Thinking responsibly: The ethics of global health research
01 February 2011
"The voluntary consent of the human subject is absolutely essential." So begins the Nuremberg Code, a key document for setting out researchers' ethical responsibilities regarding testing on human subjects, which was published in 1949 in response to experiments performed by the Nazis during World War II. In the 60 or so years since its publication, thousands of other guidelines, policies and declarations on the ethics of research have been made.
Unfortunately, the atrocities that prompted the Code are by no means isolated events. History is littered with cases of unethical research, particularly that conducted on marginalised groups, including prisoners, mental health patients and people from ethnic minority groups.
As recently as October 2010, the US Government apologised for experiments carried out in the 1960s, in which US Government researchers deliberately infected hundreds of prisoners and mentally ill patients in Guatemala with gonorrhoea and syphilis, without their consent.
In recent years, partly in response to increased awareness of examples of unethical research such as these, consideration of the ethical aspects of medical research has increasingly been recognised as an important part of good research practice. One area in which this has been noticeable is in the debate around the ethics of research in resource-poor countries triggered by an increase in projects in these locations.
"There was a huge shift between 1997 and 2004 with a lot of global health research being undertaken in resource-poor countries," says Lairumbi Mbaabu, a postdoc at the KEMRI-Wellcome Trust Research Programme in Kenya, speaking to me on the phone from Nairobi. "As much as people said this is a good move, there were concerns that this shift might end up being exploitative."
One way of ensuring that poor countries aren't being exploited, Lairumbi explains, is to ensure that the research adds value to the country and the communities involved. No one else except the people living in these countries can say what counts as a benefit for them.
Universal benefits?
It was this concept - benefit sharing - that Lairumbi examined in his PhD, carried out at the Ethox Centre, Oxford. He was supervised in the UK jointly by
Michael Parker, Professor of Bioethics and Director of the Centre, and Ray Fitzpatrick, Professor of Public Health and Primary Care, University of Oxford.
"My PhD explored how benefit sharing is understood, and how it is practised. I did this by talking to lots of stakeholders involved in research and health delivery, including researchers, research funders, ethics committees and communities who are supporting this kind of work."
"We wanted to find out if this is an issue that stakeholders in resource-poor settings can handle and, if not, what needs to be done to make this feasible. Basically, we wanted to know, if we're talking about research benefits, what exactly are we talking about?"
Lairumbi quickly realised that there was a lot of confusion. "People were getting lost in thinking about the research benefits themselves, but also about who should benefit, how these decisions could be made, and the issue of who should be responsible: the researcher, the funder, or someone else?"
Their initial plan to provide a framework for people involved in global health research was put aside. "What we ended up finding out is that some people have an idea of some of the things that they want done (what they are calling benefits), but there are quite a number of other barriers that we don't know much about."
For example, Lairumbi often found that the interests of different stakeholders were incompatible - the interests of the local researchers may not fit well with those of the local communities, or the ethics committees. "There needs to be a mechanism through which these differences can be settled," he says.
Another difficulty is with the coordination of research. "If you take research on the development of a malaria vaccine, for example, it can take a long time to come up with a product that we can call a benefit of research," says Lairumbi. "Without the means to coordinate the different strands of research, then some pieces often get lost to public imagination. This can make it hard to get people to see what the benefits are."
It's these 'organisation barriers' that Lairumbi thinks need to be addressed as a priority. "Without taking care of these systemic organisational challenges that we're uncovering here, thinking about involving communities in setting their own agenda is not going to be feasible."
Asking questions
Born and bought up in Kenya, how did Lairumbi end up in Oxford exploring research ethics? At the University of Nairobi he studied anthropology and went on to earn a postgraduate diploma in mass communication. After a period working as a communications officer at a research centre, he went to St Andrews University in Scotland to study a Master's in Research in Health Geography, which focused on studying health-care provision through social science methods.
Surprised by how many ethical issues were being raised by the work, he began working as a social scientist at the KEMRI-Wellcome Trust Research Programme in 2005.
Interested in pursuing research into the ethics of global health research, Lairumbi and his supervisor in Kenya, Dr Mike English, contacted the Wellcome Trust, who put them in touch with Michael Parker and his colleagues at the Ethox Centre. "I came over to Oxford for a week to meet people, and they were quite excited about what we wanted to do," Lairumbi remembers. Within Ethox, researchers - many from developing countries - were beginning to explore some of these and related challenges.
