This article was originally published in the journal Clinical Ethics and is reproduced here with the permission of the editors and publishers of Clinical Ethics. The article should be cited as , Parker, M. and Bull, S.J., (2009) Ethics in collaborative global health research networks Clinical Ethics 4: 165-168 DOI: 10.1258/ce.2009.009025

 

Despite enormous global inequalities in health, only a small proportion of medical research has addressed problems primarily affecting the world's poorest people. To address this, reports by the Ad Hoc Committee on Health Research (1996) and International Conference on Health Research for Development (COHRED, 2000) together established a consensus on five core recommendations for the action needed to move towards a more equitable distribution of research resources. These called for action to: correct the 10/90 gap in research funding and set priorities; build up the capacity of health research systems in developing countries; create international research networks and public-private partnerships; increase funding for health research by developing countries; and create health research forums to monitor progress in health research (Global Forum, 2004).

These recommendations, together with the United Nations’ Millennium Development Goals led to a number of important developments. The Global Forum for Health Research 10/90 Report on Health Research 2003-2004 found that the landscape of medical research funding changed significantly between 1990 and 2003 and reported that there were now ‘many more actors engaged in funding or conducting health research relevant to the needs of developing countries’, estimating that global expenditure on research had ‘more than quadrupled’. The Report noted that much of this new research took the form of emerging international research networks. Among others, the Report identified: The Roll Back Malaria Partnership; the Global Alliance for TB Drug Development; and HIV/AIDS. Such collaborations bring together diverse, distributed but interdependent groups of ‘actors’ in formations which may be temporary and partial, or long-term, substantial and interdependent. These include: researchers, institutions such as universities and research institutes in both developed and developing countries, funders, research ethics committees, national ethics advisory bodies, health professionals, and local community advisory boards. These developments continue (Global Forum, 2008) and both the scale of the research being carried out on global health, and the shift towards more collaborative, networked approaches to global health research have been further encouraged by initiatives such as the Grand Challenges in Global Health Scheme (http://www.grandchallenges.org/).

Ethical issues in collaborative global health research

The emergence of collaborative global health research initiatives has complex ethical implications arising out of the interplay between globalised research collaborations and the ways in which such research is manifested locally. These are complementary to and interwoven with the well-described ethical issues arising out of global health inequalities (Benatar and Singer, 2000; Nuffield, 2002), but present qualitatively new challenges. Our research seeks to address ethical issues arising in four such challenging areas. Specifically: community engagement, global ethics governance, the ethics of global research collaboration and the respective roles and responsibilities of research actors in large-scale global health collaborations. Each of these four areas is discussed in more detail below.

Community engagement 

‘Collaborative partnership’ and ‘social value’ have been proposed as ‘benchmarks’ against which the ethics of research in developing countries should be assessed (Emanuel et al, 2004; Lavery et al, 2008). This is driven both by recognition of the need for locally relevant health research i.e. research with ‘social value’, and by awareness of the potential for exploitation in contexts of vulnerability and inequality (NBAC, 2001, Nuffield 2002). The achievement of these benchmarks is only possible in the context of effective community engagement and accountability (Nuffield, 2005; Marsh et al, 2008;  Lairumbi et al, 2008). Despite this growing emphasis on the importance of community engagement, there is relatively little published experience of engagement in practice and there have been a number of recent calls for further research on this important topic (Diallo et al, 2005; Foster et al. 1997; Marsh et al. 2008).

Successful and appropriate community engagement presents a number of challenges. Some of these relate to the question of how the relevant community is to be identified (Marsh et al, 2008). The question ‘who is the community?’ also requires an understanding of the relationships between science and collectives such as ‘the community’ as both dynamic and complex (Hayden, 2007; Epstein, 2007; Novas and Rose, 2000). Other challenges concern the identification and establishment of procedures, principles and mechanisms of engagement that are fair, inclusive, accountable and appropriate (Chokshi et al, 2007; Daniels, 2008). A related issue concerns the relationship between community engagement and community consent, and the extent to which communities should be involved in the setting of research agendas, priorities and methods. This presents particular difficulties in collaborations where even many of the scientific partners will not understand the highly specialised research being carried out by other partners and very few will understand the collaborative enterprise as a whole. Such research also presents challenges for community engagement arising out of the complexity of concepts and practices such as ‘data-sharing’ and because the harms and benefits of such research often relate to populations rather than to individuals (Lowrence and Collins, 2007). A key practical ethical issue for scientific networks committed to community engagement is how to achieve an appropriate balance between shared good community engagement practice across the network and sensitivity to important local variation.

