Transcript MUSC Office of Research Integrity KATHY MAGRUDER, MPH, PHD DIRECTOR Office of Research Integrity (ORI)  Institutional Review Boards (IRB)  Institutional Animal Care and.

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)
 Research Integrity Committee (RIC) for scientific
misconduct
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
Institutional Review Board (IRB)
 Mandated by Federal Law to review all research
federally funded and by inclusion, all research
involving human subjects
 Regulatory agencies
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Office of Human Research Protection (OHRP)
Food & Drug Administration (FDA)
Principles of the Belmont Report
 Respect for persons
 Beneficence
 Justice
Board Activities
 New protocols
 Amendments
 Protocol continuations
 Adverse events
 Protocol deviations
 Data Safety & Monitoring Board reports
 Audits & PI responses
IRB 1
 Cell & Molecular Pharmacology
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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
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Medicine
Pediatrics
Pharmaceutical Sciences
Pharmacy Practice
Physical Therapy
Physiology
Psychiatry & Behavioral
Sciences
Radiology
Urology
IRB 2
 Anesthesiology
 Biochemistry & Molecular
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Biology
Center for Health Care
Research
Experimental Oncology
Family Medicine
General Dentistry
Medicine
Microbiology & Immunology
Molecular & Structural Biology
Neuroscience
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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 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.
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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
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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, PhD
IBC Program Manager
Office of Research
Integrity (ORI)
[email protected]
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
[email protected]
Phone: 792-4304
Fax: 792-0284
Location: HOT 908
www.musc.edu/biosafety
ORI Coordinates
 http://research.musc.edu/ori/irb/home.htm
 792.4148
 6th Floor (Room 601)
Harborview Towers