Initiating an FCOI Report

Commons users can initiate new FCOI Reports. To do so, the user must have the FCOI or FCOI_ASST role at each affiliated organization.

FCOI Reports are permissible for Active awards. FCOI reports should be submitted during an ongoing project and not after the project period end date. When initiating a new FCOI report, the report should be submitted under the current, active grant year.

To initiate a new FCOI Report:

1. After logging into Commons, navigate to the FCOI module.

   The FCOI Search screen displays. Along with the search option, the FCOI menu includes the tab to Initiate 2011 FCOI Report.

   

2. Click the Initiate 2011 FCOI Report tab.

   The Financial Conflict of Interest – Initiate New Report screen displays (see below)

   The initial fields on this screen are as follows:

   • Grant Number (IC Code, Serial Number, and Support Year are required)
   • Name of Investigator with Conflict (Last Name and First Name are required)
   • Subrecipient Report (No or Yes – along with the Subrecipient Institution Name for Yes – is required)
   • PD/PI or Contact PD/PI (populated upon initiation and disabled for entry)
   • Project Title (populated upon initiation and disabled for entry)
   • Project Period Start & End Dates (populated upon initiation and disabled for entry)
   • Budget Period Start & End Dates (populated upon initiation and disabled for entry)

   Before the FCOI report can be completed, the information in the required fields must be validated.

3. Enter the required fields. Required fields are marked with an asterisk (*).

4. Click the Validate button.

   

   Figure 2: FCOI Report - Validate Button

   Commons validates the entered information. If Commons finds that the entered grant number is invalid for initiating the FCOI Report, an error message displays as follows:

   Grant was not found or not awarded.

   If the validations pass with no errors, the Financial Conflict of Interest – Initiate New Report screen expands for entering additional information. The fields in the upper portion of the screen automatically populate based on the entered grant data. These fields are disabled for editing.

   

   Figure 3: FCOI New Report Displaying Grant Information as Read-only

   The lower portions of the screen – FCOI Information (sections 1-3), Noncompliance with Regulation section 4 (sections 5 and 6 if "Yes" answers), and Upload PDF Documents – display and are enabled for editing.

5. Update the fields in the FCOI Information block.

   Click here to show details.

   1. Enter the Entity name (required). Use the full name of the Entity as it appears on the Entity’s publicly accessible Web site or type in the full name as it is known.
   2. Select the nature of the financial interest from the Significant Financial Interest (SFI) drop-down list. The options are as follows:

      • Equity Interest – Non-publicly traded entity (e.g., stock, stock option, or other ownership interest)

      • Equity Interest – Publicly traded entity (e.g., stock, stock option, or other ownership interest)

      • Intellectual property rights (e.g., royalties, patents, copyrights) not from the awardee institution

      • Investment vehicles, such as mutual funds and retirement accounts, controlled by the investigator

      • Other (Provide an explanation that describes the SFI)*

      • Payment for services (e.g., consulting fees, honoraria, paid authorship)

      • Reimbursed or sponsored travel

      • Salary not from the awardee Institution

      *When selecting Other, enter details on the Other text field that appears.

   3. Select an option from the Annual Value... drop-down list:

      • The choices in value ranges from $0 to $599,999

      • >$600,000. If you select greater than 600,000, an additional Value field appears, where you must enter the value.

        NOTE: Do not use punctuation or symbols (i.e. commas or "$") when entering values greater than $600,000. Use numbers only.

      • The interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

   4. Click the Add New SFI button to save the information to the table. Repeat the steps if multiple SFIs for the same entity are held by an Investigator.

      The selected information displays in the table at the bottom of the FCOI Information block. Additional information may be added in the same manner, for up to 8 SFIs. To remove any SFI information, click the three-dot ellipsis menu and select Delete.

      

      Figure 4: Significant Financial Interest Entries on FCOI Report

   5. Enter text or upload an attachment to describe how each financial interest relates to the funded research (Question #2).
   6. Enter text or upload an attachment to describe the key elements of the institution’s management plan (Question #3).

      

      Figure 5: Descriptions and Uploads Supporting the FCOI Report (Questions 2 & 3)

6. Click the No or Yes radio button for question #4 Does this FCOI report include a failure to comply with the regulation?

   If the Yes radio button is selected, a pop-up displays the following message: An FCOI report represents noncompliance when an FCOI is not identified or managed in a timely manner including failure by the Investigator to disclose a Significant Financial Interest; failure by the Institution to review or manage a financial conflict of interest; or failure by the Investigator to comply with the management plan.

   

   Figure 6: Noncompliance Message

   After clicking OK to close the popup, the Description of Noncompliance with the FCOI Regulation section appears containing a text box for comments and question 5. Retrospective Review Completed? These are both required fields when Yes is selected for Question 4.

7. Only if response to Question 4 is Yes: 
   1. Enter comments in the text box below the label Describe the situation of noncompliance in the text box below.
   2. Click the No or Yes radio button for question 5. Retrospective Review Completed? to indicate whether a retrospective review was completed. If Yes is selected, the response for question #6 is enabled and required.

      

      Figure 7: Comments Required when Response to Question 4 is Yes

   3. Only if response to Question 5 is Yes:

      Click the No or Yes bias found radio button for question 6. Mitigation Report Required? to indicate whether a mitigation report is required when bias is found. If the Yes bias found button is selected, provide the Mitigation Report information in the enabled text box or upload a file in the table below it.

      

      Figure 8: Noncompliance Reporting for FCOI Report

8. Additional and Optional Information: Add any additional or optional information in the Upload PDF Documents section. Enter a brief description (up to 30 characters) and then use the browse or drag and drop feature to add the PDF file.

   

   Figure 9: Additional/Optional PDF Upload for FCOI Report

9. Perform one of the following actions:
   • Click the Save button to put the record in WIP status.
   • Click the Save and Submit button to submit to agency.
   • Click the View FCOI History button to see the actions taken so far.
   • Click Cancel to return to the FCOI Search screen.
10. Save and Submit and related comments:
    • When the Save and Submit button is clicked, a comments screen displays for entering optional comments before submission. The comments entered on this screen are recorded within the FCOI History. In addition, the comments are added to the email notification sent to the agency. After entering the appropriate comments, click the Continue button to complete the submission. (Clicking Cancel will return you to the form page)
      

      

Upon saving and submitting, the system sends out an email notification informing the FCOI user (and potentially the FCOI_ASST user) that the FCOI Report was submitted.