Restructuring and building capacity for Ethics Review at KEMRI

KEMRI 的道德审查重组和能力建设

• 批准号: 8051243
• 负责人: Elizabeth Anne BUKUSI
• 金额: $ 5.42万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-15 至 2012-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8051243
• 关键词: Bioethics; California; Clinical Trials; Collaborations; Communication; Complex; Consult; Consultations; Databases; Distant; Education; Electronics; Ensure; Ethical Review; Ethics; Goals; Growth; Guidelines; Head; Human; Institutes; Institution; Kenya; Link; Medical Ethics; Medical Research; Modeling; Online Systems; Paper; Procedures; Process; Protocols documentation; Reporting; Research; Research Institute; Research Personnel; Research Proposals; Research Training; Resources; Review Committee; San Francisco; Scientist; Services; Site; System; Time; Training; Training Support; Training and Education; Universities; Update; Work; cost; design; experience; improved; investigator training; programs; tool; user-friendly

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.

描述（由申请人提供）：近年来，肯尼亚医学研究所（KEMRI）开展的研究的数量和复杂性显著增加。由于这种理想的增长，由于研究提案提交的增加，目前的审查系统经历了持续的压力和积压。这就需要改组和扩大办公室设施、秘书处工作人员和服务。在加州大学旧金山分校（UCSF）和KEMRI之间长期研究和培训合作的基础上，该项目将启动KEMRI伦理审查过程的重组。该项目将建立一个独立的单位，并将确保该单位在研究所内配备适当的人员、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，其中几个委员会将同时审查协议。我们将进一步培训审稿人对高度复杂的方案进行专门审查。为了加快速度和提高效率，我们将设计一个电子系统，供KEMRI的所有研究中心使用。这个独立的单位还将为研究所内的科学家提供生物伦理培训，并制定将在即将成立的委员会中使用的审查准则。加州大学旧金山分校拥有完善的生物伦理部门和aahrpp认可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，特别是两所机构之间已经存在长期合作。预计通过该项目建立的伙伴关系将加强和加强研究所与UCSF医学伦理学项目的合作，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。