美国国家卫生院称肖氏手术的试验方案是不可接受的
美国国家卫生院说,经过长时间评估后决定,肖氏手术的试验方案是不可接受的
(因此该试验已在美国终止),对此前已由民间资助做过肖氏手术的儿童,研究
者可继续研究其长期影响。
Regarding your concerns about the "Xiao nerve-rerouting procedure"
at William Beaumont Hospital, the Office for Human Research
Protections (OHRP) has been informed by the National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) that after lengthy evaluations of the protocols
proposed by Dr. Kenneth Peters, the PI, and the advice NIDDK received
from the members of the External Expert Panel (EEP), the Institute
decided that the protocol submitted to enroll patients for this
surgical procedure was not found acceptable. However, the
investigators will study the longer term effects of nerve rerouting in
children who had the nerve rerouting operation performed in a
previously conducted study not supported by the government.
OHRP finds these actions to be appropriate. We anticipate no
further involvement in the matter.
OHRP appreciates your concern about the protection of human
research subjects. Please do not hesitate to contact me at any time
should you have any questions or wish to provide additional information.
Sincerely,
Kristina C. Borror, Ph.D.
Director
Division of Compliance Oversight
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
The Tower Building
Rockville, MD 20852
(XYS20130830)
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