Word: consenting
(lookup in dictionary)
(lookup stats)
Dates: all
Sort By: most recent first
(reverse)
...evidence in the literature that hexamethonium might be unsafe. Togias did a search and didn't turn that up, but after-the-fact searches using different search engines and databases did turn up references to the potential risks to humans. The FDA also raised questions about the informed-consent forms that Roche and two other subjects had signed. On them, hexamethonium is referred to as a "medication" and as "[having] been used as an anesthetic"--giving subjects a false sense that it was an FDA-approved medicine and therefore safe. An outside review board commissioned by the hospital noted...
...According to Mathias, more than a third developed severe side effects, including uncontrollable nausea, fevers, rashes, swelling and terrible headaches. Some thought the doctor's behavior was odd. While on the vaccine, one patient, Dawanna Robertson, discovered she was pregnant; she panicked when she recalled the warning on the consent form she had signed: "The potential effects of these drugs on the growing fetus...may include serious birth defects." Yet when she voiced her fears, Robertson says, McGee assured her that the vaccine couldn't pass through the placenta. She received another injection that...
Then the university review board dropped the ball. Despite federal rules requiring it to conduct "continuing review" of ongoing studies, the board met just once a month, typically for an hour, and then went out to dinner. Among other things, the board approved McGee's consent form, which contained numerous errors. McGee later got permission to add more subjects than the original 25 he had applied for. According to the OHRP investigation, 11 of McGee's first 18 subjects didn't meet eligibility criteria. Like most of the key oversight decisions, this one actually came directly from the IRB chair...
Many critics also point to the consent forms people sign when they join a clinical trial. Even when the risks are clearly spelled out--and they frequently aren't--patients tend to misunderstand what's actually going on. The truth is that less than 5% of subjects in Phase I trials, which measure the toxicity of a new drug, will receive any health benefit whatsoever. Yet when a 1995 University of Chicago study quizzed patients about why they enrolled in their Phase I cancer trials, fully 85% answered, "Possible therapeutic benefit...
Ever been so strapped for cash that you'd swallow pesticide for $460? That's what dozens of college-age Nebraskans did in 1998 after reading a school-newspaper ad urging students to "earn extra money." They called 402-474-PAYS, signed a seven-page consent form and popped a pill loaded with the active ingredient in Raid roach spray. Dow AgroSciences commissioned the trial to vouch for the safety of one of its top-selling bug killers, chlorpyrifos...