title: Innovations in research ethics governance in humanitarian settings.
abstract: BACKGROUND
  Médecins Sans Frontières (MSF) 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 (ERB) 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.
  
  
  CONCLUSIONS
  We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced.
  
  
  CONCLUSIONS
  We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.
authors.affiliation: Medical Faculty, University of Geneva, Geneva, Switzerland. Doris.Schopper@unige.ch.|Centre for Education and Research in Humanitarian Action (CERAH), Geneva, Switzerland. Doris.Schopper@unige.ch.
authors.forename: Doris
authors.initials: D
authors.lastname: Schopper
authors.affiliation: Centre for Biomedical Ethics, School of Health and Population Sciences, University of Birmingham, Birmingham, UK. a.j.dawson@bham.ac.uk.
authors.forename: Angus
authors.initials: A
authors.lastname: Dawson
authors.affiliation: Department of Family and Community Medicine, University of Toronto, Toronto, Canada. ross.upshur@gmail.com.
authors.forename: Ross
authors.initials: R
authors.lastname: Upshur
authors.affiliation: The Kidney Centre, Karachi, Pakistan. aasimahmad@gmail.com.|Aga Khan University, Karachi, Pakistan. aasimahmad@gmail.com.
authors.forename: Aasim
authors.initials: A
authors.lastname: Ahmad
authors.affiliation: Anusandhan Trust, Mumbai, India. amar.jesani@gmail.com.
authors.forename: Amar
authors.initials: A
authors.lastname: Jesani
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium. rravinetto@itg.be.|Department of Pharmaceutical and Pharmacological Sciences, Leuven, KU, Belgium. rravinetto@itg.be.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Ravinetto
authors.affiliation: Centre for Human Bioethics, Monash University, Clayton, Australia. michael.selgelid@monash.edu.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Segelid
authors.affiliation: Independent researcher in global health and bioethics, Pune, India. sunita.bandewar@utoronto.ca.
authors.forename: Sunita
authors.initials: S
authors.lastname: Sheel
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa. singhj9@ukzn.ac.za.
authors.forename: Jerome
authors.initials: J
authors.lastname: Singh
mesh_terms: D000533:Altruism; D003906:Developing Countries; D026724:Ethical Review; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007391:International Cooperation; D009938:Organizations; D010820:Physicians; D057766:Policy; D012106:Research