Improving the quality and efficiency of the Univ Zambia Research Ethics Committee with HIV Research Training

通过艾滋病毒研究培训提高赞比亚大学研究伦理委员会的质量和效率

基本信息

批准号：
9118444
负责人：
ADNAN A HYDER
金额：
$ 9.83万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-05-06 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9118444
关键词：
Accountability Administrative Efficiency Africa Africa South of the Sahara African Assessment tool Attention Bioethics Biomedical Research Caring Collaborations Committee Members Communities Complex Consultations Country Educational process of instructing Ensure Ethical Issues Ethical Review Ethics Fostering Guidelines HIV Health Human Human Subject Research Individual Institution Institutional Review Boards International Knowledge Leadership Life Measures Mentors Methods Modeling Needs Assessment Office for Human Research Protections Participant Performance Population Prevention strategy Process Protocols documentation Public Health Nurses Public Health Nursing Research Research Ethics Research Ethics Committees Research Infrastructure Research Personnel Research Training Resources Review Committee Series Services Site Telephone Time Training Training Programs United States National Institutes of Health Universities Work Zambia design effective therapy experience human subject protection improved innovation institutional capacity international center low and middle-income countries medical schools meetings member novel operation programs public health relevance response skills tool webinar

项目摘要

DESCRIPTION (provided by applicant): The proposed project will strengthen research infrastructure in low and middle income countries by working with the University of Zambia to strengthen its research ethics committee (or "IRB"). Specifically, we will enhance the ethical review quality and administrative efficiency of the University of Zambia Biomedical Research Ethics Committee (UNZABREC). This work is closely collaborative with the University of Zambia School of Medicine (UNZA SOM), building upon our existing partnership with UNZA through the Johns Hopkins-Fogarty African Bioethics Training Program and the African Bioethics Consortium; this proposed work also supports and is supported by multiple existing HIV and other biomedical research collaborations between Johns Hopkins and numerous different researchers in Zambia, all of whom are eager to see increased quality and efficiency of the UNZABREC. The specific aims of this project are to: 1) strengthen ethics knowledge and applied ethical reasoning for members of University of Zambia School of Medicine Biomedical Research Ethics Committee (UNZABREC), 2) strengthen ethics knowledge and applied ethical reasoning for UNZABREC office staff, 3) improve the administrative efficiency and accountability of UNZABREC operations, and 4) evaluate changes in UNZABREC knowledge, skills, and efficiency using an ethics knowledge tool and an original and novel REC Capacity Assessment Tool. Our three year training program will include having selected individuals participate in an intensive, one-month focused research ethics training program at JHU, on-site technical consultations from a JHU IRB expert and two African bioethics experts (both Fogarty alumni), ethics seminars led by local ethics experts, monthly support telephone calls with JHU and African IRB consultants, and a webinar series on meeting practical challenges of REC operations. These activities will provide rigorous, on-going strategies to strengthen the quality o ethics review by UNZABREC and its administrative efficiency, building both on JHU's expertise in research ethics and ethics review and leveraging the expertise of two African colleagues well versed in high quality IRB operations. We will measure UNZABREC members' ethics knowledge before and after the program using an original tool, and we will measure various administrative efficiency measures such as time to review completion. We also will implement an original needs assessment tool that more broadly measures committee strengths and needs/gaps to then training to what is needed. We expect UNZABREC ultimately to be a model and resource for other RECs in Africa and for researchers facing ethics challenges in their HIV and other studies.

描述（由申请人提供）：拟议项目将通过与赞比亚大学合作加强其研究伦理委员会（或“IRB”）来加强低收入和中等收入国家的研究基础设施。具体来说，我们将提高伦理审查质量和能力。赞比亚大学生物医学研究伦理委员会 (UNZABREC) 的行政效率这项工作是与赞比亚大学医学院 (UNZA SOM) 密切合作的，建立在我们通过 Johns 与 UNZA 现有的合作伙伴关系的基础上。霍普金斯-福加蒂非洲生物伦理学培训计划和非洲生物伦理学联盟；这项拟议的工作还支持约翰·霍普金斯大学与赞比亚众多不同研究人员之间现有的多项艾滋病毒和其他生物医学研究合作，他们都渴望看到质量和技术的提高。该项目的具体目标是：1) 加强赞比亚大学医学院生物医学研究伦理委员会 (UNZABREC) 成员的伦理知识和应用伦理推理，2) 加强伦理道德为 UNZABREC 办公室工作人员提供知识和应用道德推理，3) 提高 UNZABREC 运营的行政效率和问责制，以及 4) 使用道德知识工具和原创新颖的 REC 能力评估工具评估 UNZABREC 知识、技能和效率的变化。我们为期三年的培训计划将包括选择个人参加约翰霍普金斯大学为期一个月的强化研究伦理培训计划、约翰霍普金斯大学 IRB 专家和两名非洲生物伦理学专家（均为 Fogarty）的现场技术咨询。校友）、由当地道德专家主持的道德研讨会、每月与 JHU 和非洲 IRB 顾问进行的支持电话以及有关应对 REC 运营实际挑战的网络研讨会系列。这些活动将为加强道德质量提供严格、持续的策略。 UNZABREC 的审查及其行政效率，以约翰霍普金斯大学在研究伦理和伦理审查方面的专业知识为基础，并利用两位精通高质量 IRB 运作的非洲同事的专业知识，我们将使用一个项目前后衡量 UNZABREC 成员的伦理知识。原来的我们将衡量各种行政效率措施，例如审查完成情况的时间。我们还将实施一个原始的需求评估工具，该工具可以更广泛地衡量委员会的优势和需求/差距，然后我们期望 UNZABREC 最终达到所需的水平。为非洲其他 REC 以及在艾滋病毒和其他研究中面临伦理挑战的研究人员提供了模型和资源。