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IN WHAT is believed to be a unique action, the Office for Protection from Research Risks at the National Institutes of Health (NIH) has reprimanded an institutional review board for failing to ensure that all subjects in a clinical trial were informed.
There have been instances when investigators have failed to protect research subjects properly, but none involving institutional review boards, according to Charles R. McCarthy, PhD, director of the research risks office in Bethesda, Md.
McCarthy and the deputy director of the office, Alan L. Sandler, DDS, jointly sent a letter to Peter H. Wolff, MD, chair of the committee on clinical investigation at Children's Hospital, Boston, Mass, pointing out that prerandomization to a study is unacceptable when consent is being sought in only one arm of that study. Prerandomization is a procedure in which patients are randomized to receive the treatments that are being tested before being asked
Marwick C. NIH 'Research Risks Office' Reprimands Hospital Institutional Review Board. JAMA. 1990;263(18):2420. doi:10.1001/jama.1990.03440180016002