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Investigator Resources

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Information for Study Teams
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Institutional Review Boards
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
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
Western IRB (WIRB)
About the HSRO

Basic Folder Information

7.5 Project Verification from Outside Sources

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

August 27, 2007

Revised: May 24, 2011

7.5 Project Verification from Outside Sources

It is usual that the IRB will make its determinations based on information from the principal investigator.  However, the IRB may determine that a study shall require enhanced monitoring from sources (to be defined by the IRB) other than the investigator [45 CFR 46.103(b)(4), 21 CFR 56.108(a)].

Criteria that the IRB may use as a basis for requiring enhanced monitoring may include but are not limited to:

1)  Randomly selected studies

2)  Complex studies involving unusual levels or types of risks to subject

3)  Studies conducted by investigators who previously failed to comply with applicable regulations or institutional or IRB requirements

4)  Studies where other concerns have been raised by subjects, a DSMB, study or HSRO staff, IRB members or others about possible material changes occurring without IRB approval.

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