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June 28, 1995

Medical Devices: Significant vs Nonsignificant Risk

Author Affiliations

Cedars-Sinai Medical Center Los Angeles, Calif

JAMA. 1995;273(24):1906. doi:10.1001/jama.1995.03520480024027

To the Editor.  —After reading the recently published article regarding medical devices,1 I feel compelled to respond.As an administrative assistant to an institutional review board (IRB) and voting member of that committee, I find it inconceivable that an effective IRB could be as easily manipulated and misled as the one described in the article by Drs Sherertz and Streed. Some manufacturers may feel they can intimidate an IRB or its institution with the implied threat that funding will be awarded elsewhere to a more cooperative facility. But, an IRB makes its own determinations, after serious deliberations, on all matters, and most certainly does not rely on a manufacturer's (biased) recommendations.I feel the authors should have stated that "Unfortunately, some IRBs are sometimes confused...." When an IRB is established in an institution, it is imperative that there is support staff with expertise to offer assistance and guidance on

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