Research ethics capacity provides the bedrock that makes clinical research possible, yet many low- and middle-income countries (LMICs) lack the necessary expertise. Fogarty grantees have published a series of papers detailing the lessons learned over the past 12 years from participants in the Center's research ethics education program. The collection of papers, Ethics of Clinical Research: Multinational Research and Capacity Building, was published in the December 2013 and April 2014 issues of the Journal of Empirical Research on Human Research Ethics.
Grantees supported by Fogarty's International Research Ethics Education and Curriculum Development Award authored articles covering a wide range of bioethics topics, including mentorship, online courses and distance learning, building capacity and analysis of trainee scholarship. The collection also features five papers analyzing progress made in regions covering sub-Saharan Africa, Asia, Central and Eastern Europe, Latin America and the Middle East.
The series includes an introductory paper that summarizes key conclusions from the grantee publications and describes the history of the Fogarty bioethics program. Using an historic timeline, the introduction article also illustrates the state of international research ethics before 2000, as well as the evolution of research ethics in LMICs. The overview was co-authored by NIH bioethicist Dr. Joseph Millum, Dr. Christine Grady, chief of the Department of Bioethics at NIH's Clinical Center, former Fogarty Director Dr. Gerald Keusch and Fogarty's bioethics program officer, Dr. Barbara Sina. Sina and Millum also edited the collection.
"These papers, which come at a critical time for the global health community, highlight some of the key features and findings of the Fogarty bioethics program," said Fogarty Director Dr. Roger I. Glass, in an editorial accompanying the series. "More importantly, they will provide clear directions to advance research ethics education for the future as the global health landscape continues to evolve and new ethical issues emerge."
Development of Fogarty's bioethics program began in 1999, in the wake of a debate over perinatal HIV transmission prevention trials and a growing awareness that insufficient attention was being paid to voices from LMICs regarding clinical research and related ethical practices that directly affected their populations. Launched in 2000, the initiative is designed to develop master's level curricula and provide educational opportunities in ethics related to clinical research involving human subjects for developing country researchers and health professionals in resource-limited settings.