CIRCARE InfoMail 2003-03-01

Subject: The Lack of Informed Consent in the Case of Daniella Rogers
Date: 2003-03-01

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.

The parents of Daniella were not informed of the real risks of chemotherapy, in this case standard treatment for a type of smooth muscle tumor. Liver damage was listed, but not liver failure with a risk of death. In similar previous (IRSG-COG) studies, there had already been two previous deaths from liver failure.
Daniella was in a control group and her parents told she would be given the standard treatment which 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
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327

Additional Information

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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Last Updated: 2006-04-25

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