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National Institutes of Health Financial Conflict of Interest

Investigators who are part of a US National Institutes of Health (NIH) study have additional financial conflict of interest (FCOI) disclosure and training requirements.
This requirement is mandated under the 2011 Public Health Service regulations (PDF) and is in addition to the requirements for submitting an annual PHSA conflict of interest declaration form.

National Institutes of Health (NIH) Investigators 

Pursuant to the 2011 US Public Health Service regulations, an investigator is a Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the NIH, or proposals for NIH funding. This definition aligns with PHSA's Research Conflict of Interest Policy definition of "Researcher", and includes the Investigator’s spouse and dependent children.

If you are an investigator on a NIH proposal or project at PHSA, you need to:

  1. Complete two online training courses
  2. Submit your disclosure through the NIH FCOI section of the online PHSA Conflict of Interest Declaration website
    • Training certificates from Step 1 must be uploaded into the PHSA COI Declaration Form and renewed every 4 years.
  3. Understand that the NIH regulations require PHSA to report your conflicts of interest to the NIH and permit the public to ask for details of your disclosure and management plan 
The BC Cancer Office of Research Facilitation (ORF) will not sign off on any NIH proposal until all list investigators have completed the items above.

Disclosure & Review

NIH regulations require Investigators to disclose any significant financial interests to PHSA. For your convenience, this disclosure is built into the PHSA Conflict of Interest Declaration Form. If you are a PHSA NIH investigator, complete the NIH FCOI section of the Conflict of Interest Declaration Form and you will be in compliance with both NIH regulations and PHSA's Research Conflict of Interest Policy.

As required by NIH regulations, PHSA Institutional Officials (i.e., PHSA Conflict of Interest Declaration reviewers) review all NIH investigators' conflict of interest forms. If the Institutional Office finds that you have a conflict, you will need to develop a management plan to submit to the NIH.

Management Plans
In order to ensure that the necessary information is sent to the NIH using the electronic Research Administration Commons, you should use the PHSA NIH Financial Conflict of Interest Management Plan Template (DOCX). Remember, all information given to the NIH is subject to freedom of information requests.

Per project, you need to include the following information:

  • Role and principle duties you have on the research project
  • Conditions of management plan (e.g. eliminate equity, inform colleagues, etc.)
  • How this manages the conflict
  • How the plan will be monitored
  • Other relevant information

Reporting
PHSA must report to the NIH any identified financial conflicts of interests. British Columbia's legislation, Freedom of Information and Protection of Privacy Act (FIPPA), requires that PHSA has consent from the person with the financial conflict of interest (investigator, spouse and/or dependent child) to send this information outside of Canada to the NIH.   

If there is a financial conflict of interest:

  1. Sign the NIH Financial Conflict of Interest Consent Form (PDF): Whoever has the financial conflict of interest must sign (you, your spouse and/or dependent child). If you have used the management plan template and you have the financial conflict of interest, you only need to sign the included consent form to complete the process. Parents/guardians/substitute decision-makers (legally authorized representatives) can sign on behalf of a  dependent child if the child is under the age of 19.
  2. Email the signed form to researchadministration@phsa.ca.
  3. Renew your consent if the financial conflict of interest changes, or every three years if the financial conflict of interest is still in effect.
The consent allows:

  • PHSA to report to the National Institutes of Health your financial conflict of interest and management plan
  • PHSA to disclose your financial conflict of interest if requested by a member of the public. Note: your spouse's and/or dependent child's name will not be included in the public disclosure. The financial conflict of interest will only be linked to your name.
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SOURCE: National Institutes of Health Financial Conflict of Interest ( )
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