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 PRESIDENT FOR RESEARCH
WELCOM TURIST WE SPIK INGLISH OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Conflict of Interest A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity OFFICE OF THE VICE PRESIDENT FOR RESEARCH
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 OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
CHANGES 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. OFFICE OF THE VICE PRESIDENT FOR RESEARCH 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 . • OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
§ 50.605 (e)(1) Management and reporting of financial conflicts of interest . 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 OFFICE OF THE VICE PRESIDENT FOR RESEARCH
§ 50.605 (e)(2) Management and reporting of financial conflicts of interest . Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually , …. OFFICE OF THE VICE PRESIDENT FOR RESEARCH
§ 50.604 (b) Responsibilities of Institutions regarding Investigator financial conflicts of interest. … 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 … OFFICE OF THE VICE PRESIDENT FOR RESEARCH
No later than the time of application Financial Disclosure Less than a year old COI Training OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Who is an investigator? OFFICE OF THE VICE PRESIDENT FOR RESEARCH
NIH Definition of Investigator OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Key Personnel Principal Investigator Co-Investigator Consultants Whoever is listed as Key Personnel OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Budget Justification responsible in charge design conducting analyzing oversight supervise OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grant Submission OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grant Awarded OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grants Listing UConn Employees (only) OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Non – PHS Award OFFICE OF THE VICE PRESIDENT FOR RESEARCH
PHS Award OFFICE OF THE VICE PRESIDENT FOR RESEARCH
PHS Award OFFICE OF THE VICE PRESIDENT FOR RESEARCH
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. OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grants Listing UConn Employees (only) OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
2 Hours delay OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Where’s my worm! OFFICE OF THE VICE PRESIDENT FOR RESEARCH
. OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grants Listing Non-UConn Employees (whether paid or unpaid) (Sub award) OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Sub Awardee • Has a PHS-Compliant FCOI Policy • Subcontract indicates that Institution's Policy is being followed • No further action taken by COI office OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grants Listing Non-UConn Employees (whether paid or unpaid) (Sub award) OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Sub awardee • Doesn’t have a PHS-compliant FCOI • Sub awardee chooses to follow UConn Policy OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH
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) OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Project design Project Conduct / implementation Required reporting of the research Publications or Presentations OFFICE OF THE VICE PRESIDENT FOR RESEARCH
COI Office • COI staff work with SPS and PI to contact all External KSPs (and any other External people meeting definition of Investigator) to complete External Investigator Disclosure Form • and provide evidence of FCOI training, if training is not incorporated into the form OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Provide evidence of FCOI training OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grants Listing Non-UConn Employees (whether paid or unpaid) (non- sub award) OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Same Scenario • PI complete FCOI Certification Form . • PI ask them to complete External Investigator Disclosure Form. • Proof of COI training. OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH
UConn Health employees OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grants Listing UConn Health Employees (whether paid or unpaid) (Sub awardees) OFFICE OF THE VICE PRESIDENT FOR RESEARCH
No further action taken by Storrs SPS office (subcontract indicates Uconn Health PHS policy is being followed) UConn Health SPS office contacts COI staff OFFICE OF THE VICE PRESIDENT FOR RESEARCH
Grants Listing UConn Health Employees (whether paid or unpaid) (Sub award) OFFICE OF THE VICE PRESIDENT FOR RESEARCH
• 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. OFFICE OF THE VICE PRESIDENT FOR RESEARCH OFFICE OF THE VICE PRESIDENT FOR RESEARCH
OFFICE OF THE VICE PRESIDENT FOR RESEARCH
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