Introduction: The Fogarty International Research Ethics Education and Curriculum Development Program in Historical Context

Abstract

In response to the increasing need for research ethics expertise in low- and middle-income countries (LMICs), the NIH’s Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection.

The features and qualities of online training modules in research ethics: a case study evaluating their institutional application for the University of Botswana

“…These researchers recommended that UB "should consider developing research ethics courses at graduate level and mandatory training for researchers to help build confidence and capacity outside the IRB in identifying and addressing ethical issues" (Ralefala et al, 2016, p. 11). This finding can be generalized to other academic institutions in LMICs who are facing similar challenges (Kass et al, 2016;Loue, 2014;Matar et al, 2014;Millum et al, 2013: Mzayek & Resnik, 2010.…”

“…Opportunities for research ethics training for individuals in low-and middle-income countries (LMICs) has increased over the last two decades (Hyder, Harrison, Kass, & Maman, 2007;Hyder et al, 2013;Kass et al, 2007;Ndebele et al, 2014;Silverman, Strosberg, Luna, Philpott, & Hemmerle, 2013). This growth has come about, in part, as a response to demand for greater attention to the needs and concerns of human subjects and research populations participating in behavioral and clinical research in LMICs (Millum, Grady, Keusch, & Sina, 2013). With the growing necessity to build research ethics capacity, Fogarty International Center (FIC) launched the International Bioethics Education and Career Award in 2000 to provide grants for health professionals and academics from these countries to undergo research ethics training (Hyder et al, 2007;Millum, Sina, & Glass, 2015).…”

“…Consistent with this progress, institutions of higher learning in sub-Saharan region seem to be requiring increased training capacity for researchers (Ajuwon & Kass, 2008;Ateudjieu et al, 2010;Coetzee, Hoffmann, & de Roubaix, 2015;Hyder et al, 2013;Millum et al, 2013). Recent studies conducted in Botswana, however, show that limited research ethics training is available for UB academic staff, Institutional Review Board (IRB) members and students (Barchi, Kasimatis-Singleton, Kasule, Khulumani, & Merz, 2013;Barchi, Matlagela, Jones, Kebaabetswe, & Merz, 2015;Hyder et al, 2013;Ndebele et al, 2014;Ralefala, Ali, Kass, & Hyder, 2016).…”

Enhanced REC collaborative review through videoconferencing

“…Over the past 26 years, the Fogarty International Center, part of the US National Institutes of Health, has supported research ethics capacity throughout the world and especially in Africa; this has significantly broadened the literature related in the field. [12][13][14] Some of the ethical areas that are generally not well developed include appropriate management of vulnerable populations, the powerful manifestations of conflict of interest, confusion regarding standards of care, and the role and responsibilities of the investigator. [15] Beyond these areas, there is evidence that many African RECs have inadequate financial support and find it difficult, given the economic realities in their countries, to insist on more funding for committee education and administrative support.…”

Exploring Institutional Research Ethics Systems: A Case Study From Uganda

“…To address this need, several initiatives have funded or implemented programs to train LMIC professionals in research ethics and on how to apply research ethics principles on a local level, including the African Malaria Network Trust (Nyika et al 2009), the International Bioethics Education and Career Development Award of the National Institutes of Health’s Fogarty International Center (Millum et al 2013), the Strategic Initiative for Developing Capacity in Ethical Review (2003), the European and Developing Country Clinical Trials Partnership (2009), and the Society and Ethics funding programs of the Wellcome Trust (2014).…”