An integrated consent-centred ethical framework for human tissue research in South Africa.

Abstract

Human tissue research is essential to medical advancement; however, it raises complex ethical, legal, and regulatory challenges, particularly regarding consent, ownership, privacy, commercialisation, and emerging contemporary uses. In South Africa, these challenges are exacerbated by fragmented oversight and regulatory inconsistencies, underscoring the need for ethically coherent and contextually responsive governance. The purpose of this study was to investigate and document the ethical values underpinning human tissue research, examine the processes and regulatory frameworks governing human tissue research and human biobanks, identify gaps within existing national and international guidelines, and develop a comprehensive ethical framework to guide ethically responsible human tissue research in South Africa. This study employed a qualitative, exploratory design within a constructivist paradigm, combining empirical investigation and ethical analysis. Data were collected through semi-structured interviews with twenty-four (24) anatomists and human tissue researchers from national and international settings, fifteen (15) Human Research Ethics Committee (HREC) members from two South African universities, and nine (9) human biobank managers across South Africa. Interview data were anonymised, transcribed, and thematically analysed using NVivo, and findings were corroborated with national and international literature and validated through expert consultation. Findings from Chapter 2 revealed that anatomists and researchers perceived research involving living participants and deceased donors as ethically different, requiring differentiated consent models and regulatory approaches. While broad consent was generally supported for living participants, fully informed consent was favoured for cadaveric research. Significant governance gaps were identified relating to legacy and unconsented collections, foetal tissue research, commercialisation, the public display of human remains, and contemporary secondary uses of human tissue. Chapter 3 demonstrated that HRECs and human biobanks operate within fragmented governance environments, characterised by unclear legislative guidance, limited oversight, and the absence of a national ethics authority or human biobanking governance framework. Participants highlighted ethical challenges related to vulnerable populations, high-risk research contexts, and emerging technologies, particularly artificial intelligence (AI)-driven research. Following the synthesis of the findings from Chapter 2 and 3, the study developed an Integrated Consent-Centred Ethical Framework (ICEF) for human tissue research presented in Chapter 4. This five-layer framework positions consent as the ethical anchor and integrates five domains: 1) Foundational Consent Ethics; 2) Governance of Legacy and Unconsented Collections; 3) Sensitive Consent Contexts; 4) Biobank, Commercialisation, and Secondary Research Governance; and 5) Ethical Adaptation for Emerging Technologies, supported by continuous Governance and Regulatory Oversight. This framework could make a significant contribution to science since it provides (i) contextually grounded ethical guidance for South African researchers and (ii) practical tools, viz. structured consent form checklists, thus strengthening ethical governance, protecting human dignity, and promoting public trust in human tissue research. Overall, this thesis established a consent-centred ethical framework that strengthens governance, promotes social justice, and supports ethically responsible human tissue research in South Africa amid evolving scientific and technological change. Keywords: human tissue research, ethics, biobank, consent, governance, South Africa, framework development.