Financial Conflict of Interest (FCOI) at Seattle Children's
In an article in the November 2007 edition of interaction, James B. Hendricks, PhD, president of Seattle Children's Hospital Research Institute, announced that the institute’s Financial Conflict of Interest policy had been modified. The first two paragraphs of that article follow:
The Code of Federal Regulations requires that institutions seeking National Institutes of Health (NIH) support have a written administrative process to identify and manage Financial Conflicts of Interest (FCOI). The NIH has a longstanding interest in financial conflicts of interest, and established a Targeted Site Review (TSR) program to examine grantee institutions’ implementation of the FCOI regulation. Late last year, Children’s Hospital was visited by the TSR. The TSR team met with research leadership and several investigators during their one-day site review. At the end of the day, the site review team identified two areas of noncompliance and provided several recommendations for improving our FCOI program (see Figure 1).
In response to the issues raised in the TSR, I have modified the Research Institute’s Financial Conflict of Interest Policy. You should familiarize yourself with this policy, which goes into effect immediately.
(You can continue reading this article on page 2 of the November 2007 edition of interaction.)
The administrator of the Financial Conflict of Interest program is Pam Joy, director, Office of Research Compliance and Education (ORCE).
The Federal Regulations (42 CFR 50 Subpart F)
Children’s Financial Conflict of Interest policy has been developed to address and comply with the specific federal agency requirements defined in Title 42 Code of Federal Regulations (CFR) Part 50, Subpart F, “Responsibilities of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought.”
FCOI terms and definitions
Investigator
For purposes of FCOI, “investigator” means any person (faculty, technicians, technologists, postdoctoral fellow, etc.) who shares responsibility for the design, conduct or reporting of the results of research activities. This includes research staff (CRAs, RCs, research nurses, data specialists, etc.).
Financial Conflict of Interest (FCOI)
FCOI is a divergence between an individual’s financial interest and that individual’s hospital obligations, such that an independent observer might reasonably question whether the performance of the hospital obligations are adversely affected (or have the potential to be) by considerations of personal gain, and in the case of research, includes the existence of a significant financial interest of an investigator that could directly and significantly affect the design, conduct or reporting of the research.
Financial Interest
Anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).
Significant Financial Interest (SFI)
For a clinical trial, any financial interest is SFI.
For human subjects research other than a clinical trial, SFI is (i) any financial interest exceeding $5,000 in value, (ii) any equity interest, or (iii) any intellectual property interest.
For all research other than human subjects research, SFI is (i) any financial interest (including a compensation interest, equity interest and an intellectual property interest) exceeding $10,000 in value, or (ii) any equity interest representing more than a 5% ownership in any single entity.
These and other FCOI terms are officially defined in policy RIA-03.
Helpful Links
Policy RIA-03, Financial Conflict of Interest (PDF 577KB)
Significant Financial Interest Disclosure Form (DOC 62KB)
Fundamentals of Financial Conflict of Interest (FCOI) Part I (PDF 347KB)
FCOI FAQs (PDF 22KB)