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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

3.1 IRB Authority


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

August 8, 2008

Revised: May 10, 2011



Policy

Pursuant to the University of Miami’s commitment to protect human subjects, the University has established one or more panels each called the Institutional Review Board (IRB).  Each IRB shall have responsibilities to review assigned human subject research in accordance with federal regulations and each IRB shall have the authority and responsibilities defined within these policies and procedures.  In conducting its reviews, each IRB shall be guided by the principles of the Belmont Report, all applicable regulations and the ethical standards of the University. 

The UM IRB operates under the regulatory authorities as described within:

  1. U.S. Department of Health and Human Services Title 45, Part 46, Subparts A, B, C, and D
    (for all research, regardless of source of funding)
  2. U.S. Food and Drug Administration Chapter I of Title 21 CFR 50
    (for FDA regulated research only)
  3. U.S. Food and Drug Administration Chapter I of Title 21 CFR 56
    (for FDA regulated research only)

The IRB is authorized to review and to approve, defer and/or require modifications to secure approval, table, or disapprove all human subject research overseen and conducted by the University of Miami and covered by the University's Federal-wide Assurance to ensure the rights, welfare and protection of all human subjects.  This responsibility extends to all human subject research including pilot studies and feasibility studies, even if such studies include only one subject; and it includes all research involving human subjects performed under the auspices of the University of Miami regardless of whether the studies are extramurally funded, funded by University sources or non-funded.  IRB review applies to human subject research conducted by University and Jackson Health System faculty, students, staff, or others, either on the University of Miami/Public Health Trust premises or elsewhere.

The IRB may consider recommendations from other institutional or extramural review committees, but the IRB has the responsibility and sole authority to carry out its review responsibilities in accordance with these policies and procedures.

The IRB shall define whether proposed research is acceptable based on regulations and policies, applicable law, validity of study design as it relates to risks and benefits, sensitivity to community standards and attitudes, as well as standards of professional conduct and practice.  No one at the University may approve a study that the IRB has disapproved; and officials of the University may not approve a study if it has not been approved by the IRB [45 CFR 46.112; 21 CFR 56.112].  In order to approve human research studies, the IRB shall review the full proposal, the consent form and all supplemental information such as, but not limited to, the sponsor's protocol (if applicable), investigator's brochure, clinical trial agreement, and recruiting material.

If applicable, each IRB may require studies to be reviewed and approved by ancillary committees such as, but not limited to, the Institutional Biosafety Committee, the Pathology Research Steering Committee, and the Radiation Safety Office.  The IRB has additional authorities which include:

  1. Authority to Require Progress Reports and to Oversee the Study
    The UM IRB has the responsibility and the authority to review the progress of human subject research studies, to monitor the activities in approved studies including regularly scheduled continuing review at least annually and to require verification of compliance with approved research protocols and informed consent procedures through means such as audit, observation or third party review.  The authority to review the progress of studies includes the authority to require prompt reporting to the IRB of any planned changes in approved projects prior to the implementation of those changes and the authority to require prompt reporting to the IRB of any unanticipated problems (including adverse events) occurring in, or related to, approved protocols.
  2. Authority to Suspend or Terminate Approval of Research
    The UM IRB and/or certain members of the University Administration and/or the IRB chair/designee have the responsibility and the authority to suspend or revoke approval of any study that was originally reviewed and approved for reasons such as unanticipated problems involving risks to human subjects, serious or continuing non-compliance with any federal regulation or serious or continuing non-compliance with the requirements or determinations of the IRB [45 CFR 46.113; 21 CFR 56.113].  Such actions by the IRB shall be determined at a convened meeting of the IRB with a quorum present and shall be incorporated into the minutes of the meeting.  The IRB shall consider the rights and welfare of current research subjects when suspending or terminating approval of active studies.  (c.f. Section 13). 
  3. Authority to Restrict Research
    The IRB has the responsibility and the authority to restrict any study that it has originally reviewed and approved if it determines that such action is warranted.  Under this policy, 'restrict' is defined as suspending or terminating a portion of a study found in non-compliance either permanently or until it is brought into compliance.  One example of this may be if an aspect of a study fails to comply with federal regulations or IRB requirements or determinations.  In this circumstance, the IRB may suspend or terminate approval of the entire study pursuant to the policy on suspending or terminating approval of research (see above) or the IRB may place restrictions on one or more portions of the study.  The IRB may also request that a study audit be conducted.
  4. Authority to observe, or have a third party observe, the consent process
    [45 CFR 46.109(e); 21 CFR 56.109(e)]
    If an IRB approves a study, that IRB has sole authority for oversight of the study including the consent process.  To carry out this responsibility, the IRB may observe or have a third party observe the consent process and/or it may seek information on this process from the principal investigator or others. 
  5. Authority to observe, or have a third party observe, the conduct of the research
    [45 CFR 46.109(e); 21 CFR 56.109(f)]
    If an IRB approves a study, that IRB has sole authority for oversight of the study including the conduct of the research under the approved protocol.
  6. Authority to recommend transfer of IRB responsibility from one IRB to another
    If an IRB approves a study, that IRB has sole authority for oversight of the study.  However, there may be occasions when the IRB considers it necessary for another IRB to assume responsibility for oversight of the study.  In such instances, the original IRB may recommend, by majority vote at a convened meeting, that the responsibility for the study be transferred to another IRB.  This recommendation shall be recorded in the minutes of the convened IRB meeting and forwarded to the Associate Vice Provost for Human Subject Research for review and approval/disapproval.
  7. Authority to obtain additional expertise when reviewing a specific study
    If the IRB chair or designee reviewing an exempt or expedited study, or a member of the convened IRB reviewing an initial or continuing study, determines that additional expertise is required for this review,  the chair or member has the authority to contact one or more experts within or outside of the University by whatever means he/she believes appropriate or to request that the HSRO arrange for this additional expertise.   Review of the specific study requiring this consultative input shall be deferred until the expert advice is received and considered by the IRB.  


    Guidance/recommendations to the IRB from consultants may be given by personal contact, in writing, by phone, through the internet or other appropriate communication mechanisms.  If required and approved by the Associate Vice Provost for Human Subject Research, the HSRO is authorized to arrange for reasonable compensation to consultants.

    Verbal guidance/recommendations from consultants provided to the IRB chair or designee conducting expedited reviews shall be summarized by the IRB chair or designee and included within the study file.  Written guidance/recommendations from consultants provided to the IRB chair or designee conducting expedited reviews shall be added to the study file.  Verbal or written guidance/recommendations from consultants provided to the convened IRB shall be presented at the IRB meeting by the member or other receiving entity and summarized in the meeting minutes.  If in writing, such guidance/recommendations from consultants shall be added to the study file. 


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