Ongoing series of activities
Tackling the challenges of conducting COVID-19 research ethically in lower income settings
This webinar took place on Friday 1 May 2020.
Nearly 200 people from 37 different countries attended this webinar, the third in the series of COVID-19-related webinars being hosted by the Nuffield Council on Bioethics.
Building on the discussion at the first seminar in this series, three speakers explored issues that may be particularly challenging and important in COVID-19 research in low and middle income settings. The webinar was chaired by Hugh Whittall, Director of the Nuffield Council on Bioethics.
- Gagandeep Kang, Executive Director, Translational Health Science and Technology Institute of India; and member of the steering committee of the COVID-19 Clinical Research Coalition
- Gustavo Matta, Researcher in Public Health at Oswaldo Cruz Foundation, Brazil (Fiocruz); and coordinator of Zika Social Sciences Network
- Aissatou Touré, Director of the Alliance pour la Recherche et l'Ethique en Afrique (ARE Africa), and Vice-chair of Senegal National Ethics Committee for Health Research
Gagandeep Kang is the Executive Director, Translational Health Science and Technology Institute of India; and a member of the steering committee of the COVID-19 Clinical Research Coalition
In order to think what research should be done, and where, in low income settings, it is important to look at the local context: define the size of the problem and who is most affected; and consider what kinds of intervention may be appropriate. Interventions that work in high income countries may be very challenging to implement in lower income settings.
Given that population density is an important factor in transmission, those who are most vulnerable (for example, living in urban slums) are those least able to protect themselves. Measures such as social distancing and handwashing are impossible where five people live in one room without access to water. ‘Lockdown’ arrangements put workers who rely on daily wages in an impossible situation. Making the case for research in these environments can be very difficult – and yet evidence is needed, not only on vaccines and treatments but on the effectiveness of isolation and distancing measures.
In the clinical setting, hospital emergency departments will be far more stressed than in cities such as London or New York, starting from a much lower level of resource. From the perspective of researchers who are also clinicians, it is a real challenge to know where best to focus your time: helping patients now, or seeking evidence that will help in the future.
Structures that enable this research to be done are needed. Trust is also an important factor but trust in the medical system and in researchers is often wanting. This may be exacerbated by the fear and anxiety generated by the pandemic. A particular complication in India is the multiple systems of medicine that we have: both public and private Western health systems and also traditional health care. This raises difficult questions of how to prioritise what research to do.
Gustavo Matta is a researcher in Public Health at Oswaldo Cruz Foundation, Brazil (Fiocruz); and coordinator of Zika Social Sciences Network
Three factors are crucial in ethically-conducted research: context, dialogue and trust.
Community participative strategies play a crucial role, both in the response to COVID-19, and in associated research. In Brazil, ‘social participation’ is one of the pillars of the national health service, as part of developing health policy at local and federal level. This is not just about disease – it is about understanding the significance for health of different regional histories and experiences, and using dialogue to understand and respect diverse points of view.
Inequalities in both healthcare and science have an impact on community trust, and are a source of ethical concern. As in the Zika outbreak, resources for both healthcare and research for COVID-19 come from the same funds. Health professionals and institutions have difficult decisions to make between their responsibilities for care and for research. There is limited access to diagnostic tests, exacerbated by the concentration of supplies in high income countries. Science funding has been cut since 2016, and there is a concerning lack of diversity (both in terms of geography but also race/ gender/ class) among research leaders. The political environment (including the President’s view of COVID-19 as “just a little cold”) is challenging.
Measures taken in response to COVID-19, such as social isolation, impact differently on diverse vulnerable populations, including indigenous peoples, immigrants, and those living on the streets. Our research needs to be founded on solidarity: for example thinking not only of the health and social needs of trial participants, but also of their families and contacts. And when we think of the ‘at risk’ groups, we need to think about stigmatisation: there is a risk that deaths of elderly people, or those with particular conditions such as hypertension, are being normalised (the attitude that society and health authorities accept these deaths as normal and predictable, and it could influence decisions as to who can live or die).
The Nuffield Council’s Dakar workshop on community engagement emphasises some core aspects of community engagement, including developing mutually respectful partnerships between researchers and communities throughout the whole research process; and the importance of transparency, contextualisation and well-founded trust. Research planning must also analyse and support social and economic needs. One model being initiated in Brazil, particularly in the slums, is that of “community epidemic situation rooms” where authorities, professionals and communities come together to talk not only about research but also about how to meet those pressing needs.
