Friday, February 28, 2014

No 'IRB', UCD?

as in IRB approval?--see: UC Davis Whistleblower Case About to Go to Trial After More than Four Years

Ms. Keyzer alleges that she was retaliated against and ultimately terminated because she complained to her supervisor and the UC Davis Institutional Review Board (“IRB”) that the COPE project management did not comply with the IRB approval process before implementing human subject research activities.

Ms. Keyzer observed that the COPE project was not in compliance with standard research requirements involving human subjects. Team members also violated laws regarding confidential medical records and protected health information. Ms. Keyzer wrote and spoke with her supervisor on multiple occasions about the improprieties she witnessed. In response, the team was directed to destroy their paperwork and “trust” those in charge. On her own, Ms. Keyzer contacted UCD’s Institutional Review Board (IRB), which regulates all campus research involving human subjects. Ms. Keyzer learned that the COPE project had not received the mandatory IRB review and approval. Ms. Keyzer filed a complaint, which triggered an IRB investigation and hearing at which she was invited to speak.

-there's mention of UCSF in the story as well...
earlier: Whistleblower at UC Davis Fired Allegedly For Reporting IRB Non-Compliance and Ethical Violations
by: David Greenwald September 24, 2009

more detail here from The Aggie archives
POGO has this new piece: FDA Surveillance Threatened Whistleblowers

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