Conflict of Interest Awards Certification Workflow Gus - - PowerPoint PPT Presentation

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Conflict of Interest Awards Certification Workflow Gus - - PowerPoint PPT Presentation

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Conflict of Interest Awards Certification Workflow Gus Fernandez-Wolff 4/20/16 OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH Nuts & Bolts OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH

Conflict of Interest

Awards Certification Workflow

Gus Fernandez-Wolff

4/20/16

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH

Nuts & Bolts

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH

WELCOM TURIST WE SPIK INGLISH

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A conflict of interest is a situation in which financial or

  • ther personal considerations have the potential to

compromise or bias professional judgment and objectivity

Conflict of Interest

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The NIH is committed to preserving the public’s trust that the research supported by us is conducted without bias and with the highest scientific and ethical standards. We believe that strengthening the existing regulations on managing financial conflicts of interest is key to assuring the public that NIH and the institutions we support are taking a rigorous approach to managing the essential relationships between the government, federally-funded research institutions, and the private sector

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH

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CHANGES

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH

PHS

Affiliated Physician Agency for Healthcare Research and Quality Agency for Toxic Substances and Disease Registry CDC Centers for Disease Control and Prevention FDA Food and Drug Administration HRSA Health Resources and Services Adm. IHS Indian Health Service NIH National Institutes of Health Substance Abuse and Mental Health Services Adm.

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH

Non-PHS Agencies

  • Alliance for Lupus Research (ALR)
  • Alpha-1 Foundation
  • American Asthma Foundation
  • American Cancer Society (ACS)
  • American Heart Association (AHA)
  • American Lung Association (ALA)
  • Arthritis Foundation (AF)
  • CurePSP
  • Juvenile Diabetes Research Foundation (JDRF)
  • Lupus Foundation of America (LFA)
  • Patient-Centered Outcomes Research Institute (PCORI)
  • Susan G. Komen for the Cure
  • PCORI. Patient-Centered Outcomes Research Institute.
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OFFICE OF THE VICE PRESIDENT FOR RESEARCH

Grant Submission

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Prior to the Institution’s expenditure of any funds under a PHS funded research project, the designated official(s) of an Institution shall, consistent with § 50.604(f): review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, develop and implement a management

§ 50.605 Management and reporting

  • f financial conflicts of interest.
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Who is an investigator?

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NIH Definition of Investigator

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Key Personnel

Principal Investigator Co-Investigator Consultants Whoever is listed as Key Personnel

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Budget Justification

responsible in charge design conducting analyzing

  • versight

supervise

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Grants Listing

UConn Health Employees

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  • Training
  • Disclosure
  • Less than 365 days old
  • No significant financial interest on

it

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH

  • Training
  • Disclosure
  • Less than 365 days old
  • No significant financial interest on

it

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2 Hours delay

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Where’s my worm!

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH .

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Grants Listing

Non-UConn Health Employees

(whether paid or unpaid)

(Sub award)

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Sub Awardee

  • Has a PHS-Compliant FCOI Policy
  • Subcontract indicates that Institution's Policy is

being followed

  • No further action taken by COI office
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Grants Listing

Non-UConn Health Employees

(whether paid or unpaid)

(Sub award)

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Sub awardee

  • Doesn’t have a PHS-compliant FCOI
  • Sub awardee chooses to follow UConn

Health Policy

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COI Office

COI staff work with SPS to ask PI to complete FCOI Certification Form

(identify role of each contributor on the project, specifically whether “Independently Responsible” for key areas)

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Project design Project Conduct / implementation Required reporting of the research Publications or Presentations

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COI Office

  • COI staff work with SPS and PI to

contact all External KSPs (and any

  • ther External people meeting definition
  • f Investigator) to complete External

Investigator Disclosure Form

  • and provide evidence of FCOI training,

if training is not incorporated into the form

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Provide evidence of FCOI training

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Grants Listing

Non-UConn Health Employees

(whether paid or unpaid)

(non- sub award)

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Same Scenario

  • PI complete FCOI Certification Form.
  • PI ask them to complete External

Investigator Disclosure Form.

  • Proof of COI training.
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OFFICE OF THE VICE PRESIDENT FOR RESEARCH

UConn – Storrs employees

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Grants Listing

UConn-Storrs Employees

(whether paid or unpaid)

(Sub awardees)

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No further action taken by COI office

(subcontract indicates Storrs’ PHS policy is being followed)

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Grants Listing

UConn-Storrs Employees

(whether paid or unpaid)

(Sub award)

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  • COI staff contacts Storrs COI staff
  • for confirmation of the Storrs

contributor’s compliance with disclosure and training

  • and to ascertain whether any

SFIs were disclosed.

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Acknowledgments

Kristen Tremblay SPS Staff

In alphabetical order

Barbara, Jen, Pam, Paul, Tracy, Wendy and Zofia

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