关于结核病临床研究论文的医学伦理学分析

目的：对我国近年来结核领域发表的临床研究论文进行分析,了解我国生物医学期刊在医学伦理方面的审查情况。方法选取了在结核领域较为著名的两本杂志自2010年以来发表的与结核临床试验相关的文献进行分析。结果在纳入的33篇文献中,对知情同意描述的数量相对较高,对伦理审查的描述较少。12％的文献对知情同意的描述不规范,9％的文献没有提到伦理委员会的名称。结论我国部分期刊和科研人员对伦理学审查的重视程度有待提高,要重视医学伦理学的宣传教育,提高编辑人员和科研人员对伦理学问题的认识水平,保证受试者的权益,提高科学研究质量。     

Methodological quality and reporting of ethical requirements in clinical trials

OBJECTIVES: To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. DESIGN: Systematic review using a standardised checklist. MAIN MEASURES: Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included. RESULTS: We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups. CONCLUSION: Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects.     

Opinion survey of physicians on ethical issues in medical research

A total of 3622 physicians registered in the Association of Physicians of India were contacted through mail and requested to respond to a semistructured questionnaire pertaining to different aspects of medical ethics, with particular focus on informed consent. Six hundred twenty-nine physicians (17.4%) responded to the questionnaire; 86% of the respondents reported having had no formal training in medical ethics; 49% of the subjects who undertook research obtained oral consent only. Majority of the respondents noted the relevance of ethics in different medical situations, though in certain areas like community health and research using animals ethical issues were felt to be less important. Patients' inability to come for regular follow-up and illiteracy were opined to be the main constraints in obtaining consent. Opinion on the amount of information to be imported to research participants as part of informed consent was at variance with standard guidelines. Physicians who reported having had an orientation course in medical ethics and those with prior research experience were more aware of ethical issues. Majority of the professionals desired for inclusion of ethics in medical curriculum.     

Ethical research with participants who are deaf

When conducting research with participants who are deaf there is a range of potential issues to be considered: issues relating to language and communication, participants' past experience and culture, and the potential power imbalance between researcher and participant. From an ethical perspective these may compromise informed consent and confidentiality, may inadvertently result in deception and may interfere with the validity of the data. The consequences may be negative for both the deaf population and the research community. This paper highlights the issues that arose in four studies with participants who were deaf and discusses the extent to which the measures taken were effective.     

Beyond informed consent: the therapeutic misconception and trust

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically.     

Informed consent and participant perceptions of influenza vaccine trials in South Africa

BACKGROUND AND OBJECTIVES: There are few insights from sub-Saharan Africa on research participants' experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa.Method: Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration. RESULTS: A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication. CONCLUSION: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.     

Ethics in systematic reviews

Since its introduction by the Nuremberg Code and the Declaration of Helsinki, the place held by ethics in biomedical research has been continuously increasing in importance. The past 30 years have also seen exponential growth in the number of biomedical articles published. A systematic review of the literature is the scientific way of synthesising a plethora of information, by exhaustively searching out and objectively analysing the studies dealing with a given issue. However, the question of ethics in systematic reviews is rarely touched upon. This could lead to some drawbacks, as systematic reviews may contain studies with ethical insufficiencies, may be a possible way to publish unethical research and may also be prone to conflict of interest. Finally, informed consent given for an original study is not necessarily still valid at the systematic review level. There is no doubt that routine ethical assessment in systematic reviews would help to improve the ethical and methodological quality of studies in general. However, ethical issues change so much with time and location, and are so broad in scope and in context that it appears illusory to search for a universal, internationally accepted standard for ethical assessment in systematic reviews. Some simple suggestions could nevertheless be drawn from the present reflection and are discussed in the paper.     

药物临床试验知情同意书常见的伦理问题与对策

从伦理角度探讨目前药物临床研究知情同意书存在的常见问题，依据知情同意书的四个基本要素，重点阐述应从研究的主要内容、知情同意的过程、知情同意的签署等方面设计知情同意书，以确保药物临床试验知情同意书的规范性和科学性。     

关于遗传咨询及其相关伦理问题探讨

对遗传咨询的定义作了界定,介绍了遗传咨询的发展以及目前实践概况,提出遗传咨询应当遵守尊重个人和家庭,保护家庭完整;信息的完全告知;遗传信息的保密和适当公开;非指令性咨询等伦理原则。同时结合我国遗传咨询实践的现状,探讨了我国目前遗传咨询中涉及和存在的伦理问题:对遗传咨询的定位和认识存在偏差,对个人人格、隐私的尊重和遗传性信息的保密不到位,遗传性咨询中的知情同意落实不到位,对咨询的非指令性理解和重视程度不够等。针对没有专业的遗传咨询师和专门的咨询机构的现状,提出解决遗传咨询现实难题的相关建议:加强对临床遗传服务的重视,提高医师的伦理意识,尊重患者和保护患者个人信息,努力做好告知义务并尊重患者选择,加强对遗传咨询的专业性教育。     

