IRB Process for MultiInstitutional Proposals

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IRB Process for Multi-Institutional Proposals
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Specific Aims

• Provide a facilitated review process for
  multi-institutional proposals
• Determine delegation of review authority to a
  designated Primary IRB for a specific protocol
• Report findings and actions of the IRB of Record
  to the collaborating CTSC institution(s)
• Eliminate unnecessary regulatory redundancies

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Methods

• All partnering institutions agreed to a
  facilitated review process
• The IRB of Record form and process were based on
  existing cooperative agreements between the IRBs
  at Weill Cornell Medical College (WCMC),
  Memorial Sloan Kettering Cancer Center (MSKCC)
  and Hospital for Special Surgery (HSS).
• More recently CUNY amended its Federal Wide
  Assurance (FWA) for two IRBs of Hunter College
  for a reciprocal agreement with WCMC and HSS.

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Process
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IRB of Record Form
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Advantages

• Easy identification of CTSC collaborative
  projects
• Identification of single site projects funded by
  the CTSC for compliance purposes
• Avoid unnecessary regulatory burden on
  investigators and institutions

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Challenge

• Adding an IRB that is registered on a FWA shared
  by multiple institutions

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Future Plans

• Continue improving application and review
  procedures among partner institutions and
  regulatory committees to decrease duplication and
  increase efficiency for investigators
• Enhance sharing of information among partnering
  IRBs through our electronic Protocol Review and
  Authoring system