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Getting to Yes* Helping to Get Your Protocol Approved Thomas Diflo, MD, FACS IRB Chairman

NYU School of Medicine HRPP PI Lecture Series. Getting to Yes* Helping to Get Your Protocol Approved Thomas Diflo, MD, FACS IRB Chairman. *With Thanks to Roger Fisher. The Old Days. The Old Days. IRB Chair. PI. Criteria for IRB Approval of Research.

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Getting to Yes* Helping to Get Your Protocol Approved Thomas Diflo, MD, FACS IRB Chairman

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  1. NYU School of Medicine HRPP PI Lecture Series Getting to Yes* Helping to Get Your Protocol Approved Thomas Diflo, MD, FACS IRB Chairman NYU SoM PI Lecture Series 2010 *With Thanks to Roger Fisher

  2. The Old Days NYU SoM PI Lecture Series 2010

  3. The Old Days NYU SoM PI Lecture Series 2010

  4. IRB Chair PI NYU SoM PI Lecture Series 2010

  5. Criteria for IRB Approval of Research • Risks to subjects are minimized - Indicate How • Risks to subjects are reasonable in relation to anticipated benefit (please specify reason for risk determination) • Selection of subjects is equitable - Indicate How • Informed consent will be obtained • Informed consent will be documented • Adequate monitoring to ensure safety • Privacy is protected - Indicate How • Vulnerable populations have been additionally safeguarded

  6. Informed Consent NYU SoM PI Lecture Series 2010

  7. Informed Consent • A description of any reasonably foreseeable risks or discomforts to the subject. NYU SoM PI Lecture Series 2010

  8. Informed Consent • A description of any reasonably foreseeable risks or discomforts to the subject. • Participation is voluntary without negative consequences if you don’t participate NYU SoM PI Lecture Series 2010

  9. Informed Consent • A description of any reasonably foreseeable risks or discomforts to the subject. • Participation is voluntary without negative consequences if you don’t participate • A process, not a paper form NYU SoM PI Lecture Series 2010

  10. Code of Federal Regulations TITLE 45PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46PROTECTION OF HUMAN SUBJECTS NYU SoM PI Lecture Series 2010

  11. The Nitty-Gritty NYU SoM PI Lecture Series 2010

  12. The Nitty-Gritty • What does the IRB need? NYU SoM PI Lecture Series 2010

  13. The Nitty-Gritty • What does the IRB need? • How can the PI give it to us? NYU SoM PI Lecture Series 2010

  14. 45 CFR 46.111 – Criteria for IRB Approval of Research • In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: 1. Risks to subject are minimized: • (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and • (ii) whenever appropriate, by using procedures already being performed on the subject for diagnostic or treatment purposes NYU SoM PI Lecture Series 2010

  15. 45 CFR 46.111 – Criteria for IRB Approval of Research Risks to Subjects are Minimized NYU SoM PI Lecture Series 2010

  16. 45 CFR 46.111 – Criteria for IRB Approval of Research 2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risk and benefits, the IRB should consider only those risks and benefits that may result from research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). NYU SoM PI Lecture Series 2010

  17. 45 CFR 46.111 – Criteria for IRB Approval of Research Risks are Reasonable NYU SoM PI Lecture Series 2010

  18. 45 CFR 46.111 – Criteria for IRB Approval of Research The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. NYU SoM PI Lecture Series 2010

  19. 45 CFR 46.111 – Criteria for IRB Approval of Research 3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. NYU SoM PI Lecture Series 2010

  20. 45 CFR 46.111 – Criteria for IRB Approval of Research NYU SoM PI Lecture Series 2010

  21. 45 CFR 46.111 – Criteria for IRB Approval of Research Subject selection is Equitable NYU SoM PI Lecture Series 2010

  22. 45 CFR 46.111 – Criteria for IRB Approval of Research • Equitable Subject Selection • The special case of non-English speakers NYU SoM PI Lecture Series 2010

  23. 45 CFR 46.111 – Criteria for IRB Approval of Research 4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 46.116. NYU SoM PI Lecture Series 2010

  24. 45 CFR 46.111 – Criteria for IRB Approval of Research NYU SoM PI Lecture Series 2010

