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美国政府对临床和转化研究的要求。

US Government mandates for clinical and translational research.

机构信息

Department of Health Outcomes and Policy and Clinical and Translational Science Institute, College of Medicine, University of Florida, Gainesville, Florida, USA.

出版信息

Clin Transl Sci. 2012 Feb;5(1):83-4. doi: 10.1111/j.1752-8062.2011.00371.x. Epub 2012 Jan 10.

DOI:10.1111/j.1752-8062.2011.00371.x
PMID:22376263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5439907/
Abstract

This commentary is germane for clinical and translational researchers. Basic scientists may face different obstacles to developing their research careers. Over the past several years, the federal government has seen reductions in funding for extramural research. It seems that under the adverse economic forecasts, things are going to get worse. It might seem logical for the federal government to stretch whatever limited resources exist, by asking the institutions to cost-share greater fractions of the actual research costs, and as an incentive, avoid the imposition of unfunded mandates. But alas, although well intended, there have been expensive requirements imposed by the government, making it difficult for investigators and institutions to adequately fund and conduct their research and for scientific journals to maintain paying subscribers. Five prominent and costly changes, which are the focus of this commentary are (1) HIPAA, (2) http://ClinicalTrials.Gov, (3) Clinical and Translational Science Awards, (4) Upcoming rule changes for IRBs, and (5) PubMedCentral, each of which will be discussed in the ensuing paragraphs.

摘要

这篇评论与临床和转化研究人员有关。基础科学家在发展研究事业时可能会面临不同的障碍。在过去几年中,联邦政府的外部研究资金有所减少。在不利的经济预测下,情况似乎会变得更糟。联邦政府通过要求机构承担更多实际研究成本的份额,并作为激励避免实施未资助的任务,来利用现有的有限资源,这似乎合乎逻辑。但是,尽管意图良好,但政府已经实施了昂贵的要求,使得研究人员和机构难以充分为其研究提供资金并进行研究,也使得科学期刊难以维持付费订阅者。本评论重点讨论了五个突出且昂贵的变化,分别是(1)HIPAA、(2)ClinicalTrials.gov、(3)临床和转化科学奖、(4)即将对 IRB 进行的规则更改,以及(5)PubMedCentral,每个变化将在接下来的段落中进行讨论。

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本文引用的文献

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2
A randomized factorial trial of vitamins C and E and beta carotene in the secondary prevention of cardiovascular events in women: results from the Women's Antioxidant Cardiovascular Study.维生素C、维生素E和β-胡萝卜素用于女性心血管事件二级预防的随机析因试验:妇女抗氧化剂心血管研究结果
Arch Intern Med. 2007;167(15):1610-8. doi: 10.1001/archinte.167.15.1610.
3
Local perspective of the impact of the HIPAA privacy rule on research.《健康保险流通与责任法案》隐私规则对研究影响的本地视角
Cancer. 2006 Jan 15;106(2):474-9. doi: 10.1002/cncr.21599.
4
Health Insurance Portability Accountability Act (HIPAA) regulations: effect on medical record research.《健康保险流通与责任法案》(HIPAA)规定:对病历研究的影响。
Ann Surg. 2004 Jun;239(6):772-6; discussion 776-8. doi: 10.1097/01.sla.0000128307.98274.dc.
5
The HIPAA privacy rule: practical advice for academic and research institutions.《健康保险流通与责任法案》隐私规则:给学术和研究机构的实用建议。
Healthc Financ Manage. 2002 Feb;56(2):50-4.