Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to best oversee research to protect these participants from harm.
For over 15 years, many institutions have been developing research compliance programs that monitor misconduct and conflict of interest (COI), and may interact with IRBs. In 2002, the Institute of Medicine (IOM) report, “Responsible Research: A Systems Approach to Protecting Research Participants,” called for increased assessment of the overall human research protections system, and oversight of research.