Strengthening ethical oversight in genomics and biobanking: a retrospective analysis of research practices in Zimbabwe.

Background: As genomics and biobanking expanded rapidly across Africa, ethical governance frameworks for genomic research and biobanking often failed to keep pace, particularly in countries like Zimbabwe, where research increasingly involved international collaboration, but regulatory oversight remained limited. This study analysed how Zimbabwean researchers addressed the ethical, legal, and sociocultural issues (ELSIs) central to human biospecimen and genomic research.

Methods: We conducted a comprehensive review of research protocols submitted to the Medical Research Council of Zimbabwe between 2009 and 2016, specifically those involving human biospecimen collection, biobanking, and genomic research. A structured abstraction form was employed to evaluate how these protocols addressed key ELSIs, including informed consent, biospecimen and data sharing, benefit sharing, and intellectual property considerations.

Results: Of the 200 eligible protocols, 92(46%) were submitted by independent research institutions and 67(33.5%) by universities. Consent practices varied: 99(49.5%) protocols utilized specific consent, 37(18.5%) employed broad consent, and 37(18.5%) used blanket consent. Notably, 2(1%) protocols did not use consent forms, opting instead for broad or specific notifications. Only 44(22%) protocols included plans for the destruction of collected samples. While 44(22%) protocols involved exporting biospecimens, nearly two-thirds of these lacked a material transfer agreement (MTA). Critically, benefit sharing was absent across all protocols, and only 26(13%) addressed intellectual property rights.

Conclusions: This review exposes systemic gaps in the ethical planning of genomics and biobanking research in Zimbabwe. Although researchers are increasingly engaging in cutting-edge science, the regulatory and ethical frameworks require transformation. The limited attention to benefit sharing, consent for future use, and intellectual property reflects deeper governance and equity challenges. To protect research participants and ensure ethical integrity, Zimbabwe urgently needs updated national guidelines that define minimum standards for addressing a full range of ELSIs, moving beyond consent and privacy to embrace justice, accountability, and long-term stewardship. Strengthening these frameworks is crucial to ensuring ethical integrity in Zimbabwe's growing biobanking and genomic research landscape.