Other Resources

HUMAN SUBJECTS WORKING GROUP
SPRING WORKSHOP
AGENDA

May 7-8, 2008
Hotel:  Sheraton Rockville
920 King Farm Blvd
Rockville, MD 20850
Room:  King Farm A & B

Pre-Workshop Assignment:
Complete status report on your program and return to SC-23.2.

Complete quick review of:
OHRP Self-Assessment - http://www.hhs.gov/ohrp/qi/
http://www.hhs.gov/ohrp/humansubjects/qip/qatooli.htm
http://www.hhs.gov/ohrp/humansubjects/qip/qasatool.rtf

AAHRPP Self-Assessment - http://www.aahrpp.org/www.aspx?PageID=221

AAHRPP Tip Sheets - http://www.aahrpp.org/www.aspx?PageID=105$9

Wednesday, May 7, 2008


Time

Presentation

Speakers

8:00 – 8:15 a.m.

Registration and Continental Breakfast

 

8:15 – 8:30 a.m.

Welcome and Introductions

Anna Palmisano, Associate Director, Office of Biological and Environmental Research, DOE
All

8:30 – 8:45 a.m.

Headquarters Expectations

  • For this Workshop
  • For DOE Sites

            Self-Assessment

Peter Kirchner and
Libby White, SC-23.2

8:45 – 10:30 a.m.

Brief Site-specific Program Descriptions

  • Types of Research Conducted
  • Number of Active Protocols
  • Structure of HSPP
  • Issues
  • Resource Needs
  • How SC-23.2 Can Assist

All

10:30 – 10:45 a.m.

Break

 

10:45 – 12:15 p.m.

OHRP Quality Improvement Program - Tutorial

Lynda Lahl and Michelle Feige, OHRP

12:15 – 1:15 p.m.

Working Lunch

  • Q&A Session with OHRP Representatives

All

1:15 – 2:30

OHRP Quality Improvement Program – Tutorial (continued)

Lynda Lahl and Michelle Feige, OHRP

2:30 – 3:00 p.m.

Experience Using OHRP Self-Assessment Tool

Judy Matuk, Stony Brook

3:00 – 3:15

Break

 

3:15 – 4:45

AAHRPP Accreditation Tutorial

  • Overview
  • Self-assessment Tool
  • Available Resources
  • Online Submission Using Different Electronic Systems
  • Site Review
  • Differences between DOE Labs and Other Organizations Pursuing Accreditation
(AAHRPP handout)

Susan Rose, USC
Sherry Davis, PNNL

4:45 – 5:30 p.m.

Optional Session: Classified HS Research:  Problems and Solutions
(for those whose sites do or may in the future do classified HS Research)

All

6:00 p.m.

Meet in Hotel Lobby for Dinner

 


Thursday, May 8, 2008


Time

Presentation

Speakers

8:00 – 10:00 a.m.

Interactive Discussion Regarding Innovative Solutions at DOE Sites, to include:

  • Central IRBs (Oak Ridge Site-wide IRB, Central Beryllium IRB, PNNL IRB)
  • Programs that Provide IRB Review for Other Sites’ Protocols (Oak Ridge Site-wide IRB, LLNL, PNNL)
  • Educational Programs (BNL)
  • Maintaining Commitment to Human Subjects Protection When IRB is Offsite (ANL, BNL, LBNL)
  • IRB Review of Former Worker Medical Screening Program  (DOE Sites, Mary Fields(HS-10)
  • Other

All

10:00 – 10:30 a.m.

BREAK

 

10:30 –11:30 a.m.

Workshop Review

  • What did you learn that was useful?
  • How can SC-23.2 assist field sites/resource needs?
  • Next Steps

All

11:30 – 12:00 p.m.

Closing Session

  • Topics for November Meeting
  • Other (if time, HS Database, Newsletter Topics, SharePoint Website)