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4/7/2015
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The IRB Ecosystem of a BusyClinical Research Institution
HCCA Compliance Institute / April 21, 2015Orlando, FL
Charles Eibeler, Director, Business DevelopmentStuart Horowitz, PhD MBA, President, Institutions & Institutional Services
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Agenda
The IRBs and your HRPP
What is an IRB Ecosystem?
Why & when an IRB Ecosystem?
How to work with outside IRBs
Human Research Protection Program (HRPP)
A shared responsibility
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An HRPP is a shared responsibility
Institution
IRBs Investigators
IRBs
IRB
IRB
IRB
Components of the HRPP
Investigators and research staff
Grants and Contracts Office
Legal counsel
Employees
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Authorities
• Approve research
• Modify research
• Disapprove research
• Suspend research
• Terminate research
• Observe research
Acts on research
• Disapprove research
• Non‐compliance
• Select IRBs
• Restrict investigators
• Hire/fire staff
• Allocate funds
Acts on individuals and systems
IRB Institution
IRB Ecosystem
A set of co-existing, human research review units integrated with an institution’s HRPP.– Based on trust
– Efficient, with non-duplicative activities
– Partners in human research protections Open communication
Honesty
Single-minded focus
Integrated with institution’s HRPP
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Simple IRB Ecosystem
Captive IRB NCI CIRB
NeuroNext or StrokeNet
Independent IRB
HRPP
Partners in Human Research Protections
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Teammates in Overcoming Obstacles
Why Rely on Outside IRBs?
By requirement:– Sponsor
– Funding Agency
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By Choice: – Captive IRB workload
– Multi-campus institution wants to consolidate IRBs
– Desire to focus on IIR
– Desire for more
clinical trials
Why Rely on Outside IRBs?Continued
Changing Landscape of Clinical Research
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Serious decline in federal research dollars for US institutions
Pharma: Urgent Need To Change
$100
$300
$800
$1,300
$1,900
1979 1991 2000 2005 2010
90% of R&D expenditures result in NO new drug approvals
Total Cost Per New Drug
($mm)$1,900
56
29
$36
$147
$0
$20
$40
$60
$80
$100
$120
$140
$160
0
10
20
30
40
50
60
FDA Approved
Drugs
Global Pharma R&D Budget ($bn)
‘96 ‘00 ‘14‘12‘04 ‘08‘02‘98 ‘06 ‘10
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84%72%
63% 59% 61%
9%
14%
16%12% 13%
7%14%
21%29% 26%
1998 2000 2004 2008 2012
North America Western Europe Emerging Regions
Source: Tufts CSDD
Globally dispersed clinical trial activityOffshoring means fewer activities for US investigators
Global research snapshot & forecast
Chris Toller, Clinical Studies in Asia‐Pacific: A Regional Perspective.J. Clin Studies Vol 5;3. pp 20‐23.
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In an environment of research budget cuts, can clinical trials provide alternate research funding opportunities?
Time for a change
From CenterWatch December 2014
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When?
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How to work with outside IRBs
Decision-making
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Choosing IRB Partner(s)
Some may be chosen for you
NCI-CIRB
Novartis Signature
StrokeNet, etc
Choosing IRB Partner(s) – continued
You get to choose others
Your needs
Your desires
Your expectations
Your limitations
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Careful Transition Management
Regulatory notifications/filing
Communication – Internal stakeholders
– External stakeholders
Integration with institutional workflows & eIRBsoftware
Policy adjustments
Informed consent templates
Gatekeepers
Costs & invoicing
Key Issues to Manage
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Contract or MSA – Required by IRB?
– Required by institution?
– Terms & conditions?
Single point of contact
Performance expectations
Redacted minutes
Reports
Management of noncompliance
Key Issues to Manage – continued
Ongoing Relationship Management
