Genetics and genomic research in Uganda: Towards context specific ethics guidelines

项目摘要/摘要 这一拟议项目的总体目标是系统地发展与文化相适应的模范伦理。 乌干达开展遗传学和基因组学研究的指导方针。这个目标一定会实现的 通过以下具体目标：1)评估利益攸关方对GGR的认识，以及道德和 与乌干达GGR相关的社会关切，以更好地了解当地需求和问题，并提供 为以后的准则制定提供可靠的数据；2)评估关于道德操守和监督的现有准则 适用于乌干达环境的GGR，特别强调由和为 非洲；以及(3)在乌干达制定和传播《全球气候变化框架公约》道德准则范本。GGR一直是 在乌干达进行了20多年，GGR活动的数量预计将继续 增加，因为它有潜力促进有针对性的疾病检测和干预，以应对显著的 该国传染病和非传染性疾病的负担。道德、法律和社会挑战 --例如涉及知情同意的复杂性；数据所有权、访问和 使用；减少风险；选择主题--是乌干达日益增长的讨论和关注的焦点 撒哈拉以南非洲的其他国家。事实上，H3Africa财团的学者们已经制定了一项详细的 非洲全球GGR的道德框架开始考虑到其中的许多问题。在这一重要的基础上 工作以及乌干达正在进行和已完成的H3非洲项目(UH2 HG007051-01A1和UH2 HG007051-01A1)我们提出了一个直接响应乌干达内部需求的项目 制定能够被当地监管机构采纳的国别指导方针 这反映了乌干达独特的社会、法律和文化背景。拟议的项目带来了 拥有一支具有长期研究合作历史的跨学科专家团队，在 研究伦理，以及制定国家和国际指南方面的专门知识，以促进知识和 对乌干达GGR的监督。拟议的为期四年的项目将进行强有力的混合方法研究，以 产生信息，不仅有助于集体理解面临的道德挑战 GGR在非洲，而且还提供了制定文化上适当的道德准则所需的证据基础 在乌干达开展GGR。事实上，该项目的最终结果将是开发和传播 国家监管当局制定了乌干达全球GGR示范准则。在这样做的过程中，我们组建了一个团队 乌干达和国际生物伦理学家、社会科学家、临床医生、基因组研究人员、公共卫生 专业人员和研究监督专家为促进知识和实践作出贡献 GGR。

PROJECT SUMMARY/ABSTRACT The overall goal of this proposed project is to systematically develop culturally appropriate model ethics guidelines for conducting genetics and genomics research (GGR) in Uganda. This goal will be achieved through the following specific aims:1) to assess stakeholder awareness of GGR, and the nature of ethical and social concerns associated with GGR in Uganda, to better understand local needs and issues and provide robust data for later guideline development; 2) to evaluate existing guidelines on the ethics and oversight of GGR for applicability to the Ugandan setting with a particular emphasis on guidelines developed by and for Africa, and; 3) to develop and disseminate a model guideline for the ethics of GGR in Uganda. GGR has been conducted in Uganda for more than 20 years, and the volume of GGR activity is expected to continue to increase because of its potential to advance targeted disease detection and interventions to address significant burdens of communicable and non-communicable disease in the country. Ethical, legal and social challenges that accompany such research – such as complexities involving informed consent; data ownership, access and use; risk mitigation; and subject selection – are the focus of increasing discussion and concern in Uganda and other countries in sub-Saharan Africa. Indeed, scholars of the H3Africa consortium have developed a detailed ethics framework for GGR in Africa that begins to account for many of these issues. Building on this important work, as well as ongoing and completed H3Africa projects in Uganda (UH2 HG007051-01A1 and UH2 HG007051-01A1) we propose a project that is directly responsive to demands from within Uganda to move towards the development of country-specific guidelines that are capable of being adopted by local regulatory authorities and that reflect the unique social, legal and cultural context of Uganda. The proposed project brings together an inter-disciplinary team of experts with a long history of research collaboration, experience in research ethics, and expertise in national and international guideline development to advance knowledge and oversight of GGR in Uganda. The proposed four-year project will conduct robust, mixed-methods research to generate information that will contribute not only to collective understandings of the ethical challenges facing GGR in Africa, but also to the evidence base needed to develop culturally appropriate ethical guidelines for conducting GGR in Uganda. Indeed, the project will culminate with the development and dissemination to national regulatory authorities, of a model guideline for GGR in Uganda. In doing so, we bring together a team of Ugandan and international bioethicists, social scientists, clinicians, genomics researchers, public health professionals and research oversight experts to contribute to the advancement of knowledge and practice of GGR.