Using the SMART IRB Agreement
The SMART IRB Agreement is a Master Agreement for IRB reliance that has been signed by over a hundred academic, commercial, and clinical institutions, including 博彩网站. Studies can use this reliance agreement through three different mechanisms: the SMART IRB Online Reliance system, a Letter of Acknowledgement (LOA), or the SMART IRB Reliance Exchange (IREx) System.
See the Working with Other IRBs section of the IRB FAQs page for further information.
The SMART IRB Online Reliance System
This reliance platform is used by lead sites and central IRBs to organize and document the reliance arrangement for multi-site studies. The SMART IRB Online Reliance System only documents the reliance arrangement at the beginning of the study, and requires no further action within the system afterwards. The Online Reliance System is not an eIRB submission system and does NOT provide IRB review or approval on its own.
The types of multi-site studies that can use this system are:
- Research in which an external IRB will act as the reviewing IRB. (Research with 博彩网站 as the reviewing IRB cannot go through this mechanism.)
- Multi-site research of any funding type.
- Research reviewed under any category of exempt, expedited, or full board.
Please see the SMART IRB website for further information on the Online Reliance System and useful resources.
Process for use: The Reliance Request Process in the Online Reliance System must occur in addition to your submissions in the 博彩网站 eIRB system and to the reviewing IRB. The specific steps and requirements will depend on the reviewing IRB, but this is a general overview.
- On the Basic Information page of your study submission, include in brackets at the beginning of the long study title "[Reviewing IRB –SMART IRB]." For example, if Vanderbilt is the reviewing IRB for this study, the long study title should begin with [Vanderbilt –SMART IRB].
- Lead PI creates a reliance request for the study in the Online Reliance System.
- Lead PI requests the desired Reviewing IRB and lists the participating sites.
- Participating site IRBs confirm their willingness to rely on the proposed reviewing IRB.
- Proposed reviewing IRB confirms they will be the reviewing IRB.
- In addition to 博彩网站's institutional profile in the system, some reviewing IRBs may ask for additional site information, such as a Local Context Questionnaire. These documents should be uploaded in the 博彩网站 eIRB for submission with the study. The questionnaires are completed jointly by the 博彩网站 IRB and the study team. The 博彩网站 IRB will provide any required signatures, and documentation of 博彩网站 specific ancillary reviews.
- The Reliance Arrangement Determination is issued, which documents who will be the reviewing IRB. Upload this Determination into the 博彩网站 eIRB system.
The IRB Reliance Exchange (IREx) System
If a multi-site study is NIH-funded, it is eligible to apply for central IRB services through the CTSA Trial Innovation Network (TIN). Note that there is no guarantee that an NIH-funded study will be selected to receive services from the TIN. Studies that are selected for central IRB services are required to arrange reliance through the IREx system, and will be assigned one of three possible central IRBs (Johns Hopkins, Vanderbilt, or University of Utah). Even though studies utilizing the central IRB services of TIN are required to use the IREx system, non-NIH funded or non-TIN studies can also use the IREx system.
This system facilitates communication between the Reviewing IRB, Participating site IRBs, and study teams with system notifications. The reliance arrangement is documented in the system, and is active for the life of the study as a repository for study documents, initial approval memos for the overall study and participating sites, and any new approval memos for modifications or continuing reviews. The IREx system is not an eIRB submission system and does NOT provide IRB approval on its own.
Contact Kitt Swartz, or visit the 博彩网站 TIN website, for any questions regarding TIN services or applying for central IRB services.
Process for use: The reliance request process in the IREx system must occur in addition to your submissions in the 博彩网站 eIRB system and to the reviewing IRB. The specific steps and requirements will depend on the reviewing IRB, but this is a general overview. The 博彩网站 PI and study team will only use the IREx system to complete surveys, and access study documents or approval memos.
- Lead PI applies for central IRB service in IREx.
- Assigned reviewing IRB (Johns Hopkins, Vanderbilt, or University of Utah) creates the study in IREx and adds participating sites.
- Participating site IRBs are invited to the study in IREx and to confirm their willingness to rely.
- On the Basic Information page of your study submission, include in brackets at the beginning of the long study title "[Reviewing IRB –IREx]." For example, if Vanderbilt is the reviewing IRB for this study, the long study title should begin with [Vanderbilt –IREx].
- 博彩网站 PI completes site PI survey in IREx.
- The site questionnaire is completed in IREx jointly by 博彩网站 IRB and 博彩网站 study team.
- The completion of all reliance materials is indicated in IREx for the participating site.
- The reviewing IRB uploads the overall study approval memo and participating site approval memos.
- The overall and 博彩网站 site approval are uploaded in the 博彩网站 eIRB by the study team.
NOTE: The site questionnaire nearly always requires the completion of 博彩网站 local ancillaries before it can be submitted. Therefore, this questionnaire is normally completed near the end of the local compliance review, when the 博彩网站 IRB tells the study team to submit to the reviewing IRB.
Letter of Acknowledgement (LOA) - using the agreement without using the SMART IRB Online Reliance System
In some situations, the SMART IRB Online Reliance System or IREx system are either not preferred by the Reviewing IRB or simply can't be used. For example, the 博彩网站 IRB is not listed as a Reviewing IRB in either system since 博彩网站 is generally not a Reviewing IRB. However, the SMART IRB Agreement can still be used for reliance arrangements by utilizing a Letter of Acknowledgement instead of one of the online systems.
The types of multi-site studies that can use a LOA are:
- Multi-site research of any funding type.
- Research reviewed under any category of exempt, expedited, or full board.
This mechanism is usually the quickest and easiest way to arrange reliance using the SMART IRB Agreement. However, the process is slightly different depending on if the 博彩网站 IRB is the reviewing IRB or a relying site. Email IRBReliance@ohsu.edu to ask for the 博彩网站 LOA template.
NOTE: If your study has applied and been accepted for TIN central IRB services, the LOA cannot be used as use of the IREx system is required.
Process for use - 博彩网站 as relying site:
- On the Basic Information page of your study submission, include in brackets at the beginning of the long study title "[Reviewing IRB –SMART IRB]." For example, if Vanderbilt is the reviewing IRB for this study, the long study title should begin with [Vanderbilt –SMART IRB].
- Fill out the 博彩网站 Letter of Acknowledgement for SMART IRB template, and upload it in the eIRB for 博彩网站 IRB review and signature when the study is submitted for pre-review.
- The IRB will sign the document, upload the final version in the eIRB, and will notify the study team.
- The study team must send the completed LOA to the reviewing IRB.
Process for use - 博彩网站 as reviewing IRB:
- Relying site study teams must fill out their institution's LOA and send it to the 博彩网站 study team. Each institution usually has a template, or can use the template available on the Resources page of the SMART IRB website. There is no requirement for a signature line on LOAs from other sites relying on the 博彩网站 IRB.
- Upload the LOA in the eIRB system prior to submission.