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What is the FDA role in IRB liability in malpractice suits?

April 26, 2017fda IRB liability malpractice suits

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What is the FDA role in IRB liability in malpractice suits?

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FDA regulations do not address the question of IRB or institutional liability in the case of malpractice suits. FDA does not have authority to limit liability of IRBs or their members. Compliance with FDA regulations may help minimize an IRB’s exposure to liability.