Mweemba Oliver, Musuku John, Mayosi Bongani M, Parker Michael, Rutakumwa Rwamahe, Seeley Janet, Tindana Paulina, De Vries Jantina
Department of Health Promotion and Education, University of Zambia, Lusaka, Zambia.
Children Hospital, University Teaching Hospitals, Lusaka, Zambia.
Glob Bioeth. 2019 Mar 24;31(1):184-199. doi: 10.1080/11287462.2019.1592868.
The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were conducted with RHDGen participants ( = 18), study staff ( = 5) and with individuals who refused to participate ( = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use.
基因组学研究中广泛同意的使用给基因组学研究的开展带来了重要的伦理问题，包括其对研究参与者的可接受性以及对复杂科学概念的理解。为了探究这些及其他挑战，我们采用定性方法开展了一项研究，研究对象是参与赞比亚一项H3非洲风湿性心脏病基因组学研究（风湿性心脏病基因组网络）的参与者，以探讨他们对广泛同意、样本和数据共享以及二次使用的看法。我们对风湿性心脏病基因组网络的参与者（18人）、研究人员（5人）以及拒绝参与的个人（3人）进行了深入访谈。总体而言，如果披露了将样本储存用于未来研究的原因，广泛同意被认为是合理的。一些人认为，广泛同意应通过明确规定未来计划开展的研究加以限制，并且二次研究理想情况下应与采集样本所针对的原始疾病相关。少数参与者认为，广泛同意会延迟向参与者反馈研究结果。这项研究与非洲其他地区其他类似研究的结果相呼应，这些研究表明，如果认真考虑对再利用的限制，广泛同意在非洲可能是一种可接受的同意模式。
