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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
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eProst User Guide
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About the HSRO


Basic Folder Information

5.3 IRB Members


Approval Date

 

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

July 1, 2008

Revised: May 24, 2011; June 8, 2011

 



policy

5.3(A) Appointment of IRB Members 

The Associate Vice Provost for Human Subject Research shall appoint IRB members and alternate members with the advice of the Assistant Provost for IRB Affairs. These appointments shall be based on candidate interviews, recommendations from institutional leaders and others including relevant academic department and IRB chairs, review of the candidate’s expertise, qualifications and accomplishments as demonstrated in his/her curriculum vitae and other academic documents deemed relevant, and pursuant to the needs for expertise within IRB panels.  

IRB members and alternate members shall be appointed to one-year terms and are eligible for reappointment at one-year intervals.  During the appointment period, an IRB member or alternate member may be removed at the discretion of the Associate Vice Provost for Human Subject Research.  At least annually during each appointment year, the Associate Vice Provost for Human Subject Research shall decide upon reappointment with the advice of the Assistant Provost for IRB Affairs.  This decision shall be based on recommendations from the IRB Chair and other relevant information sought as deemed necessary from IRB members, HSRO staff and others, and on review of IRB minutes.   Additional criteria of satisfactory performance for the continuance of IRB member and alternate member appointments, and for their reappointment, shall include attendance at meetings and training sessions, success in required training and education, meeting preparation, professionalism in the review process, and diligence in accomplishing the needs of the IRB and the HSRO for timely and appropriate review and decision-making of all assigned research studies.

5.3(B) Authorities and Responsibilities of IRB Members and Alternate Members

IRB members and alternate members are appointed to serve the University of Miami and affiliated institutions as a whole.  Members and alternate members must put their duty to protect the rights and welfare of human subjects above their own interest or that of their academic department.

IRB members are responsible for attending, for their full duration, all convened IRB meetings in a timely manner.  If an IRB member cannot attend a meeting or a part of a meeting, he/she should notify the HSRO well in advance of the meeting to facilitate the preparation and attendance of an appropriate alternate IRB member.

All IRB members and alternate members should understand and apply the ethical principles of the Belmont Report and all federal, state and local regulations related to the protection of human research participants.  Members and alternates should commit time and effort to receive training in these requirements.  All members and alternate members shall be given copies of pertinent documents to review and understand including federal regulations and the University of Miami's Written Policies and Procedures for the Protection of Human Subjects in Research.  Attendance at University of Miami seminars pertaining to human subject protections is encouraged.  These seminars are intended to provide background and new information.  In addition, IRB members and alternates are encouraged to attend relevant local and national meetings and may be provided support to do so.
 
IRB members (and alternate members when appropriate) are expected to serve as primary reviewers for assigned studies and to participate as general reviewers on all studies discussed at convened meetings.  IRB members (and alternate members when appropriate) shall vote to approve, set conditions for approval, defer review to expedited reviewer or convened IRB or disapprove studies submitted to the IRB following discussion of these studies.  IRB members (and alternate members when appropriate) may discuss and vote on other matters pursuant to UM Policies and Procedures such as compliance audit reports or reports of adverse events.

IRB members may be appointed as IRB-designees by the IRB Chair or Vice-Chair. IRB-designees are expected to conduct exempt and expedited reviews.

5.3(C) Administrative-Designees

Upon recommendation of the Associate Vice Provost for Human Subject Research, the IRB Chair may appoint trained administrative staff members of the Human Subject Research Office as administrative-designees of the IRB.  Administrative-designees have specific review and approval authority that is defined in other sections of these Policies and Procedures.  These responsibilities are limited to such matters as non-human subject research, final reports and informational amendments.



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