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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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About the HSRO

Basic Folder Information

3.3 IRB Policy and Procedure Committee

Approval Date

Review Responsibility:

Medical and Social/Behavioral IRBs

Original Approval Date:

October 11, 2005

Revised: May 10, 2011

3.3 Policy and Procedure Committee

The University of Miami maintains written IRB policies and procedures reflecting current practices of the IRB in conducting reviews and approvals under its Assurance and also reflecting the supporting responsibilities of the HSRO.  These policies and procedures were written and implemented with three essential goals:

1.   To ensure that the IRB and all institutional employees carry out their responsibilities pursuant to research involving human subjects in compliance with federal regulations and the high ethical standards of the University

2.   To provide a clear foundation, and a basis for consistency of, IRB review and actions

3.   To provide a structure for training of university faculty and staff, IRB members and HSRO staff  

The University has a committee named the IRB Policy and Procedures Committee.  The chair of this committee shall be the Associate Vice Provost for Human Subject research who is a voting member of the committee.  Voting members are also the IRB chairs and the Assistant Provost for IRB Affairs.

New IRB policies and procedures, or revisions to such policies and procedures, may be recommended by HSRO staff, University faculty and staff, IRB members or the convened IRB, and by the IRB Policy and Procedures Committee.  Such recommendations should be addressed to the IRB Policy and Procedures Committee for review.  By majority vote, the IRB Policy and Procedure Committee shall approve or disapprove any or all sections of the policies and procedures and/or revisions.  The dates of approval and/or revision shall be documented at the top of each section. Changes in IRB policies and procedures are subject to review and approval by the Vice Provost for Research.

It is the responsibility of the IRB Policy and Procedures Committee to ensure that the IRB policies and procedures are reviewed periodically and to ensure that IRB members and HSRO staff are informed of any changes.  The Committee shall meet at least annually and shall undertake a review of IRB policies and procedures at least once during a 36 month period.

It is the responsibility of the Associate Vice Provost for Human Subject Research to ensure that these written policies and procedures are provided to all HSRO staff and IRB members and that they are posted on the HSRO website at the University.

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