Human Research Protection Program

Office Hours:
Monday - Friday
8am - 5pm

Mailing Address:
Michigan State University

207 Olds Hall
East Lansing, MI 48824

Phone: (517) 355-2180
Fax: (517) 432-4503
Email: irb@msu.edu

Office Location:
207 Olds Hall.
Olds Hall is located between the Administration Building and MSU Main Library. Campus Map

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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. Reserved

4-3-B. Reserved

4-3-C. Reserved

4-3-D. Reserved

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. Request for 45CFR46.118 Designation

8-5. Initial Review

8-6. Revisions to an Approved Project

8-7. Renewed Approval

8-8. Demonstration Projects

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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Biomedical and Health Institutional Review Board (BIRB)

Community Research Institutional Review Board (CRIRB)

Social Science/Behavioral/Education Institutional Review Board (SIRB)

MSU Privacy Board