title: Variations among Institutional Review Board reviews in a multisite health services research study.
abstract: OBJECTIVE
  To document the Institutional Review Board (IRB) review process and to explore the impact of different patient notification procedures.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  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.
  
  
  RESULTS
  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.
authors.affiliation: Research and Analysis, National Committee for Quality Assurance, Washington, DC 20036, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Dziak
authors.forename: Roger
authors.initials: R
authors.lastname: Anderson
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Sevick
authors.forename: Carol S
authors.initials: CS
authors.lastname: Weisman
authors.forename: Douglas W
authors.initials: DW
authors.lastname: Levine
authors.forename: Sarah Hudson
authors.initials: SH
authors.lastname: Scholle
mesh_terms: D000328:Adult; D003219:Confidentiality / Q000941:ethics*; D028744:Ethics Committees, Research; D005260:Female; D006302:Health Services Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics*; D011446:Prospective Studies; D045808:Refusal to Participate; D014481:United States