the use of inconsistent or contradictory terminology in the consent forms to describe important information such as the operation procedures, risks of the genetic research, and explain medical concepts that the participants are normally unfamiliar.[50] Thus, the decision of the human subjects to participate the experimental trial or not may be mislead by the consent form.

It is therefore asserted under the circumstances that information is not properly provided and due respect to the autonomy and autonomous of choices is insufficient, the subject's right appertaining to his personality is unlawfully infringement. No lawsuit in this regard has ever happened in Taiwan. It is debatable though; to what extent a person's dignity can be offended under circumstances as such, especially in the environment of Taiwan. However, provided it is deemed as dignitary harm, it would be necessary to examine whether Taiwan's laws are ready to serve for the plaintiffs suffering dignitary harm to bring action for compensation or solatium.

According to article 18 of the Civil Law, whenever a natural person's right appertaining to his personality is unlawfully infringement by the others, he can request the Court to suppression of the infringement. In a broad term, article 18 is a provision for wrongful acts yet specifies in rights regarding to personality only. This provision is useful to prevent the subjects' rights from infringement during the process of the biomedical research in question. However, if the subjects realized they are not properly informed or treated only after the experiment, this provision is far from applicable, since the Court's order for suppression the infringement is no longer needed.

As far as the compensation is concerned, article 18 makes it clear that an action for damages or for solatium may be brought under the above circumstances. However, the basis for claiming such damages or solatium must be specifically provided by law.[51] In the Civil Law, damages for the infringement of personality rights are located in two articles. Article 19 deals with the infringement to right of a natural person in regard to the use his name. Article 195 addresses the case of injury to the body, health, reputation or liberty of a natural person. In the other words, when no physical harm is induced, a person can claim compensation for the injury of his rights appertaining to his personality only when such right is in conjunction with his name, health, reputation or liberty. Therefore, it seems unlikely for a human subject resorting to wrongful acts to obtain compensation when he considers that his emotion was offended.

As a consequence, compensation for emotional harm is anticipated only when the human subjects claiming the failure of the investigator to implement his duty under the medical contract. Nevertheless, it would be necessary to carry on observing the further development of Taiwan's legal regime in this regard.

4.3.3 Remedies for Research Injuries Occurred with no Researchers' Fault

Research injuries may occur even without any fault on the part of researchers. There are several reasons. Most interventions employed in clinical research, such as chemotherapy or tissue biopsy, possess a definite harm even when competently performed. Often there are times where the use of new drugs or medical devices results in harm that could not be anticipated based on prior knowledge. Public concerns over the safety of clinical trials are periodically aroused by revelations of harm and deaths among the human subjects involved. For examples, eight out of 45,000 children died and numerous other adverse events as the result of clinical trials of new conventional drugs occurred around the year of 2001.[52] The other possibility for the cause of injury is that many research subjects have diseases or disabilities that result in a heightened susceptibility to the harmful effects of medical interventions.

Other instances may be observed when operating clinical trials for gene therapy.[53] The rapidly advancement in genetic knowledge during the last few years makes it seems likely to most experts that the use of recombinant-DNA techniques as part of program of medical therapy is now virtually at hand. The ability to alter the basic machinery of life to correct its malfunctioning is surely the most powerful form of therapy imaginable.[54] Even though some suggested the risks involved in gene therapy are not unique one and in most respects, they exactly parallel those involved in any new medical treatment. Problems in relation to how to accurately assess the risks that may be caused by the unpredictable performance of the vector or delivery system remain to be addressed.[56] To a large degree it is beyond our knowledge to say that the gene delivery system is efficient, or the subjects' safety are guaranteed. With this scientific uncertainty, an injury could be the result when the whole research process is conducted with no fault.

Obviously, no legal recourse is applicable to deal with injuries induced by not wrongful acts but scientific uncertainty. In fact, very few research institutions have formal compensation programs to address research injuries that occur without researcher negligence. When debating how and where to offer a fair and just treatment or compensation in the cases no redress is legally available, resorting to moral rights seems to be an alternative.[57] This view asserts that compensation is owed to injured research subjects as a matter of social justice for at least three reasons. First, the injured subject has accepted a position of risk. Second, the activity is for the benefit of society as a whole. Third, it is the society who, directly or indirectly, sponsors or mandates the practices in question.[58] However, it is arguable if subjects knowingly and freely participate in cooperative ventures possessing a risk of harm, the researchers or the conducting institutions should be responsible for injuries that materialize without negligent behavior. In addition, the consent of subjects to participate in research is made knowing that the compensation is not available; such consent is secured with disclosure of the information that a reasonable person would need to know. The choice to participate without this guarantee would seem to relieve any prima facie obligation to redress resulting injuries.[59]

