Saturday, August 19, 2017

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 

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