部分中文医药杂志伦理保护措施的报告情况

对2002年之前和之后(2000年7月~2001年12月和2003年1月~2004年6月)对6种中文医药杂志发表的临床研究类文章进行比较,并对文中报告知情同意和伦理委员会批准情况的比例给予评价。     

Grey Matter: Ambiguities and Complexities of Ethics in Research

Ethical dilemmas are often not discussed in the dissemination of educational research. While the ethical guidelines for research seem clear at first glance, a closer look at the intimate nature of qualitative research reveals that there are many ambiguities or ‘grey’ areas where researchers must rely on their personal value systems. This article discusses the challenges faced by an experienced educator, although novice researcher, in considering the ethical parameters of her own research with adolescents with hearing loss. In particular, the grey ethical areas identified by the researcher include: (a) vulnerable population; (b) researcher role confusion; (c) consent; (d) privacy, confidentiality, and anonymity; as well as (e) the nature of risk. Based on the author’s own reflections on beginning the research process, the article presents possible pitfalls and ways of overcoming the possibility of becoming immobilized by the ethical enigmas of research.     

Informed consent and the use of placebo in poland: Ethical and legal aspects

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Legal and Ethical Issues in the Court-Mandated Treatment of Batterers

Summary

In the following article, we will explore the nature of the therapeutic relationship as it relates to batterers' treatment programs. We will consider the impact of obligations created by forces outside the relationship, such as those imposed by legal proceedings. We will discuss the concepts of confidentiality, privilege, and agency and their impact on the therapeutic relationship and the extent to which the therapists' understanding of the role these concepts play may be altered by court orders that impose treatment on a client/patient. Finally, we examine the issues and choices a therapist must make when engaging in court-ordered treatment of batterers, and the implications of those choices for both therapist and client; we will also suggest guidelines to help therapists sort through the often conflicting goals of therapy and the legal process.     

Piercing the Veil: Ethical Issues in Ethnographic Research

It is not unusual for researchers in ethnography (and sometimes Institutional Review Boards) to assume that research of “public” behavior is morally unproblematic. I examine an historical case of ethnographic research and the sustained moral outrage to the research expressed by the subjects of that research. I suggest that the moral outrage was legitimate and articulate some of the ethical issues underlying that outrage. I argue that morally problematic Ethnographic research of public behavior can derive from research practice that includes a tendency to collapse the distinction between harm and moral wrong, a failure to take account of recent work on ethical issues in privacy; failure to appreciate the deception involved in ethnographers’ failure to reveal their role as researchers to subjects and finally a failure to appropriately weigh the moral significance of issues of invasion of privacy and inflicted insight in both the research process and subsequent publication of research.

临床试验中的利益冲突：伦理和政策问题

人们对于研究人员、赞助商和研究机构三者之间的经济利益关系给予越来越多的关注,人体试验研究中的经济利益与其他利益有所不同,这种经济利益会导致偏见或诱导不正当的行为,尤其是当有从研究中获益的机会存在时,将会影响到研究人员关于应该选择哪个受试者,应该提供给受试者什么样的医疗服务,甚至应该如何正确使用受试者保密的健康信息方面的判断,由经济利益引起的明显的风险同样也会威胁公众的学术机构研究使命的支持,从处理临床试验中利益冲突的准则,什么样的经济利益是研究中的重大经济利益。准则的实施等方面进行了详尽的叙述,最后指出没有潜在受试者和公众的信任,我们就不能有效地开展研究。     

药品临床试验的伦理规范与医学科技进步--对非洲等地开展HIV药品临床试验的思考

目前,在非洲等地进行的HIV药品临床试验已成为国际上最有争议的话题之一.药品临床试验促进了医学科技的进步和发展,但同时带来了一些突出而复杂的伦理问题.面对这一难题,我们应正确看待医学科技进步与伦理之间的关系,以"尊重、公正、不伤害、受益"这一伦理基本原则指导HIV药品临床试验,促进医学和伦理道德的共同进步、协调发展.     

Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

口腔临床医疗实践中知情同意的实现

知情同意是一项重要的伦理学原则和患者自主权的具体表现形式。本文分析了在口腔临床医疗实践中知情同意存在的突出问题和原因,并探讨了实现的方法和途径。本文认为只有遵循全面、精确、真实的告知原则,让患者在充分理解的基础上做出自主地选择,才能保障知情同意原则的实现。     

Faith-to-faith at the bedside: theological and ethical issues in ecumenical clinical chaplaincy.

Chaplains who serve in a clinical context often minister to patients representing a wide variety of faiths. In order to offer the best pastoral care possible, the chaplain should first possess a set of personal theological convictions as a foundation for ministry. Second, he or she needs to be sensitive to the beliefs and practices of the patients. Third, it is vital to develop a relationship of acceptance and trust not only with patients under their care, but also with family members and caregivers as well. At times, situations will arise that are purely religious or theological. In a clinical setting, however, the questions and problems that arise more often are both theological and ethical. It is beneficial for the chaplain to be involved in an ethics committee, where the specifics of each case can be discussed, and staff can offer counsel to patients and their families. This study examines issues that chaplains face at the bedside, such as terminal care, life-prolonging treatments, dementia, persistent vegetative state, and euthanasia-assisted suicide. We will discover that those who are involved in clinical pastoral ministry will be called upon to be a comforter, mediator, educator, ethicist, and counselor.     

