Muyiwa Adigun, Babatunde Ojebuyi, Joshua Akinyemi, Kolawole Wahab, Albert Akpalu, Fred S Sarfo, Lukman F Owolabi, Rabiu Musbahu, Abiodun Bello, Reginald Obiako, Mayowa Ogunronbi, Michelle Nichols, Carolyn Jenkins, Ayodele Jegede, Rajesh Kalaria, Mayowa Owolabi, Bruce Ovbiagele, Oyedunni Arulogun, Rufus Akinyemi
{"title":"撒哈拉以南非洲卒中生物库和基因组学研究的象征性立法和监管。","authors":"Muyiwa Adigun, Babatunde Ojebuyi, Joshua Akinyemi, Kolawole Wahab, Albert Akpalu, Fred S Sarfo, Lukman F Owolabi, Rabiu Musbahu, Abiodun Bello, Reginald Obiako, Mayowa Ogunronbi, Michelle Nichols, Carolyn Jenkins, Ayodele Jegede, Rajesh Kalaria, Mayowa Owolabi, Bruce Ovbiagele, Oyedunni Arulogun, Rufus Akinyemi","doi":"10.1080/20508840.2022.2025741","DOIUrl":null,"url":null,"abstract":"<p><p>Stroke is a major cause of death in Sub-Saharan Africa (SSA) and genetic factors appear to play a part. This led to the development of stroke bio-banking and genomics research in SSA. Existing stroke studies have focused on causes, incidence rates, fatalities and effects. However, scant attention has been paid to the legal issues about stroke bio-banking and genomics research in the sub-region. Therefore, this article examines how genomics research and stroke bio-banking in SSA can be regulated through legislation. The article reports that there are germane issues to be addressed such as appropriate consent model, commercial use of biological samples, ownership right in biological samples and return of research results but that the position of the law on these issues is not satisfactory because there are no statute directly regulating them while existing regulations in these countries are either absent, outdated, conservative or difficult to navigate. The article therefore applies the theory of symbolic legislation and argues for legislative intervention through positive symbolic approach. It recommends that the statute to be enacted should only address policy issues by way of legal rules without being detailed while the understanding of the rules should be fostered in explanatory notes. The explanatory notes should contain examples borne of decided cases, cases settled out of court and the ethical guidelines prepared by Human Heredity and Health in Africa (H3 Africa). Where they are inadequate, recourse may be had to other ethical guidelines subject to the demands of local circumstances.</p>","PeriodicalId":75198,"journal":{"name":"The theory and practice of legislation","volume":"9 3","pages":"404-424"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8863338/pdf/nihms-1769949.pdf","citationCount":"0","resultStr":"{\"title\":\"Symbolic Legislation and the Regulation of Stroke Biobanking and Genomics Research in Sub-Saharan Africa.\",\"authors\":\"Muyiwa Adigun, Babatunde Ojebuyi, Joshua Akinyemi, Kolawole Wahab, Albert Akpalu, Fred S Sarfo, Lukman F Owolabi, Rabiu Musbahu, Abiodun Bello, Reginald Obiako, Mayowa Ogunronbi, Michelle Nichols, Carolyn Jenkins, Ayodele Jegede, Rajesh Kalaria, Mayowa Owolabi, Bruce Ovbiagele, Oyedunni Arulogun, Rufus Akinyemi\",\"doi\":\"10.1080/20508840.2022.2025741\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Stroke is a major cause of death in Sub-Saharan Africa (SSA) and genetic factors appear to play a part. This led to the development of stroke bio-banking and genomics research in SSA. Existing stroke studies have focused on causes, incidence rates, fatalities and effects. However, scant attention has been paid to the legal issues about stroke bio-banking and genomics research in the sub-region. Therefore, this article examines how genomics research and stroke bio-banking in SSA can be regulated through legislation. The article reports that there are germane issues to be addressed such as appropriate consent model, commercial use of biological samples, ownership right in biological samples and return of research results but that the position of the law on these issues is not satisfactory because there are no statute directly regulating them while existing regulations in these countries are either absent, outdated, conservative or difficult to navigate. The article therefore applies the theory of symbolic legislation and argues for legislative intervention through positive symbolic approach. It recommends that the statute to be enacted should only address policy issues by way of legal rules without being detailed while the understanding of the rules should be fostered in explanatory notes. The explanatory notes should contain examples borne of decided cases, cases settled out of court and the ethical guidelines prepared by Human Heredity and Health in Africa (H3 Africa). Where they are inadequate, recourse may be had to other ethical guidelines subject to the demands of local circumstances.</p>\",\"PeriodicalId\":75198,\"journal\":{\"name\":\"The theory and practice of legislation\",\"volume\":\"9 3\",\"pages\":\"404-424\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8863338/pdf/nihms-1769949.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The theory and practice of legislation\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/20508840.2022.2025741\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/1/31 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The theory and practice of legislation","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/20508840.2022.2025741","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/1/31 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Symbolic Legislation and the Regulation of Stroke Biobanking and Genomics Research in Sub-Saharan Africa.
Stroke is a major cause of death in Sub-Saharan Africa (SSA) and genetic factors appear to play a part. This led to the development of stroke bio-banking and genomics research in SSA. Existing stroke studies have focused on causes, incidence rates, fatalities and effects. However, scant attention has been paid to the legal issues about stroke bio-banking and genomics research in the sub-region. Therefore, this article examines how genomics research and stroke bio-banking in SSA can be regulated through legislation. The article reports that there are germane issues to be addressed such as appropriate consent model, commercial use of biological samples, ownership right in biological samples and return of research results but that the position of the law on these issues is not satisfactory because there are no statute directly regulating them while existing regulations in these countries are either absent, outdated, conservative or difficult to navigate. The article therefore applies the theory of symbolic legislation and argues for legislative intervention through positive symbolic approach. It recommends that the statute to be enacted should only address policy issues by way of legal rules without being detailed while the understanding of the rules should be fostered in explanatory notes. The explanatory notes should contain examples borne of decided cases, cases settled out of court and the ethical guidelines prepared by Human Heredity and Health in Africa (H3 Africa). Where they are inadequate, recourse may be had to other ethical guidelines subject to the demands of local circumstances.