Chanda-Kapata Pascalina, Kapata Nathan, Moraes Albertina Ngomah, Chongwe Gershom, Munthali James
Directorate of Disease Surveillance Control and Research, Ministry of Health, Lusaka, Zambia.
National TB/Leprosy Programme, Ministry of Community Development, Mother and Child Health, Lusaka, Zambia.
Health Res Policy Syst. 2015 Oct 29;13:60. doi: 10.1186/s12961-015-0053-4.
Genomic research has the potential to increase knowledge in health sciences, but the process has to ensure the safety, integrity and well-being of research participants. A legal framework for the conduct of health research in Zambia is available. However, the ethical, policy and regulatory framework to operationalise genomic research requires a paradigm shift. This paper outlines the current legal and policy framework as well as the ethics environment, and suggests recommendations for Zambia to fully benefit from the opportunity that genomic research presents. This will entail creating national research interest, improving knowledge levels, and building community trust among researchers, policymakers, donors, regulators and, most importantly, patients and research participants. A real balancing act of the risk and benefits will need to be objectively undertaken.
基因组研究有潜力增进健康科学领域的知识，但这一过程必须确保研究参与者的安全、完整和福祉。赞比亚有开展健康研究的法律框架。然而，实施基因组研究的伦理、政策和监管框架需要范式转变。本文概述了当前的法律和政策框架以及伦理环境，并就赞比亚如何充分利用基因组研究带来的机遇提出建议。这将需要激发国家研究兴趣、提高知识水平，并在研究人员、政策制定者、捐助者、监管机构以及最重要的患者和研究参与者之间建立社区信任。需要客观地对风险和益处进行真正的权衡。
