MANAGEMENT OF CONFLICT OF INTEREST FOR PARTICIPATION IN RESEARCH PROJECTS FUNDED BY THE US PUBLIC HEALTH SERVICE

 

Significant financial interest (SFI) disclosure related to projects funded by the US Public Health Service

Significant financial interest (SFI) disclosure is mandatory for each UL employee, who plans to participate in or is already participating in research funded by Public Health Service (PHS) and the US Department of Health and Human Services (HHS). Each UL employee is required to disclose his/her Significant Financial Interests (SFI) and SFI of their close relatives.

Prior to embarking on research associated with any kind of funding from the PHS, UL employees have to:

  • become acquainted with the Policy on the management of financial conflict of interest in research at the University of Ljubljana funded by the Public Health Services of the United States of America (PUFNIR UL),
  • sign an employee statement on the Form for disclosure of significant financial interests for PHS-funded research at the latest upon the submission of the UL application for funding of research by the PHS, and
  • undergo SFI training.

 

UL Rules on the management of financial conflict of interest

The University of Ljubljana developed the Policy on the management of financial conflict of interest in research at the University of Ljubljana founded by the Public Health Services of the United States of America (PUFNIR UL), which include detailed definitions of significant financial interests and other rules that investigators must become acquainted with.

·       Policy on the management of financial conflict of interest in research at the University of Ljubljana funded by the Public Health Services of the United States of America (PUFNIR UL)

The present PUFNIR UL Rules serve to supplement the Rules on Avoidance of Conflict of Interest and Work Outside UL (PINI UL) with the specific requirements of the Public Health Services (PHS) of the United States of America, which funds research. These requirements proceed from regulation 42 CFR 50, Subpart F “Promoting objectivity in research”.

 

Signing an employee statement on the Form for disclosure of significant financial interests for PHS-funded research

Following the US and PUFNIR UL regulations, the provision of information on this form is mandatory for all leading researchers as well as for other UL staff and associates (e.g. Postdoctoral candidates, researchers, physicians) who are responsible or are involved in design, implementation or reporting on PHS-funded research:

·       Form for disclosure of significant financial interests for PHS-funded research

The UL Faculty shall provide the form to each employee who plans to apply for or participate in PHS-funded research . The employee will submit the Form to the dean of the Faculty. In the event the dean identifies an FCOI, he/she sends the completed and signed form to e-mail: .

 

Mandatory FCOI Training for investigators

Before embarking on research associated with any kind of funding from the PHS each employee shall be bound to undergo FCOI training on the website of NIH, the National Institute of Health. Training should be renewed at least once every four years, and immediately upon the onset of any of the following circumstances:

  1.      UL amends the PUFNIR UL or procedures, such that this affects the requirements on investigators;
  2.      an investigator is newly employed at UL or collaborates in some other way with UL; or
  3.      UL determines that an investigator is not acting in compliance with the PUFNIR-UL or the FCOI management plan.

One can access the training on the NIH website (on the right side of the website) at the following link: https://grants.nih.gov/grants/policy/coi/index.htm or https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html

Slika FCOI

 

NIH Office of Extramural Research Conflict of Interest

The NIH Office of Extramural Research Conflict of Interest Website contains helpful information and resources about the financial conflict of interest (FCOI) regulations. See: https://grants.nih.gov/grants/policy/coi/coi_faqs.htm

 

Public accessibility

Prior to the UL’s expenditure of any funds under a PHS funded research project, UL shall ensure public accessibility, via written response within five business days of a request, of information concerning any SFI disclosed to UL that meets the following three criteria:

  •     The SFI was disclosed and is still held by the senior/key personnel;
  •     UL determines that the SFI is related to the PHS funded research; and
  •     UL determines that the SFI is a FCOI.

 The information that UL makes available via written response shall include, at a minimum, the following: 

  1.      Investigator’s name;
  2.      Investigator’s title and role with respect to the research project; 
  3.      Name of the entity in which the SFI is held;  
  4.      Nature of the SFI; and   
  5.      Approximate dollar value of the SFI (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000  by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 

 

For the above information individuals can send in their written request to Bruna Korent via .