美国学术医疗中心利益冲突政策与报告做法的比较。
Comparison of conflict of interest policies and reported practices in academic medical centers in the United States.
作者信息
Dinan Michaela A, Weinfurt Kevin P, Friedman Joëlle Y, Allsbrook Jennifer S, Gottlieb Julie, Schulman Kevin A, Hall Mark A, Dhillon Jatinder K, Sugarman Jeremy
机构信息
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, NC 27715, USA.
出版信息
Account Res. 2006 Oct-Dec;13(4):325-42. doi: 10.1080/08989620601003414.
Abstract
The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.
摘要
作者们审查了美国9家学术医疗中心的利益冲突政策，并采访了这些机构的机构审查委员会（IRB）和利益冲突委员会（COIC）的成员。他们发现，许多机构用于报告和管理利益冲突的流程比其政策中描述的流程更加分散。此外，大多数机构没有明确和全面的政策来指导研究人员向潜在研究参与者披露利益冲突。IRB和COIC官员在对利益冲突政策的理解上存在相当大的差异。
相似文献
1
Comparison of conflict of interest policies and reported practices in academic medical centers in the United States.美国学术医疗中心利益冲突政策与报告做法的比较。
Account Res. 2006 Oct-Dec;13(4):325-42. doi: 10.1080/08989620601003414.
2
Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.学术医疗中心向潜在研究参与者披露经济利益冲突的政策。
Acad Med. 2006 Feb;81(2):113-8. doi: 10.1097/00001888-200602000-00003.
3
Policies and management of conflicts of interest within medical research institutional review boards: results of a national study.医学研究机构审查委员会内部利益冲突的政策与管理：一项全国性研究的结果
Acad Med. 2009 Apr;84(4):488-94. doi: 10.1097/ACM.0b013e31819a8ae7.
4
"Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest.“同一俱乐部的成员”：美国机构审查委员会在识别和管理利益冲突方面面临的挑战和决策。
PLoS One. 2011;6(7):e22796. doi: 10.1371/journal.pone.0022796. Epub 2011 Jul 29.
5
Responses of medical schools to institutional conflicts of interest.医学院校对机构利益冲突的应对措施。
JAMA. 2008 Feb 13;299(6):665-71. doi: 10.1001/jama.299.6.665.
6
Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators.披露临床研究中的利益冲突：机构审查委员会、利益冲突委员会及研究者的观点
J Law Med Ethics. 2006 Fall;34(3):581-91, 481. doi: 10.1111/j.1748-720x.2006.00072.x.
7
Fraud, conflict of interest, and other enforcement issues in clinical research.临床研究中的欺诈、利益冲突及其他执法问题。
Cleve Clin J Med. 2007 Mar;74 Suppl 2:S63-7; discussion S68-9. doi: 10.3949/ccjm.74.suppl_2.s63.
8
American Society of Clinical Oncology policy statement: oversight of clinical research.美国临床肿瘤学会政策声明：临床研究监督
J Clin Oncol. 2003 Jun 15;21(12):2377-86. doi: 10.1200/JCO.2003.04.026. Epub 2003 Apr 29.
9
National evaluation of policies on individual financial conflicts of interest in Canadian academic health science centers.加拿大学术健康科学中心个人财务利益冲突政策的全国性评估。
J Gen Intern Med. 2008 Nov;23(11):1896-903. doi: 10.1007/s11606-008-0752-4. Epub 2008 Aug 21.
10
Creating an institutional conflict-of-interest policy at Johns Hopkins: progress and lessons learned.在约翰霍普金斯大学制定机构利益冲突政策：进展与经验教训。
Cleve Clin J Med. 2007 Mar;74 Suppl 2:S70-2; discussion S77-80. doi: 10.3949/ccjm.74.suppl_2.s70.
引用本文的文献
1
Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.机构审查委员会给研究带来的负担：证据现状及其对监管改革的影响。
Milbank Q. 2011 Dec;89(4):599-627. doi: 10.1111/j.1468-0009.2011.00644.x.
2
Key personnel and "long distance" settings: determining who must report financial conflict of interest.关键人员和“远距离”设置：确定谁必须报告财务利益冲突。
Account Res. 2010 Jul;17(4):211-22. doi: 10.1080/08989621.2010.493096.
3
Nine key functions for a human subjects protection program for community-engaged research: points to consider.社区参与研究的人体受试者保护计划的九项关键功能：需考虑的要点。
J Empir Res Hum Res Ethics. 2010 Mar;5(1):33-47. doi: 10.1525/jer.2010.5.1.33.
4
Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings.对学术和非学术环境中商业赞助研究的财务利益冲突的监督。
J Gen Intern Med. 2010 May;25(5):460-4. doi: 10.1007/s11606-010-1264-6. Epub 2010 Feb 26.
5
Community hospital oversight of clinical investigators' financial relationships.社区医院对临床研究人员财务关系的监督。
IRB. 2009 Jan-Feb;31(1):7-13.
6
National evaluation of policies on individual financial conflicts of interest in Canadian academic health science centers.加拿大学术健康科学中心个人财务利益冲突政策的全国性评估。
J Gen Intern Med. 2008 Nov;23(11):1896-903. doi: 10.1007/s11606-008-0752-4. Epub 2008 Aug 21.
本文引用的文献
1
Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators.披露临床研究中的利益冲突：机构审查委员会、利益冲突委员会及研究者的观点
J Law Med Ethics. 2006 Fall;34(3):581-91, 481. doi: 10.1111/j.1748-720x.2006.00072.x.
2
Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure.潜在研究参与者对经济利益冲突的看法：有效披露的障碍与机遇
J Gen Intern Med. 2006 Sep;21(9):901-6. doi: 10.1111/j.1525-1497.2006.00502.x.
3
Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.学术医疗中心向潜在研究参与者披露经济利益冲突的政策。
Acad Med. 2006 Feb;81(2):113-8. doi: 10.1097/00001888-200602000-00003.
4
Financial anatomy of biomedical research.生物医学研究的资金剖析
JAMA. 2005 Sep 21;294(11):1333-42. doi: 10.1001/jama.294.11.1333.
5
Bounty-hunting and finder's fees.赏金狩猎与中介费。
IRB. 2005 May-Jun;27(3):16-9.
6
Implementation of financial disclosure policies to manage conflicts of interest.实施财务披露政策以管理利益冲突。
Health Aff (Millwood). 2004 Mar-Apr;23(2):206-14. doi: 10.1377/hlthaff.23.2.206.
7
Financial conflict-of-interest policies in clinical research: issues for clinical investigators.临床研究中的财务利益冲突政策：临床研究人员面临的问题。
Acad Med. 2003 Aug;78(8):769-74. doi: 10.1097/00001888-200308000-00002.
8
American Society of Clinical Oncology: revised conflict of interest policy.美国临床肿瘤学会：修订后的利益冲突政策。
J Clin Oncol. 2003 Jun 15;21(12):2394-6. doi: 10.1200/JCO.2003.04.524. Epub 2003 Apr 29.
9
10
Financial conflict of interest: an unresolved ethical frontier.利益冲突：一个尚未解决的道德前沿问题。
Am J Law Med. 2001;27(2-3):149-62.
Zotero 插件