美国NIH称肖氏手术的试验方案是不可接受的


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送交者: 新平 于 2013-08-31, 10:30:11:

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




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