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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
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Basic Folder Information

6.5 Confidentiality of IRB Meetings and Guest Policy

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

March 14, 2006

Revised: May 24, 2011


6.5 Confidentiality of IRB Meetings and Guest Policy

Proceedings of IRB meetings are considered confidential. IRB members, alternate members and ex officio members should not disclose information about studies including (but not limited to) contents of files, details of discussions and the attribution of comments to specific committee members.  Such members must sign IRB confidentiality agreements.

Persons may be permitted to attend UM IRB meetings as guests under the following conditions:

1)  Guest attendance is at the discretion of the IRB chair or IRB-designee

2)  Guests may be asked to leave at any time

3)  Guests may not be in attendance during the deliberations relative to a study in which they serve as PI, co-investigator or key personnel

4)  Guests must sign a confidentiality agreement

5)  Guests must reveal any conflicts of interest prior to attendance and/or must excuse themselves if a potential conflict reveals itself

6)  Guests shall sign in and may be asked to document the purpose of their visit

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