Human Studies Review Board
Human Studies Review Board
- HSRB Home
- About the HSRB
- Meetings
- Agenda
- Meeting Minutes
- Reports
- Federal Register Notices
- Members
- Charter
- Protections for Subjects in Human Research: Final Rule
- Bylaws
- A to Z Index
- Contact HSRB
- HSRB Orientation Training Program
Ethics Training for Members and Consultants Serving on the HSRB
EPA Human Studies Review Board Public Meeting, January 17, 2013
- Report Final (PDF) (20 pp, 214K, About PDF)
- Final Minutes (PDF) (37 pp, 250K, About PDF)
- Agenda Final (PDF) (2 pp, 55K, About PDF)
- Federal Register Notice
- Transmittal & Charge to HSRB for November 1, 2012 Meeting (PDF) (5 pp, 77K, About PDF)
- AEATF Liquid Pour Completed Study
- EPA Reviews
- EPA Science Review (PDF) (50 pp, 806K, About PDF)
- EPA Science Review - Appendix A - Statistical Review (PDF) (79 pp, 1.7MB, About PDF)
- EPA Science Review - data in Excel format Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- EPA Science Review - SAS Code Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- EPA Ethics Review (PDF) (16 pp, 195K, About PDF)
- Background Documents
- AEA05 Final Report v7.3 Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- 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
- EPA Science and Ethics Review of Liquid Pour Protocol (dated 10-23-11) (PDF) (54 pp, 276K, About PDF)
- HSRB Report of October 2011 meeting (reviewing AEA05 protocol) (PDF) (22 pp, 138K, About PDF)
- EPA Reviews
- 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
- SOPs for IIRB, A Shulman Company - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- IIRB, Inc. Current Membership Roster 9-11-12 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
- Charge Questions (PDF) (1 pp, 7K, About PDF)