Informed Consent Process and Documentation: What Can Go Wrong?

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

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

12. Comprehension University of Kentucky

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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

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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