Publications of the Research Compliance Services Staff

Making Research Trustworthy for Native Americans

Daniel R. Vasgird — Wed, 13 Feb 2008 11:52:27 PST

Goal: To learn what research approaches are considered respectful and trustworthy by Native American populations.
Ethical and scientific justification: The Federal Regulations of human research and other ethical guidelines did not prepare us for what we have learned, by trial and error, about conducting research on Native American populations. If research with these populations is to be conducted validly and respectfully, the ground rules need to be learned inductively, and ideally shared with other investigators.

Prevention over Cure: The Administrative Rationale for Education in the Responsible Conduct of Research

Daniel R. Vasgird — Wed, 13 Feb 2008 11:49:18 PST

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.

Resisting Power and Influence: A Case Study in Virtue Ethics

Daniel R. Vasgird — Tue, 05 Feb 2008 14:00:24 PST

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.