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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.

The information here applies to NIH investigators at BC Cancer. If you are an NIH Investigator elsewhere at PHSA, you will be covered by the NIH process at your affiliated university: UBC, SFU or UVic

National Institutes of Health investigators at BC Cancer

If you are an investigator on an NIH proposal or project at BC Cancer, you need to:

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.

Training

Two online training tutorials must be completed by each NIH Investigator before engaging in NIH-funded research:

Training certificates need to be uploaded into the PHSA COI Declaration form. Every four years, an automated email will be sent to you reminding you to renew your training.
Disclosure & review
National Institutes of Health regulations require the disclosure to PHSA of any significant financial interests held by an investigator. For your convenience, this disclosure is built into the PHSA Conflict of Interest Declaration website as an additional section. If you are a BC Cancer National Institutes of Health investigator, simply complete that section and you will be in compliance with both the National Institutes of Health regulations and the PHSA Research Conflict of Interest Policy. Read PHSA's instructions for submitting financial conflict of interest disclosures (PDF).

As required by National Institutes of Health regulations, the PHSA Institutional Official (IO) reviews all BC Cancer National Institutes of Health 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 National Institutes of Health. 
Management plans
In order to ensure that the necessary information is sent to the National Institutes of Health using the eRA Commons, you should use the BC Cancer/PHSA National Institutes of Health Financial Conflict of Interest Management Plan Template (PDF). Remember, all information given to the National Institutes of Health 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 National Institutes of Health any identified financial conflicts of interests (FCOIs). 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 National Institutes of Health.   

If there is a financial conflict of interest:

  1. Sign the National Institutes of Health Financial Conflict of Interest Consent Form (PDF): Whoever has the financial conflict of interest must sign (you, your spouse 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 BCCACOI@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:

  • BC Cancer/PHSA to report to the National Institutes of Health your financial conflict of interest and management plan
  • BC Cancer/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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