Webinar – Tackling the challenges of conducting COVID-19 research ethically in lower income settings

Friday 1 May 2020, 12.00-12.40 BST

This webinar has taken place. A recording and summary of the webinar are available below.

Chair: Hugh Whittall, Director, Nuffield Council on Bioethics

Speakers:

• 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

The first webinar
in the Nuffield Council’s current series of COVID-19-related webinars
explored a number of the ethical issues that arise in the context of
research in global health emergencies such as the current pandemic. This
follow-up seminar considers in more detail some of the issues that may
be particularly challenging and important in connection with such
research in low and middle income settings. These include:

• ensuring the relevance of research to local populations: both in
  
  terms of responding to local needs and circumstances, and in terms of
  
  the affordability of research interventions that prove effective;
• the role of community engagement in helping ensure that research is locally relevant and acceptable; and
• how
  
  best to support the capacity of ethics committees to ensure that they
  
  are not overburdened during the pandemic, and are able to scrutinise
  
  research proposals in a timely and effective manner.

Attendees
will not be audible or visible during the webinar, but will be able to
put questions to the panel through a Q&A tool.

Presentations

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.

Questions

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.