Office of Research and Sponsored Programs
IMPORTANT Proposal Submission Changes Due to the Revised PHS Financial Conflict of Interest Regulations
UPDATED June 18, 2013
Changes to the PHS regulations require that MUSC take a pro-active role in identifying and managing potential financial conflicts of interest (FCOI). These regulations apply to MUSC and also to any sub-recipients and consultants (paid or unpaid) who are participating on a sponsored project. The following processes have been developed to ensure compliance with the regulations.
Changes to the ePDS (electronic Proposal Data Sheet) and Proposal Submission Process
Since 8/24/2012, MUSC Principal Investigators are required to certify that ALL MUSC contributors on a proposal submission are listed in the PI Assurance Section of the ePDS. Only a COMPLETE listing of all MUSC personnel involved on the proposal will allow ORSP staff to verify that ALL MUSC contributors have a current COI disclosure on file with the MUSC Conflict of Interest Office. A current disclosure is defined as less than 1 year old (filed within 365 days of proposal submission).
External Contributors (i.e. individuals, consultants, collaborators, mentors, etc.):
All external contributors meeting the PHS definition of investigator* (see definition below) must demonstrate they are fully PHS FCOI compliant. It is the responsibility of the Principal Investigator to make this determination for each external contributor to the project and document this using the External Contributor Listing Form.
For each external contributor that has been designated as an investigator,
- the external investigator’s institution/organization must have a PHS FCOI compliant policy, or
- the external investigator can choose to follow MUSC’s COI policies.
Regardless of which option is applicable, ORSP MUST have this documented PRIOR TO PROPOSAL SUBMISSION via the External Investigator Financial Conflict of Interest (FCOI) Certification Form (see form link below).
*Per the Federal Regulations, 42 CFR Part 50, Subpart F, the PHS defines “investigator” as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Who must complete the necessary forms?
For all proposals involving External contributors being submitted to NON-CORPORATE ENTITIES, the MUSC Principal Investigator must certify/sign a completed External Contributor Listing Form. This form documents for MUSC exactly which External Contributors, if any, meet the PHS definition of investigator.
Any External Contributor, designated by the MUSC PI as an investigator, must complete an External Investigator Financial Conflict of Interest (FCOI) Certification Form. This form documents for MUSC exactly how the external investigator will comply with the PHS FCOI requirements. NOTE: Any proposed sub-recipient organizations listed on theFDP Clearinghouse DO NOT have to complete this Form.
When are the forms due?
All necessary forms must be completed and certified before the proposal can be approved and submitted to the sponsoring entity by MUSC’s ORSP.
What forms are to be completed and certified?
If any external contributors (organization or individual outside of MUSC) are involved with the NON-CORPORATE funded proposal, the following form must be completed and certified. ORSP encourages everyone to distribute and complete this form early on in the proposal development process.
If designated as such by the MUSC PI, each external investigator must complete the following form, unless the external investigator’s institution/organization is listed on the FDP Clearinghouse of Compliant Institutions and Entities.
If an organization does not have a Conflict of Interest policy or cannot verify their policy is compliant with the PHS regulations, they must agree to follow the COI policy established and enforced by MUSC. This mandates completing the MUSC COI disclosure prior to proposal submission, updating the disclosure within 30 days should circumstances change from what was originally disclosed and ensuring the disclosure is not greater than 1 year old. For those entities choosing to comply with MUSC’s PHS compliant COI policies, they must complete and return the following form to MUSC’s ORSP.
Additional information is available on the ORSP COI FAQs page.