Lessons from the West African Ebola epidemic
Conventional wisdom—and an article in the Journal of Medical Ethics reviewed on this blog two years ago—advise that health research should not be
conducted during times of crisis. Yes, such conditions compromise the
controlled environments that studies typically require to produce reliable
results, but they can also threaten the ethical integrity of research. Without
institutional mechanisms to hold them accountable, investigators may cut
corners, violate standards of privacy and informed consent, and even endanger
participants. Disruption in the normal function of medical services can also
apply pressure on individuals unable to access care by traditional means to
seek it out by participating in risky research. And even if one assumes that
researchers display honesty beyond reproach, it is still unreasonable to expect
that they would be able to keep their cool in the midst of widespread panic and
social collapse. But there is a fly in the ointment, at least when it comes to
crises caused by epidemics. Public health organizations are first-responders at
these moments, but they would be dead in the water without relevant data
collected under real-world conditions to guide their actions. In this
situation, the precautionary principle alone is not enough to stop a study
altogether. In fact, it could be argued that an absolute prohibition against
biomedical research in such situations may itself be unethical. The question
then becomes, not whether, but how to guarantee ethical research during
outbreaks?
The Ethics Review Board (ERB) of
Médecins Sans Frontières (MSF) had to contend with this question during the
2014 Ebola epidemic. They recently chronicled their
experience in the April issue
of Public Health Ethics. Beyond the herculean task of evaluating 27 research
proposals in the space 12 months—40% of which required review by the entire
board—, they had to take into account the extremely vulnerable environment in
which investigators intended to operate.
They noted critical ethical
shortcomings in many of the studies they reviewed. Perhaps the most significant
was the failure of many researchers to engage substantively with local ethical
review committees. As a result, several studies did not develop adequate
protocols to deal with the collection and storage of blood samples. This was
particularly troubling in light of the importance many local
communities attach to human blood. While the MSF ERB is to be commended for its remarkable
performance under considerable pressure, the authors’ account suggests areas
for improvement. The article does not mention whether the MSF ERB considered
that the studies under review could implicitly coerce participation in exchange
for care. This is a tricky ethical dilemma to work through. Normal medical
systems were entirely overwhelmed in West Africa; many in need of treatment had
no other recourse to access care. Those who had contracted the virus might feel
that involvement in research—even if it was risky or poorly understood—was
their only option. Can participants grant true informed consent under such
pressure? However, there is a counter argument to consider. These studies could
offer some semblance of medical services, perhaps even life-saving ones, in
places where there previously were none. Is it really ethical to deny this
opportunity simply because a study fell short of perfection? Is no choice
better than a forced choice? These questions
have no easy answers, but they certainly are ones that ERBs should grapple
with. In the words of the authors, “ethics corner-cutting is neither justified nor necessary even in an
emergency.” Public health research during times of crisis or disruption may be
a necessity. However, this is no excuse for slipshod consideration of ethical
consequences, whether by researchers or review boards alike.
Gaelen Snell
Labels: Doctors without Borders, Ebola, ethics, Research ethics
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