TY - JOUR
T1 - Closing the translation gap for justice requirements in international research
AU - Pratt, Bridget
AU - Zion, Deborah
AU - Lwin, Khin Maung
AU - Cheah, Phaik Yeong
AU - Nosten, Francois
AU - Loff, Beatrice
PY - 2012
Y1 - 2012
N2 - 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.
AB - 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.
UR - http://jme.bmj.com/content/38/9/552.full.pdf+html
U2 - 10.1136/medethics-2011-100301
DO - 10.1136/medethics-2011-100301
M3 - Article
VL - 38
SP - 552
EP - 558
JO - Journal of Medical Ethics
JF - Journal of Medical Ethics
SN - 0306-6800
IS - 9
ER -