COI Disclosure Requirements For Researchers
In accordance with Federal regulations, Georgetown University’s Financial Conflicts of Interest Policy (FCOI Policy) and MedStar Health’s conflict of interest policies, individuals involved in the design, conduct, or reporting of sponsored research and any individual listed as a study team member on an IRB protocol (“Investigators”) are subject to applicable financial conflict of interest (FCOI) disclosure requirements. A current (i.e. in the last 365 days) annual FCOI disclosure must be on file in either Georgetown’s GU-PASS system or MedStar’s COI-Smart system prior to proposal submission and/or IRB protocol approval. For externally funded proposals, senior/key personnel (or other covered individuals as defined by applicable sponsors) must additionally complete a Study-Specific Disclosure Form (SSDF) in GU-PASS or other sponsor-specific COI disclosure forms as required by the sponsor (refer here for additional information on sponsor-specific COI policy requirements).
Georgetown University employees must complete an annual FCOI disclosure in Georgetown University’s GU-PASS system. Login to GU-PASS using your GU NetID and password. To complete a new disclosure, click on the green button, “Financial COI Policy Disclosure,” complete the questions, and press submit to complete the process.
MedStar employees (including physicians holding GUMC faculty appointments) must complete an annual FCOI disclosure in MedStar’s COI-Smart system. View instructions for completing a MedStar COI-Smart disclosure.
Georgetown’s COI Officers have access to MedStar’s COI-Smart system to complete research-related COI reviews for research submitted by and conducted through Georgetown.
Investigators must update their FCOI disclosures in GU-PASS or COI-Smart within 30 days (or within the timeframe identified by applicable research sponsors) of acquiring a new Significant Financial Interest, as defined in Georgetown’s FCOI Policy
External Investigator Financial COI Disclosure Form
To be used only for Non‐Georgetown University Investigators / Study Team Members:
a) that are not covered under an institutional subcontract and the non-Georgetown University investigator agrees to abide by Georgetown’s Financial Conflict of Interest Policy for the purposes of this research; or
b) that are covered under an institutional subcontract and the subrecipient institution and subrecipient investigator agree to abide by Georgetown’s Financial Conflict of Interest Policy for the purposes of this research