Denise Viator Technical Assistance Project Manager Oak Ridge Associated Universities

1. U.S. Department of EnergyHuman Subject Protection ProgramCollaborative IRB Training Initiative Task Team Recommendations Denise Viator Technical Assistance Project Manager Oak Ridge Associated Universities DOE Human Subject Working Group Workshop December 7, 2012 San Diego, California

2. CITI Improvement Task Team Members • Libby White, DOE • John Ordaz, NNSA • Darcy Mallon, BNL • Chris Byrne, LBNL • Betsy Ellis, ORISE • Becky Hawkins, ORISE • Denise Viator, ORISE • Kathy Ertell, PNNL • Terry Reser, Sandia • Karen Brown, SRS

3. DOE Site Survey Results • 7 sites responded • 7 sites use CITI • Required passing score – 80-85% • Should a minimum score be required? Yes – 4, No – 3 • Learner Groups at sites using CITI • IRB Members – 7 sites • Researchers – 6 sites • Grant Proposal Staff – 1 site • Other • 1 site - Manager of Researchers • 1 site – IO, IRB Program Manager, Legal Counsel to IRB

4. DOE Site Survey Results, cont. • Suggested Improvements • Add new modules • HTM – 5 sites • Energy Efficiency – 5 sites • Man-Machine Interface – 6 sites • Evolving Technology – what we know about & what we don’t • Limit mandatory modules to 2 • Eliminate the requirements to complete any electives • Improve navigation within CITI • Allow sites to add modules as needed • Include a short description of each module • Simplify updating site-specific pages

5. Task Team Recommendations • Six core modules or equivalent • IRB Managers can designate additional modules for his or her site • Work with CITI to set up & implement to test out option for any module • Set 80% as the minimum passing score • Develop new on HTM and Energy Efficiency

6. 2012 Total: 353

7. 5-year Total: 1293

9. QUESTIONS?