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Enhancing Research Compliance and Support: OPRS, IRB, ACUC, and OSR Overview

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15 diapositives · 308 Views · Sep 18, 2014

This document outlines the essential roles of the Office for Protection of Research Subjects (OPRS), Institutional Review Board (IRB), Animal Care and Use Committee (ACUC), Office of Sponsored Research (OSR), and other affiliated programs at Northwestern University. It details the review and approval process for human and animal research, grant application support, safety protocols, and investigator advocacy. Key features include improved turnaround times for reviews, pre-review processes, and comprehensive training. Our commitment is to facilitate a balanced approach to compliance and innovation in research.

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  1. Research Support Offices and Programs • OPRS-IRB – humans • OPRS-ACUC – animals • OSR – research grant applications to external agencies • ORS – research safety • NUCATS – investigator advocacy and support, plus more

  2. IRB - Total Active Studies Over 3 Years

  3. Number of Submissions Received by OPRS

  4. The OPRS/ IRB review and approval process – five stages * Determine if research meets criteria for approval PI submits new application Distribution for review Study approved OPRS pre-review Major Modifications Required Minor Modifications Required Review of required minor modifications Modification required for approval* PI Action Required OPRS/ IRB Action *Sponsor Action

  5. Review Process – Key Features • OPRS pre-review for completeness; ensures all regulatory requirements addressed • With exception of the VA panel, no submission deadlines • Improving turn-around times for both initial and continuing reviews • Communication between OPRS staff, IRB members and members of the research community is essential; decreased number of deferred applications • http://www.research.northwestern.edu/oprs/irb/?src=or-hdr

  6. IRB Turn Around Times – February 2009 Up to 24 protocols/site; NU had 20; 34 CTSA sites with 425 protocols Phase 1: Application received to IRB meeting Phase 2: IRB meeting to final approval At NU, 75% approved in 64 days and 90% approved in 76 days

  7. IRB Turn Around Times – Jan-Sept 2009

  8. NU Committee on Human Stem Cell Research • Catalogues all research involving human stem cells • Reviews and approves all research involving human embryonic stem cells • http://www.research.northwestern.edu/committees/human-stem-cell/index.html

  9. Animal Subjects • Institutional Animal Care and Use Committee (IACUC) • IRB equivalent for research involving animals (ensure compliance with all federal and local regulations) • Training modules – required • Occupational health and safety program • Review animal study protocols (ASP) • Post-approval monitoring • Semi-annual inspections of labs (e.g., medical records, drug logs) • Serves both Evanston and Chicago campuses • Administratively supports the work of the Committee on Animal Resources (CAR – advisory to VP Research) • Works collaboratively with Center for Comparative Medicine (CCM) • http://www.research.northwestern.edu/oprs/acuc/?src=or-hdr

  10. Animal Subjects • Center for Comparative Medicine (CCM) • Veterinary staff, technicians and animal caretakers • Over 100 employees • Primary care and oversight of animals used in research • Surgery; training • Facilities in Evanston and Chicago • Large and small animals • http://www.research.northwestern.edu/ccm/

  11. Office of Sponsored Research (OSR) • Proposal identification and development • Budget preparation • Grant writing tutorials • Limited submission proposals • Applicable University and Federal policies • Material transfer agreements • http://www.research.northwestern.edu/osr/?src=or-hdr

  12. Contract Turn-Around Times - CTSAs

  13. Contract Turn-Around Times – NU vs. all CTSAs

  14. Office for Research Safety • Laboratory safety – chemicals, biologics. • Blood borne pathogens • Radiation safety • Recombinant DNA • Laser safety • http://www.research.northwestern.edu/ors/

  15. NUCATS • Bioinformatics Center (NUBIC) • Biostatistical Collaboration Center • Center for Education and Career Development (CECD) • Education/training • Career Development • Community Engaged Research Center (CERC) • Center for Translational Innovation (CTI) • Pilot Projects • Center for Clinical Research (CCR) • Clinical Research Unit (CRU) • Regulatory Support Program – investigator advocacy