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Human Studies Review Board

Human Studies Review Board

Ethics Training for Members and Consultants Serving on the HSRB

October 19 - 20, 2011 Public Meeting

EPA Human Studies Review Board Live Video Webcast, Oct. 19-20

Your are invited to attend the on-line Internet TV webcast of the EPA Human Studies Review Board October 2011 Public Meeting, October 19-20, 2011, live from the EPA in Washington D.C.

» Read more about this event

  1. AEATF Liquid Pour Scenario Protocol
    1. EPA Science and Ethics Review (PDF) (54 pp, 618K, About PDF)
    2. Submission Documents
      1. Volume 1: Transmittal Letter, Checklist, Study Design Document Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. Volume 2: Protocol, IRB Approval Letter, Supporting Documents Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      3. Volume 3: IRB Review Records Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      4. Volume 4: CVs and Ethics Training Records, SOPs Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. Reference Files
      1. AEATF Governing Document, Version 3 (dated 7-08-11) Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. IIRB, Inc. Human Research Protection Plan (dated 11-3-10) Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      3. IIRB, Inc. Current Membership Roster (dated 11-3-10)Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. Charge Questions (PDF) (1 pp, 29K, About PDF)
  2. AHETF Closed System Liquid Loading Scenario Protocol
    1. EPA Science and Ethics Review (PDF) (59 pp, 750K, About PDF)
    2. Submission Documents
      1. Monitoring Unit Selection and Construction Plan, SOPs, IRB Review Records Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. Reference Files
      1. AHETF Governing Document Version 2 - August 2010 Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. 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
      3. IIRB, Inc. Current Membership Roster 11-3-10 Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. Charge Questions (PDF) (1 pp, 19K, About PDF)
  3. No Mas Completed Mosquito Repellent Study
    1. EPA Reviews
      1. EPA Science Review - No Mas-003 Completed Study 9-29-11 (PDF) (8 pp, 123K, About PDF)
      2. EPA Ethics Review - No Mas-003 Completed Study 9-29-11 (PDF) (7 pp, 112K, About PDF)
    2. Submission Document
      1. No Mas-003 Final Report Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. Explanatin re Statistical Programs Used From Scott Carroll Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      3. No Mas-003 CPT for Survival Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. Reference Files
      1. CLBR Protocol Submission - No Mas-003 (7-15-10) Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. EPA Science & Ethics Review of No Mas-003 Protocol (10-1-10) Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      3. 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
      4. IIRB, Inc. Roster 9-12-11 Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    4. No Mas Charge Questions (PDF) (1 pp, 20K, About PDF)
  4. Moiemen 2011
    1. EPA Reviews
      1. EPA Science Review Moiemen 2011 MRID 48607501 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. EPA Ethics Review Moiemen 2011 MRID 48607501 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    2. Background Documents
      1. Moiemen 2011 MRID 48607501 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      2. Volume 1 - Response to Questions from US EPA re Moiemen 2011 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      3. Volume 2 - Ethics Application 1 dated 11-22-05 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      4. Volume 3 - Response to Ethics Application 1 (Not Approved) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      5. Volume 4 - Ethics Application 2 dated 1-27-06 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      6. Volume 5 - Response to Ethics Application 2 (Revisions Requested) - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      7. Volume 6 - Info back to Ethics Committee 3-14-06 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      8. Volume 7 - Approved of Ethics Application 2 4-5-06 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      9. Volume 8 - Protocol Amendments 2, 3 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
      10. Volume 9 - Protocol Amendment 4 - Please Contact Lu-Ann Kleibacker at 202-564-7189 for an accessible copy of this document
    3. Charge Questions - Moiemen (PDF) (1 pp, 15K, About PDF)
  5. Final Presentations
    1. EPA Follow-up on Previous HSRB Recommendations (PDF) (8 pp, 367K, About PDF)
    2. AEATF Liquid Pour Protocol (PDF) (45 pp, 1.3Mb, About PDF)
    3. AHETF CSLL Protocol (PDF) (44 pp, 2.68Mb, About PDF)
    4. Dermal Absorption of Silver from ActicoatTM Wound Dressings (PDF) (41 pp, 2.31Mb, About PDF)
    5. No Mas Completed Report (PDF) (36 pp, 1.57Mb, About PDF)

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EPA Human Studies Review Board Live Video Webcast, Oct. 19-20

Your are invited to attend the on-line Internet TV webcast of the EPA Human Studies Review Board October 2011 Public Meeting, October 19-20, 2011, live from the EPA in Washington D.C.

The Human Studies Review Board (HSRB) is a Federal advisory committee operating under the Federal Advisory Committee Act (FACA) that provides advice, information, and recommendations on issues related to scientific and ethical aspects of human subjects research. The HSRB reports to the EPA Administrator through EPA's Science Advisor.

This live video webcast event is free, open to the public, and will be accessible at this URL. http://www.tvworldwide.com/events/HSRB/111019/ Exit EPA Disclaimer .

The agenda for this two-day event is also available at this site. The event will go from 10:30 AM to 5:00 PM ET on Wednesday, Oct. 19 and 9:00 AM to 3:45 PM ET on Thursday Oct. 20.

Topics for this meeting include:

  1. A completed Carroll-Loye Biological Research, Inc. (CLBR) study (No Mas 003) to evaluate the field repellent efficacy against mosquitoes.

  2. A new scenario design and associated protocol from the Antimicrobial Exposure Assessment Task Force II (AEATF-II), describing proposed research to monitor the dermal and inhalation exposure of workers while pouring liquid antimicrobial pesticide products from both conventional and reduced-splash containers.

  3. A new scenario design and associated protocols from the Agricultural Handler Exposure Task Force (AHETF) describing proposed research to measure dermal and inhalation exposure to workers who use closed system equipment to load liquid pesticide products from returnable and non-returnable containers.

  4. A published report by Moiemen et al (2011) of an intentional exposure human study measuring dermal absorption of silver from the use of nanosilver-containing wound dressings to treat major burns.

Please go to this webcast event site in advance to test your Flash or Windows Media video player in preparation for the October 19-20 event. If you have technical questions, please click on the 'Technical Support' in the upper right hand corner of the site.

Please click here for more information on EPA’s Human Studies Review Board.

 

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