Collaborative International Research: An Example of Partnership for Genetic Studies of Orofacial Clefts

International collaboration faces ethical challenges in the design, approval and conduct of research. Some of these challenges include differences in research ethics capacity, cultural differences in interpretation and application of ethical principles, and cooperation between ethics review boards at collaborating institutions. In partnership with the University of Southern California (USC) and the Children’s Hospital Los Angeles, Operation Smile, Inc. is investigating genetic and environmental factors in the etiology of clefts through the collection of self-reported questionnaire data and saliva samples during Operation Smile surgical missions and at local maternity wards in 4 countries: Democratic Republic of Congo (DRC), Vietnam, Honduras and the Philippines. In order to uphold the highest ethical standards when conducting research, the partners have established a multi-country Institution Review Board (IRB) protocol. The research proposal, questionnaires, information sheet and informed consent are translated into local languages and then reviewed by in-country institutions, including government entities and nonprofit organizations, and partnering hospitals. Research experience and methodology including developing focus groups to facilitate discussion at each institution to increase understanding and respect for the other's culture are outlined. Final ethical approval is obtained by USC’s IRB, which oversees the international study. Overall we found that the participants at each location agreed on the major principles and issues in research ethics and on the importance attributed to them; however, practical issues with the conduct of research need to be continually addressed.