Caruso Rebecca, Myatt Theodore, Bierer Barbara E
Harvard Medical School, Boston, MA, USA.
Brigham and Women's Hospital, Boston, MA, USA.
J Clin Transl Sci. 2020 Feb 26;4(2):90-95. doi: 10.1017/cts.2019.405. eCollection 2020 Apr.
Increasingly, basic, translational, and clinical research has become more collaborative, resulting in multi-institutional studies that involve common approaches to a central question. For multi-institutional projects that involve recombinant or synthetic nucleic acids, Institutional Biosafety Committee (IBC) review is generally required at each separate site. Duplicative review may result in both administrative costs and delays, without evidence of increased safety or protections, and investigator frustration. To address these inefficiencies, IBC leaders drafted a collaborative IBC Reliance Authorization Agreement. The Agreement allows one or more institutions to cede IBC review to a reviewing IBC that accepts the responsibility. The ability to cede IBC review, and the ability to rely on one decision on behalf of all collaborating institutions for a given protocol, removes delays in approval of multi-center protocols, and collaborating principal investigators are able to focus on research rather than administrative tasks. In the process, we found promotion of this collaborative model led to stronger connections among institutions and among IBC members. The requirement for IBC member representation from the local community, however, limits its broader dissemination; we make several recommendations to mitigate this challenge.
基础研究、转化研究和临床研究越来越趋于合作化,从而产生了多机构研究,这些研究针对核心问题采用共同的方法。对于涉及重组或合成核酸的多机构项目,通常需要在每个独立的地点接受机构生物安全委员会(IBC)的审查。重复审查可能会导致行政成本增加和延误,却没有证据表明安全性或保护措施得到了提高,还会让研究人员感到沮丧。为了解决这些低效问题,IBC的负责人起草了一份合作性的IBC信赖授权协议。该协议允许一个或多个机构将IBC审查工作让渡给承担责任的审查IBC。让渡IBC审查的能力,以及代表所有合作机构就给定方案依赖一个决定的能力,消除了多中心方案批准过程中的延误,合作的主要研究人员能够专注于研究而非行政任务。在此过程中,我们发现推广这种合作模式加强了机构之间以及IBC成员之间的联系。然而,要求IBC成员中有来自当地社区的代表,这限制了该模式的更广泛传播;我们提出了几项建议来应对这一挑战。