Notice Number: NOT-OD-14-081
Release Date: April 18, 2014
National Institutes of Health (NIH)
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.
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:
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:
An Email Reminder to FCOI Signing Officials (SOs) That Annual Report is Due:
FCOI Reports to be Submitted under the Current, Active Grant Year:
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:
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:
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.
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 https://grants.nih.gov/grants/policy/coi/index.htm and the eRA webpage at http://era.nih.gov/modules_user-guides_documentation.cfm.
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 Service Desk
Submit a web ticket (Preferred method of contact)
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