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)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues (...) in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method. We performed a systematic qualitative review of disaster research ethics guidelines to (...) collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases, 2) an Internet search, and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method for analysis of included guidelines. Fourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified. Some concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines. (shrink)

Médecins Sans Frontières is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper.

Biomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed.