Initiating an IAA | Determining the IoR | Documenting the Reliance | Using an External IRB | Local Context Review

IRB Authorization Agreement (IAA):  

An IRB Authorization Agreement (IAA) is a written agreement between two or more institutions used to document the delegation of IRB review responsibilities. This agreement may also be referred to as a reliance agreement or cede review agreement. Any non-Exempt research study in which Brown University is considered engaged is eligible for an IAA. Any US institutions engaged in a non-Exempt, federally-funded research study is required to comply with the single IRB Mandate (sIRB)

** In October, both OHRP and NIH released notices regarding an exception to the single IRB mandate for certain HHS conducted or supported cooperative research activities. This provision is in place primarily for clinical trials administering interventions related to COVID-19 or whose reliance agreements have been operationally disrupted by the pandemic. HRPP does not anticipate that this will be applicable to most Brown University research. Questions? Contact HRPP at [email protected]. 

Initiating an IAA at Brown

Whether we are acting as the IRB of Record or ceding review to another institution, all submissions should be completed and signed by the Brown researcher and submitted to [email protected].

Use the IAA Investigator Checklist to ensure all procedural requirements are met. 

If we are serving as the IRB of Record

 If we are the relying institution  

  • IAA Application for each relying site
     

  • For new studies  

  • For amendments 

    • Revised documents inclusive of new study sites and personnel reflecting any changes in procedure, recruiting and consenting  

  • IAA Application
     

  • Approved protocol with study materials including Brown University investigators and research activities from IRB of Record
     

  • IRB approval notice from IRB of Record

    • Initial submission or

    • Most recent continuing renewal

  • IAA Attestation
     

  • ​​Submissions to Advarra require a signed cover page. See below for further details.

 

 

 

HRPP will internally create an amendment once your study has been approved. This is a more efficient approach as it allows a timely approval of the study while accommodating the procedural demands of coordinating with the relying site. Additionally, relying sites generally want an approved protocol before agreeing to cede review. 

 

Determining the IRB of Record

There are several factors that can influence the decision on which site should maintain ethical oversight. In making this choice, the following factors could be components:

  • Sponsor Requirements

  • Prime Awardee

  • Home Institution of the overall Principal Investigator

  • Location of Research Activities

  • Location of Data Storage and Analysis

  • Budgetary Considerations

Brown is only able to be the IRB of record for up to 3 sites total, including Brown. Studies that involve more than 3 sites must either a) rely on one of the other sites or b) contract an independent IRB.  

 

Documenting the Reliance

SMART IRBLink to SMART IRB

SMART IRB serves as a central, cloud-based location where all sites involved can view the procedures, access study documents and make a determination to cede or provide oversight. Brown University has joined SMART IRB by signing their joinder agreement, which delineates all of the expectations and requirements in entering into a reliance agreement.  By using Smart IRB, institutions agree to comply with the established terms, eliminating the need to sign reliance agreements for each study.

The SMART IRB request is in conjunction with the actual submission to be reviewed and approved by Brown's IRB. Investigators must submit an IAA Application with accompanying required materials to [email protected]. Once approved, HRPP will take action to execute the reliance in the SMART IRB portal.

The initiation of the reliance should be done by the overall PI. Investigators can delegate this role to a member of their research team (e.g., a co-investigator or study coordinator) or other staff by having them request an account. To establish yourself as a Brown investigator, you should first Request Investigator Access. Once granted, you can begin the reliance request in the SMART IRB portal

Letter of Agreement

There is a standard IAA Letter of Agreement that we can use for sites that prefer not to use the SMART IRB portal. This usually occurs with international studies, though there are some domestic sites that prefer not to use Smart IRB. In this situation, we will send our letter to their IAA contact for review and signature from their signatory official.