Ethical issues in the clinical application of fMRI: factors affecting the validity and interpretation of activations

The ability of functional magnetic resonance imaging (fMRI) to localize activations in a single patient, along with the safety and widespread availability of this methodology, has lead to an increasing use of fMRI for clinical purposes such as pre-surgical planning. As methodology continues to improve and more experience with fMRI in the clinical setting is acquired, clinical functional neuroimaging will likely have an increasing influence over patient care. Therefore, ethical use of fMRI, as with other medical techniques, requires understanding the factors impacting the interpretation of the methodology. Issues affecting the validity and interpretation of clinical functional neuroimaging, including effects of altered hemodynamic response function, head motion, and structural changes in the brain, are reviewed. The distinction between correlated and necessary activation in a clinical context is discussed. Different types of statistical errors in fMRI analysis are described, along with their consequences to the patient. Finally, for the future of clinical fMRI development, the need for normative patient data, as well as standardized tasks, scan protocols, and data analyses, is discussed.     

Ethical,and practical issues in applying functional imaging to the clinical management of Alzheimer's disease

This review outlines ethical, legal, and practical issues related to conducting functional imaging research with Alzheimer's disease (AD) patients. Imaging techniques, with an emphasis on functional MRI and positron emission tomography, are compared and contrasted with respect to the manner in which they can be applied to issues of clinical relevance to AD. Methodological difficulties are raised to assist with critical evaluation of current imaging results. Various potential clinical applications of functional imaging are briefly reviewed and discussed with respect to associated ethical conflicts.     

A general linear model for estimating effect size in the presence of publication bias

When the process of publication favors studies with smallp-values, and hence large effect estimates, combined estimates from many studies may be biased. This paper describes a model for estimation of effect size when there is selection based on one-tailedp-values. The model employs the method of maximum likelihood in the context of a mixed (fixed and random) effects general linear model for effect sizes. It offers a test for the presence of publication bias, and corrected estimates of the parameters of the linear model for effect magnitude. The model is illustrated using a well-known data set on the benefits of psychotherapy.Authors' note: The contributions of the authors are considered equal, and the order of authorship was chosen to be reverse-alphabetical.     

自我保护性医疗的伦理扫描--论患方知情同意与医方规避风险

自我保护性医疗是近年来医方为应对医患关系重构而采取的一种行为模式,其本身和影响具有全新特点,充满价值冲突;这种行为模式,客观上是对应医疗风险尤其是重大医疗风险的;主观上同医方免责期待的张扬以及对知情同意的解读直接相关;因而,正当的自我保护性医疗既取决于医方合理的免责期待,以及改变对知情同意的误读,更依赖于自身的医学伦理综合素质的打造和完善。     

Professional Ethical Issues and the Development of Professional Ethical Standards in Counseling and Clinical Psychology in China

This article aims to summarize the current ethical issues in the field of clinical and counseling psychology and the process of developing professional ethical standards in China. First, through a review of the history of counseling and psychotherapy in China, general background information is provided. Important ethical issues are then discussed based on the results from several empirical studies. Finally, the process of developing the new edition of the Chinese Psychological Society Code of Ethics for Clinical and Counseling Psychology, the main contents as well as the considerations taken into account in the development of this code are presented.     

知情同意在中医药临床诊疗中的应用思考

知情同意在中医药临床诊疗中的应用,医生要掌握知情同意的要素和方法,将中医药的不良反应及中医药特殊性告知病人,让病人的充分知情、自愿选择、实施同意。医疗机构也要承担推进知情同意应用的责任,开展不良反应监测、建立实施规范,教育和评估知情同意落实情况。     

关于肿瘤专科诊疗最优化与过度医疗

肿瘤专科诊疗最优化准则有狭义、广义之分,二者既有区别,更有联系.肿瘤专科诊疗的过度医疗的内容是动态发展的,在特定情况下有其积极意义.实现肿瘤专科诊疗最优化,避免过度医疗,要重视矛盾问题底线的研究,提供相对宽松的技术、学术、文化氛围;医者持续的、有计划的专业学习与培训是增强其主体性的保证和前提;要充分考虑可承受性原则;用新的医德价值观指导现实中的医学道德实践;积极发挥医院伦理委员在肿瘤专科诊疗决策中的作用;建立与利用医务人员诚信档案.     

Ethical Challenges in the Treatment of Individuals With Intellectual Disabilities

The effective provision of psychotherapy services to individuals with intellectual disability requires consideration of ethical issues related to clinical competence, access to services, obligations to multiple parties, guardianship, and appropriate assessment practices. This article provides an overview of major ethical considerations with guidance for clarifying and resolving common ethical concerns. Psychologists are encouraged to expand access to psychotherapy services for this population while maintaining awareness of potential modifications, training needs, and boundaries of professional competence. The authors provide recommendations and resources for effective and ethical treatment of psychotherapy clients with intellectual disabilities.     

知情同意权在手术同意书中的法律探讨——李丽云死亡案引发的思考

李丽云因为丈夫拒签手术同意书而造成“一尸两命”的事件,“拒签”事件击中了医疗法规知情同意权在医疗实施过程中的软肋。如何保护病人的生命权、被救助权和手术权,如何让医院救死扶伤而没有后顾之忧,建议政府部门应该建立相应的“国家担保”制度,使病人得到最为及时有效的抢救和治疗。以免类似的悲剧再次发生。