What's New (OUHSC Campus)

A new IRB roster for Board 2, effective 3/9/2021, has been published on the HSC Campus IRB Rosters page available here. 

The HSC Campus has launched a revamped single IRB process for investigators who wish to use OUHSC as the single IRB of record for multi-site research. The process will separate the reliance agreement process from IRB review of the research study, allowing each to be completed concurrently. Additionally, the IRB will review and approve the research study before IRB approval of the external, relying sites will be granted. This new process is intended to provide a clear and separate workflow without impacting turnaround times for IRB review of the research protocol.

Below is a brief summary of form updates related to the process change. Stay tuned for Single IRB Workshops via Zoom!   

HSC IRB Application:

• Section 1810 – Study Sites: The old non-OU site table has been archived and no longer available for use. It will remain visible on existing applications for historical purposes. A new question with revamped table has been created which will walk you through the engagement criteria. This criteria will help us determine whether an agreement is required or not, making it much easier to complete.
• All users must convert their application in iRIS when prompted by the system.

NEW! Relying Site Form:

• Brand new iRIS form for “activating” external sites that will rely on OUHSC IRB. This is submitted after a reliance agreement has been executed and after IRB approval of the research has been granted. Additional local context information and attachments will also be required.

NEW! REDCap Reliance Request:

• Brand new form in REDCap that investigators must submit to initiate the reliance agreement process. This should be done at the same time the IRB is reviewing your study in iRIS.
• Link to REDCap Reliance Request Form: https://bbmc.ouhsc.edu/redcap/surveys/?s=D9XMA3PJJN 

The HSC IRB has published an updated HSC IRB application in iRIS. All users must convert to the new application when prompted.

• Section 825 – Demographics: This section will appear for all studies, regardless of direct participant interaction.  Therefore, all investigators and study personnel must verify that Section 825 has been completed before submitting a revised application to the IRB.
• Section 1810 – Study Sites: a new Non-OU site table has been added to the application. For ongoing studies that include one or more non-OU sites, investigators will not be expected to move existing study sites to the new table. The existing site information/table remains visible and read only to display archived information. The new Non-OU site table was created as part of our initiative to revamp the single IRB process when it is proposed for external sites to rely on the OUHSC IRB as the IRB of record.

New IRB rosters for Board 1, Board 3, and Board 4, effective 2/10/2021, have been published on the respective HSC Campus IRB Rosters pages available here. 

Several policies have been updated as a part of the HRPP's biannual SOP review. The effective date of the policies is 12/31/2020. The Searchable SOP link has also been updated! You can access all of the SOPs on the Policies and Procedures page.