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Informed Consent Process and Documentation: What Can Go Wrong?

Informed Consent Process and Documentation: What Can Go Wrong?. March 3, 2009 Judi Kuhl, B.S., C.I.P. QI Program Coordinator Office of Research Integrity University of Kentucky. Objectives. Describe common problems with the informed consent process

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Informed Consent Process and Documentation: What Can Go Wrong?

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  1. Informed Consent Process and Documentation: What Can Go Wrong? March 3, 2009 Judi Kuhl, B.S., C.I.P. QI Program Coordinator Office of Research Integrity University of Kentucky

  2. Objectives • Describe common problems with the informed consent process • Describe how those concerns and/or problems are identified • Describe remedies for concerns and/or problems with the informed consent process University of Kentucky

  3. Respect for Persons • Informed Consent/Surrogate Consent/Assent • Provide Information • Promote Comprehension • Establish Voluntariness University of Kentucky

  4. Common Findings • Office for Human Research Protections (OHRP) Compliance Oversight Activities: Significant Findings and Concerns of Noncompliance [2/4/2009] http://www.hhs.gov/ohrp/compliance/findings.html University of Kentucky

  5. Common Findings • Failure to Obtain Informed Consent • Deficient and/or Inadequate • Informed Consent Document • Lack of Basic Elements • Lack of Additional Elements University of Kentucky

  6. Common Findings University of Kentucky

  7. Common Findings • Failure to Document • Informed Consent University of Kentucky

  8. Common Findings University of Kentucky

  9. Common Findings • Too much detail • Language too • complex University of Kentucky

  10. University of Kentucky

  11. Common Findings So, how about that research study? University of Kentucky

  12. Comprehension University of Kentucky

  13. University of Kentucky

  14. Identifying ICP Issues Continuation Review • Signed consent form for two most recently enrolled subjects University of Kentucky

  15. Identifying ICP Issues Continuation Review • “Clean” copy of current IRB approved consent document for re-approval University of Kentucky University of Kentucky

  16. Identifying ICP Issues IRB Review • Initial • Modification University of Kentucky

  17. Identifying ICP Issues QI Administrative Assessment -- Elements of Informed Consent • Eight federally mandated elements • Additional elements as applicable • Documentation when exclusion (or alteration) of one of the additional elements is permissible University of Kentucky

  18. Remedies • Educating researchers • At Continuation Review • Online PI Self-Assessment Form [https://www.research.uky.edu/cfdocs/ORI/IRB_QA/] University of Kentucky

  19. Remedies (informed consent observation) Subject Researchers IRB University of Kentucky

  20. Remedies • Informed Consent Document Template • Informed Consent Checklist – guide • Follow-up QI Administrative Assessments University of Kentucky

  21. University of Kentucky

  22. Questions? Judi Kuhl, B.S., C.I.P. QI Program Coordinator Office of Research Integrity University of Kentucky Judi.Kuhl@uky.edu 859-257-9764

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