Financial Conflict of Interest Disclosures

This page outlines the compliance requirements for research conducted with funding from any agency of US Public Health Services (PHS), including National Institutes of Health (NIH), and any other research funding sources which have adopted US PHS Financial Conflict of Interest (FCOI) Regulations (42 C.F.R. Part 50 and 45 C.F.R. Part 94). In this Procedure, these various sources of research funding are collectively referred to as “PHS”.

These procedures apply to anyone involved in NIH (and more broadly PHS) funded research, including principal investigators, co-investigators, collaborators, and institutions receiving this funding.

These regulations require that participating researchers be trained in the regulations and disclose to the University of Alberta (U ofA) their significant financial interests.

The University of Alberta is required to do the following:

Review disclosed significant financial interests to determine whether they constitute FCOIs.

• Manage any FCOIs and report them to the sponsoring agency
• Monitor and enforce researcher compliance with the Regulations
• Maintain records and make certain information publicly accessible

By adhering to the FCOI policy, researchers and institutions uphold the highest standards of ethics and maintain public trust in scientific advancements.

Requirements

For any PHS/NIH funded research, before submission of a grant application, on annual grant renewal, and within an update on awarded grant, the University of Alberta PI must:

• Provide a List of Investigators . This list must include all U of A Investigators, as well as any Subrecipient Investigators involved with the study;
• Provide evidence of training: The UA PI and all Investigators must complete the NIH FCOI tutorial . The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health to provide education training on what constitutes a financial conflict of interest. It provides guidance on the proper policies and practices regarding these issues and is required for anyone involved This tutorial includes a quiz at the end which when successfully passed produces a certificate which you must print off and submit via nih@ualberta.ca.
• Review the University’s Policy on Financial Conflict of Interest for National Institutes of Health (NIH) and Other Applicable Research Funding Sources Reporting and Assessment Procedure .
• Submit an FCOI Disclosure form: using the Alberta Research Information Services (ARISE) . Before your application can be submitted all key personnel must submit and receive approval for an FCOI disclosure.
  • Note: If you have never used this FCOI module before evidence of training must be submitted to nih@ualberta.ca before you can access ARISE for this purpose.

For questions about these requirements, contact nih@ualberta.ca.