Nevertheless, the actual process of informed consent may be far from ideal and perfection. For instance, it is possible that in some research the risk profile of interventions is not yet established, therefore it would be unlikely to disclose that which specific injuries might occur and may be harmful to the interests of the prospective subjects. Experimental evidence suggests that the importance of substantial harms with a very low probability of occurrence seems to be discounted. In light of these imperfections in knowledgeable decision-making, it might be argues that subjects do not really intend to waive their security against the personal losses imposed by injuries.[60]

Other alternatives such as the establishment of a compensation program, the public fund mechanism, or compulsory insurance regime confront with a variety of disagreements. For instance, the concept that a compensation program will have consequences that improve the overall cost-benefit ratio of clinical research leads to an assumption that the no-fault compensation produces incentives to encourage investigators to engage in less dangerous research and reduce risk in planning research. However it is criticized that this assumption is based on unproven events. In deed, the incentives created by a compensation program may depend on its exact administrative configuration, and particular schemes may inconsistently both promote and undermine specific goals cited.[61]

No definite scheme seems in position to address compensation for research injuries occur with no researchers fault. The increase of biomedical researches involves scientifically uncertain risks are however anticipated according to the evolving development of modern biotechnology. The DOH of Taiwan initiated regulation and guideline to deal with gene therapy since several years ago, and issued the Guideline for Clinical Trial on Gene Therapy in 1997. This Guideline is now revised. Other guidelines such as the Guideline for Good Clinical Practice on Gene Therapy, the Standards for Testing Gene Therapy, are under construction. However, the primary purposes of these guidelines/standards target on monitoring the research protocol and ensuring the safety of the research process are properly protected, but not on compensating injured human subjects in the cases of scientific uncertainty. The society as whole seems not well prepared to offer remedy for uncertain risks as such. It is therefore important to observe the further movement of either legal rules or ethical principles in this regard.

5. Conclusion

Recent cases in the USA illustrates not only physical injuries can bring the human subjects a lawsuit, and a huge amount of compensation. Even in the situation that emotional harm is asserted, due to the failure of respect to the subjects from research part, a settlement for compensation may be made. Cases as such seem have overruled the "no harm no foul" principle in the biomedical research, and suggest that touching someone without their consent would violate their basic human dignity and is independently compensable The major principles of bioethics serve to guide the procedures of research and guard the research subjects from injury. Only limited ethical norms seeks to address remedy for the injured human subjects.

In Taiwan, the Civil Law is applicable to physical injuries as well as dignitary harm, under the circumstances the research parts are with negligence and responsible to the suffering. Yet, when scientific uncertainty is the cause of injuries, and no misconduct is made by the research part, neither law nor ethical principle can offer a ground for compensation. It would be necessary to develop a feasible regime, either by law or ethics, to deal with these events.

In the era that modern biotechnology is rapidly developed and the scientifically uncertain risks to human subjects are likely to increase biomedical research, perhaps Professor Walters's statement can be a good note to end this paper: "The precise role for gene transfer, cell transfer, organ and tissue transplantation remains to be clarified. The future success of gene transfer in the treatment of disease cannot be guaranteed. What can be definitely be achieved, however, is the creation of a transparent, accountable oversight system that assures that the human subjects who make this research possible will be dealt with honestly and with the highest measure of respect."[62]




[1][1] M Baram, gMaking Clinical Trials Safer for Human Subjectsh, 27 American Journal of Law and Medicine (2001) 253, 254.

[2] R Weiss and D Nelson, Philadelphia Inquirer, (9/29/1999), 1. For the brief history of the development of gene therapy, please see R Munson, Intervention and Reflection Basic Issues in Medical Ethics, fifth ed. 1996, Wadswroth Publishing Company, 432-455. L Walter, gGene therapy: Overviewh, in Murray T.M. et aliedsj, Encyclopedia of Ethical, Legal, Policy issues in Biotechnology, 2000, John Wiley & Sons, Inc. 336-342.

[3] A Dembner, gLawsuit Target Medical Research ? Patient Safeguards, Oversight Key Issuesh, Globe Staff (8/12/2002). D L Bush, Gene Therapy Trials: The Role of the National Institutes of Health Conflicts of Interest, 19 Biotech. L. Rep. (2000) 576, 576-578.

[4] Ibid.

[5] Ibid. In both the cases, the defendants admitted no wrongdoing, and denied the allegations and asserted the plaintiffs suffered no harm. In the case of the University of South Florida and Tampa General Hospital, the 3.8 million settlement leave no room for legal precedent.

[6] Ibid.

[7] H Wigodsky & S K Hoppe, gHuman as Research Subjectsh, in D C Thomasma and T Kushner (eds) Birth to Death, Cambridge University Press 1996, 259, 259-260.

[8] Nuremburg International military Tribunal, (1947) 41 American Journal of International Law, 172.

