ABSTRACT
The value of responsible conduct of research (RCR) education from an administrative perspective can be summed up in the oft-used adage, an ounce of prevention is worth a pound of cure. The National Academy of Sciences has underscored the importance of RCR education in three major reports relating public trust in research to the perception and reality of integrity within the field. Compliance and integrity cannot simply be hoped for. Rising numbers of reported cases of research misconduct support this view. This scenario calls for institutions to provide an environment where research integrity is a fundamental prerequisite. Supporting this notion is the adoption by federal oversight agencies of the compliance elements delineated in the Federal Sentencing Guidelines for Organizations as a guide for determining whether an institution promotes a culture of integrity. RCR education is most valuable to the administrator in raising the awareness of researchers regarding compliance and integrity issues and thereby reducing the risk of infraction. In turn, the overall level of confidence among users and supporters may be improved also. Therefore, RCR education has become a primary operational arm of administration in the quest for institutional stability.
Subject(s)
Academic Medical Centers/standards , Biomedical Research/education , Biomedical Research/ethics , Ethics, Research/education , Scientific Misconduct/trends , Academic Medical Centers/ethics , Ethics Committees, Research , Ethics, Professional , Guideline Adherence , Humans , National Institutes of Health (U.S.) , Public Policy , Research Personnel/education , Research Personnel/ethics , United States , United States Office of Research IntegrityABSTRACT
THIS IS A CASE STUDY based on the author's experience while serving as an ethics committee (IRB) chair in New York City. It addresses the issues of power and coercion as they apply to the human research participants protection process. It primarily focuses on the power imbalance that can exist between research participants and their IRB advocates on the one hand and the research institutions, funding agencies, and investigators with their unlimited resources on the other. IRB Chairs and IRB leaders must be fire-walled from conflicts of interest arising not just from financial factors but from factors related to power, hierarchy, structure, and control. Senior staff, IRB members, administrators and ethicists best advocate for human volunteers in research through personal identification and solidarity.
