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Human Studies Review Board

Human Studies Review Board

Ethics Training for Members and Consultants Serving on the HSRB

The Human Studies Review Board (HSRB) is a Federal advisory committee operating under the Federal Advisory Committee Act (FACA) that provides advice, information, and recommendations on issues related to scientific and ethical aspects of human subjects research. The HSRB reports to the EPA Administrator through EPA's Science Advisor.

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 (57 pp, 362K, About PDF)
    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(1 pp, 12K, About PDF)

  2. AEATF Completed Sutdy - Aerosol EPA Reviews
    1. EPA Science Review - AEATF Aersol Completed Study(38 pp, 506K, About PDF)
    2. EPA Science Review - Appendix A - Aerosol statistical review(112 pp, 1.8MB, About PDF)
    3. EPA Science Review - Appendix B AEATF II Letter 2.17.2010(4 pp, 85K, About PDF)
    4. EPA Science Review - Appendix B AEATF II Letter 2.21.2010(6 pp, 115K, About PDF)
    5. EPA Ethics Review - AEATF Aerosol Completed Study(20 pp, 232K, About PDF)

  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(52 pp, 268K, About PDF)
    6. HSRB Dec 2009 Report reviewing AEAFT Aerosol Protocol(26 pp, 141K, About PDF)

    1. 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



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


  5. 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


  6. Charge Questions(1 pp, 62K, About PDF)

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