17
Mar2009

By Andrew Olmstead, director, member services and development, IRBNet

IRBNet, a frequent exhibitor at PRIM&R’s conferences, recently talked with Dr. Greg Koski about his views on critical issues IRBs face today. We have excerpted the beginning of their discussion here, but you can read the complete version by downloading the PDF at the bottom of the post. Please note that the inclusion of this article should not be construed as PRIM&R's endorsement of IRBNet or IRBNet's product.

CONTEXT: THE PAST 10 YEARS
Andrew Olmsted: For context, I’m going to describe two waves of change that have taken place in the world of IRBs and the management of the ethics review for humans. Wave one was… about years ago when we saw the proliferation of commercial IRBs coming into existence as an alternative to using local IRBs for review….

One outcome of the first wave is the number of commercial entities out there that make their living doing this—Western IRB being perhaps the oldest and most well known in the U.S.—but there are many others. The second wave I describe as the response from institutions… that have watched this change taking place, have considerable pressure on themselves to respond, and are trying to make decisions. And so it’s in this context that I was hoping we could chat. Is that a reasonable way to describe these waves?

Dr. Koski: Well, I think it’s fine to separate it into wave one and wave two although there may have been many other waves, if not tsunamis and ripples, along the way. I think that in the first wave you described is largely accurate, although it began well more than 10 years ago.

The drivers were also a bit different than the way you characterized them. The independent IRBs basically grew largely out of the need for efficient review of studies that were not under the traditional institutional model that had been set up at or by NIH, HHS. These non-institutional IRBs instead were dealing with studies that were being reviewed and approved largely for industry, corporate sponsored studies that were primarily under FDA oversight rather than…OHRP oversight. In fact, the so-called private or independent IRBs (hopefully all IRBs are independent), the private and often for profit IRBs, were focused primarily on reviewing this industrially sponsored clinical research or other private sponsored research that did not have U.S. government support or funding and therefore came under a different set of regulations.

There’s a slight difference there but indeed, as history progressed, we found that when institutional IRBs actually began to get into trouble or recognized shortcomings in their own processes, institutions did begin, as you said, to turn to some of these independent IRBs in order to supplement what could be provided within the institution by its own structure and resources….

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