Applies to: (examples; Faculty,Staff, Students, etc)
Faculty , Staff , Students , Contractors_Vendors
Faculty , Staff , Students , Contractors_Vendors
The goal of this policy is to assure that the objectivity and integrity of the researcher, the University, and academic research, training, or other activities are not compromised or perceived to be compromised by considerations of personal gain or financial benefit. It is not the intention of this policy to ban all potential financial conflicts of interest, but rather to develop strategies to effectively and successfully manage financial conflicts of interest.
This policy applies to all University faculty, students, and any other individual who is independently responsible for the design, conduct, or reporting of research at UHSP, which includes, but may not be limited to, a principal investigator, project director, co-investigator and key personnel. The principal investigator/project director is responsible for making the initial determination of any other individuals who meet this definition.
Term |
Definition |
Research Integrity and Safety Committee (RISC) |
The committee responsible for assessment of personal financial interests reported by Covered Individuals |
Covered Individual |
See Applies To section above |
Entity |
Includes public or non-publicly traded companies/non-profit organizations |
Equity or Debt Instrument |
Includes, but is not limited to, preferred and common stock, stock options, warrants, bonds, and notes |
Family |
A covered individual’s spouse and/or dependent children |
Financial Conflict of Interest (FCOI) |
A financial conflict of interest exists when it is reasonably determined that a personal or “family” (see above) financial interest could directly and significantly affect the design, conduct, or reporting of research |
Financial Interest |
Anything of monetary value, whether or not the value is readily ascertainable |
Human Subjects Research |
Any investigation or organized activity, regardless of funding source, involving patient oriented research, behavioral research, or epidemiological, outcomes, or health services research, which requires approval by the University of Health Sciences and Pharmacy in St. Louis Institutional Review Board
|
Institutional responsibilities |
An individual's professional duties and responsibilities on behalf of the University. These may include, but are not limited to activities such as research or other scholarly inquiry, education, professional practices, clinical activities, administration, institutional committee membership, and service on panels such as internal review boards and data and safety monitoring boards
|
Manage |
Taking action(s) to address a FCOI, to ensure, that the design, conduct, and reporting of research will be free from bias
|
Public Health Service (PHS) |
Federal agencies designated as components of the US Public Health Service with the Department of Health and Human Services (e.g. Center for Disease Control & Prevention, Food & Drug Administration, National Institutes of Health, The Agency for Healthcare Research & Quality) |
Research |
a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This includes basic, behavioral, and social sciences research and encompasses basic and applied research (e.g. a published article, book or book chapter) and product development research (e.g. diagnostic test or drug) |
Research Activities |
any research, including clinical research, materials evaluations, or general research projects that may be unfunded or performed under an agreement or grant with an entity in which the entity provides full or partial funding of the project |
All Covered Individuals are required to complete or update and submit to the Director of Research Administration (DRA) as the designee of the Research Integrity and Safety Committee (RISC) a financial disclosure statement that: (i) identifies all research in which the covered individual is engaged at the time of the disclosure, and (ii) discloses all personal financial interests and those of their family, regardless of value, that appear to be related to the covered individual’s institutional responsibilities (See Form, Financial Conflicts of Interest Disclosure Statement). However, only certain personal financial interests will be deemed material in determining whether a financial conflict of interest (FCOI) exists. Individuals involved in Public Health Service (PHS) funded research must disclose payment of travel related expenses paid for by outside parties other than government agencies, higher education institutions (including affiliated academic or research institutes). (See Form, PHS Travel Disclosure Statement). A Covered Individual should resolve any doubt about whether research or a personal financial interest should be disclosed, in favor of disclosure. The RISC will work with Covered Individuals to effectively manage and monitor material FCOIs.
Procedures
Position/Office/Department |
Responsibility |
Director of Research Administration |
Coordinate implementation of this policy, provide administrative support to the RISC |
Vice President of Research |
Consult with deans and administrators on the application and interpretation of this policy |
Appendix A, Financial Conflict of Interest Guideline
Form A, Financial Conflicts of Interest Disclosure Statement
Form B, Public Health Service Travel Disclosure
Name |
Contact Information |
Brandi Clements, Director of Research Administration |
Brandi.Clements@uhsp.edu, 314-446-8482 |
Vice President of Research |
|
Appendix A, Financial Conflict of Interest Guideline
Form A, Financial Conflicts of Interest Disclosure Statement
Form B, Public Health Service Travel Disclosure