Further reflections on the impact of clinical writing on patients

Though it is unlikely that instituting universal guidelines will ever be possible for patient approval of the analyst's use of clinical material outside of the treatment setting, the author offers some supplementary refl ections to those already available in the literature. Broadly applied informed consent guidelines would increase the distortion that already exists in our clinical literature due to self-imposed restraints by writers. Moreover, the powerful irrational forces mobilized by consent in the dyad are not easily 'held' by traditional applicable legal categories. Metapsychological formulations of the intrapsychic and intersubjective impact of patient participation in the writing process on individual analytic dyads are needed. Notions of privacy protection, validation, dyadic co-construction, or writing-as-containment by a third as rationales for informed consent fail to encompass the transindividual and external sources of human identity and the ineradicable lack of unity in the unconscious. Nevertheless, theoretical affi nity and preferred technique may be mediating factors in positive outcomes of the consent process. Some paradigms not only accommodate more comfortably but also actively seek the intersubjective repercussions of informed consent. Asanalternativeorcomplementaryviewpoint, theauthoroffersthehypothesis that the clinical ramifi cations of either disguise or consent are not exclusively, nor even necessarily, concerned with what patients read about themselves, but what they assess or intuit-directly or indirectly through the material presented-of their analyst's unconscious strivings. To truly triangulate the clinical reporting project, it is wisest to consult the third ear of a colleague to assess the potential impact on patients on what might be being unconsciously transmitted by the analyst in the writing and the consent process     

医学期刊载文的伦理学审查情况分析——以《中国学校卫生》为例

通过查阅《中国学校卫生》近5年纸质期刊,查看文章“对象与方法”中有无“知情同意”或“获得伦理学审查”等信息。结果显示,获得伦理学审查或知情同意的文章884篇,各年份获得伦理学审查、知情同意及总体检出率差异均有统计学意义(χ²=366.29,43.58,219.83,P<0.01)。各年份获得伦理学审查、知情同意的心理学研究及总体检出率(χ²=107.55,16.80,58.66);获得伦理学审查的干预性研究及总体检出率(χ²=44.40,18.46);获得伦理学审查的涉及生物样本的研究检出率(χ²=17.47),差异均有统计学意义(P<0.01)。今后应不断加强引导和教育,加强科研人员及编辑的伦理意识。     

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。     

Writing about patients III: Comparisons of attitudes and practices of analysts residing outside and within the USA

When analysts write about patients, they find themselves in a position of conflict. Their first loyalty is to their patients and maintaining confidentiality. However, they are also committed to advancing scientific knowledge in the psychoanalytic field. The attitudes and practices of 36 analysts residing outside the USA, who published articles using clinical material from their patients, are reported. Their attitudes and practices are compared with those of 30 author-analysts residing within the USA, who had been previously interviewed. Among the 66 analysts, geographic region was not a basis for distinguishing differences in attitudes or practices. Slightly more than twice as many analysts use only disguised material as regularly ask permission of their patients to write about them. The decision to use only disguise is somewhat more frequent for analysts who reside outside the USA than for those living within it. Analysts around the world are increasingly concerned about the accessibility of published material. More analysts have come to believe that it is necessary to ask permission before publishing material. Some analysts also believe that the request itself, and the patients reading written material about themselves, focus issues that are central to patients' characters and confl icts that can then be explored analytically.     

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.     

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.     

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.     

基因组学研究免除具体知情同意的伦理挑战与审查实践

精准医学时代基因组学研究与临床的结合愈加紧密,研究规模和范围大大扩展。然而,机构既往采集保存样本和信息时征询知情同意的方式和质量不尽相同。指引研究者合法合理使用既往留存资源是伦理委员会面临的重要挑战。在适用国际和我国有关规范时,伦理审查应注意基因组信息的身份关联性、终身伴随性和族群相关性,不能仅以研究采样风险不大于最小风险、不免除知情同意增加研究难度为由批准研究者免除具体知情同意的申请,还应结合研究内容,从隐私保护、意外发现对资源提供者健康权益的影响等方面整体权衡个体和群体的风险受益,审慎决定。     

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.     

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.     

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.     

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。     

精神卫生领域行使代理同意的伦理风险及其应对

在精神卫生领域,行使代理同意虽然获得了医学伦理的有力辩护,但同时也存在诸多伦理风险。精神卫生领域行使代理同意的伦理风险主要包括家长主义、至上主义和专制主义三大方面。它的形成与代理同意人性预设“扬善蔽恶”始源缺陷导致的“错位性解读”“非理性旁观”“非理性自信”以及“无原则纵容”等问题紧密相关。推广知情同意能力培训、建构代理同意承诺制、建立代理同意定期检查制是防范和抑制精神卫生领域代理同意伦理风险的针对性措施。

     

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.     

浅析脑胶质瘤临床试验中知情同意的问题

通过对医院目前开展的脑胶质瘤临床试验知情同意过程中的观察,综合科室脑胶质瘤临床试验的开展情况,针对不同类型脑胶质瘤病人尤其是功能区受损以及伴有认知功能受限的病人,分析签署知情同意过程中存在的问题,经探讨并提出整改及解决办法。通过规范的签署知情同意,针对病情不同的脑胶质瘤受试者采取个体化签署知情同意,充分尊重受试者意愿,保证临床试验顺利进行,使受试者权益得到充分保障,促进临床试验规范、安全、有序的开展。