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Information for Research Participants
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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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eProst User Guide
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

21.4 Informed Consent Documents


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 17, 2006



21.4 Informed Consent Documents

When studies are approved by the IRB, the PI shall receive from the HSRO written notification together with a copy of the approved consent form containing the stamped/watermarked date of approval and the expiration date of the study's approval on each sheet. The Principal Investigator may make copies of the stamped/watermarked consent form for use in obtaining informed consent from each research subject. A copy of the stamped/watermarked approved consent form shall also be filed in the study files maintained in the HSRO. Only informed consent documents bearing the HSRO approval stamp/watermark may be used in the conduct of research.

Consent forms signed by research participants and others should be retained by the Principal investigator for a period of at least three years after the study is completed and a final report is approved by the IRB.



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