Document ID: EPA-HQ-ORD-2014-0411-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-06T04:00Z

US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                        JUNE 2014 PUBLIC MEETING AGENDA
                                       
               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal Drive, Arlington, VA 22202 

                           Wednesday, June 11, 2014

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone: (202) 566 1752
                  Docket Number: EPA - HQ - ORD - 2014 - 0411
                                       
10:30 AM*	Convene Public Meeting  -  Jim Downing, Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
            Introduction of Board Members  - Rebecca Parkin, Ph.D., MPH, HSRB Chair
	Opening Remarks  -  Toby Schonfeld, Ph.D., Human Subjects Research Review Official, EPA
	Welcome  -  Mr. Jack Housinger, Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention, EPA
	
Session 1:	A published report by Paul et al (1988) of an intentional exposure human study measuring the effects of small increases of dietary iodine on thyroid function.

10:45 AM 	EPA Science Review  -  Jonathan Leshin, Ph.D. (OPP, EPA)
11:00 AM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
11:15 AM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
11:25 AM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff 
11:35 AM 	Public Comments 
11:40 AM	Board Discussion 

Charge to the Board - Science:

   * Was the research reported in the published report by Paul et al (1988) faithful to the design and objectives of the protocol and governing documents of AEATF?

   * Has EPA adequately characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating the exposure?

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?
           
Session 2:	A published report by Gardner et al (1988) of an intentional exposure human study measuring the effects of low dose oral iodide supplementation on thyroid function. 

12:05 PM 	EPA Science Review  -  Jonathan Leshin, Ph.D. (OPP, EPA)
12:20 PM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
12:30 PM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
12:40 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), and EPA staff
12:50 PM 	Public Comments 
12:55 PM	Board Discussion

Charge to the Board - Science:

   * Was the research reported in the published report by Gardner et al (1988) faithful to the design and objectives of the protocol and governing documents of AEATF?

   * Has EPA adequately characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating the exposure?

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?
           
1:20 PM 	Lunch

Session 3: 	A published report by Lemar et al (1995) of an intentional exposure human study measuring the effects of chronic tetraglycine hydroperiodide water purification tablet use on thyroid function.

2:00 PM 	EPA Science Review  -  Jonathan Leshin, Ph.D. (OPP, EPA)
2:15 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
2:25 PM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
2:35 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
2:45 PM 	Public Comments
2:50 PM 	Board Discussion

Charge to the Board - Science:

   * Was the research reported in the published report by Lemar et al (1995) faithful to the design and objectives of the protocol and governing documents of AEATF?

   * Has EPA adequately characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating the exposure?
Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?
           
3:20 PM	Discussion of HSRB Work Group on Return of Individual Research Results Report

4:00 PM* 	Adjourn