Variations among Institutional Review Board reviews in a multisite health services research study.
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.
Dziak
Kathleen
K
Research and Analysis, National Committee for Quality Assurance, Washington, DC 20036, USA.
Anderson
Roger
R
Sevick
Mary Ann
MA
Weisman
Carol S
CS
Levine
Douglas W
DW
Scholle
Sarah Hudson
SH
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