Subject: Pediatric Death in Study at the University of Chicago
We would like to alert you to the letter of determination issued by the Office of Human Research Protection to the University of Chicago on 23 April 2002, available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/apr02u.pdf
A pediatric research subject died on 2001-09-14 while enrolled in the study titled
Controlled Trial of Intermittent Pamidronate Use in Childhood Osteoporosis Associated with Cerebral Palsy. OHRP determined
Department of Health and Human Services (HHS) regulations at 45 CFR 46.111(a)(1) require that in order to approve research the Institutional Review Board (IRB) shall determine that the risks to the subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk. OHRP finds that the UC IRB failed to ensure that this requirement was satisfied for the above-referenced research.
Please consult the letter of determination for further details.
The report of this death comes one day after the close of Ethics of Research on Children, a conference co-sponsored by Friends Research Institute, Inc. and CME Inc., at which Adil Shamoo and Michael Susko presented papers along with leading bioethics scholars and US government officials. See the conference web site for further details: http://web.archive.org/web/20011230213257/http://www.friendsresearch.org/conf_intro.html
In his closing remarks yesterday, Greg Koski, M.D., Ph.D., Director Office for Human Research Protections (OHRP), reminded the audience that there ought to be no rush to conduct human research, and emphasized the need for caution and thorough deliberation prior to commencing research, sentiments with which CIRCARE fully concurs.
Michael A. Susko MS, CIRCARE President
Adil Shamoo Ph.D., CIRCARE Co-Founder
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Last Updated: 2006-03-04
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