VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

The President and Provost or designee will oversee all identified breaches of conflict of interest reporting, review and management processes, including: a. Failure of Investigators to report financial interests, b. Failure to update financial interests as req uired, c. Failure to respond to Conflict of Interest Committee or IRB inquiries or responding with

incomplete or knowingly inaccurate information, d. Failure to adhere to the management plan, and e. Failure to comply with a prescribed monitoring plan, if applicabl e.

10. SUB RECIPIENT R EQUIREMENTS FOR PHS - FUNDED R ESEARCH

Any written subaward agreement with any organization that falls under a PHS - sponsored research project at the College, must include terms establishing the applicable Financial Conflict of Interest in Research policy governing the subrecipient’s w ork, whether it be the College P olicy or the policy of the subrecipient instit ution (see 42.CFR.50.604 (c) ). The College Office of Research Administration (ORA) shall submit the Subrecipient FCOI Certification Form to all pote ntial subrecipient institutions. This form must be completed and returned along with the subrecipient institution’s ap plication to the ORA. The subrecipient institution shall provide written certification that its policy is established in a ccord with sponsor requirements or , if unable to prove such certification, the College’s Policy shall be applicable to all subrecipie nt Investigators. If the subrecipient institution complies with their own financial conflicts of interest policy, the written subaward agreement shall specify timelines for the subrecipient institution to report all identified financial conflicts of inte rest to the College. These time periods shall be sufficient as to enable the College to provide timely reports to the PHS awarding agency. Alternatively , i f the subrecipient institution applies the College’s Policy to its Investigators, the written subaw ard agreement shall establish timelines and information requirements for the subrecipient institution to submit all Investigator disclosures of significant financial interest to the College. The time frame for these reports shall be such that they allow th e College ample time for evalu ation, management and reporting obligations to the PHS awarding agency. In all cases, the College is responsible for providing reports to the PHS awarding agency regarding all financial conflict of interest of all subrecipien t Investigators prior to the expenditure of funds and within 60 days of any subsequently identified financial conflicts of interest. RECORDS AND C OMPLIANCE Records related to the identification, evaluation and response to financial conflicts of interest in research shall be retained for three years following the date that the final research expenditure report has been submitted to the sponsor, or for a longer period when specified by sponsor or College requirements. TRAINING R EQUIREMENTS Each Investigator is required to complete training prior to beginning extramural research and , for federally - sponsored research, at least every four years. Training is also required if this Policy changes substantially, if an Investigator is new to the College and if an Investigator is found to be non - compliant with this Policy or the management p l an. 11. 12.

Training will be carried out through on - line modules developed by the Col laborative Institutional Training Initiative (CITI), which is available to all College faculty, staff and students. Certification that

Financial Conflicts of Interest in Research Policy

Page 12 of 13