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Single IRB Review of Clinical Research
- 1. IRB Office Final Rule:Single IRB Requirement Amy Schwarzhoff, MS, MBA, CIP Director, Human Subjects Research 1
- 2. IRB Office Agenda • Background •Terminology • Process - CHOP is Reviewing IRB • Process – CHOP is Relying Institution • Frequently Asked Questions • eIRB Updates • Resources and Questions 2
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- 4. IRB Office Traditional IRBReview Model Protocol X Boston Children’s Hospital Boston IRB Oversight Boston PI Cincinnati Children’s Hospital Medical Center Cincinnati IRB Oversight Cincinnati PI Children’s Hospital of Philadelphia CHOP IRB Oversight CHOP PI
- 5. IRB Office sIRB Model ProtocolX CHOP is the Central IRB BCH PI CHOP PI CCHMC PI CHOA PI Lurie PI
- 6. IRB Office sIRB Requirement •Current regulations allow for reliance on outside IRBs • More research funders are requiring or strongly encouraging reliance agreements • NIH sIRB Policy · Non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United State · Effective September 25, 2017
- 7. IRB Office sIRB: FinalRule (effective January 2020) • Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States
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- 9. IRB Office Relying Institution/Site •A hospital, clinic, doctor's office where research will take place and which will rely on an external IRB (Central IRB) which will serve as the Reviewing IRB for a multi-center study CHOP as the Central IRB BCH PI CHOP PI CCHMC PI
- 10. IRB Office Reviewing IRB ·The IRB that is responsible for the review, approval and regulatory oversight of a multi- center research study and serving more than one site · Other terms used: sIRB IRB of Record Central IRB CHOP as the Central IRB BCH PI CHOP PI CCHMC PI
- 11. IRB Office Site PrincipalInvestigator • A Principal Investigator who is responsible for the conduct of the research at their Relying Institution
- 12. IRB Office Reliance Agreement •The agreement outlines responsibilities of the Reviewing IRB and the Relying Institution · Institutional Officials usually sign (not a study PI) · Matthew Hodgson signs for the CHOP IO (during the IRB review process) • Other terms used: · Cooperative Agreement · IRB Authorization Agreement (IAA) · IRB Reliance Agreement
- 13. IRB Office Master RelianceAgreements • The agreement allows signatory institutions to cede IRB review to another signatory institution · These agreements are not study specific · A Determination Form is used to document the Reviewing IRB and Relying Institutions
- 14. IRB Office Currently ActiveCHOP Master Reliance Agreements • University of Pennsylvania and CHOP Agreement • PEDSNet Master Reliance Agreement • SMART IRB • NCI Central Pediatric IRB • Columbia University Medical School for NAMDC Protocols
- 15. IRB Office Master RelianceAgreement Determination Forms • Documents that the Master Reliance Agreement applies to a particular study · Both the Reviewing and the Relying IRB sign the form · At CHOP, the determination forms can be signed by the IRB Chair, the Director or the Institutional Official (or their designee) · The form is signed during the review process
- 16. IRB Office Reviewing IRBResponsibilities: Review of Local Context for Relying Site • Must review state/local laws, regulations, policies, standards (social or cultural) or other factors applicable to the research for · Information about the Relying Institution is collected via the CHOP Relying Site Survey · Each Reviewing IRB must have a process for the collection and review of this information
- 17. IRB Office sIRB Process WhenCHOP Is The Reviewing IRB
- 18. IRB Office Protocol Review •The CHOP IRB will review and approve the protocol first · Only CHOP-Penn request can be reviewed with the protocol • Relying Institutions will be reviewed and approved as amendments to the approved research
- 19. IRB Office Relying SiteReviews • Once the protocol is approved the CHOP study team submits an amendment with Relying Site Information: · Applicable reliance documentation (e.g. IRB Authorization Agreement or Determination Form) · CHOP IRB approved consent form with limited site- specific edits · Conflict of Interest Management Plans · Institution-specific recruitment materials · Relying Site Survey Each relying site should complete the form in consultation with their local IRB about the responses
- 20. IRB Office eIRB StudyApplication • Section 1.03 (Multi-center protocol) – “Yes” • Section 1.04 (1.0) – “Yes, CHOP will serve as the reviewing IRB for one or more other institutions “ • Section 1.05 · (2.0) Institutions – PI and Institution (pulled from table of Institutions we have worked with) entered and documents uploaded · Email the IRB Office if the institution is not listed
- 21. IRB Office Relying SiteApproval Notice • Each PI should have a CHOP IRB Approval Letter: · IRB approval date for protocol · IRB approval date for relying site · Expiration date (same for everyone) • IRB Approved (stamped) consent form with site-specific edits • Executed Agreement
- 22. IRB Office eIRB Submission& Distribution CHOP PI Gathers Relying Site Documents (Reliance Agreement, Relying Site Survey, etc.) CHOP PI Submits Amendment(s) in eIRB for approval CHOP PI distributes IRB approval documents to Relying Sites (Approval letter, consent form, etc.)
