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The NIH Office of Biotechnology Activities Site Visit Program: Observations About Institutional Oversight of Recombinant and Synthetic Nucleic Acid Molecule Research

机译:美国国立卫生研究院生物技术活动办公室实地考察计划:关于重组和合成核酸分子研究的制度监督的观察

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摘要

Institutions that receive National Institutes of Health (NIH) funding for research involving recombinant or synthetic nucleic acid molecules are required, as a term and condition of their funding, to comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) (). Under the NIH Guidelines, institutions must establish and register an Institutional Biosafety Committee (IBC) with the NIH. The IBC is then responsible for reviewing and approving research projects subject to the NIH Guidelines. The IBC review of projects involving recombinant or synthetic nucleic acid molecules is critical to ensuring that such research is conducted in a safe and responsible manner.In 2006, staff from NIH began conducting educational site visits to institutions that had an IBC registered with NIH. The purpose of these site visits is to assist IBCs with their institutional programs of oversight for recombinant or synthetic nucleic molecules. Based on our findings, the site visit program has been beneficial to institutional biosafety programs. The information gathered during the site visits has allowed NIH to tailor its educational materials to help institutions address their oversight challenges. Additionally, since NIH’s visits are primarily educational in nature, we have been able to foster a positive environment in which IBC members and staff feel comfortable reaching out to NIH for advice and assistance.
机译:作为资助的条款和条件,需要获得美国国立卫生研究院(NIH)资助用于涉及重组或合成核酸分子研究的机构,以遵守《 NIH涉及重组或合成核酸分子的研究指南》(NIH指南) )()。根据《 NIH指南》,机构必须在NIH上建立并注册机构生物安全委员会(IBC)。然后,IBC负责根据NIH指南审查和批准研究项目。 IBC对涉及重组或合成核酸分子的项目的审查对于确保以安全和负责任的方式进行此类研究至关重要。2006年,NIH的工作人员开始对已在NIH注册IBC的机构进行教育性实地考察。这些实地考察的目的是帮助中型散货箱进行重组或合成核酸分子的机构监督计划。根据我们的发现,实地考察计划对机构生物安全计划很有帮助。 NIH在现场访问期间收集的信息使NIH可以定制其教育材料,以帮助机构应对其监管挑战。此外,由于NIH的访问主要是教育性质的活动,因此我们能够营造一个积极的环境,在这种环境中,IBC成员和员工可以轻松地向NIH寻求建议和帮助。

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