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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
Board of Governor’s MeetingWashington, DCSeptember 24, 2012
Larry Becker, Chair, SCCOI and Member, Board of Governors
Standing Committee on Conflict of Interest (SCCOI)
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
Agenda
1. Introduction – COI Rules Approved by the Board on June 19, 2012
2. Operationalizing the COI Rules for the Methodology Committee
3. Next Steps
4. Discussion
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Today’s Agenda
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
COI Rules Approved by the Board on June 19, 2012
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Introduction
Intended to “safeguard the integrity and public trust in the process for funding patient-centered outcomes research (PCOR)”
Full text available at www.pcori.org
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
PCORI FUNDING ANNOUNCEMENT APPLICATIONS• 483 applications received• Review process underway• ~ 100 awards expected in December 2012
OPERATIONALIZING THE COI RULES FOR THE METHODOLOGY COMMITTEE (MC)
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
COI Rules Pertaining to the MC
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Operationalizing the COI Rules for the MC
Creates the MC-PFA Development Subcommittee* to function as a liaison to PCORI’s Board and staff
− These MC members will not be eligible to apply for PFA funding
* Previously referred to as the Methodology Executive Subcommittee in Patient-Centered Outcomes Research Institute (PCORI) Draft Conflict of Interest Rules for Research Funding, June 19, 2012
Methodology Committee
(MC)
MC-PFA Development Subcommittee
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
Operationalizing the COI Rules for the MC
MC-PFA Development Subcommittee
Jean Slutsky, PA, MSPH
Clyde Yancy, MD
Naomi Aronson, PhD
Alfred Berg, MD, MPH
Mike Lauer, MD
Sherine Gabriel, MD(MC Chair)
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
The Methodology Committee will remain united in its mission to provide scientific guidance to PCORI…
…the new operating model will not change this
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Operationalizing the COI Rules for the MC
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
Elements of PCORI’s COI Policy Regarding the Methodology Committee
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Operationalizing the COI Rules for the MC
Protect against COI when awarding funding for non –PFA research (RFPs)
Non-Disclosure
Agreements
Firewalls for PFAs
MC Recusal and COI
Disclosure
Require all members of PCORI community (e.g., MC, Board, staff) to preserve confidentiality of non-public information
Create firewalls to preserve Methodology Committee eligibility for PFA funding
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
Firewalls will be implemented to preserve eligibility of most MC members for PFAs
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Operationalizing the COI Rules for the MC
Firewall Goals:
Avoid an unfair advantage for MC members
Control access to information
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
MC Firewall Implementation Strategies
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Operationalizing the COI Rules for the MC
IT Governance
Distribution Controls
Meeting Controls
Mitigating Time
Advantage
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
SCCOI Guidance
Operationalizing the COI Rules for the MC
• Importance of IT solutions to maintain firewalls
• Emphasis on policy training for the Board, Methodology Committee, and staff
• Encouragement of preparation of public-facing document that reinforces the significance of guarding against COI as a core PCORI value
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Operationalizing the COI Rules for the MC
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
PCORI FUNDING ANNOUNCEMENT APPLICATIONS• 483 applications received• Review process underway• ~ 100 awards expected in December 2012
NEXT STEPS
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
Next Steps
Operationalizing the COI Rules for the MC
Develop and adopt the COI policy regarding external parties (e.g., advisory panels, consultants)
Implement the firewalls for the Methodology Committee
Monitor and regularly review COI compliance
Next Steps
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
PCORI FUNDING ANNOUNCEMENT APPLICATIONS• 483 applications received• Review process underway• ~ 100 awards expected in December 2012
DISCUSSION
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
Questions or Comments?
Operationalizing the COI Rules for the MC
Discussion
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PAT I E N T- C E N T E R E D O U TC O ME S R E SE A RC H I N ST I T U T E
• Appendix A: Proposed Internal Firewall Policies and Procedures Related to the Eligibility of Methodology Committee Members for PCORI Research Funding
• Appendix B: Checklist: Implementation of Firewalls for Methodology Committee
• Appendix C: PCORI Conflict of Interest Rules for Research Funding (June 19, 2012)
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Appendix