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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

3.2 HSRO Responsibility

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

February 13, 2006

Revised: May 10, 2011

3.2 HSRO Responsiblity

The mission of the UM Human Subject Research Office (HSRO) is to facilitate human subject research among the faculty, staff, and students from all schools and departments within the University of Miami and the Jackson Health System and to support the UM IRB in conducting its reviews and other responsibilities.  The HSRO shall be committed to ensuring that University research is conducted according to the University's high ethical standards and in compliance with federal, state and local regulations.

The HSRO is supervised by the Associate Vice Provost for Human Subject Research and the Vice Provost for Research who is the Institutional Officer of the University.  The Associate Vice Provost for Human Subject Research shall ensure that adequate resources (i.e. staff support, equipment, space and other resources) are available and appropriately allocated to and within the HSRO for the HSRO to accomplish its mission.  The Vice Provost for Human Subject Research is also responsible for the effective allocation of resources to various activities of the IRB.

The Associate Vice Provost shall ensure that the commitment and performance of HSRO staff and the IRB are evaluated and that standards are met on a continual basis.  The Associate Vice Provost shall lead efforts to ensure human subject research regulatory compliance by establishing educational programs, providing relevant resources, ensuring that faculty, staff, students, HSRO staff and IRB members receive the necessary education in the area of human subject protections and in federal, state and local regulations related to human subject protections and by establishing and monitoring quality assurance programs.

The Associate Vice Provost for Human Subject Research shall also ensure the independence of the HSRO and IRB processes such that they are free from coercion and undue influence.  IRB members and others with knowledge of undue influence are encouraged to report such to the Associate Vice Provost who shall charge one of the IRBs (without involvement in the allegations) with the responsibility to conduct a thorough investigation and to make recommendations for action, if required, to the Associate Vice Provost for Human Subject Research, Vice Provost for Research and to the Executive Vice President and Provost of the University.

The Associate Vice Provost for Human Subject Research has the authority to appoint, reappoint and terminate the appointments of IRB chairs, vice-chairs and IRB members, and to review decisions of an IRB.  The Associate Vice Provost for Human Subject Research may withhold permission, administratively disapprove, suspend, or terminate research studies on behalf of the institution.  In the case of a decision by the IRB to disapprove, suspend or terminate a project, the decision may not be reversed by the Associate Vice Provost for Human Subject Research or any other officer/agency of UM, state government, or federal government [45 CFR 46.112 and 21 CFR 56.112].  In the case of a decision by the IRB to disapprove, suspend or terminate a study, the Associate Vice Provost may request that the IRB re-evaluate the study but only because of procedural questions related to the IRB review.

The Vice Provost for Research is the signatory Institutional Official responsible for the program of human subject protections at the University and Jackson Health System.  The Associate Vice Provost is advised by the Assistant Provost for IRB Affairs who is responsible for coordinating IRB chair practices and interactions among individual IRBs, IRB members and the HSRO.  The Assistant Provost for IRB Affairs shall supervise the HSRO when necessary in the absence of the Associate Vice Provost for Human Subject Research and may be designated by the Vice Provost for Research as interim Institutional Officer with signatory authority in the absence of the Vice Provost for Research.

The Vice Provost for Research, the Associate Vice Provost and the Assistant Provost may attend IRB meetings and participate in deliberations but may not vote and shall not be included in determining or establishing a quorum at the meetings.  IRB meeting minutes shall reflect the presence of the Vice Provost , the Associate Vice Provost and/or the Assistant Provost.  In the absence of the Chair or Vice-Chair, the Associate Vice Provost or the Assistant Provost may serve as a non-voting Chair for purposes of administering the IRB meeting.

Specific responsibilities of the HSRO to the IRB and the University include:

  1. Assist the IRB in preparing for and monitoring IRB meetings
  2. Recommend to the IRB as to whether a study under review constitutes human subject research and if so, the review category for new and continuing studies
  3. Forward studies recommended for exempt or expedited reviews to IRB Chairs or IRB-designees for their review
  4. Assign studies to the appropriate IRB panel pursuant to the guidance of the IRB chairs and the Assistant Provost for IRB Affairs or Associate Vice Provost for Human Subject Research. Where possible, continuing studies shall be assigned to the original, approving IRB
  5. Assign studies to primary and secondary reviewers under guidelines defined by the IRB Chair or IRB-designee and the Associate Vice Provost for Human Subject Research. Where possible, assignments shall be made to the original, approving IRB primary and secondary reviewers or to similarly qualified members
  6. Maintain files on all active human subject research studies (including copies of all correspondence between the IRB and investigators) that take place at the University, JHS and affiliated sites. Following study closure, the HSRO shall maintain for a minimum of three years - study files by appropriate storage means that permit subsequent perusal if required. These files may be stored as 'paper' files or they may be archived as a microfilm or microfiche, scanned for computer storage or stored within the computer system as submitted
  7. Maintain databases for tracking studies
  8. Prepare minutes of convened IRB meetings
  9. Maintain permanent files of minutes of convened IRB meetings, subcommittee meetings (if applicable) and meetings of the Conflict of Interest Committee
  10. Screen research applications for completeness prior to initiating the IRB review process
  11. Serve as a resource for investigators on general regulatory information, guidance with forms, and assistance in preparing an application for IRB review
  12. Maintain the institution’s Federalwide Assurance and the IRB membership rosters
  13. Provide staff support to the IRB for all written correspondence
  14. Provide trained staff to serve as administrative –designees of the IRB chair to ensure the correctness of written correspondence and to sign such correspondence as requested by the IRB chair. The individuals selected to serve as administrative-designees shall be approved by the IRB chairs based on skill and training and by the Associate Vice Provost for Human Subject Research
  15. Send notices of study suspension or termination (due to serious or continuing non-compliance) to Principal Investigators and to  appropriate University offices
  16. Maintain information on federal regulations relating to human subject research
  17. Facilitate education regarding the IRB process to the University community
  18. Maintain records of IRB membership including training
  19. Maintain the meeting schedule and create agendas for each IRB meeting
  20. Arrange for adequate meeting space for the IRB
  21. Maintain the HSRO web page as a resource for information for the IRB and University
  22. Recommend modifications of these Written Policies and Procedures as necessary to the IRB Policies and Procedures Committee
  23. Ensure that HSRO staff are adequately trained

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Human Subjects Research Office

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