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Keywords:

  • Institutional Review Boards;
  • health services research;
  • privacy rule

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.