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Human Studies Review Board

Human Studies Review Board

Ethics Training for Members and Consultants Serving on the HSRB

November 1, 2012 Public Meeting

EPA Human Studies Review Board Public Meeting, November 1, 2012

 

 

  1. AEATF Liquid Pour Completed Study
    1. EPA Reviews
      1. EPA Science Review (PDF) (50 pp, 806K, About PDF)
      2. EPA Science Review - Appendix A - Statistical Review (PDF) (79 pp, 1.7MB, About PDF)
      3. EPA Science Review - data in Excel format Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      4. EPA Science Review - SAS Code Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      5. EPA Ethics Review (PDF) (16 pp, 195K, About PDF)
    2. Background Documents
      1. AEA05 Final Report v7.3 Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. Corrected Tables for AEA05 Report (dated 9_26_2012) Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      3. EPA Science and Ethics Review of Liquid Pour Protocol (dated 10-23-11) (PDF) (54 pp, 276K, About PDF)
      4. HSRB Report of October 2011 meeting (reviewing AEA05 protocol) (PDF) (22 pp, 138K, About PDF)

    1. AEATF II SOPs
      00. SOP Table of Contents - 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.pdf - 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 QAU 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 Inspection 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 Storage of Raw 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 Specimen and Retention Sample Storage - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      7A.1Test, Control, and Reference Substances Receipt and Shipment - 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.1Body 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 Observations - 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.3 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
      11G.0 Ethics Training - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      11H.0 Subject Compliance with Label - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      11I.0 Recruiting Study Participants - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      11J.1 Obtaining Informed Consent - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document

  2. SOPs for IIRB, A Shulman Company - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document


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


  4. Charge Questions (PDF) (1 pp, 7K, About PDF)


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