FAQ: Single IRBs and IRB Reliance Agreements

  1. An external IRB is the IRB of record for my study. Do I need to submit anything in eIRB, and if so, why?

    Yes. Even though the CHOP IRB may not have oversight over the study, CHOP’s Human Subjects Protection Program (HRPP) still needs to know and track what human subjects research activities go on at the institution. In addition, the CHOP IRB must confirm that the consent form aligns with CHOP's requirements (e.g. HIPAA and injury compensation language), and CHOP Ancillary Committees may need to review and approve the study (e.g. the Investigational Pharmacy, Contracting, IBC, Conflict of Interest Committee, Medical Device Committee, etc.).

  2. Once I have submitted in eIRB and indicated that an external IRB is the reviewing IRB, do I have to wait for an acknowledgement before I can start my research, and if so, why?

    Yes. The CHOP IRB must confirm that the consent form aligns with CHOP's requirements (e.g. HIPAA and injury compensation language), and CHOP Ancillary Committees may need to review and approve the study (e.g. the Investigational Pharmacy, Contracting, IBC, Conflict of Interest Committee, Medical Device Committee, etc.). Once all the institutional requirements are met, the CHOP IRB will send a letter to accept the reliance on the outside IRB. Human subjects research at CHOP for that particular study cannot start until that letter has been issued and reliance documentation has been executed.

  3. If CHOP is relying on another IRB for my study, do I have to submit updates in eIRB, and if so, why?

    Yes. CHOP’s Human Subjects Protection Program (HRPP) still needs to track what human subjects research activities go on at the institution. In addition, CHOP Ancillary Committees, such as the Investigational Pharmacy, need access to currently approved documents (such as the Investigator’s Brochure).

  4. How do I submit Cooperative Updates?

    In the main study workspace for the study in eIRB, under the ‘Create’ header on the left side of the workspace, find the “New Cooperative Update” button. Clicking on it will open a new smartform. After the smartform has been completed by the investigator, using the “Submit Cooperative Update” activity will send the submission to the IRB. The IRB has created a Job Aid (under 'eIRB Help') to facilitate the submission process.

    Note: Multiple, separate Cooperative Updates can be active at once.

  5. Once I submit a cooperative update, do I have to wait for an acknowledgement before I can implement e.g. amendment changes?

    No. Once CHOP has accepted the reliance on an outside IRB, amendment changes can be implemented as soon as the reviewing IRB has approved the amendment.

  6. I’m writing a grant for a multi-center study and would like CHOP to be the Reviewing IRB. What is the process?

    Contact the IRB Director to discuss the grant requirements and sIRB logistical issues.

  7. What is CHIRP?

    CHIRP is the CHOP IRB's tool that allows investigators from external institutions who are relying on the CHOP IRB for IRB review to communicate directly with the CHOP IRB. See Single IRBs and IRB Reliance Agreements for more information.

  8. The relying PI for my study has received an email from CHIRP, but the link states 'The invite token is expired'! What do I do?

    This error can be resolved by having the external PI navigate to the CHIRP homepage, and request a password reset. Note: Each time a password reset is requested, a new automated email is issued. The new email will invalidate any prior emails, so the relying investigator should be sure to always use the most recent email.

  9. Do relying sites need to update their CHIRP application with investigators or their training(s)?

    Other than the relying PI and Study Coordinator, no. The CHIRP application asks relying sites to “Confirm that all study team members are in compliance with local institutional training requirements for human subjects research. (e.g. CITI training and/or other institution specific training)”. Otherwise, any relying personnel-specific changes are the responsibility of the relying institution to manage.

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