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NIH拟通过加强使用单独伦理委员会(IRB)加快临床研究启动

2014年12月11日来自:药物临床试验网 作者:翻译:刘丽娜 点击:
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美国国立卫生研究院(NIH)拟通过使用单独的伦理委员会(IRB)来加快临床研究启动的效率

        今天,美国国立卫生研究院(NIH)发出一份草案,以推动在多中心临床试验中使用单独的伦理委员会(IRB)。伦理委员会(IRB)在确保临床试验中伦理行为方面有极其重要的作用,一项研究若想顺利开展,必须先获得伦理委员会(IRB)的审核与批准。在刚开始出现对受试者进行保护的法规时,临床试验大多只在一家中心进行。慢慢的,研究蓝图开始被设想,并且越来越多的试验开始在多个中心实施,规模越来越大。多中心的临床试验可以在更广泛的人群中获得受试者,并且也能在相对较短的时间内获得临床上的重要结果。然而,每一家研究中心都要获得伦理审查,不仅没有增加对受试者的保护,反而拖延了获得临床数据的时间。

  该政策中提议,所有由NIH资助的、在美国开展的多中心研究,无论是通过授权赞助,合约还是内部程序支持,都应当使用单独的IRB,除非在联邦或州法规中有明确规定或为满足特殊人群需求,则须当地IRB审核。通过在多中心的临床试验中广泛使用单独的伦理委员会(IRB),NIH资助的临床试验项目其中心启动效率将会得到很大的提升。

  “保证我们资助项目较高的伦理水平是非常重要的,”NIH总裁,医学博士Francis S. Collins说,“通过在多中心研究中使用单独的伦理委员会(IRB),我们可以减少重复劳动,加快重要研究的启动,节省时间及开支。”

  大量的NIH机构和中心已经开始支持在多中心研究中使用单独的伦理委员会(IRB),他们的经验已经证实了单独伦理委员会(IRB)模式的优势及可行性。例如,从1999年开始,美国国家癌症研究所(NCI)中心伦理委员会(IRB)承担所有NCI发起的临床试验伦理审查。美国国家神经性疾病和卒中研究所也在他们的神经性疾病研究及脑卒中研究中采用了单独的伦理委员会(IRB)。

刘丽娜:药物临床试验网志愿撰稿人,北京赛德盛医药科技股份有限公司CRC。曾就职于浙江贝达药业药物研发中心任纯化员,北京赛德盛医药科技股份有限公司质量培训部助理。
 

NIH takes step to speed the initiation of clinical research by ensuring use of single IRB

The National Institutes of Health issued a draft policy today to promote the use of single institutional review boards or IRBs, in multi-site clinical research studies.

IRBs play a critical role in assuring the ethical conduct of clinical research, and studies must be reviewed and approved by an IRB before they can begin.

When the regulations for protection of human subjects were first published, most clinical research was conducted at a single institution. Since then, the research landscape has evolved, and many studies are carried out at multiple sites and within large networks. Studies that go beyond a single site are often able to recruit more individuals from diverse populations.

These multi-site studies can often generate important results in less time. However, working through IRB review at each site can add delay without increasing the protections for the research participants in the study.

The draft NIH policy proposes that all NIH-funded, multi-site studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program, should use a single IRB.

Exceptions to the policy would be allowed if local IRB review is necessary to meet the needs of specific populations or where it is required by federal, state or tribal laws or regulations.

Wider use of single IRB review in multi-site studies will help achieve greater efficiencies in the initiation of studies across NIH’s entire clinical research portfolio.

“Maintaining the highest ethical standards in the research we fund is of utmost importance,” said NIH Director Francis S. Collins, M.D., Ph.D. “By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”

A number of NIH institutes and centers have been supporting the use of a single IRB in multi-site studies, and their experiences have shown the benefits and feasibility of the single IRB review model.

Examples include the National Cancer Institute’s (NCI) Central Institutional Review Board, which has been in place for the review of NCI-sponsored clinical trials since 1999.

 

The National Institute of Neurological Disorders and Stroke has also incorporated the use of a single IRB for its Network for Excellence in Neuroscience Clinical Trials’ (NeuroNEXT) and its stroke research network, NIH StrokeNET.
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