Research Ethics Blog

There has been plenty of discussion about Coast IRB and the resulting implications of the governmental sting, including closure of the company (which reported an annual revenue of $9.3 million US dollars in 2008). Most of the discussion focuses on how irresponsible the people at Coast IRB were, how easily they were “duped” and how the monitoring of private-for-profit ethics review boards must be much more vigilant. I was at first planning on being somewhat unpopular here by saying that I still don’t think that Coast wasn’t doing their job, as an ethics review board. But I’ve since found out more details about the government sting since my original posting.

I will, however, reiterate that any ethics review board, private or housed within a hospital or academic setting, could have fallen victim to some of the aspects of the sting. What the sting demonstrated was that Coast didn’t do their homework in a few particular ways. At first I thought, from the details about the case that were available, that the kind of homework Coast didn’t do was the kind of homework that most ethics review boards typically don’t do, but I’ve since found out otherwise.

In an article from Your Lawyer, it’s stated that not only did Coast fail to note that the companies, products and researchers associated with the project didn’t actually exist, they also failed to ask more about what was considered by other ethics review boards to be significant risk involved in the phony study:

During the sting operation, a Coast IRB private review panel unanimously approved a fake medical protocol for testing which called for a full liter of a fictitious product to be poured into a woman’s stomach after surgery. Coast IRB’s minutes of the approval meeting showed that board members thought the protocol was “probably very safe.” According to the GAO, the Coast IRB approval came after two other private boards rejected the protocol. One called it “junk”, while a member of another board said it was the “riskiest thing I’ve ever seen on this board.”

But there needs to be an important distinction made here between the things that should have been done, and the things that must always be done, and in this case clearly were not.

First, the things that probably should have been done, but were not.

Originally, it was noted that Coast failed to identify that the researcher, the researcher’s office and the product were phony. As I said in my previous posting, few ethics review boards ever meet researchers face-to-face. Documents are delivered on-line or by couriers and communications between most ethics review boards and researchers are done electronically or by hard copy letter. Occasionally, yes, as Chair, I might call a researcher, but I have no way of knowing if that phone number is in fact a real lab office or an empty space in a strip mall with a phone and nothing else. When reviewing clinical trials on new technologies, like the one in the sting, most ethics review boards never see the actual products, only brochures, product monographs or approval documents from Health Canada (or a similar kind of regulatory body). If the documents look fine, usually nothing further is asked.

In yet another report on the Coast IRB case, from The Great Beyond, it was noted that the researcher had a fictitious medical license that expired 18 years ago, if anyone at Coast had bothered to check it. Few, if any ethics review boards ask for physician researchers to submit their medical license along with their research protocol. If a physician lists an affiliation with an institution, it is, again, usually left at that.

Again, some of these are “mistakes” that many ethics review boards might make. I’m not justifying them, though; I’m simply noting that the way the system is set up, for either for-profit boards or institution-based boards, there isn’t a clear role for an ethics review board to investigate all these kinds of details. The assumption is that these kinds of checks are done elsewhere. This is arguably a problematic assumption, as we’re seeing now, of course.

So what are the things that must always be done, and in this case, were not?

The new details of the case, apparently from the actual minutes of the Coast IRB meetings, demonstrate that they did not ask questions about what was considered to be a research protocol involving significant risk. As noted above, the risk was so high that two other private ethics review board actually rejected the protocol outright. Every single ethics review starts with giving attention to the risk. In fact, before any reviews can take place, risk must be assessed in order to determine the level of review that will be required. If a higher risk is identified up front, more reviewers are assigned, experts may be called and the level of scrutiny increases appropriately. Pouring a liter of an unknown substance into a participant, as this protocol apparently called for, would require, at minimum, that an ethics review board know what the substance is, and ensure that the risks along with the full spectrum of side effects (common, uncommon, rare) are fully understood, documented and communicated to participants in consent processes and other communications. Monitoring by a safety board must be in place. A mechanism to report adverse events must be initiated. Most importantly, the ethics review board must determine that the level of risk is justifiable in light of the potential benefits. The balance between risk and benefit are clearly the most important parts for any reviewer to understand. This is not homework that Coast simply missed. This is homework that is required of any ethics review board looking at any research protocol. In other words, failure to address risk is not an understandable or minor oversight but a fundamental responsibility of an ethics review board.

As of now, Coast is closing its doors, which has affected over 300 active clinical trials involving ~ 3000 researchers. Most of these protocols have been shunted to other private accredited ethics review boards. Let’s hope they do their homework.

~ by Nancy Walton on April 27, 2009.

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