Global ethics governance

Ensuring that collaborative research meets the needs of people in developing countries requires the development of appropriate models of governance. The governance environment within which such research currently takes place is highly complex. The US Office for Human Research Protections lists more than 1100 international, regional and national examples of guidance and regulation on the ethical conduct of research (OHRP, 2009). Researchers in collaborative studies are sometimes faced with applying multiple and conflicting forms of guidance; or alternatively, may be working in novel scientific fields or contexts with little specialist guidance available. This means that one of the challenges facing collaborative research networks is how to develop rigorous and transparent procedures to inform the development of best practice in conducting their research against the background of guidance which may be complex, conflicting or absent. 

It is widely accepted that medical research requires independent, competent and transparent ethical review (Emanuel et al, 2004; NBAC, 2001; Nuffield, 2002; Helsinki). In practice however, the effective and appropriate functioning of research ethics review in developing country settings is frequently undermined not only by the complexity of the guidance but also by inadequate training and resources (Milford et al, 2006; Effa et el, 2007; Kass, 2007). In some settings effective local review may be entirely non-existent (NCOB, 2005). A number of collaborative groups have been established to enhance ethics review capacity such as: The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER); the South African Research Ethics Initiative (SARETI); the International Research Ethics Network for Southern Africa (IRENSA); the Training and Resources in Research Ethics Evaluation (TRREE); and the African Malaria Network Trust (AMANET). Nevertheless, against a background of partial and stretched capacity, collaborative research networks present significant governance challenges. Some of these result from the distribution of scientific and technological expertise across the diverse and multiple sites of ‘the project’ in developed and developing countries when the nature of the research enterprise may only make sense in the context of activities going on in a number of distant socially, technologically and scientifically diverse locations. Reviewing such research often requires expertise not available locally. Others arise out of the shipping of large numbers of blood or DNA samples and data between different sites and the distributed nature of the intellectual property in such research. These may be further complicated by increasing moves to ‘open access’ and data sharing with the wider scientific community.

The ethics of research collaboration 

Collaborative global health research requires the establishment of large and diverse multinational scientific networks bringing together diverse yet interdependent forms of expertise and institutions in developed and developing countries. This means that a key factor in successful research is the building and maintenance of the relationships, shared values, practices and trust underpinning collaborative science, and the mechanisms for working in the context of different ethical values and commitments. Such consortia will for example need to reach agreement on particular occasions about important ethical principles relating to their relationship with ‘their’ research participants. This may involve negotiating the appropriate balance between the need for standardisation and shared ethical practices across the network and for diversity and appropriateness to local settings.

This suggests that in addition to, but interwoven with recognisable ethical issues such as consent, collaborative research presents a number of ‘internal’ ethical issues including those arising in the fair sharing of data and samples between partners, the development of scientific capacity across the network, the allocation of scientific resources, decisions about authorship and ownership of intellectual property. Some such issues have both an ‘internal’ and an ‘external’ aspect. For example, the need to reach agreement about the development of appropriate mechanisms for the management of the release of data raises questions about the balance between promoting research in the wider scientific community on the one hand and the responsibility for networks to protect the emerging scientific capacity in developing countries, and particularly the capacity of partners within the network. If the data produced by the network on the basis of samples and phenotype descriptions collected by partners in developing countries is exploited by institutions in the North at the expense of emergent capacity in the South, this has the potential to undermine long term collaboration (Parker et al, 2009).

Roles and responsibilities of research actors

Responsibility for addressing global health inequalities and key development goals is inevitably shared (Global Forum, 2004; Daniels, 2008). It has been argued that researchers have an obligation to promote equity in health in developing countries (Daniels, 2008; Theobald and Nhlema-Simwaka, 2008). But how should such responsibilities be understood in the context of collaborative global health research? These are important questions about the moral responsibilities arising during research in developing countries and raise important questions about how such responsibilities and roles are to be identified and negotiated in the context of collaborative global health research and what forms of accountability might be appropriate.

The fact that collaborative global health research involves multiple collaborative relationships and communities suggests the importance of negotiating and reaching clarity about roles and responsibilities before research begins (NBAC, 2001; Nuffield, 2002), and as it proceeds. There may be particular advantages in this regard to the development of long-term community engagement. This suggests the possibility, and perhaps desirability (given concerns about 'one-size-fits-all' approaches), of the emergence of different solutions in different sites. Where this is the case, who will be responsible for achieving good practice across the network? What will this mean and how will it be achieved?

