A PRACTICUM IN CLINICAL RESEARCH ETHICS

背景：实践中的知情同意理想 关于研究参与的新的经验性文献促使人们对知情同意的标准进行建设性的重新评估，并认识到其实际局限性。由于法规通常对同意研究的能力的含义没有规定，研究人员留下了决策能力的“英雄标准”，许多患者和许多环境往往无法满足这一标准。例如，精神分裂症患者在对自己的疾病和护理需求的认识上往往存在严重缺陷。他们可能对正在考虑的研究的关键方面有妄想症，他们可能有注意力和信息处理缺陷，或者他们可能表现出深刻的矛盾心理或被动。抑郁症患者可能会表现出绝望和绝望，这可能会影响决策，或者只是让他们“不在乎”与方案相关的风险。穷人可能无法抗拒巨大的现金奖励或提供其他方面无法获得的医疗服务，等等。住院患者的治疗误区或绝症患者寻求的绝望解决方案，揭示了知情自愿同意概念在实际临床环境中的复杂性。 此外，无论是研究还是监管都没有对知情同意程序的发展产生重大影响。鉴于更加强调“脆弱性”的许多方面和对信息披露的更大要求，必须认为传统的同意方法是不够的。尽管将研究人员的意识集中在特定人群中知情同意的障碍上仍然至关重要，但如果我们要在保护脆弱患者的同时推进有价值的科学研究，我们最关注的是努力将同意的理想转化为有意义的实践。 课程：研究伦理学的实践 我们为临床研究人员和机构审查委员会成员开发了一门应用研究伦理课程。该项目解决了我们医疗中心未得到满足的需求，并推动了纽约州精神病学研究所和哥伦比亚大学社会与医学研究中心的教职员工之间的宝贵合作。该课程由知名临床研究人员和伦理学家授课，旨在让项目参与者熟悉人类实验伦理学历史上的核心原则和开创性事件，重点是与弱势群体的工作。教学大纲借鉴了研究伦理方面的理论和经验文献，对参与者进行知情同意和能力评估方面的教育。将讨论对少数族裔和少数族裔以及移民人口的研究，以强调往往被忽视的伦理和社会重要性问题。课程结构和内容是为那些积极参与研究和研究监督的人的需求和兴趣而量身定做的；该计划采取了实用和临床的方法。将在以个案为导向的小型讲习班上介绍加强知情同意程序的方法。研究伦理实践旨在通过教授核心伦理原则、提高对特殊人群脆弱性的认识、提供能力评估方面的共识培训以及鼓励讨论和辩论，促进临床研究的伦理行为。

Background: The Ideal of Informed Consent in Practice An emerging empirical literature on research participation has provoked a constructive re-evaluation of the standard of informed consent and an awareness of its practical limitations. Since regulations are often silent as to the meaning of capacity to consent to research, researchers are left with a "heroic standard" of decisional capacity that often cannot be met by many patients and in many settings. Patients with schizophrenia, for example, often have profound deficits in their awareness of their illness and need for care. They may be delusional about critical aspects of the study being considered, they may have attention and information processing deficits, or they may evidence profound ambivalence or passivity. Patients with depression may evidence despair and hopelessness that may influence decision-making, or simply make them "not care" about the risks associated with a protocol. The poor may be unable to resist significant cash incentives or offers of otherwise unavailable medical care, and so on. The hospitalized patients' "therapeutic misconception" or the desperate solutions sought by the terminally ill reveal the complexities of the concept of informed and voluntary consent in actual clinical circumstances. Furthermore, neither research nor regulation has significantly influenced the development of procedures for informed consent. Traditional approaches to consent have to be considered inadequate given the greater emphasis on the many dimensions of "vulnerability" and the greater demand for information disclosure. While it remains vitally important to focus awareness among researchers on barriers to informed consent in specific populations, if we are to protect vulnerable patients while furthering worthwhile scientific inquiry, we most devote more attention to efforts to translate the ideal of consent to meaningful practice. Course: A Practicum in Research Ethics We have a developed a course in applied research ethics for clinical investigators and members of institutional review boards. The program addresses an unmet need at our medical center, and initiates a valuable collaboration between the faculty and staff of the New York State Psychiatric Institute and the Center for the Study of Society and Medicine at Columbia University. The curriculum, taught by established clinical investigators and ethicists, is designed to familiarize program participants with core principals and seminal events in the history of the ethics of human experimentation with a focus on work with vulnerable populations. The syllabus draws upon the theoretical and empiric literature in research ethics to educate participants on informed consent and the assessment of capacity. Research with ethnic and racial minorities and immigrant populations will be discussed to underscore often overlooked matters of ethical and social importance. The course structure and content is tailored to the needs and interests of those actively involved in research and research oversight; the program takes a practical and clinical approach. Methods to enhance the informed consent process will be presented in small, case-oriented workshops. A practicum in research ethics aims to promote the ethical conduct of clinical investigation by teaching core ethical principles, by increasing awareness of the vulnerabilities of special populations, by providing consensus training in the assessment of capacity, and by encouraging discussion and debate.