Multiple federal agencies have regulations requiring universities to have a financial conflict of interest disclosure process. The Public Health Service (PHS), which includes the National Institutes of Health (NIH) and seven other funded agencies, has changed its financial conflict of interest rules effective August 24, 2012. Accordingly, RIT has established new procedures for investigators involved in PHS funded proposals, research projects, and subawards.
Previous PHS regulations and the rules governing the National Science Foundation (NSF) awards require that each investigator certify that he/she has appropriately disclosed any significant financial interests related to any submitted proposal. RIT meets these requirements through its Conflict of Interest Policy and its annual Conflict of Interest Disclosure process. This requires all faculty and staff to disclose certain information via the RIT Oracle Self Service website. In addition, all investigators are required to indicate any financial conflict of interest (FCOI) on the required RIT Proposal Routing Form for any proposed externally funded research project at the time of application. After RIT’s review of any disclosed conflict of interest pursuant to its Conflict of Interest policy, if necessary, a plan to manage or eliminate the conflict is developed. RIT will notify the PHS funding agency if a conflict exists; RIT will notify NSF if the conflict cannot be resolved.
These RIT procedures will continue. However, as of August 24, 2012, PHS regulations require a change to RIT procedures regarding PHS research funds:
- Annual FCOI Disclosure, and at time of application. As part of the annual RIT conflict disclosure process, all faculty and staff will now be asked if they have applied, or intend to apply, for PHS research funds in the coming year. If yes, those affected individuals will be asked additional disclosure questions. This annual disclosure will be reviewed as part of the RIT Conflict of Interest Policy and Procedures. Investigators will still be asked on the RIT Proposal Routing Form at the time of application for PHS funded research to certify if any financial conflict of interest exists in each proposed project.
- PHS FCOI Procedures. PHS regulations require any individual designing, conducting, or reporting on the research to complete FCOI training and additional financial disclosures. RIT defines such individuals as the PI or Co-PIs on the project pursuant to section 3.3.1 of the RIT Administrative Policy and Procedures for Externally Sponsored Projects. RIT recognizes that other individuals working on a project may have such responsibilities in a particular project as determined by the PI. In such cases, it is the responsibility of the PI to provide the names of those individuals to SRS in writing. SRS shall then require those individuals to complete FCOI training and the additional financial disclosures requested in the RIT Oracle Self Service website (specifically Part III).
- Disclosure review upon receipt of Award. After notice of receipt of a PHS funded award, SRS will coordinate with other offices to review the disclosures of the PI/Co-PIs for possible FCOI. If there is no disclosed possible conflict and no relatedness issue a determination will be made to process the account request for the award. If there is a possible conflict and an initial relatedness issue is present, then the RIT PHS FCOI Review Committee chaired by the Vice President for Research (the RIT Institutional Official for PHS funded research) will coordinate with the administrator of RIT’s Conflict of Interest Policy to solicit and review any additional disclosures required for the PHS funded project investigators. After review of all the disclosures and input from the investigator, the PHS FCOI Review Committee will determine if a Significant Financial Interest (SFI) exists pursuant to the regulations, and if it is related to the PHS funded research. If so, the PHS FCOI Review Committee will communicate this decision in writing to the investigator and the administrator of the RIT Conflict of Interest Policy to assist in developing and implementing with the applicable Dean and Department a conflict management plan consistent with RIT Conflict of Interest Policy and Procedures as well as the PHS regulations.
- Reporting. The PHS FCOI Review Committee will coordinate all required annual, compliance, and situation specific PHS related FCOI reports to the PHS funded agency, including any retrospective reviews reviewed required for non-timely disclosures or noncompliance by an investigator.
- Subrecipient Compliance. The Office of Sponsored Research Services (SRS) will ensure subrecipient compliance with all PHS FCOI procedures prior to any subawardee obtaining PHS funds through RIT. Prior to funds expended to a subrecipient, SRS will obtain a written agreement indicating that the RIT subrecipient will follow and submit to RIT’s PHS funding procedures herein for FCOI review on the project, or a certification that the subawardee will follow their own procedures, and their FCOI procedures comply with the PHS regulations.
- Required Training. PHS regulations require that each investigator (including co-PIs) complete FCOI training at least every four years, and/or prior to engaging in PHS funded research, or immediately for new investigators, noncompliance situations, or these RIT procedures are changed. RIT provides this required training through the Collaborative Institutional Training Initiative (CITI) training FCOI module located at www.citiprogram.org. This required training will be in addition to any RIT required training as part of the RIT Conflict of Interest Policy.
- Public Access. RIT’s Conflict of Interest Policy and these Procedures will be publicly available on RIT websites. Any determination by the RIT FCOI Review Committee that a SFI exists that is related to a PHS funded research project shall have the minimum regulatory required elements of that FCOI available to the public within five days of written request for that information having been received by the Vice President for Research.