Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial.
OBJECTIVE
The primary responsibility of institutional review boards is to protect human research subjects and, therefore, ensure that studies are performed in accordance with a standard set of ethical principles. A number of groups have compared the responses of institutional review boards in multicenter clinical trials involving medical therapies. To our knowledge no such studies have been performed to date of trials investigating surgical intervention. We investigated the consistency of the recommendations issued by various institutional review boards in the Minimally Invasive Surgical Therapies study for benign prostatic hyperplasia, a multicenter trial with a uniform consent and study protocol.


METHODS
We obtained the institutional review board response from 6 of the 7 participating institutions after initial submission of the Minimally Invasive Surgical Therapies study protocol and classified the responses. We then redistributed the approved protocols to an institutional review board at another participating institution and analyzed that review of these protocols.


RESULTS
We found that the number and type of responses required for institutional review board approval of an identical study protocol varied significantly among participating institutions. We also found that institutional review board responses were inconsistent in the second review, although all protocols were ultimately approved.


CONCLUSIONS
The current system of local institutional review board review in the context of a multicenter surgical trial is inefficient in the review process and may not provide expertise for overseeing surgical trials. Based on these results a central surgical institutional review board may be needed to improve the ethical review process in multicenter trials.
Helfand
Brian T
BT
Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois 60611, USA.
Mongiu
Anne K
AK
Roehrborn
Claus G
CG
Donnell
Robert F
RF
Bruskewitz
Reginald
R
Kaplan
Steven A
SA
Kusek
John W
JW
Coombs
Laura
L
McVary
Kevin T
KT
D002985:Clinical Protocols / Q000592:standards*; D028744:Ethics Committees, Research / Q000592:standards*; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000592:standards*; D015337:Multicenter Studies as Topic / Q000592:standards*; D011470:Prostatic Hyperplasia / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*