IRB Authorization Agreement (IAA)

 

To allow a single-IRB approval process when multiple institutions are involved in the same study.  By executing IAA, time-consuming duplication of IRB processes can be reduced and the oversight can be assigned to a single centralized entity.  Although simply stated, IAA does pose several challenges and technicalities relating to how oversight-sharing or oversight-reliance can be achieved without comprimising participant safety.  Here are a few scenarios for which MTSU currently has a process by with an IAA can be requested.

This agreement will be executed between an external IRB and MTSU IRB.  The purpose is to allow their IRB to provide oversight to a protocol that was approved by them.  There are several possible scenarios where such oversight reliance can take place and I have listed a few here:

  1. A non-MTSU researcher proposes to enroll MTSU students/staff/faculty in a study approved by his/her institution's IRB and the PI does not plan to collaborate with an MTSU researcher
  2. A non-MTSU researcher proposes to collaborate with an MTSU faculty/student/staff and requests for permission to use his/her institution's IRB approval - the oversight for this study, whether it will be conducted within MTSU or elsewhere or both, will be provided by the external institution while MTSU only plays a passive role.
  3. A non-MTSU researcher collaborates with an MTSU researcher to collaborate in a project that has been approved by a non-MTSU IRB and seeks mutual oversight sharing with MTSU IRB
  4. An MTSU researcher collaborates with an external researcher in a study approved by MTSU IRB and requests the external IRB to rely on the oversight provided by MTSU IRB
  5. An MTSU researcher collaborates is seeking permission from an external IRB to rely on the oversight provided by MTSU IRB
  6. An MTSU researcher collaborates with an external researcher in a study that was approved by the MTSU IRB and they seek the external institution which does not have a FWA to rely on MTSU IRB's oversight

Additional administrative processes will be introduced depending on future needs for cooperation between MTSU IRB and external institutions.  Each of the above mentioned scenarios are described in more detail with how to obtain an authorization approval from MTSU and what it means to the researcher.

1. A non-MTSU researcher proposes to use MTSU resources or enroll MTSU students/staff/faculty in a study thas has been approved by an outside IRB and the PI does not collaborate with an MTSU researcher:
  • The pursuent initially contacts irb_submissions@mtsu.edu to notify the intent
  • The Office of Compliance will request for most current documentation for the approved protocol - such as informed consent form, methods and interventions, instruments, recruitment details and etc. 
  • An MTSU record number will be generated for future reference
  • Once the Office of Compliance has determined that the protocol approval process is in alignment with the MTSU IRB's current policies, it will make its recommendation to the MTSU IRB Chair and the MTSU Institutional Official (IO)
  • After its recommendation has been acknowledged, the Office of Compliance will generate the paperwork needed to execute this agreement
  • The pursuent will have the agreement document filled and signed by the external institution's signatory official and return two original copies to the Office of Compliance.  
  • Both originals will be signed by the MTSU IO and both parties will retain one original each
  • Summary of Terms and Conditions:
    • The external institution takes up responsibility for oversight by enforcing its FWA
    • Any change to the protocol and adverse events must be reported to MTSU immediately
    • MTSU and its IRB will not be held liable because none of the MTSU personnel is part of the research team
    • However, the MTSU IRB reserves the right to take appropriate action in the event the researcher fails to properly fulfill the terms of the approved protocol including the cancelation of this agreement
    • If the external institution fails to take approriate action in the event the researchers' conduct or negligence was notified, then MTSU may not enter into such agreement in the future
  • Additional Conditions: It is important to note that an IRB agreement does not imply that MTSU has given permission to use its resources or students.  The IRB agreement merely allows the external researcher to avoid additional paperwork.  To actually allow the research to take place within MTSU or to allow the researcher to enroll MTSU students/staff/faculty, the researcher will have to clear with cocerned Dean or Department Chair.  
2. A non-MTSU researcher collaborates with an MTSU faculty/student/staff and requests for permission to use an external IRB approval in a study that may or may not use MTSU resources:
  • The pursuent initially contacts irb_submissions@mtsu.edu to notify the intent - it can be either the non-affiliated researcher or the MTSU collaborator
  • The Office of Compliance will request for most current documentation for the approved protocol - such as informed consent form, methods and interventions, instruments, recruitment details and etc. 
  • An MTSU record number will be generated for future reference and the Office of Compliance will determine if the protocol approval process aligns with the MTSU IRB's current policies.  Additional consultation will be held with IRB Chair and the IO
  • If found acceptible,, the Office of Compliance will generate the paperwork needed to execute this agreement
  • The pursuent will have the agreement document filled and signed by the external institution's signatory official and return two original copies to the Office of Compliance.  
  • Both originals will be signed by the MTSU IO and both parties will retain one original each
  • Summary of Terms and Conditions:
    • The oversight for this study, whether it will be conducted within MTSU or elsewhere or both, the external institution takes up the responsibility for oversight by enforcing its FWA while only a minor role is played by the MTSU IRB 
    • Any change to the protocol and adverse events must be reported to MTSU immediately
    • MTSU and its IRB will be responsible for the oversight for the portion of study to be conducted by its researcher(s) by enforcing its own FWA including taking action in the event researcher negligence is brought its notice
    • MTSU and its IRB will take prompt and suitable action if the external IRB should report negiligence or unethical practices by the MTSU researcher
  • Additional Conditions: It is important to note that an IRB agreement does not imply that MTSU has given permission to use its resources or students.  The IRB agreement merely allows the external researcher to avoid additional paperwork.  To actually allow the research to take place within MTSU or to allow the researcher to enroll MTSU students/staff/faculty, the researcher will have to clear with cocerned Dean or Department Chair.  
3. A non-MTSU researcher collaborates with an MTSU researcher to collaborate in a project that has been approved by a non-MTSU IRB and seeks mutal oversight sharing with MTSU IRB

 

4. An MTSU researcher collaborates with an external researcher in a study that was approved by the MTSU IRB and they seeking an external IRB to rely on the oversight provided by the MTSU IRB
 
5. An MTSU researcher is seeking permission from an external IRB to rely on the oversight provided by the MTSU IRB

 

6. An MTSU researcher and an external collaborator are seeking a reliance authorization from the collaborator's Institution which does not have its own IRB
an enteral researcher in a study approved by MTSU IRB.  The other institution does not have an IRB.  The MTSU researcher then requests the other administration to rely on the protocol approved by MTSU IRB
 

An MTSU researcher collaborates with an external researcher in a study approved by MTSU IRB and requests the external IRB to rely on the oversight provided by MTSU IRB

 

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