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Symbolic Legislation and the Regulation of Stroke Biobanking and Genomics Research in Sub-Saharan Africa
Muyiwa Adigun1, Babatunde Ojebuyi2, Joshua Akinyemi3
1Department of Public Law, Faculty of Law, University of Ibadan, Ibadan, Nigeria.
Insights
Genomic research and stroke bio-banking in Sub-Saharan Africa (SSA) face legal gaps. New legislation is needed to address consent, sample ownership, and commercial use, ensuring ethical research practices.
Area of Science:
- Genomics
- Biobanking
- Public Health Law
Background:
- Stroke is a leading cause of death in Sub-Saharan Africa (SSA), with genetic factors implicated.
- Stroke bio-banking and genomics research initiatives are emerging in SSA.
- Existing research primarily addresses stroke's causes, incidence, and effects, neglecting legal aspects.
Purpose of the Study:
- To examine the legislative regulation of genomics research and stroke bio-banking in SSA.
- To identify and address critical legal issues in stroke bio-banking and genomics research.
- To propose a legislative framework for regulating these research areas in SSA.
Main Methods:
- Analysis of existing legal and regulatory frameworks in SSA concerning bio-banking and genomics.
- Application of the theory of symbolic legislation to advocate for legislative intervention.
- Review of germane issues including consent, sample ownership, commercialization, and data sharing.
Main Results:
- Significant legal gaps exist in SSA regarding stroke bio-banking and genomics research.
- Current regulations are often absent, outdated, or difficult to navigate.
- Key issues like consent, ownership, and commercial use lack satisfactory legal provisions.
Conclusions:
- Legislative intervention is crucial for regulating stroke bio-banking and genomics research in SSA.
- A positive symbolic legislative approach is recommended, focusing on policy issues with detailed explanatory notes.
- Statutes should be adaptable, incorporating local ethical guidelines such as those from H3 Africa and relevant case law.
Abstract:
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.

