Human Studies Review Board

Ethics Training for Members and Consultants Serving on the HSRB

April 13 - 14, 2011 Public Meeting

Final Report (PDF) (31 pp, 488K, About PDF)
Final Minutes (PDF) (53 pp, 413K, About PDF)
Final Agenda (PDF) (4 pp, 22K, About PDF)
Federal Register Notice
Transmittal Memo/Charge Questions (PDF) (8 pp, 144K, About PDF)

1. AHETF Open Cab Airblast Completed Studies and Monograph.

a. EPA Reviews

EPA Science Review of OCAB Completed Studies (PDF) (62 pp, 2.5Mb, About PDF)
EPA Science Review of OCAB Monograph (PDF) (40 pp, 718K, About PDF)
EPA Ethics Review of OCAB Completed Studies (PDF) (51 pp, 1.4Mb, About PDF)

b. Background Documents

AHE62
1. AHE62 Final Cluster Report (MRID 48289611) - November 2010 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
2. AHE62 IIRB Correspondence Report (MRID 48289614) - November 2010 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
3. AHE62 Excel Files Calcs-malathion- No MEC-post QA 6-21-10-to EPA 11-18-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
AHE63
1. AHE63 Final Cluster Report (MRID 48289612) - November 2010 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
2. AHE63 IIRB Correspondence Report (MRID 48289615) - November 2010 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
3. AHE63 Excel File Calcs-carbaryl-No MEA-revis-9-2-10-to EPA 11-18-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
AHE64
1. AHE64 Final Cluster Report (MRID 48289613) - November 2010 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
2. AHE64 IIRB Correspondence Report (MRID 48289616) - November 2010 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
3. AHE 64 Excel File Calcs-carbaryl-No MEA-QA'd 9-10-10-to EPA 11-18-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
AHE07 (Pre-rule Study)
1. AHE07 Amended Summary Report FINAL - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
2. AHE07 Field Rpt Open-Cab Airblast - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
3. AHE07 Analytical Phase Report - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
4. AHE07 Excel File Calcs-Carbaryl-No MEC-to EPA 11-18-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
Monograph
1. OCAB Final Monograph Report (MRID 48326701) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
2. Final MU Selection Plan OCAB 7-21-08 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
3. OCAB Monograph Excel Files
  1. OCAB Data with MEA-QAd FINAL 9-15-010 to EPA 11-18-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  2. OCAB before MEA-QAd FINAL 9-14-10 & 10-4-10 to EPA 11-18-10 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
4. OCAB Monograph SAS Files
  1. Eval_OCAB.sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  2. Marcro_GetEmpStats.sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  3. Macro_NormScores.sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  4. Macro_ObjEval_OCAB.sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  5. Macro_TestVCs_OCAB.sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  6. MakeSet_OCAB.sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  7. OCAB Derm Inh - No Hats - No MEA - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  8. OCAB Derm only - wi Hats - no MEA - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
  9. OCAB Derm only -wi Hats - wi MEA - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
Reference Files
1. AHETF SOP Manual for AHE62-AHE63-AHE64 effective February 2009 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
2. AHEFT Governing Document Version 2 - August 2010 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
3. EPA Science & Ethics Review Protocol AHE62 (9-23-08) (PDF) (53 pp, 378K, About PDF)
4. EPA Science & Ethics Review Protocol AHE63 (9-23-08) (PDF) (53 pp, 377K, About PDF)
5. EPA Science & Ethics Review Protocol AHE64 (9-23-08) (PDF) (53 pp, 371K, About PDF)
6. HSRB Report of Oct 2008 Meeting - Protocols AHE62, AHE63, AHE64 (PDF) (28 pp, 175K, About PDF)
7. IIRB, Inc. Human Research Protection Plan 11-3-10 (PDF) (121 pp, 5.6Mb, About PDF)
8. IIRB, Inc. Current Membership Roster 11-3-10 (PDF) (2 pp, 174K, About PDF)

2. AEATF Wipe Study

a. EPA Reviews

EPA Science Review of AEATF Wipe Completed Study (PDF) (40 pp, 1Mb, About PDF)
Appendix A - Statistical Review of AEATF Wipe Study Using Trigger Spray and Wipe (PDF) (89 pp, 2.1Mb, About PDF)
Appendix B - Statistical Review of AEATF Wipe Study Using Ready-to-Use Wipes (PDF) (87 pp, 1.98Mb, About PDF)
EPA Ethics Review of AEATF Wipe Completed Study (PDF) (19 pp, 587K, About PDF)

b. Background Documents

Final Report AEATF Wips Study 070264 - 1-21-2011 signed - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
EPA Science and Ethics Review of Wipe Study Proposal (PDF) (41 pp, 267K, About PDF)
HSRB Report of April 2008 meeting - reviewing Mop and Wipe Study Proposals (PDF) (37 pp, 171K, About PDF)
AEATF II SOPs (7-15-09)
1. SOP Table of Contents_Effective 071509
  - 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 QUA 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.1 Test, 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.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 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 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 Workers 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
2. IIRB, Inc. Human Research Protection Plan 11-3-10 (PDF) (171 pp, 5.6Mb, About PDF)
3. IIRB, Inc. Current Membership Roster 11-3-10 (PDF) (2 pp, 173K, About PDF)

3. Gulson et al 2010

a. EPA Reviews

EPA Science Review of Gulson et al 2010 (PDF) (17 pp, 2.8Mb, About PDF)
EPA Ethics Review of Gulson et al 2010 (PDF) (16 pp, 63K, About PDF)

b. Background Documents

Gulson et al 2010 (MRID 48387301) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
Supplement 1 - Excerpt from Australian National Statement on Ethical Conduct in Human Research 2007 (PDF) (12 pp, 223K, About PDF)
Ethics Approval Letter (5 pp, 562K, About PDF)

4. Background material focusing on the reexamination of a Kisicki study involving intentional human dosing with chlorpyrifos (PDF). (12 pp, 223K, About PDF)

Human Studies Review Board

Human Studies Review Board

1. AHETF Open Cab Airblast Completed Studies and Monograph.

a. EPA Reviews

b. Background Documents

2. AEATF Wipe Study

a. EPA Reviews

b. Background Documents

3. Gulson et al 2010

a. EPA Reviews

b. Background Documents

4. Background material focusing on the reexamination of a Kisicki study involving intentional human dosing with chlorpyrifos (PDF). (12 pp, 223K, About PDF)

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