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April 8-9, 2014, Meeting of the Human Studies Review Board

  1. AEATF Solid Pour Scenario Protocol
    1. EPA Science and Ethics Review
    2. AEATF Volume 1: Transmittal Letter, Checklist, Study Design Document - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. AEATF Volume 2: Protocol, IRB Approval Letter, Supporting Documents - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document  
    4. AEATF Volume 3: IRB Review Records - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    5. AEATF Volume 4: CVs and Ethics Training Records, AEAFT-II SOPs - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    6. AEATF Supplemental Submission of tox study summaries for CYA - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    7. Schulman Associates IRB Standard Operating Procedures - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    8. Schulman Associates IRB Board Members - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    9. Charge Questions:
      • Protocol Title: A Study for Measurement of Potential Dermal and Inhalation Exposure During Manual Pouring of Two Solid Formulations Containing an Antimicrobial (AEA07)
      • If the AEATF-II study proposal AEA07 is revised as suggested in EPA’s review and if the research is performed as described:
        1. Is this research is likely to generate scientifically reliable data, useful for assessing the exposure of those who pour solid formulation antimicrobial pesticide products
        2. Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?




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  2. AEATF Brush and Roller Painting Protocol
    1. EPA Science and Ethics Review
    2. AEATF Volume 1: Transmittal Letter, Checklist, Study Design Document – Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. AEATF Volume 2: Protocol, IRB Conditional Approval Letter, Supporting Document - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. AEATF Volume 3: IRB Review Records - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    5. AEATF Volume 4: AEATF-II SOPs cited in the protocol - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    6. Statistics file: Fold accuracy (LST file) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    7. Statistics file: Fold accuracy (SAS file) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    8. Statistics file: Power (LST file) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    9. Statistics file: Power accuracy (SAS file) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    10. Schulman Associates IRB Standard Operating Procedures - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    11. Charge Questions:
      1. Is this research is likely to generate scientifically reliable data, useful for assessing the exposure of those who apply latex paint containing an antimicrobial pesticide using a brush or roller?
      2. Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?




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  3. AEATF Removal Efficiency Study Protocol
    1. EPA Science and Ethics Review
    2. AEATF Volume 1: Transmittal Letter, Checklist - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. AEATF Volume 2: Protocol, IRB Conditional Approval Letter, Supporting Documents - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. AEATF Volume 3: IRB Review Records - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    5. AEATF Volume 4: AEATF-II SOPs cited in the protocol - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    6. Schulman Associates IRB Standard Operating Procedures - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    7. Charge Questions:
      1. Is this research likely to generate scientifically reliable data, useful for determining the removal efficiency of BIT from the hands due to dermal exposure associated with the use of latex paint and non-paint liquid solutions containing containing BIT?
      2. Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?




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  4. USDA Protocol – Evaluation of Bite Protection from Repellent-Treated Clothing for the United States Military
    1. EPA Science and Ethics Review
    2. SDA Volume 1: Protocol, consent form, recruitment materials, IRB approval letter - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. USDA Volume 2: Records of IRB review - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. USDA Volume 3: Statistical Methods: Supplemental Information - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    5. Western IRB SOPs and Policies - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    6. Western IRB Meeting Minutes - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    7. Charge Questions:
      1. Is the protocol “Laboratory Evaluation of Bite Protection From Repellent Impregnated Clothing for the United States Military” likely to generate scientifically reliable data, useful for estimating the level of mosquito bite protection provided by two different textiles treated with etofenprox?
      2. Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?




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  5. Final Presentations
    1. Proportionality Presentation: Estimating Pesticide Handler Exposure
    2. AEATF Solid Pour Protocol Presentation
    3. AEATF Brush Roller Paint Protocol Presentation
    4. AEATF Hand Wash Efficiency Protocol Presentation
    5. USDA Protocol – Etofenprox Impregnated Military Uniforms – Presentation
    6. Repellency Awareness Program – Presentation