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Meeting Information



Project Title: Return of Individual-Specific Research Results Generated in Research Laboratories

PIN: HMD-HSP-17-05         

Major Unit:
Health and Medicine Division

Sub Unit:
Board on Health Sciences Policy

RSO:
Mancher, Michelle

Subject/Focus Area:
Health and Medicine; Policy for Science and Technology


Meeting 1 of the Committee on Return of Individual-Specific Research Results Generated in Research Laboratories
July 19, 2017 - July 20, 2017
Keck Center
500 5th Street, NW
Washington D.C. 20001



If you would like to attend the sessions of this meeting that are open
to the public or need more information please contact:


Contact Name: Caroline Cilio
Email: ccilio@nas.edu
Phone: 2020334-2651
Fax:


Agenda:

DAY 1:
July 19, 2017—Room 208
Meeting Objectives:
• Receive study background and charge from NIH, CMS and FDA.
• Clarify Committee questions on the statement of task via open discussion with the sponsors.
• Discuss report audience and expected products.


OPEN SESSION
1:00 p.m.–2:45 p.m.

1:00–1:15 p.m. Opening Remarks to Public Audience
Jeffrey Botkin, Committee Chair
1:15–2:00 p.m. Presentation by Sponsors Panelists:
Representatives from CMS, FDA, and NIH (TBD)
2:00–2:45 p.m. Sponsor Q&A with Committee
Time to ask clarifying questions to understand scope and charge
Moderator: Jeffrey Botkin, Committee Chair
2:45 p.m. ADJOURN open session


Closed Session Summary Posted After the Meeting

The following committee members were present at the closed sessions of the meeting:
Paul Appelbaum
Suzanne Bakken
Jeffrey Botkin
Wylie Burke
Gregg Gonsalves
Rhonda Kost
Debra Leonard
Amy McGuire
James Nichols (unpaid consultant)
Bray Patrick-Lake
Consuelo Wilkins
Brian Zikmund-Fisher

The following topics were discussed in the closed sessions:
Bias and conflict of interest discussion; overview of study process; discussion of study charge, background discussion, and upcoming meetings were discussed during the closed session.

The following materials (written documents) were made available to the committee in the closed sessions:
Briefing book

Date of posting of Closed Session Summary: July 24, 2017