Human Studies Review Board
Human Studies Review Board
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- Federal Register Notice
- Final Agenda (PDF) (5 pp, 46KB)
- Meeting Minutes (PDF) (57 pp, 34MB)
- June 24-25, 2009 Human Studies Review Board Meeting Final Report (PDF) (40 pp, 227KB)
- Transmittal memo/Charge Questions (PDF) (7 pp, 45KB)
- Materials Considered at Earlier HSRB Meetings Potentially Relevant to Topics for October (PDF) (1 pg, 11KB)
- Final Report (PDF) (26 pp, 142KB)
1. Pyrethrins Pyrethroid Pre-Rule Studies
- EPA White Paper: A Review of the Relationship between Pyrethrins, Pyrethroid Exposure and Asthma and Allergies (PDF) (28 pp, 204KB)
- Asthmatic reactions to a commonly used aerosol insect killer (PDF) (3 pp, 227KB) – Please contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document.
- Study Review - Newton, J. G. and Breslin, A. B. X. (1983) Asthmatic reactions to a commonly used aerosol insect killer (PDF) (4 pp, 34KB)
- Ethics Review of Pre-Rule Intentional Exposure Human Toxicity Study – Newton, J.G., Breslin, A.B. (1983) Asthmatic Reactions to a Commonly Used Aerosol Insect Killer (PDF) (8 pp, 37KB)
- Sensitization risk of pyrethroid insecticides (PDF) (2 pp, 1.3MB)
- Study Review – Lisi, P. (1992) Sensitization risk of pyrethroid insecticides (PDF) (3 pp, 28KB)
- Ethics Review of Pre-Rule Intentional Exposure Human Toxicity Study – Lisi, P. (1992) Sensitization Risk of Pyrethroid Insecticides (PDF) (8 pp, 37KB)
2. LNX-003 Carroll-Loye Tick Protocol
- Efficacy Test of KBR 3023 (Picaridin; Icaridin) (PDF) (152 pp, 22MB)
- Supplemental IIRB, Inc., Documentation (PDF) (111 pp, 7.4MB)
- Response to EPA reviewer concerns about Carroll-Loye Protocol LNX-003 (PDF) (6 pp, 36KB)
- Science and Ethics Review of Protocol for Human Study of Tick Repellent Performance – Carroll, S. (2009) Efficacy Test of KBR3023 (Picaridin; Icaridin) (PDF) (31 pp, 196KB)
3. AEATF Aerosol Protocol
- Antimicrobial Exposure Assessment Task Force II (AEATF II) Aerosol Application Study, Volume 1 (56 pp, 533KB)
- AEATF II Aerosol Application Study, Volume 2 – Primary Documentation: Study Protocol and IIRB Approval and Documentation (PDF) (203 pp, 4.4MB)
- AEATF II Aerosol Application Study, Volume 3 – Secondary Documentation: IIRB Communications (PDF) (317 pp, 103MB)
- AEATF II Aerosol Application Study, Volume 4 – Standard Operating Procedures for a Multi-Year Antimicrobial Chemical Exposure Monitoring Program (PDF) (128 pp, 7.4MB)
- Memos Clarifying AEATF II Aerosol Proposal (PDF) (2 pp, 51KB)
- Science and Ethics Review of AEATF II Aerosol Scenario Design and Protocol for Exposure Monitoring (PDF) (52 pp, 303KB)
4. Final Presentations
- HSRB Chair Summary of October 20 Recommendations (PPT) (11 pp, 251KB)
- Two Pre-Rule Studies of Pyrethrins/Pyrethroids (PPT) (59 pp, 924KB)
- AEATF II Aerosol Application Scenario (PPT) (65 pp, 1.2MB)
- EPA Review of Carroll-Loye Protocol LNX-003 (PPT) (32 pp, 247KB)
- HSRB Criteria for Review of Pre-Rule Intentional Dosing Studies (PPT) (8 pp, 162KB)
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