Federal regulations in the United States have shaped Institutional Review Boards to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on (...) individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public. (shrink)