The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about (...) therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: the specification of exceptional circumstances, the specification of unproven interventions, the goals of interventional research in terms of individual versus collective interests, the place of adaptive trial designs and the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. (shrink)

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about (...) therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: the specification of exceptional circumstances, the specification of unproven interventions, the goals of interventional research in terms of individual versus collective interests, the place of adaptive trial designs and the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. (shrink)

Institute for Biomedical Ethics, Geneva University Medical School * Corresponding author: Médecins Sans Frontières (OCG), rue de Lausanne 78, CH-1211 Geneva 21, Switzerland. Tel.: +41 (0)22 849 89 29; Fax: +41 (0)22 849 84 88; Email: philippe_calain{at}hotmail.com ' + u + '@' + d + ' '//--> Abstract Outbreaks of filovirus (Ebola and Marburg) hemorrhagic fevers in Africa are typically the theater of rescue activities involving international experts and agencies tasked with reinforcing national authorities in clinical management, biological diagnosis, sanitation, (...) public health surveillance and coordination. These outbreaks can be seen as a paradigm for ethical issues posed by epidemic emergencies, through the convergence of such themes as: isolation and quarantine, privacy and confidentiality and the interpretation of ethical norms across different ethnocultural settings. With an emphasis on the boundaries between public health investigations and research, this article reviews specific challenges, past practices and current normative documents relevant to the application of ethical standards in the course of outbreaks of filovirus hemorrhagic fevers. Aside from commonly identified issues of informed consent and institutional review processes, we argue for more clarity over the specification of which communities are expected to share benefits, and we advocate for the use of collective definitions of duty to care and standard of care. We propose new elaborations around existing normative instruments, and we suggest some pathways toward more comprehensive approaches to the ethics of research in outbreak situations. CiteULike Connotea Del.icio.us What's this? (shrink)

New mechanisms to ensure that counter ter ror ism ac t ivit ies do not contravene international law or ethical values and principles will require careful design. Apart from the ethical and legal grounds, there are good practical rea-sons to design more effective counterter-rorism measures. Preventable harms to population health contribute to mistrust and instability and undermine the stated objectives of the intelligence services.

For medical humanitarian organizations, making their sources of legitimacy explicit is a useful exercise, in response to: misperceptions, concerns over the ‘humanitarian space’, controversies about specific humanitarian actions, challenges about resources allocation and moral suffering among humanitarian workers. This is also a difficult exercise, where normative criteria such as international law or humanitarian principles are often misrepresented as primary sources of legitimacy. This essay first argues for a morally principled definition of humanitarian medicine, based on the selfless intention of individual (...) humanitarian actors. Taking Médecins Sans Frontières (MSF) as a case in point, a common source of moral legitimacy for medical humanitarian organizations is their cosmopolitan appeal to distributive justice and collective responsibility. More informally, their legitimacy is grounded in the rightfulness of specific actions and choices. This implies a constant commitment to publicity and accountability. Legitimacy is also generated by tangible support from the public to individual organizations, by commitments to professional integrity, and by academic alliances to support evidence-based practice and operational research. (shrink)

Chiara Lepora and Robert Goodin invite us to join their insightful ‘conversation’ on complicity and compromise. Their book makes a dense, utterly precise and rewarding reading, as one proceeds stepwise through the logic of their philosophical arguments. For those unfamiliar with the relatively new discipline of ‘humanitarian ethics’, it might be disconcerting at first to see humanitarian actions brought to illustrate theories on complicity, with the Rwandan refugees crisis of 1994 and the tortured patient taken as two exemplary cases. Actually, (...) this connects with an increasing body of research and reflexions, showing that humanitarian workers face frequent ethical challenges, some of them amounting to a distressful sense of complicity. Lepora and Goodin carefully elaborate on definitions, arguing that complicity stricto sensu implies both causality with morally wrong actions and knowledge thereof. Nothing else. Perhaps controversially but in any case convincingly, in their strict definition of complicity they leave out of account a ‘shared …. (shrink)

After 4 years of relief activities, it is difficult to keep managing the lead poisoning epidemic in northern Nigeria as an emergency situation, while it appears clearly to be a more complex, widespread and chronic public health issue than anticipated. Making the continuing treatment of children conditional upon commitments from impacted families to adhere to safe mining practices is unlikely to bring about any long-term benefit. This is because such commitment is ultimately not in the hands of the victims or (...) their families. Demands for better collaboration from the affected communities should take into account local power imbalances and broader networks of human exploitation, which are the ultimate causes of the outbreak. (shrink)