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 2012

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  http://grants.nih.gov/grants/compliance/42_CFR_50_ Subpart_F.htm

 New Rules: Revised Final Rule published on 8-25-11  http://www.gpo.gov/fdsys/pkg/FR-2011-08 25/pdf/2011-21633.pdf

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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 4

What is the Purpose of the Regulation?

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. 5

FCOI Regulations Framework

Disclosure of SFI Compliance with Institutional Policy Investigator Institutional Policy Implementation Evaluation of SFI Identification of FCOI Management Compliance with Regulations Reporting to NIH Institution NIH Oversight

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

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.

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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 investigators; 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 department  Encourage faculty to attend departmental or general sessions  Be ready for change! Modifications to systems and processes are on the way.

 Don’t shoot the messenger. We’re all in this together.