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The normative importance and practical achievement of valid informed consent to research participation, particularly in low income settings, has been one of the most discussed topics in bioethics. It is widely accepted that, exceptions notwithstanding, the obtaining of valid consent to research participation is a benchmark of ethical practice and there is much national, regional, and international guidance on how this is to be achieved. Despite this, valid consent to research participation in low income settings has resisted being transformed into primarily practical challenge: it continues to be highly productive of complex, irreducibly normative difficulty. Social science literature continues to demonstrate that interesting and complex unresolved issues arise in practice when engaging with and recruiting research participants. This has been confirmed in the work of the Global Health Bioethics Network, which has identified a variety of new ethical issues that arise when designing consent processes and recruiting research participants. Why is it that valid consent continues to be so productive of normative complexity?

This study aims to address a key gap in the current bioethics literature about the contextual normative complexity of ethical issues arising during recruitment and ongoing engagement with research participants in low and middle income settings. Qualitative empirical research is being conducted in Kenya, South Africa, Malawi and Thailand, to identify and analyse the contextual complexity of ethical issues arising when seeking consent and during ongoing engagement with research populations in these low and middle income settings. Key stakeholder groups to be engaged with are senior researchers, junior researchers and staff recruiting participants, community advisory board members and ethics committee members.

This project is funded by a enhancement to the Global Health Bioethics Network Wellcome Strategic Award (096527)

The other researchers on this project are the following Ethox Research Associates: