Conflict of Interest Flashcards
What is a Financial Conflict of Interest?
A conflict that exists when the Association reasonably determines that an Investigator’s Significant Financial Interest (SFI) is related to a research project and could directly and significantly affect the design, conduct, or reporting of this research.
Applies to PHS-funded research.
What is PHS-funded research?
PHS funded research means grants and cooperative agreements funded by PHS Awarding Components.
The following agencies are PHS Awarding Components – collectively referred to as “PHS agencies,” “PHS funding components,” or “PHS funders” –
● National Institutes of Health
● Centers for Disease Control and Prevention
● Indian Health Service
● Food and Drug Administration
● Agency for Toxic Substances and Disease Registry
● Health Resources and Services Administration
● Agency for Healthcare Research and Quality Care
● Substance Abuse and Mental Health Services Administration
What is a Significant Financial Interest (SFI)?
A SFI is defined as a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) received from a single external entity in the 12 months prior to disclosure:
● Remuneration exceeding $5,000
● Any equity interest in a non-publicly traded entity, and equity interests in publicly traded entities exceeding a value of $5,000
● Intellectual property interests exceeding $5,000
● Sponsored or reimbursed travel exceeding $5,000
FCOI Sample Quest -
I’m a PHS-Investigator and I received $5,000 in compensation for serving on the Scientific Advisory Board of a local biotechnology company, I anticipate receiving an additional $2,000 for these services in the next few months—am I required to disclose this compensation?
Yes, compensation exceeding $5,000 received, or anticipated to be received, within a twelve (12) month period requires disclosure under GIM 10.
FCOI Sample Quest - I’m a Non-PHS Investigator and I received $6,000 in compensation for serving on an Engineering Advisory Board for an Industrial Engineering firm—am I required to disclose this compensation?
If you advised on products or services you are evaluating in the course of your University research, or you believe the work you are doing on the Advisory Board is related to any of your University research, you must disclose this compensation and be put on a Conflict Management Plan to mitigate any concerns which may arise under Washington State Ethics laws.
FCOI Sample Quest - I am working with CoMotion to patent technology that I developed in my University laboratory. Do I need to disclose this as an Intellectual Property interest? What if I’m on the Board of Directors for a Company that wishes to license my technology?
No. Intellectual Property, and any associated royalties or payments that are managed by the UW are considered to fall within your University responsibilities and compensation. Disclosures of Significant Financial Interests in private companies should be submitted by PHS-Investigators regardless of the entities’ interest in University technology. All Innovators with SFI in an entity licensing technology for which they are a contributor will be issued a Conflict Management Plan—CoMotion and the Office of Research work together closely at time of Option or License to ensure compliance with applicable policies.
FCOI Sample Quest - I am receiving money from Industry, both for my salary and for expenses to conduct research related to one of their products or services, should I disclose this as SFI?
No. Any sponsored-research managed by the University, that is—it was routed through an eGC1 and negotiated by the Office of Sponsored Programs—is considered to fall within the scope of your University responsibilities and compensation. If the entity sponsoring University research is also paying you directly for other services, that compensation may require disclosure as outlined by GIM 10.
4 ways conflicts of interest threaten research objectivity
- Influencing study design to favor outcomes
- Restricting publications
- Avoiding adverse events reporting
- Distorting interpretations of data
PHS “Promoting Objectivity in Research Regulations”
- Applies to research that NIH sponsors and to all organizations that apply for NIH funding
- Requires that investigators must be trained every four years on conflicts of interest AND Disclose their significant financial interest that reasonably appear related to their institutional responsibilities annually AND within 30 days of acquiring a new significant interest (SFI)
Significant Financial Interest Disclosures
o must disclose significant financial interests in the context of yourself, your spouse, and dependent children living in your household (i.e., your “immediate family”).
o For a single publicly traded entity, payments and equity value (determined through public prices) must be greater than $5,000 in total
o For a single non-publicly traded entity, payments must be greater than $5,000 or any equity interest
SFI Disclosures - Payments can include…
Salary
Payments for services not otherwise identified as salary (e.g., consulting fees, honoraria)
Intellectual property payments
Travel reimbursements or payments on one’s behalf
Income from investment vehicles if you directly control the investment decisions made in these vehicles
SFI Disclosures - Equity interests can include…
Stock
Stock option
Other ownership interest
Exempt from SFI Disclosures…
> Payments or equity unrelated to your institutional responsibilities
> If you receive ≤$5,000 in payments from a single entity
> Income from home institution
> Income from a U.S. federal, state, or local government agency; a U.S. institution of higher education or research institute affiliated with a U.S. institution of higher education; or a U.S. academic teaching hospital, medical center
> Income from investment vehicles, such as mutual funds and retirement accounts, if you do not directly control the investment decisions made in these vehicles
Export Control Relevant Regulations
- Export Administration Regulations (EAR)
- Governed by Dept of Commerce
- Applies to items that fall under export control laws
- Fundamental Research Exclusion (FRE) - research in science, engineering or mathematics where results are shared broadly and researchers have not accepted restrictions can remain unrestricted. Allows research to be freely published and shared with foreign nationals. - International Traffic in Arms Regulations (ITAR)
- Governed by Dept of State
- Requires that all manufacturers, exporters, and brokers of defense articles, related technical data and defense services be registered with the State Dept. - Office of Foreign Assets Controls (OFAC)
- Governed by Dept of Treasury
- Administers and enforces economic sanctions programs
Intellectual Property - What is it, What rights does it confer?
> IP = legal rights that result from intellectual activities in the industrial, scientific, literary and artistic fields
> An IP right entitles a person an exclusiveness for their own innovative idea or an invention which they want to protect for a specified time period.
