Meyer Esmeralda L, Jenkins Chris, Rengarajan Kalpana
Emory University, Environmental Health and Safety Office, Atlanta, GA, USA.
Clinical Biosafety Services, Wildwood, MO, USA.
Appl Biosaf. 2019 Dec 1;24(4):179-181. doi: 10.1177/1535676019871146.
Following the required review period initiated in August 2018, the Department of Health and Human Services, National Institutes of Health (NIH), published the final changes to the Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) in April 2019. This amendment focused on the review, registration, and reporting requirements for human gene transfer studies. In addition, the Recombinant DNA Advisory Committee (RAC) was renamed the Novel and Exceptional Technology and Research Advisory Committee (NeXTRAC) to serve as an advisory body on emerging technologies.
在2018年8月启动所需的审查期之后,美国卫生与公众服务部国立卫生研究院(NIH)于2019年4月发布了《涉及重组或合成核酸分子的研究指南》(《NIH指南》)的最终修订内容。此次修订重点关注人类基因转移研究的审查、注册和报告要求。此外,重组DNA咨询委员会(RAC)更名为新型特殊技术与研究咨询委员会(NeXTRAC),以作为新兴技术的咨询机构。