Tag Archives: irb

VA: Consent forms for human studies incomplete

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

According to a report released by the Department of Veterans Affairs Office of Inspector General, an audit of representative VA hospitals found that about 31 percent of informed consent documentation for human studies was incomplete. In the vast majority (97 percent) of cases, this was due to lack of a witness signature.

Among the report’s other findings:

  • An estimated 1 percent (1,023) of the 110,231 non-compliant lacked the subject’s signature or that of their authorized representative, rendering them legally ineffective.
  • An estimated 1.7 percent of the 367,103 consent forms could not be located, the report extrapolated the national range to be somewhere between 0.6 percent and 4.5 percent.
  • In specific situations, Institutional Review Boards can waive informed consent. In two of the 33 such cases examined, sufficient documentation of this waiver was not found.

Reports: Clinical trial oversight lacking

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

ProPublica’s Alexandra Andrews reviewed two recent reports on conflicts of interest in the institutional review boards tasked with overseeing clinical trials and found that these boards may not be as independent as the public might like.

Board members “frequently” had connections with drug companies that can cause conflicts of interest, and while IRB chairs said they’d never presided over a session in which a conflicted member had voted, only 65 percent of surveyed members said they recused themselves every time a conflict came up. One third of surveyed IRB’s don’t even require members to disclose conflicts of interest, Andrews reported.

Sen. Chuck Grassley (R-IA), who has been a prominent advocate for the disclosure of doctor-industry ties, told ProPublica, “People have to trust that decisions about clinical trials are unbiased, and this study calls that into question. Lack of disclosure of financial ties can damage confidence in important medical research. Disclosure policies ought to be established and enforced to safeguard the integrity of that research because of its tremendous influence on the practice of medicine and public health.”

Even more alarming was a recent GAO release detailing the lack of barriers to the creation of for-profit IRBs.

GAO investigators created phony IRBs [7] (PDF), which they were successfully able to register with HHS using no more than an online registration form. One such company listed its address as “1234 Phulovit Lane” in “Chetesville, AZ” with employees named “April Phuls, Timothy Wittless, (and) Alan Ruse.” (You can still find its deactivated listing [8] on HHS’s Web site.)

Subsequent oversight wasn’t any better.

HHS then approved an assurance [9] for a bogus medical device company, also created by GAO, which listed one of GAO’s fake IRBs on its application. An assurance basically promises that the company will adhere to federal standards and, once approved, paves the way for that company to request federal research funds. According to GAO, “By approving our assurance application, HHS essentially deemed our bogus IRB as adequate to oversee human subjects research.”

And it almost sounds like some actual IRB’s weren’t much better than the one run by April Phuls and Alan Ruse.

GAO’s pièce de résistance was a sting operation involving real IRBs. GAO’s medical device company sent out plans for a fake trial to three real IRBs. Two of them responded with cries of “awful,” “a piece of junk” and the “riskiest thing I’ve ever seen on this board.” But the third IRB, now identified as Colorado-based Coast IRB, found it “probably pretty safe” and voted unanimously to approve it.

In HHS’ defense, at a hearing, Jerry Menikoff, director of the Office for Human Research Protections, which oversees IRBs along with the Food and Drug Administration, said “by registering an IRB, the government, the federal government is in no way endorsing that IRB or in any way saying that that IRB meets any standards.”