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Human Studies Review Board
Human Studies Review Board
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Draft October 18-19, 2006 report (PDF) (30 pp, 159K)
Meeting was held at One Potomac Yard. 2777 Crystal Drive, Arlington, VA 22202.
Meeting Agenda (PDF) (5 pp, 35K)
Meeting Minutes (PDF) (45 pp, 236K)
Background Documents
Chromium Roat
- Read This First (PDF) (1 page, 15K)
- Skin Sensitization non-guideline (ROAT) (PDF) (27 pp, 978K)
- Ethics Review of Cr(VI) Human Study (PDF) (12 pp, 100K)
Draft Guidance to Submitters of Human Research
- PR Notice on HSRB Submission (PDF) (15 pp, 113K)
IR3535 Protocols
- Read This First (PDF) (2 pp, 18K)
EMD-003
- Read This First (PDF) (1 page, 14K)
- Summary and rationale for revisions protocol EMD-003 'Test of Personal Insect Repellents' (PDF) (3 pp, 23K)
- Efficacy Test Protocol EMD-003 (PDF) (51 pp, 2.32MB)
- Memorandum of Errata and Corrections, EMD-003 (PDF) (3 pp, 25K)
- Handling ticks and observing their movement on the skin (PDF) (1 page, 38K)
- Practicing and performing dosimetry with Pump Spray, Aerosol Spray and Lotion delivery systems (PDF) (7 pp, 203K)
- IRB Review of EMD-003 (PDF) (26 pp, 1.32MB)
- IRB Correspondence Record (PDF) (15 pp, 583K)
EMD-004
- Read This First (PDF) (1 page, 14K)
- Summary and rationale for revisions protocol EMD-004 'Test of Personal Insect Repellents'(PDF) (3 pp, 23K)
- Efficacy Test Protocol EMD-004 (PDF) (57 pp, 2.56MB)
- Memorandum of Errata and Corrections, EMD-004 (PDF) (2 pp, 21K)
- Observing mosquito landings and learning mechanical aspiration (PDF) (1 page, 38K)
- Practicing and performing dosimetry with Pump Spray, Aerosol Spray and Lotion delivery systems (PDF) (7 pp, 203K)
- IRB Review of EMD-004 (PDF) (31 pp, 1.75MB)
- IRB Correspondence Record (PDF) (15 pp, 654K)
- CDPR Approval of EMD-004 (PDF) (2 pp, 36K)
- Science and Ethics Review of Protocol for Human Study of Mosquito Repellent Performance (PDF) (1 page, 142K)
Transmittal Memo 9-15-06
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