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The protection of human subjects in research is of the utmost importance to Hektoen Institute and all researchers who actively partner with Hektoen under the terms and conditions of sponsored investigations. While Hektoen and peer research institutions have instituted multiple, complementary policies to ensure the safety of study subjects and to preserve the integrity of the research itself, in an increasingly complex research environment, a new policy is required to additionally assure that such research is not compromised by financial interests.
In accord with the rule issued by the U.S. Department of Health and Human Services that amends PHS regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), Hektoen herein revises the institutional Financial Conflict of Interest Policy (FCOI) policy to protect against real or apparent biases in study design, data collection and analysis, adverse event reporting, or the presentation and publication of research findings. As an institution applying for or receiving federal funding from a grant or cooperative agreement, Hektoen must be in compliance with all of the revised regulatory requirements; and, as described in 42 CFR Part 50.604(a), Hektoen will make the Institution’s Financial Conflict of Interest policy publicly accessible via the Hektoen Institute website at www.hektoen.org.
Hektoen upholds HHS requirements for reporting as follows: full prior reporting of each covered individual’s significant financial interests that would reasonably appear to affect research related decisions on an annual basis; updated reporting of any relevant change in financial circumstances, and review of any significant financial interests in a research project by the FCOI Committee prior to final IRB approval of the research. Hektoen promotes these reporting standards and introduces new organizational structure and procedure to assure that financial conflict of interest is effectively mitigated and that the risk of bias in research is minimized. Announcements about training for Investigators are forthcoming, and will be available via this website.