Michael Parker had spent the majority of his early career in bioethics working on the ethics of clinical genetics. Around six years ago he was made professor and although he had done some work on global health issues, this honour marked a major turning point in his thinking about his research focus.
"At around that time I went through a period of thinking about my own responsibilities as a researcher. As someone working in ethics, I think there's an obligation to address the big ethical issues of the day. To me, global health inequality is biggest of all of them and the result of this period of reflection was that I made a decision to focus more on this area in my work in the future."
"My experience has showed that a lot of medical researchers are working in a very complicated range of situations. The main problem isn't that there's a lot of deliberate bad practice out there, it's that there's lots of complexity in these issues, particularly in the context of large-scale collaborations. Ethics support and research can help them to achieve their goals and maintain high ethical standards."
He cites MalariaGEN (Malaria Genomic Epidemiology Network) as an example of where ethics and social science research is run alongside scientific research. He is a Principal Investigator within the network, something that he thinks shows how seriously the ethics is taken.
"This set-up has worked really well - we've been able to provide ethics support to the scientists when they've encountered ethical issues, we've been able to do training and we've been able to do ethics research around more longer term issues, such as community engagement, consent and benefit-sharing."
Experiences at Ethox
I asked Lairumbi, who is now back in Kenya pursuing a postdoc, about his experience in the UK. "I found my time in Oxford very fulfilling," says Lairumbi, who conducted his fieldwork in Kenya but spent one year, in three-month blocks, at the Ethox Centre. "The multidisciplinary nature of the unit was particularly valuable. In a small team we had a great range of expertise: clinicians, social scientists, lawyers, epidemiologists and philosophers.
"There were also the resources I wouldn't otherwise have reached, such as talks and guest lecturers by distinguished scholars in research ethics. Additionally, fellows and visiting researchers from the UK and developing countries made it an enriching environment, which is particularly useful when you're looking into research that relies on other people's values."
"Lairumbi's right about the multidisciplinary nature of the unit," Michael adds. "Just as in science you might need to bring together epidemiologists, people working in informatics, etc. - a whole range of different disciplines to engage with a research question - the same thing is true in much ethics research. My view for ethics is that you need to be able to bring different disciplinary and methodological perspectives to bear on a particular problem; it's what we need to do good quality research."
Having a mixture of expertise is also important to build people's capacity, Michael adds. "As part of a PhD, people might want to learn how to do social science research, for example, or philosophical ethics. A multidisciplinary team means that we can provide people with the skills that can help them do their project, but will also be helpful for their future career."
The benefits are reciprocal: "By working together with colleagues in developing countries, I feel like I'm developing my own understanding of what ethics is and how it might be done," says Michael. "This kind of collaboration builds our capacity too."
When asked if there's an appetite for ethics research in developing countries, Michael is emphatic. "There are a lot of people who are interested, but there is a lack of funded PhD or Master's places," he replies. As evidence, he tells me about a Wellcome Trust grant he and colleagues were awarded to fund one PhD place per year for three years. For both places offered so far, they received over 60 full applications.
The need to build capacity goes beyond training for individuals, Michael says, as there's also a need to build international networks of capacity in ethics.
"There is a need for 'local' people on the ground in different countries, and there is also a need for them to be talking to each other. In international collaborations you want local solutions as well as solutions that achieve and maintain standards of good practice across the collaboration. And there need to be sustainable career opportunities for people like Lairumbi, back in Kenya," he adds. "We need more than just PhDs."
Food for thought
Image: Members of the community participating in research during a forum organized by KEMRI in Kilifi, Kenya. Credit: Wellcome Library, London.
References
Parker M et al. Ethical data-release in genome-wide association studies in developing countries. PLoS Medicine 2009;6(11): e1000143.
Benatar SR and Singer PA. Responsibilities in international research: a new look revisited. J Med Ethics 2010;36(4):194-197.
Parker M, Bull S: Ethics in collaborative global health research networks. Clin Ethics 2009;4(4):165-168.
Lairumbi GM et al. Promoting the social value of research in Kenya: Examining the practical aspects of collaborative partnerships using an ethical framework. Soc Sci Med 2008;67(5):734-47. Epub 2008 Apr 9.
