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Investigator Resources

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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

11.4 Informational Materials

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

April 10, 2006

Revised: February 13, 2012


11.4 Informational Materials

Informational materials such as Investigator's Brochures, updated package inserts and any other materials requiring submission via a Notification (reportable event) in eProst should be submitted to the HSRO in a timely manner.  The HSRO shall acknowledge receipt of such materials either by correspondence to the principal investigator or by executing the 'Acknowledged/Noted' activity in eProst.  The HSRO shall make these items available to the IRB Chair or designee who shall determine whether further IRB action is required.  If no further IRB action is required, the material shall be added to the study file kept by the HSRO.  If further action is required, the IRB Chair or designee may request that the HSRO seek information or modifications from the principal investigator or he/she may refer the submission to the convened IRB for its deliberation and resolution.  Investigators are reminded that all changes in research, including changes to study personnel, must be submitted as an Amendment and not in a Notification form.  Notification forms communicating changes in research shall not be accepted by the HSRO.

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