直肠癌保肛术后患者排便功能临床研究的伦理审查情况分析

Analysis of Ethical Review of Clinical Study on Defecation Function of Patients with Rectal Cancer after sphincter-preserving Surgery

为了解直肠癌保肛术后患者排便功能临床研究的伦理审查现状,分析其原因并提出相应建议,在后续相关临床研究中引起研究者对伦理审查的重视。对近10年发表在中国知网上的直肠癌保肛术后患者排便功能相关文献伦理审查情况进行梳理归纳。结果显示直肠癌保肛术后患者排便功能临床研究类论文的伦理审查情况不太乐观。应从加强研究者伦理培训,提高研究者伦理意识、严格落实论文发表的伦理规范,加强稿约伦理要求、完善伦理审查制度,注重知情同意审查监督三个层面进行相应的改善,推进临床研究文献的伦理审查规范建设。

In order to understand the status quo of ethical review of clinical research on the defecation function of patients with rectal cancer after sphincter-preserving surgery,analyze its causes and put forward corresponding suggestions,to arouse researchers'attention to ethical review in subsequent relevant clinical studies.The ethical review of literatures related to the defecation function of patients with rectal cancer after sphincter-preserving surgery published on CNKI in recent 10 years was sorted out and summarized.The results showed that the ethical review of clinical research papers on defecation function of patients with rectal cancer after sphincter-preserving surgery was not optimistic.We should strengthen the ethical training of researchers,improve the ethical awareness of researchers,strictly implement the ethical norms of paper publication,strengthen the ethical requirements of manuscript contracts,perfect the ethical review system,and pay attention to the examination and supervision of informed consent,so as to promote the construction of ethical examination and approval norms of clinical research documents.