Submitting to a Commercial IRB Kyle Conner, MA, CIP Associate Director Office of Human Research.

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Presentation transcript:

Submitting to a Commercial IRB Kyle Conner, MA, CIP Associate Director Office of Human Research

Jefferson currently has Master Service Agreements (MSA) with:

The MSA allows Jefferson to accept the IRB approval and regulatory oversight of the commercial IRB Using a commercial IRB gives Jefferson investigators the opportunity to get onboard with a study at its inception

How to submit: Notify JCRI Business Operations of intention to join a study approved by Quorum or WIRB They will generate ePTF Follow the standard process for creating a new study record in JeffTrial

How to submit: In the Portal, at the ‘Create an IRB Application’ drop-down menu, select WIRB or Quorum, and upload an OHR-1 Be sure to check off ‘Quorum Review IRB or Western IRB (WIRB)’ at the top of the OHR-1 This is the only document you will upload in the Portal. There is no paper submission OHR will a signed TJU-Quorum Institutional Cover Page or WIRB Cover Page

Screening Criteria for Jefferson Investigators Applying to Commercial IRBs: Study is a phase 2, 3, or 4, multi-center, commercially sponsored clinical trial PI has history of sound ethical judgment and the ability to manage clinical trials PI is in good standing with institution in regard to human subjects research compliance (e.g., PI is not currently on probation for violations)

Screening Criteria for Jefferson Investigators Applying to Commercial IRBs: PI does not have a unmanaged financial COI with the sponsor of the clinical trial PI & research staff have completed appropriate CITI training and are up to date with COI disclosures OHR-1 is complete and includes all required signatures

Instructions and contact information for Commercial IRBs available at: _research/resources/using-a-central-irb.html Questions?