A PRACTICUM IN CLINICAL RESEARCH ETHICS

背景：知情同意的理想在实践中 一个新兴的实证文献研究参与引起了建设性的重新评估知情同意的标准，并认识到其实际的局限性。 由于法规往往对同意研究的能力的含义保持沉默，因此研究人员的决定能力往往是“英雄标准”，而许多患者在许多情况下往往无法达到这一标准。例如，精神分裂症患者往往对自己的疾病和护理需求有着深刻的认识缺陷。 他们可能对正在考虑的研究的关键方面产生妄想，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“不关心”与协议相关的风险。 穷人可能无法抗拒重大的现金奖励或其他无法获得的医疗服务等，住院患者的“治疗误解”或绝症患者的绝望解决方案揭示了知情和自愿同意概念在实际临床情况下的复杂性。 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。 鉴于对“脆弱性”的许多方面的强调和对信息披露的更大要求，必须认为传统的同意办法是不够的。 虽然让研究人员关注特定人群中知情同意的障碍仍然至关重要，但如果我们要保护脆弱的患者，同时促进有价值的科学研究，我们最应该把更多的注意力放在将同意的理想转化为有意义的实践上。 课程：研究伦理学实践 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学课程。 该计划解决了我们医疗中心未满足的需求，并启动了纽约州立精神病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。该课程由既定的临床研究人员和伦理学家教授，旨在使计划参与者熟悉人体实验伦理学历史上的核心原则和开创性事件，重点是与弱势群体合作。 教学大纲借鉴了研究伦理学的理论和经验文献，对参与者进行知情同意和能力评估的教育。 将讨论与少数民族和种族以及移民人口的研究，以强调经常被忽视的道德和社会重要性问题。 课程结构和内容是针对那些积极参与研究和研究监督的人的需求和兴趣量身定制的;该计划采用实用和临床的方法。 将在面向案例的小型讲习班上介绍加强知情同意程序的方法。 在研究伦理学的实习旨在通过教学核心伦理原则，通过提高对特殊人群的脆弱性的认识，通过提供能力评估的共识培训，并通过鼓励讨论和辩论，促进临床研究的道德行为。

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.