The pressure is building on Institutional Review Boards. Those venerable groups are charged with protecting patients in clinical trials, largely by providing ethical oversight and making sure informed consent guidelines are followed. However, the expanding size, complexity, and public visibility of clinical trials have strained Institutional Review Boards (IRBs), and are leading to a reevaluation of their role and function.
In particular, IRBs are being plagued with "mission creep"-an increase in duties and responsibilities without an increase in funds, or an acknowledgment of the additional burdens on board members.
"The mission creep is coming from external sources. It's not like the IRB is saying, 'we want to do everything.' They are feeling the pressure from the outside," says Wendy Baldwin, executive vice president for research at the University of Kentucky. The "outside" includes other staff members at their institutions, external regulators, the media, and the public.
"We've blurred the boundary, ...
