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Human Studies Review Board

Human Studies Review Board

Ethics Training for Members and Consultants Serving on the HSRB

January 26, 2012 Public Meeting

EPA Human Studies Review Board Public Meeting, January 26, 2012

 


  1. AHETF Protocol - AHE600 Handgun in Greenhouse & Nurseries
    1. EPA Science and Ethics Review of Protocol AHE600
    2. Protocol Submission for AHE600 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. AHETF Governing Document Version 2 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. IIRB, Inc. Human Research Protection Plan 11-3-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    5. IIRB Membership Roster 9-12-11 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    6. Charge Questions - AHETF Protocol AHE600

  2. AEATF Completed Sutdy - Aerosol EPA Reviews
    1. EPA Science Review - AEATF Aersol Completed Study
    2. EPA Science Review - Appendix A - Aerosol statistical review
    3. EPA Science Review - Appendix B AEATF II Letter 2.17.2010
    4. EPA Science Review - Appendix B AEATF II Letter 2.21.2010
    5. EPA Ethics Review - AEATF Aerosol Completed Study

  3. Background Documents
    1. FINAL Study Report for AEATF Aerosol Study 11-14-2011 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    2. Addendum - Protocol Amendment 4 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. Aerosol analysis with inhmass sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. Aerosol.data.121611 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    5. EPA Science and Ethics Review Aerosol Protocol 9-21-09
    6. HSRB Dec 2009 Report reviewing AEAFT Aerosol Protocol

  4. AEATF II SOPs
                      00. SOP Table of Contents_Effective 071509 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      1A.1  Organizational Structure - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      1B.1  Personnel Responsibilities - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      1C.1  Study Director Selection - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      1D.1  Inspection of AEATF II Facilities Data - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      1E.0  communication Directives - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      1F.0  Adverse Effects Reporting - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      2A.1  Study Authorization and approval - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      2B.1  Study Number Assignment - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      2C.1  Protocol Design and Preparation - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      3A.1  SOP Preparation, Approval, Maintenance, and Distribution - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      3B.1  Use of AEATF II and Contractor SOPs - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      4A.1  Study Report Preparation - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5A.1  QA Personnel Administration - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5B.1  AEATF II QAU Responsibilities - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5C.1 QUA Records - Please Contact Lu-Ann Kleibacker at
    202-564-7189 for an accessible copy of this document
                      5E.1  Protocol and Amendment Review - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5F.1  Inspectin Audit types and Frequency - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5G.1  Study Inspections - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5H.1  Data Audits - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5I.1  Facility Inspections - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5J.1  Report Audits - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      5K.1  Inspection Report Distribution - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      6A.1  Access to Archived Data - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      6B.1  Access to Archived Data - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      6C.1  Speccimen and Retention Sample Storage - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      7A.1  Test, Control, and Reference Substances Receipt and Shipm - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      7B.1  Test, Control, and Reference Substances Labeling
    - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      7C.1  Disposal of Test, Control, and Reference Substances -Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      7D,1  Test, Control, and Reference Substances Chain of Custody - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      7E.1  Test and Reference Substance Analysis - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      8A.2  Whole Body Sampling - Inner, Outer and Socks Dosimeters - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      8B.3  Hand Wash Samples - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      8C.2  Dermal Face Neck Wipe Samples - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      8D.1  Collection of Air Samples using OVS Tubes - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      8E.1  Fortification of Matrix Samples - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      8F.1  Sample Identification - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      8H.0  Pre-Washing Dosimeter Garments - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9A.1  Body Surface Areas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9B.3  Field Fortification Adjustment Factors - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9C.1  Numerical Formatting and Handling - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9D.1  Analytical Method Number Assignment - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9E.1  Raw Data Collection - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9F.1  Data Corrections - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9G.1  Raw Data Handling - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9H.1  Preparation of True Copies - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9I.1  Analytical method Development and Validation - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      9J.1  Storage Stability - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      10A.1  Rotameter Calibration - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      10B.1  Packing, Handling and shipping of Samples - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      10C.1  Worker and Study Observatons - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      10D.1  Application Equipment Operation Verification - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      10E.1  Worker Sample Collection Sequence - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      10F.1  GPI Electronic Digital Flow Meter - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      10G.1  Personal air Sampling Pump Calibration - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      11A.1  Pregnancy Testing and Nursing Status - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      11B.1  Heat Stress - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      11C.1  Emergency Procedures - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      11E.0  Heat Stress Management for observational Worker Expos - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
                      11F.0  Adverse Events Reporting to IRB - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document


  5. IIRB Membership Roster 9-12-11 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document

  6. IIRB, Inc. Human Research Protection Plan 11-3-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document

  7. Charge Questions

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