The protection of patients’ rights in clinical trials

The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. This paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005. The author is Chairman, Bioethics Committee of the Warsaw Regional Chamber of Physicians and Dentists.     

A national study of ethics committees

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they have played compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent of ethics committees report that they played a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies.     

Consulting the Many and the Wise

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they play compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent of ethics committees report that they play a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies.     

The clinical ethicist at the bedside

In this paper we attempt to show how the goal of resolving moral problems in a patient's care can best be achieved by working at the bedside. We present and discuss three cases to illustrate the art and science of clinical ethics consultation. The sine qua non of the clinical ethics consultant is that he or she goes to the patient's bedside to obtain specific clinical and ethical information. Unlike ethics committees, which often depend on secondhand information from a physician or nurse, clinical ethics consultants personally speak with and examine patients and review their laboratory data and medical records. The skills of the clinical ethics consultant include the ability to delineate and resolve ethical problems in a particular patient's case and to teach other health professionals to build their own frameworks for clinical ethical decision making. When the clinical situation requires it, clinical ethics consultants can and should assist primary physicians with case management.     

Participants' postexperimental reactions and the ethics of bystander research

Researchers and review boards lack an empirical base for evaluating the ethics of proposed research procedures. This paper contributes to such a base by reporting participants' postexperimental affective reactions to bystander experiments employing deception and their evaluations of the ethics of these experiments. Anonymous “ethics” questionnaires were administered to 231 subjects who had participated in one of three laboratory experiments on helping and had been debriefed. Participants reported very little negative affect. Most viewed the research as ethically justified, and found their participation both instructive and enjoyable. There was little variation in reactions as a function of subjects' sex, the particular experiment they had participated in, and their behavior during the experiment. Implications of these findings for assessing the ethics of future deceptive and stressful research are discussed.     

Clinical Audit and Reform of the UK Research Ethics Review System

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue.     

Training in clinical ethics: launching the clinical ethics immersion course at the Center for Ethics at the Washington Hospital Center

In May 2011, the clinical ethics group of the Center for Ethics at Washington Hospital Center launched a 40-hour, three and one-half day Clinical Ethics Immersion Course. Created to address gaps in training in the practice of clinical ethics, the course is for those who now practice clinical ethics and for those who teach bioethics but who do not, or who rarely, have the opportunity to be in a clinical setting. "Immersion" refers to a high-intensity clinical ethics experience in a busy, urban, acute care hospital. During the Immersion Course, participants join clinical ethicists on working rounds in intensive care units and trauma service. Participants engage in a videotaped role-play conversation with an actor. Each simulated session reflects a practical, realistic clinical ethics case consultation scenario. Participants also review patients' charts, and have small group discussions on selected clinical ethics topics. As ethics consultation requests come into the center, Immersion Course participants accompany clinical ethicists on consultations. Specific to this pilot, because participants' evaluations and course faculty impressions were positive, the Center for Ethics will conduct the course twice each year. We look forward to improving the pilot and establishing the Immersion Course as one step towards addressing the gap in training opportunities in clinical ethics.     

医学伦理学是否可教及其他--关于医学伦理学教育的再思考

医学伦理学是否可教?如果可教,应该教规范还是教价值?如何拉近医学伦理学教育与现实的距离?怎样评价医学伦理学教学的效果?不仅是临床医生和卫生管理工作者,即使作为医学伦理学研究工作的学者也都对这些问题存在着不同程度的误解,这影响了医学伦理学学科地位的确立.     

WHY NO GUIDELINES FOR BEHAVIOR MODIFICATION?

This paper reviews the guidelines for behavioral programs published by the National Association of Retarded Children. The review discusses a number of reasons why guidelines should not be enunciated for behavior modification, e.g., the procedures of behavior modification appear to be no more or less subject to abuse and no more or less in need of ethical regulation than intervention procedures derived from any other set of principles and called by other terms. The review recommends alternative methods for protecting the rights of clients who participate in behavioral programs. Specifically, behavioral clinicians, like other therapists, should be governed by the ethics codes of their professions; also, the ethics of all intervention programs should be evaluated in terms of a number of critical issues.     

Global ethics: increasing our positive impact

Global ethics is no ordinary subject. It includes some of the most urgent and momentous issues the world faces, such as extreme poverty and climate change. Given this, any adequate review of that subject should, I suggest, ask some questions about the relation between what those working in that subject do and the real-world phenomena that are the object of their study. The main question I focus on in this essay is this: should academics and others working in the field of global ethics take new measures aimed at having more real-world positive impact on the phenomena they study? Should they take new measures, that is, aimed at bringing about more improvements in those phenomena, improvements such as reductions in extreme poverty and in emissions of greenhouse gases? I defend a positive answer to this question against some objections, and also discuss some of the kinds of measure we might take in an attempt to have more positive impact.     

Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial

The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research--social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants.     

