Conflicts of Interest Review Committee
Effective: August 31, 1998
Revised: September, 28, 2023
Agency Notifications of a Financial Conflict of Interest (FCOI)
Washington University has developed the following procedures and guidelines regarding the requirements for notifying funding agencies, sponsors, or prime awardees of FCOI identified related to funded research. The Office of Research Integrity & Ethics has the delegated responsibility under the Research COI Policy for submitting FCOI notifications to the agency or institution in accordance with applicable federal regulations or contractual requirements.
Procedures
1. Applicability
FCOI reports will be provided to funding agencies or prime awardees (when WashU is the subrecipient) when required by federal regulation or the terms of contractual agreement between WashU and the sponsoring organization.
2. Timing and Frequency
- Pending Awards/Agreements
If a FCOI is identified related to a new or competitive pending award (grant awaiting funding) and a FCOI report is required, the fund(s) cannot be set-up until the FCOI notification is sent to the applicable organization. To ensure the award is not prematurely set-up prior to sending the notification, the following steps will be taken:- ORIE will e-mail the PT Record Number, the project title, and the PI’s name to the applicable OSRS grant Managers or designee stating that a FCOI notification is required and the account cannot be set up until ORIE confirms the notification has been issued.
- Manager will document the requirement in the applicable PT record on the PT Record Summary folder, in the Conflict of Interest section.
- Prior to setting up the fund, the SPA individual processing the award should ensure the notification has been sent to the PHS agency by obtaining confirmation from ORIE the notification has been sent and/or approval from ORIE to set-up the fund.
- Pre-award Costs or Prior Approvals (PA)
The FCOI notification does not need to be submitted in advance of PA for pre-award costs or project advances. The FCOI notification must be submitted prior to expenditure under the award. - Active Awards/Agreements
If a FCOI is identified during the period of award, and a FCOI report is required, ORIE will submit the notification within 60 days or as required by applicable federal regulation or agency requirements. - Subagreements where WashU is the Prime Recipient
- When the subreceipient’s COI policy applies: The subrecipient must notify WashU’s Institutional Official (IO) or the Manager of ORIE a FCOI has been identified and the corresponding information needed to notify the applicable organization.
- When WashU’s COI policy applies: ORIE will notify the agency once the review and management process has completed and prior to the expenditure of funds or within 60 days of identifying the FCOI as described above in 2A and 2C.
- Subagreements where WashU is the Subrecipeint
ORIE will notify the prime institution of a FCOI prior to the expenditure of funds or within 60 days of identifying a new FCOI for active awards. The communication will be signed and sent with corresponding information needed to notify the applicable agency. The prime institution is responsible for submitting the FCOI notification.
3. Reporting Process
The specific mechanism and corresponding information provided as part of a FCOI report is determined by the applicable federal regulation or contractual agreement.
- Public Health Services (PHS) Funding
The initial notification, and the subsequent notifications due annually for the duration of the award (which includes extensions with or out without funds), will be submitted through eRA Commons or via signed letter (when WashU is the subrecipient) as required under 42 CFR 50.605(b). - National Science Foundation (NSF) Funding
In instances of a conflict of interest that cannot be managed, reduced, or eliminated or where research will proceed without the imposition of conditions or restrictions when a conflict of interest exists, NSF will be notified by signed letter via use of NSF’s electronic systems. - Department of Energy (DOE) Funding
Unless otherwise required under the specific Funding Opportunity Announcement (FOA) or the terms and conditions of the award notification, DOE must be notified of any financial conflict of interest that cannot be managed, reduced, or eliminated by signed letter sent via email to the applicable Program Officer. - Other agencies that require notification
The procedures outlined in Section 2 will be followed for other agencies requiring notification regarding the identification and management of a FCOI. The mechanism for reporting and information provided will be based on agency requirements.
4. FCOI Notification Format
Unless specified by the funding agency or organization, the following elements are included in a FCOI report:
- Project number;
- PD/PI or Contact PD/PI if a multiple PD/PI model is used;
- Name of the individual with the financial conflict of interest;
- Name of the entity with which the individual has a financial conflict of interest;
- Nature or associated activity(ies) of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
- Value of the financial interest provided in dollar ranges or noting if the value cannot be readily determined;
- A description of how the financial interest relates to the funded research, the basis for the determination that the financial interest conflicts with such research, and any mitigating factors that impact the conflict; and
- A description of the key elements of the management plan, including:
- Role and principal duties of the conflicted Investigator in the research project;
- Conditions of the management plan;
- How the management plan is designed to safeguard objectivity in the research project;
- Confirmation of the individual’s agreement to the management plan;
- How the management plan will be monitored to ensure compliance; and
- Other information as needed.
Prior revisions: 9/28/23, 8/31/98