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