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Investigator Resources

Information for Research Participants
Information for Study Teams
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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
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

2.4 Federalwide Assurance (FWA)


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

November 30, 2005

Revised: May 10, 2011



2.4 Federalwide Assurance (FWA)

The University of Miami requires review and approval by an IRB of all research involving human subjects, if any UM faculty, staff, or students are engaged as key personnel in that research ("engagement" in research is defined in section 3.7a of this document). Such IRB approval must occur before the involvement of human subjects may begin.  The review of research at the University of Miami is conducted in accordance with its Federal Wide Assurance (FWA), which is a binding written agreement with the federal government that is approved by the Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP) affirming that the University is in compliance with DHHS regulations contained within 45 CFR 46.  In studies involving products regulated by the Food and Drug Administration, UM also complies with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812.

Under the FWA, the University commits to DHHS that it will comply with the requirements set forth in 45 CFR 46 as well as 21 CFR 50 and 56 to protect human subjects participating in research.  This assurance is required because the University is engaged in human subjects research that is not exempt from the regulations and that is conducted or supported by an HHS agency.  Under certain conditions, the University may extend its FWA to cover a collaborating individual investigator.

The FWA states that the University is guided by the ethical principles of the Belmont Report and will comply with federal regulations.  The FWA also authorizes registered University of Miami IRB panels to review, approve and disapprove all human subject research projects regardless of funding sources (if any), in order protect the rights and welfare of the subjects through a review process detailed in 45 CFR 46.  In addition, the UM IRB has the responsibility and authority to review and take appropriate actions regarding conflict of interest.

The IRB panels at the University of Miami are referred to as the Institutional Review Boards (one or more) for the Protection of Human Subjects in Research involving medical sciences and the Institutional Review Boards (one or more) for the Protection of Human Subjects in Research involving social and behavioral sciences.

The FWA, which is effective for 3 years and which must be renewed at the end of that period of time in order to remain effective, describes the responsibilities of the institution, institutional officer, the Institutional Review Boards, and the investigator.

All investigators at UM are expected to conduct research in accordance with the provisions of the Federalwide Assurance.  Primary responsibility for assuring that the rights and welfare of human subjects involved in research are protected rests with the Principal Investigator conducting the research.  Faculty members who assign or supervise research conducted by students have an obligation to consider carefully whether those students are qualified to safeguard adequately the rights and welfare of human subjects.



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Human Subjects Research Office

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