Closing the translation gap for justice requirements in international research
- Bridget Pratt1,
- Deborah Zion2,
- Khin Maung Lwin3,
- Phaik Yeong Cheah3,4,5,
- Francois Nosten3,4,5,
- Bebe Loff1
- 1Michael Kirby Centre for Public Health and Human Rights, Dept. of Epidemiology and Preventive Medicine, Monash University, Melbourne Australia
- 2International Public Health Unit, Dept. of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia
- 3Shoklo Malaria Research Unit, Mae Sot, Thailand
- 4Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
- 5Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, United Kingdom
- Correspondence to Bridget Pratt, Dept. of Epidemiology and Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia;
Contributors All authors participated in the design and completion of the study and writing of the paper. BP wrote the first draft of the paper and the co-authors contributed to the development of the final version.
- Received 18 October 2011
- Revised 11 January 2012
- Accepted 17 February 2012
- Published Online First 16 March 2012
Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed if research groups and other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements.
- Research on special populations
- distributive justice
- research ethics
- philosophical ethics
- public health ethics
- HIV infection and AIDS
- informed consent
- behaviour modification
- clinical ethics
- ethics committees/consultation
Linked article YES.
Competing interests None.
Ethics approval Mahidol University Faculty of Tropical Medicine Ethics Committee; Oxford Tropical Research Ethics Committee (Oxtrec); Monash University Human Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode