Informed consent for somatic gene editing for sickle cell disease in sub-Saharan Africa: a scoping review

Abstract

Somatic gene editing targets non-reproductive cells to treat genetic diseases like sickle cell disease (SCD) without affecting future generations. However, there are challenges in obtaining informed consent in sub-Saharan Africa (sSA) due to language barriers, cultural differences, and low health literacy. While promising, somatic gene editing carries risks such as off-target effects, unintended gene transfer, and potential activation of oncogenes. The aims of the review are to conduct an in-depth literature review of the current approaches to informed consent for somatic gene editing and gene therapy and identify potential areas for improvement, specifically in relation to SCD in sSA. Arksey and O’Malley five steps approach was adopted for this scoping review. A combined search via PubMed and EBSCOhost retrieved a total of 57 articles, Screening was conducted and a total of 23 articles were included in this review. Of the 23 articles 5 were original cross-sectional studies, 4 were reports, 10 were literature reviews, and 4 were opinion pieces, most of the articles were conducted in the USA (56.5%) and the least from Africa (4.3%). Themes included Patient Education, Risk Assessment, Paediatric Consideration, Ethical & Legal Consideration, Decision Making/Support, Privacy & Indemnification, Consenting process & Culture. In SSA, the consent process should use simple, clear language and visual aids for complex ideas, respect local customs and cultural norms and involve parents in decisions for children when appropriate. Privacy is a key concern, particularly due to stigmatization of genetic conditions like SCD. Informed consent is essential for gene therapy research in SCD in sSA. It is crucial to conduct a study to assess the level of gene therapy literacy among various stakeholders.