Revising the history of Cold War research ethics

President Clinton's charge to the Advisory Committee on Human Radiation Experiments included the identification of ethical and legal standards for evaluating government-sponsored radiation experiments conducted during the Cold War. In this paper, we review the traditional account of the history of American research ethics, and then highlight and explain the significance of a number of the Committee's historical findings as they relate to this account. These findings include both the national defense establishment's struggles with legal and insurance issues concerning human experiments, and the medical profession's perspective on human experimentation in the years following the Nuremberg Medical Trials. We conclude that the Committee's work both enriches the traditional view of the history of research ethics and opens important new areas for study.     

Secular ethics education as an alternative to religious education – Finnish teachers’ views

This study provides a Finnish perspective to international discussions on religious and worldviews education through the subject of secular ethics. This subject has been offered in Finland since 1985 throughout comprehensive schools and is primarily directed at students who are non-affiliated. Secular ethics education has scarcely been researched and is here investigated through secular ethics teachers’ views. The results highlight key characteristics of the subject, which in teachers’ views single out the subject from religious education classes. Key characteristics include gaining multiple perspectives on religions and worldviews, focusing on interactive, social and critical skills, and focusing on students’ personal identities and growth as human beings. In addition, specific challenges and possibilities of the subject of secular ethics arise, which may be taken into consideration in developing a future integrative subject of worldview education in Finland.     

The Ethical Standard of Care

The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research—social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants.     

试论信息伦理的特点与本质

信息伦理学作为科技哲学与伦理学的边缘学科 ,不仅要关注现实生活中出现的各种各样的信息行为 ,而且要深入研究信息的“元伦理学”问题 ,同时还要对信息化与传统社会现象交融过程中出现的“交叉伦理”问题进行相关分析 ,准确把握。信息伦理本质上有三个层面。即从信息伦理的起源上看 ,信息伦理是人类交往活动的现实需要和规律反映 ;从信息伦理的应用上看 ,信息伦理调节着人们在信息交往活动中的功利实现 ;从信息伦理的目的上看 ,信息伦理追求人类社会在信息时代的和谐与进步。     

Hidden in Plain View: Feminists Doing Engineering Ethics, Engineers Doing Feminist Ethics

How has engineering ethics addressed gender concerns to date? How have the ideas of feminist philosophers and feminist ethicists made their way into engineering ethics? What might an explicitly feminist engineering ethics look like? This paper reviews some major themes in feminist ethics and then considers three areas in which these themes have been taken up in engineering ethics to date. First, Caroline Whitbeck’s work in engineering ethics integrates considerations from her own earlier writings and those of other feminist philosophers, but does not use the feminist label. Second, efforts to incorporate the Ethic of Care and principles of Social Justice into engineering have drawn on feminist scholarship and principles, but these commitments can be lost in translation to the broader engineering community. Third, the film Henry’s Daughters brings gender considerations into the mainstream of engineering ethics, but does not draw on feminist ethics per se; despite the best intentions in broaching a difficult subject, the film unfortunately does more harm than good when it comes to sexual harassment education. I seek not only to make the case that engineers should pay attention to feminist ethics and engineering ethicists make more use of feminist ethics traditions in the field, but also to provide some avenues for how to approach integrating feminist ethics in engineering. The literature review and analysis of the three examples point to future work for further developing what might be called feminist engineering ethics.     

A plea for pragmatism in clinical research ethics

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.     

围绕ICU的几个问题的思考

ICU是现代医学中的新兴事物,发挥着重要作用,但是围绕ICU方方面面问题,无论是业界还是公众还有许多争论及认识上的误区,有待研究探讨,比如ICU是否是一个真正意义上的独立学科?ICU的业态形式?ICU一定是高投入高装备吗?ICU注定是高消费?ICU有人文伦理缺失的特权吗?本文试图对这些问题给予一点作者的观察和己见。     

关于医学伦理学教育的几点思考

医学伦理学教育中长期存在的一些问题尚未很好解决.由于较多强调课程的道德教育功能,对其作为独立学科存在的性质和意义仍重视不够,医学伦理学是进行道德分析、准则与价值评判的理论体系,通过医学伦理学的学习和训练,应使学生能够对有关问题在广阔的背景中进行深层次思考并做出独立判断.我们应在进一步更新观念的基础上,改进哲学、伦理学基础教育,以促进医学伦理学教育的发展,而其意义已远超出医学伦理学之外.     

Punctuated Equilibrium,Moral Panics and the Ethics Review Process

A review of the literature and ethnographic data from Australia, Canada, New Zealand, the United States, and the United Kingdom on the research ethics review process suggest that moral panics can become triggers for punctuated equilibrium in the review process at both the macro and microlevel, albeit with significantly different levels of magnitude and impact. These data suggest that neither the development of the ethics review process nor the process itself proceeds gradually, but both are characterized by periodic major shifts evoked by particular events or situations that result in varying levels of moral panic. One way to deal with this moral panic is to increase the regulation of research and the depth or intensity of the scrutiny of applications under ethics review. Moral panics at the macrolevel influence those at the microlevel and, if the moral panic evoked at the local or microlevel is not satisfactorily resolved, it will evoke action at a higher level. Understanding the evolution of research ethics review processes from this perspective might help make actions by ethics committees and policy makers more understandable and help explain why attention to research ethics are heightened at particular points in time. It may also provide a basis for developing recommendations for adaptations to the ethics review process and policy at both the local and macrolevel.