Developing Capacity of Moi Teaching and Referral Hospital / Moi University Institutional Research Ethics Committee (MTRH/MU IREC), Kenya to Prevent and Manage Research Misconduct.

项目摘要/摘要 研究不端行为，定义为故意捏造、伪造和抄袭提出、实施、 报告和或审查研究，对全球研究企业来说是一个重大但潜伏的威胁。这个 我们项目的总体目标是增加MOI教学和转诊医院/MOI大学的能力 机构研究和伦理委员会(MTRH/MU IREC)，以预防、发现和管理研究 肯尼亚莫伊大学健康科学学院的不当行为，通过开发和实施可扩展的 预防、发现和管理研究不端行为的模块化体制框架。要做到这一点 目标，我们将邀请艾滋病毒研究人员、研究伦理委员会(REC)领导和国家研究 监管机构评估最近艾滋病毒研究和文件中研究不端行为的流行率 对研究不当行为发生的看法(AIM1)；记录对当前能力的看法 预防、发现和管理研究和管理的示范组织框架的特点 研究不当行为(目标2)，并通过广泛的文献确定和记录国际最佳做法 对有这种能力的美国和撒哈拉以南非洲机构进行审查和基准访问 并且是功能性的(目标3-子AIM3a)。利用通过AIM1、2和3-子AIM3a收集的知识主体， 我们将举办一个为期两天的全国性研讨会，由当地研究利益相关者和国际生物伦理学人士参加。 专家，使国际最佳做法适应当地情况，并制定可扩展的模块化机构 肯尼亚风湿病预防、检测和管理框架(AIM3-Sub-AIM3b)。最后，我们将 在MTRH/MU IREC和MOI大学试点实施示范机构框架， 概括地讲，并记录所吸取的经验教训(AIM3-SUB-AIM3c)。 为期3年的项目将在第一个项目年实施AIMS1、2和3-Sub-AIM3a，在第一个项目年实施AIM3-Sub-AIM3b 项目第二年的季度和AIM3-从项目第二季度到项目第三年的子AIM3c。 项目可交付成果将包括一些艾滋病毒研究人员和研究监管机构敏感的项目报告 和同行评议出版的关于肯尼亚研究不端行为普遍程度的手稿(AIM1) 以及研究人员、REC管理人员和研究人员对研究不端行为发生的看法 (AIM1)；对肯尼亚区域经济共同体目前预防、发现和管理研究不端行为的能力的看法 以及管理研究不端行为的示范机构框架的可感知特征(AIM2)； 至少3个职能体制框架的国际最佳做法和案例研究(AIM3-Sub-AIM3a)； 关于肯尼亚研究不端行为研讨会和肯尼亚示范模块的结构和功能的报告 预防、发现和管理研究不端行为的体制框架(根据国际最佳做法 (AIM3--AIM3b分项目)，最后是关于#年的经验教训的报告和手稿 在MTRH/MU IREC(AIM3-)领导的MOI大学健康科学学院实施模块化框架 Sub-AIM3c)。其他结果应为MTRH/MU IREC成员和MOI大学的数量 研究人员接受了负责任地开展研究和在框架单元下建立结构方面的培训。 该项目的总体影响将是提高莫伊大学处理研究不端行为的能力； 在全国范围内认识到研究不端行为对肯尼亚研究企业的威胁；发起 关于研究不端行为的全国对话，并利用可在全国范围内推广的管理体制框架 研究不端行为，可在肯尼亚其他机构实施。

Project Summary / Abstract Research Misconduct, defined as deliberate fabrication, falsification and plagiarism in proposing, performing, reporting and or reviewing research, is a significant but insidious threat to the research enterprise globally. The overall goal of our project is to increase the capacity of Moi Teaching and Referral Hospital / Moi University Institutional Research and Ethics Committee (MTRH/MU IREC) to prevent, detect and manage research misconduct in Moi University College of Health Sciences, Kenya by developing and implementing a scalable modular institutional framework for preventing, detecting and managing research misconduct. To achieve this goal, we will engage HIV researchers, the research ethics committee (REC) leadership and national research regulatory bodies to estimate the prevalence of research misconduct in recent HIV research and document perceptions on occurrence of the research misconduct (AIM1); document perceptions on the current capacity to prevent, detect and manage research and the characteristics of a model institutional framework to manage research misconduct (AIM 2) and identify and document international best practices through broad literature review and benchmarking visits to United States and sub-Saharan Africa institutions where such capacity exists and is functional (Aim 3-sub-AIM3a). Utilizing the body of knowledge gathered through AIM1, 2 & 3-sub-AIM3a, we shall hold a 2-day national workshop, involving local research stakeholders and international bioethics experts, to adapt the international best practices to the local setting and formulate a scalable modular institutional framework for prevention, detection and management of RM in Kenya (AIM3- Sub-AIM3b). Finally, we shall implement, on a pilot basis, the model institutional framework in MTRH/MU IREC specifically and Moi University, broadly, and document the lessons learned (AIM3-sub-AIM3c). The 3-year project will implement AIMS1, 2, & 3-sub-AIM3a in the first project year, AIM3- Sub-AIM3b in the first quarter of project year 2 and AIM3-sub-AIM3c from project year 2, quarter 2 to project year 3. The project deliverables will include number of HIV researchers & research regulators sensitized, project reports and manuscripts for peer reviewed publication on perceived prevalence of research misconduct in Kenya (AIM1) and perceptions of researchers and REC managers and researchers on occurrence of research misconduct (AIM1); perceptions on current capacity of RECs in Kenya to prevent, detect and manage research misconduct and perceived characteristics of a model institutional framework to manage research misconduct (AIM2); international best practices and cases studies of at least 3 functional institutional frameworks (AIM3-Sub-AIM3a); report on Kenya Research Misconduct workshop and the structure and functions of a model Kenyan modular institutional framework to prevent, detect and manage research misconduct (based on international best practices and locally relevant)(AIM3-Sub-AIM3b) and finally a report and manuscript on lessons learnt in implementing the modular framework in Moi University College of Health Science led by MTRH/MU IREC (AIM3- Sub-AIM3c). Additional outcomes shall be the number of MTRH/MU IREC members and Moi University researchers trained in responsible conduct of research and structures established under the framework modules. The overall impact of the project will be to increased capacity of Moi University to address research misconduct; create a national awareness on research misconduct as a threat to the research enterprise in Kenya; initiate a national dialogue on research misconduct and avail a nationally scalable institutional framework for managing research misconduct that can be implemented in other Kenyan institutions.