Monday, December 30, 2019

Calvin Ho et al on Ethical Governance Policies on Sharing of Biological Materials for Biomedical Research (Wellcome Open Research)

"Diffusion of ethical governance policy on sharing of biological materials and related data for biomedical research"
Manjulika Vaz1, Ana G. Palmero, Wongani Nyangulu, Alpha A. Diallo, Calvin W. L. Ho 
Wellcome Open Research online
First published: 12 Nov 2019
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.

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