Letter to the Editor
Letter to the Editor
What message is being sent to IRBs when focus is on streamlining reviews
Dear Editor:
I read this article ["Sharing of IRB approvals raises questions, concerns," - October, 2006, IRB Advisor] with growing concern for the message it sends for streamlining the IRB review process to be able to "reduce delay" and satisfy "concerned investigators" and "sponsors who want to get their investigational product more quickly to market" and the "unnecessary burden" of multiple IRB reviews. This is scary thinking when you consider the IRB process was developed to protect subjects not to enhance the process of getting a new product or treatment to market. Given the data on the average timeline from R&D for the release of a new product to the market, can an "IRB review delay" adversely impact in any significant way? I worry that we have listened to the complaints with the current system but have not appropriately sorted the sources of the complaints and the motivations.
Have we dug into the complaints as deeply as necessary to accurately evaluate them? For example, what is the formula for measuring "IRB review delays"? When does the clock start to tick — from the very first efforts of the investigative team to package the protocol for IRB review or when the package is submitted, determined complete and accepted for review by the IRB? Lack of knowledge of institutional requirements for submission and limited research experience are two issues that come to mind that can greatly delay the submission and ultimate review by an IRB. Because of the many roles in research, the four issues raised above have multiple definitions. Thus are we careful when listening to complaints to sort through the verbiage and evaluate the accuracy of the complaint?
Lastly, as an IRB Administrator, I get concerned with a system offering solutions that run counter to the role of the IRB. Have we, as human subject protection specialists, lost our focus? Has our focus shifted to placating the industry side of research because of all the noise in the marketplace?
Signed:
Paulette M. Vandzura
IRB Administrator
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