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 investigators

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

Complete two online training courses (NIH FCOI Regulation training tutorial and PHSA Institutional NIH FCOI training tutorial (PDF));
Submit your disclosure through the NIH FCOI section of the online PHSA Conflict of Interest declaration; and
Understand that the NIH regulations require PHSA to report your COIs 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.

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

NIH 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 PHSA NIH investigator, simply complete that section and you will be in compliance with both the NIH regulations and the PHSA Research Conflict of Interest Policy. Read PHSA's instructions for submitting financial conflict of interest disclosures (PDF).

As required by NIH regulations, the PHSA Institutional Official (IO) reviews 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 (Word). 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

View a sample NIH Financial Conflict of Interest Management Plan (PDF).

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:

Sign the NIH 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.
Email the signed form to researchadministration@phsa.ca.
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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National Institutes of Health Financial Conflict of Interest

National Institutes of Health investigators

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