Last Updated Mar 18, 2010 12:57 PM EDT
The omission will be seized upon by the company's legion of critics, writing yet another gloomy PR chapter for a company that can't do anything without triggering negative headlines.
The murk surrounding whether PositiveID got proper permission -- either from a panel of experts or the patients themselves -- for implanting the Florida senior citizens with microchips linked to their healthcare records was revealed by Penn Bullock in a story on James Randi's web site for pseudoscience skeptics.
In 2007, a press release from VeriChip, PositiveID's old name, repeatedly called the move "a study," which in the research community is the nomenclature for standard experimental science conducted according to a set of official ethics rules:
In the two-year, 200 patient study, participating individuals suffering from Alzheimer's disease and other forms of dementia, as well as their caregivers, would receive the VeriMed(TM) implantable microchip to provide emergency department staff easy access to those patients' identification and medical information.Bullock reports that such a study would definitely have needed IRB approval in order to prevent ethical violations against humans in medical experiments. But a spokesperson for PositiveID now says it was a "project, not a study," Bullock reports:
Our relationship with Alzheimer's Community Care to provide their patients and caregivers with the microchip-- was not a research study or experiment, so IRB review is not required.The project/study/whatever was covered by the AP:
Mary Barnes, the care center's chief executive, counters that both the patients and their legal guardians must consent to the implants before receiving them. And the chips, she says, could be invaluable in identifying lost patients -- for instance, if a hurricane strikes Florida.Although the AP called the event a "study" at the time, Barnes now also calls it a "project":
"We did participate in a project with [PositiveID]," she said, pausing dramatically. "A project. We had legal documents reviewed by counsel. The project was for the benefit of patients and caregivers--" When asked if the ACC had gotten an IRB, she abruptly hung up the phone.That raises the issue of whether the patients or guardians properly consented to the microchips. The microchips are useless in locating patients after hurricanes because they do not contain GPS tracking devices. Bullock reports PositiveID admits some patients could not consent, and the consent of their guardians was used instead. But without IRB guidelines governing consent disclosures, and whether guardians were bamboozled by irrelevant information about hurricanes, it's not clear what information they were given about the study before their consent was obtained.
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