iSTAR: Changes at the Human Subjects Division

1. iSTAR:Changes at the Human Subjects Division Karen Moe, Director With the support and commitment of over 40 HSD staff members and over 100 IRB members

2. iSTAR at HSD: An integrated framework • Communication, education, and outreach • Process improvement (Efficiency, consistency, transparency) • Performance metrics • Cultural change

3. Example: Maximize use ofregulatory flexibility to identify research that doesn’t require IRB review Impact • IRB application & review not required • Saves researchers time and resources • Faster research startup • More efficient use of HSD and IRB resources

4. Example: (continued) Already accomplished • Public data sets, some biol. specimens: no review Pending (spring 2009) • Coded data, more biol. specimens: no review • HSD staff training: recognize & return unnecessary applications Pending (fall 2009) • Reduced need for “dual” review

5. Example: Regularly publish turn-around times for different types of IRB review Impact • Faster research startup due to better planning, better able to achieve targeted startup dates • More efficient use of researcher resources & funding • Increased accountability and transparency

6. Example: (continued) Already accomplished • Infra-structure: database, basic metrics & reports Pending (March 2009) • Post basic turn-around times for IRB applications Pending (summer 2009) • Post more detailed turn-around time metrics Pending (two years) • Research Roadmap Initiative: a Research Portal and Database providing application status to researchers

7. Example: Reduce turn-around time for review and approval of IRB applications Impact • Faster research startup • Faster access to research funding • More efficient use of researcher, HSD, and IRB resources

8. Example: Already accomplished