Policy Platform Addressing Ethical, Social, and Cultural Issues in Global Health Research James V. Lavery 1,2 *, Shane K. Green 2,3 , Sunita V. S. Bandewar 3 , Anant Bhan 3 , Abdallah Daar 2,3 , Claudia I. Emerson 3 , Hassan Masum 3 , Filippo M. Randazzo 4 , Jerome A. Singh 2,3,5 , Ross E. G. Upshur 2,3,6 , Peter A. Singer 3 1 Ethical, Social and Cultural Program for Global Health, Centre for Research on Inner City Health and Centre for Global Health Research, Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Ontario, Canada, 2 Dalla Lana School of Public Health and Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada, 3 Ethical, Social and Cultural Program for Global Health, Sandra Rotman Centre, University Health Network & University of Toronto, Toronto, Ontario, Canada, 4 Bill & Melinda Gates Foundation, Seattle, Washington, United States of America, 5 Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Congella, Durban, South Africa, 6 Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada Introduction The past decade has seen unparalleled investment in large-scale global health science initiatives and international re- search consortia, such as the International HapMap Project, Grand Challenges in Global Health program, and International AIDS Vaccine Initiative. These initiatives have resulted in promising advances, such as candidate vaccines for malaria and HIV, nutritionally enhanced staple crops, novel vector control strategies, and an advanced understanding of human genetic diversity. They have also reflected the growing emphasis on innovation in global health and on the urgent need to test innovations in real-world settings, espe- cially resource-constrained ones, to deter- mine their potential effectiveness and value. Alongside—and necessitated by— these shifts in global health research, there has also been a broadening in the conversation about the ethical aspects of that research, from an almost singular focus on standard of care issues [1] to a more holistic consideration of a wide range of ethical, social, and cultural (ESC) influences on the conduct, success, and impact of biomedical science on underlying public health problems. This broadening, in turn, has helped to fuel a growing interest within the health research community in consultation ser- vices in research ethics (CSRE). These are teams of experts in research ethics, typically based at academic bioethics centres, that provide advice and guidance to researchers and institutions about ethical issues that arise in the design and conduct of research. Since first proposed [2], there has been some attention to the evolution of CSREs in the literature [3,4], with much of the focus on how to achieve an appropriate balance between the advi- sory/consulting role of the emerging CSREs and the review, monitoring, and oversight responsibilities of their counter- part institutional review boards (IRBs) [5]. Most recently, an article published in Science Translational Medicine from the Stan- ford University CSRE has provided im- portant insights into circumstances that the authors argue should ‘‘trigger’’ inves- tigators to seek consultations with the service [4]. Although the authors point to ‘‘research in developing nations’’ as one such trigger, there continues to be a gap in the literature about why and how CSREs might play an important role in proac- tively considering and helping to address the unique ESC challenges posed by global health research—in particular, re- search in low- and middle-income coun- tries (LMICs) that is funded and conduct- ed, in whole or in part, by organizations and investigators from high-income coun- tries—and thereby provide a valuable complement to customary institutional re- search ethics review for this type of research. The purpose of this paper is to encour- age reflection among the global health research community, including funders, researchers, research institutions, and ad- ministrators of large-scale global health research initiatives, about how ESC issues can best be addressed within these initia- tives. We draw on lessons we have learned during our experiences with the Ethical, Social and Cultural Program (ESC Pro- gram) of the Grand Challenges in Global Health (GCGH) initiative, funded by the Bill & Melinda Gates Foundation between 2005–2011 [6], to propose key features of a focused CSRE, which may prove useful for those designing or implementing sim- ilar programs. Citation: Lavery JV, Green SK, Bandewar SVS, Bhan A, Daar A, et al. (2013) Addressing Ethical, Social, and Cultural Issues in Global Health Research. PLoS Negl Trop Dis 7(8): e2227. doi:10.1371/journal.pntd.0002227 Editor: David Joseph Diemert, The George Washington University Medical Center, United States of America Published August 8, 2013 Copyright: ß 2013 Lavery et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: JVL, SKG, AB, AD, CIE, JAS, REGU, and PAS performed this work as members of and/or consultants to the Ethical, Social and Cultural (ESC) Program for Global Health, which receives funding from the Bill & Melinda Gates Foundation. FMR is an employee of the foundation. Other than FMR’s contributions as an author, the funder had no role in the preparation or revision of the manuscript, or in the decision to publish the manuscript. Competing Interests: The authors have declared that no competing interests exist. * E-mail: laveryj@smh.ca Summary The purpose of this paper is to encourage reflection among the global health research community and the research ethics community about how a wide range of ethical, social, and cultural (ESC) influences on the conduct, success, and im- pact of global health research can best be addressed by consultation services in research ethics (CSRE). We draw on lessons we have learned during our experiences with the ESC Program of the Grand Challenges in Global Health initia- tive to propose key features of CSRE that may prove useful for those designing or implementing similar programs. PLOS Neglected Tropical Diseases | www.plosntds.org 1 August 2013 | Volume 7 | Issue 8 | e2227