- 23. IRB Office Relying SiteDocumentation • Submission Documents • IRB Approval Documents • Submission Documents • IRB Approval Documents • Submission Documents • IRB Approval Documents • Submission Documents • IRB Approval Documents CCHMC BCH CHOAWash U
- 24. IRB Office sIRB Process: CHOPIs Relying Institution
- 25. IRB Office CHOP HumanResearch Protection Programs (HRPP) SubjectsCHOP IRB Principal Investigator Contracting Institutional Official Pathology Pharmacy Radiology
- 26. IRB Office CHOP HumanResearch Protection Program (HRPP): External IRB • CHOP’s IRB does not provide oversight when an external IRB is the reviewing IRB • CHOP’s HRPP remains responsible for all research activities that take place at CHOP • eIRB is the tool used to ensure all institutional requirements are met for the HRPP, including Conflict of Interest disclosures and HSR Training
- 27. IRB Office CHOP HRPPwith External IRB SubjectsExternal IRB Principal Investigator Contracting Institutional Official Pathology Pharmacy Radiology
- 28. IRB Office eIRB Submission •Select: “Research Study involving CHOP reliance on an outside reviewing IRB” • Application is a shorter version of the form completed when CHOP is the reviewing IRB • Documents to submit: · Applicable Reliance Agreement or Determination form · Protocol · Reviewing IRB approval letter · Consent with CHOP-specific changes
- 29. IRB Office Consent FormRevisions for Use at CHOP • The consent form approved by the Reviewing IRB for the main site must be adapted for use at CHOP and must conform to institutional requirements · To ensure that the Reviewing IRB includes all of the CHOP-required elements, the IRB has created instructions for the CHOP investigator and the Reviewing IRB – “CHOP Consent Form Requirements: Instructions for the Investigators and the Review IRB (2017)”
- 30. IRB Office Finalized InstitutionalAcceptance • After the eIRB application is complete, all ancillary approvals are issued and an approved consent form has been uploaded that conforms to CHOP's requirements, the agreement to cede review can be finalized · The applicable reliance agreement will be signed · The CHOP IRB will issue a letter to the CHOP investigator indicating that CHOP has accepted review by the external IRB
- 31. IRB Office Additional Submissions: UpdatesFor CHOP • The CHOP Office of Research Compliance requires that all amendments and continuing reviews continue to be uploaded into eIRB to ensure that the external IRB approval hasn't lapsed and that the only the most current, approved documents are being used
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- 33. IRB Office What happensif relying sites are included in initial protocol submission? • The IRB will probably not ask for the site information to be removed from the eIRB SmartForm, but we will clearly indicate that the approval does not include the relying sites • An amendment will be required to request review and updated consent forms (with site- specific edits) must be included
- 34. IRB Office Does CHOPenter into agreements with independent IRBs? • CHOP does not regularly enter into IRB authorization Agreements with independent IRBs (e.g. Schulman IRB, Western IRB) • Currently CHOP may consider entering into agreements for multi-site research when the following criteria are met: · research is minimal risk; · NIH or a Foundation is funding the research; and · the funder is mandating the use of the central IRB (documentation from funder provided with submission)
- 35. IRB Office When arereliance agreements signed? • During the IRB review process the IRB staff will obtain the appropriate IRB signatures • Include the agreement that requires signatures in the eIRB submission
- 36. IRB Office Distribution ofdocuments to relying sites • When is the CHOP study team required to distribute documents? • The IRB Office is currently working with eIRB developers to make significant changes to eIRB to support access for external investigators for submitting relying site applications directly in eIRB
- 37. IRB Office Distribution ofdocuments to relying sites (continuted) • The CHOP Study Team will enter the Relying Principal Investigator, Institution and contact information in eIRB. · eIRB will send emails to the included investigators for completion of a simplified application. · The CHOP Study Team will have visibility to the status of these submissions and reviews · The CHOP IRB will distribute IRB approval documents via the enhanced functionality
- 38. IRB Office Upcoming eIRBChanges
- 39. IRB Office Upcoming eIRBChanges
- 40. IRB Office Upcoming eIRBChanges
- 41. IRB Office Upcoming eIRBChanges
- 42. IRB Office CHOP’s Preparations •Template Language for Grant Applications • Justification for Direct Costs to support the additional resources required to provide oversight for external institutions • eIRB Development
- 43. IRB Office Resources • irb.research.chop.edu •IRB Office: · IRBOffice@email.chop.edu · 215.590.2830 • IRB Office Hours · First and Third Thursdays: 2 -4 pm Roberts Center in Conference Room 4-110 · Second and Fourth Fridays: 9 -11 am Colket Translational Research Building in Rm 2400