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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
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Ancillary Committee Information
eProst User Guide
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Western IRB (WIRB)
About the HSRO

Basic Folder Information

23.2 IRB Approval and HHS

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 24, 2006

23.2 IRB Approval and HHS

For studies involving vulnerable subjects who are included in 45 CFR 46 Subparts B-D (i.e. pregnant women, human fetuses and neonates, prisoners and children) and/or 21 CFR 50 Subpart D, IRB approval may only be considered if one or more of the following conditions is met:

1)  The research does not involve more than minimal risk to the subjects

2)  The research is likely to benefit the subjects directly, even if the risks are considered to be more than minimal

3)  The research involves greater than minimal risk with no prospect of direct benefit to individual subjects, but is likely to yield generalized knowledge about the subject's disorder or condition

If the study is approved by the IRB but it involves subjects considered vulnerable according to federal regulations in Subparts A-D of 45 CFR 46 and/or Subpart D of 21 CFR 50, and if the IRB deems that none of the above conditions is met, the study must also be submitted to the United States Secretary of Health and Human Services for review and approval.

For populations not considered with 45 CFR 46 Subparts B-D and/or 21 CFR 50 Subpart D but who are considered vulnerable by UM ethical standards and the IRB (for example, persons with dementia or other cognitive disorders, students, employees and particularly vulnerable patients), IRB review shall be guided by the principles of the three criteria listed above.

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