Research Support Offices and Programs

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