Shah Pruthak C, Panchasara Ashwin K, Barvaliya Manish J, Tripathi C B
Student, Department of Pharmacology, Government Medical College , Bhavnagar, Gujarat, India .
Assistant Professor, Department of Pharmacology, GMERS Medical College , Sola, Ahmedabad, Gujarat, India .
J Clin Diagn Res. 2016 Sep;10(9):FC10-FC12. doi: 10.7860/JCDR/2016/18393.8488. Epub 2016 Sep 1.
Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC).
To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital.
The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents.
Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases.
Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.
研究工作申请表是一项基本要求，需要与研究提案一并提交给伦理委员会（EC）。
检查提交给三级医院伦理委员会的申请表的完整性，并找出其中的错误。
对2014年1月至2015年6月期间提交给印度古吉拉特邦巴夫那加尔政府医学院机构审查委员会（IRB）的研究项目申请表进行分析，检查其在以下方面的完整性和错误情况：研究类型、研究调查人员信息、样本量、研究参与者、研究标题、所有调查人员的签名、监管批准、招募程序、对研究参与者的补偿、知情同意过程、资助者信息、利益冲突声明、数据存储和维护计划、患者信息表、知情同意书以及研究相关文件。
共分析了100份申请表。其中，98份是学术研究，2份是行业研究。大多数学术研究属于基础科学类型。在63.26%的研究中，研究类型在标题中未提及。8.16%的申请表未提及受试者的年龄组。在34.6%的知情同意书中，未提及研究的益处。3.06%的情况缺少调查人员/共同调查人员/部门负责人的签名。
我们的研究建议，如果调查人员在填写申请表时提高警惕，审查的效率和速度将会提高。定期会议将有助于解决与申请表内容相关的问题。如果所有伦理委员会都有通用的申请表，伦理委员会运作的一致性就能实现。
