ORSP Guidance on PHS Financial Conflict of Interest Regulations

For All Proposal Submissions to Non-Corporate Entities

Changes to the Public Health Service (PHS) regulations require that MUSC take a proactive role in identifying and managing potential financial conflicts of interest (FCOI). These regulations apply to MUSC and to any subrecipients 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 Proposal Submission Process

ALL MUSC investigators on a proposal submission should be listed on the Institutional Proposal Form. A complete listing of proposal personnel would include 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. The Principal Investigator is required to certify whether any potential conflict exists regarding the project for any member of the research team. This will allow ORSP staff to identify whether there is a potential conflict and work with the appropriate institutional committee to get it resolved.

Definition of Investigator

*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.

External Investigators on Sponsored Projects

If the project involves collaborations with outside contributors (i.e. individuals, consultants, collaborators, mentors, etc.), the following procedures need to be followed. All external personnel meeting the PHS definition of investigator* (see definition above) must demonstrate they are fully PHS FCOI compliant. The forms can be found on ORSP's Horseshoe site.

If the proposal includes non-MUSC personnel and is being submitted to a non-corporate entity, the required forms must be completed. Please use the decision tree below to determine which forms are due.

The forms are available and may be downloaded from the ORSP's Horseshoe site which can be accessed from the Resources page.

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. They should be uploaded into the proposal routing and approval system before submitted for approval. Forms are available on ORSP's Horseshoe site.

What forms are to be completed and certified?

If any external investigators (organization or individual outside of MUSC) are involved and the proposal is being submitted to a non-corporate entity, the following form must be completed and certified. ORSP encourages everyone to distribute and complete this form early in the proposal development process. It must be signed by the MUSC PI.

The External Investigator Listing Form lists each outside individual, their role on the project, and their affiliated organization.

• For each organization listed on the form, check the FDP Clearinghouse of Compliant Institutions and Entities website.
• If the listed investigator’s institution/organization is on the FDP Clearinghouse website, no further action is required.
• If the investigator's institution is not on the website, the External Investigator Financial Conflict of Interest Policy Certification Form is also required. It must be completed by each external investigator whose institution is not listed on the FDP Clearinghouse website. It indicates whether the individual's organization has a conflict of interest policy that is PHS compliant (Option 1) or whether they agree to use MUSC's conflict of interest policy (Option 2). If they select option 1, no further action is required after they sign and return the certification form to MUSC. NOTE: The investigator may not sign for the organization unless they are an authorized organizational official.
• If an organization does not have a Conflict of Interest policy or cannot verify their policy is compliant with the PHS regulations, the investigator must agree to follow the COI policy established and enforced by MUSC (Option 2). To comply with this, each investigator from the non-compliant organization must complete MUSC’s Conflict of Interest Disclosure Form. It contains information, training, and a financial disclosure questionnaire for those agreeing to comply with MUSC's conflict of interest policy. Completion and signature of this form indicates acceptance of MUSC's terms and conditions. When this form is returned to MUSC, no further action is required.

Additional information is available at ORSP COI FAQs.