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Implications of Noncompliance

Implications of Noncompliance. Skye McDougall, PhD Network Research Officer VISN 22. Elements of Success. Implications of Noncompliance. Restriction or Shut Down. Research Programs. Ongoing Research. Assurance to conduct research. Federal Wide Assurance. The Research Process.

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Implications of Noncompliance

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  1. Implications of Noncompliance Skye McDougall, PhD Network Research Officer VISN 22

  2. Elements of Success Implications of Noncompliance • Restriction or Shut Down

  3. Research Programs

  4. Ongoing Research • Assurance to conduct research • Federal Wide Assurance

  5. The Research Process

  6. Restriction or Shut Down Assurance to conduct research

  7. Why Does This Happen? • Do not understand the rules and regulations • Inadequate resources • Inadequate documentation

  8. Research Stops-Impact • Confused patients-human subjects • Upset, angry, frustrated investigators • Academic affiliate

  9. Research Stops-Impact • The PRESS

  10. Research Stops-Impact • CHAOS

  11. Fiscal Impact • Continuing research slows down • No new grants • New staff • VERA $ decrease

  12. Elements of SuccessStaffing Needs • HRPP staff • IRB and R&D committee members • Where do you find qualified staff?

  13. Elements of SuccessProtocol Management • Accurate database? • How many research protocols do you have?

  14. Elements of SuccessTracking System • Resources?

  15. Elements for SuccessCommittee Structure IRB Animals Biosafety Budget Space R & DCommittee Governing Body

  16. Elements for SuccessSupport • Education • Culture

  17. Unanticipated Problemsin Research • New approach to local management

  18. Mission • Ensure that local management of unanticipated problems in research, including Adverse Events, assures maximal protection for research participants, and complies fully with all laws, regulations, and standards

  19. Charge • Identifying/Reporting • What should be reported • When should it be reported • Where should it be reported

  20. Charge • Tracking/Database • Monitoring • Who monitors • What is monitored • What trends/patterns require further action

  21. Charge • Research v. Patient Safety • Corrective Action • Who takes action • What are appropriate actions • When does it become research misconduct • Education • Communication

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