Developing Ethics Principles for Guiding Benefit Sharing in Biobanking in Kenya

Sudoi, Allan (2024). Developing Ethics Principles for Guiding Benefit Sharing in Biobanking in Kenya. PhD thesis The Open University.

DOI: https://doi.org/10.21954/ou.ro.00100054

Abstract

Biobanking, the sharing of human biological samples and associated pseudo-anonymised data for research, is nascent in Kenya. Recent studies document ethical issues around biobanking, but few address the nature of benefits that arise, if and how they should be shared, with whom and why. This thesis examines benefit sharing within Kenyan biobanks through an empirical ethics approach, leveraging ethical principles and frameworks to guide research questions and interpret findings.

The primarily qualitative research was conducted in two purposively selected research institutions hosting biobanks in Kenya, involving interviews with 23 respondents, and engaging 70 community members in deliberative consultations and focused group discussions. This was complemented by a quantitative survey in 24 public health laboratory facilities.

Diverse infrastructural capacities exist within Kenyan laboratories, with the majority (90.5%) storing samples that remain after initial use. Notably, 23.5% of the laboratories reported storage exceeding 25 years. Sample sharing mainly occurs with post-graduate students (28.6%) and original researchers (23.8%), with minimum involvement of commercial industry stakeholders.

Benefit sharing in biobanking is complicated by the inherent challenge of distinguishing between biobanking and primary research benefits, further complicated by the long time-lag between sample collection, sharing, and the realisation of shareable benefits. The lack of specific guidelines and the variety of stakeholders with differing interests add to this complexity.

Three ethical concepts emerged as important in guiding benefit sharing in biobanking: Inclusivity, framed as ensuring wide and diverse representation of stakeholders, especially under-represented and marginalised communities, in decision-making spaces; Reciprocity, premised on the need to acknowledge and prioritise benefit sharing to those that directly contributed to the biobanking processes; and Equity based on recognising disparities in resources, knowledge, and power among stakeholders, aiming to benefit the most disadvantaged. This thesis further suggests these three principles can be useful in counter-balancing the negative influences of power.