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

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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.