Health service research: The square peg in human subjects protection regulations

L. S. Gittner*, M. J. Roach, G. Kikano, S. Grey, N. V. Dawson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


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.

Original languageEnglish
Pages (from-to)118-122
Number of pages5
JournalJournal of Medical Ethics
Issue number2
StatePublished - Feb 2011
Externally publishedYes


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