Conflict of Interest Regulatory Update

Jill Mortali, Director OSP
Liz Bankert, Assistant Provost
Conflict of Interest Updates
February 2012
 Public Health Service (NIH, CDC, AHRQ, etc) released new rules
August 2011
Changes are significant
All institutions receiving PHS funding are required to be in
compliance with new rules by August 2012
Task Force convened Fall 2011 to review new rules and make
recommendations– Duane Compton (Chair)
Recommendations delivered January 2012
Outreach and educational sessions to be delivered
Spring/Summer 2012
Modifications to COI system and process in place by Summer
Financial Conflict of Interest (FCOI)
A Little Reading….
 Old Rules: 42 CFR Part 50 Subpart F (grants and
cooperative agreements) 45 CFR Part 94 (contracts)
Initial Regulation effective 10-1-95
 New Rules: Revised Final Rule published on 8-25-11
2011 Revised FCOI Regulation
Revised regulations on:
Responsibility of Applicants for Promoting Objectivity in
Research for which Public Health Service Funding is Sought
Responsible Prospective Contractors
Published in Federal Register on August 25, 2011
Implementation by August 24, 2012
Applies to each Notice of Award issued subsequent to
compliance dates of final rule
What is the Purpose of the
This regulation promotes objectivity in research by
establishing standards that provide a reasonable
expectation that the design, conduct, and reporting of
research funded under NIH grants or cooperative
agreements will be free from bias resulting from
Investigator financial conflicts of interest.
FCOI Regulations Framework
Disclosure of SFI
Compliance with Institutional Policy
Compliance with Regulations
Reporting to NIH
Institutional Policy
Evaluation of SFI
Identification of FCOI
PHS regulation 42 CFR Part 50, Subpart F and 45 CFR Part 94
Summary of major changes for investigators:
High Level
More Details Coming to a Conference Room Near You!
 Threshold for reporting financial interests
changed/lowered from $10k to $5k
Reporting based upon relations to Institutional
Responsibilities versus just research
Annual and Project based disclosure
Travel reimbursed from sponsors reported within 30 days
(some exclusions including government & higher ed.)
Information to make accessible to the Public (upon request
or via a website.)
New financial interests must be updated within 30 days
Mandatory Education Requirement for Investigators
Investigator means the project director or principal
Investigator and any other person, regardless of title or
position, who is responsible for the design, conduct, or
reporting of research funded by the NIH, or proposed
for such funding, which may include, for example,
collaborators or consultants.
Dartmouth Implementation
 Memo from Martin Wybourne January 2012
 Changes mainly isolated to PHS-funded investigators for the
present time
 Hire a Conflict of Interest Officer (our favorite)
 Review Dartmouth’s COI policy and thresholds, and how they
might need to be amended;
 Prepare guidelines for researchers about what constitutes COI
under the new rules;
 Develop educational programs (in person and online) for
 Establish a method to meet public disclosure requirements
 Enhance the current online COI disclosure mechanism
How Can I Help?
 Help us arrange educational sessions in your
 Encourage faculty to attend departmental or general
 Be ready for change! Modifications to systems and
processes are on the way.
 Don’t shoot the messenger. We’re all in this together.
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