Compile IRB Submission

Key Reminders

• It important to initiate the IRB submission process in tandem with submitting for contract and budget approval.
• The Investigational Drug Service (IDS) will be alerted about a new study when Section 1.04 (Drug Information) is submitted in eSIFTER. It is helpful to meet with IDS pharmacy once the study obtains IRB approval. Contact IDS at investigationalpharmacy@chop.edu
• Certificates of Confidentiality (CoC) are granted by the National Institutes of Health (NIH) or the Food and Drug Administration (FDA) to protect identifiable research information from forced disclosure that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. All human subjects research studies funded by the NIH will automatically be issued a CoC. Follow the instructions in Certificates of Confidentiality page for obtaining a CoC from the NIH for non-NIH funded studies and from the FDA.

Reliance Agreements for Multicenter Studies

If CHOP will be the Reviewing IRB, you must first submit and receive approval from the CHOP IRB before another institution agrees to cede oversight. Other sites can be added later through a full amendment in eIRB. Once the amendment has been submitted, the CHOP IRB Reliance Portal CHIRP will be available to the PI at the relying institution (an automated email will be sent to the Relying PI to alert them) to complete the PI profile, site-specific study application and to add their study coordinator.

Once the required information is entered and submitted by the relying investigator, the CHOP IRB will review the materials and communicate directly with the relying investigator via CHIRP. You will have visibility into the status of the relying investigator's application and CHOP's IRB review of the application in eIRB. For more information about the process, refer the CHOP PI Toolkit created by the CHOP IRB.

If CHOP will rely on an External IRB, submit an abbreviated eIRB application (select "Research Study involving CHOP reliance on an outside reviewing IRB") along with the approved protocol, consent form, approval letter from the Reviewing IRB and signed IRB Authorization Agreement or Determination Form (if available). For CHOP to agree to cede, the CHOP IRB must confirm that the consent form aligns with CHOP's requirements, ancillary approvals including contract approval, and CHOP specific recruitment plan have been received. All amendments and continuing reviews should be uploaded into eIRB to ensure that the study approval hasn't lapsed and that the most current, approved documents are being used. Find additional information on CHOP's consent form requirements and SMART IRB.

CHOP-Penn Master Reliance Agreement If you are relying on Penn services including their CHPS services for adult studies (e.g. ECHO interpretation for subjects above 21 years), answer "yes" to Section 1.04 (1.0) of the eIRB application. Complete Section 1.05 (Reliance agreement: CHOP is the Reviewing IRB) and attach the completed CHOP Penn Determination Form. After you receive IRB approval, the IRB analyst will email Penn IRB with the approved study documents and protocol. Penn IRB will reach out to the study team with some questions during their review process. An approval letter and countersigned CHOP Penn Determination Form will be provided after the review is complete. These documents should be forwarded to your IRB Analyst and uploaded to the eIRB application (Section 1.05) with the next amendment.

Contact Carl Shaw along with the Protocol, Stamped Consent Form, PI Assurance and finalized CHOP Penn Determination Form for study startup at Penn CHPS. A different IRB number will be assigned by the Penn IRB. Use this number for communicating with the Penn team.

CHOP has entered into Master Reliance agreements with several institutions to speed up the study startup process and to reduce the need to negotiate individual agreements. Check the list of institutions and their requirements.