Clinical ethics committees, due process and the right to a fair hearing

The development of clinical ethics committees in the United Kingdom raises a number of important questions about the extent to which they are compatible with the normative values of due process. If committees are to be active in delivering ethics services, it is argued that attention to due process is important. Based on research outcomes, it seems that the chairs of the United Kingdom clinical ethics committees who responded are reasonably satisfied about the ability of their committees to make ethical decisions and slightly less confident about their ability to make legal decisions. If these committees are to make potentially far-reaching decisions (whether or not involving live consultations), it is argued here that they must pay attention to the rules associated with the legal concept of due process. Equally, evaluation of the clinical ethics committee's counterpart in the United States suggests that they may become increasingly authoritative, especially as their role becomes entrenched. This makes attention to due process even more important. However, it is also proposed that, when committees become concerned about due process, their ability to "do ethics" is constrained.     

Error Reduction, Patient Safety and Institutional Ethics Committees

Institutional ethics committees remain largely absent from the literature on error reduction and patient safety. In this paper, the author endeavors to fill the gap. As noted in the Hastings Center's recent report, "Promoting Patient Safety," the occurrence of medical error involves complex web of multiple factors. Human misstep is certainly one such factor, but not the only one. This paper builds on the Hastings Center's report in arguing that institutional ethics committees ought to play an integral role in the transformation of a "culture of blame" to a "culture of safety" in healthcare delivery.     

Privacy and research involving humans

Human research ethics committees in Australia are required to consider compliance with privacy law as an element of the ethics of research. Recent legislation has introduced federal private sector privacy protection, as well as privacy protection at State and Territory levels. In Victoria, which is used as an example in this article, State privacy legislation covers public sector information and health records. This article considers the implications for research involving human participants and for ethics committees of the new privacy regimes. Although privacy law is a potential barrier to research about humans, the need for exceptions has been dealt with effectively in the context of medical or health research. However, privacy law and its chilling effect could potentially be a serious impediment to some forms of non-health-related research, such as social and socio-legal research.     

Protecting health information privacy in research: what's an ethics committee like yours doing in a job like this?

The Commonwealth and State legislation designed to protect the privacy of personal health information has attracted the criticism that the constraints imposed on the use of the information in research obstructs that research. A central and common feature of the legislation is the reliance upon the review by human research ethics committees of research that proposes to use personal health information for research without prior consent from those whose information it is. The origins of this reliance are explored and explained and it is suggested that this has proved to be an inappropriate policy choice. The extension of the reliance is then described and the conceptual, procedural, workload and structural consequences of requiring these voluntary committees to conform to legislative standards of review of issues of the public interest are critically examined. In recent reviews of the Commonwealth legislation, there is recognition of the underlying uncertainty as to the appropriate balance between protection of personal privacy and the promotion of beneficial research. In the further exploration of these matters that those reviews recommended, a close and critical examination of the wisdom of continuing to rely on ethics committees is needed.     

法医学研究中的伦理审查建设

法医学研究伦理审查既是法医学研究管理工作的内容,也是法医学研究的对象,本文针对法医学研究中的伦理审查问题,论述开展伦理审查的必要性,并对法医学研究伦理审查委员会建设指导原则进行探讨,呼吁开展伦理审查建设。     

The Metropolitan New York Ethics Committee Network: coming together at a time of concern

Approximately two years ago, colleagues at some of the major teaching hospitals in the New York City area began to consider the possibility of pooling resources and providing the opportunity for the over 100 hospital-based ethics committees currently in existence in and around New York City to come together. It was thought that by joining together in a network type of organization, committees could exchange experiences and wisdom, and jointly examine and develop responses to some of the more unique, as well as the more conventional, ethical dilemmas they confronted. Those efforts culminated in the start-up of the Metropolitan New York Ethics Committee Network.     

A comparative analysis of selected European guidelines and recommendations for biobanks with special regard to the research / non-research distinction.

Classifying an activity as research has considerable normative consequences: On the one side research activities are especially protected ("freedom of research"), on the other side stricter ethical rules legal regulations may apply to such activities, e.g. compulsory review by ethics committees. It is therefore important to find criteria to delimit research from non-research activities. The aim of the present study is to analyse some European guidelines and recommendations for biobanks and to see whether these documents provide comments that help to elucidate the research/non-research distinction.     

