RESUMO
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.
RESUMO
Background: There is growing interest in advancing biobanking and genetic research in many countries, including India. Concurrently, more importance is being placed on participatory approaches involving the public and other stakeholders in addressing ethical issues and policymaking as part of a broader governance approach. We analyse the tools, purposes, outcomes and limitations of engaging people towards biobanking and genetic research governance that have been undertaken worldwide, and explore their relevance to India. Methods: Papers to be reviewed were identified through a targeted literature search carried out using ProQuest and PubMed. Retrieved papers were analysed with the Rpackage for Qualitative Data Analysis using inductive coding and thematic analysis, guided by the Framework Method. Results: Empirical studies on public and community engagement in the context of biobanking and or genetic research show a predominance towards the end of the last decade, spanning 2007 to 2019. Numerous strategies-including public meetings, community durbars, focus group discussions, interviews, deliberations, citizen-expert panels and community advisory boards-have been used to facilitate communication, consultation and collaboration with people, at the level of general and specific publics. Engagement allowed researchers to understand how people's values, opinions and experiences related to the research process; and enabled participants to become partners within the conduct of research. Conclusions: Constructs such as 'co-production', 'engagement of knowledges', 'rules of engagement' and 'stewardship' emerge as significant mechanisms that can address the ethical challenges and the governance of biobanking and genetic research in India. Given the inherent diversity of the Indian population and its varying cultural values and beliefs, there is a need to invest time and research funds for engagement as a continuum of participatory activity, involving communication, consultation and collaboration in relation to biobanking and genetic research. Further research into these findings is required to explore their effective employment within India.