Diffusion of ethical governance policy on sharing of biological materials and related data for biomedical research

Abstract

This paper considers how ethical norms on sharing of human biological materials and related data in international policy documents diffuse from global forums to national policies and practices. With focus on the domestic policies of four countries (i.e. Guinea, Argentina, India and Malawi), this paper seeks to explain policy diffusion by broadly applying an analytical framework wherein policy learning is one of four theories used to explain how countries learn policy norms from expert epistemic communities and international organizations. While the governance structures of all four countries broadly incorporate key ethical provisions in international policy documents on sharing of biological materials and related data for biomedical research, relative emphasis on certain provisions differ among them. In three of these countries (i.e. Guinea, Argentina and India), international ethical norms have had direct influence over their domestic governance policies. Their impact has been greatest for Guinea and Argentina, whose governance policies had to be adapted in response to the Ebola virus epidemic in West Africa and the Zika virus epidemic in Latin America. In both countries, sharing of biological materials and related data with international organisations increased significantly to meet therapeutic and research needs during the outbreaks. International organisations have had a comparatively greater role in bringing about policy change in Guinea when compared with Argentina, mainly due to the fragility of the health system in Guinea in 2014. In contrast, policy in India and in Malawi occurred under less strenuous conditions. This may account for the relatively greater emphasis on control and limits to cross-border transferability in their policies when compared with those of Guinea and Argentina. While all four countries have made significant progress in establishing accountable governance arrangements, still more needs to be done to ensure that the ethical goal of equitable sharing of benefits is realised.

The ethics of data sharing and biobanking in health research

“…At present, many LMIC countries have limited regulatory and governance structures for biobanking and data sharing 7 , and very few research institutions in these countries have formal data sharing policies. The case-studies and discussions at the GFBR meeting highlighted the importance of developing approaches to governing data sharing and biobanking which are appropriately tailored to context at national and institutional levels 8 . Such systems should ensure that the interests of study participants and communities, data providers and data users, and the public are appropriately recognized and respected 9 .…”

Engaging publics in biobanking and genetic research governance - a literature review towards informing practice in India

“…Enabling participants to become partners in research 7. Community approval for research and publications in primary and secondary uses of samples and data the need to protect participants' rights in the governance of biobanking and genetic research 6,7,9,74,75 .…”

“…Eliciting public perceptions within India, on biomedical research using stored HBM samples and genome editing has found that there is a lack of confidence in regulatory processes among people, who believe mechanisms such as broad consent are instituted to primarily protect researchers interests 7,8 . Public engagement has the potential to build trust, accountability and fair research practices, however it is still at a nascent stage in India 8,9 .…”

Handling Ethics Dumping and Neo-Colonial Research: From the Laboratory to the Academic Literature

“…That research was criticized by Rochmyaningsih ( 2018 ), who claimed that it benefitted international researchers at the expense of Indonesian scientists, with no benefit to the Bajau tribe. In Guinea, India and Argentina, HIC-based ethics policies tend to guide LIC-based health policies, such as for the Ebola virus (West Africa) and the Zika virus (Latin America) (Vaz, Palmero, and Nyangulu 2019 ). In Kenya, there is increasing awareness among RECs about the risks of ED via the abuse of local underdeveloped governance to exploit researchers in LICs (Chatfield et al 2021 ).…”