title: Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership?
abstract: Despite their universal character, the ethical principles governing clinical research need to be translated into procedures and practices, which will vary among countries and regions because of differences in local cultural norms and in the available resources. Double ethical review, by which a research protocol is submitted for ethical clearance both in the country or countries where the research takes place and in the country of the sponsor or funding agency, will then help ensure that all relevant perspectives are taken into account. In addition, a geographically and culturally close ethics committee can do a much better informed and comprehensive assessment of the respective skills of the clinical sites and of the sponsor. But the practical implementation of double ethical review can bring significant difficulties and delays, especially in multi-site and multi-country researches. Currently, most ethics committees do not proactively seek communication with others evaluating the same research protocol in different socio-economical and cultural contexts, so in practice there is no mutual learning process. Proactive communication would help to build collaborative partnership among ethical bodies, promoting common practices and resolving conflicting opinions.
authors.affiliation: Clinical Trials Unit, Institute of Tropical Medicine Prince Leopold, Antwerp, Belgium. rravinetto@itg.be
authors.forename: Raffaella
authors.initials: R
authors.lastname: Ravinetto
authors.forename: Anne
authors.initials: A
authors.lastname: Buvé
authors.forename: Tinto
authors.initials: T
authors.lastname: Halidou
authors.forename: Pascal
authors.initials: P
authors.lastname: Lutumba
authors.forename: Ambrose
authors.initials: A
authors.lastname: Talisuna
authors.forename: Mohammad
authors.initials: M
authors.lastname: Juffrie
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002986:Clinical Trials as Topic / Q000941:ethics; D003299:Cooperative Behavior; D026724:Ethical Review; D017041:Ethics Committees; D006801:Humans; D007391:International Cooperation; D026706:Paternalism / Q000941:ethics