ORSP Conflict of Interest FAQs
1. I have an external investigator who is affiliated with an institution that is listed in the FDP Clearinghouse. Do they need to fill out the external investigator FCOI policy certification and disclosure forms?
It depends on how the external investigator is participating in the project as part of their institutional responsibilities or as an individual.
Scenario 1 – An external investigator is affiliated with an institution that is listed in the FDP Clearinghouse of Compliant Institutions and Entities AND is working within their institutional responsibilities (i.e. if any money changed hands, it would go to the institution), then the External Investigator Financial Conflict of Interest Policy Certification Form is not needed.
Scenario 2 – If the external investigator is NOT working within their institutional responsibilities (i.e. If any money changed hands, it would go to the individual), then the contributor will need to complete the External Investigator Financial Conflict of Interest Policy Certification Form. If they cannot document that they have a PHS-compliant FCOI Policy, they will also need to complete the External investigator Conflict of Interest Disclosure Form.
NOTE: MUSC cannot assume the individual is performing the activities as part of their institutional responsibilities solely based on a support letter printed on institutional letterhead.
2. I have an external investigator who is a Federal employee (e.g. NIH scientist). Do they need to fill out the external investigator FCOI policy certification and disclosure forms?
NO – Federal agencies are exempt from the definition of “Institution” in the PHS FCOI regulations, and Federal employees acting in their official roles* must disclose any SFI per the Federal ethics policies and procedures. So the Federal employee’s FCOI status would be “N/A” for the proposal, and no written agreement would be necessary at the award stage to ensure proper SFI/FCOI reporting.
*Note: If acting as an individual separate from their Federal employment responsibilities, then they would disclose as individuals/consultants (as shown in Scenario 2 of Question 1 above).
3. I am submitting a grant during the MUSC annual FCOI disclosure period (annually in April). How will I know if ALL contributors to the project have current FCOI disclosures so that the application may be submitted in compliance with the University and PHS FCOI guidelines?
During MUSC’s annual FCOI disclosure period (annually, April 1 – April 30), the ERMA system will automatically review each listed contributor’s FCOI disclosure record to ensure it is current based on the most recent disclosure date. Those without a current FCOI disclosure on file will be contacted by ORSP and asked to complete the online disclosure process so the application may be submitted in compliance with University and PHS FCOI guidelines.