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IRB Best Practices Case Study: Transforming a Hospital-based IRB
Parker Nolen, MBA, CCRC, CIP
MAGI West 2014Workshop W870
Manager, Human Subjects Office/Institutional Review Board
Let’s take a minute…Why do all of us in the room really do this?
• Network snapshot• Operating environment• Options• What it was like?• What we wanted to do• How we got there• Performance Metrics• What’s next for 2015 and beyond
What am I going to talk about?
• 9 county geographic catchment area• 8 hospitals• 11 pavilions• 73 physician sites
Network Snapshot
What type of research is conducted?
Clinical Trials - Drug
Clinical Trials - Device
Clinical Trials - Other Intervention
Genetic Studies
Clinical Outcomes Research
Basic Research
Qualitative Research
Imaging and Diagnostics
Chart reviews/case reports
Registry or Repository
Training/Education/Quality Improvement
Users of the Network IRB
Internal 73%
External 27%
The Operating Environment
• 3 large health care providers in region • Indiana CTSI (IU, Purdue, Notre Dame)• All have established research programs• Implementation of the ACA
– New and different economic pressures on providers
– Baseline question: “Can we survive on Medicare reimbursements only?”
• Outsource IRB functions completely– Transfer costs – Maintenance costs– Organizational Values
• Partner in a hybrid model– Very few partners available– Cost considerations
• Shut-down research – Teaching hospital – Not an option
• Get lean
Options
• Meetings lasted 2.5 hours• Used only Full Board review
• Even Expedited- and Exempt-eligible items• Electronic tracking system broken • Board members received 400-600 pages• 26 members on 1 board• Questionable composition
• Unaffiliated meant retired employees• Non-scientific meant not an MD• Diversity meant only gender
• No SOPs• Met 1x Monthly• TAT ≈ >60 days (regardless of item)
October, 2013
Level of Customer Service and Responsiveness from the IRB Office
Very Satisfied16%
Satisfied26%
Neither Satisfied nor Unsatisfied
34%
Unsatified24%
• Unacceptable TAT• Unacceptable customer satisfaction (< 50%)• Inefficient use of Full Board review• Meetings too long• Membership composition issue• Electronic tracking system inhibiting compliance• No meeting cost had ever been calculated• Meeting Cost per hour ≈ $1000 (prime cost)
Our Analysis
• More efficient use of Full Board time– What can be handled administratively?– What REALLY requires Full Board review?
• Quicker TAT• Higher user satisfaction• Better compliance• Reduce costs
What did we want?
• Re-paneled the IRB– Moved from 1 Board to 5 Boards
• Considered multiple Board compositions– Prime cost critical consideration– Personalities also an important consideration
• Increased meeting frequency– 1x month to 1x week
• HSO staff triage/Pre-Review of submissions• Expedited/Exempt reviews handled by staff*
How did we do it?
* non-scientific and administrative items only
• Contracted for different electronic system– Translation: we are temporarily a paper-based IRB
• Created new forms to serve as:– submission– documentation of review – written determination
• Drafted and implemented new SOPs• Eliminated submission deadlines• Committed to 72 hour TAT metric
How did we do it?
• 4 Regular Boards• 1 Emergency Board• Each Panel meets composition requirements set forth in 21 CFR 56.107 and
46 CFR 46.107• At least five (5) members• Varying backgrounds• Sufficient qualification of members• Diversity with regard to race, gender, culture• Professional Competence• At least one (1) nonscientific member• At least one (1) unaffiliated member
• Consultants used for specialty gap• Member commitment is the same – 1x month• Investigators see weekly meetings – 4x month
New Boards
Panel Assignments
* Board 5 is Emergency Use/Compassionate Use only (not regularly scheduled)
• The IRB Meeting is a service• There is an associated cost for that service
Two Basic Assumptions
• Critical variable in transformation• IRB Volunteer ≠ No cost• Focused on identifying the Prime Costs
– Prime costs are the costs directly incurred to create a product or service.
• Prime costs do not include indirect costs, such as allocated overhead.
• Administrative costs are generally not included in the prime cost category.
The Cost of Meeting
Legacy New
One (1) Panel Four (4) Panels
1x Month 4x Month
≈ 2.5 hours per meeting ≈ .25 hours per meeting
≈ $1,000 per hour prime cost ≈ $300 per hour prime cost
≈ $2,500 meeting cost ≈ $75 meeting cost
≈ $30,000 annual prime cost ≈ $900 annual prime cost
Legacy vs. New
New Forms
Performance Metrics
Source: 2013 AAHRPP Metrics on Human Research Protection Program Performance for Hospitals – Updated August 1, 2014
October 2013
September 2014
• Faster access to points of care • Increased investigator satisfaction*• Increased sponsor satisfaction*• Increased attendance (65% to 95%)• Increased Board member satisfaction• Increased quality of review due to smaller agenda• 97% reduction in prime cost• Revenue Positive• 75% Contribution Margin to Network (projected)
Outcomes
* Anticipated based on 2014 IRB User Satisfaction Survey administered October 1 – November 30 2014
• AAHRPP Accreditation process • Q4 2015
• Transition to new electronic system • Q1 2015
• Implementation of new revenue model– Demand-based forecast using historical data– Tired system– Expected 3-5% increase in revenue
• Development of regional review system • Q2 2015
• Potential spin-off into separate business unit • Q1 2017
What’s Next – 2015 and Beyond
What will our revenue look like?
Current Anticipated
• Understand that time is money• Identify and know your meeting costs
– Focus on Prime Costs initially– Fixed costs are probably out of your control
• Small panels, frequent meetings • Use staff for pre-review/triage
– Trained, competent, CERTIFIED staff is key• Look at your revenue curve
– Do you have one?– Is it flat?
• Be nimble – critical!
Conclusion
Discussion