Aissatou Touré is the Director of the Alliance pour la Recherche et l'Ethique en Afrique (ARE Africa), and Vice-chair of Senegal National Ethics Committee for Health Research
Ethics committees reviewing research during the COVID-19 pandemic have to contend with operational challenges; complex and novel issues; and difficulties around getting timely support.
The influx of urgent projects for review at a time when populations are being asked to respect ‘social distancing’ requires ethics committees to adapt the way they work – for example holding virtual meetings through Zoom, adding in extra meetings, and channelling comments through the secretariat for synthesis. This requires a committed and adequately resourced secretariat; committed members willing to review complex applications in a short time-frame, and a stable internet connection (not always available). The availability of members can be affected by their involvement in direct response to the pandemic; and it is very difficult for committees to monitor what actually happens on the ground, particularly when the research takes place in isolation facilities.
Challenges concerned with the content of applications include: assessing the scientific value of the project when the science is still at an early stage; accessing scientific or ethical journals that may be behind paywalls; assessing what is an acceptable control group treatment (for example where chloroquine is already routinely provided alongside supportive care); identifying the boundary lines between care and research; and finding appropriate approaches to consent for quarantined or unconscious persons.
On the question of support, it would be very helpful to have a list of ethics experts who are available for rapid discussion and exchange. While some new networks have been established, they are not yet able to provide rapid answers and have limitations. For example, the new WHO Public Health Emergency Preparedness and Response Emergency Network (PHEPREN) only permits people with an institutional email address to register. However, personal emails are often used in low income settings because of problems with institutional servers. Some ethics experts are also not affiliated with an institution or may be retired. [Note: the issue of PHEPREN registration is now being reviewed by WHO colleagues in the light of these concerns.]
Other areas of support that would be valuable include training resources in languages other than English (in particular, French and Portuguese for African audiences); advocacy for funding (recognising that international financial support for ethics committees is often competitive, and those with the best written English may be most likely to succeed); and advocacy for funding for regional networks. Networks such as WANEC (West African Network of Ethics Committees) can play a valuable role in supporting capacity, but need funding to support a stable and efficient secretariat.
19 questions were submitted by participants, three of which were put to the panel in the time remaining during the webinar.
Multicentre / multi-country trials. Are there adequate systems available so that local researchers can join as co-investigators?
This has certainly been a problem in the past. It is now more the case that local researchers are involved as co-investigators – but sometimes only on paper. In practice they may simply be involved as data-collectors, with data being taken abroad for analysis. It is important to balance the interests of the research itself, and those of the various researchers. Ethics committees can push back on this if they are concerned about the role of local researchers.
In some circumstances, especially in the case of migrants or refugees, participating in research can constitute a social risk. Can this be managed?
This is a real risk and needs to be considered carefully – for example in the case of migrant workers who are not accepted by local populations, and can be excluded and stigmatised. We need to be confident that the questions we are asking are really relevant to this particular subset of population rather than just to the population as a whole. It’s challenging to do, for both researchers and the community.
Questions of privacy and vulnerable populations – for example in connection with domestic violence, or those living in violent areas – are a particular concern in pandemics. Because of the focus on the collective good in responses to pandemics, it is more difficult to keep the particular needs of individuals in view.
The pressure on health systems and health professionals is intense regarding existing resources and the redirection of resources to COVID-19, and switching attention to research. How can this be approached?
This needs to depend on the context – every country is suffering but in different ways. A supportive initiative for health workers who are also trying to run research projects would be valuable – involving dialogue to understand their personal and institutional ethical constraints. Funders also need to be involved.
Where there is a lack of scientific evidence, an international expert group, such as the one that prioritised candidate treatments for Ebola, is a very helpful resource for ethics committees. There doesn’t seem to be the same level of support yet for COVID-19 research priorities.
One approach for individual institutions, such as medical schools, is to look at what kinds of studies would be most valuable for the institution, and establish a team to focus on these. However, challenges still arise getting national permissions to take part in international studies – even when funders are supportive.
You can download Arabic, Chinese, French, Portuguese and Spanish translations of our Research in global health emergencies: ethical issues materials. French, Portuguese and Spanish translations of our short report will be available imminently.