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
