Financial Conflict of Interest

New Regulation on Financial Conflict of Interest Requires On-line Education for Researchers

Carilion researchers who conduct studies with external funding will need to take online education modules on financial conflict of interest beginning August 24, 2012. The education is one of the new requirements of a revised federal regulation. A completed FCOI Questionnaire is required for ALL persons identified on the research team.

The revised regulation, issued by the Department of Health and Human Services, applies to institutions receiving Public Health Service funds to conduct research, including basic research, applied research and product development such as a diagnostic test or drug. Most institutions, including Carilion, have chosen to apply the standards of the revised regulation to all funded research, whether or not there is support from the PHS.

The revised regulation is designed to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of funded research will be free from bias resulting from investigator financial conflicts of interest.

To meet the education requirement under the new regulation, Carilion investigators will be prompted in the process of submitting a research application to take an on-line “mini-course” that can be found on the CITI website. This website is used currently by Carilion investigators to fulfill research ethics training requirements. The mini-course is required to be taken only once every four years for investigators conducting externally-funded research.

Under the new regulation, the term “investigator” means not only the principal investigator for a research project but also any other person on the research team who has any responsibility for the design, conduct or reporting of the project. Therefore, the on-line conflict of interest modules also must be taken by study coordinators, co-investigators, data analysts and others who take part in externally-funded research.

One mini-course module specifically addresses the process used at Carilion to comply with the new regulation. This process includes the use of a revised financial conflict of interest questionnaire which should be completed as part of the research application process. Investigators will be prompted to complete this questionnaire as part of the application process with the Office of Sponsored Projects. The questionnaire can be found on the OSP web site or the Carilion IRB web site. Please view the Financial Conflict of Interest in Research policy.

If you have questions about the new on-line education mini-course or Carilion’s policy on financial conflicts of interest in research, please call or email Charles Hite, Director of Biomedical and Research Ethics, at 981-8096 or cahite@carilionclinic.org.