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

项目摘要/摘要(原始提案) 提交本补编是为了请求延长遗传学和基因组学项目 在乌干达的研究：走向特定背景的道德准则U01HG009822，至6月30日， 2023年。这一拟议项目的总体目标是系统地开发适合于文化的 乌干达开展遗传学和基因组研究(GGR)的示范伦理指南。这 将通过以下具体目标实现目标：1)评估利益攸关方对 GGR，以及乌干达与GGR相关的伦理和社会关切的性质，以更好地 了解当地的需求和问题，并为以后的准则制定提供可靠的数据；2) 评估关于GGR的道德和监督的现有准则是否适用于乌干达 特别强调由非洲制定和为非洲制定的准则，以及；3)制定 并在乌干达传播GGR道德准则范本。已经进行了GGR 在乌干达已经持续了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 解决该国严重的传染病和非传染性疾病负担。 伴随这类研究而来的伦理、法律和社会挑战--例如复杂性 涉及知情同意；数据所有权、访问和使用；风险缓解；以及主题选择 -是乌干达和次区域其他国家日益增长的讨论和关注的焦点 撒哈拉非洲。事实上，H3非洲联盟的学者们已经制定了一套详细的伦理 非洲全球GGR框架开始考虑到其中的许多问题。以此为基础 重要工作，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需求的方案 从乌干达内部着手制定针对具体国家的指导方针，这些指导方针是 能够被当地监管部门采纳，并反映独特的社会、法律 以及乌干达的文化背景。拟议的项目汇集了一个跨学科的团队。 拥有长期研究合作历史、研究伦理经验的专家，以及 在国家和国际准则制定方面的专门知识，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采取强有力的混合方法 研究产生的信息不仅有助于集体理解 GGR在非洲面临的道德挑战，以及发展所需的证据基础 在乌干达开展GGR的道德准则在文化上是适当的。事实上，该项目将 最终制定并向国家监管当局传播一种模式 乌干达GGR的指导方针在这样做的时候，我们汇集了一个由乌干达和国际组织组成的团队 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 请研究监督专家为增进GGR的知识和实践作出贡献。 项目总结(补充提案) 提交本补编是为了请求延长遗传学和基因组学项目 在乌干达的研究：走向特定背景的道德准则U01HG009822，至6月30日， 2023年。这一拟议补充项目的总体目标是提高认识和 采纳乌干达开展遗传学和基因组学研究的伦理准则。 这一目标将通过传播制定的GGR道德准则来实现，使用 一个严格的流程，以实现关键业务的全面和有意义的利益相关者参与 利益相关者，包括区域经济共同体成员和研究团队。使用指南的REC成员 将聘请GGR研究人员进行伦理审查和监督，以促进 了解和理解指导方针。

PROJECT SUMMARY/ABSTRACT (ORIGINAL PROPOSAL) This supplement is submitted to request an extension of the project Genetics and genomics research in Uganda: Towards context-specific ethics guidelines U01HG009822 until June 30, 2023. 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. PROJECT SUMMARY (SUPPLEMENTARY PROPOSAL) This supplement is submitted to request an extension of the project Genetics and genomics research in Uganda: Towards context-specific ethics guidelines U01HG009822 until June 30, 2023. The overall goal of this proposed supplementary project is to is to increase awareness and uptake of the ethical guidelines for the conduct of genetics and genomics research in Uganda. This goal will be achieved through dissemination of the developed GGR ethical guidelines using a rigorous process to attain comprehensive and meaningful stakeholder engagement of key stakeholders including REC members and research teams. REC members who use guidelines for ethical review and oversight as well as GGR researchers will be engaged to facilitate awareness and uptake of the guidelines.