Restructuring and building capacity for Ethics Review at KEMRI

描述(由申请人提供)：近年来，在肯尼亚医学研究所(KEMRI)进行的研究的数量和复杂性显著增加。由于这一可取的增长，目前的审查制度由于提交的研究提案增加而持续紧张和积压。这就需要重组和扩大办公设施、秘书处工作人员和服务。在加州大学旧金山分校(UCSF)和KEMRI之间长期的研究和培训合作的基础上，该项目将启动KEMRI伦理审查程序的重组。该项目将建立一个独立的单位，并将确保研究所内有适当的工作人员、培训和资源，以监督KEMRI的伦理审查过程。为了实现这一目标，我们将试点实施多委员会模式，在这种模式下，几个委员会将同时工作，审查议定书。我们将进一步培训审查员，以便对高度复杂的议定书进行专门审查。为了加快和提高效率，我们将设计一个提交方案的电子系统，KEMRI的所有研究中心都可以访问该系统。该独立单位还将为研究所内的科学家提供生物伦理培训，并制定审查指南，供即将成立的委员会使用。加州大学旧金山分校拥有完善的生物伦理学部门和AAHRPP认证的人类研究保护计划(HRPP)，是支持KEMRI这一倡议的理想合作伙伴，特别是因为两个机构之间已经存在长期合作。预计通过该项目的伙伴关系将加强和加强研究所与加州大学旧金山分校医学伦理计划的合作，并将进一步改变KEMRI的研究审查系统，供所有KEMRI研究人员和附属合作机构使用。 公共卫生相关性：在加州大学旧金山分校(UCSF)和肯尼亚医学研究所(KEMRI)长期广泛研究合作的基础上，该项目将启动KEMRI伦理审查程序的重组。该项目将建立一个独立的单位，并将确保研究所内有适当的工作人员、培训和资源，以监督KEMRI的伦理审查过程。

DESCRIPTION (provided by applicant): The volume and complexity of research conducted at the Kenya Medical Research Institute (KEMRI) has significantly increased in recent years. As a consequence of this desirable growth, current review systems have experienced a persistent strain and backlog due to the increase in research proposal submissions. This has necessitated the need for restructuring and expansion of office facilities, secretariat staff, and services. Building on the long-standing research and training collaboration between the University of California, San Francisco (UCSF) and KEMRI, this project will initiate a restructuring of the ethical review process at KEMRI. The project will establish an independent unit and will ensure it is appropriately staffed, trained, and resourced within the Institute to oversee the ethical review process at KEMRI. To achieve this, we will pilot the implementation of a multi-committee model in which several committees will work simultaneously to review protocols. We will further train reviewers for specialized review of highly complex protocols. To expedite and improve efficiency, we will design an electronic system for submission of protocols that will be accessible to all research centers in KEMRI. The independent unit will also provide bioethics training for scientists within the Institute and establish guidelines for review that will be utilized in the committees that will be created. UCSF, with its well developed bioethics unit and AAHRPP-accredited Human Research Protection Program (HRPP), is an ideal partner to support this initiative at KEMRI, particularly as a long-standing collaboration between the two institutions already exists. It is envisaged that partnership through this project will strengthen and enhance the Institute's collaboration with the UCSF Program in Medical Ethics, and will furthermore transform the research review system at KEMRI for use by all KEMRI researchers and affiliated collaborations. PUBLIC HEALTH RELEVANCE: Building on the long-standing and extensive research collaboration between the University of California, San Francisco (UCSF) and Kenya Medical Research Institute (KEMRI), this project will initiate a restructuring of the ethical review process at KEMRI. The project will establish an independent unit and will ensure it is appropriately staffed, trained, and resourced within the Institute to oversee the ethical review process at KEMRI.