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Office of Research and Sponsored Programs

Proposal Submission Procedures to Comply with PHS Financial Conflict of Interest Regulations

Applicable to all proposal submissions to Non-Corporate Entities

Changes to the ePDS (electronic Proposal Data Sheet) and Proposal Submission Process (March 2016)

MUSC Principal Investigators are required to certify that ALL MUSC investigators on a proposal submission are listed in the PI Assurance Section of the ePDS.    In addition to investigators, MUSC also tracks all faculty with effort on the project regardless of the role.   A complete listing of proposal personnel will include both the faculty and/or staff that meet the PHS definition of "investigator," and any other faculty with effort on the project that may not meet this definition.  This will allow ORSP staff to verify that all appropriate faculty and staff 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 to Sponsored Projects

Forms for proposals submitted to Non-Corporate Entities

External Investigator Listing Form  (MS Word Form) (PDF fillable form)
Listing of all non-MUSC investigators involved on a proposed project to be completed and signed by MUSC principal investigator

External Investigator Financial Conflict of Interest POLICY Certification Form (MS Word Form)  (PDF Fillable Form)
To be completed by individuals/organizations identified as investigators on the Listing Form that are NOT listed on the FDP clearing house for PHS compliant COI policies

MUSC’s Conflict of Interest Disclosure Form
To be completed by all investigators that selected option 2 on the FCOI Certification Form above.

Instructions

Who must complete the necessary forms?

For all proposals involving external (non-MUSC) personnel being submitted to NON-CORPORATE ENTITIES,  the MUSC Principal Investigator must certify/sign a completed External Investigator 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 Policy 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 the FDP 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 investigators (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.

External Investigator Listing Form  (MS Word Form) (PDF fillable form)

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.

External Investigator Financial Conflict of Interest Policy Certification Form (MS Word Form)  (PDF Fillable Form)

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.

MUSC’s Conflict of Interest Disclosure Form

Additional information is available on the ORSP COI FAQs page.

History/Guidance

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.

External Contributors (i.e. individuals, consultants, collaborators, mentors, etc.):

All external personnel 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 them using the External Investigator 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 Policy Certification Form.

*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.