Children’s Financial Conflicts of Interest (FCOI) in Research Policy
Fundamental to Children’s contributions to biomedical science is the preservation of research integrity―both in our studies and in our researchers. Towards this endeavor, the reporting of financial conflicts of interest by Children’s study investigators is essential. Without conflict transparency, we risk perceived scientific bias, compromising our integrity at the detriment of Children’s research, our patients, and the entire scientific community.
Financial conflicts, by themselves, are not necessarily discouraged or always problematic. Even though financial interest could potentially affect professional judgment, conflicts are not considered a problem if identified prior to undertaking research, and managed appropriately. Only when a researcher fails to make known their potential conflicts to their respective institutions will these financial conflicts threaten our research integrity, and our ability to contribute to the scientific and medical community. As such, Children’s implements this Financial Conflicts of Interest in Research (FCOI) Policy to ensure that all research conducted at Children’s is performed with the utmost integrity.
Not only is Children’s committed to minimizing potential for scientific bias, but to remain compliant with laws and regulations governing research. In 1995, The Department of Health and Human Services (HHS) published regulations designed to promote objectivity in Public Health Service (PHS) funded research. These regulations required, in part, that study investigators disclose their financial conflicts of interest to their respective institutions. On August 25, 2011, HHS updated the 1995 rules expanding conflict of interest requirements (45 CFR Part 50, Subpart F & 45 CFR Part 94) ―taking effect on August 24, 2012. Children’s FCOI Policy incorporates these new requirements.
Under Children’s FCOI Policy, study investigators generally have three responsibilities. All individuals responsible for the design, conduct, or reporting of research must do the following:
- File Financial Disclosures: prior to each study and yearly, file Children’s FCOI Financial Disclosure Form with Children’s IRB.
- Attend Training: Initially, and every four years thereafter, take Children’s FCOI training.
- Compliance: Agree to abide by Children’s FCOI Policy, provided above.
Current Financial Conflicts of Interest
Striving towards research objectivity, Children’s makes public its investigators’ financial conflicts related to federal research grant. This web page will be periodically updated as conflicts arise, if any.
FCOI Contact Information