How to ethically conduct clinical research during public health emergencies

Following the 2014-2015 Ebola outbreak in West Africa, the U.S. National Academy of Sciences, Engineering and Medicine established a committee to assess the clinical trials conducted in Guinea, Sierra Leone and Liberia. In a report entitled "Integrating Clinical Research into Epidemic Response: The Ebola Experience" the committee outlined ways to facilitate rapid, well-coordinated responses to future public health emergencies.

Carnegie Mellon University's Alex John London, a prominent bioethicist, served on the National Academies committee and has co-authored a viewpoint article in PLOS: Neglected Tropical Diseases on the ethics of clinical research during public health emergencies.

<p>&quot;The latest outbreak of Ebola in the Democratic Republic of the Congo is a tragic reminder that public health emergencies are often unpredictable, complex situations.  It is critical that stakeholders recognize the lessons that we have learned from the 2014-2015 outbreak,&quot; said London, the Clara L. West Professor of Ethics and Philosophy in the Dietrich College of Humanities and Social Sciences.</p>     <p>The paper describes the committee's key findings and conclusions, including:</p>    <ul><li>Conducting research and clinical trials during outbreaks is necessary to determine which interventions actually advance the humanitarian mission of minimizing mortality and morbidity.      </li><li>To learn how to improve care, research must be designed to generate evidence that can support reliable inferences about safety and efficacy.      </li><li>The standard of clinical equipoise, which requires the existence of genuine uncertainty or disagreement in the expert medical community about the interventions being tested in a clinical trial, is applicable to research conducted in a public health emergency and should play a key role in determining when randomization is permissible during an emergency health situation.      </li><li>Effectively communicating reliable scientific information to local communities, including uncertainty about the effectiveness and safety of investigational treatments, is an essential component of ethically responsible research.      </li><li>Communication and engagement strategies must be initiated early, ideally during interepidemic periods so that reliable, ethically acceptable research can be organized, reviewed and launched when the next outbreak strikes.      </li><li>Sustained coordinated international support for health systems in low- and middle-income countries is crucial. This will help mitigate concerns that frontline caregivers in these areas have over supplies and resources being directed towards research. </li></ul>  <p>###</p>    <p>In addition to London, Nigeria's Institute of Child Health's Olayemi O. Omotade, Stanford University's Michelle M. Mello and Boston University's Gerald T. Keusch wrote the PLOS article.</p>              <p><strong>Media Contact</strong></p>    <p>Shilo Rea<br />[email protected]<br />412-268-6094<br /> @CMUScience <h4>Related Journal Article</h4>