INSTITUTIONAL REVIEW BOARD GOVERNANCE AND OPERATING POLICIES Revised January 8, 2020 Effective January 9, 2020 Table of Contents 1.0 MISSION STATEMENT .................................................................................................. 1 1.1 Institutional Authority under which the is Established and Empowered ........................ 2 1.2 Purpose of the IRB....................................................................................................... 2 1.3 The Principals that Govern the IRB .............................................................................. 2 2.0 THE AUTHORITY OF THE IRB ...................................................................................... 3 2.1 Types of Studies that must be Reviewed ..................................................................... 3 2.2 Disapproving, Modifying, or Approving Studies based on Human Subject Protection ... 3 2.2.1 Actions on Protocols Reviewed by the IRB. .......................................................... 3 2.3 Progressive Reports .................................................................................................... 4 2.4 Monitoring for Compliance ........................................................................................... 4 2.5 Termination or Suspension .......................................................................................... 5 3.0 THE IRB ORGANIZATIONAL STRUCTURE .................................................................. 5 3.1 Administration of the Institution .................................................................................... 5 3.2 Institutional Official ....................................................................................................... 5 3.3 Other Committees ........................................................................................................ 6 3.3.1 Institutional Biosafety Committee (IBC) ................................................................. 6 3.3.2 Radiation Safety Committee ................................................................................. 6 3.3.3 Institutional Animal Care and Use Committee (IACUC) ......................................... 6 3.4 Other Institutions .......................................................................................................... 6 3.5 Regulatory Agencies .................................................................................................... 7 4.0 ROLES AND RESPONSIBILITIES ................................................................................. 7 4.1 Institutional Official ....................................................................................................... 7 4.2 IRB Chair ..................................................................................................................... 7 4.3 Institutional Review Board (IRB) .................................................................................. 8 4.4 Principal Investigators (PIs) ......................................................................................... 9 4.5 Faculty Sponsors ........................................................................................................11 5.0 TRAINING ......................................................................................................................12 5.1 Researcher Training Requirements ............................................................................12 5.2 IRB Chair and Member Training Requirements ...........................................................12 5.3 IRB Staff Training Requirements .................................................................................13 6.0 THE MEMBERSHIP OF THE IRB ..................................................................................14 6.1 Composition ................................................................................................................14 6.1.1 Number of Members ............................................................................................14 6.1.2 Qualification of Members .....................................................................................14 6.1.3 Diversity of Members ...........................................................................................14 Revised January 8, 2020 Effective January 9, 2020 6.2 The Chairperson .........................................................................................................15 6.2.1 Selection and Appointment ..................................................................................15 6.2.2 Length of Term/Service ........................................................................................15 6.2.3 Removal ..............................................................................................................15 6.3 IRB Members ..............................................................................................................15 6.3.1 Length of Term/Service ........................................................................................15 6.3.2 Duties ..................................................................................................................15 6.3.3 Attendance Requirements....................................................................................16 6.3.4 Removal ..............................................................................................................16 6.3.5 Alternate Members...............................................................................................16 6.4 Liability Coverage for IRB Members ............................................................................16 6.5 Use of Consultants......................................................................................................16 6.6 Chair, Member, and Staff Evaluations .........................................................................17 7.0 CONFLICT OF INTEREST AND CONFIDENTIALITY ...................................................17 7.1 Conflicts of Interest for Members ................................................................................17 7.2 Conflicts of Interest for Researchers ...........................................................................18 7.3 Confidentiality of IRB Meetings ...................................................................................18 8.0 OPERATION OF THE IRB .............................................................................................19 8.1 IRB Administrator Responsibilities ..............................................................................19 8.2 Scheduling of Meetings ...............................................................................................19 8.3 Information Provided Prior to Meeting .........................................................................20 8.4 Voting Requirements ..................................................................................................20 8.4.1 Quorum ................................................................................................................20 8.4.2 Absence or Loss of Quorum ................................................................................21 8.4.3 Diversity Requirements of Quorum ......................................................................21 8.4.4 Approval Percentage ...........................................................................................21 8.4.5 Voting Rights .......................................................................................................21 8.4.6 Proxy Votes .........................................................................................................21 8.5 Communication from the IRB ......................................................................................21 8.5.1 Additional Information Required from the Investigator ..........................................21 8.5.2 Conveying the IRB Decision to the Investigator ...................................................22 8.5.3 Conveying the IRB Decision to the Institutional Official ........................................22 8.6 Communicating to the IRB ..........................................................................................22 8.7 Appeal of the IRB Decision .........................................................................................22 8.7.1 Criteria for Appeal ................................................................................................22 8.7.2 Appeal of the IRB Decision ..................................................................................22 Revised January 8, 2020 Effective January 9, 2020 8.7.3 Resolving an Appeal ............................................................................................23 8.8 Resources ..................................................................................................................23 8.9 IRB Quality Improvement Program .............................................................................24 9.0 INITIAL IRB REVIEW OF RESEARCH ACTIVITIES ......................................................25 9.1 General .......................................................................................................................25 9.2 Full Committee Review ...............................................................................................27 9.2.1 Materials for Submission ......................................................................................27