Human Studies Review Board

Ethics Training for Members and Consultants Serving on the HSRB

June 24 - 25, 2009 Public Meeting

Meeting to be held at Holiday Inn National Airport/Crystal City, 2650 Jefferson Davis Hwy, Arlington, VA 22202, 703-684-4780

Final Agenda (PDF) (4 pp, 52K)
Federal Register Notice
Meeting Minutes (PDF) (74 pp, 427KB)
Board/consultant list (PDF) (4 pp, 24K)
February 17, 2009 EPA Human Studies Review Board Meeting Report (PDF) (22 pp, 130KB)
Background Presentation (PDF) (13 pp, 141K)
June 24-25, 2009 Human Studies Review Board Meeting Final Report (PDF) (40 pp, 227KB)

1. Chlorpyrifos

1a. EPA White Paper

1b. Nolan et al (1982)

MRID 124144 Nolan et al (1982) – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Qs and DAS Response Re Nolan Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Science Rvw (DER) Nolan (5-26-09) (PDF) (13 pp, 229KB)
EPA Ethics Review Nolan (5-29-09) (PDF) (6 pp, 45KB)

1c. Honey Cut & DeGeare (1993)

MRID 43062701 Honeycutt & DeGeare 1993 – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
DAS Supplement Re-Honeycutt & DeGeare Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Science Rvw (DER) Honeycutt Study (5-22-09) (PDF) (63 pp, 862KB)
EPA Ethics Review Honeycutt & DeGeare (5-29-09) (PDF) (9 pp, 60KB)

1d. Kisicki et al (1999)

MRID 44811002 Primary Report of Kisicki (1999) Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
MRID 45144101 Brzak (2000) Report of Analytical Phase of Kisicki Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
MRID 47429401 DAS Response to EPA Query (5-14-08) – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Science Rvw (DER) Kisicki (5-28-09) – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Science Rvw (DER) Kisicki (5-27-09) (PDF) (45 pp, 438KB)
EPA Ethics Rvw Kisicki et al (6-1-09) (PDF) (11 pp, 77KB)

1e. SAP Materials

1f. Coulston et al (1972)

MRID 95175 Coulston – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Qs and DAS Response Re Coulston Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Science Rvw (DER) of Coulston et al (5-26-09) (PDF) (8 pp, 141KB)
EPA Ethics Review Coulston (5-29-09) (PDF) (9 pp, 61KB)

2. CLBR Protocol LNX-002

3. ICR Completed Study A382

MRID 47732701 A382 Primary Report – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA 4-9-09 Email notification of gaps in record (PDF) (2 pp, 19KB)
MRID 47734901 Supplemental LANXESS submission – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
EPA Science & Ethics Rvw ICR Protocol A382 3-7-08 (PDF) (34 pp, 242KB)
Discussion of ICR A382 Protocol from HSRB Report on April 2008 mtg (PDF) (4 pp, 23KB)
EPA Ethics Rvw ICR Study A382 5-22-09 (PDF) (15 pp, 150KB)
EPA Science Rvw Completed Study A382 5-29-09 (PDF) (5 pp, 88KB)

4. AHEFT Mix-Load Water Soluble Packages Scenario

5. Final Presentations

HSRB Criteria for Review of Pre-Rule Intentional Dosing Studies (PPT) (8 pp, 287KB)
Three Pre-Rule Studies of Chlorpyrifos (PPT) (84 pp, 1.1MB)
EPA Review of Carroll-Loye Protocol LNX-002 (PPT) (29 pp, 223KB)
EPA Review of Completed ICR Study A-382 (PPT) (29 pp, 1MB)
General AHETF Model(PPT) (1 pg, 200KB)
AHETF Scenario Design and Field Study Protocol for Mixing and Loading of Pesticide Products in Water-Soluble Packaging (PPT) (33 pp, 2.4MB)
Chair's Summary of Board Recommendations (PPT) (17 pp, 293KB)

For a hard copy of any of these documents, please contact Lu-Ann Kleibacker at 202-564-7189.

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