Subject: The Lack of Informed Consent in the Case of Daniella Rogers
The case of Daniella Rogers, for which a determination letter by the Office of Human Research Protection has recently been issued, raises serious concerns, as layers of protection broke down leading to a lack of informed consent and an avoidable death.
controlgroup and her parents told she would be given the
standard treatmentwhich had a high success rate. The parents were not informed, however, that dosing was two times the normal rate and that it would be given as one dose rather than pulsed over a five day period – in effect becoming a type of experimental treatment itself. The attending physician, Dr. Wilson, commented in his notes that live failure was the direct result of
high dose cytoxan.
Human beings are not simply material for novel protocols, and experimenters should risk accurately informing their subjects of possible harms, so that true informed consent can be obtained.
CIRCARE believes that great care and caution should be exercised in all human subject studies, especially with vulnerable children.
For more information on this story see the web site: http://www.daniellarogers.org
Michael A. Susko MS, CIRCARE President
Adil Shamoo Ph.D., CIRCARE Co-Founder
Meyer RJ. OHRP Determination Letter to Washington University School of Medicine. 2003-01-04. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR03/jan03a.pdf
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<a href="http://www.circare.org/im/im1Mar2003.htm">The Lack of Informed Consent in the Case of Daniella Rogers</a>. CIRCARE InfoMail (2003-03-01)
Last Updated: 2006-04-25
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