IRB的依赖

IRB可靠性/单一IRB审查

When multiple institutions are engaged in one research project that involves human subjects, it often makes sense for only one of the institutions' IRB to conduct the review and approval of the study. 这就是所谓的IRB依赖，或者单一的IRB审查. 联邦资助的合作研究需要单独的IRB审查.  

If an newbb电子平台 researcher collaborating with another institution wishes for newbb电子平台 to serve as the IRB of record for a non-exempt study or wishes for newbb电子平台 to rely on the IRB review of the other institution, 授权协议必须到位. Authorization agreements must be signed by the Institutional Officials (IO) of both institutions. newbb电子平台 has master authorization agreements with several institutions with whom we frequently collaborate and participates in SMART IRB. newbb电子平台 can only enter into an IRB authorization agreement with an institution with an 现行联邦保险(FWA). If you have questions about the process, please contact the 研究合规办公室 (ORC), compliance@俄亥俄州.edu. 

豁免研究不需要IRB授权协议, 但是需要一些文件.  

 

 什么时候newbb电子平台会成为审查委员会  

你将像往常一样提交给newbb电子平台学术审查委员会. 在IRB协议中, please clearly indicate that the research team is requesting that newbb电子平台 serve as the reviewing IRB for another institution. 外部(非newbb电子平台)研究人员不被添加到Cayuse, 但有一个问题，您可以在文本框中列出它们. We recommend that these external researchers communicate with their own IRB office early on about their intent to be listed as personnel on the study; many institutions have their own internal processes that must be followed and, 在某些情况下, they may decline to have newbb电子平台 serve as the reviewing IRB and instead elect to conduct their own IRB review.   

当我们收到包含外部研究人员的IRB提交时, ORC will either reach out to the other institutions directly (for non-exempt research) or ask the study team to provide documentation that the external sites are aware of and have authorized the inclusion of their researchers on the protocol (exempt studies). 当需要新的IRB授权协议时, ORC将与其他机构一起促进这一进程.  

Please be aware that the additional steps for external researchers will likely prolong the IRB review process, as IRB approval cannot occur until all required documentation is finalized. 

newbb电子平台 reserves the right to decline to serve as the reviewing IRB for other sites.   

 

 什么时候newbb电子平台将成为依赖IRB(延期)

需要延期，当newbb电子平台教员, 工作人员, or students will be engaged in research with human subjects reviewed by another institution. 在提交延期之前, it is a good idea that the study team check in with the reviewing IRB to see if reliance will be possible; 在某些情况下, the external IRB may decline to serve as the reviewing IRB for non-federally funded research. 当这种情况发生时, the newbb电子平台 researchers must instead submit to an newbb电子平台 IRB for review and approval.  

请注意，根据newbb电子平台 政策19.052, approval of research by another IRB does not negate the need for IRB review at newbb电子平台 or, 代替newbb电子平台的IRB审查, 完全执行的IRB授权协议. newbb电子平台 must either approve the deferral or issue its own IRB approval before our researchers may begin the research activities regardless of IRB approval elsewhere. 

newbb电子平台 Heritage College of Osteopathic Medicine students need to submit a deferral request for all research activities conducted outside of newbb电子平台, even though in many cases the external site may consider you to be an affiliate of their institution at the time of the research activity. Currently enrolled medical students are always considered an agent of newbb电子平台 when engaged in research and scholarly activities, 根据传统骨科医学院 政策7.11.  

请求延期:  

  • 登录Cayuse Human Ethics并创建一个新的研究. 在研究中，开始一个新的初始提交.  

  • 当你看到初始提交表格的第二部分, 对于出现的第一个问题, 选择“是, 我正在提交延期申请." 

  • 回答出现的其余问题. 在页面底部，你可以附上相关的文件. 这些包括但不限于最近的IRB批准信, 将方案提交审查内部审查委员会, and a copy of any consent forms if newbb电子平台 researchers will be involved in explaining or obtaining consent. We will need something that shows the level of review (exempt, expedited, or full board).  

  • 在第5部分，研究团队，不要列出任何外部研究人员. PI应该是提交表格的人, 或者是否有多名newbb电子平台的研究人员被列入名单, PI应该是承担领导角色的人. (If additional newbb电子平台 researchers need to request a deferral later for the same study, this can be done via a modification request; a new deferral is not needed).  

  • 对于PI资格问题, you may enter "N/A" unless the overall project PI is an newbb电子平台 investigator (this is uncommon for deferrals).  

  • 对于COI问题，请只包括newbb电子平台的研究人员.  

  • 完成第6部分“研究经费”中的问题. 如果研究正在接受外部资助, please be sure to indicate in the “how will the funds be used” question whether newbb电子平台 will receive any of the funds, 直接或通过次级奖励.  

一旦提交完整，ORC将对提交进行审查. If the reviewing IRB is one with whom we do not have an existing IRB authorization agreement, 这项研究也不能幸免, 我们将联系审核委员会以促成新的协议. Please be aware that the timeline for this process can vary from days to weeks. If the study has received an exempt determination from another institution, newbb电子平台可能会选择接受这一决定, 或者我们可以选择进行我们自己的豁免审查. 

 

External 刊物特色dual Investigators Not Affiliated with an FWA-Holding institution 

If you are submitting to an newbb电子平台 IRB and your protocol includes external researchers who are not affiliated with another university or other FWA-holding institution, 那么IRB授权协议就不是合适的机制. 相反，外部研究人员需要签署一份文件 刊物特色双重调查员协议. 该协议也将由newbb电子平台签署 representative in the 研究部门 before final IRB approval is granted.  

 

国际研究  

Collaborative research with international institutions should be reviewed by both newbb电子平台 and the international IRB or equivalent. newbb电子平台不会放弃对国际机构的审查, 它也不会作为一个国际机构的审查委员会, 除非研究经费协议有要求. 在适当的时候, the newbb电子平台 IRB will incorporate the findings of the international IRB or ethics board into their review to ensure local context considerations are addressed.