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

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

11. IRB Contacts IRB 1 1 st Tuesday  Mark Hamner, M.D.Chair  Susan Anderson, Ph.D.Vice-chair  Linda Bunch Administrator IRB 23 rd Tuesday  Susan Sonne, Pharm.D.Chair  Rob Hawes, M.D. Vice-chair  Lisa Johnson Administrator IRB 32 nd and 4 th 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, CPIA IACUC Program Manager  Rupak Mukherjee, PhD IACUC Interim Chair  research.musc.edu/ori/iacuc  iacuc@musc.edu 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 (September 2009) 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 6 th Floor (Room 601) Harborview Towers