ORI Declines to Investigate Claims against Xiao Procedure
The Office of Research Integrity of Department of Health and Human Services responded to the open letter concerning Xiao Procedure. It declines to investigate citing lack of jurisdiction and absence of specific allegations. Here is the response letter in its entirely, dated March 15, 2010.
The Division of Investigative Oversight (DIO) of the Office of Research Integrity (ORI) has received your letter of March 1, 2010, and additional documentation describing concerns over a controversial procedure first described by Dr. Chuan-Guo Xiao to treat neurologenic bladder in subjects with spinal cord injury (SCI) or spina bifida. The material you provide raises concerns about the extent and quality of long-term followup of the many subjects that Dr. Xiao and his colleagues have operated on in China and suggests that the high success rate that he and others have claimed of this procedure (the “Xiao Procedure”) has been overstated. This material also notes that Dr. Xiao, while working at New York University prior to his return to China, and others at the William Beaumont Hospital Research Institute, have received funds from the National Institutes of Health to conduct clinical trials to test the safety and efficacy of similar nerve re-routing procedures in children with spina bifida.
After reviewing your concerns, DIO has determined that this office cannot assist you. There are several reasons for this determination. Nearly all of the patients who have received this surgical procedure are in China and ORI does not have jurisdictional authority to intervene.[footnote] The procedure as practiced in the United States has to some extent been funded by PHS funds at NYU and the Beaumont Hospital Research Institute. However, these grant applications clearly identify the procedure as experimental and high risk, and as safety and efficacy trials. The preliminary results of the pilot studies described in the applications are described as providing some benefit for otherwise extremely compromised patients, and the risks and benefits are adequately described. Long term follow-up results will have an impact, when available, on determining the viability of the procedure for more patients.
More important for this office is the absence of specific allegations of possible research misconduct in NIH funded research that are suitably specific to claims that could be shown to be significant and intentional falsification or fabrications of data that could be ascribed to specific individuals. Broad claims that the procedure has been shown to not work in China are not sufficient to establish that appropriate care has been taken in NIH funded research to ensure appropriate care of subjects, and that the risks and possible benefits have been appropriately explained to patients. I also wish to point out that it seems likely that the conflicting opinions on the efficacy of this procedure may, at least in part, be due to honest differences of opinion in what constitutes therapeutic success.
Thank you for raising your concerns with ORI. However, as noted, we are unable to assist you at this time.
John E. Dahlberg, Ph.D. Director Division of Investigation Oversight Office of Research Integrity
【footnote】For ORI to have jurisdiction, allegations must meet the definition of research misconduct at 42 C.F.R. 93.103 and the questioned research must be supported by funds from Public Health Services agencies such as the National Institutes of Health.
美国的健康和人力资源部的科研诚信办公室 (以下称ORI) 对一封质疑肖氏手术的公开信做出了答复。ORI拒绝对此质疑作调查的原因是缺乏特定的指控和管辖权。下面是落款于2010年３月15日的答复信的全部内容。
美国健康和人力资源部的科研诚信办公室(ORI) 的调查科 (DIO) 于2010年３月１日收到了你们的来信和附带的材料。在信中你们对于一个由肖传国医生首先描述的用于治疗脊髓损伤和脊柱裂病人神经源性膀胱的手术表达了担心。你们提供的材料质疑了肖医生及其同事所开展的手术的程度和对很多病人进行长期随访的质量同时认为他们夸大了该手术的成功率。你们的材料也注意到了肖医生在回到中国前也就是在纽约大学任职期间和William Beaumont 医院研究所的医生得到了美国国立卫生研究院（以下称NIH) 的资助用以为脊柱裂 (spina bifida) 患儿开展类似的神经通路重建手术从而评估该手术的有效性和安全性。
在审阅了你们的材料后，DIO决定无法帮助你们。有几个原因使我们做出这样的决定。 首先几乎所有接受该手术的病人都在中国，美国的ORI没有管辖权去介入调查[脚注]。是的这个在美国纽约大学和William Beaumont 医院研究所开展的手术在一定程度上接受了NIH的资助。但是在他们的基金申请书中点明了这个实验性手术存在的高风险。该临床研究的目的就是为了对该手术的安全性和有效性作出评估。在所提供的预实验的结果中证明他们的手术可以为一些极端危重的病人提供帮助－利远大于弊同时他们也按要求恰当的讨论了该手术的风险和益处。而长期随访的结果将会有助于决定在更多病人开展此类手术的可行性。
John E. Dahlberg, Ph.D. 科研诚信办事室调查科主任
[脚注] 要ORI 具有管辖权指控必须满足在42C.F.R.93.103中对科研行为不端下的定义并且所质疑的研究必须是由公共健康服务下属机构（如NIH）资助的。