方舟子的Blog

新语丝网友中的一些志愿者通过其代表程鹗，于2010年3月2日向美国卫生与人类服务部（HHS）下属的科研诚信办公室（ORI）和人类研究保护办公室（OHRP）分别举报肖传国的学术造假问题、以及肖氏手术在中国的推广应用和在美国的临床试验所存在的医学伦理问题。

ORI于2010年3月15日回复：因为超出其管辖范围（指肖传国被指控的学术造假问题发生在中国）和举报人未提供针对美国临床试验实施者的具体指控事项，ORI无法启动调查。

OHRP于2010年10月22日回复：“OHRP已经开始调查评估举报信所列举的主要事项。我们已经将你们的举报通知了研究资助机构。他们已经停止招募病人参与临床研究。”

OHRP在其回复中指出：“美国卫生与人类服务部制定法规保护人类研究对象。OHRP的职责是监督这些法规的实施情况。为实施该职责，对于HHS主导的、或HHS提供资助的、或其他受这些法规管辖的以人类为对象的研究项目所受到的有根有据的违规举报，OHRP有权决定进行调查评估。”

新语丝志愿者将继续向有关机构提供新发现的肖氏手术违反医学伦理的证据。

From: Borror, Kristina C (HHS/OASH)
To: Eddie Cheng
CC: Menikoff, Jerry (HHS/OASH)
Subject: “Xiao Procedure”
Dear Mr. Cheng:
The Office of Human Research Protections (OHRP) has received your letter concerning research conducted at William Beaumont Hospital. I apologize for the delay in responding you.
OHRP has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protections of human research subjects (see 45 CFR Part 46 at http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). In carrying out this responsibility, OHRP evaluations, at OHRP’s discretion, substantive allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations (see OHRP memorandum dated October 14, 2009 at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf for an explanation of OHRP’s jurisdiction).
OHRP has initiated an evaluation of the matter reference in your letter. We notified the funding agency of your allegations and they have stopped enrollment into the study. We will advise you when the evaluation has been completed.
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 of Human Research Protections
1101 Wooton Parkway, Suite 200
The Tower Building
Rockville, MD 20852