EMBEDDING ETHICS IN A CLINICAL RESEARCH TRAINING PROGRAM

这门研究伦理学课程是阿尔伯特·爱因斯坦医学院为临床医生(均为医学博士)新的临床研究方法培训计划的组成部分。这门课程是培训计划第一年的必修课，该计划提供理科硕士学位。为期12周的课程包括两个独立的模块，基础研究伦理学和高级研究伦理学，它们可以单独使用，也可以在其他环境中一起使用。整个课程还包括为学位课程二年级的参与者开设的研究伦理专题选修课。该课程的评估由教育研究和评估办公室主任进行。每年大约有12-14名学者报名参加该项目。 涵盖的主题包括风险效益评估；知情同意；研究对象和数据的隐私和保密；流行病学、社会和行为研究中的伦理问题；负责任的科学研究；机构审查委员会的作用和职能；研究对象的弱势群体；艾滋病和人类遗传学研究中的问题；将妇女和少数群体纳入研究；以及在发展中国家进行的国际研究。所有课程都以研讨会形式授课，使用互动教学方法，包括基于互联网的形式。其中一节专门介绍了一个“模拟的”IRB会议，在会上，学者们回顾了实际的研究方案。另一项研究要求学者为生物医学研究中常用的各种程序分配风险水平。课程间歇的作业以电子方式发布，供学员评论和批评。在高级模块的六个环节中，有三个环节是学者们关于他们作为硕士课程要求而设计的研究项目中出现的伦理问题的陈述，然后是小组讨论。基本单元有一个带回家的考试，而高级单元需要一份基于学者口头陈述的修订版的简短论文。

This course in research ethics is developed as an integral part of a new Training Program in clinical Research Methods for clinicians (all are MDs) at Albert Einstein College of Medicine. The course is required in the first year for scholars in the Training Program, which offers a Master of Science degree. The twelve-week course comprises two separable modules, Basic Research Ethics and Advanced Research Ethics, which can be adapted for use separately or together in other settings. The overall program also includes elective courses on special topics in research ethics for participants in the second year of the degree program. Evaluation of the course is carried out by the Director of the Office of Educational Research and Evaluation. Approximately 12-14 scholars enroll each year in the program. Topics covered include risk-benefit assessments; informed consent; privacy and confidentiality of research subjects and data; ethical issues in epidemiological, social and behavioral research; responsible conduct of scientific research; the role and functions of Institutional Review Boards; vulnerable populations of research subjects; issues in AIDS and human genetics research; inclusion of women and minorities in research; and international research conducted in developing countries. All classes are taught in seminar fashion, using interactive teaching methods, including internet-based formats. One session is devoted to a "mock" IRB meeting, in which scholars review actual research protocols. Another asks scholars to assign risk levels to various procedures commonly used in biomedical research. Assignments between course sessions are posted electronically and designed for participants' comments and critique. Three of the six sessions in the Advanced Module are devoted to presentations by the scholars on ethical issues arising in the research projects they are designing as a requirement of the Master's Program, followed by group discussion. The Basic Module has a take-home examination, and the Advanced Module requires a short paper based on a revised version of the oral presentations made by scholars.