Background Information

1. Lessons Learned: The Statewide IRB Consortium Development Indiana Health Information Forum (IHIF) Background Information Purpose To position Indiana as a premier state for the creation and growth of the health and life sciences industry enterprises Task Force Purpose To position Indiana as a premier state for the creations and growth of clinical trials. Recommendation 1 Create Indiana Clinical Trial Alliance (ICTA) with a mission to build a network of companies and individuals involved in clinical trials in Indiana. • CTSI continues to work to strengthen arrangements and better advertise policies for researchers to facilitate submission processes. • Development • Indiana CTSI was awarded: RCA Director involvement in IHIF clinical trials working group (separate from an Indiana CTSI, IU, ND, or PU initiative) to explore and recommend cost, speed, and overall process of IRBs statewide. • Indiana Health Information Forum(IHIF) • Universities used to be where most studies were done. • Now alternative models such as commercial IRBs are reviewing more and more studies. • A baseline premise is that all CTSI-related work will be reviewed by a University-based IRB. • Regardless of the type of IRB reviewing a study, IHIF focuses on what minimum standards should be in place and how efficiently the IRB processes studies. • Lessons Learned • 1 state-wide IRB is impracticable • From centralization to simple and streamline • Can maintain local control and input • Reciprocity is key • Recommendation 2 • Develop ICTA Committee devoted to IRBs across the state of Indiana. • To include: • Address statewide IRB challenges • Propose minimum standards • Harmonize forms, policies, and procedures • Share expertise - loan IRB members • Promoted shared learning opportunities • Developing agreements to provide for reciprocal reviews • Need to leverage and coordinate efforts with CTSI/shared goals • Challenges • Incorporations of our new CTSI partner, ND, in such arrangements. • Advertising the use of such agreements, services. • Gaining momentum for consortium development • Funding to support • NIH priority on these initiatives Network Meetings Outreach Educational Opportunities Programs Unified Public Policy Needs CTSI & Clinical Trials Summit Champion of Change: Marcia Gonzales JD, Executive Director, Research Compliance Administration, Office of Research Administration, Indiana University Contact Info: Shelley Bizila, MS, CIP, Director, Research Compliance Administration, Office of Research Administration, Indiana University