1.0 Purpose [Top]
This Procedure describes the process for complying with Public Health Service (PHS) regulations addressing Financial Conflict of Interest (FCOI) http://grants.nih.gov/grants/policy/coi/. The PHS FCOI regulations require disclosure of significant financial interests by Investigators participating in PHS-funded research, either directly or through subawards. Institutional compliance with PHS FCOI regulations is dependent upon Investigators accurately disclosing the existence of potential financial conflicts of interest. This Procedure provides guidance to Investigators as they complete the relevant portion of the Proposal Approval Sheet (SP10, a/k/a the "Goldenrod"), and identifies the Institutional actions that will be taken based upon the information reported on the Goldenrod. The Procedure also discusses the State Conflict of Interest Statute and the PHS FCOI training requirement.
2.0 Policy Reference [Top]
2.1 General [Top]
Investigators must disclose significant financial interests when submitting proposals for externally funded research. "Investigator" and "significant financial interest" are defined terms within the University’s Policy on Financial Conflicts of Interest for Research Investigators, hereinafter the "FCOI Policy."
The Goldenrod (Question Five, Part Two) directs Investigators to the University’s online financial interest disclosure system. https://avillage.web.virginia.edu/uvacoi. This system is used to disclose significant financial interests related to an Investigator’s institutional responsibilities for externally funded projects (with one caveat, described in the next paragraph). All Investigators seeking PHS funding must use the online system to make all required disclosures or confirm the absence of any significant financial interest. Be advised that a growing number of organizations have adopted the new PHS regulations – meaning disclosure of significant financial interest related to institutional responsibilities must be made using the online disclosure system for these sponsors as well. Investigators should contact their respective grants office or OSP if they have not previously completed the online disclosure process and have questions regarding whether such disclosure is required for a particular sponsor.
The disclosure requirements for non-PHS funded research are different. First, "significant financial interest" is less inclusive as it does not include any requirement to disclose sponsored travel. Second, only those significant financial interests that relate to the particular research project at issue need to be disclosed. Disclosure of significant financial interests for non-PHS funded research is also made using the online system. For School of Medicine faculty, investigators must use the online system to disclose significant financial interests related to their institutional responsibilities for all externally funded research. Investigators in all other Schools do not need to use the online system to confirm the absence of any significant financial interests for sponsors that have not adopted the PHS FCOI regulations.
2.2 Procedure for Reviewing and Resolving Potential Financial Conflicts of Interest [Top]
For non-PHS funded Research:
Investigators acknowledge the existence of a significant financial interest related to the proposed research by checking the appropriate box on the Goldenrod.
- For non-School of Medicine Investigators, OSP will submit the proposal, and thereafter contact the Institutional Official specified in the University’s FCOI Policy (currently Dave Hudson). The Institutional Official will review the disclosures in the online system and also contact the Investigator with any questions regarding the relationship between the disclosure and the specific proposal in question.
- For School of Medicine Investigators, the SoM’s Office of Grants and Contracts will submit the proposal, and the School’s designated official (currently Steve Wasserman) will review the disclosures in the online system and also contact the Investigator with any questions regarding the relationship between the disclosure and the specific proposal in question.
The relevant official (either the School of Medicine’s designated official or the University’s Institutional Official) will review the disclosure to make a "relatedness" determination – determining whether the significant financial interest could be affected by the proposed research.
The Investigator will be involved in the process, and the determination of relatedness will be made using guidelines developed by the relevant official.
If the relevant official determines there is no relatedness for FCOI purposes, the matter will be considered closed. If the relevant official determines the interest is related to the research, the entire matter will be referred to the Research Conflict of Interests Committee as outlined in the University’s FCOI Policy.
OSP will not accept or set up any award for non-PHS funded research until such time as any and all FCOI matters are deemed closed by the Institutional Official. This includes the establishment of at-risk PTAEOs in advance of an award. If an Investigator acquires a significant financial interest during the course of an award, the interest must be disclosed within thirty days and reviewed in accordance with the FCOI policy.
For PHS funded Research, or for any sponsor that has adopted the new PHS-FCOI rules:
Any Investigator seeking PHS funding must disclose all significant financial interests related to their institutional responsibilities prior to proposal submission. For all Investigators, this is done using the University’s online disclosure system. Even if there are no significant financial interests to disclose, the Investigator must confirm this using the online system.
Proposals will be submitted by the appropriate grants office or OSP once all Investigators have made all necessary disclosures.
