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Research Compliance at OSU: An Overview

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Research Compliance at OSU: An Overview

  1. 1. Research Compliance at OSU An Overview Presented by Beth McTernan Office of University Research Compliance March 2, 2004
  2. 2. Office of University Research Compliance Compliance is a team effort!
  3. 3. The Office of University Research Compliance Team Members Dr. Carol Olson, Director Beth McTernan, Research Compliance Specialist Jada Bruner Gailey, Coordinator Diana Jacobs, Senior Staff Assistant Web Site Address: http://vpr.okstate.edu/compliance/
  4. 4. University Research Compliance Coordinates  Institutional Review Board (IRB) for Human Subject Research  Institutional Animal Care & Use Committee (IACUC)  Radiation Safety  Biosafety  Laser Safety  Scientific Misconduct  Conflict of Interest  EREDF Facility Security Officer (classified research contracts)
  5. 5. University Research Compliance Regulations/Policies  Human Subject Research DHHS Office of Human Research Protections under 45 CFR Part 46  Animal Models USDA, Animal Welfare Act (1966) 9 CFR Ch. 1 DHHS Public Health Service,1996 Guide for Care & Use of Laboratory Animals PHS Policy on Humane Care and Use of Laboratory Animals  Biosafety Public Law 107-188; 42 CFR 73; 7 CFR 331; 9 CFR 121 USA Patriot Act
  6. 6. University Research Compliance Regulations/Policies  Radiological Safety U.S. Nuclear Regulatory Commission Oklahoma Department of Environmental Quality Oklahoma Department of Health Part 20, “Standards for Protection Against Radiation,” U.S. Nuclear Regulatory Commission Title 10, Chapter 1, Code of Federal Regulations  Laser Safety OSHA
  7. 7. Office of University Research Compliance Mission  To foster the responsible conduct of research;  To ensure conformance to governmental and university regulations and policies that affect research using humans, animals, recombinant DNA, infectious agents and toxins, radiological materials and devices, and research lasers;  Provide oversight of these research activities, including investigation of improprieties and research misconduct.
  8. 8. Office of University Research Compliance Responsible Conduct of Research Faculty Involvement  Expanded faculty and staff membership on committees  Cross-linking membership for health & safety  Environmental Health Services  Student Health Center  Stillwater Community  Joint meetings of committee chairs  Assistance with educational training development
  9. 9. Compliance Committees Office of University Research Compliance Responsible Conduct of Research
  10. 10. Office of University Research Compliance Institutional Review Board (IRB) Carol Olson,Chair * Office of the Vice President for Research Ed Arquitt Sociology David Balk Human Development & Family Science Gordon Edwards First Presbyterian Church Scott Fern* Legal Counsel Michael Gunzenhauser Educational Studies Kathryn Castle School of Teaching and Curriculum Leadership Miki Couch Court Appointed Special Advocates (CASA) Adrienne Hyle Education Extension Kouider Mokhtari Curriculum & Educational Leadership Robert Murphy, Jr. Payne County Courthouse Kathy Keim Nutritional Sciences Kathleen Kelsey Ag Education Beth McTernan* Office of Research Compliance Mike Strange Student Health Center David Thomas Psychology Margaret White Business Administration Elizabeth Williams History *non-voting member
  11. 11. Office of University Research Compliance Institutional Animal Care & Use Committee (IACUC) Kent Olson, Chair Economics & Legal Studies in Business Bahram Arjmandi Nutritional Sciences Scott Carter Animal Science Michael Davis Physiological Sciences Stan Fox Zoology Alexander Lai Microbiology & Molecular Biology Brad Bentz Veterinary Clinical Sciences Denver Marlow Director of Lab Animal Resources Don Pierce Environmental Health & Safety Robert Phillips Community Member Surgeon, Retired Mark Rochat Veterinary Clinical Sciences Mike Strange Student Health Center John Talley Community Member Non-Scientist
  12. 12. Office of University Research Compliance Radiological Safety Committee Steve McKeever, Chair Vice President for Research Howard Johnson Radiological Safety Officer Electronics/Computer Technology Robert J. Bahr Radiology, Veterinary Teaching Hospital Ron Buchanan Certified Health Physicist Robert Burnap Microbiology & Molecular Genetics Greg Fox Environmental Health & Safety Art Lucas Certified Health Physicist Robert Matts Biochemistry & Molecular Biology Mike Strange Student Health Center Ron Van Den Bussche Zoology
  13. 13. Office of University Research Compliance Institutional Biosafety Committee (IBC) William Barrow Chair Veterinary Pathobiology Denver Marlow Vice Chair Lab Animal Resources Elaine Ackerson, R.N. Stillwater Medical Center Michael Anderson Plant and Soil Sciences Mike Bale Risk, Plant & Property Management Richard Essenberg Chair Emeritus Babu Fathepure Microbiology & Molecular Genetics Greg Fox Environmental Health Services Robert Fulton Director, Environmental Safety Services, Stillwater Stan Gilliland Food & Ag Products Research & Tech Center Robert Matts Biochemistry and Molecular Biology Robert Miller Biosafety Officer Microbiology & Molecular Genetics Larry Millikin Fire Chief, City of Stillwater Jerry Saliki OADDL & Veterinary Pathobiology Mike Strange Student Health Center Charles Tauer Forestry Ron Van Den Bussche Zoology Jeanmarie Verchot-Lubicz Entomology
  14. 14. Office of University Research Compliance Laser Safety Committee J. D. Brown Laser Safety Officer Division of Engineering Technology Ken Bartels Veterinary Teaching Hospital Mike Strange Student Health Center Al Rosenberger Physics Greg Fox Environmental Health & Safety
  15. 15. Office of University Research Compliance Responsible Conduct of Research Training  Human Subjects  OSU IRB Training Quiz  Investigator 101  OHRP Human Assurance Training  OSU web page  Seminars by committee chair  Workshops by scientific experts  Animal Models  PHS Tutorial on Care and Use of Laboratory Animals  Animal Use Refresher Course for Principal Investigators  OSU web Page  Seminars by committee chair  Workshops by scientific experts
  16. 16. Office of University Research Compliance Responsible Conduct of Research Training  Radiological Safety  Provided by radiological safety officer and staff  Web version available  OSU web page  Seminars by committee chair  Workshops by scientific experts  Biosafety/Recombinant DNA  NIH Guidelines for Research Involving Recombinant DNA Molecules  Biosafety in Microbiological Laboratories, 4th ed.  Web modules in progress  OSU web page  Seminars by committee chair  Workshops by scientific experts
  17. 17. Office of University Research Compliance Oversight & Compliance Centralized Committee Administration Office of the President Vice President for Research & Tech Transfer Dr. Stephen McKeever Office of University Research Compliance Dr. Carol Olson, Director Inst. Review Board Dr. Carol Olson, Chair Laser Safety Committee Dr. J.D. Brown, LSO Inst. Animal Care & Use Committee Dr. Kent Olson, Chair Conflict of Interest Management Inst. Biosafety Committee Dr. William Barrow, Chair Scientific Misconduct Radiological Safety Committee Dr, Howard Johnson, RSO
  18. 18. Office of University Research Compliance Oversight & Compliance  Electronic tracking system for human subjects & animal models  Centralized database for radiological protocols & training  Centralized database for biosafety protocols  Resources provision (e.g., radiation testing equipment, space, professional development)  Staff support to committees  Web-based protocol review: IACUC
  19. 19. Office of University Research Compliance Summary  Increasing oversight by federal government  Costs of compliance  Time  Funding  Infrastructure  Administration  Costs of non-compliance
  20. 20. Compliance is a team effort!

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