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

Initiating a Reliance Agreement at Brown

A reliance agreement is a written contract between two or more research partners used to document the delegation of IRB review responsibilities. 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.

Whether we are acting as the IRB of Record or ceding review to another institution, all requests must be submitted in Huron for review and approval. Upon approval in our offices, we will take action to authorize the reliance agreement. After that, you will receive an official approval memo and can begin research activities

IRB Authorization Agreement (IAA)

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

Individual Investigator Agreement (IIA)

Discuss with HRPP to determine that the reliance is appropriate

Organizational Authorization Agreement (OAA)

Discuss with HRPP to determine that the reliance is appropriate

Brown as
IRB of Record

  • Collaborative Research Application for each relying site
     

  • For new studies*  

    • Complete study submission in Huron  including Human Subjects Research Application and all accompanying documents (i.e. appendices, study materials, consent documents, recruitment materials) 

  • For amendments 

    • Modification submission in Huron including revised documents inclusive of new study sites and personnel reflecting any changes in procedure, recruiting and consenting

  • Local Context Form 

  • Documented Reliance Agreement

    • SMART IRB

    • IREx

    • Signed Letter of Agreement

Brown as
Relying Site

  • Complete study submission in Huron

  • Collaborative Research 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

  • Documented Reliance Agreement

    • SMART IRB

    • IREx

    • Signed Letter of Agreement

Brown as
IRB of Record

  • Collaborative Research Application for each investigator 

  • PI with qualifications that meet the requirements for an Investigator

    • Not affiliated with Brown University or any other institution with respect to this project OR acting as an employee or agent of a non-assured institution that is not engaged in the research.

    • Defined Research Background

      • CV w/ qualifications

      • Verify professional associations and/or medical licensure.

  • Human subjects research training in compliance with institutional policies

  • External Investigator FCOI review for PI and Co-Is

  • Local Context Form 

  • Signed Individual Investigator Agreement (IIA)

    • Affiliation attestation of individual investigator

    • Institutional PI signature

  • For new studies*  

    • Complete study submission in Huron  including Human Subjects Research Application and all accompanying documents (i.e. appendices, study materials, consent documents, recruitment materials) 

  • For amendments 

    • Modification submission in Huron including revised documents inclusive of new study sites and personnel reflecting any changes in procedure, recruiting and consenting

Brown as
IRB of Record

  • Collaborative Research Application for each site 

  • PI with qualifications that meet the requirements for an Investigator

    • Not affiliated with Brown University or any other institution with respect to this project OR acting as an employee or agent of a non-assured institution that is not engaged in the research.

    • Defined Research Background

      • CV w/ qualifications

      • Verify professional associations and/or medical licensure.

  • Established Organization 

    • Searchable online presence corroborating organizational mission and values aligned with the research activities

    • Organizational infrastructure able to provide the required resources 

    • An organizational representative or delegate able to serve as an Authorized Signatory 

  • External Investigator FCOI review for PI and Co-Is

  • Human subjects research training for all study staff

  • Federalwide Assurance (FWA)

    • Apply and attach the FWA to institutional IRB for the term of the current project  

  • Local Context Form

  • Signed Organizational Authorization Agreement (OAA) 

    • Terms for a singular project 

    • Expectations to disassociate 

    • Institutional PI signature 

  • For new studies*  

    • Complete study submission in Huron  including Human Subjects Research Application and all accompanying documents (i.e. appendices, study materials, consent documents, recruitment materials)   

  • For amendments 

    • Modification submission in Huron including revised documents inclusive of new study sites and personnel reflecting any changes in procedure, recruiting and consenting

* For new studies where Brown is the IRB of Record, a modification must be created after initial approval to enact the reliance agreement. 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 research partner.

 

Note: The collaborating organization will have its own requirements for approving the request. For an efficient review and approval period, please communicate with your collaborator to ensure these requirements have been met.


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 IRB    Link 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 Collaborative Research Application with accompanying required materials into Huron. 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

 

 

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 a Collaborative Research 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.

 

 

  

 

Letter of Agreement

HRPP has standard Letters of Agreement for all forms of reliance agreements:

  • IRB Authorizations
  • Individual Investigators
  • Collaborating Organizations

When using a Letter of Agreement, we will send our contract for review and signature from their Authorized Signatory once our internal review is complete. When we receive the signed document back, we will issue an official approval memo and research activities can begin.


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 a Collaborative Research 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 IRB

WCG 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.