The increasingly burdensome regulation of clinical research and the unique challenges it presents to clinical investigators have gained visibility during the past several years.  Many of the Society's clinical researcher members, as well as investigators from other scientific organizations, have shared experiences about difficulties they have encountered related to inconsistent protocol review by Institutional Review Boards (IRBs) and numerous other regulatory hurdles associated with research involving human subjects.  Investigators whose research focuses on children have been especially affected by regulations that, in some cases, significantly impede the progress of their research. 

Because of the prevalence of these issues, the Society's advocacy work includes efforts to ease regulatory burdens for clinical researchers and work toward regulatory harmonization, especially with regard to IRBs.