Private IRB subject of sting operation

University-based research is overseen by university ethics boards. Hospital-based research is reviewed by hospital ethics review boards. But research conducted by private companies is typically overseen by private ethics boards. Some people worry about how careful private boards will be. Here’s a story about that.

From the NY Times: Testing Firm Finds Itself Being Tested

Like other federal undercover operations, this one had the usual trappings, like a company whose address turned out to be a P.O. box in a strip shopping mall and a businessman whose credentials proved fraudulent.

But the investigation had an unusual focus: determining whether companies that are paid to oversee the safety of patients in clinical studies of drugs and medical devices do their job. The inquiry came to light this week when one of its targets, a Colorado company, exposed it — via news release.

The company, Coast Independent Review Board, said it had been duped by federal officials last year when it agreed to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery.

As it turns out, there is no such product….

The New York Times article was highly critical of Coast for not “checking” into the investigators’ claims of affiliations and qualifications or even the location of the study, which, upon investigation, was actually a store in a strip mall. As it turned out, the only revisions requested in the protocol were on the consent form and someone from Coast IRB actually spoke with a person who represented himself as a researcher affiliated with the study and who agreed to make the changes prior to approval.

This story isn’t as much about private IRBs, though, as it is about what an ethics review board should be asked to do. And whether or not we should hold private ethics review boards to higher standards.

Many ethics review boards — private or not — accept protocol submissions, send them out to reviewers, get the reviews completed, discuss the requested changes and send the protocol back to the researcher, who then makes the required changes, resubmits. At some point in this process, the protocol gets approved. But this entire process can be done by email or by hard copies of protocols delivered to assistants by couriers. In other words, most ethics boards never meet most of the researchers whose work they are reviewing. At a small University or hospital, people know each other. Names on research ethics protocols are familiar, well known. But take any large hospital or University and it is guaranteed that many protocols will come before the Board with unknown names, external researchers who no one has ever met, along with companies and sponsors that are unfamiliar. Ethics review board members simply can’t meet every researcher, visit their study lab or clinic or check professional associations to ensure that researchers are in fact who and what they say they are.

Is it a case of blind trust? Or a case of “what we don’t know won’t hurt us”? I think neither. No already overworked ethics review board can be expected to be checking up on these sorts of things with every protocol that comes to them. The House Subcommittee that led the sting was checking up on the wrong thing. Coast did its due diligence. It ensured that the study was ethically sound. That’s the job that they — like any other ethics review board — are mandated to do. Could they have done more? Absolutely, yes. But does every other ethics review board — private or not — always do more? Almost never.

Here, FYI, is Coast IRB’s website.

~ by Nancy Walton on March 16, 2009.

2 Responses to “Private IRB subject of sting operation”

  1. Nancy, I would add one additional point. The REB system of oversight is designed to help researchers and institutions navigate the complex waters of involving human beings as research participants. As such the system is not premised on an expectation that the submission of grossly freudulent information requiring extensive vetting and validation of applications will be the norm. To do so would cripple the enterprise and would send a clear message of “guilty until proven innocent” to researchers. I don’t know any system that is not susceptible to deliberate freud. THis was not a fair test. One has to ask whether the ‘weaknesses’ that were revealed actually represented a real threat to the security of research participants, or set of circumstances so incredibly improbable as to represent a neglible risk.

  2. Dear Nancy:For the benefit of your readers, please find below the link to the US Committee on Energy and Commerce (Subcommittee on Oversight and Investigations) hearing titled, “Institutional Review Boards that Oversee Experimental Human Testing for Profit” which was held on March 26, 2009: http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1552

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