Three bioethicists from Uganda and Kenya talk about how they address ethics in genetics, a scientific field that is still new to many parts of Africa.
The NeuroGAP-Psychosis project is collecting and studying DNA and medical data from 35,000 Africans to find genetic markers linked to schizophrenia and bipolar disorder. The four-year collaboration between research centers in the United States and eastern and southern Africa is boosting equity in global genetics research. It also raises a host of knotty ethical questions, especially in low- and middle income nations. How can researchers make sure vulnerable people and populations are adequately protected? How should valuable biological samples and data be collected and cataloged? What constitutes informed consent?
We spoke with three bioethicists: Drs. Erisa Mwaka and Janet Nakigudde from Makerere University in Uganda, and Professor Violet Naanyu from Moi University in Kenya. All three are part of the Global Initiative in Neuropsychiatric GenEthics (NeuroGenE) — an international research and advisory project based out of the University of Oxford and led by Oxford's Professor Ilina Singh — that has been working in partnership with NeuroGAP-Psychosis. Through NeuroGenE, clinicians and ethicists are helping guide the project's activities and working to ensure that research on psychiatric genetics respects and benefits all communities involved.
Speaking as members of NeuroGenE's African Ethics Working Group, Mwaka, Naanyu, and Nakigudde talked about the ethics landscape for genetics research in Africa, particularly in the context of mental health.
Q: What's the state of genetic and mental health research in Kenya and Uganda, and how does that relate to ethical concerns?
Mwaka: Genetics is still an emerging field in Africa, and as a result, the level of knowledge among researchers and research ethicists in many countries is relatively low. Very few of the research ethics committees here in Uganda, for instance, have a level of knowledge needed to effectively review genetic and genomic studies. And in focus groups I've held, few researchers here are well-versed in genetics.
Naanyu: You could say that Kenya is also just starting in genetics. And beyond that, mental health in general, not just in the context of genetics, has been ignored for a long time, all across the globe. In Africa, other conditions are prioritized, particularly because we have limited resources, human and otherwise. Because there have been so few similar studies, ethics committees and their institutions face challenges when a proposal covering genetics comes their way. But Africa is now building capacity to review and implement these protocols.
Q: What are some of the ethical issues related to genetic or mental health research?
Mwaka: The biggest concern in my opinion is autonomy, the principle that somebody has to understand before they make a voluntary decision. But there are many others. For instance, commercialization. Often the results of studies help the development of new tests or products. Individual participants might not benefit from these discoveries, but does the country or community stand to benefit?
Two more that come to mind are the return of results — often participants in a study will want to see their genetic test results — and withdrawal of consent.
Naanyu: I'm also thinking about the future uses of participants' samples and data. If someone participates in one study, and researchers want to use their samples or data for other, additional studies, how do you ensure consent for that? What about issues related to biobanking, such as the storage and transfer of samples, and participants' and scientists' access to those samples in the future?
Q: What are the roots of these concerns?
Naanyu: The history here of exploitation at the hands of colonial governments and other foreign powers is certainly one factor, but there are many current factors as well. For instance, we see a very large power difference between researchers and participants. We have high levels of poverty and illiteracy, and in the case of NeuroGAP-Psychosis, we are working with a vulnerable population. All of these can leave people open to abuse.
Q: What were some of the more challenging research ethics issues you helped NeuroGAP-Psychosis leaders address when the project was getting started?
Mwaka: Our first duty is to make sure the patients who participate in the study are protected and are able to provide consent voluntarily. Most people here, even those on ethics committees, do not believe that someone with schizophrenia or bipolar disorder has the capacity to consent for themselves to participate in research. That's why we use the UBACC. [N.B. The University of California, San Diego Brief Assessment of Capacity to Consent, or UBACC, which helps establish whether a person has the capacity and autonomy to understand and agree to participate in research.]
Nakigudde: Yes, developing the consenting process itself was a challenge. We're working with people with a disorder, and who may not have gone beyond primary school. We really had to think about how much potential participants would understand the study and the consent process itself.
Another major issue was the translation of consent materials into local languages. In mental health, we talk about psychosis, we talk about schizophrenia; how do you translate that in a local language? Just in Uganda, there are several languages spoken at the study’s different recruitment sites.
Q: What were the cultural aspects of the study that needed to be addressed?
Mwaka: NeuroGAP-Psychosis participants provide saliva for DNA extraction. But saliva is a powerful substance in some African traditions. It is used as a blessing during rituals, but some believe that it can also be used in witchcraft. So providing a saliva sample can be risky for those who believe that the sample could be used to do them harm.
So when a potential participant asks, "Why do they want my saliva? Where are they taking my saliva?" we have to be very careful and very clear with our explanation of what will happen with their sample.
Nakigudde: There is a family dynamic in our culture that we had to consider as well. Sometimes a person cannot do things here without the consent of the head of the family, even things that are really about that person as an individual. And because we think from a collective point of view, sometimes you want to talk with your family, so they are all in agreement regarding your treatment and your participation in research. That's why we have had to discuss letting people take the consent form home with them, discuss it with their families, and then come back to consent.
Q: We've talked a lot about the different concerns. What's being done, and what could be done, to help alleviate them?
Naanyu: I see many efforts on many avenues simultaneously. There is work aimed at creating more awareness about new treatment opportunities that come out of genetics and related research. I and others are helping train ethics committees on genetics, biobanking, and their associated ethical considerations. We are also developing research and material transfer guidelines for use by researchers in Kenya doing genetics work.
In addition, we are trying to demystify genetics and mental health and reduce fears about sample collection and biobanking, for instance related to saliva samples and witchcraft, by creating detailed explanations about the science and what happens with the samples.
Mwaka: I know of at least two projects going on in Africa investigating the ethical, legal, and social implications of genetic and genomic research. There's also a great need for public engagement and community engagement to educate the populace and dispel the misinformation and misperceptions they have about genetics, biobanking, and mental health.
But I think the biggest thing we as ethicists can do is to advocate for local infrastructure and capacity building. We can encourage our researchers to undergo training, to develop labs, and to incorporate infrastructural development in their grants. And we can champion the establishment of proper national biobanks, not just institutional repositories, to support local genomics research.