Understanding barriers to North-South collaborative research: contextual issues in a case study of chlorhexidine trial by AKU & UAB
Date of Award
Master of Science in Health Policy & Management (MSc Health Policy & Mgmt)
Community Health Sciences
International Collaborative Research has a long history, which brings together the best and the brightest research minds and encourage rich and developed nations to share some of their "good fortunes" with the developing nations to tackle global heath issues. Over the last decade, the increasing global nature of biomedical collaborative research on human subjects has been the subject of intensive debate and given rise to unique and difficult ethical issues that reflect differences in history, culture, education, politics, wealth and power between developing host countries where research is conducted and developed countries that sponsor research. Current institutional arrangements to safeguard subjects in science have also a long history. In 1947, the Nuremberg Code banned forced experiments in humans, setting the basis for the Declaration of Helsinki a few years later which is considered as a landmark in research involving human subjects. The present study set out to explore and document various issues arising from the ethical review process and approval in two different settings, lead to delays to implementation of planned research and pose a barrier to increased cooperation as it happened in the case of Chlorhexidine Trial, a collaborative project between UAB & AKU. For this, a qualitative case narrative study design was selected in which direct open-ended, semi-structured interviews through separate interview guides were conducted with ERC/AKU members & AKU researchers and telephonic interviews with UAB--IRB members &UAB researchers involved in the ethical review/approval process and conduct of Chlorhexidine pilot project. A range of factors emerged from the coded textural data which were then broadly categorized after identifying key words into various themes. The important findings of the study are cultural & contextual differences and misunderstandings, who will pay for the research related side effects, litigation issues, post trial compensations, skepticism about developing country's capacity, lack of coordination between two human subjects' protection bodies, unequal relationships and prior agreements to avoid confusion, conflict and misunderstandings in collaborative research. The study has highlighted some very important ethical issues of provision for the treatment for research injuries and responsibility of researchers& sponsors to host population which the Chlorhexidine AKU-UAB team faced and has not been properly documented earlier in collaborative research in developing countries especially Pakistan. The recommendations drawn from the study are broadly divide into different portions including general recommendations related to lessons learned from the Chlorhexidine trial case study that may be useful to local & international bodies and scholars deliberating related issues, and specific recommendations for the GNRU which may help them better formulate policies for collaborative research in developing countries. These recommendations will further help in building research enabling environment in the country and will help minimize conflicts & misunderstandings and better protection of study subjects in collaborative research.
Dawar, Z. K. (2006). Understanding barriers to North-South collaborative research: contextual issues in a case study of chlorhexidine trial by AKU & UAB (Unpublished doctoral thesis). Aga Khan University, Karachi, Pakistan.