PT - JOURNAL ARTICLE AU - L S Gittner AU - M J Roach AU - G Kikano AU - S Grey AU - N V Dawson TI - Health service research: the square peg in human subjects protection regulations AID - 10.1136/jme.2010.037226 DP - 2011 Feb 01 TA - Journal of Medical Ethics PG - 118--122 VI - 37 IP - 2 4099 - http://jme.bmj.com/content/37/2/118.short 4100 - http://jme.bmj.com/content/37/2/118.full SO - J Med Ethics2011 Feb 01; 37 AB - Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance use screening would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results.