RT Journal Article
SR Electronic
T1 Health service research: the square peg in human subjects protection regulations
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 118
OP 122
DO 10.1136/jme.2010.037226
VO 37
IS 2
A1 L S Gittner
A1 M J Roach
A1 G Kikano
A1 S Grey
A1 N V Dawson
YR 2011
UL http://jme.bmj.com/content/37/2/118.abstract
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.