If any Investigator has disclosed a significant financial interest, a "relatedness" determination will be made by the University’s Institutional Official, in consultation with the Investigator, using the same procedures previously noted for non-PHS funded research. If the significant financial interest is deemed related to the research, the matter will be referred to the Research Conflict of Interests Committee, as outlined previously for non-PHS funded research. Note, a finding of "relatedness" does not necessarily mean that there is a FCOI. All FCOI determinations must be made prior to the expenditure of any funds. Accordingly, OSP will not accept or set up any award until such time as any and all FCOI matters are deemed closed by the Institutional Official.
If an Investigator has disclosed any significant financial interest, then it is in his/her best interest to confirm that the relatedness determination has been completed once the Investigator learns that funding may be forthcoming. In practice, this may be when the Investigator receives any Just-in-Time request.
Non-Competing Continuations, No-Cost Extensions
The FCOI regulations also require the annual disclosure of significant financial interests. On or before the date of a Progress Report/Non-Competing Continuation proposal, all Investigators must disclose the existence of any significant financial interests. The review process is the same as previously indicated, with the exception that in certain circumstances the award may remain open and funds expended for a brief time while the relatedness determination (if any) is completed. Investigators should contact OSP with questions. Moreover, for awards already in progress as of August 24, 2012, Investigators must disclose in accordance with the new regulations before the due date of the progress report/non-competing continuation for any subsequent year of that award and prior to that award being released by OSP.
2.3 Sub-awards from UVA to subrecipients when PHS funding is involved [Top]
Each subrecipient must complete the UVA Subrecipient commitment form (available from OSP), which allows OSP to determine if a subrecipient has a PHS-compliant policy in place.
In most cases, a subrecipient will be an educational institution or non-profit entity, which will have a PHS-compliant policy in place as of August 24, 2012. However, in those rare instances where this is not the case the subrecipient must agree to rely on the UVA policy, including submission of the UVA financial disclosure forms (to be provided by OSP) and adherence to the procedures and processes set out in the UVA FCOI Policy.
For those subrecipients without a PHS-compliant policy: Each investigator of the subrecipient must complete the UVA PHS Financial Disclosure Form (available from OSP) before UVA submits its proposal to PHS. A proposal will not be considered complete and cannot be submitted by OSP or the School of Medicine’s Office of Grants and Contracts unless the UVA PHS Financial Disclosure Form has been submitted by all Investigators of the subrecipient. If the proposal is selected for funding, then the review process previously identified in this Procedure will apply.
Those subrecipients with a PHS-compliant policy will be expected to rely on that subrecipient’s policy and report FCOIs to UVA in accordance with the PHS requirements; they will not have the option of relying on the UVA policy.
3.0 State Conflict of Interest Act [Top]
The State Conflict of Interest Act is unrelated to the University’s disclosure requirements for financial conflicts of interest. The Act bars University employees from having "personal interests" in a company (including ownership of more than 3% of the equity, or anticipated annual compensation from the company of more than $10,000) if the company enters into a contract with the University, unless an exception within the Act applies. This prohibition applies even if the personal interest is unrelated to the contract (e.g., if an investigator has equity in or receives income from a company negotiating a contract with the University that is unrelated to the investigator’s research). This prohibition also applies if a University employee other than the PI has a financial interest in the outside entity in this research agreement.
Employees must disclose "personal interests" under the Act to the Institutional Official prior to execution of the contract. If the Employee has such a personal interest, she/he should so indicate on the Goldenrod. The proposal will be submitted, and the matter will be referred to the Institutional Official who will assist the Employee in determining whether an exception under the Act is available, and in applying for the approvals needed to qualify for an available exception. In addition, under the Act these Employees will be required to complete a state financial disclosure form promptly and annually thereafter during the contract period and to complete a state COI training bi-annually.
4.0 Training [Top]
All Investigators are required to take PHS-compliant training prior to engaging in PHS-funded research for new awards or no later than the due date of the next subsequent progress report/non-competing continuation proposal for ongoing projects, whether receiving remuneration or not, and at least every four years while engaging in PHS-funded research. Training is also required immediately if a PHS-funded Investigator is new to the institution, if UVA policies change in a way that affects Investigator requirements or if UVA finds that an Investigator is noncompliant with the PHS COI policy or management plan under that policy. This training requirement applies equally for those funding agencies that have adopted the PHS regulations. The training requirement must be met as follows:
Investigators should visit the CITI home page, www.citiprogram.org and register as new users as participants at the University of Virginia and then proceed to take the CITI Conflicts of Interest course.
5.0 Approvals and Revisions [Top]