A three-legged dog named Trooper overseeing experiments on humans? An ethics committee named “Phaké Medical Devices” and based in “Paynesville, South Carolina”? No problem, sign right up.

It was a sting operation tailor-made for congressional theatrics, and the US House of Representatives Committee on Energy and Commerce obliged yesterday as they heard accounts of an undercover operation to expose weaknesses in the country’s fragmented system of human research oversight.

In the United States, such research is overseen by institutional review boards (IRBs, known as ethics committees in many other countries). Traditionally, IRBs were based at the hospitals and universities conducting the research, but in recent years the push for speedier review of research protocols has led to a burgeoning industry of independent, for-profit IRBs. In 2007, Congress tasked the Government Accountability Office with investigating the for-profits. That’s where Trooper came in.

Investigators created several fake IRBs, including one called Maryland Hause and presided over by Trooper. “Trooper didn’t know anything about protecting human subjects in testing, but for a three-legged dog, he sure could catch a Frisbee,” said committee chairman Bart Stupak yesterday as he held up a picture of the handicapable dog.

Another, called E-Z Reviews, was based in “Chetesville, Arizona” and was staffed by April Phuls, Timothy Wittless, and Alan Ruse. The fictitious IRBs filed their applications with the Office for Human Research Protections, and were registered. “We do not have our staff going through the names to see if people have put funny names on the list,” protested Jerry Menikoff, director of the office. To be fair, Menikoff also noted that registration of IRBs is a semi-automated process that does not involve background checks, and said this was the procedure recommended by a 1998 Office of the Inspector General report.

The Government Accountability Office then placed an ad for Maryland Hause in trade magazines promising “fast approvals guaranteed” and was contacted by six companies, one of which attempted to hire Maryland Hause to review its protocols.

In a second phase of the investigation, a bogus research protocol for an imaginary product called “Adhesiabloc” was put together and submitted to three for-profit IRBs. The protocol lacked critical details, called for pouring a liter of 2.5% Adhesiabloc gel into the abdominal cavity of female surgical patients, and was backed by a fictitious doctor with a medical license that was not only fake, but one that would, if it were real, have expired 18 years ago. Two of the IRBs rejected the protocol, with one board member calling it “the riskiest thing I’ve ever seen”.

But a third approved it unanimously, investigators say. Notes from the approval meeting said the “gel is probably very safe”. the company caught onto the ruse months later during what it says was a routine audit, and then issued a press release indicting the government for perpetrating the fraud. (See the resulting New York Times story for more.)

The details of the investigation are amusing, but many are justifiably uneasy with the intuitive conflict of interest that an IRB-for-hire represents. Are for-profit IRBs more inclined to approve a shoddy protocol in order to keep their customers happy? Do their pledges of speedy turnaround mean less oversight? We have a few cautionary anecdotes here and there, but there has been no systematic comparison between for-profit and non-profit IRBs. (Keep in mind that non-profit IRBs have had foibles of their own, and surveys have found that many don’t bother to monitor potential conflicts-of-interest among their staff.)

So I was glad to see that some legislators are taking up the issue, but disappointed to learn that the GAO only sent their fake proposal to three for-profit IRBs – hardly a comprehensive survey. Without real follow-through by the committee, I can easily imagine this troublesome tale tossed aside on the pile of anecdotes.

For additional coverage, check out The Scientist and the Wall Street Journal.

Image: National Cancer Institute