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www.fdanews.com/articles/176378-fda-slams-irb-with-warning-letter-over-protocol

FDA Slams IRB With Warning Letter Over Protocol

April 27, 2016

The FDA has hit Oeyama-Moto Cancer Research Foundation’s IRB for failing to define its operational protocol, leading to inadequate communication with clinical investigators and meager documentation.

According to the April 7 warning letter, which stems from an inspection conducted between Aug. 11 to Sept. 29, 2015, Oeyama-Moto’s IRB did not prepare written procedures to regulate its operations, fell short in documenting IRB activities — including the minutes and votes of meetings — and failed to notify investigators and the institution of proposed research approvals and disapprovals.

The agency’s first complaint relates to the IRB’s lack of written procedures for initial and continuous review of research, decision-making on research review frequency and reporting to the institution and the FDA on risks, changes and noncompliance.

 

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