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DOE HUMAN SUBJECTS WORKING GROUP
SPRING WORKSHOP AGENDA

Washington, DC Latham Hotel

FOCUS: CONTINUOUS IMPROVEMENT

Wednesday, May 6, 2009

Presentation

Speakers

Welcome and Introductions
Expectations for Workshop

Sharlene Weatherwax, Director, Biological Systems Sciences Division, DOE/SC
Libby White, DOE/SC

Site Status Report Update
Moderator: Libby White, DOE/SC
Discussion: What has changed since you submitted the 2008 DOE status report?
Administrators should be prepared to share any substantial changes made to their programs since the 2008 status report was submitted.

Each site reports 10 minutes each

Meet in Lobby to break into groups for Dinner

 


Thursday, May 7, 2009

Presentation

Speakers

Program Improvement: Process
Project Monitoring and Oversight

Moderator: Libby White, DOE/SC
Discussion: We will share ideas to improve processes and develop best practices in this area.
Questions:

  • How many projects at your site require review more often than annually?
  • What monitoring does your site do other than mandatory continuing review?
  • What do you do differently for high-risk research?
  • What characteristics or concerns trigger additional monitoring or oversight?
  • Who determines when a study needs additional monitoring or oversight?
  • Do you have an established process for additional monitoring and oversight of approved studies?

Terry Reser, Sandia
Darcy Mallon, BNL
Ann Marie Dake, LLNL

Program Improvement: Succession Planning for the HRPP and IRB
Moderator: Peter Kirchner, DOE/SC
Discussion:

  • Do you have a succession plan for the IRB Administrator and Chair positions?
  • Do you have a back-up plan for these positions?/li>
  • Besides mandatory training, how do you mentor new IRB administrators, chairs, and members?
  • What do you do to educate and help Institutional Officials understand the human subjects program?

Kathy Ertell, PNL

Program Improvement: Tools
IRBNet and Websites

Moderator: Sherry Davis
Discussion:

  • Overview of experiences by IRB Administrators using IRBNet for more than a year and by new users of IRBNet.
  • Laboratory Human Subjects Website

Becky Hawkins, ORISE
Darcy Mallon, BNL
Charles Pietri, HITECH
Betsy Ellis, ORISE

What would you like to do to improve your Human Subjects Program if funding were not an issue?
Moderator: Libby White, DOE/SC

All

LUNCH - provided

 

PII Incident/DOE Requirements
Moderator: Dena Tomchak, INL

Ray Holmer, DOE/HS
Libby White, DOE/SC
Mary Fields, DOE/HS

Program Improvement: Procedures for IRB Review of Former Worker Studies

Libby White, DOE/SC
Mary Fields, DOE/HS

New Policy & Guidance

Julie Kaneshiro, OHRP

Title: Other Information Shared: LLNL Be Sensitization Concern Cases – Analysis 1998-2008

Content reviewed: May 27, 2009