Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership? [viewpoint]

R Ravinetto, A Buvé, T Halidou, P Lutumba, A Talisuna, M Juffrie, U D'Alessandro, M Boelaert

    Research output: Contribution to journalA1: Web of Science-article

    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.
    Original languageEnglish
    JournalTropical Medicine and International Health
    Volume16
    Issue number4
    Pages (from-to)527-530
    ISSN1360-2276
    DOIs
    Publication statusPublished - 2011

    Keywords

    • B780-tropical-medicine
    • Research
    • Clinical trials
    • Ethics
    • Review of the literature
    • Procedures
    • Protocols
    • Practices
    • Culture
    • Socioeconomic factors
    • Informed consent
    • Assessment
    • International collaboration
    • Implementation
    • Barriers
    • Communication
    • Global

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