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IRB Application: Materials for Primary Reviewer and Detailed Protocol/Grant Application Review
Section 6
FORM X. Externally-Funded
Research -- Research Financial Interest Disclosure Statement (RFIDS)
The IRB is responsible for ensuring that financial conflicts of interest in research, derived from significant financial relationships and the financial interests they create, do not affect the rights and welfare of human subjects in research. In order to enable the IRB to make this determination, certain information must be made available for review. The two ways the IRB collects this information is determined by whether or not the research is externally-funded.
1) Externally-Funded Research [Use Form X]
In accord with University of Kentucky (UK) conflict of interest policy, all investigators (defined as anyone responsible for the design, conduct or reporting of the research) conducting externally-funded research at the University of Kentucky are required to complete a Research Financial Interest Disclosure Statement (RFIDS) [PDF] and submit it to the Office of Sponsored Projects Administration (OSPA). If any Investigator answered "yes" to ANY of the questions on the RFIDS, the IRB requires submission of a copy of the RFIDS with the IRB application.
University regulations require that any significant financial interest be managed, reduced or eliminated prior to IRB approval. If the interest is not eliminated, a management plan must be proposed by the Investigator, reviewed by dean, center director or senior administrator, reviewed by the Research Conflict of Interest Committee and approved by the Vice President for Research.
The IRB cannot issue final IRB approval without reviewing the final approved management plan. OSPA will forward the final plan to the IRB.
If you are proposing externally-funded research, please mark the appropriate selection(s) in the space provided on the General Information Sheet [Section 1, Form A].
2) Non-Externally-Funded Research
The Principal Investigator (PI) conducting research that is not externally-funded is required to complete the IRB’s Research Financial Interest Disclosure Form – Form Y, and include it with the IRB application submission. The Principal Investigator of non-externally-funded research answers the questions on Form Y for himself/herself, as well as on behalf of study staff who are considered Investigator (defined as anyone responsible for the design, conduct or reporting of the research). If the PI answers “yes” to ANY of the questions in Section 1 of Form Y, Form X must also be completed. In addition, if other Investigators answer "yes" to any of the questions, they must fill out Form X. Completion of Form X will require a description of the safeguards that will be put in place to ensure that the significant financial interest does not inappropriately impact recruitment of subjects in the informed consent process.
If any of the eight questions in Section 1 of Form Y are answered "yes," the Office of Research Integrity (ORI) will notify OSPA that a PI/Investigator has disclosed a significant financial interest. The PI should contact OSPA in accord with UK's conflict of interest (COI) Administrative Regulation [PDF] and complete the UK COI process (see OSPA's web page for guidance).
If you are proposing non-externally-funded research, please mark the appropriate selection(s) in the space provided on the General Information Sheet [Section 1, Form A].