Empty ethics: the problem with informed consent

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centering on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from its clinical and social setting. By flashing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current 'empty ethics' model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials.     

医疗技术人体试验中受试者的知情同意权

自纽伦堡大审判以来,医疗技术人体试验中取得受试者的知情同意已经成为人体试验的首要原则.受试者知情同意权包括知情权和同意权.对缺陷告知而实质上影响到受试者的选择权或未经受试者同意实施的试验行为,不管在人体试验中试验者是否尽到注意义务,由此试验行为造成的损害均由试验者承担.     

整形美容手术中知情同意的伦理探讨

目的 明确知情同意在整形美容行业中的必要性和重要性,探讨其中隐藏的伦理学意蕴,用知情同意这一重要的伦理原则规范医务人员的行为.方法 使用文献检索法、专家咨询法、抽样调查等方法对整形美容手术中的知情同意情况进行调查,分析实施过程中的规范化情况和遇到的难点和伦理困境.结果 整形美容医师牢牢把握了知情同意这一原则,作为术前常规工作执行,但在实际操作过程中还有些难点.结论 整形美容医生应规范履行知情告知义务,尊重患者的知情权;院方须制定一系列的制度来规范知情同意这一原则.     

浅谈医事法学视野下知情同意权的制度研究

知情同意权是医患关系的一项重要内容,它既是患者的权利,同时也是医生的义务.医疗知情同意的实现,有助于增进医患之间和谐的关系.要确保知情同意权的有效实现,不仅需要医患双方对知情同意的深入理解和正确认识,还需要相应的法律制度做保障.     

Informed consent for mammography screening: modelling the risks and benefits for American women

INTRODUCTION: In order to facilitate informed decision making, women require information on the probabilities of different outcomes with mammography screening. This paper derives these probabilities for a US population and illustrates them visually in a readily understandable format. METHODS: Probabilities of the breast cancer mortality, all cause mortality and further investigation are derived from published data on mortality from breast cancer and published estimates of effectiveness using a life-table method. Probabilities are calculated of surviving to age 75 from age 40 with and without two-yearly mammography screening from age 40 and age 50. Probabilities are also calculated that a woman will be referred for further assessment or biopsy or die from breast cancer despite screening. To avoid being misled, these outcomes are presented in the form of a single decision aid illustrating the outcomes for 1000 women choosing each alternative: mammography screening or no mammography screening. RESULTS: Of 1000 women undergoing two-yearly mammography screening from age 40 an additional four (3.7 per 1000) will reach the age of 75; of the survivors 514 will be referred for further investigation and 138 will undergo biopsy. Of 1000 women screened from age 50 an additional three (3.3 per 1000) will reach age 75; of the survivors 408 will be referred for further investigation and 94 will undergo biopsy. Mammography from age 40 to 49 reduces mortality by 0.4 in 1000. This information is readily presented visually. CONCLUSIONS: It is possible to provide realistic estimates of the effects of mammography screening on mortality in a readily understandable format. Women require this information if they are to make informed choices about mammography screening.     

论生物医学研究中受试者知情同意权的保护

保护生物医学研究中受试者的知情同意权具有重要意义.本文从国内外法律依据、研究者的义务、伦理委员会的作用及受试者自身的维权等方面,探讨如何保护受试者的知情同意权.     

论药物临床试验中知情同意权的内涵及保护

药物临床试验在国内日渐频繁,知情同意权作为受试者的核心权益却未受到应有的保护,为试验方和受试者之间的纠纷留下了隐患.文章通过分析知情同意权的内涵,阐述权利实践中存在的问题,旨在为寻求解决方法提供思路.     

Changing constructions of informed consent: qualitative research and complex social worlds

Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.     

Embryo futures and stem cell research: the management of informed uncertainty

In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.     

Respect for persons,informed consent andthe assessment of infectious disease risks in xenotransplantation

Given the increasing need for solid organ and tissue transplants and the decreasing supply of suitable allographic organs and tissue to meet this need, it is understandable that the hope for successful xenotransplantation has resurfaced in recent years. The biomedical obstacles to xenotransplantation encountered in previous attempts could be mitigated or overcome by developments in immunosuppression and especially by genetic manipulation of organ source animals. In this essay we consider the history of xenotransplantation, discuss the biomedical obstacles to success, explore recent developments in transgenic sourcing of organs and tissues, and analyze the problem of infectious disease resulting from xenotransplantation (xenosis). We then apply a model of risk analysis to these risks. The conclusions of this risk analysis are used in an ethical evaluation of informed consent in xenotransplantation, with an ethical foundation in Kantian autonomy and Levinasian heteronomic alterity. Our conclusion is that individual and collective informed consent to the infectious disease risks of xenotransplantation requires an open, participatory and dialogical public policy process not yet seen in the United States and Europe. Until that process is created, we propose caution in xenotransplantation in general and a postponement of solid organ xenotransplants in particular.This revised version was published online in October 2005 with corrections to the Cover Date.     

Perils and possibilities: achieving best evidence from focus groups in public health research

Objective: Focus group research is often seen as a cost-effective way of gathering evidence from multiple research participants about the diversity of their views, experiences or beliefs. Our objective is to argue that focus group research only fulfils its potential if analysis of individual views is extended to include analysis of interaction between participants, so that we learn more why people hold these views.
Approach: We outline the literature on focus group research, contrasting the 'quick-and-easy' approach with the demands of studies that are designed, conducted and analysed in a methodologically rigorous way to yield high quality public health evidence.
Conclusion: Well-conducted focus groups contribute good evidence for public health decision making. The challenges of conducting high-quality studies should not be underestimated, and must involve rigorous analysis of both interaction and content.     

