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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

6.6 Meetings and Quorum


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

March 14, 2006

Revised: May 24, 2011

 



6.6 Meetings and Quorum

A goal to assure the effectiveness of the review process shall be to schedule IRB meetings at least once every other week.  The HSRO shall ensure that meetings are scheduled in advance and that an agenda and all pertinent documents are made available to members (and alternates if appropriate) with sufficient time prior to meetings.  Individual meetings may be cancelled by the Associate Vice Provost for Human Subject Research or his/her designee following consultation with the IRB Chair due to:

1)  Insufficient applications or other matters requiring convened board review

2)  University holiday

3)  Inability to secure a quorum for attendance

4)  Other reasons (such as inclement weather) that make a scheduled meeting unnecessary or otherwise inappropriate

Except when an exempt or expedited review procedure is used, the IRB shall review initial or continuing studies at convened meeting at which a quorum is present.  A quorum for a convened IRB meeting is 50% of the voting primary membership (including alternate members who may replace voting members) plus one.  A quorum must be maintained for each vote to occur.  If a quorum is not maintained, the meeting shall end or be suspended and the study shall be tabled.

Additional quorum policies are:

1)  The IRB chair and vice chair count toward the quorum

2)  At least one member whose primary concerns are in nonscientific areas must be present to complete a quorum

3)  If research involving an FDA-regulated article is involved, a licensed physician must be included in the quorum

4)  Members absenting themselves due to conflicts of interest may not be counted toward quorum requirements

Although the physical presence of IRB members at meetings is encouraged, a member or alternate member (if appropriate) may be considered present if participating through teleconferencing or videoconferencing.  In this case, the member or alternate member must have received all pertinent material prior to the meeting and must be able to participate activity and equally in all discussions and votes.  Minutes of such meetings shall clearly document that these two conditions have been satisfied in addition to the usual regulatory requirements.



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