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MUSC Office of Research Integrity

MUSC Office of Research Integrity. KATHY MAGRUDER, MPH, PHD DIRECTOR. Office of Research Integrity (ORI). Institutional Review Boards (IRB) Institutional Animal Care and Use Committee (IACUC) Institutional Biosafety Committee (IBC)

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MUSC Office of Research Integrity

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  1. MUSC Office of Research Integrity KATHY MAGRUDER, MPH, PHD DIRECTOR

  2. Office of Research Integrity (ORI) • Institutional Review Boards (IRB) • Institutional Animal Care and Use Committee (IACUC) • Institutional Biosafety Committee (IBC) • Research Integrity Committee (RIC) for scientific misconduct

  3. Institutional Review Board (IRB) • Full AAHRPP accreditation • Serve both MUSC and VA investigators • Purpose • To protect the rights and welfare of human research subjects • Authority to approve, require modification, and disapprove any research involving human subjects

  4. Institutional Review Board (IRB) • Mandated by Federal Law to review all research federally funded and by inclusion, all research involving human subjects • Regulatory agencies • Office of Human Research Protection (OHRP) • Food & Drug Administration (FDA)

  5. Principles of the Belmont Report • Respect for persons • Beneficence • Justice

  6. Board Activities • New protocols • Amendments • Protocol continuations • Adverse events • Protocol deviations • Data Safety & Monitoring Board reports • Audits & PI responses

  7. IRB 1 • Cell & Molecular Pharmacology and Experimental Therapeutics • Clinical Services • College of Health Professions • College of Nursing • College of Pharmacy • Dermatology • Harper Student Life Center • Medical Lab Sciences • Otolaryngology • Pathology & Laboratory Medicine • Pediatrics • Pharmaceutical Sciences • Pharmacy Practice • Physical Therapy • Physiology • Psychiatry & Behavioral Sciences • Radiology • Urology

  8. IRB 2 • Anesthesiology • Biochemistry & Molecular Biology • Center for Health Care Research • Experimental Oncology • Family Medicine • General Dentistry • Medicine • Microbiology & Immunology • Molecular & Structural Biology • Neuroscience • Obstetrics & Gynecology • Ophthalmology • Oral & Maxillofacial Surgery • Orthopedic Surgery • Pediatric Dentistry/ Orthodontics • Physical Medicine & Rehabilitation • Prosthodontics • Radiation Oncology • Stomatology • Surgery

  9. IRB 3 • All Departments • Industry sponsored studies only

  10. Eligibility • Department of Medicine investigators • Phase 3, multi-site clinical trials • Industry sponsored Western IRB (WIRB) 12 month pilot ending December 2011

  11. IRB Contacts • IRB 1 1st Tuesday • Mark Hamner, M.D. Chair • Susan Anderson, Ph.D. Vice-chair • Linda Bunch Administrator • IRB 2 3rd Tuesday • Susan Sonne, Pharm.D. Chair • Rob Hawes, M.D. Vice-chair • Lisa Johnson Administrator • IRB 3 2nd and 4th Tuesdays • David Lewin, M.D. Chair • Donald Courtney, M.D. Vice-chair • Jackie Shedrow Administrator

  12. Institutional Animal Care & Use Committee (IACUC) • Fully AAALAC accredited • Purpose • Reviews all requests for the use of live animals for research or training at MUSC. • Ensures that • Animals used in research receive humane care and treatment; • All applicable laws, regulations and requirements are met.

  13. IACUC Activities • Activities • Review applications & amendments • Establish guidelines and policies to ensure highest standards • Educate and train faculty and staff • Oversee all aspects of the animal care and use program in conjunction with Division of Laboratory Animal Resources (DLAR)

  14. IACUC • Contact Information • Cyndi Rosenblatt, CPIAIACUC Program Manager • Rupak Mukherjee, PhDIACUC Interim Chair • research.musc.edu/ori/iacuc • iacuc@musc.edu • 792-6553

  15. Institutional Biosafety Committee (IBC) Purpose: Review research involving use of recombinant DNA (rDNA), and/or microbes, and/or biologically derived toxins in accordance with NIH Guidelines (September2009) and the MUSC IBC Charter

  16. IBC Activities: • PI conducts a risk assessment and submits an application electronically. • IBC reviews initial applications, amendments, & continuing reviews to protect the health of MUSC personnel, the public, & the environment. • As part of the approval process, the Institutional Biosafety Officer (BSO) conducts required laboratory inspections & reviews the safety protocol.

  17. IBC Contacts Cynthia Karr, PhD IBC Program Manager Office of Research Integrity (ORI) karrc@musc.edu Phone: 792-3370 Fax: 792-6507 Location: HOT 601 Application: http://erma.musc.edu/ Dan Eisenman, PhD Biosafety Officer (BSO) Occupational Health and Safety Programs eisenman@musc.edu Phone: 792-4304 Fax: 792-0284 Location: HOT 908 www.musc.edu/biosafety

  18. ORI Coordinates • http://research.musc.edu/ori/irb/home.htm • 792.4148 • 6th Floor (Room 601) Harborview Towers

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