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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. IRB - Total Active Studies Over 3 Years. Number of Submissions Received by OPRS.

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research support offices and programs
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
the oprs irb review and approval process five stages
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

review process key features
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
irb turn around times february 2009
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

nu committee on human stem cell research
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
animal subjects
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
animal subjects1
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/
office of sponsored research osr
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
office for research safety
Office for Research Safety
  • Laboratory safety – chemicals, biologics.
  • Blood borne pathogens
  • Radiation safety
  • Recombinant DNA
  • Laser safety
  • http://www.research.northwestern.edu/ors/
nucats
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