Ethics and Epidemics: Are lessons ever learned? Global Forum on Bioethics in Research Fondation Merieux Annecy, November Ross E.G. Upshur, BA (Hons.), MA, MD, MSc, CCFP, FRCPC Head, Division of Clinical Public Health, Dalla Lana School of Public Health Director, Bridgepoint Collaboratory for Research and Innovation Professor, Department of Family and Community Medicine and DLSPH University of Toronto

3 Plague of Athens Thucydides Neither were the physicians at first of any service, ignorant as they were of the proper way to treat it, but they died themselves the most thickly, as they visited the sick most often; nor did any human art succeed any better. Supplications in the temples, divinations, and so forth were found equally futile, till the overwhelming nature of the disaster at last put a stop to them altogether.

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Ebola

Lessons Learned?

Lessons Learned Comprehensive search of documents regarding EVD outbreak Only one of the documents explicitly identified an ethical issue None of the documents framed any lesson as having an explicit ethical nature, or affirmed that lessons learned are based on normative considerations.

Learning from Ebola 1 Standard research ethics norms/guidance apply, emergency situation does not require them being abandoned However it does require reflection and adaptation to the context. More attention to knowledge translation

Learning from Ebola 2 Ethics review process did not result in undue delay WHO decision to fast track research Aug 11 th 2014 First patient enrolled Dec 27 th Huge surge in protocols, severe time constraints, strain on local capacity Need for creative solutions and investment in capacity building

Key Ethical Issues Monitored Emergency Use vs Compassionate Use Appropriate Study Methodology in Outbreaks Harmonization of Multiple Reviews Biological Samples, Biobanks and Consent Inclusion of pregnant women and children in clinical trials Companion anthropological studies

Key Concepts Community Engagement Trust Reciprocity Solidarity Equity

Critical Questions What is the purpose of engaging in research during a Public Health Emergency? What questions are being answered? How are differing institutional and organizational missions best navigated in the context of research?

FDA Mission FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

NIH Mission NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

MSF Charter Médecins Sans Frontières provides assistance to populations in distress, to victims of natural or man-made disasters and to victims of armed conflict. They do so irrespective of race, religion, creed or political convictions.

Sergei Korsakoff Those who do not remember the past are condemned to repeat it.

Jonathan Lear Radical Hope In the face of a cultural challenge…there is ever more pressure to explain things in the traditional ways, yet there is an inchoate sense that the old ways of explaining are leaving things unsaid. And yet one does not yet have the concepts with which to say it.