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Variations among Institutional Review Board Reviews in a Multisite Health Services Research Study


  • Kathleen Dziak,

  • Roger Anderson,

  • Mary Ann Sevick,

  • Carol S. Weisman,

  • Douglas W. Levine,

  • Sarah Hudson Scholle

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    • Address correspondence to Sarah Hudson Scholle, M.P.H., Dr. P.H., Assistant Vice President, Research and Analysis, National Committee for Quality Assurance (NCQA), 2000 L Street NW, Suite 500, Washington, DC 20036. Dr. Scholle is also with the Schools of Medicine and public Health, University of Pittsburgh. Kathleen Dziak, B.A., and Roger Anderson, Ph.D., are with Public Health Science, Wake Forest University School of Medicine. Mary Ann Sevick, Sc.D., R.N. is with the University of Pittsburgh School of Nursing and the Center for Health Equity Research and Promotion, VA Pittsburgh Health Care System. Carol S. Weisman, Ph.D., is with Penn State Collage of Medicine. Douglas W. Levine, Ph.D., is with PFRC, University of South Carolina.

  • This work was supported by the Office on Women's Health, Department of Health and Human Services.


Objective. To document the Institutional Review Board (IRB) review process and to explore the impact of different patient notification procedures.

Data Sources/Study Setting. Review of IRB application and correspondence records prospectively collected during a multisite study of health care quality involving telephone interviews of 3,000 participants across 15 primary care sites.

Study Design. Records were reviewed to ascertain: (1) the type of IRB review conducted, (2) the number of days from submission to approval of the IRB application, (3) whether the IRB required patient notification and/or consent prior to the release of names, and (4) patient participation rates.

Data Collection/Extraction Methods. The study coordinating center prepared a common study protocol for IRB submission and assisted sites with submission. The application, correspondence with the IRB, consent script, and patient letters were collected, reviewed, coded, and analyzed.

Principal Findings. IRBs at the 15 sites and survey center varied in the type of IRB required and the number of days from submission to approval (range of 5–172 days). Four sites required patient notification in advance of the study; 2–11 percent of patients refused in opt-out sites and 37 percent in the single opt-in site. Participation among contacted patients did not appear to be related to patient notification procedures.

Conclusions. Variations in IRB requirements can affect response rates and sample generalizability.