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As point of Dr. Atif A Baig, this should not be ethical issue but a legal one. After suitable statement of conflict of interest, it is must be no issue. However, Dr. Atif A Baig's conclusion may be obtained without understanding the regulations in China's National Natural Science Foundation (NNSF).
The newest China's NNSF funded project funding regulation, see http://www.nsfc.gov.cn/publish/portal0/tab229/info48335.htm, has been taken effect in 2015 and now is running. There are clear rules for usage of left over funding in its article 28. First, the left over funding should be returned to NNSF of China in 2 years after the project has been closed. Second, the left over funding can only be used in direct expenditure of basic research. Moreover, article 37 also said that misappropriation of funding is illegal.
As common sense of scientific research, there are many differences between basic research and applied research, see 1953's annual report of National Science Foundation of US, https://www.nsf.gov/pubs/1953/annualreports/ar_1953_sec6.pdf. In China, the definition of basic research is similar, see http://www.most.gov.cn/kjgh/kjfzgh/200708/t20070824_52690.htm.
The content of e015983 has cla...
The content of e015983 has claimed itself as an applied research project clearly because it said "This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom." in its abstract.
For the first 2 project, 81202849 and 30600834, if they are funding article e015983 and ChiCTR-IOR-1701039 after they were closed, they have violated Article 28 in China's NNSF regulation. If the 3rd project, 81603659, is funding article e015983 and ChiCTR-IOR-1701039, it has violated Article 37. As the same time, article e015983 and ChiCTR-IOR-1701039 are facing the same issues.
Despite the legitimacy investigation exceeded scope of ethical, even from an ethical point of view, author of article e015983 should explain the real fund source of this project as soon as possible. These explanations are critical for readers and editors to clarify whether there are any improper issues in this article.
Dear Editor of BMJ.
I was reading it all and I assume that many times the issues can’t be ethical but are still legal. Being a neutral moiety, I assume just based on a fact to get justification from author or anyone sending a response is not enough for such serious ethical concerns. There is a serious need to look into the legal implications of use of funding. As per usual practice, the report of all grants are submitted to the funding bodies and if the “authors” have explained and mentioned the use of this all funding or “left over funding” in specific time to be used later as per rules and regulations, there must be no issue as far as no “conflict of interest “ is there between the authors and the funding agency. Seems it’s a very minor issue but for me it’s a new issue of its type and thank you for a very positive attitude from BMJ Open editor for facilitating science and honesty not in science but the concern minor issues.
The editorial team of BMJ Open are currently investigating the issues raised by Yuzhen Li in response to this article.
We have asked the authors to respond to the points raised and will investigate the case in line with the principles of the Committee On Publication Ethics (COPE).
Dear editorial board of BMJ Open,
In article e015983, http://bmjopen.bmj.com/content/7/11/e015983, and registration information, http://www.chictr.org.cn/showprojen.aspx?proj=17715, of its RCT, it was claimed that this RCT, ChiCTR-IOR-1701039, is running and funded by 3 projects of National Natural Science Foundation of China, namely 81202849, 30600834 and 81603659.
However, none of these three projects could fund this RCT. The first project has been closed in 2015, see http://npd.nsfc.gov.cn/projectDetail.action?pid=81202849. The second project also has been closed in 2009, see http://npd.nsfc.gov.cn/projectDetail.action?pid=30600834. But the RCT in article e015983 is running from 2017-1-1 to 2018-1-1. Time difference results in that the first 2 projects were impossible to fund this RCT.
The third project is only one project listed which could fund this RCT because it is to be implemented from 2016 to 2018. But content of project 81603659 is prevention and treatment of cognitive impairment in epileptic rats, not a human RCT. Although the content of project 81603659 is still not revealed, this fact can be confirmed on web site of National Natural Science Foundation of China,...
The third project is only one project listed which could fund this RCT because it is to be implemented from 2016 to 2018. But content of project 81603659 is prevention and treatment of cognitive impairment in epileptic rats, not a human RCT. Although the content of project 81603659 is still not revealed, this fact can be confirmed on web site of National Natural Science Foundation of China, http://npd.nsfc.gov.cn/fundingProjectSearchAction!search.action, with search results of number 81603659. If this project is funding ChiCTR-IOR-1701039, both of them will face serious ethical issues.
First of all, adequate and legitimate financial support is one of the most important conditions to guarantee basic ethical requirements of a clinical trial for human-being such as completeness of the RCT and safety of research subjects involved. Second, fake fund declaration in research article is an academic misconduct because it results in serious ethical issues described before. Finally, reading and references for protocol of an RCT with ethical issues, i.e. article e015983, will mislead readers of this journal and result in inappropriate financial support for further research projects.
In view of the above reasons, I would like to request editorial board of BMJ Open to confirm the authenticity of financial support of RCT ChiCTR-IOR-1701039 and article e015983 and reconsider whether publication of article e015983 meets fundamental medical ethical standards or not.
Hangzhou Street Community Health Service Center, Binhai New Area, Tianjin, PRC