A key cluster of issues relating to the roles and responsibilities of research actors, and their negotiation, will inevitably be those related to questions of benefit-sharing; social value; intellectual property; appropriate standards of care; and the identification of post research responsibilities (Nuffield, 2005; Lairumbi et al, 2008). Similar issues arise in relation to capacity-building. Questions arise about to what extent is capacity-building a responsibility of research networks and their funders and what forms might it be appropriate for such capacity building to take (Benatar and Singer, 2000)

Conclusions

The growth of collaborative global health networks presents a number of ethical issues not previously encountered in combination. It also presents a number of new theoretical challenges. It is our view that an ethics capable of making sense of these emerging and interdependent phenomena will itself need to be collaborative and multi-sited if it is to be capable of grasping the implications of both global collaboration and the manifestation of the global in the local, where the ‘local’ is to be found both in developed and developing country sites. It is also our view that such research will necessarily have a strong empirical component.

 

References

Ad Hoc Committee on Health Research Relating to Future Intervention Options (1996) Investing in Health Research and Development. Geneva: World Health Organization.

Angell, M. (1997) 'The ethics of clinical research in the third world', New England Journal of Medicine 337(12): 847–9.

Benatar, S. and Singer, P. (2000) 'A new look at international research ethics', British Medical Journal 24: 221-222.

Berlinguer, G. (2004) 'Bioethics, health and inequality', Lancet 364: 1086-91.

Bull, S. J., Farsides, C. C. S., Hill, P. C., Jackson-Sillah, D. J. and Adegbola, R. A. (2008 forthcoming) 'Tailoring consent processes to context in developing countries: the value of rapid ethnographic assessments', paper in preparation.

Chokshi, D. A., Parker, M. and Kwiatkowski, D. P. (2006) 'Data sharing and intellectual property in a genomic epidemiology network: Policies for large-scale research collaboration', Bulletin of the World Health Organization 84(5).

Chokshi, D., Thera, M., Parker, M., Diakite, M., Makani, J., Kwiatkowski, D. and Duombo, O. (2007) 'Valid consent for genomic epidemiology in developing countries', PLOS Medicine 4(4): 636-641.

Council for International Organizations of Medical Sciences (CIOMS) (2002) International ethical guidelines for biomedical Research involving human subjects. Geneva: CIOMS.

Council on Health Research for Development (COHRED) (1990) Commission's Report - Health Research: Essential Link to Equity in Development. New York: Oxford University Press.

Council on Health Research for Development (COHRED) (2000) International Conference on Health Research for Development, Bangkok, www.conference2000.ch

Daniels, N. (2008) Just Health: Meeting Health Needs Fairly. Cambridge and New York: Cambridge University Press.

Diallo, D. A. et al. (2005) 'Community permission for medical research in developing countries', Clin Infect Dis 41(2): 255-259.

Dodgson, R., Lee, K., and Drager, N. (2002) 'Global health governance: A conceptual review', World Health Organisation and Centre for Global Change and Health, London School of Hygiene and Tropical Medicine.

Effa, P., Massougbodji, A., Ntoumi, F. (2007) 'Ethics committees in western and central Africa: Concrete foundations', Dev World Bioethics 7: 136-142.

European Group on Ethics in Science and New Technologies to the European Commission (EGE) (2003) Opinion Nr 17 on ethical aspects of clinical research in developing countries. Brussels: EGE.

Emanuel, E. J. et al. (2004) 'What makes clinical research in developing countries ethical? The benchmarks of ethical research', The Journal of Infectious Diseases 189: 930-937

Epstein, S. (2007) Inclusion: The Politics of Difference in Medical Research. Chicago and London: Chicago University Press.

Farmer, P. and Campos, N. G. (2004) 'Rethinking medical ethics: A view from below', Developing World Bioethics 4: 7-41.

Forster, H. P., Emanuel, E. and Grady, C. (2001) 'The 2000 revision of the Declaration of Helsinki: A step forward or more confusion?', Lancet 358(9291): 1449-1453.

Foster, M. W., Eisenbraun, A. J. and Carter, T. H. (1997) 'Communal discourse as a supplement to informed consent for genetic research', Nature Genetics 17(3): 277-279.

Global Forum for Health Research (2004) 10/90 Report on Health Research 2003-2004. Switzerland: Global Forum for Health Research.

