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

发展肯尼亚莫伊教学和转诊医院/莫伊大学机构研究伦理委员会 (MTRH/MU IREC) 预防和管理研究不当行为的能力。

• 批准号: 9337547
• 负责人: Edwin Onyango Were
• 金额: $ 9.94万
• 依托单位: MOI UNIVERSITY COLLEGE OF HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-21 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9337547
• 关键词: Accreditation; Address; Adopted; Africa South of the Sahara; Awareness; Benchmarking; Bioethics; Case Study; Characteristics; Collaborations; Committee Members; Detection; Development; Educational process of instructing; Educational workshop; Focus Groups; Goals; HIV; Health Sciences; Hospital Referrals; Indiana; Individual; Institution; Institutional Policy; International; Interview; Investigation; Journals; Kenya; Knowledge; Leadership; Manuscripts; Modeling; Outcome; Output; Peer Review; Perception; Phase; Plagiarism; Policy Maker; Prevalence; Prevention; Publications; Qualitative Methods; Questionnaires; Reporting; Research; Research Ethics; Research Ethics Committees; Research Misconduct; Research Personnel; Rest; Review Literature; Scientific Misconduct; Societies; Structure; Surveys; Testing; Training; United States; United States Office of Research Integrity; Universities; Visit; base; college; experience; informant; institutional capacity; prevent; responsible research conduct

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.

项目总结/摘要 研究不端行为，定义为在提出、执行、 报告和/或审查研究是对全球研究企业的一个重大但潜在的威胁。的 我们项目的总体目标是提高莫伊大学教学和转诊医院的能力 机构研究和伦理委员会（MTRH/MU IREC），以防止，检测和管理研究 肯尼亚莫伊大学健康科学学院的不当行为，通过开发和实施一个可扩展的 防止、发现和管理研究不端行为的模块化体制框架。实现这一 为了实现这一目标，我们将让艾滋病毒研究人员、研究伦理委员会（REC）领导层和国家研究人员参与进来， 监管机构估计最近艾滋病毒研究和文件中研究不端行为的普遍性 对研究不端行为发生的看法（AIM1）;记录对当前能力的看法， 预防、发现和管理研究和示范体制框架的特点，以管理 研究不端行为（AIM 2），并通过广泛的文献确定和记录国际最佳实践 对具备这种能力的美国和撒哈拉以南非洲机构进行审查和基准评估访问 并且是功能性的（目标3-子AIM 3a）。利用通过目标1、2和3-子目标3a收集的知识， 我们将举办为期两天的国家研讨会，邀请当地研究利益相关者和国际生物伦理学界人士参加。 专家，使国际最佳做法适应当地环境，并制定一个可扩展的模块化机构 肯尼亚RM预防、检测和管理框架（AIM 3-Sub-AIM 3b）。最后，我们将 在试点基础上，在MTRH/MU IREC和Moi大学具体实施示范体制框架， 并记录所吸取的经验教训（目标3-子目标3c）。 该3年期项目将在第一个项目年实施AIMS1、2和3-子AIM3a，在第一个项目年实施AIM3-子AIM3b。 项目第2年第2季度和目标3-子目标3c，从项目第2年第2季度到项目第3年。 项目交付成果将包括提高艾滋病毒研究人员和研究监管机构认识的人数、项目报告 和手稿，供同行评审的出版物，关于肯尼亚研究不端行为的普遍性（AIM1） 以及研究人员、REC管理人员和研究人员对研究不当行为发生的看法 （目标1）;对肯尼亚区域经济共同体预防、发现和管理研究不当行为的现有能力的看法 和感知特征的一个模型的制度框架，以管理科研不端行为（AIM 2）; 至少3个职能性体制框架的国际最佳做法和案例研究（目标3-子目标3a）; 关于肯尼亚研究不当行为讲习班和肯尼亚模块模型的结构和功能的报告 防止、发现和管理研究不端行为的体制框架（基于国际最佳做法） （目标3-子目标3b），最后是一份报告和手稿，介绍 实施由MTRH/MU IREC领导的莫伊大学健康科学学院的模块化框架（AIM 3- 子目标3c）。其他成果应是MTRH/MU IREC成员和莫伊大学的数量 在负责任地开展研究方面接受培训的研究人员和根据框架模块建立的结构。 该项目的总体影响将是提高莫伊大学处理研究不当行为的能力; 在全国范围内提高对研究不端行为的认识，将其视为对肯尼亚研究企业的威胁; 就研究不端行为进行全国对话，并利用全国可扩展的体制框架进行管理 可以在其他肯尼亚机构实施的研究不端行为。