The FCOI Module will allow institutional users to manage the Financial Conflict of Interest (FCOI) reporting process for their particular institution by reporting the existence of any identified FCOI to the granting agency as required by the federal grant and cooperative agreement regulation (42 CFR Part 50 Subpart F).
The FCOI module, accessed via eRA Commons, allows institutions to:
- electronically submit FCOI reports and supporting documents via the eRA Commons
- submit an annual FCOI report
- submit additional information when requested by the agency
- search and view FCOI reports and associated data previously submitted through the Commons
New features were added to the FCOI module in June 15, 2012 to accommodate the additional reporting requirements of the 2011 FCOI Revised Regulation. Institutions are now required to submit the following additional information:
- The name of the Entity with which the Investigator has an FCOI.
- The Nature of the Significant Financial Interest (SFI). The SFI information will be selected from a drop-down menu.
- The Value of the financial interest. The Value of the SFI will be selected from a drop-down menu.
- Description via text box or uploaded PDF of how the financial interest relates to the NIH-funded research and why the Institution determined that the financial interest conflicts with such research.
- Description via text box or updated PDF of the key elements of the Institution’s management plan, including other required information.
- Verification that the Institution is submitting an FCOI report that is compliant with the regulation.
In situations of noncompliance, the module will allow for the submission of a revised FCOI report following a Retrospective Review, if needed, to specify the actions that will be taken to manage the FCOI going forward. In addition, the module will allow for the submission of a Mitigation Report when bias is found following a Retrospective Review.
The FCOI Module is part of the eRA Commons, an online interface where grant applicants, grantees and federal staff can access and share administrative information related to grants and cooperative agreements.