kathy magruder, mph, phd director musc office of research integrity
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KATHY MAGRUDER, MPH, PHDDIRECTOR
MUSC Office of Research Integrity
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
Institutional Review Board (IRB)
Full AAHRPP accreditationServe both MUSC and VA investigatorsPurpose
To protect the rights and welfare of human research subjects
Authority to approve, require modification, and disapprove any research involving human subjects
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)
Principles of the Belmont Report
Respect for personsBeneficence Justice
Board Activities
New protocolsAmendmentsProtocol continuationsAdverse eventsProtocol deviationsData Safety & Monitoring Board reportsAudits & PI responses
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
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
IRB 3
All Departments Industry sponsored studies only
Western IRB (WIRB)
12 month pilot ending December 2011
Eligibility Department of Medicine
investigators Phase 3, multi-site clinical trials Industry sponsored
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
Institutional Animal Care & Use Committee (IACUC)
Fully AAALAC accreditedPurpose
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.
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)
IACUC
Contact Information Cyndi Rosenblatt, CPIA
IACUC Program Manager Rupak Mukherjee, PhD
IACUC Interim Chair
research.musc.edu/ori/iacuc [email protected] 792-6553
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 (September 2009) and the MUSC IBC Charter
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.
IBC Contacts
Cynthia Karr, PhDIBC Program
ManagerOffice of Research
Integrity (ORI)[email protected]: 792-3370Fax: 792-6507Location: HOT 601Application:http://erma.musc.edu/
Dan Eisenman, PhDBiosafety Officer (BSO)Occupational Health
and Safety [email protected]: 792-4304Fax: 792-0284Location: HOT 908www.musc.edu/
biosafety
ORI Coordinates
http://research.musc.edu/ori/irb/home.htm792.41486th Floor (Room 601)
Harborview Towers