生物医学科研伦理可持续发展之研究

我国生物医学科研伦理的发展经历了不到10年的时间,作者简要归纳了我国目前伦理委员会的工作存在的综合问题,其中主要为:知情同意不充分、目前的审查相对宽松、伦理委员会自身科研伦理审查的能力和对本单位提供教育均较缺乏和尚未顾及到审查通过之后的持续审查等.本文通过了解美国在发展过程中存在的问题和我国的现状进行比较,发现存在诸多相似之处,因此着重介绍了其改革思路--地区性伦理审查模式,以资借鉴.作者的目的是就我国进行科研伦理能力建设、继续进行培训、加强政府监管和需要注意的文化因素等方面提出自己的初步设想.     

Biobanks for non-clinical purposes and the new law on forensic biobanks: does the Italian context protect the rights of minors?

Biobanks are an important resource for medical research. Genetic research on biological material from minors can yield valuable information that can improve our understanding of genetic-environmental interactions and the genesis and development of early onset genetic disorders. The major ethical concerns relating to biobanks concern consent, privacy, confidentiality, commercialisation, and the right to know or not to know. However, research on paediatric data raises specific governance and ethical questions with regard to consent and privacy. We have considered the Italian normative context focusing on what is mentioned in each document on the ethical and legal requirements that guarantee the rights of minors. We found out that there is no systematic reflection on the ethical and policy issues arising from the participation of minors in biobank research. Moreover, we have focused on the same aspects for the new Italian Law on the National Forensic Biobank.     

神经精神疾病治疗研究中的可论证伦理学问题

讨论了神经精神治疗学研究中利益动机、验证创新干预方式的风险-获益分析、以及无决策能力受试对象的知情同意三个方面引发的伦理挑战.     

What makes clinical research ethical?

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.     

尊重精神病人的知情同意权

由于社会文化的原因,知情同意原则在精神病人中并未得到充分实施,作者通过介绍精神病人知情同意权的依据、知情同意在精神科的应用范围、精神病人的知情同意能力及在精神科如何实施知情同意,指出应尊重精神病人的知情同意权.     

开展异种器官移植临床试验的几个关键伦理问题

目前，异种器官移植由于动物道德权、医疗资源分配及危害大众健康等问题而受到广泛地关注与争论，本文提出了四个关键伦理问题，即利弊界限、供研究患者的知情同意、第三方组织的知情同意及临床试验的监督和批准，作为开展异种器官移植临床试验的先决条件。     

剖析生物样本库建设中的伦理问题

生物样本库建设中有诸多问题,主要包括：样本收集的知情同意及“再次同意”有关的问题、广泛同意的问题、保密性问题、所有权问题及商业化问题、参与者重新接触的伦理问题,出生队列研究中生物样本库建设也同样面临着上述生物样本库需面临的伦理问题,对于这些问题,为生物库建设及运作过程中的伦理管理框架提出了生物样本库共享、知情同意及特殊人群保护、样本采集方面及生物样本库有关经济方面等几个具体建议.     

超说明书用药的伦理研究

超说明书用药现象在临床上较普遍,主要源于特殊人群药物安全信息不足、医生对临床研究和常规治疗的界限把握不严和知情同意落实不力等原因。对临床研究中的超说明书用药存在的主要伦理问题进行探讨,提出伦理审查要点应涵盖研究的合法性、研究的科学性、严格的试验流程、充分的知情同意、明确补偿方法和声明利益冲突等,以期更规范地防范和控制风险。     

Ethical questions must be considered for electronic health records

National electronic health record initiatives are in progress in many countries around the world but the debate about the ethical issues and how they are to be addressed remains overshadowed by other issues. The discourse to which all others are answerable is a technical discourse, even where matters of privacy and consent are concerned. Yet a focus on technical issues and a failure to think about ethics are cited as factors in the failure of the UK health record system. In this paper, while the prime concern is the Australian Personally Controlled Electronic Health Record (PCEHR), the discussion is relevant to and informed by the international context. The authors draw attention to ethical and conceptual issues that have implications for the success or failure of electronic health records systems. Important ethical issues to consider as Australia moves towards a PCEHR system include: issues of equity that arise in the context of personal control, who benefits and who should pay, what are the legitimate uses of PCEHRs, and how we should implement privacy. The authors identify specific questions that need addressing.     

Emergency research in children: options for ethical recruitment

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research.