irb approval: consideration of power is essential for ethical approval

Neurourology and Urodynamics 24:397 (2005)

LETTERTOTHEEDITOR

IRB Approval: Consideration of Power is Essentialfor Ethical Approval

To the Editor:

Dr. Daneshgari, in Sounding Board, claims that Institu-tional Research Boards (IRB) or their equivalent ethics com-mittees do not consider the power of a study in theirdeliberations [Daneshgari, 2005]. If so, then they are not ableto carry out their business properly. It is the responsibility ofthe IRB to balance the potential bene¢ts and potential harmsof each study they consider. If the study is unable to answerthe question that it proposes then the potential bene¢ts fromthe study are extremely small or zero and thus likely to be out-weighed by the potential harms, even if these are minor oreven if they only constitute the time and e¡orts of the peopleinvolved.

The power of a study is one of the crucial elements ofdeciding whether it can answer the question posed. It is clearlyunethical to carry out a study that has no potential bene¢tfor the population from which the participants come. I

would hope that it is not common for IRBs and ethics commit-tees to not consider power, and there are certainly manythat do.Of course the heading of Dr. Daneshgaris’article is correct,

the ¢nal responsibility for the ethics of a study always falls onthe investigators, not the ethics committee.

PeterHerbison*Departmentof Preventive

andSocialMedicineDunedinSchoolofMedicine

UniversityofCicagoDunedin,NewZealand

REFERENCE

Daneshgari F. 2005. IRB Approval: Needed but insu⁄cient. NeurolurolUrodyn 24:151.

*Correspondence to: Peter Herbison, Department of Preventive and SocialMedicine, Dunedin School of Medicine, University of Cicago, Dunedin,New Zealand. POBox 913; Zip Code 9001.E-mail: peter.herbison@otago.ac.nzPublished online 15 June 2005 inWiley InterScience(www.interscience.wiley.com)DOI 10.1002/nau.20145

�2005Wiley-Liss, Inc.