These appear to be the first reported deaths of unconsenting
experimental subjects since the 1996 changes in policy.  The
policy changes bypassed the Nuremberg Code and allowed
human experimentation without consent of the subjects.

----------------------------------------------------


   Firm hid info from experiment subjects
      http://www.usatoday.com/news/ndssun03.htm

   CHICAGO - A company conducted an ill-fated blood substitute trial
   without the informed consent of patients in the study - some of whom
   died, federal officials say.

   Baxter International was able to test the substitute known as
   HemAssist without consent because of a 1996 change in federal
   Food and Drug Administration regulations.

   The changes broke a 50-year standard to get consent for nearly all
   experiments on humans. They were designed to help research in
   emergency medicine that could not happen if doctors took the time to
   get consent.

   But the problems with the HemAssist trial are prompting some medical
   ethicists to question the rule change.

   ''People get involved in something to their detriment without any
   knowledge of it,'' George Annas, a professor of health law at the
   Boston University School of Public Health, told the Chicago Tribune.
   ''We use people. What's the justification for that?''

   No other company has conducted a no-consent experiment under
   the rule, FDA officials said.



   [...]




--
Allen L. Barker
http://www.cs.virginia.edu/~alb



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