作者: Bridget Pratt , Deborah Zion , Khin Maung Lwin , Phaik Yeong Cheah , Francois Nosten
DOI: 10.1136/MEDETHICS-2011-100301
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摘要: Bioethicists have long debated the content of sponsors and researchers' obligations justice in international clinical research. However, there has been little empirical investigation as to whether how responsiveness, ancillary care, post-trial benefits research capacity strengthening are upheld low- middle-income country settings. In this paper, authors argue that ethics guidelines need be more informed by practice. Practical guidance on fulfil these is needed if groups other actors successfully translate them into practice because doing so often a complicated, context-specific process. Case study methods offer one avenue for collecting data develop guidance. The describe such used relation Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying VHX example, paper shows information can gathered from not only researchers but also participants, community advisory board members funder representatives order to: (1) measure evidence provision access research; (2) identify contextual factors roles responsibilities were instrumental fulfilment ethical obligations. Such work necessary inform articulation facilitate better adherence guidelines' requirements.