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 5/26/16 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

5/26/16

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

Nuts & Bolts

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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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CHANGES

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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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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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Require that each Investigator who is planning to participate in the PHS-funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS funded research

§ 50.605 (e)(1) Management and reporting of financial conflicts of interest.

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Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually, ….

§ 50.605 (e)(2) Management and reporting of financial conflicts of interest.

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… require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and at least every four years …

§ 50.604 (b) Responsibilities of Institutions regarding Investigator financial conflicts of interest.

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No later than the time of application

Financial Disclosure Less than a year old COI Training

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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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Grant Submission

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Grant Awarded

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Grants Listing

UConn Employees (only)

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Non – PHS Award

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PHS Award

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PHS Award

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OFFICE OF THE VICE PRESIDENT FOR RESEARCH In addition to yourself, are there any other investigators that are working on the project based on the definition below:

The principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.

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Grants Listing

UConn Employees (only)

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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 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 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

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 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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UConn Health employees

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Grants Listing

UConn Health Employees

(whether paid or unpaid)

(Sub awardees)

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No further action taken by Storrs SPS office

(subcontract indicates Uconn Health PHS policy is being followed) UConn Health SPS office contacts COI staff

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Grants Listing

UConn Health Employees

(whether paid or unpaid)

(Sub award)

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  • UConn SPS contacts COI staff
  • for confirmation of the UConn

Health contributor’s compliance with disclosure and training

  • and to ascertain whether any

SFIs were disclosed.

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Acknowledgments

Kristen Tremblay

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Kim O’Connor Jen Johnson, Laura Kozma &Tracy Walters

SPS Staff (proposal & post award )

Kyle Pelletier

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