Office of Research and Sponsored Programs

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 certification and disclosure forms?

It depends on how the external investigator is participating in the project. It doesn’t matter for FCOI purposes if the external investigator is paid or unpaid. The key to being covered by their institution’s policy or MUSC’s is whether they are performing the activity 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 Certification Form is not needed

However, if the external investigator’s institution is not listed in the FDP Clearinghouse, then the form will need to be completed and forwarded to ORSP prior to proposal submission. 

If Option # 1 is selected, it may be necessary for MUSC’s COI Officer to review the other institution’s FCOI policy to make sure it is FCOI compliant.  If so, then the other institution will be asked for a copy of or a link to their FCOI policy.

If Option # 2 is selected, then an External investigator Conflict of Interest Disclosure Form will be needed for each individual contributor from that institution. 

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 Certification Form to show that they will be following MUSC’s FCOI policy (unless they can document they have a PHS-compliant FCOI Policy) AND 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 onto 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 certification and disclosure forms?

NO – federal agencies are exempted 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 will 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 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 continue to automatically review each listed contributor’s FCOI disclosure record to ensure each individual’s FCOI disclosure 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.

Other FCOI FAQs:

MUSC Conflict of Interest Office FCOI FAQs:

http://academicdepartments.musc.edu/coi/frequently%20asked/frequentlyaskedquestions

NIH FCOI FAQs:

http://grants.nih.gov/grants/policy/coi/coi_faqs.htm