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June 1997

On Knowledge of Regulations for Clinical Trials

Author Affiliations

Hyde Park, NY

Arch Surg. 1997;132(6):682. doi:10.1001/archsurg.1997.01430300124026

The tone of the article by Randi et al1 would allocate responsibilities for the unsatisfactory findings (read ignorance of regulations) on the shoulder of the investigator and those of the Institutional Review Board. This perception should be rejected offhand.

In general, investigators bring to bear on the subject a desire to do investigative work, a keen analytical or synthetic mind, an established capacity to do work, and finally a desire to get the work done. Given this type of premise, one should rather ask the question, "Why is it that such individuals appear to be ignorant of pertinent rules and regulations?"

For anybody who has attempted to wade through reams of federal purple jargon, the answer should become readily apparent and it is "because the rules and regulations are arcane, occasionally contradictory and in general designed to advance the level of bureaucratic control and power."

In this respect, it

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