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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

2.3 Federal Regulations

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

November 30, 2005

Revised: May 10, 2011; June 8, 2011


2.3 Federal Regulations

Until 1991, federal departments and agencies that conduct, support, or regulate research used a variety of policies and procedures to protect human research subjects. To eliminate confusion and promote uniformity, each of these departments and agencies has adopted as regulation a common Federal Policy for the protection of human research subjects. The Federal Policy applies to research involving human subjects that is conducted, supported, or otherwise subject to regulation by any of the following fifteen federal departments and agencies: 

  1. Department of Agriculture 
  2. Department of Energy
  3. National Aeronautics and Space Administration
  4. Department of Commerce
  5. Consumer Product Safety Commission
  6. International Development Cooperation Agency
  7. Agency for International Development
  8. Department of Housing and Urban Development
  9. Department of Justice
  10. Department of Defense
  11. Department of Education
  12. Department of Veterans Affairs
  13. Environmental Protection Agency
  14. Department of Health and Human Services
  15. National Science Foundation

The FDA has concurred with the Federal Policy, but has additional requirements.

The shared responsibility of all investigators to protect human subjects in biomedical and social/behavioral research from unnecessary risk is codified in Federal rules and regulations governing human research. These are contained in DHHS Code of Federal Regulations 45 CFR 46 (“the Common Rule”) and its subparts B, C and D.   [NOTE – Although all federal agencies have adopted the Common Rule, some federal agencies have yet to adopt all subparts]. In addition to the "Common Rule" human subject research involving drugs, biologics, and devices must comply with FDA regulations found in 21 CFR 50, 54, 56, 312, 600, and 812.

In addition to compliance with federal regulations, the University of Miami and its IRBs are committed to compliance with applicable state and local laws. In taking these and federal regulations into account in its review and oversight of human subject research, the IRB may seek guidance from attorneys in the UM Office of General Counsel especially when there appears a need for resolution of differences among federal, state and local laws. UM legal counsel shall advise the IRB on any issue/concern that the IRB believes is appropriate to its responsibilities for human subject protection in research including but not limited to: a) whether someone is acting as an agent of the organization; b) whether someone meets the definition of legally authorized representative; c) whether study protocols are compliant with applicable laws/regulations; and d) resolution of conflicts among applicable laws/regulations.

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