Notice of NIH Improving the Financial Conflict of Interest (FCOI) Module for Submission of Financial Conflict of Interest Reports to the NIH Beginning on April 25, 2014

Notice Number: NOT-OD-14-081

Key Dates
Release Date: April 18, 2014

Related Announcements
NOT-OD-09-072

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) is making improvements to the FCOI module for submission of financial conflict of interest (FCOI) reports for NIH grants and cooperative agreements, subject to the Federal regulation at 42 CFR Part 50 Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.

Background

The NIH requires grantees to use the FCOI module, via eRA Commons, to submit FCOI reports. Beginning on April 25, 2014, two major changes as described below will be implemented that will improve Institutional reporting and promote compliance.

The purpose of the Annual FCOI report is to specify whether an Investigator's FCOI is still being managed or explain why the FCOI no longer exists.  Any changes to the management plan are also included in the Annual Report. The following rules apply to FCOI reports and remain unchanged:

  • Annual FCOI reports must be submitted to the NIH for the duration of the project period (including extensions with or without funds).

  •  Annual reports are due at the same time as when the Institution is required to submit the annual progress report (i.e., two months prior to the start date or 45 days prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of the extension.

  •  Annual FCOI reports are not to be submitted as part of the annual progress report nor are they part of grant closeout requirements. 

The following changes will apply to the submission of any type of FCOI report (i.e., Original, Annual or Revised FCOI report) on or after April 25, 2014.

The FCOI Annual Report link in eRA Commons will appear closer to when it is due:

  • For ongoing projects: The Annual Report link will appear 75 days prior to the next budget period start date, following the submission of an Original Report or Annual Report when there is a future noncompeting year pending within a current competitive segment.

  • For eRA Commons No Cost Extensions: The Annual Report link will appear the day after the grantee takes action to extend the project via the Commons.

  • For Notice of Award (NoA) extensions: An Annual Report link will not be available. Instead, until eRA implements a change in the FCOI module, the NIH will send the grantee a "Request for Additional Information" asking the grantee to provide a status of the FCOI and any changes to the management plan, if applicable, prior to the issuance of the revised NoA.

An Email Reminder to FCOI Signing Officials (SOs) That Annual Report is Due:

  • An email reminder will now be sent to the FCOI SO, when the Annual Report link becomes available in the FCOI module (as described above).

FCOI Reports to be Submitted under the Current, Active Grant Year:

  • When an FCOI SO enters a grant number for a grant year that is not the current, active grant year, a warning message will appear to allow the SO to select another grant year, if appropriate.

  •  Future Annual Reports will be submitted under the currently funded grant year (e.g., year 04) without regard to the grant year in which the Original Report was submitted (e.g., year 01). This is a change to the way the system currently functions.

 Revised FCOI Reports May Be Submitted up to 150 days After Submitting an Original Report:
Revised FCOI reports are only needed following the completion of a Retrospective Review when the grantee needs to provide:

  • New FCOI information that results in a change to a previously submitted FCOI report (e.g., an increase in value of a previously reported significant financial interest (SFI), discovery of a new SFI, or changes to the management of the FCOI, etc.) or

  • A Mitigation Report if bias is found.

Grantees should not submit a Revised FCOI report to notify NIH that either the Retrospective Review has been completed or that bias is not found.

When the Original Report is submitted and the grantee indicates that the Retrospective Review is not completed, the system will allow the Institution to submit a Revised FCOI report up to 150 days after the Original Report's submission date.

Change in Business Process when Grantees Identify Errors in Submitted Data:
Corrections to some FCOI report data can be made without NIH taking action to rescind the Original report and requiring the grantee to submit a new report. Depending on the error, these are the options:

  • Errors in the following data can be corrected only by NIH rescinding the Original Report and requiring the grantee to submit a new report:
    • Grant Number,
    • Investigator Name with the conflict, and
    • Subrecipient information

When these corrections are needed, the FCOI SO should contact the Grants Management Specialist/Officer identified on the latest Notice of Award to ask NIH to rescind the FCOI report.

  • Errors to the following data can be corrected by NIH sending the Institution a "Request for Additional Information," which allows the grantee to make the correction and submit the corrected FCOI report:
    • FCOI data (entity name and significant financial interest data)
    • Responses to the compliance questions (i.e., questions numbered 4, 5 or 6).

When these corrections are needed, the FCOI SO should contact the Grants Management Specialist/Officer identified on the Notice of Award to explain the nature of the error and the need to make a correction.

This information will also be available in the FCOI Online Help (accessed by clicking on the question marks on the screens of the FCOI module) and the FCOI User Guide that is posted on the Office of Extramural Research FCOI webpage at http://grants.nih.gov/grants/policy/coi/index.htm and the eRA webpage at http://era.nih.gov/modules_user-guides_documentation.cfm.

Inquiries

Please direct all inquiries to:

General questions concerning the eRA Commons and the FCOI Module should be directed to the eRA Commons Helpdesk at:

eRA Commons Help Desk
Submit a web ticket (Preferred method of contact)
Toll-free: 1-866-504-9552
Phone: 301-402-7469
TTY: 301-451-5939
Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Time

General inquiries about this Notice and FCOI requirements may be directed to:
Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration
Telephone: 301-435-0949
Email: FCOICompliance@mail.nih.gov

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