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

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