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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
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Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

5.2 IRB Chairs and Vice-Chairs


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

July 1, 2008

Revised: May 24, 2011



Policy

5.2(A) Appointment of IRB Chairs and Vice-Chairs

Based on candidate interviews and recommendations from institutional leaders including relevant academic department chairs and the Vice Provost for Research, the Associate Vice Provost for Human Subject Research shall appoint the IRB Chairs with the advice of the Assistant Provost for IRB Affairs.  The Associate Vice Provost for Human Subject Research shall appoint the IRB Vice-Chairs with the advice of the IRB Chair of the panel that the Vice-Chair will serve.  IRB Chairs shall appoint their IRB-designees and administrative-designees.

IRB Chairs and Vice Chairs serve as voting members of the IRB and, as for all members; they must have the knowledge, skills and abilities necessary to carry out the functions of the IRB. In addition, IRB members who serve as Chairs or Vice Chairs must have the leadership and administrative skills necessary to conduct meetings and to exercise the authorities and responsibilities of their positions.  Such individuals must also be highly motivated to fulfill the duties of IRB Chairs and Vice-Chairs with the commitment of time/effort necessary for these essential functions. 

IRB Chairs and Vice-Chairs will be appointed to one-year terms and are eligible for reappointment at one-year intervals.  During the appointment period, an IRB Chair or Vice-Chair 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 the policy and criteria for appointment of IRB members (c.f. Section 5.3A) and upon review of the leadership and administrative performance of each IRB Chair and Vice Chair, on relevant information sought as deemed necessary from IRB members, HSRO staff and others, on review of IRB minutes and determinations and on performance review meetings with each Chair and Vice Chair. 

In addition to their authorities and responsibilities as IRB Chairs and Vice-Chairs, such individuals serve as members of the IRB and are counted for the quorum.  They shall have voting privileges and other authorities and responsibilities of members including the responsibility to review, make motions, participate in discussions and vote on approval/disapproval of studies.

5.2(B) Authorities and Responsibilities of IRB Chairs and Vice-Chairs

Responsibilities of the IRB Chair include but are not limited to those defined in the following three sections.  In the absence of the IRB Chair, the Vice-Chair shall assume the responsibilities of the IRB Chair. In the absence of both the IRB Chair and Vice-Chair, the IRB Chair may appoint an IRB member to assume the responsibilities of the IRB Chair.

  1. Ongoing IRB Chair Responsibilities:
    1. Review and approve, when appropriate, expedited submissions in accordance with regulatory requirements
    2. Determine exempt submissions in accordance with regulatory requirements
    3. Review (or defer to the primary reviewer or other IRB-designee to review) all on-site serious adverse event reports (SAEs) and unexpected problems affecting the safety of subjects and, as necessary, determine if one or more of the following is necessary:
      • Immediate action to address the safety of subjects
      • Call an emergency meeting of the IRB
    4. Appoint qualified IRB members as IRB-designees with authority for expedited reviews and other actions as defined in these Policies and Procedures
    5. Appoint qualified HSRO staff members as administrative-designees with review and signature authority as defined in these Policies and Procedures
    6. Maintain a thorough understanding of federal regulations pertaining to human subject protections, the UM IRB Written Policies and Procedures, and other applicable state, and local regulations. Assure that regulations and policies are applied in all IRB matters with a commitment to foster ethically and scientifically sound human subject research
    7. Respect the diverse backgrounds, perspectives and sources of expertise of all IRB members and foster such respect among the IRB members
    8. Uphold IRB judgments no matter how these are received or perceived by Principal Investigators
  2. IRB Chair Responsibilities Prior to Each Convened Meeting:
    1. Review IRB meeting schedule and agenda composed by the HSRO
    2. Ensure coverage by the Vice-Chair when not able to serve as Chairperson for the meeting and notify the HSRO when not able to serve
    3. Provide guidance to the HSRO on the assignment of reviewers to studies requiring convened IRB review
    4. Assist the IRB reviewers and other IRB members with any concerns in preparing for the meeting, as necessary
    5. Recommended consults when appropriate to assist in IRB reviews
  3. IRB Chair Responsibilities during IRB Meetings:
    1. Preside over IRB meetings and ensure that meetings are conducted in an efficient, orderly and fair manner with respect given to the opinions of all members. Robert's Rules of Order should be used as a guidebook for conducting the meeting.
    2. Ensure a quorum for each study review and ensure that this quorum is properly documented.
    3. Ensure that all regulatory-required elements of review are addressed during the meeting and that there is meaningful and substantive discussion of relevant matters and/or questions.
    4. Ensure that assigned reviewers present a clear and concise review of study materials including consent documents and recruitment items and process
    5. Ensure that all IRB-required changes to consent and other documents are documented
    6. Ensure that the IRB discusses specific findings, as required by regulations, whenever these is the involvement of vulnerable populations, e.g. children, prisoners, pregnant women and fetuses
    7. Accept appropriate motions from voting members of the IRB.
    8. As necessary, ensure that the specific elements pertaining to the motion are clearly understood by the IRB and accurately recorded in the meeting minutes
    9. Ensure that IRB decisions are made in accordance with federal, state and local regulations and with the UM IRB Written Policies and Procedures
    10. Ensure that minutes of IRB meetings and votes of the IRB members accurately reflect discussions and actions


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