COI Disclosure Requirements
In accordance with Federal regulations, Georgetown University’s Financial Conflicts of Interest Policy (FCOI Policy) and MedStar Health’s conflict of interest policies, all individuals listed as senior/key personnel on an externally funded proposal or award 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 must additionally complete a Study-Specific Disclosure Form (SSDF) in GU-PASS.
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 annual FCOI disclosures in GU-PASS or COI-Smart within 30 days 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
Conflict of Interest Training
Senior/Key Personnel working on PHS-funded Awards (or other sponsors that require COI training) must complete conflict of interest training at time of award and a refresher every four (4) years thereafter (or more frequently if required by a sponsor) through the Collaborative Institutional Training Initiative (“CITI”). Award fund set-up (or proposal submission, if/as applicable based on sponsor requirements) does not occur until CITI COI training is completed by all named Senior/Key Personnel on a project.
Individuals can self-register at CITI and affiliate themselves with Georgetown. Upon completion of the registration process, CITI will ask a series of questions. You may answer “not at this time” to all questions except question 5. You must check “yes” to the conflict of interest training to receive access to the correct training module. Questions related to registration can be sent to Kenya Carter, Research Compliance Specialist, Office of Research Oversight, at kenya.carter@georgetown.edu.