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EMBEDDING ETHICS IN A CLINICAL RESEARCH TRAINING PROGRAM

将道德规范融入临床研究培训计划

基本信息

批准号：
6169142
负责人：
RUTH MACKLIN
金额：
$ 15.25万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-09-30 至 2001-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6169142
关键词：
EMBEDDING ETHICS CLINICAL RESEARCH TRAINING

项目摘要

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.

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（所有医学博士）开发的临床研究方法新培训计划的一个组成部分。该课程是在第一年的培训计划，提供科学学位的硕士学者所必需的。为期12周的课程包括两个可分离的模块，基础研究伦理和高级研究伦理，可以单独使用或在其他环境中一起使用。整体计划还包括在学位课程的第二年参与者的研究伦理专题选修课程。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名学者参加该计划。所涉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;负责任地进行科学研究;机构审查委员会的作用和职能;研究对象中的弱势群体;艾滋病和人类遗传学研究中的问题;将妇女和少数民族纳入研究;以及在发展中国家进行的国际研究。所有课程都以研讨会的方式教授，使用互动式教学方法，包括基于互联网的格式。其中一个会议是专门的“模拟”IRB会议，学者们在会上审查实际的研究方案。另一项研究要求学者们为生物医学研究中常用的各种程序分配风险水平。课程之间的评论以电子方式发布，供参与者评论和批评。在高级模块的六个会议中，有三个专门由学者介绍他们作为硕士课程的要求设计的研究项目中出现的伦理问题，然后进行小组讨论。基本模块有一个带回家的考试，和高级模块需要一个简短的论文的基础上，由学者所作的口头报告的修订版。