483
Legacy Health IRBFDA 483 - Legacy Health IRB - December 17, 2021
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Record Details
An FDA inspection of Legacy Health IRB in Portland, OR, revealed critical deficiencies in its oversight of human subject protection. The firm failed to ensure informed consent documents accurately described risks and withdrawal rights, presenting inconsistent information to subjects. Additionally, the IRB did not maintain updated registration information or adhere to its own written procedures for board composition and review processes.
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ID · c890a095-597d-48f5-8aaa-ff997a644117