Research Compliance at OSU

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Research Compliance at OSU An Overview P
resented by Beth McTernan Office of Universit
y Research Compliance
March 2, 2004
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Office of University Research Compliance

• Compliance is a team effort!

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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/complianc
  e/
  

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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)

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University Research Compliance Regulations/Polici
es

• 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

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University Research Compliance Regulations/Polici
es

• 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

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Office of University Research ComplianceMission

• 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.
  

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Office of University Research ComplianceResponsib
le 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

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Office of University Research ComplianceResponsib
le Conduct of Research

• Compliance Committees

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Office of University Research ComplianceInstituti
onal Review Board (IRB)
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Office of University Research ComplianceInstituti
onal Animal Care Use Committee (IACUC)
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Office of University Research ComplianceRadiologi
cal Safety Committee
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Office of University Research ComplianceInstituti
onal Biosafety Committee (IBC)
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Office of University Research ComplianceLaser
Safety Committee
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Office of University Research ComplianceResponsib
le 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

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Office of University Research ComplianceResponsib
le 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

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Office of University Research Compliance
Oversight Compliance

• Centralized Committee Administration

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Office of University Research ComplianceOversight
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

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Office of University Research ComplianceSummary

• Increasing oversight by federal government
• Costs of compliance
• Time
• Funding
• Infrastructure
• Administration
• Costs of non-compliance

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Compliance is a team effort!