OHSU Human Subject Research Enhancement Program

OHSU提交这一请求，要求为其加强人类受试者研究保护的项目提供短期、临时支持，以获得额外的、最终的、一年的奖励。此外，我们将利用这第二轮资金与其他没有资格申请这些资金的机构合作。我们建议继续对我们的计划进行增强，这些计划是由NIH RFA OD-02-003项下授予的资金启动的，并增加了三个具体目标。一个具体的目标是与四个确定的合作者共享我们增强的人类受试者保护系统的流程、技术和其他“便携”组件。由于我们已决定购买商业(Webridge)系统以增强我们对文档、报告、提交和跟踪的电子管理，我们正在与该供应商合作，以确保我们可以与这些非OHS U合作者共享我们新系统的5%。第二个具体目标是在全州范围内举办一次关于人类主体保护的会议。我们将召集一个小组，包括来自我们四个合作地点的代表和全州其他人，为这次为期一天的会议制定议程并挑选教师。会议将分享在实施我们的新系统的过程中学到的商业和最佳实践，讨论当前感兴趣的人类研究主题，并包括一位全国公认的主旨演讲者。第三个新的具体目标是开始 认证过程中对我国民歌主体制度的保护。OHSU将申请人类研究保护计划认证协会(AAHRPP)的认证，并将受益于我们计划的差距分析和外部审计。我们建议使用根据这一RFA授予的资金进行审计。

OHSU submits this request for an additional, final, one-year award for short-term, interim support of its program for strengthening human subjects research protections. In addition, we will use this second round of funding to collaborate with other institutions that are not eligible to apply for these funds. We propose to continue the process of enhancements for our program that were initiated with funds awarded under NIH RFA OD-02-003 and have added three specific aims. One specific aim is to share the processes, technologies, and other "portable" components of our enhanced human subjects protections system with four identified collaborators. Because we have made the decision to purchase a commercial (Webridge) system to enhance our e lectronic management of documents, reports, submissions, and tracking, we are working with that vendor to insure that we may share per tions of our new system with these non-OHS U collaborators. A second specific aim is to host a statewide conference on hum an subjects protections. We will convene a group to include representatives from our four collaborating sites and others throughout the state to develop an agenda and select faculty for this one-day conference. T he conference will share business and best practices learned through the process of implementing our new systems, discuss human research topics of current interest, and include a nationally recognized keynote speaker. T he third new specific aim is to begin the process of accreditation of our system of hum an subjects protections. OHSU will be applying for accreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP) and will benefit from a gap analysis and external audit of our program. We propose to use funds awarded under this RFA for performing that audit.