Comprehensive Ethics Program

约翰霍普金斯大学致力于保护人类研究对象。我们总共有8个IRB，负责监督约3,500项协议，直接涉及约50,000名人类参与者。这项建议的目标是制定一个全面的伦理计划，以支持我们的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调查人员。这项计划以及对我们研究人员的教育/培训将通过利用我们大学菲比·R·伯曼生物伦理学研究所的教员和专业知识并通过实施以下具体目标来实现： 1.加强我们机构的能力，以解决涉及人类受试者的研究的伦理问题。伦理学家将被招募到约翰·霍普金斯大学的所有8个IRBs中。2.发展研究伦理咨询服务，就伦理问题向调查人员提供建议。这项服务将独立于IRB程序，并将在人类主题研究项目的规划和实施阶段向调查人员提供。3.提高调查人员保护人类受试者权益的能力，办法是为调查人员提供机会，审查其调查领域特有的研究道德问题。这些机会将补充我们现有的在线课程和课堂教学，并超出联邦法规的要求。将开发三种不同的课程：1)为期一天的课程，量身定做 具体的研究社区。本课程将包含讨论所有人类主题研究的共同问题的讲座。将针对人类主题研究的具体领域开发五个版本的下午讲习班；2)两个小时的在线课程，提供对研究伦理的更深入介绍；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主题。所有从事人体研究的教师、研究员和学生将被要求参加上述三项活动中的至少一项。在资助期结束后，这些活动将 得到了大学的支持。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极大地加强我们保护人类研究对象的能力。

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.