Human Studies Review Board
Human Studies Review Board
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EPA Human Studies Review Board Public Meeting, January 26, 2012
- Final Report (PDF) (22 pp, 154k, About PDF)
- Meeting Minutes (38 pp, 249k, About PDF)
- Agenda (2 pp, 36K, About PDF)
- Federal Register Notice
- Transmittal & Charge to HSRB for January 26, 2012 Meeting (5 pp, 76K, About PDF)
- AHETF Protocol - AHE600 Handgun in Greenhouse & Nurseries
- EPA Science and Ethics Review of Protocol AHE600 (57 pp, 362K, About PDF)
- Protocol Submission for AHE600 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- AHETF Governing Document Version 2 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- 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
- IIRB Membership Roster 9-12-11 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- Charge Questions - AHETF Protocol AHE600(1 pp, 12K, About PDF)
- AEATF Completed Sutdy - Aerosol
EPA Reviews
- EPA Science Review - AEATF Aersol Completed Study(38 pp, 506K, About PDF)
- EPA Science Review - Appendix A - Aerosol statistical review(112 pp, 1.8MB, About PDF)
- EPA Science Review - Appendix B AEATF II Letter 2.17.2010(4 pp, 85K, About PDF)
- EPA Science Review - Appendix B AEATF II Letter 2.21.2010(6 pp, 115K, About PDF)
- EPA Ethics Review - AEATF Aerosol Completed Study(20 pp, 232K, About PDF)
- Background Documents
- 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
- Addendum - Protocol Amendment 4 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- Aerosol analysis with inhmass sas - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- Aerosol.data.121611 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- EPA Science and Ethics Review Aerosol Protocol 9-21-09(52 pp, 268K, About PDF)
- HSRB Dec 2009 Report reviewing AEAFT Aerosol Protocol(26 pp, 141K, About PDF)
- 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 - IIRB Membership Roster 9-12-11 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- 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
- Charge Questions(1 pp, 62K, About PDF)