MaineHealth’s Financial Conflict of Interest in Research policy adheres to the Code of Federal Regulations 42 CFR §50 & 45 CFR §94 that promotes objectivity in research. These standards provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from investigator and institutional financial conflicts of interest regardless of whether the research study/project is funded or not.

Requirements for Research Key Personnel:

  • Must disclose Significant Financial Interest at least annually regardless of whether the project is funded or not.
  • Must complete mandatory COI training every 4 years.
  • Must disclose any new Significant Financial Interest within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance).

Key Personnel means the project director/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 PHS, or proposed for such funding, industry sponsored research, and non-funded research, and can include collaborators or consultants. All senior/key personnel on an NIH proposal or grant would qualify as Key Personnel.

Significant Financial Interest (SFI) is a financial interest in an entity that provides products or services relevant to the Key Personnel’s position or research activity (salary, consulting fees, honoraria, paid authorship, stocks, travel reimbursement, etc.) that exceeds a financial threshold as specified in the disclosure.

A Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research, industry-sponsored research, or non-funded research

Questions? Contact the Research Compliance Office (RCO) at hrppIRB@mainehealth.org

Research Compliance Office

hrppIRB@mainehealth.org
207.661.4474

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