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

• 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
• 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

 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.

 该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”），加强低收入和中等收入国家的研究基础设施。具体而言，我们将提高赞比亚大学生物医学研究伦理委员会（UNZABREC）的伦理审查质量和行政效率。这项工作与赞比亚大学医学院密切合作（UNZA SOM），通过约翰霍普金斯-福格蒂非洲生物伦理培训计划和非洲生物伦理联合会，在我们与UNZA现有的伙伴关系基础上进一步发展;这项拟议的工作也支持约翰霍普金斯和赞比亚许多不同研究人员之间的多个现有艾滋病毒和其他生物医学研究合作，他们都渴望看到联合国非洲和平与裁军谈判会议的质量和效率得到提高。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成员的伦理知识和应用伦理推理（a）加强联合国非洲和平与裁军中心（非洲和平与裁军中心），2）加强非洲和平与裁军中心办公室工作人员的道德操守知识和实用道德推理，3）提高非洲和平与裁军中心业务的行政效率和问责制，4）评价非洲和平与裁军中心知识、技能、利用道德知识工具和新颖的区域环境中心能力评估工具，提高道德操守和效率。我们为期三年的培训计划将包括让选定的个人参加JHU为期一个月的集中研究伦理培训计划，JHU IRB专家和两名非洲生物伦理专家的现场技术咨询（均为Fogarty校友），由当地伦理专家领导的伦理研讨会，与JHU和非洲IRB顾问的每月支持电话，以及关于应对REC运营实际挑战的系列网络研讨会。这些活动将提供严格、持续的战略，以加强UNZABREC的道德审查质量及其行政效率，同时利用JHU在研究道德和道德审查方面的专业知识，并利用两位精通高质量伦理审查的非洲同事的专业知识。我们将使用原始工具测量UNZABREC成员在计划前后的道德知识，我们将测量各种行政效率措施，如审查完成时间。我们还将实施一个原始的需求评估工具，更广泛地衡量委员会的优势和需求/差距，然后根据需要进行培训。我们期望UNZABREC最终成为非洲其他地区经济共同体以及在艾滋病毒和其他研究中面临伦理挑战的研究人员的典范和资源。