Research Ethics Review: Identifying Public Policy and Program Gaps

Efforts to build research ethics capacity have mostly concentrated on strengthening the research ethics committee (REC), which is viewed as the primary vehicle for protecting human research subjects. To this end, the Advanced Certificate Program in Research Ethics for Central and Eastern Europe, like other Fogarty International Center (FIC) programs, trains its fellows to be research ethicists capable of serving on RECs. The Advanced Certificate Program also emphasizes public policymaking and in particular the identification of gaps in the policies establishing research ethics systems that impede RECs from doing their job of protecting human research subjects. In this paper we present a framework from the public policy and public management literature for identifying these gaps based on an understanding of the public policymaking process and how research ethics policy is formulated, implemented, and managed. Identifying such gaps is a necessary first step in repairing them. Attention in the program curriculum to the public policymaking process and the identification of policy gaps is intended not only to guide those fellows who conduct analyses of their research ethics review systems but to increase the awareness of those who go on to serve on RECs, oversight and regulatory agencies, and on advocacy, educational, and professional bodies dedicated to human subjects protection. The aim is to facilitate change at the institutional, national, and even international level. Research ethics review for the protection of human subjects must be understood in relation to the larger context in which it is embedded. In this regard Hyder et al. (2009) conceptualize research ethics review as systemically linked to: (1) national and regional strategies (e.g., legal and regulatory authority for RECs, national guidelines, budget priority for research ethics, investment in training and capacity building); (2) institutional commitment (e.g., organizational structures and procedures, conformity with national and regional laws and guidance); and (3) researcher’s conduct (e.g., respect for government, institution, REC). Surrounding this system are enabling conditions including a strong civil society, public accountability, and trust in basic transactional processes, which are in turn surrounded by development conditions including political freedoms, economic facilities, social opportunities, and transparency guarantees.