Global Forum for Health Research (2008) Equitable Access: Research Challenges for Health in Developing Countries. Geneva, Global Forum for Health Research.

Grand Challenges in Global Health, http://www.gcgh.org/Pages/default.aspx, accessed 21st July 2008

Hayden, C. (2007) 'Taking as giving: Bioscience, exchange, and the politics of benefit-sharing', Social Studies of Science 37(5): 729-758.

Helsinki, Declaration of ([1964], revisions 2000, 2002, 2004) World Medical Association, http://www.wma.net/e/policy/b3.htm, accessed 21 July 2008.

ICH GCP (1996) Guidelines for Clinical Trials, http://www.ich.org/

Kass, N. E. et al. (2007) 'The structure and function of research ethics committees in Africa: A case study', PLoS Med 4(1): e3. doi: 10.1371/journal.pmed.0040003

Lairumbi, G. M. et al. (2008) 'Promoting the social value of research in Kenya: Examining the practical aspects of collaborative partnerships using an ethical framework', Social Science and Medicine, doi: 10.1016/j.scoscimed.2008.02.016

Lavery, J. V. et al. (eds) (2007) Ethical Issues in International Biomedical Research: A Casebook. Oxford and New York: Oxford University Press.

Lowrence, W. W. and Collins, F. S. (2007) 'Identifiability in genomic research', Science 317: 600-602.

Lurie, P. and Wolfe, S. M. (1997) 'Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries', New England Journal of Medicine 337(12): 853–6.

Macklin, R. (1999) Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine. OUP, New York.

Marsh, V. et al. (2008) 'Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya', Social Science and Medicine, doi: 10.1016/j.socscimed.2008.02.007

Milford, C., Wassenaar, D. and Slack, C. (2006) 'Resources and needs of research ethics committees in Africa: Preparations for HIV vaccine trials', IRB 28(2): 51-59.

Molyneux, S. C., Peshu, N. and Marsh, K. (2004) 'Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast', Social Science and Medicine 59(12): 2547-2559.

Molyneux, S. and Geissler, P. W. (2008) 'Ethics and the ethnography of medical research in Africa', Social Science and Medicine, doi: 10.1016/j.socscimed.2008.02.023

National Bioethics Advisory Commission (United States) (NBAC) (2001) Ethical and policy issues in international research: clinical trials in developing countries. Volume 1: Report and Recommendations of the National Bioethics Advisory Commission. Bethesda, Md: National Bioethics Advisory Commission.

National Bioethics Advisory Commission (United States) (NBAC) (2001) Ethical and policy issues in international research: clinical trials in developing countries. Volume 11: Commissioned papers and staff analysis. Bethesda, Md,: National Bioethics Advisory Commission.

Novas, C. and Rose, N. (2000) 'Genetic risk and the birth of the somatic individual', Economy and Society 29(4): 485-513.

Nuffield Council on Bioethics (2002) The Ethics of Research Related to Healthcare in Developing Countries. London: Nuffield Council on Bioethics.

Nuffield Council on Bioethics (2005) The Ethics of Research Related to Healthcare in Developing Countries: A Follow-up Discussion Paper. London: Nuffield Council on Bioethics.

Office for Human Research Protections (OHRP) (2008) International Compilation of Human Research Protections. U.S. Department of Health and Human Services.

Parker, M., Bull, S., de Vries, J., Doumbo, O., Agbenyega, T., Kwiatkowski, D. (200) Ethical data-release in genome-wide association studies in developing countries, PLoS Medicine 6(11): e1000143. doi:10.1371/journal.pmed.1000143.

Resnik, D. (2004) 'The distribution of research resources and international justice', Developing World Bioethics 4: 42-57.

Rose, N. and Miller, P. (eds) (2008) Governing the Present: Administering Economic, Social and Personal Life. Cambridge: Polity.

Snow, R. W. et al. (2005) 'The global distribution of clinical episodes of Plasmodium falciparum malaria', Nature 434: 214-217.

Strathern, M. (ed) (2000) Audit Cultures: Anthropological Studies in Accountability, Ethics, and the Academy. London: Routledge.

Theobald, S. and Nhlema-Simwaka, B. (2008) 'The research, policy and practice interface: Reflections on using applied social research to promote equity in health in Malawi', Social Science and Medicine, doi: 10.1016/j.socscimed.2008.02.015

United Nations Millennium Development Goals http://www.un.org/millenniumgoals/, accessed 21st July 2008

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