Recovering from research: a no-fault proposal to compensate injured research participants

National advisory committees have considered the obligations owed to research participants in the event of research-related injuries. These committees have repeatedly concluded that injured research participants are entitled to compensation for their injuries, that the tort system provides inadequate remedies, and that the United States should adopt no-fault compensation. But because the advisory committees have made no concrete proposals and have taken no steps toward implementing no-fault compensation, the United States continues to rely on the tort system to compensate injured research participants. This Article argues that recent legal developments and a transformation in the global research landscape make maintaining the status quo morally indefensible and practically unsustainable. Recent legal developments exacerbate the longstanding difficulties associated with the tort system as a method of compensation; nearly every injured research participant will have difficulty recovering damages, and certain classes of injured research participants--those in federal research and those abroad--are prevented from recovering altogether, resulting in substantial unfairness. In the past ten years, many of the countries substantially involved in research have mandated systematic compensation. By not mandating compensation, the United States has become a moral outlier and risks having its noncompliant research embargoed by foreign ethics committees, thereby delaying important biomedical advances. This Article examines alternative compensation mechanisms and offers a concrete no-fault compensation proposal built on systems already in place. The proposed system can be implemented in the United States and countries around the world to help harmonize various national compensation systems and to more equitably and effectively make those injured by research whole.     

The Swiss regulatory framework for paediatric health research

Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.     

Survival at what cost? Origins and effects of the modern controversy on treating severely handicapped newborns

This paper examines the background of technological innovation, ethical debate, and social change, against which the 1980s debate over how to treat severely handicapped newborns in general, and Baby Jane Doe in particular, took place. A commentary follows examining the relative place of government, practitioners, hospital ethics committees, and parents in making decisions about treatment for handicapped newborns.     

Pushing the Dead into the Next Reproductive Frontier: Post Mortem Gamete Retrieval under the Uniform Anatomical Gift Act

In re Matter of Daniel Thomas Christy authorized post mortem gamete retrieval under the most recent revision of the Uniform Anatomical Gift Act. This article recommends that the National Conference of Commissioners on Uniform State Laws explicitly address the issue of post mortem gamete retrieval for reproductive purposes; that legislators specify whether their states will follow the Christy ruling; and that ethics committees and consultants prepare for the questions about human identity and self determination that post mortem gamete retrieval raises.     

The importance of national laws in the implementation of European legislation of biomedical research

The industrialization and internationalization of biomedical research is not without consequences on the regulation of research or, at least, on the interpretation of that regulation. As more research is done at the international level, the pharmaceutical industry and the research community are calling for a harmonized regulation to limit the administrative burden of controlling clinical trials and to fasten the R&D process. The purpose of this paper is to analyse briefly the role of the national laws in that process. Part I will outline the structure and the nature of the international regulation of research in a European perspective. Using the examples of research ethics committees (RECs), informed consent and the question of liability and liability insurance, Part II will analyze the importance of the national laws in the implementation of this international regulation.     

Physician Participation in Executions: Care Giver or Executioner?

The "medicalization" of the death penalty has ignited a debate, by those within the medical profession and by others outside it, about the appropriateness of physicians participating in state-sponsored executions. Physicians participating as "agents" of the State in executions argue that their presence ensures a more humane execution. Opponents argue physician participation violates the Hippocratic Oath which states clearly that physicians should never do harm to anyone. How any physician, who is dedicated to "preserving life when there is hope," can argue that taking the life of a healthy person because the state commands it is in the patient's best interest, and does not conflict with the goals of medicine is beyond comprehension. Physician participation in executions is unethical because it violates the four basic principles that govern medical ethics: respect for persons, beneficence, nonmaleficence, and justice.     

The Eletsk Gambit

In Eletsk—the city second in significance in Lipetsk Oblast—they have still not begun the reform of local self-government. The matter has reached such a state that two committees of the oblast council have considered taking an extreme measure—making recourse to a court with a suit against the Eletsk city council of deputies, who are unable to overcome an internal disagreement.     

