印度一家三级转介中心的一个研究部门在首次提交项目后,对机构伦理委员会提出的质疑进行了审计。

Q2 Medicine
Perspectives in Clinical Research Pub Date : 2023-04-01 Epub Date: 2022-11-29 DOI:10.4103/picr.picr_91_22
Jeffrey Pradeep Raj, Unnati Saxena, Nithya Jaideep Gogtay, Sandeep B Bavdekar, Urmila Mukund Thatte
{"title":"印度一家三级转介中心的一个研究部门在首次提交项目后,对机构伦理委员会提出的质疑进行了审计。","authors":"Jeffrey Pradeep Raj,&nbsp;Unnati Saxena,&nbsp;Nithya Jaideep Gogtay,&nbsp;Sandeep B Bavdekar,&nbsp;Urmila Mukund Thatte","doi":"10.4103/picr.picr_91_22","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants.</p><p><strong>Methods: </strong>Queries received after the initial review and replies sent by a single research department were evaluated. A content analysis was done to identify the domains and categories of queries. We categorized these queries as administrative, ethics related, and scientific. The impact of each query in improving the science or safeguarding the rights and safety of research participants (ethics) was evaluated by two authors of this manuscript: one affiliated and the other nonaffiliated to the institute. Kappa statistics were used to evaluate for agreement between the two.</p><p><strong>Results: </strong>A total of 13 studies (investigator-initiated studies [IISs]: 7 and pharmaceutical industry-sponsored studies [PSSs]: 6) formed the final sample size for analysis. The total number of queries was 364 (IIS: 106 and PSS: 258; <i>P</i> < 0.001). With regard to the categories, we found <i>n</i> = 42 (11.54%) to be irrelevant at that stage of the review process; <i>n</i> = 51 (14.01%) were about information already available which the IEC had missed; <i>n</i> = 67 (18.41%) queries where the IEC needed paraphrasing; n = 50 (13.74%) were entirely relevant with the need for further clarification; and n = 154 (42.31%) had been missed by the investigator during the initial submission. The overall agreement between the affiliated and unaffiliated investigators was just 12.9% (P < 0.001).</p><p><strong>Conclusions: </strong>We found that approximately 25% of the queries raised by the IEC were redundant. It is our opinion that this redundancy could have been channeled into greater focus on scientific and ethical aspects of the protocol. Ongoing dialog between investigators and ethics committees may help address this. Perspectives between the affiliated and the unaffiliated investigators with regard to the relevance of queries were grossly different.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/21/bb/PCR-14-86.PMC10267993.pdf","citationCount":"0","resultStr":"{\"title\":\"An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India.\",\"authors\":\"Jeffrey Pradeep Raj,&nbsp;Unnati Saxena,&nbsp;Nithya Jaideep Gogtay,&nbsp;Sandeep B Bavdekar,&nbsp;Urmila Mukund Thatte\",\"doi\":\"10.4103/picr.picr_91_22\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants.</p><p><strong>Methods: </strong>Queries received after the initial review and replies sent by a single research department were evaluated. A content analysis was done to identify the domains and categories of queries. We categorized these queries as administrative, ethics related, and scientific. The impact of each query in improving the science or safeguarding the rights and safety of research participants (ethics) was evaluated by two authors of this manuscript: one affiliated and the other nonaffiliated to the institute. Kappa statistics were used to evaluate for agreement between the two.</p><p><strong>Results: </strong>A total of 13 studies (investigator-initiated studies [IISs]: 7 and pharmaceutical industry-sponsored studies [PSSs]: 6) formed the final sample size for analysis. The total number of queries was 364 (IIS: 106 and PSS: 258; <i>P</i> < 0.001). With regard to the categories, we found <i>n</i> = 42 (11.54%) to be irrelevant at that stage of the review process; <i>n</i> = 51 (14.01%) were about information already available which the IEC had missed; <i>n</i> = 67 (18.41%) queries where the IEC needed paraphrasing; n = 50 (13.74%) were entirely relevant with the need for further clarification; and n = 154 (42.31%) had been missed by the investigator during the initial submission. The overall agreement between the affiliated and unaffiliated investigators was just 12.9% (P < 0.001).</p><p><strong>Conclusions: </strong>We found that approximately 25% of the queries raised by the IEC were redundant. It is our opinion that this redundancy could have been channeled into greater focus on scientific and ethical aspects of the protocol. Ongoing dialog between investigators and ethics committees may help address this. Perspectives between the affiliated and the unaffiliated investigators with regard to the relevance of queries were grossly different.</p>\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/21/bb/PCR-14-86.PMC10267993.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.picr_91_22\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/11/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.picr_91_22","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/11/29 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

摘要

引言:机构伦理委员会(IEC)在协议审查后提出质疑。这些查询的质量将是一个有用的衡量标准,用于评估IEC在保护参与者方面的基本作用。方法:对初步审查后收到的问题和单个研究部门发出的回复进行评估。进行了内容分析,以确定查询的域和类别。我们将这些问题分为行政、伦理和科学三类。这份手稿的两位作者评估了每一个问题在改善科学或保障研究参与者的权利和安全(伦理)方面的影响:一位隶属于该研究所,另一位非该研究所。Kappa统计数据用于评估两者之间的一致性。结果:共有13项研究(研究者发起的研究[IISs]:7项,制药行业发起的研究[PSS]:6项)形成了分析的最终样本量。查询总数为364(IIS:106,PSS:258;P<0.001)。就类别而言,我们发现n=42(11.54%)在审查过程的那个阶段无关紧要;n=51(14.01%)是关于IEC遗漏的现有信息;n=67(18.41%)询问IEC需要转述的地方;n=50(13.74%)与进一步澄清的必要性完全相关;研究者在初次提交时遗漏了n=154(42.31%)。附属和非附属研究人员之间的总体一致性仅为12.9%(P<0.001)。结论:我们发现IEC提出的问题中约有25%是多余的。我们认为,这种冗余本可以引导人们更加关注议定书的科学和伦理方面。调查人员和道德委员会之间正在进行的对话可能有助于解决这一问题。附属调查人员和非附属调查人员对查询相关性的看法大相径庭。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India.

Introduction: The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants.

Methods: Queries received after the initial review and replies sent by a single research department were evaluated. A content analysis was done to identify the domains and categories of queries. We categorized these queries as administrative, ethics related, and scientific. The impact of each query in improving the science or safeguarding the rights and safety of research participants (ethics) was evaluated by two authors of this manuscript: one affiliated and the other nonaffiliated to the institute. Kappa statistics were used to evaluate for agreement between the two.

Results: A total of 13 studies (investigator-initiated studies [IISs]: 7 and pharmaceutical industry-sponsored studies [PSSs]: 6) formed the final sample size for analysis. The total number of queries was 364 (IIS: 106 and PSS: 258; P < 0.001). With regard to the categories, we found n = 42 (11.54%) to be irrelevant at that stage of the review process; n = 51 (14.01%) were about information already available which the IEC had missed; n = 67 (18.41%) queries where the IEC needed paraphrasing; n = 50 (13.74%) were entirely relevant with the need for further clarification; and n = 154 (42.31%) had been missed by the investigator during the initial submission. The overall agreement between the affiliated and unaffiliated investigators was just 12.9% (P < 0.001).

Conclusions: We found that approximately 25% of the queries raised by the IEC were redundant. It is our opinion that this redundancy could have been channeled into greater focus on scientific and ethical aspects of the protocol. Ongoing dialog between investigators and ethics committees may help address this. Perspectives between the affiliated and the unaffiliated investigators with regard to the relevance of queries were grossly different.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信