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Chapter 1
Institutional Authority
Chapter 2
Purpose
Chapter 3
Guiding Principles and Regulatory Requirements for Human Subject Protection
Chapter 4
IRB Authority
Chapter 5
IRB Relationships to Others
Chapter 6
Membership of the IRB
Chapter 7
IRB Organization
Chapter 8
IRB Record Keeping and Required Documentation
Chapter 9
Functions of the IRB
Chapter 10
Operations of the IRB
Chapter 11
IRB Review and Approval Considerations
Chapter 12
Informed Consent and Documentations
Chapter 13
Authorization for the Use and Disclosure of Protected Health Information (PHI) (Under Construction)
Chapter 14
Social Science and Education Research
Chapter 15
IRB Review of Research Using Data or Specimens
Chapter 16
Potentially Vulnerable Participant Groups
Chapter 17
Management of FDA Regulated Research
Chapter 18
Managing Conflicts of Interest
Chapter 19
Education and Training
Chapter 20
Mechanisms for Periodic Review of Policies and Procedures
Appendix A
Handling Allegations of Noncompliance
Appendix B
Reporting of Unanticipated Problems Involving Risks to Participants or Others
Abbreviations
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