[9] H Wigodsky & S K Hoppe, supra no. 7, 259, 262.

[10] H Wigodsky & S K Hoppe, ibid, 259, 263-4.

[11] National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, DHEW Publ No. (OS) 78-0012, U.S. Government Printing office, DC, 1978.

[12] R J Levine, gHuman Subjects Research, Ethics, Principles Governing Research with Human Subjecth, in Murray T.M. et aliedsj, Encyclopedia of Ethical, Legal, Policy issues in Biotechnology, 2000, John Wiley & Sons, Inc.622, 623.

[13] T L Beauchamp, J F Childress, Principles of Biomedical Ethics, 3rd ed. 1989 Oxford University Press, 67-119.

[14] The Belmont Report, supra no.11.

[15] Ibid.

[16] P S Appelbaum, C W Lidz & A Meisel, Informed Consent, Oxford University Press 1987, 211-241. R Munson, supra no 2, 323- 355.

[17] T L Beauchamp, J F Childress, supra no 13, 194-255.

[18] R J Levine (2000), supra no 12, 622, 623.

[19] R Bartz, g Remembering the Hippocratics: Knowledge, Practice, and Ethos of Ancient Greek Physician-healersh, in Bioethics Ancient Themes in Contemporary Issues, M G Kuczewski & R Polansky eds. 2000 Massachusetts Institute of Technology, 3, 18; H Wigodsky & S K Hoppe, supra no 7, 259, 265.

[20] The Belmont Report, supra no 11.

[21] The Belmont Report, supra no 11.

[22] Nuremberg Code, principle 6.

[23] Nuremberg Code, principle 3.

[24] R J Levine, Ethics and Regulation of Clinical Research, 2nd ed, Urban & Schwarzenberg, Baltimore and Munich, 1986.

[25] T L Beauchamp, J F Childress, supra no13, 256-306.

[26] H Wigodsky & S K Hoppe, supra no 7, 259, 265.

[27] R J Levine (2000), supra no 12, 622, 624.

[28] R J Levine (1986), supra no 24.

[29] Council for International Organization of medical Sciences in collaboration with the World Health Organization, International Ethical Guidelines for Biomedical Research Involving Human Subject, CIOMS, Geneva, 1993.

[30] Ibid.

[31] T F Ackerman, gHuman Subjects Research, Ethics, Competition of Subject's for Injuryh, in Murray T.M. et aliedsj, Encyclopedia of Ethical, Legal, Policy issues in Biotechnology, 2000, John Wiley & Sons, Inc.585, 586.

[32] T F Ackerman, ibid.

[33] T F Ackerman, ibid.

[34] T F Ackerman, ibid.

[35] T F Ackerman, ibid. 585, 588-590.

[36] Medical Care Act 1986, Article 56.

[37] IbidGThe Enforcement Rules of Medical Care Act , Article 50, 51.

[38] Medical Care Act 1986, Article 57. The Enforcement Rules of Medical Care Act , Article 52, the contents of informed consent form.

[39] The Pharmaceutical Act (1993), Article 44.

[40] Publication date: Nov. 20, 1996.

[41] Publication date: June 16, 1997.

[42] Publication date: August 28, 1997. This Guideline is now being revised by the DOH.

[43] Civil Law, Article 184, first half of paragraph one.

[44] Civil Law, Article 184, second half of paragraph one.

[45] Civil Law, Article 184, paragraph two.

[46] Civil Law, Article 193, paragraph one.

[47] Civil Law, Article 195, paragraph one.

[48] Medical Care Act 1986, Article 56, paragraph one.

[49] Medical Care Act 1986, Article 56, paragraph two.

[50] V Brower, Many Gene Research Consent Forms Misleading, cited from http://story.news.yahoo.com/news?tmpl=story2&cid=571&ncid=751&e=5&u=/nm/20021101/hl_nm/research_consent_dc, 2002/11/01.

[51] Civil Law, Article 18, paragraph two.

[52] M Baram, supra no 1, 253, 255.

[53] Such as the above mentioned Jesse Gelisinger case in University of Pennsylvania, 1999.

[54] R Munson, no 2, 452.

[55] R Munson, ibid, 454.

[56] N A Wivel, g Gene Therapy, Ethics, Somatic Cell Gene Therpayh, in Murray T.M. et aliedsj, Encyclopedia of Ethical, Legal, Policy issues in Biotechnology, 2000, John Wiley & Sons, Inc. 311, 316.

[57] T F Ackerman, supra no. 31, 586- 588.

[58] J F Childress, Hastings Cent. Rep. 6(60), 1976, 21-27 in T F Ackerman, ibid, p 589, no. 18.

[59] T F Ackerman, supra no 31, 589.

[60] Ibid, 590.

[61] Ibid, 588, 589.

[62] L Walters, supra no 2, 336, 341.

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