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.     

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.     

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.     

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 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.     

论急救知情同意制度的理解和适用

对于急救病例,医务人员机械地执行知情同意制度不是最佳的选择,应当考虑患者的根本利益而不囿于患者或者其家属的错误决定,有权行使医疗干涉权并及时对患者采取手术治疗等紧急抢救措施。     

知情同意权实施难的原因及对策

知情同意权是近年来学术界争论的一个热点之一。实行知情同意制度主旨在于保护病人的权益不受侵犯。然而知情同意原则实施中，常会受到多方面因素的影响，特别是受医生和患者的影响。文章通过对影响知情同意权实施的因素进行分析，找出实施难的原因，并针对这些问题提出了若干对策。     

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.     

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.     

代理行使知情同意权的难点探究

代理行使知情同意权在医疗实践中广泛存在,在实施过程中可能出现一些难点问题。文章对特定情况下代理行使知情同意权过程中的难点问题作出分析,结合医疗实践,就代理行使知情同意权的难点问题提出相应建议·为这个领域的代理实践提供一些思路。     

Personal autonomy and informed consent

Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.     

论精神障碍者的知情同意权

随着精神医学的发展和世界人权运动的兴起,精神障碍者的知情同意权也得到社会普通的重视.各类国际组织先后就保护精神障碍者的权利发表宣言,一些国家也有判例来保护精神阵碍者的知情同意权,临床精神病学家也在积极探索精神障碍者的认知能力问题.从精神病科学和法学结合的角度来看,在对精神障碍者认知功能科学评定的基础上,有区别地保护精神障碍者的知情同意权才是当前可行的途径.     

The price of autonomy

The randomized controlled trial produces a clash of ethical principles with the need for informed consent (autonomy) in conflict with the principles of beneficence and justice. Informed consent is one of the major rate‐limiting factors of recruitment and this delays the discovery of life‐saving treatments indirectly. Whilst supporting the concept of non‐exploitation we wish to challenge the prevailing dogma by asking the awkward question ‘what is the price of autonomy?’. Using breast cancer as an example we have developed a decision model with explicit assumptions allowing numerical values to be fed into a mathematical equation, which calculates the cost in lives. With conservative assumptions we estimate that the price of autonomy is 2500 lives over a 10‐year period in the United Kingdom alone. We issue the challenge to health policy makers and ethicists to survey public opinion to determine the value placed on autonomy in the war against cancer.     

Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS)

Background  Patients and clinicians report difficulties with the process of informed consent to clinical trials and audiotape audits show that critical information is often omitted or poorly presented. Decision aids (DAs) may assist in improving consent.
Aims  This study piloted a DA booklet for a high priority breast cancer prevention trial, IBIS-II DCIS, which compares the efficacy of an aromatase inhibitor (anastrozole) with tamoxifen in women who have had surgery for ductal carcinoma in situ (DCIS).
Method  Thirty-one Australian women participating in the IBIS-I breast cancer prevention trial and who are currently in follow-up agreed to read the IBIS-II DCIS participant information sheet and the DCIS DA booklet, complete a set of standardized questionnaires, and provide feedback on the DA via a semi-structured phone interview.
Results  Women found the DA helpful in deciding about trial participation, reporting that it aided their understanding over and above the approved IBIS-II DCIS participant information sheet and was not anxiety provoking. Women's understanding of the rationale and methods of clinical trials and the IBIS-II DCIS trial was very good; with more than 80% of items answered correctly. The only areas that were not understood well were the concepts of randomization and blinding.
Conclusions  This study suggests that the DA will be acceptable to and valued by potential participants in the IBIS-II DCIS study. The revised DA is currently being evaluated prospectively in a randomized controlled trial. If successful, such DAs could transform the consent process to large clinical trials and may also reduce dropout rates.     

预防接种知情告知专家共识(下)

《中华人民共和国疫苗管理法》和其他相关法律法规对受种者或其监护人的疫苗和预防接种工作知情提出了要求,对预防接种告知方式和内容作出了规定.本共识以该法和《预防接种工作规范》为基础,借鉴国内外经验,阐述了预防接种知情告知的发展和形式,制定了预防接种知情告知理论框架、标准流程和信息、非免疫规划疫苗知情告知原则以及各疫苗知情同...     

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.     

Proposing modesty for informed consent

The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.     

预防接种知情告知专家共识(上)

《中华人民共和国疫苗管理法》和其他相关法律法规对受种者或其监护人的疫苗和预防接种工作知情提出了要求,对预防接种告知方式和内容作出了规定。本共识以该法和《预防接种工作规范》为基础,借鉴国内外经验,阐述了预防接种知情告知的发展和形式,制定了预防接种知情告知理论框架、标准流程和信息、非免疫规划疫苗知情告知原则以及各疫苗知情同意书格式,为疾病控制和预防保健人员在预防接种服务中参考。本部分共识包括总则以及乙型肝炎疫苗、卡介苗、含脊髓灰质炎成分疫苗、含百日咳/白喉/破伤风成分疫苗、含麻疹/风疹/流行性腮腺炎成分疫苗、乙型脑炎疫苗、脑膜炎球菌疫苗、甲型肝炎疫苗预防接种知情告知内容。