Financial Conflict of Interest Disclosure



NEWS & UPDATES

Submitting your Annual FCOI Disclosure

Federal regulations require PSU to have Financial Conflict of Interest (FCOI) Disclosures on file for each principal investigator and their designated senior research staff. To complete your FCOI disclosure, follow this link

Contacts

Financial Conflict of Interest questions, requests and submissions should be directed by email to fcoi@pdx.edu.

Other Conflict of Interest contacts are listed here.

PSU FCOI Policy

PSU's Financial Conflict of Interest Policy 

FCOI Determination Procedures

As relationships between Portland State researchers and community business partners continue to grow, it is important that PSU maintain high research integrity standards. Therefore, any potential for conflict of interest--where an individual's financial or personal considerations may affect or appear to affect their PSU activities related to externally sponsored programs--is disclosed, reviewed, and managed in accordance with state and federal regulations and PSU policy.

The institutional annual disclosure process requires Principal Investigators and other individuals who meet the definition of an "investigator" under the Financial Conflict of Interests regulations, (responsible for the design, conduct or reporting of research), and who are included on submitted proposals to PHS or NSF or who have externally funded research projects to complete a Financial Conflict of Interest disclosure. This disclosure must be completed no later than the day of submittal for PHS and NSF proposals and during the annual disclosure process for all other externally funded projects.  Updated disclosures must be completed within 30 days for significant changes such as new significant financial interests.

What is a Financial Conflict of Interest?

The NIH (National Institutes of Health) requires that research institutions uphold "standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest."

A financial conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain.  Potential and actual financial conflicts of interest depend on the situation and both must be managed accordingly.

When will I need to submit my disclosure?

  • Any new researchers are required to submit an FCOI disclosure at the time of submission of proposals for federal funding to PHS or NSF.

  • All existing researchers are required to complete the annual FCOI disclosure, (starts October 15 and ends December 15 of each year).

  • All researchers are required to submit an updated FCOI disclosure immediately as significant changes occur, such as the obtaining of a new significant financial interest.

I am applying for and/or receiving PHS funding. How can I satisfy my FCOI training requirement?

All Principal Investigators and all others designated as an "investigator" by the Principal Investigator will need to take the federal tutorial. This training will be required of all new and existing federally-funded researchers, and must be re-taken every four years.

Where can I get help with my online disclosure?

If you have trouble with the online disclosure system, try one of the following options:

  • Be sure to read and follow the instructions at the beginning of the survey
  • Close the survey and browser window and try back after a few hours
  • Clear your computer's cache (also called "cookies") and start over
  • Attempt to take the survey in a different type of web browser (Safari, Firefox, etc.)
  • Attempt to take the survey using a different computer or operating system

If none of these work, please contact us at fcoi@pdx.edu and describe the problem in detail. We will do our best to troubleshoot the problem with you.

I already know that I will disclose a Significant Financial Interest (SFI) this year. What information do I need to have before I start the online survey?

If you know that you will be disclosing an entity with which you have a significant financial interest, you will need to report the following information, so be sure to have it ready.

For FCOI disclosures:

  • Name, type, and purpose of the entity, corporation, business, etc.as well as the nature of you/your family's relationship with the entity
  • Specific dollar amounts of you/your family's financial interests in the entity (number of stock shares, total compensation, etc.)
  • If relevant, information about intellectual property rights or royalty fees
  • If relevant, information about any PSU student employees also associated with the entity
  • If relevant, information about any PSU facilities or space utilized by/for the entity

For PHS & NSF funded research:

  • Ensure you are up to date on your required FCOI training
  • If relevant, any travel information that you need to disclose
  • If relevant, the names, email addresses, and phone numbers of all investigators for your PHS-funded research, which includes anyone responsible for the design, conduct, or reporting of the research.
You will have the option to upload .doc or .pdf files for the travel information and names of investigators, so those may be prepared in advance.

If you have PHS funding, we will need to know whether you also have funding from NSF, as regulations require us to communicate with NSF in the event of an unsatisfactorily-manged FCOI.

Management Plans

If it is determined that your significant financial interests result in an FCOI, you may need a management plan.  Typical management plans involve agreements about facilities, students, human subjects research, institutional vs. private work activities, committee/community service roles, and any other relevant topics. You can review our management plan template here. Please contact us if you have questions. 

What do all these acronyms stand for?

FCOI: Financial Conflict of Interest
NIH: National Institutes of Health
NSF: National Science Foundation
ORI: Office of Research Integrity
PHS: Public Health Service
PI: Principal Investigator
PIAF: Proposal Internal Approval Form
RSP: Research and Strategic Partnerships
SBIR/STTR: Small Business Innovation Research/Small Business Technology Transfer
SFI: Significant Financial Interest 

What funding organizations require adherence to PHS FCOI regulations?

According to the U.S. DHHS Organizational Chart and the Catalog of Federal Domestic Assistance, the following organizations require compliance with PHS regulations. (Please note that this list is not exhaustive.)

U.S. Public Health Services Agencies include:

  • Agency for Healthcare Research and Quality (AHRQ)
  • Centers for Disease Control (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA, including
    • Office of Rural Health Policy
    • Office of Women's Health
  • Indian Health Services (IHS)
  • National Institutes of Health (NIH), including
    • National Cancer Institute
    • National Institute on Aging
    • National Institute on Alcohol Abuse and Alcoholism
    • National Institute of Child Health and Human Development
    • National Institute on Drug Abuse
    • National Institute on Mental Health
    • National Institute of Environmental Health Sciences
  • Office of Global Affairs (OGA)
  • Office of the Assistant Secretary for Health, including
    • Office of Adolescent Health (OAH)
    • Office of Disease Prevention and Health Promotion (ODPHP)
    • Office of HIV/AIDS and Infectious Disease Policy (OHAIDP)
    • Office of Minority Health (OMH)
    • Office of Population Affairs (OPA)
    • Office of Research Integrity (ORI)
    • Office on Women’s Health (OWH)
  • Office of the Assistant Secretary for Preparedness and Response, including
    • Office of the Biomedical Advanced Research and Development Authority (BARDA)
    • Office of Emergency Management (OEM)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Non‐PHS organizations which have adopted the PHS regulations:

  • Alliance for Lupus Research
  • American Cancer Society
  • American Heart Association
  • Arthritis Foundation
  • California Institute for Regenerative Medicine (CIRM)
  • Susan G. Komen for the Cure
Because there may be changes, if the agency you are interested in is not listed above and you are unsure if it is a PHS agency, check with your funding source or the Office of Research Integrity.

2012 Revised FCOI regulations

Beginning August 24th, 2012, federal PHS (Public Health Service) regulations regarding financial conflict of interest underwent significant changes. As a recipient of federal funding, Portland State University was required to comply with these new disclosure guidelines.

The major changes to the previous guidelines included:

  • financial disclosure thresholds were lowered from $10,000 to $5,000

  • rules about disclosure of sponsored and/or reimbursed travel became more stringent for those applying for or receiving PHS funding

  • new training requirements for research personnel were enforced for those applying for or receiving PHS funding

  • rules regarding public accessibility to FCOI disclosures changed for those applying for or receiving PHS funding.

 

 

 
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