Data Sharing in Collaborative Research: Ethical Issues Carel IJsselmuiden, Debbie Marais EC International Dialogue on Bioethics Copenhagen, 19 June 2012 In the context of low- and middle-income countries

Large Databases in Collaborative Research Considerations: Quality and management of data Access and protections Obligations to partners, researchers, participants, communities Sharing between sites Sharing outside of sites Available guidance: technical, ethical, legislative INDEPTH network

Framework for the Ethics of Data Sharing 2 o User 1 o Researcher Participants Context

1. Legislative Framework & Oversight Mechanisms Protection of data & privacy laws, intellectual property laws Legal vacuum in LMICs Lack of institutions / structures to implement legislation or oversight mechanisms to monitor What recourse in the absence of such policies? Discordance between ethical & legal guidance Decisions made strictly according to existing data policy may not always be ethical. (Sieber, 2005).

2. Priorities & Benefits Return of results & benefits to participants, researchers, communities, countries Who is responsible? Career incentives: Data as currency Secondary researcher/s within country Whose public health? Sharing data with policy makers National priorities

3. Capacity Unlevel playing field in LMICs in terms of: Technical capacity (analysis, quality, access) Management capacity Legal capacity (e.g. contracting) Ethical capacity & oversight mechanisms Infrastructure Sustainability: indirect costs for storage, management of data post-study, are not factored into most funding grants Fair Research Contracting

Carel IJsselmuiden, Debbie Marais EC International Dialogue on Bioethics Copenhagen, 19 June 2012 THANK YOU