IRB Reliance Exchange (IREx)

IRB Reliance ExchangeIREx serves as a central, cloud-based location where all sites involved can view the procedures, access study documents and make a determination to cede or provide oversight. The IREx platform includes an Institutional Profile that serves as a Local Context Review and allows for the documentation of amendments and continuing reviews.

IREx does not have an internal Master Agreement and requires documentation of the terms and conditions of the reliance agreement either through SMART IRB or a Letter of Agreement.  Investigators must submit an IAA Application indicating your request to use IREx to [email protected]. Upon review and acceptance, HRPP will initiate the study in the IREx portal. Investigators will receive notification from IREx to log-in and complete the required elements within the IREx portal.

Using an External IRB 

According to institutional policy, Brown is only able to be the IRB of record for up to 3 sites. Studies that involve more than 3 sites must rely on one of the collaborating organizations or engage an independent IRB. There are several independent IRBs that can be contracted. Investigators are not obligated to use a particular IRB's services. Below are some options of commercial IRBs that have collaborative experience with Brown. If you are proposing to use an IRB that is not featured below, please contact the HRPP so that we may vet their services prior to the initiation of reliance. There is no institutional funding available to cover costs associated with using a commercial IRB.

Advarra

Advarra is a commercial IRB providing comprehensive ethical oversight for all areas of research. Brown has negotiated a Master Reliance Agreement with Advarra, which eliminates the need for an additional signed contract to rely on Advarra for IRB review. A signed cover page is required with all submissions to indicate to Advarra that Brown is aware and accepting of the pending review.
To initiate this process:

  • Submit an IAA Application to [email protected] indicating your request to rely on Advarra.
  • Upon initial review and acceptance, a cover page will be issued for inclusion with any submission to Advarra. 
  • Once Advarra has approved the study, an approved protocol and approval letter must be submitted to Brown for processing. A Brown Approval Memo will be issued once the IAA has been fully executed. 

 Advarra's fee schedule is available upon request.

WCG IRB

WCG IRBWCG IRB provides high-quality, full-service independent review for single and multi-site studies spanning all phases of research. WCG is the parent company of several integrated IRBs (New England IRB, Aspire IRB, Copernicus IRB and Midlands IRB) dedicated to improving the quality and efficiency of clinical trials. WCG IRB's fee schedule is available upon request.

 

Researcher responsibilities for externally reviewed research

Brown University PIs are responsible for following the policies of the external IRB and knowing the terms and conditions of your IAA. This includes submitting to the reviewing IRB using their forms and processes (or assisting the lead site with that process), following their reporting requirements for unanticipated problems and new information about the study, and complying with the stipulations of the IRB’s approval.

Brown University PIs are also responsible for:

  • Ensuring that any relevant financial conflicts of interest are disclosed to the reviewing IRB as required;

  • Obtaining any required ancillary review and approvals (e.g., biosafety, radiation safety, etc.) and providing the results of these reviews to the reviewing IRB if requested;

  • Making copies of IRB approvals available for inspection.

Local context review

IRBs must consider many different regulations as part of their review, including state and local policies. A Reviewing IRB may request this information in a variety of ways (e.g. worksheets, surveys, questionnaires), which generally require a signature from an authorized signatory. SMART IRB and IREx allow for institutional profiles within their platform, eliminating the need for ancillary forms. 

  • Brown as the IRB of Record
    • For studies in which Brown serves as the reviewing IRB, HRPP may request the completion of our Local Context Review form. This form can be submitted with the IAA Application or HRPP will communicate with IRB Administration at the Relying Organization for form completion.
      *Not all Relying Organizations will be required to complete this form. Determinations are dependent on familiarity of collaboration and platform used for documentation.
  • Brown as the Relying Institution
    • When a collaborating IRB requires ancillary documentation, it should be submitted with the IAA Application or directly to the IAA reviewer. The Brown HRPP will work with the Brown PI and/or the collaborating institution to provide information about local context considerations and supply an authorized signature.
      *PIs and study administrators are not authorized to sign reliance documents on behalf of Brown University.