沉默的大多数：谁在机构审查委员会会议上发言？
The silent majority: who speaks at IRB meetings?
作者信息
Candilis Philip J, Lidz Charles W, Appelbaum Paul S, Arnold Robert M, Gardner William, Myers Suzanne, Grudzinskas Albert J, Simon Lorna J
机构信息
Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA.
出版信息
IRB. 2012 Jul-Aug;34(4):15-20.
Abstract
Institutional review boards (IRBs) are almost universally considered over-worked and under-staffed, at the same time requiring substantial commitments of time and resources. Although some surveys report average IRB memberships of 15 persons or more, federal regulations require only five. We present data on IRB meetings at 8 of the top 25 NIH-funded academic medical centers in the U.S., indicating substantial contributions from primary reviewers and chairs during protocol discussions but little from other members. The implications of these data for current IRB functioning are discussed and an alternative model proposed.
摘要
机构审查委员会（IRB）几乎普遍被认为工作负担过重且人员配备不足，同时还需要投入大量的时间和资源。尽管一些调查显示IRB的平均成员人数为15人或更多，但联邦法规仅要求5人。我们展示了美国国立卫生研究院（NIH）资助的25家顶尖学术医疗中心中8家的IRB会议数据，这些数据表明在方案讨论期间，主要审查员和主席做出了重大贡献，而其他成员的贡献很少。我们讨论了这些数据对当前IRB运作的影响，并提出了一种替代模式。
相似文献
1
The silent majority: who speaks at IRB meetings?
IRB. 2012 Jul-Aug;34(4):15-20.
2
The paradoxical problem with multiple-IRB review.
N Engl J Med. 2010 Oct 21;363(17):1591-3. doi: 10.1056/NEJMp1005101. Epub 2010 Oct 13.
3
Alternatives to local institutional review board (IRB) system debated.
Hum Res Rep. 2006 Apr;21(4):1-2.
4
The need to understand IRB deliberations.
IRB. 2006 Jan-Feb;28(1):1-5.
5
IRB reform.
N Engl J Med. 2002 May 2;346(18):1402-4. doi: 10.1056/NEJM200205023461813.
6
The process is the product: a new model for multisite IRB review of data-only studies.
IRB. 2010 May-Jun;32(3):1-6.
7
Community vs. enclave: the moral voice of community can be reflected in IRB composition.
Prot Hum Subj. 2002 Summer-Fall(7):6.
8
Research subject complains about how she was treated by an institutional review board (IRB).
Hum Res Rep. 2005 Dec;20(12):7.
9
Where the innocent bear the consequences: lessons from an institution's IRB crisis.
Bull Park Ridge Cent. 2000 Nov-Dec(18):11-2.
10
Status of Institutional Review Board Meetings Conducted Through Web Conference Systems in Japanese National University Hospitals During the COVID-19 Pandemic: Questionnaire Study.
J Med Internet Res. 2020 Nov 19;22(11):e22302. doi: 10.2196/22302.
引用本文的文献
1
Institutional Review Board Use of Outside Experts: What Do We Know?
Ethics Hum Res. 2022 Mar;44(2):26-32. doi: 10.1002/eahr.500121.
2
Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.
AJOB Empir Bioeth. 2021 Jan-Mar;12(1):33-40. doi: 10.1080/23294515.2020.1818877. Epub 2020 Sep 25.
3
Evaluating IACUCs: Previous Research and Future Directions.
J Am Assoc Lab Anim Sci. 2020 Nov 1;59(6):656-664. doi: 10.30802/AALAS-JAALAS-20-000077. Epub 2020 Sep 14.
4
Institutional Review Board Assessment-Balancing Efficiency and Quality.
Ochsner J. 2020 Spring;20(1):50-55. doi: 10.31486/toj.19.0075.
5
Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.
AJOB Empir Bioeth. 2018 Jul-Sep;9(3):164-172. doi: 10.1080/23294515.2018.1510437. Epub 2018 Oct 4.
6
Factors Influencing IACUC Decision Making: Who Leads the Discussions?
J Empir Res Hum Res Ethics. 2017 Oct;12(4):209-216. doi: 10.1177/1556264617717827. Epub 2017 Jun 29.
7
Barriers to Effective Deliberation in Clinical Research Oversight.
HEC Forum. 2016 Sep;28(3):245-59. doi: 10.1007/s10730-015-9298-0.
8
Those Responsible for Approving Research Studies Have Poor Knowledge of Research Study Design: a Knowledge Assessment of Institutional Review Board Members.
Acta Inform Med. 2015 Aug;23(4):196-201. doi: 10.5455/aim.2015.23.196-201. Epub 2015 Jul 30.
9
Decision Making and the IACUC: Part 1- Protocol Information Discussed at Full-Committee Reviews.
J Am Assoc Lab Anim Sci. 2015 Jul;54(4):389-98.
10
Redressing past wrongs: changing the common rule to increase minority voices in research.
Am J Public Health. 2013 Dec;103(12):2136-40. doi: 10.2105/AJPH.2013.301356. Epub 2013 Oct 17.
本文引用的文献
1
How closely do institutional review boards follow the common rule?
Acad Med. 2012 Jul;87(7):969-74. doi: 10.1097/ACM.0b013e3182575e2e.
2
Effects of local institutional review board review on participation in national practice-based research network studies.
Arch Pediatr Adolesc Med. 2009 Dec;163(12):1130-4. doi: 10.1001/archpediatrics.2009.206.
3
Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts.
Clin Infect Dis. 2009 Aug 1;49(3):328-35. doi: 10.1086/605454.
4
Variability in institutional approaches to ethics review of community-based research conducted in collaboration with unaffiliated organizations.
J Empir Res Hum Res Ethics. 2008 Jun;3(2):69-76. doi: 10.1525/jer.2008.3.2.69.
5
Survey of U.S. Boards that Review Mental Health-related Research.
J Empir Res Hum Res Ethics. 2008 Dec;3(4):71-9. doi: 10.1525/jer.2008.3.4.71.
6
Survey of u.s. Human research protection organizations: workload and membership.
J Empir Res Hum Res Ethics. 2008 Dec;3(4):57-69. doi: 10.1525/jer.2008.3.4.57.
7
Universal and uniform protections of human subjects in research.
Am J Bioeth. 2008 Nov;8(11):3-5. doi: 10.1080/15265160802513077.
8
Variability in the costs of institutional review board oversight.
Acad Med. 2006 Aug;81(8):708-12. doi: 10.1097/00001888-200608000-00006.
9
The cost of institutional review boards in academic medical centers.
N Engl J Med. 2005 Apr 28;352(17):1825-7. doi: 10.1056/NEJM200504283521723.
10
Regional ethics organizations for protection of human research participants.
Nat Med. 2004 Dec;10(12):1283-8. doi: 10.1038/nm1204-1283.
Zotero 插件