Indian J Psychiatry. 2009 Jan;51(1):34-7. doi: 10.4103/0019-5545.44902.
Reporting of informed consent and ethical approval are important aspects of published papers which indicate the knowledge and sensitivity about ethical aspects of research by the researchers.
This study reports description of informed consent and ethical approval in the published psychiatric research in the main journal of psychiatry in India. All original research articles (n=157) published in the Indian Journal of Psychiatry in the years 2000, 2003 to 2007 were included.
Informed consent was mentioned in 51% of studies in 2000, which gradually rose to 82% by the year 2007. Ethics committee approvals were mentioned in 2% of studies in 2000, and 25% of reports in 2007. Consent was reported to be written in only 40%, content of the consent forms was mentioned in 17%, and the language of consent form was reported in 3% of the studies where consent was reported.
Regulation of ethical principles and formulation of necessary guidelines or rules for research as well as for publications are necessary and desirable to ensure the safety of participants and good quality of research.
知情同意和伦理批准的报告是已发表论文的重要方面,这表明研究人员对研究伦理方面的了解和敏感性。
本研究报告了印度主要精神病学杂志上发表的精神病学研究中知情同意和伦理批准的描述。纳入了印度精神病学杂志 2000 年、2003 年至 2007 年发表的所有原始研究文章(n=157)。
2000 年,51%的研究提到了知情同意,到 2007 年逐渐上升到 82%。2000 年的研究中有 2%提到了伦理委员会的批准,而 2007 年的报告中有 25%提到了伦理委员会的批准。只有 40%的研究报告了书面同意,17%的研究报告了同意书的内容,3%的研究报告了同意书的语言。
有必要制定必要的伦理原则规定和指南或规则,以确保参与者的安全和研究质量。