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                    Without Consent

The May 15, 1994 Of Note (ON9405B.*) noted:

     A congressional report, obtained by the Associated
     Press, concluded that government regulations on when
     doctors can experiment on patients without their
     consent are contradictory and the oversight is
     negligible. "It would seem investigators often exceed
     the bounds of good judgment and ethical consideration," 
     Rep. Ron Wyden (D-OR) wrote the chiefs of the National
     Institutes of Health and Food and Drug Administration.
     "Uncertainty and confusion with regard to federal
     requirements... could play havoc with patient's lives."

The report cited the following unauthorized experiments:

     --Several hospitals without FDA permission, sidestepped
     standard cardiopulmonary resuscitation--CPR--and
     substituted a machine that pumps the chest. FDA halted
     the tests and said further research must be on
     consenting patients. The subcommittee said the adults-
     only pump was used on children and on patients who had
     requested they not be resuscitated. The manufacturer,
     Ambu International did not return calls seeking
     comment.

     --A hospital drew blood samples from drunken patients
     for up to eight hours to test blood sugar in a study
     unrelated to their treatment. Drunken patients are
     generally hospitalized that long to sober up, and
     drawing blood to measure alcohol-induced glucose
     fluctuation met the the NIH's risk requirement, said
     Kenneth Arnold, attorney for Rhode Island Hospital in
     Providence. But a worker complained, so the study was
     stopped until the hospital writes its own ethics
     guidelines. 

     --Unconscious head-trauma patients were given an
     experimental drug, designed to stop cell damage from
     the lack of oxygen, or a placebo. NIH wouldn't sanction
     the trial. The FDA briefly halted it and asked the drug
     manufacturer to seek family permission. The company.
     Sterling Winthrop Inc., called that too costly, said an
     official who reviewed FDA's private files and requested
     anonymity. The company refused comment on family
     consent. 

{Panel Questions Ethics of Experiments, Martinsburg Journal,
4/21/94] 

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