Thursday, April 2, 2009

Scientific Misconduct and Human Research Subjects

The Center for Genetics and Society is non-profit watchdog group reporting on problems within the scientific realm. Here is an disturbing article from their weblog on the subject of Human experimentation and regulations:

Human research subjects protection: Under fire from Congress (by Jesse Reynolds on March 31st, 2009)

In the past two months, the new US president directed the federal government to develop some oversight of human embryonic stem cell research, and two scandals in the fertility industry (with a potential third one brewing) led to demands that the $3 billion baby business be brought under responsible regulation.Now, a sting-style investigation by Congress into the protection of human research subjects may lead to new legislation. The Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee held a hearing last week, focusing on a two-pronged undercover operation conducted by Congresses' Government Accountability Office.On one front, the GAO created a fictitious company, product, and proposed clinical trial, based on a rejected proposal from a few years ago. It was was then submitted to three private Institutional Review Boards (IRBs) for approval. Although two of the IRBs similarly rejected the vague proposal, Coast IRB approved the project unanimously. Coast seems to epitomize the shortcomings of private companies which approve research on humans. It advertises its fast 48 hour turnaround time on submissions, and even publishes a coupon for a free review, offering prospective customers to "take us for a free test drive" and to "coast through your next study." In the last five years, Coast approved all 356 submitted protocols. And in the case of the GAO's faked application, Coast didn't even examine the submitted data.
Rep. Henry Waxman (D-CA), said in his opening statement [PDF]:
This is actually a coupon for experimental testing on human beings. The company virtually guarantees approval, and it offers the first review for free. Can you imagine going to the hospital for major invasive surgery and having your doctor ask whether he can use a device approved after cashing in a coupon?
On the other front, the GAO took on government oversight of private IRBs. It created a clearly bogus IRB, and sought authorization from the Department of Health and Human Services. Not only did HHS give its seal of approval, but the fake IRB began to receive inquiries from researchers, and even received a full protocol for its approval.
For more on private IRBs, see "Big Pharma's Shameful Secret," [PDF] Bloomberg Markets (Dec. 2005).

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