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• Summary of Approved Revisions to the HRP Manual
• Section 1. MSU Agreements
• Section 2. Ethical Principles, Federal, State and Local Guidelines and Regulations
• Section 3. MSU Human Research Protection Program Plan
• Section 4. Jurisdiction and Responsibilities
• Section 5. IRB Organization and Structure
• Section 6. IRB Evaluation Criteria
• Section 7. Research Involving Investigational Drugs and Devices
• Section 8. Types of IRB Review
• Section 9. Urgent Situations
• Section 10. Conflict of Interest
• Section 11. Education
• Section 12. Guidance
• Section 13. Glossary
• Section 14. Appendices

Section 1. MSU Agreements

• 1-1. Federal Wide Assurance
• 1-2. CRIRB Partner Institution Agreement
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Section 2. Ethical Principles, Federal, State and Local Guidelines and Regulations

• 2-1. Ethical Principles
• 2-2. Federal Guidelines and Regulations
• 2-3. State and Local Guidelines and Regulations
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Section 3. MSU Human Research Protection Program Plan

• 3-1. MSU Human Research Protection Program Plan
• 3-2. Policy Development and Approval
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Section 4. Jurisdiction and Responsibilities

• 4-1. Applicability
• 4-2. Authority of IRBs
• 4-3. Determination of Human Subject Research
• 4-3-A. Use of Commercially Available Human Cell Lines
• 4-3-B. Use of Human Cadaver Tissues or Cells
• 4-3-C. Use of Human Tissues from Commercial Sources or Tissue Banks
• 4-3-D. Public Use Data Files
• 4-3-E. Clinical Case Reports
• 4-4. Institutional Official
• 4-5. Responsibilities of the IRBs
• 4-6. Responsibilities of Investigators
• 4-7. Recordkeeping
• 4-8. Reporting Policy
• 4-9. Responsible Project Investigator
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Section 5. IRB Organization and Structure

• 5-1. IRB Chairs
• 5-2. IRB Staff and IRB Administrators
• 5-3. IRB Membership
• 5-4. Additional Expertise
• 5-5. Meetings
• 5-6. Contact Information
• 5-7. Privacy Board
• 5-8. IRB Fees
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Section 6. IRB Evaluation Criteria

• 6-1. Criteria for IRB Approval of Research
• 6-2. Minimization of Risks
• 6-2-A. Sound Research Design
• 6-2-B. Adequate Resources
• 6-3. Risk Benefit Ratio
• 6-3-A. Incomplete Disclosure/Deception
• 6-4. Informed Consent
• 6-4-A. Documentation of Informed Consent
• 6-4-B. Waiver or Alteration of Informed Consent
• 6-4-C. Parental Permission and Child Assent
• 6-5. Selection of Subjects and Recruitment
• 6-6. Privacy, Confidentiality and Anonymity
• 6-6-A. Student PID Policy
• 6-6-B. Health Insurance Portability and Accountability Act
• 6-7. Data and Safety Monitoring
• 6-8. Special Categories of Research Subjects
• 6-8-A. Pregnant Women, Human Fetuses and Neonates
• 6-8-B. Prisoners
• 6-8-C. Children
• 6-8-D. Individuals with Diminished Capacity
• 6-8-E. HIV and AIDS
• 6-9. Special Considerations
• 6-9-A. Student Classroom Research
• 6-9-B. Graduate Student Research
• 6-9-C. Reserved
• 6-9-D. Reserved
• 6-9-E. Emergency Research
• 6-9-F. Multiple Research Sites
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Section 7. Research Involving Investigational Drugs and Devices

• 7-1. Research Involving Investigational Drugs and Devices
• 7-2. Significant Risk and Nonsignificant Risk Medical Devices
• 7-3. Emergency Use of Investigational Drugs and Devices
• 7-4. Charging for Investigational Drugs
• 7-5. Investigational Use with Approved Drugs
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Section 8. Types of IRB Review  

• 8-1. Exemptions
• 8-2. Expedited Review Procedure
• 8-3. Full Board Review Procedure
• 8-4. Preliminary Approval
• 8-5. Initial Review
• 8-6. Revisions to an Approved Project
• 8-7. Renewed Approval
• 8-8. Reserved
• 8-9. Closure
• 8-10. Project Audits
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Section 9. Urgent Situations

• 9-1. Unanticipated Problems Involving Risks to Subjects or Others
• 9-2. Noncompliance
• 9-3. Termination or Suspension of Research
• 9-4. Subject Complaints
• 9-5. Unapproved Change in Protocol
• 9-6. Undue Influence on IRB
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Section 10. Conflict of Interest

• 10-1. Conflict of Interest
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Section 11. Education

• 11-1. Education
• 11-1-A. Investigators and Research Staff
• 11-1-B. IRB Member Education
• 11-1-C. IRB Staff Education
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Section 12. Guidance

• 12-1. Reserved
• 12-2. Storage and Handling of Investigational Drugs and Devices
• 12-3. Reserved
• 12-4. Consent Form Guidelines
• 12-5. Guidance on the Use of Anonymous and De-identified Data
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Section 13. Glossary

• 13-1. Glossary
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Section 14. Appendices

• 14-1. MSU Federal Wide Assurance
• 14-2. Terms of Assurance
• 14-3. IRB Registration
• 14-4. The Nuremberg Code
• 14-5. The Declaration of Helsinki
• 14-6. The Belmont Report
• 14-7. Title 45 Code of Federal Regulations Part 46
• 14-8. Title 45 Code of Federal Regulations Part 160 & 164
• 14-9. Title 21 Code of Federal Regulations Part 50
• 14-10. Title 21 Code of Federal Regulations Part 56
• 14-11. Title 21 Code of Federal Regulations Part 312
• 14-12. Title 21 Code of Federal Regulations Part 812
• 14-13. Protection of Human Subject Regulations for Other Federal Agency/Departments
• 14-14. Michigan State University Guidelines on Research Data: Management, Control and Access
• 14-15. Faculty Handbook
• 14-16. Researchers' Guide
• 14-17. CRIRB Partner Institutions
• 14-18. IRB Initial Application
• 14-19. Reserved
• 14-20. IRB Application for Revision
• 14-21. IRB Application for Renewal
• 14-22. IRB Reporting for Non-Local Subject Adverse Event
• 14-23. IRB Reporting for Local Subject Adverse Event – Clinical Unanticipated Problem
• 14-24. IRB Reporting for Unanticipated Problem (Non-Clinical)
• 14-25. IRB Application for Closure
• 14-26. Fees for For-Profit Sponsors
• 14-27. Fee for Non-Profit Partners or Sponsors
• 14-28. Registered Public Databases
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