Reliance
Reliance and Single IRB
The Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform, which is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. Smart IRB is not an IRB, but a master reliance agreement with many participating institutions, which are listed here. The Smart IRB master reliance agreement replaces the need to have an individual Institutional Authorization Agreement (IAA).
Texas Christian University is a participating institution of Smart IRB and this method can be utilized to complete the reliance process for a study being conducted with another Smart IRB participating institution. The TCU IRB can rely on any non-TCU IRB that has also signed on with Smart IRB.
TCU Smart IRB Process
If you think you will lead or participate in multi-site research involving human subject participants, first research out to the collaborating institutions to find their preferred method of reaching reliance via Smart IRB or IAAs.
Please make sure you select the appropriate option in Cayuse HE for Reviewing or Relying when asked about multi-site research when creating your initial submission or amendment modification. Complete the multi-site section of your Cayuse HE submission. Once your submission has been approved you can proceed to request investigator access to Smart IRB (decide who will complete to online application) and complete and submit the application. The Office of Research Compliance can only review the application after it is submitted. Please do not communicate to another institution that TCU IRB is willing to pursue a reliance agreement until you have received confirmation/approval back from the TCU IRB.
Smart IRB online reliance system
The online Smart IRB reliance system allows research teams to submit an electronic request to utilize the Smart IRB master reliance agreement for the reliance process. The request is typically initiated by the Lead study team whose IRB will be serving as the IRB of Record for all sites. Each person requiring access to the online reliance system will need to submit a separate request for access to the system (https://reliance.smartirb.org/invitations/new).
Upon approval and if you are a part of the Lead study team, the next steps are required to proceed with entering the request in the online system and provide:
- Basic information about the research (title of study and a brief description)
- Name of Principal Investigator
- List the engaged sites which are requesting to cede review to the IRB of Record
- Identify activities and study team personnel at each site (be specific)
- Upload the research protocol and consent form templates and any local context from other institutions
Before Beginning Research Activities
Reliance decisions in Smart IRB apply only to the determination of IRB reliance and do not reflect IRB approval for the research project itself. Approval for each collaborating institution must be obtained from the overall IRB of Record prior to beginning research with that site or its collaborators.
Please note: If the reliance request was initiated after the reviewing IRB approved the study, the addition of sites and/or collaborators will need to be specifically review and approved, which is usually accomplished via a modification to the existing study. You will then login to Smart IRB reliance system to submit a site amendment to add the additional site(s).
Additional resources are available on the Smart IRB webpage (https://smartirb.org/resources/) some resources documents can be found here.
