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Health service research: the square peg in human subjects protection regulations
  1. L S Gittner1,
  2. M J Roach2,
  3. G Kikano3,
  4. S Grey4,
  5. N V Dawson2
  1. 1Case Western Reserve University, School of Nursing, Cleveland, OH, USA
  2. 2MetroHealth Medical Center, Case Western Reserve University, School of Medicine, Cleveland, OH, USA
  3. 3Case Western Reserve University, School of Medicine, Cleveland, OH, USA
  4. 4Kent State University, USA
  1. Correspondence to Dr Lisaann S Gittner, Case Western Reserve University, School of Nursing, 19000 Euclid Ave, Cleveland, OH, 44106, USA; lsg7{at}


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.

  • Scientific research
  • policy guidelines/Inst. Review Boards/Review Cttes

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  • Funding Robert Wood Johnson Foundation, Princeton, NJ, USA.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the MetroHealth Medical Center and Kaiser Permanente IRBs Cleveland, Ohio, USA.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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