Obtaining IRB Approval: The eirb Application Process
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1 Obtaining IRB Approval: The eirb Application Process Frederick W. Luthardt, D.Be, MA Manager, OHSR Compliance Monitoring Program Johns Hopkins School of Medicine
2 Segment Objectives: Appreciation of the role of the IRB Understanding the basics of completing the eirb application Awareness of the eirb application elements that require PI planning and input
3 IRBs and Investigators and Sponsors/CROs Not always a match made in heaven Problems and complaints abound: The time from application submission to approval/start up is long Sponsors/CROs approve amendments, but PIs fail to submit change-in-research to their IRBs Tediousness of submitting numerous protocol amendments received from sponsors Timeliness of IRB submissions is not compliant, e.g., Unanticipated problems reported to the IRB in 10 days Collecting/Collating CVs, licenses, certifications, etc.
4 The Role of the Institutional Review Board (IRB) Per the Institution's Federal Wide Assurance (FWA), IRB review is required, using two mechanisms: Convened (more than minimal risk) Expedited/Exempt (minimal risk or Non-HSR) The IRB reviews protocols and supporting materials for: Compliance with regulatory and institutional requirements Scientific soundness Human subject safety and well-being (ethics) Benefit is maximized Harm is minimized Fairness is safe-guarded
5 What the IRB is not... (despite what you ve heard!): The Infernal Review Board An implacable apparatchik A rubber stamp An obstinate mechanism bent solely on delaying study-start up A face-less group that can t be talked to, insensitive to institutional dynamics and outside pressures.
6 The eirb application: Gather and Upload Protocol Informed Consent Form Will be revised by the IRB Consent Form Specialists Supplemental Documents FDA documents (e.g., IND letter, etc.) Study team member training certificates Drug/Device information Investigator Brochure For Industry-sponsored clinical trials, most documentation is provided Coordinate with your sponsor/cro CRA to be sure you all you need.
7 The eirb Application: Additional Elements Study team member agreements High Risk determination Conflict of Interest Informed Consent process description Who, when, where, how? Recruitment narrative (including recruitment materials) Who, when, how? Incidental findings response Data Safety Monitoring Plan HIPAA forms (e.g., For future contact)
8 Other IRB approval issues Changes in Research Get IRB approval before initiation of any non-emergent change Protocol exemptions/exceptions approved by sponsor still require prior IRB approval Emergent/Ad hoc changes, communicate with IRB ASAP Problem-event reporting AEs, SAEs/Unanticipated Problems IND Safety Letters Any of the above requiring immediate submission and IRB acknowledgement Continuing Reviews Submit on time
9 The IRB Approval Process: Pain Reduction Pain: eirb application returned incomplete Prophylaxis: Complete the eirb application fully and correctly Pain: IRB review questions (generated with a tabled study) Treatment: Answer all questions completely ( Done isn t always acceptable) Pain: Uncertainty about any IRB application element or process Preventative Medicine: Ask, Ask, Ask Do not self-medicate or ignore Review online resources (e.g., policies and guidelines) Prognosis: Improved turn-around time/through-put
10 Questions? IRB Website: IRB Policies and Guidelines: nes_policies/ IRB Help and Training: g_requirements/eirb_training.html
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