The main aim of this workshop was to bring together the ethics and social science research teams of KEMRI, Malawi and MalariaGEN to share research experiences, to discuss emerging themes in the ethics of human research in Africa, and to identify challenging social science research avenues. Specific objectives for the workshop were to:

1. Bring together the MalariaGEN/Ethox Centre, Malawi and KEMRI teams, and external experts and local stakeholders;
2. Present and discuss the KEMRI, Malawi and MalariaGEN/Ethox Centre Ethics research programmes;
3. To identify ERC perspectives on ethical challenges, including those specific to human genetics research in Africa,;
4. Develop a shared research agenda around these challenges using a social science studies perspective.

The workshop had 29 participants from 10 institutions.  The programme included overview presentations from the three main research groups, discussions on current controversies in ethics led by representatives of research ethics committees, and inputs on social science approaches to ethics research.  Eight current empirical research projects and proposals at KEMRI, Malawi and MalariaGEN/Ethox were discussed, leading to a refining of the research questions, sampling strategies and methods.  All activities contributed to ideas sharing around further areas of potential future research and collaboration, and discussion around methodological and ethical challenges around carrying out social science research on biomedical ethics in Africa.

Outcomes

The empirical research projects covered ethical issues ranging from consent and benefit sharing to project evaluation and the release of genetic data (see attached agenda).  In addition to such existing work, the meeting identified four main areas of interest, namely:

A. Methodological and Ethical Issues in Social Science Research on Ethics

• Emanuel’s 2002 review of empirical social science research around ethics suggested many studies were methodologically and theoretically limited.  There is a need to review studies published since then; to learn about the ethical issues covered, the methods applied, if and how findings are being fed back to stakeholders and the opportunities and challenges involved.  Specific potential outputs could include a database of high quality social science studies on ethical issues in Africa, and a review paper linking published studies, and our own inputs, ideas and experiences, to Emanuel’s 2004 framework for conducting ethical research in developing countries. 
• Challenges identified for social science research around ethics were who to involve in developing a social science research agenda and how (The community? How defined?  When and how to include communities?), and how to translate the ‘lessons learned’ from social science research into the global debate on the ethics of research in resource-poor countries?  How can empirical research inform theoretical ethical debates, and how can social science research on ethical issues be used to inform health policy?  This requires consideration of the generalisability of findings from what are often in-depth understandings of complex processes and interactions in specific contexts, and the bringing together of individuals and institutions often operating from fundamentally different epistemological bases. 

B. Ethics Review Process

• RECs are a key site of negotiation and decision-making for research.  Ethnography/ research on the functioning of ethics committees could highlight the dilemmas and challenges faced by committees and those involved with them, and thereby contribute to developing guidelines and mutual learning. 
• Particular areas of interest would include a study of decision-making processes and how these differ by committee; the implications of relationships or links with researchers; ways of dealing with unknown research techniques and areas; how community members are represented; community members’ awareness of committees and their role; follow up between communities and RECs and the diversity and links between different ethics committees and other actors.

C. Community-level Research

• Research is essentially a social enterprise, and all research will involve the co-production of new relationships between various actors at the local level (researchers, fieldworkers, participants, non-participants, ‘community representatives’, health workers), and up the system.  These impacts and their implications re ethics are rarely considered in biomedical research.   We identified a series of interesting questions including:  How do current and new governance systems function in terms of representing individuals and communities in research? What is the impact of biomedical research on social relationships and vice versa?  And of social science research?

D. Genetic Exceptionalism?

• A point of debate throughout the meeting was:  How different/unique is genetics in the study of ethical issues related to biomedical research in Africa? In a range of respects, for instance with regard to REC review, consent and community partnership, ‘genetics’ appears to take on a special status – but are the issues really that different?
• Also, how different/unique are the ethical challenges in low-income settings compared to other settings (in relation to governance systems, legal protections, levels of education/comprehension, perceptions of risks and required protections and so forth).
• What are the legal frameworks around protection? How do the various stakeholders view population genetics and associated risks (e.g. stigmatisation, perceptions to ownership of life forms and materials) and what protections are needed to ensure that populations are not ‘damaged’? What is ‘damage’?
• What are good models for communicating about genetics research with different actors?
• What are scientists’ perceptions and understandings and how do these influence and respond to community views?

Ways Forward

This workshop was instrumental in bringing closer together the ethics research groups in KEMRI, Malawi and MalariaGEN/Ethox, and provided an important means for each of these three groups to discuss research ideas and projects, receiving valuable feedback on projects, questions and methods. In addition, it brought together internationally renowned experts in the field of social science studies of ethical issues in biomedical research to discuss the ethical and methodological implications of such work. The workshop has helped improve the quality of the various projects discussed at the meeting, and has, we believe, served as a spring-board for further networking and collaborations to support good quality social science around ethics in the future. 

The success of the workshop and the enthusiasm of the Centres involved and the participants suggests that a regular, perhaps annual, Agenda Setting Workshop of this kind would be a valuable resource for building research capacity in social science and ethics in Africa and supporting researchers new to the field.

AGENDA