论癌症患者的知情同意权——以社会法律关系为视角

癌症患者的知情同意权既是法律问题,也是医学伦理问题,对调整和规范医患关系,提高医生的治疗水平,都具有重要作用.文章通过患者知情同意权的形成历史,在用社会法视角探讨患者知情同意权之本质的基础上,提出了我国癌症患者知情同意权的内容,告知程序及策略,以有益于癌症理论研究和治疗实践.     

上海市部分公立医院涉及人体医学研究项目知情同意过程分析

建议进一步加强医院伦理委员会的作用,规范知情同意的操作,加强公众宣传、改善医患关系,以改善公立医院涉及人体研究项目的知情同意工作。     

论儒家文化对我国实践患者知情同意权的影响

目前我国正处于社会经济转型期,传统的文化现念与现代多元化的权利诉求之间也经历着磨合期.其中患者知情同意权作为患者的基本权利,在我国的临床实践中就深受儒家文化的影响.文章通过研究儒家文化对我国实践患者知情同意权的影响,找出相应的应对方法,为我国真正落实患者知情同意权探索有效途径.     

Exploring informed choice in the context of prenatal testing: findings from a qualitative study

Purpose This study explored whether and how a sample of women made informed choices about prenatal testing for foetal anomalies; its aim was to provide insights for future health policy and service provision. Methods We conducted semi‐structured interviews with 38 mothers in Ottawa, Ontario, all of whom had been offered prenatal tests in at least one pregnancy. Using the Multi‐dimensional Measure of Informed Choice as a general guide to analysis, we explored themes relevant to informed choice, including values and knowledge, and interactions with health professionals. Results Many, but not all, participants seemed to have made informed decisions about prenatal testing. Values and knowledge were interrelated and important components of informed choice, but the way they were discussed differed from the way they have been presented in scientific literature. In particular, ‘values’ related to expressions of women’s moral views or ideas about ‘how life should be lived’ and ‘knowledge’ related to the ways in which women prioritized and interpreted factual information, through their own and others’ experiences and in ‘thinking through’ the personal implications of testing. While some women described non‐directive discussions with health professionals, others perceived testing as routine or felt pressured to accept it. Conclusions Our findings suggest a need for maternity care providers to be vigilant in promoting active decision making about prenatal testing, particularly around the consideration of personal implications. Further development of measures of informed choice may be necessary to fully evaluate decision support tools and to determine whether prenatal testing programmes are meeting their objectives.     

The person of the voice: narrative identities in informed consent

Abstract This paper explores the dominant rational approach to informed consent and challenges the appropriateness of this approach to ethical decision‐making with people with dementia. In dementia care a dominant assumption exists that people are not autonomous because of their inability to make decisions and exercise freedom of choice. The rational understanding of autonomy being the capacity to exercise freedom of choice means that health and social care professionals feel justified in making decisions on behalf of the person with dementia. If a person cannot consent to an intervention then a proxy is used to make the decision. This paper argues that such an approach reinforces the mind‐body dualism that dominates health and social care discourse. Whilst acknowledging the place of proxy decision‐making, it is argued that there is a need to hear the voice of the person with dementia that goes beyond rational understandings of what is heard and that does not reinforce separation of the mind and body. An understanding of the person through their ‘narrative identity’ is proposed and illustrated through a case example. Drawing on the philosophy of Ricoeur it is argued that an individual's narrative identity can be developed and used to underpin informed consent decisions. Using a case example it is argued that paying attention to an individual's narrative identity provides a way of respecting the autonomy of the individual with dementia in a way that is consistent with their overall life plan.     

Defining the "community" in community consultation for emergency research: findings from the community VOICES study

This article explores the application of the concept "community consultation" in the context of emergency medical research. Emergency medicine researchers are permitted, by the World Medical Association regulations and in the United States by U.S. Federal Regulations, to conduct emergency medical research on individuals with a life-threatening condition without obtaining their consent or that of their surrogates if certain conditions are met. Among these conditions is the requirement that researchers observe a number of special protections for the participants, including "community consultation and notification" prior to the initiation of such studies. The term "community" is not defined clearly and the process for conducting community consultations is not specified in these regulations. This study explores the feasibility of conducting community consultation in the context of emergency medical research by examining: research participant's definitions of community in New York, the factors that help shape their definitions of community and the people they would authorize to render participation decisions on their behalves. Findings from this study suggest that participants' definitions of community vary as a function of the purpose of the definition and the demographics of the respondents. Most significantly, this study reveals that although respondents can identify potential spokespersons for their communities, these community spokespersons were rarely identified as those who should have decision-making authority in medical emergencies. Finally, this article explores the implications of these findings for the definition of community as it applies to community consultation for emergency medical research.     

The role of psychology in the teaching of medical ethics: the example of informed consent

Summary: Over the past two decades, psychology has become well established in the medical curriculum. This paper argues that it has much to say about ethical issues, particularly informed consent. Because psychology addresses such areas as providing information, ensuring understanding of this information, identifying situations in which coercion occurs and assessing competence, its inclusion in the curriculum is justified on ethical as well as scientific grounds. This has several implications, including the allocation of resources, collaboration with health and clinical psychologists and the timing of the teaching.