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Variability in institutional review board assessment of minimal-risk research
Jon Mark Hirshon1, Scott D Krugman, Michael D Witting
1Division of Emergency Medicine, School of Medicine, The Charles McC. Mathias, Jr., National Study Center for Trauma and EMS, University of Baltimore, 701 West Pratt Street, Room 548, Baltimore, MD 21201, USA. jhirs001@umaryland.edu
Objectives:
To examine variability in responses from institutional review boards (IRBs) to submission of a proposed minimal-risk survey.
Methods:
Identical research proposals to obtain information concerning beliefs about the needs of victims of intimate partner violence via surveys were submitted for IRB approval to three institutions in the Baltimore metropolitan area. One institution is an academic center, one is an inner-city hospital affiliated with the academic center, and the third is a suburban community hospital. The study population consisted of emergency department health care providers and individuals in emergency department waiting areas.
Results:
Inconsistencies emerged among the three IRBs in the review process itself, the need for participant consent, and the need for revision of the consent form and study protocol. One institution approved the proposal in 15 business days after expedited review. The second institution approved the proposal in 12 business days and waived the requirement for informed consent. The third institution approved the research in 77 business days after three revisions. Questions raised included: methodology for selecting participants; appropriateness of surveying individuals in emergency department waiting areas; a request for background literature to assure that the research questions had not already been answered; and concerns about study methodology and sample size justification.
Conclusions:
In this sample, there is considerable variability in IRB processes even for minimal-risk studies.