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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
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Ancillary Committee Information
eProst User Guide
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

7.1 Submission of New or Continuing Studies


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

March 14, 2006

Revised: May 24, 2011

 



7.1 Submission of New or Continuing Studies

Documents and necessary forms required for substantive and meaningful IRB review of new or continuing studies shall be submitted by the Principal Investigator to the HSRO through its computer system (ePROST).

The HSRO shall screen submitted documents and forms for completeness before assigning the study to the appropriate IRB.  If the application is found to be incomplete or otherwise not fully prepared for IRB review, it shall be returned to the Principal Investigator or a request shall be made for necessary changes or to provide additional information.  The HSRO or an IRB member may contact the Principal Investigator to request clarification of study issues or revisions in document(s) prior to review by the IRB or during the review process.



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