File A Disclosure Form
In accordance with Federal regulations, Georgetown University’s Financial Conflicts of Interest Policy (FCOI Policy) and MedStar Health’s conflict of interest policies, all Investigators who are listed as key personnel on an externally funded proposal or award or listed as a study team member on an IRB protocol must have a conflict of interest disclosure on file in either Georgetown’s GU-PASS system or MedStar’s COI-Smart system and, for each externally funded proposal or award, a Study-Specific Disclosure Form (SSDF) is required as well.
Georgetown University conflict officers now have access to MedStar’s COI-Smart system and will review MedStar Georgetown University Hospital (MGUH) physicians’ conflict disclosures in COI-Smart. The following are the instructions on the system in which individuals must disclose:
Georgetown University/GU Medical Center Employees
All key personnel on sponsored research proposals and awards, as well as study team members on IRB protocols who are employed by Georgetown University or Georgetown University Medical Center, must complete a general conflict of interest disclosure in GU-PASS (or update their GU-PASS disclosure if their circumstances have changed since the disclosure was last completed).
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. Alternatively, you may also check under My Requests, Needs Attention, to see whether you can complete a disclosure that has been started but not yet submitted. To view a previous disclosure, once in GU-PASS, click on the blue button that says “Archived Submission.”
MedStar Health Physicians and Employees
Effective July 1, 2020, MedStar employed physicians with a Georgetown University faculty appointment conducting research at MedStar Georgetown University Hospital will not be required to complete a GU-PASS conflict of interest disclosure. Instead, all study team members employed by MedStar Health must complete a conflict of interest disclosure in COI-Smart (or update their COI-Smart disclosure if their circumstances have changed since it was last completed).
Study-Specific Disclosure Form (SSDF) & General Disclosure Form (GDF)
An SSDF is a form that is completed with the submission of each proposal that is routed in GU-PASS prior to submission to the external sponsor. The SSDF notifies the conflict of interest officers as to whether the investigator believes that any of the financial interests on the investigator’s general conflict of interest disclosure relate to the project being proposed.
Georgetown University investigators entered on an initial (new) proposal to an external sponsor submitted through GU-PASS will receive an alert to submit their SSDF via GU-PASS. Pending SSDFs are listed on your GU-PASS homepage under Menu –> External Funding –> View and Submit your SSDF page. MedStar employees do not need to complete a SSDF.
Outside Investigators (Not Employed by Georgetown or MedStar Health)
Outside investigators (i.e., those who are not employed by Georgetown or MedStar and without access to GU-PASS and who are included on an initial or non-competing continuation sponsored research proposal) must submit a fillable Conflict of Interest Disclosure and SSDF using the links below.
- Download a Study-Specific Disclosure Form
- Download a General Disclosure Form – Outside Investigators Only
NOTE: Any Georgetown, MedStar Health, or outside investigator added after the time of the initial proposal must have a conflict of interest disclosure on file.