Background Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. Objective To explore such perceptions and attitudes in Lebanese parents. Study design 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in (...) colloquial Arabic, and later subjected to thematic analysis. Results Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term ‘randomisation’ hindered parental approval of participation. Conclusion Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation. (shrink)

Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research practices, including obtaining institutional approval, access (...) to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social, when the study employed quantitative compared to qualitative or mixed methodologies, and when the journal required a statement on ethical declarations. Institutional approval was least likely to be reported in papers that were sole-authored, when these did not mention a funding source, or when published in national journals. Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings. (shrink)

This paper presents challenges facing researchers in applying basic ethical principles while conducting research with youth in a developing country context. A discussion of the cultural and social challenges to adherence to the elements of informed consent: disclosure, comprehension, capacity, voluntariness and consent is presented. The authors argue that the current institutional review board requirements that guide research reflect values and stem from western contexts that may not be fully applicable to non-western contexts. More dialogue is needed among researchers in (...) developing world contexts on challenges of and possible revisions to requirements that maintain respect for persons, beneficence, autonomy and justice, particularly when working with youth. (shrink)