| 1. |
Introduction to the Human Research Participant Protection Program. |
| 2. |
History of Medical Research: |
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Describe the historical context from which federal regulations governing human subjects research protections were developed. |
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Describe the current regulatory environment in health care research. |
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Introduce the basic ethical principles supporting the regulations. |
| 3. |
Ethics and Governance: |
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Research Funding |
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Federal Oversight of Research |
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o Office of Human Research Protection |
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o Food and Drug Administration |
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o Office of Research Integrity |
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Health Insurance Portability and Accountability Act |
| 4. |
Informed Consent: |
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Describe the Research Study |
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Discuss Participation |
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Assess Understanding |
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Document Consent and Study Participation |
| 1. |
Introduction of KP Human Research Participant Protection Program |
| 2. |
Review committees (Institutional Review Board/Research Review Committee) and Investigator responsibilities: |
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Participants Rights, Safety, and Welfare |
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Risks Reasonable in Relation to Benefits |
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Informed Consent Process |
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HIPAA Privacy Board for research |
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Applying Institutional, State and Federal Regulations |
| 3. |
New Study Submission |
| 4. |
Continued IRB oversight: |
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Modifications |
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Continuing Reviews |
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Protocol Deviations/Violations/Exemptions |
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Adverse Event Reporting |
