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.     

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.     

Top ten types of informed consent your supervisor never told you about

ABSTRACT

When we conduct ethically sound research, we know that any reason given by an informant to decline or withdraw participation is a legitimate reason. However, some situations can be averted or prevented, increasing your chance of getting the data that you need for your study. In order to be most successful, it might be good to know of some core pitfalls, that you may plummet into when trying to ensure a properly informed consent from your young participants. In this commentary I present my top ten most challenging examples (some experienced, some observed) related to informed consent — in ascending order by level of frustration.     

医方保护性医疗与患者知情同意权冲突的制衡研究

保护性医疗与患者知情同意权间的矛盾已经浮出水面.虽然两者在理论和实践中存在一系列冲突,但这并不意味着其完全没有相容之处,其相容之处正在于它们的伦理一致性.文章在正确认识两者冲突的基础上,通过采取完善立法、区分各自适用情况等方法寻求制衡点,以期在保护下医疗制度下兼顾医患双方的权益.     

喉癌患者本人知情前后情绪和免疫功能变化的对比研究

目的探讨喉癌患者本人知情同意对情绪和免疫功能的影响。方法60例喉癌患者按随机数字表法分为患者本人知情同意组（A组）30例和家属知情同意组（B组）30例。采用焦虑自评量表（SAS）和抑郁自评量表（SDS）评分评估两组患者知情同意前及术后2周焦虑、抑郁程度;检测两组患者知情同意前及术后2周的细胞免疫功能水平。结果两组知情同意前SAS、SDS评分及细胞免疫功能水平比较差异均无统计学意义（P〉0．05）。术后2周,A组SAS、SDS评分分别为（43．17±7．63）、（37．43±8．69）分,均低于B组的（47．84±8．46）、（42．67±9．82）分,差异有统计学意义（P〈0．05）;A组术后2周CD3、CD4、NK细胞分别为0．5762±0．0941、0．3832±0．0751和0．1521±0．0491,明显高于B组的0．5160±0．0821、0．3140±0．0561和0．1163±0．0422,差异有统计学意义（P〈0．05）,而两组CD8和CD4/CD8比较差异无统计学意义（P〉0．05）。结论本人知情同意有利于缓解喉癌患者术后情绪障碍,并可在一定程度上防止免疫功能下降。     

The informed consent aftermath of the genetic revolution. An Italian example of implementation

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework.     

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.     

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.     

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.     

Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast

In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the 'subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.     

The "choose with care system" - development of education materials to support informed Medicare health plan choices

People aging into Medicare need to choose a health plan. Several challenges exist for consumers in choosing a Medicare health plan, including limited knowledge of Medicare, limited experience in using comparative health plan quality information, and limited experience and ability to pull together and use plan information from different sources like employers and the Medicare program. The Choose with Care System was developed to help consumers aging into Medicare make informed Medicare health plan choices. Choose with Care is an innovative decision support tool for employers to use to assist people approaching age 65 to learn about their Medicare health plan options and how to incorporate information on the quality of care and services offered by health plans into their choices. Employers are the targeted channel for distributing the Choose with Care materials because they are one of the most recognized and accessible formal intermediaries for information about health insurance. We used multiple methods to test the Choose with Care products. Product testing showed that the Choose with Care materials increase older consumers' knowledge of Medicare and how it relates to retiree health insurance and improves their comprehension and use of comparative quality information when choosing a health plan.     

Making informed choices in social care: the importance of accessible information

The current policy trend is to encourage greater choice in the use of welfare services. To make informed choices, people need information. The process of finding and using information has costs for individuals in terms of effort, time and material resources. These costs are different for different people and impact on their use of information in different ways. Thus, the accessibility of information is important in ensuring those people who need to make choices can do so in an informed way. This paper discusses the importance of information in making informed choices about social support by drawing on the findings of a scoping review of government research and development activity on the accessibility of information about adult social care services. The scoping review was carried out in spring 2006. Details of recent, current and planned projects were obtained through discussions with staff in government departments, government agencies and other related organisations identified using a snowballing technique. Forty-two contacts were made. Eleven research and 36 development projects were identified that aimed to investigate or improve the accessibility of information about social care services. A limited literature search was undertaken on information needs in areas not already under investigation by government. Eighteen articles were identified. Information and helpline staff from six voluntary organisations gave their views on the accessibility of information about social care services. Our findings show that there is no government-related or other recent research evidence on the specific information access needs for some user groups and services, for example, people from ethnic minority groups. For other user groups, such as people with chaotic lifestyles, there is evidence on information needs but no current or planned development projects to address these needs. The implications for the costs of finding and processing information to aid informed choices are discussed.     

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk-based Mammascreening study

Introduction

Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data.

Methods

Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach.

Findings

Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed.

Conclusion

Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research.

Patient and Public Contribution

Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.     

Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working 'in the field'.     

Provision of surgical care in Ethiopia: Challenges and solutions

With the lowest measured rate of surgery in the world, Ethiopia is faced with a number of challenges in providing surgical care. The aim of this study was to elucidate challenges in providing safe surgical care in Ethiopia, and solutions providers have created to overcome them. Semi-structured interviews were conducted with 10 practicing surgeons in Ethiopia. Following de-identification and immersion into field notes, topical coding was completed with an existing coding manual. Codes were adapted and expanded as necessary, and the primary data analyst confirmed reproducibility with a secondary analyst. Qualitative analysis revealed topics in access to care, in-hospital care delivery, and health policy. Patient financial constraints were identified as a challenge to accessing care. Surgeons were overwhelmed by patient volume and frustrated by lack of material resources and equipment. Numerous surgeons commented on the inadequacy of training and felt that medical education is not a government priority. They reported an insufficient number of anaesthesiologists, nurses, and support staff. Perceived inadequate financial compensation and high workload led to low morale among surgeons. Our study describes specific challenges surgeons encounter in Ethiopia and demonstrates the need for prioritisation of surgical care in the Ethiopian health agenda.

Abbreviations: LCoGS: The Lancet Commission on Global Surgery; LMIC: low- and middle-income country     

系统性健康教育在成人心血管围手术期护理中的应用

目的通过系统性健康教育,促进成人心脏病患者术后康复,减少并发症发生。方法将2007年1月—2010年1月共239例成人心血管病手术患者,随机分成2组,用不同教育方法分别进行健康教育,比较2组患者泌尿系感染人数,二次插管人数,拔除心包、纵隔引流管天数,外科心脏护理单元(SCCU)滞留时间。结果与对照组相比,试验组患者泌尿系感染人数差异无统计学意义(P0.05),二次插管人数减少(P0.05),拔除心包、纵隔引流管天数减少(P0.01),SCCU滞留时间缩短(P0.01)。结论系统性健康教育降低了心血管手术围手术期并发症的发生。