授权协议

如果你 是 conducting research at 电子游戏软件 in conjunction with another university, 医院, or other institution that has an IRB, you may request an IRB Authorization Agreement (IAA), also known as a Single IRB or Reliance Agreement.

什么是IAA?

An IAA is an agreement between multiple IRBs to cede review to one of the IRBs engaged in the research (the IRB of record). An IAA is helpful because it takes the burden off the PI to have to submit revisions, 修正案, 等. to multiple IRBs for the same study. 用IAA, the PI can submit any changes to ONE institution (the IRB of record), who then reviews and approves the protocol. The PI has the responsibility of sending the other IRBs (the relying IRBs) any updated approvals from the IRB of record to keep on file.

How do I decide who the IRB of record is?

通常, the IRB of record is the IRB where the majority of the research will be conducted, 主要资助对象, or the institution that the main PI is affiliated with. Sometimes it is best to choose an institution whose IRB has expertise reviewing the type of research that is proposed in the protocol.  如果你 是 unsure of which IRB should act as the IRB of record, you should first discuss this with your co-PIs. If it still is not clear who is better suited to be the IRB of record, you can send us an email at irb@hjexports.net and we can help guide you.

我如何申请IAA?

电子游戏软件 is a participating institution in 聪明的IRB. 聪明的IRB is a platform designed to ease challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy. 它是一个综合的, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, 无论资金状况如何.

The method for requesting an authorization agreement depends on whether the site(s) you 是 working with 是 also 聪明的IRB members. 首先，询问你的合伙人 检查在这里 to see whether the other institution is a member of the 聪明的IRB system. See the table below to understand what you will need to do, depending on whether or not the partnering institution is part of 聪明的IRB, and whether or not BC is the IRB of record.

For those using the 聪明的IRB system for the first time, we ask that you watch this 11 minute video for an overview of the process: Online Smart IRB Reliance System.

接下来会发生什么?

如果你 是 utilizing the 聪明的IRB system, each institution will work together to determine the reviewing institution and finalize the agreement. If BC is the IRB of record you will then need to submit a Cyber IRB application. We will process it just like we would process a regular IRB application.

如果你 不 utilizing the 聪明的IRB system, you’ll submit through Cyber IRB only. With the information provided in your application, our staff will contact the other IRB and initiate the authorization agreement.  A form will be signed by each institution to finalize the agreement. Once the form is signed by all signatory officials, your agreement has been executed. We will send you the fully executed agreement via e-mail, and an official IRB approval letter (if we 是 the IRB of record). The amount of time this process takes is dependent on how quickly the other institution reviews and signs off on the authorization agreement.

请注意

IAAs 是 only executed between IRBs that 是 both engaged in the research. 如果你 是 simply recruiting participants and collecting data at another institution, but that institution is not engaged (researchers working on the study) in the research, it would simply be considered a research site, and an IAA would not be appropriate. (See here and here for OHRP’s definition of institutions engaged in research)