Human Subjects Research Enhancement

该项目的具体目标是：（1）在Meharry医学院制定两个关于保护人类受试者的教育方案，一个针对研究者，一个针对IRB成员;（2）通过就该领域的突出问题举办季度研讨会，加深研究者对人类保护的理解;和3）使Meharry IRB能够通过购买电话会议设备来检查参与Meharry研究项目的组织的当地研究背景。 第一个目标将通过五个步骤实现：1）修订现有的IRB表格和文件，并改进撰写知情同意书的辅助工具; 2）修订和更新现有的IRB手册; 3）在机构监管场所和其他大学调查现有的基于网络的人类保护材料; 4）审查书面和电子材料后，决定将哪些信息放入每个程序; 5）汇编书面的，基于网络的，和每个教育计划的现场版本。第二个和第三个目标很简单。 该项目将帮助梅哈里的人类保护计划应对三个具体挑战。第一、 由于梅哈里与范德比尔特大学的正式联系，即梅哈里-范德比尔特联盟，参与人体研究的新研究人员的数量正在迅速增加。Meharry需要一个强有力的人类保护计划，以确保这些教师充分了解他们对人类受试者的责任。其次，作为一所历史悠久的黑人大学，梅哈里已经成为其他研究健康差异的机构的研究人员的一个有吸引力的合作者。结果是，更多的新梅哈里调查人员将参与差异研究;再次，学院需要一个有力的人类保护计划，以适当地培训新的调查人员。第三，在当前的监管“ 环境IRB的责任和程序已经迅速改变;我们的人类保护计划需要巩固这些变化成为方便，彻底的纲要教师调查员和IRB成员。

The specific aims of this project are 1) to develop two educational programs on protection of human subjects at Meharry Medical College, one for investigators and one for IRB members; 2) to deepen investigators' understanding of human protections by conducting quarterly seminars on salient issues in this area; and 3) to enable the Meharry IRB to examine the local research context of organizations participating in Meharry research projects by acquiring equipment for teleconferences. The first objective will be accomplished in five steps: 1) Revise existing IRB forms and documents and improve aids for writing consent forms; 2) revise and update existing IRB manual; 3) survey existing web-based materials on human protections, both at agency regulatory sites and at other universities; 4) having examined both written and electronic materials, decide which information to put in each program; 5) assemble written, web-based, and live versions of each educatonal program. The second and third objectives are straightforward. This project will help Meharry's human protections program meet three specific challenges. First, the number of new investigators involved in human subjects research is rising rapidly because of Meharry's formal affiliation with Vanderbilt University known as the Meharry-Vanderbilt Alliance. Meharry needs a robust human protections program to ensure that these faculty members understand fully their responsibilities toward human subjects. Second, as an historically black university, Meharry has become an attractive collaborator for investigators at other institutions who study health disparities. The outcome is that still more new Meharry investigators will become involved in disparities research; again, the college needs a vigorous human protections program to train new investigators properly. Third, in the current regulatory' environment the IRB's responsibilities and procedures have changed rapidly; our human protections program needs to consolidate these changes into convenient, thorough compendia for faculty investigators and IRB members.