Teaching medical ethics and law

The teaching of medical ethics is not yet characterised by recognised, standard requirements for formal qualifications, training and experience; this is not surprising as the field is still relatively young and maturing. Under the broad issue of the requirements for teaching medical ethics are numerous more specific questions, one of which concerns whether medical ethics can be taught in isolation from considerations of the law, and vice versa. Ethics and law are cognate, though distinguishable, disciplines. In a practical, professional enterprise such as medicine, they cannot and should not be taught as separate subjects. One way of introducing students to the links and tensions between medical ethics and law is to consider the history of law via its natural and positive traditions. This encourages understanding of how medical practice is placed within the contexts of ethics and law in the pluralist societies in which most students will practise. Four examples of topics from medical ethics teaching are described to support this claim. Australasian medical ethics teachers have paid less attention to the role of law in their curricula than their United Kingdom counterparts. Questions like the one addressed here will help inform future deliberations concerning minimal requirements for teaching medical ethics.     

Post-legislative scrutiny in the UK Parliament: adding value

ABSTRACT

Legislatures appoint committees for different purposes. Both Houses of the UK Parliament separate legislative committees from non-legislative, or select, committees. Each is unusual in that it utilises select committees to engage in post-legislative scrutiny. We examine why each engages in this type of scrutiny, given competing demands for limited resources. Distributive and informational theories are utilised to explain the difference between the two chambers, identifying why the form of asymmetrical bicameralism to be found in the United Kingdom facilitates scrutiny that would otherwise not be undertaken. The genesis and impact of post-legislative scrutiny committees are considered, with a focus on the House of Lords and why the use of such committees plays to the strengths of the House.     

NONJUDICIAL ALTERNATIVES FOR RESOLVING END-OF-LIFE DECISIONS FOR MINORS

This note will discuss end-of-life decision making for minors. Minors who suffer from a terminal illness or who are in a persistent vegetative state are "children on the edge"—they are on the edge of life and death, as well as on the edge of the law. The judicial system and legislative action have proven to be ineffective tools in helping families find a peaceful resolution to life-threatening questions. Judicial intervention is often intrusive, as well as emotionally and financially difficult for the family to endure. As a result, alternatives have arisen, such as hospital ethics committees and mediation, which address these issues. These alternatives demonstrate respect for patient autonomy and family privacy, by considering the family's wishes in addition to the minor's medical condition. If people avail themselves of the resources already in place, judicial intervention only becomes necessary in extreme circumstances. Nonjudicial alternatives provide a more appropriate forum for resolution than the courtroom by eliminating opportunities for public spectacle and family intrusion.     

公务员行政责任的实现路径分析

公务员在做出具体行政行为时往往会面临着多重困境,这些困境主要来自于权力、角色与利益方面的冲突。当公务员无法正确解决这些冲突或没有能力解决这些冲突时,就容易出现行政行为失范现象。本文在分析我国公务员责任冲突产生原因的基础上,提出了责任的实现路径：制定公务员伦理法规;培育公务员的伦理自主性;完善公务员绩效考评系统,充分发挥社会监督的作用。     

"出嫁女"土地权益保护的困境与出路——从民间法角度切入

村委会以村规民约等方式限制、剥夺"出嫁女"的土地权益,而这种以村规民约等形式表现的民间法以单系继替偏重的社会继替规律以及"男婚女嫁"的习俗为其存在的社会基础。因此,要实现对"出嫁女"土地权益的有效保护,必须通过发展农村经济、贯彻国家计划生育政策、开展法治宣传、完善农村社会保障制度,动、消除这种民间法存在的基础,实现国家法在农村的有效推进。     

Christian Ehrenfried Eschenbach (1712-1788)--a pioneer of legal medicine in German universities

Christian Ehrenfried Eschenbach (1712-1788) belongs to the forerunners of the embossed natural science scholars of legal medicine in Germany. As a principal re-elected 11 times and dean of the medical faculty at Rostock University he defended academic positions in difficult times. His bibliography comprises numerous text books, e.g. on surgery, anatomy, pathology and obstetrics as well as various fields of mathematics. His Medicina legalis (1746 and 1775) belongs to the first systematic editions of forensic medicine in the German-speaking community. Thanks to his extensive practical experience as a physician and public health officer he took a very progressive position on questions of forensic medicine, issues of professional ethics in medicine and the assessment of injuries. He has wrongly been forgotten.