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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
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

6.1 Agenda

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

March 14, 2006

Revised: May 24, 2011


6.1 Agenda

Convened meetings of an IRB shall have an agenda, constructed by HSRO staff, which clearly shows the topics and items that the members will consider at the meeting.  The agenda shall identify each study by title, UM IRB number and Principal Investigator name.  Agendas shall be considered a "tool" utilized by the HSRO and IRB to assist in the organization and conduct of meetings and in preparation of minutes.  Agendas will become part of the official meeting record to assist location of a specific item or action in the minutes of the meeting.

Examples of agenda items include:

·         Review of previous meeting minutes

·       Discussion Items

·       Staff Reports

·         Reports of Unanticipated Problems and Adverse Events

·         Reports of Changes in Research (Amendments)

·         New studies submitted for review

·         On-going studies submitted for continuing review

·         Reports of expedited and exempt reviews

·         Exempt Reviews

·       Audit Report

·         Educational sessions and materials

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