Comprehensive Ethics Program

综合道德计划

• 批准号: 6591596
• 负责人: Theodore O Poehler
• 金额: $ 25万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591596
• 关键词: behavioral /social science research tag; clinical research; computer assisted instruction; data management; education evaluation /planning; ethics; health science research analysis /evaluation; health science research support; information systems; workshop

The Johns Hopkins University is deeply committed to the protection of human research subjects. We have a total of 8 IRB's that oversee approximately 3,500 protocols that directly involve about 50,000 human participants. The goal of this proposal is to develop a comprehensive ethics program to support the chairs, members and staff of our institutional review boards as well as all investigators involved in human subjects research. This program, as well as the education/training of our researchers, will be realized by utilizing the faculty and expertise of our University's Phoebe R. Berman Bioethics Institute and by implementation of the following specific aims: 1. To enhance the capacity of our IRBs to address the ethical dimensions of research involving human subjects. Ethicists will be recruited to sit on all 8 of the Johns Hopkins IRBS. 2. To develop a research ethics consultation service to provide advice to investigators regarding ethical issues. This service will be independent of the IRB process and will be available to investigators in both the planning and the implementation phases of human subject research projects. 3. To improve the competency of investigators to protect the rights and interests of human subjects by developing opportunities for investigators to examine intellectually engaging issues in research ethics that are specific to their areas of investigation. These opportunities will supplement our existing on-line courses and classroom teaching and go beyond that required by federal regulations. Three different programs will be developed: 1) a one-day course, tailored to specific research communities. This course will contain lectures that address issues common to all human subject research. Five versions of the afternoon workshops will be developed that will be tailored to specific areas of human subject research; 2) a two-hour, on-line course that provides a more in-depth introduction to research ethics; and 3) eight two hour seminars on topics in research ethics that arise in different types of research. All faculty, fellows and students engaged in human subjects research will be required to participate in at least one of the above three activities. After the period of grant funding is over, these activities will be supported by the University. The Ethics consultation service will also be continued through consultation fees. The programs outlined in this proposal will greatly strengthen our ability to protect human research subjects.

约翰霍普金斯大学致力于保护人类研究对象。我们共有8个IRB，负责监督约3，500个协议，直接涉及约50，000名人类参与者。该提案的目标是制定一项全面的道德计划，以支持我们机构审查委员会的主席、成员和工作人员以及参与人类受试者研究的所有研究人员。该计划以及我们研究人员的教育/培训将通过利用我们大学的Phoebe R.伯曼生物伦理研究所，并通过实施以下具体目标： 1.提高我们的IRB解决涉及人类受试者的研究的伦理问题的能力。伦理学家将被招募到约翰霍普金斯的所有8个IRBS。2.发展研究伦理谘询服务，就伦理问题向研究者提供意见。这项服务将独立于IRB流程，并将在人类受试者研究项目的规划和实施阶段提供给研究者。3.提高研究者保护人类受试者权利和利益的能力，为研究者提供机会，以审查其研究领域特有的研究伦理学中的智力参与问题。这些机会将补充我们现有的在线课程和课堂教学，并超越联邦法规的要求。将开发三个不同的项目：1）为期一天的课程，专为 具体的研究社区。本课程将包含演讲，解决所有人类主题研究的共同问题。下午的研讨会将开发五个版本，将针对人类受试者研究的特定领域; 2）一个两小时的在线课程，提供更深入的研究伦理学介绍;和3）八个两小时的研讨会，讨论不同类型研究中出现的研究伦理学主题。所有从事人类受试者研究的教师，研究员和学生将被要求参加上述三项活动中的至少一项。资助期结束后，这些活动将 由大学支持。道德操守咨询服务也将通过咨询费继续提供。该提案中概述的计划将大大加强我们保护人类研究对象的能力。