International research ethics education.

Abstract

Nearly 20 years ago, a series of trials evaluating short-course zidovudine for the prevention of mother-to-child transmission of human immunodeficiency virus (HIV) provoked global controversy when the sponsors were accused of ethical double standards—conducting research on vulnerable developing country populations that would not be permitted in high-income countries.1 Following this controversy, and responding to underrepresentation of developing countries in these debates, the Fogarty International Center at the National Institutes of Health (NIH) launched a grants program to support masters-level, socioculturally relevant training in research ethics in low- and middle-income countries (LMICs). Since the program began, the volume of research in LMICs and the funds devoted to global health have expanded substantially.2,3 The majority of the research is still sponsored by institutions based in high-income countries, including pharmaceutical companies, governmental agencies like NIH, and private foundations. Some of the increase in LMIC-based research results from greater funding for diseases that affect people in these countries; some is a result of private companies seeking lower costs and patients naive to treatment.2,4 New challenges have emerged, as LMICs increasingly must address the dual burden of communicable and noncommunicable diseases. New technologies, including wide-spread access to mobile phones and the decreasing cost of genomic analysis, have expanded the scope of research. Ethical controversies continue to arise, tarnishing the reputation of global health research and, in some countries, halting research altogether. In the face of these changes, grantees, program staff, and outside experts conducted a collaborative self-assessment of the Fogarty International Center program 12 years after its inception. Fourteen articles present this extensive evaluation.5,6 The authors examine the state of research ethics in LMICs, summarize the lessons learned, identify future needs, and attempt to chart a way forward to address them. Despite significant progress, the mission of building research ethics capacity in LMICs is not finished. However, the landscape of research and research ethics is substantially different than in 2000. New approaches are needed to build on what has been achieved and respond to new challenges.