Respecting values and perspectives in biobanking and genetic research governance: Outcomes of a qualitative study in Bengaluru, India

Abstract

Background: The promise of biobanking and genetic research (BGR) in the context of translational research towards improving public health and personalised medicine has been recognised in India. Worldwide experience has shown that incorporating stakeholders’ expectations and values into the governance of BGR is essential to address ethical aspects of BGR. This paper draws on engagement with various stakeholders in the South Indian city of Bengaluru to understand how incorporating people’s values and beliefs can inform policy making decisions and strengthen BGR governance within India. Methods: We adopted a qualitative research approach and conducted six focus group discussions with civil society members and seven in-depth interviews with key informants in BGR, identified through a targeted web search and snowballing methods, until data saturation was reached. Data were thematically analysed to identify emergent patterns. Results: Specific themes relating to the ethics and governance of BGR emerged. Fears and uncertainty about future sample and data use, possibilities of discrimination and exploitation in the use of findings and the lack of comprehensive data protection policies in India along with expectations of enhanced contributor agency, control in future use of samples and data, benefit sharing, enhanced utility of samples, sustained BGR and public good, reflected tensions between different stakeholders’ values and beliefs. Fair governance processes through an independent governance committee for biobanks and a system of ongoing engagement with stakeholders emerged as best practice towards building trust and respecting diversity of views and values. Conclusions: Ensuring public trust in BGR requires listening to stakeholders’ voices, being open to counter narratives, and a commitment to long term engagement embedded in principles of participatory democracy. This is central to a ‘people-centred governance framework’ involving a negotiated middle ground and an equilibrium of governance which promotes social justice by being inclusive, transparent, equitable, and trustworthy.

What constitutes equitable data sharing in global health research? A scoping review of the literature on low-income and middle-income country stakeholders’ perspectives

“…The second author is a bioethicist currently based in New Zealand, whose research interests have focused on global health ethics since 1999. Over the past decade, she has conducted empirical ethics research on data and sample sharing and biobanking in collaboration with colleagues in Australia, Ghana, Hong Kong, India, Kenya, Malawi, South Africa, Thailand, UK and Vietnam 1 19–21 29–40. She has a longstanding interest in inequities and the exercise of power during the construction of global health data sharing landscapes and associated knowledge production processes.…”