Suppr超能文献

实时机构审查委员会:一项减少机构审查委员会审查时间的合作创新。

The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.

作者信息

Spellecy Ryan, Eve Ann Marie, Connors Emily R, Shaker Reza, Clark David C

机构信息

1 Medical College of Wisconsin, Milwaukee, USA.

出版信息

J Empir Res Hum Res Ethics. 2018 Oct;13(4):432-437. doi: 10.1177/1556264618780803. Epub 2018 Jun 14.

Abstract

Lengthy review times for institutional review boards (IRBs) are a well-known barrier to research. In response to numerous calls to reduce review times, we devised "Real-Time IRB," a process that drastically reduces IRB review time. In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%. While this process is time and resource intensive, and cannot address all delays in research, it shows great promise for increasing the pace by which research is translated to patient care.

摘要

机构审查委员会(IRB)冗长的审查时间是研究中一个众所周知的障碍。为响应众多缩短审查时间的呼声,我们设计了“实时IRB”流程,该流程可大幅减少IRB的审查时间。在此流程中,研究人员和研究团队成员参加IRB会议,并在IRB继续会议的同时对方案进行修改,以便在会议上即可获得最终批准。这使得从提交给IRB到最终批准的总时间减少了40%。虽然这个流程耗费时间和资源,且无法解决研究中的所有延误问题,但它在加快研究转化为患者护理的速度方面显示出了巨大潜力。

相似文献

1
The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.
J Empir Res Hum Res Ethics. 2018 Oct;13(4):432-437. doi: 10.1177/1556264618780803. Epub 2018 Jun 14.
2
Understanding institutional review boards: practical guidance to the IRB review process.
Nutr Clin Pract. 2007 Dec;22(6):618-28. doi: 10.1177/0115426507022006618.
3
American Society of Clinical Oncology policy statement: oversight of clinical research.
J Clin Oncol. 2003 Jun 15;21(12):2377-86. doi: 10.1200/JCO.2003.04.026. Epub 2003 Apr 29.
4
The Impact of Institutional Review Boards (IRBs) on Clinical Innovation: A Survey of Investigators and IRB Members.
J Empir Res Hum Res Ethics. 2015 Dec;10(5):481-7. doi: 10.1177/1556264615614936.
5
Do N-of-1 Trials Need IRB Review?
J Empir Res Hum Res Ethics. 2016 Jul;11(3):250-5. doi: 10.1177/1556264616662560.
9
Confidence of IRB/REC Members in Their Assessments of Human Research Risk: A Study of IRB/REC Decision Making in Action.
J Empir Res Hum Res Ethics. 2017 Jul;12(3):140-149. doi: 10.1177/1556264617710386. Epub 2017 May 30.
10
Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.
J Empir Res Hum Res Ethics. 2017 Jul;12(3):131-139. doi: 10.1177/1556264617704294. Epub 2017 Apr 16.

引用本文的文献

1
Institutional Review Board Use of Outside Experts: A National Survey.
AJOB Empir Bioeth. 2022 Oct-Dec;13(4):251-262. doi: 10.1080/23294515.2022.2090459. Epub 2022 Jun 24.
2
COVID-19 pandemic response varies by clinical trial sponsor type.
J Clin Transl Sci. 2021 Mar 16;5(1):e111. doi: 10.1017/cts.2021.25.
4
Reimagining IRB review to incorporate a clear and convincing standard of evidence.
Account Res. 2022 Jan;29(1):55-62. doi: 10.1080/08989621.2021.1880902. Epub 2021 Feb 8.
6
Operational Characteristics of Institutional Review Boards (IRBs) in the United States.
AJOB Empir Bioeth. 2019 Oct-Dec;10(4):276-286. doi: 10.1080/23294515.2019.1670276. Epub 2019 Oct 16.

本文引用的文献

1
Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.
J Empir Res Hum Res Ethics. 2017 Jul;12(3):131-139. doi: 10.1177/1556264617704294. Epub 2017 Apr 16.
2
Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards.
J Surg Res. 2016 Aug;204(2):481-489. doi: 10.1016/j.jss.2016.06.004. Epub 2016 Jun 8.
3
Ethical Issues and Practical Challenges in Suicide Research.
Crisis. 2017 Mar;38(2):107-114. doi: 10.1027/0227-5910/a000415. Epub 2016 Aug 26.
4
What scientists want from their research ethics committee.
J Empir Res Hum Res Ethics. 2006 Mar;1(1):67-82. doi: 10.1525/jer.2006.1.1.67.
6
Principal investigator views of the IRB system.
Int J Med Sci. 2008 Apr 2;5(2):68-72. doi: 10.7150/ijms.5.68.
8
Variation in institutional review board responses to a standard, observational, pediatric research protocol.
Acad Emerg Med. 2007 Apr;14(4):377-80. doi: 10.1197/j.aem.2006.11.031. Epub 2007 Feb 20.
9
Variation in Institutional Review processes for a multisite observational study.
Am J Surg. 2005 Nov;190(5):805-9. doi: 10.1016/j.amjsurg.2005.07.024.
10
Central challenges facing the national clinical research enterprise.
JAMA. 2003 Mar 12;289(10):1278-87. doi: 10.1001/jama.289.10.1278.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验