课题基金 / 基金详情

Education & Training-Biomed & SocioBehavioral Research

Education & Training-Biomed & SocioBehavioral Research
教育
批准号:
6778984
负责人:
WAYNE R PATTERSON
金额:
$14.96万
依托单位国家:
美国
项目类别:
财政年份:
2002
资助国家:
美国
项目状态:
已结题
起止时间:
2002-09-01 至 2005-08-31

项目摘要

项目成果

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中文摘要
翻译
加尔维斯顿的德克萨斯大学医学分校、泰勒的德克萨斯大学健康中心和休斯顿-克利尔湖大学提议合作开发和实施一项针对生物医学和社会行为科学研究人员的全面教育和培训计划,并建立工具将机构研究合规、IRB和其他流程联系起来,以加强对人类研究对象的全面保护。教育和培训计划将分为两个部分。第一个项目将涉及开发一个基于网络的人类研究保护信息中心,具有历史前瞻性和教育材料,以及旨在提供伦理知识库的超级链接。 进行人体受试者研究的考虑和程序。第二部分将涉及开发和实施一个多方面的、基于网络的教育和培训计划,这三个合作机构可以利用该计划。为了将机构研究合规、内部评审委员会和其他程序的领域联系起来,有必要实施和利用数据库来跟踪研究方案修改、持续审查和不良事件,还将用于记录遵约问题,以及确保研究方案得到遵守。理想情况下,数据库将在协议的整个生命周期中跟踪协议。我们的教育和培训计划的目的是传达 致力于精心设计、合乎道德规范并适当地进行人体研究。所有机构的一个目标是扩大各自的研究项目。在这样做时,有必要提高对人类主体保护问题、政策和程序的认识。针对调查人员、管理人员和IRB成员的教育倡议需要扩大。该项目将增强我们各自机构在保护人类受试者方面的资源和知识,并提供一个教育和培训计划,传达各机构对精心设计、符合道德规范和适当开展人类受试者研究的态度和理念。
英文摘要
The University of Texas Medical Branch at Galveston, The University of Texas Health Center at Tyler and the University of Houston - Clear Lake propose to collaboratively develop and implement a comprehensive education and training program for biomedical and socio-behavioral science researchers and to establish tools to link areas of institutional research compliance, the IRB and other processes to strengthen the overall protection of human research subjects. There will be two parts to the education and training program. The first will involve development of a web based human research protection information center with a historical prospective and educational material and hyperlinks intended to provide a knowledge base on the ethical considerations and procedures for performing human subject research. The second part will involve development and implementation of a multi-faceted, web-based education and training program that can be utilized by the three collaborating institutions. In order to link areas of institutional research compliance, the IRB and other processes, it will be necessary to implement and utilize databases to track research protocol modifications, continuing review and adverse events, and will also be used to document compliance issues, as well as insure that the research protocol is followed. Ideally, the database will track the protocol through its entire life cycle. Our intent with the education and training program is to convey the critical importance of a profound commitment to carefully designed, ethically sound, and appropriately conducted human subject research studies. A goal of all institutions is to expand their respective research programs. In so doing, it is necessary to increase awareness of human subject protection issues, policies and procedures. Educational initiatives for investigators, administrators and IRB members are in need of expansion. This project will enhance our respective Institutions' resources and knowledge for protecting human subjects and provide an education and training program that conveys the Institutions' attitude and philosophy of profound commitment to carefully designed, ethically sound, and appropriately conducted human subject research.
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