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Size, Not Money.

Posted by plosmedicine on 30 Mar 2009 at 23:57 GMT

Author: Joal Hill
Position: Director, Research Ethics
Institution: Advocate Health Care
Submitted Date: July 31, 2006
Published Date: August 3, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

I read with interest the debate about for profit versus non-profit IRBs, but was disappointed that no one addressed the ability (or inability) of for-profit IRBs to review studies with the local context of research subjects in mind and then monitor what actually occurs during the consent process throughout the research trial.

To my mind it may be that the "bigness" of for profit IRBs is more of an impediment in protecting research subjects than their inherent conflict of interest. Our IRB has reviewed consent forms approved by central/for-profit IRBs that contained obvious errors such as schemas that do not match protocol narrative and use of 8 point font in a study of geriatric subjects. Even when the initial review is outstanding it seems a practical impossibility that a single IRB can provide meaningful monitoring of the actual consent process and implementation of the protocol at sites throughout the country. The greater "efficiency" of for-profit IRBs is only a meaningful benefit if increased speed can be shown not to occur at the expense of careful review of consent forms, real understanding of the local research context, and a commitment to audit the informed consent process throughout the study for the protection of research subjects, including ongoing education and advice for researchers and their teams.

This is not to say that all local/institutional IRBs perform this function as they should, but it does seem almost impossible for one IRB to perform local review and oversight for research sites around the nation in a way that really makes a difference for the men, women, and children who give of their time and their bodies so that society can benefit.

Competing interests declared: I declare that I have no competing interests.