  25. 45 CFR 46.111 – Criteria for IRB Approval of Research • The Process NYU SoM PI Lecture Series 2010

  26. 45 CFR 46.111 – Criteria for IRB Approval of Research • The Process • Who NYU SoM PI Lecture Series 2010

  27. 45 CFR 46.111 – Criteria for IRB Approval of Research • The Process • Who • How NYU SoM PI Lecture Series 2010

  28. 45 CFR 46.111 – Criteria for IRB Approval of Research • The Process • Who • How • Competency NYU SoM PI Lecture Series 2010

  29. 45 CFR 46.111 – Criteria for IRB Approval of Research • The Process • Who • How • Competency • Need for Surrogate NYU SoM PI Lecture Series 2010

  30. 45 CFR 46.111 – Criteria for IRB Approval of Research • The Process • Who • How • Competency • Need for Surrogate • Assent for children NYU SoM PI Lecture Series 2010

  31. 45 CFR 46.111 – Criteria for IRB Approval of Research • The Process • Who • How • Competency • Need for Surrogate • Assent for children • How many parents need to sign NYU SoM PI Lecture Series 2010

  32. 45 CFR 46.111 – Criteria for IRB Approval of Research 5. Informed consent will be appropriately documented, in accordance with 46.117. NYU SoM PI Lecture Series 2010

  33. 45 CFR 46.111 – Criteria for IRB Approval of Research NYU SoM PI Lecture Series 2010

  34. 45 CFR 46.111 – Criteria for IRB Approval of Research 6. When appropriate, the research plan makes adequate provision for monitoring the data collection to ensure the safety of subjects. NYU SoM PI Lecture Series 2010

  35. 45 CFR 46.111 – Criteria for IRB Approval of Research 6. When appropriate, the research plan makes adequate provision for monitoring the data collection to ensure the safety of subjects. Patient Safety NYU SoM PI Lecture Series 2010

  36. 45 CFR 46.111 – Criteria for IRB Approval of Research 6. When appropriate, the research plan makes adequate provision for monitoring the data collection to ensure the safety of subjects. Patient Safety The Role of Data Safety Monitoring NYU SoM PI Lecture Series 2010

  37. 45 CFR 46.111 – Criteria for IRB Approval of Research 7. When appropriate, there are adequate provisions to protect the privacy of the subjects and to maintain the confidentiality of the data. NYU SoM PI Lecture Series 2010

  38. 45 CFR 46.111 – Criteria for IRB Approval of Research NYU SoM PI Lecture Series 2010

  39. Hierarchy of Research The PI is the leader of the research team. NYU SoM PI Lecture Series 2010

  40. Human Research Protection Program 4-point Responsibility in Research Plan • Accountability NYU SoM PI Lecture Series 2010

  41. Human Research Protection Program 4-point Responsibility in Research Plan 2. Renew Commitment NYU SoM PI Lecture Series 2010

  42. Human Research Protection Program 4-point Responsibility in Research Plan 3. Training and Development NYU SoM PI Lecture Series 2010

  43. Human Research Protection Program 4-point Responsibility in Research Plan 4. Transparency NYU SoM PI Lecture Series 2010

  44. Criteria for IRB Approval of Research • Risks to subjects are minimized - Indicate How • Risks to subjects are reasonable in relation to anticipated benefit (please specify reason for risk determination) • Selection of subjects is equitable - Indicate How • Informed consent will be obtained • Informed consent will be documented • Adequate monitoring to ensure safety • Privacy is protected - Indicate How • Vulnerable populations have been additionally safeguarded

  45. NYU School of Medicine PI Lecture Series 2010 • June 16th – “How Can You Recruit for Your Project” • Frederick G. More, DDS, IRB Chairman • September 16th – “Get to Know Your HRPP” • Kenneth Delany, SPA • Elan Czeisler, IRB • Jeanie Gatewood, OCT • Keisha Lightbourne, Regulatory Compliance • December 2nd – “Areas PI Find Vexing” • Frederick G. More, DDS, IRB Chairman • Sylvia Adams, MD, Co-IRB Chairwoman NYU SoM PI Lecture Series 2010

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