irb approval: needed but insufficient
TRANSCRIPT
Neurourology and Urodynamics 24:151 (2005)
SOUNDINGBOARD
IRB Approval: Needed but Insu⁄cient
Increased awareness of proper conduct in clinical studieshas encouraged the majority of investigators to obtainapproval from their Institutional Research Boards (IRB) priorto conducting any study (retrospective or prospective obser-vational; surveys, or interventional studies). Increasingly, theyalso mention this approval in the presentation of their work atnational and international meetings.
Nonetheless, confusion may exist on the part of junior phy-sicians or co-investigators of some of these studies. They maybe unaware that IRB approval is not a replacement for all theelements of a properly designed clinical study, including thenecessity of having an adequately powered study with a su⁄-cient sample size. IRBs generally tend to be concerned withissues related to the safety of patients and, thus, do not scruti-nize factors related to the ‘‘power’’of the study.
As a result, in many clinical studies presented at nationaland international meetings, investigators fail to mention thatboth the reported results and their subsequent conclusions arebased on a sample size designed for a ‘‘pilot’’ or ‘‘feasibility’’study. It is, therefore, inaccurate to conclude the same ‘‘e¡ect-size’’ as might be seen in a properly powered and conductedstudy. Participants at national or international meetings�orthe readers of abstracts�who may not be familiar with the¢nely detailed, fundamental di¡erences between properlypowered studies and those involving smaller sample size may
unfortunately interpret the conclusions of the latter at theirface value. The practical implication of such an interpretationcould well be alarming: a physician may decide to apply thereported results of a study to his or her own patient, citingthe supposedly conclusive results presented at these meetings!The program committees of the annual meetings of profes-
sional organizations such as American UrogynecologicSociety, International Continence Society, International Uro-gynecological Association, and Society for Urodynamics andFemaleUrology should be congratulated for adopting the pol-icy that no clinical study should be accepted or presentedwithout appropriate IRB approval. However, it may be timeto take the next step towards enhancing the quality of the stu-dies presented at these meetings by requiring that the ele-ments of ‘‘power’’ or ‘‘sample size’’ be reported for each study.Such clari¢cation would only add to the scienti¢c value of thematerial presented at these meetings while providing ‘‘addedvalue’’ for the participants.
FirouzDaneshgari,M.D.*Director
Center forFemalePelvicMedicine&ReconstructiveSurgeryTheClevelandClinicFoundation
Cleveland,Ohio
*Correspondence to: Firouz Daneshgari,The Cleveland Clinic Foundation,9500 Euclid Avenue, Cleveland, OH 44195. E-mail: [email protected] 20 September 2004; Accepted 27 October 2004Published online 19 January 2005 inWiley InterScience(www.interscience.wiley.com)DOI 10.1002/nau.20098
�2005Wiley-Liss, Inc.