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ARDSNet – AHRP Reply to OHRP Response
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 212-595-8974 ahrp@researchprotection.org September 4, 2002 Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Re: Acute Respiratory Distress…
1964: Declaration of Helsinki diverges from the Nuremberg Code
In 1962, the World Medical Association (WMA) Committee distributes a Draft Code of Ethics on Human Experimentation specifying populations that could not be used as research subjects. These include: children in institutions; all prisoners and persons retained in prisons, penitentiaries, or reformatories, mental hospitals and hospitals for mental defectives. (Draft…
OHRP Caves Under SUPPORT Pressure Re: oxygen experiment tiny premature babies
BEWARE of the powerful influence of institutional medical research. They have pushed hard to get the federal research. . . .
2003: VA 90-day national “stand down” for all human subject research
In 2003, the Veterans Affairs ordered a 90-day national “stand down” for all human subject research activities “in response to the death of subjects”; as well as use of “unqualified researchers.” In January 2004, the Director of Defense Research and Engineering (DDR&E) initiated a review of all Defense Department human subjects…
Introduction: Unethical Medical Experiments 1980–2010
“The whole discipline of biomedical ethics rises from the ashes of the Holocaust…” Arthur Caplan The Nuremberg Code (1947) laid the foundation for biomedical ethics mandating that medical experiments conducted on human beings must conform to well-defined humane, ethical standards; foremost is immutable standard: “The voluntary consent of the human…
FDA Internal Document: Use of Placebo-Controls in Life Threatening Diseases
The efficacy and safety of a new drug that treats a serious and life threatening illness in premature infants will be studied versus sham/placebo in Latin America. The sponsor plans to apply for FDA approval, in addition to local and European registration. There are approved therapies (surfactants) for this illness (Respiratory Distress Syndrome, or RDS) in those countries where this trial is proposed to take place, and surfactants are even used in some of their hospitals. However, surfactants are completely unavailable to infants at many other hospitals, secondary to rationing or economic limitations.