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 any individual 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 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
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).
View instructions for completing a MedStar COI-Smart disclosure.
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 are defined as individuals who are not employed by Georgetown or MedStar, and who are either included on an initial or non-competing continuation sponsored research proposal or as a study team member on an IRB protocol, and are affiliated with Georgetown through a SUA. Outside investigators must submit a fillable Conflict of Interest Disclosure and SSDF using the instructions and links below.
- Download a General Disclosure Form – outside Investigators on proposals, awards, or IRB protocols
- Download a Study-Specific Disclosure Form – for sponsored research proposals and awards only
NOTE: Any Georgetown, MedStar Health, outside investigator or volunteers added after the time of the initial proposal must have a conflict of interest disclosure on file.
Georgetown Global Health and Center for Global Health Practice and Impact
Georgetown Global Health (“GGH”) and the Center for Global Health Practice and Impact (“CGHPI”) are the recipients of U.S. Government funded grants and contracts (“Awards”) to conduct activities and engage in initiatives in various countries outside of the U.S. These Awards for research and programs are subject to U.S. Department of Health & Human Service’s (“DHHS”) conflict of interest regulations as well as Georgetown University’s Financial Conflict of Interest Policy. Both the DHHS regulations and Georgetown policy govern externally sponsored Awards and require that a conflict of interest disclosure be on file at time of proposal submission.
GGH and CGHPI Project Personnel, regardless of their job title, who are employed by Georgetown University and have a Georgetown Net ID must complete a conflict of interest disclosure prior to a proposal being submitted, if their role on the project involves any of the following:
- You are listed as Key Personnel;
- Unless otherwise specified in a Funding Opportunity Announcement (FOA), senior/key personnel are defined as all individuals who contribute in a substantive, meaningful way to the development or execution of the project, whether or not salaries are requested. Consultants should be included if they meet this definition.
- PIs, Co-PIs, Co-Investigators, and any other role on a proposal that would have their CV/Resume included, or any other personnel that would be included on a publishing is considered key personnel.
- You are not listed as key personnel but your work involves the design, conduct, or reporting of the project activity;
To facilitate this process, ORO initiates an annual disclosure process and utilizes GU-PASS as the system of record. For GGH employees, this is being launched in January and February 2024.
How to Complete your Conflict of Interest Disclosure
GGH and CGHPI Project Personnel who fit the above definitions but are not yet employed by Georgetown/GGH must complete their conflict of interest disclosure using this form:
- Download a GGH General Disclosure Form – GGH Personnel Only
GGH and CGHPI employees with a Net ID may complete their conflict of interest disclosures by logging into GU-PASS using their Georgetown NetID and password. Once in the system, click on the green button, “Financial COI Policy Disclosure,” complete the questions, and press “submit” to complete the process. Please note that if you have completed a conflict disclosure in the past, when you click on “Financial COI Policy Disclosure,” the system will open your previous disclosure and you can update it as needed, i.e., to add new information or delete outdated information. 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.”
Conflict of Interest Training
Named/Key personnel working on DHHS funded Awards must complete conflict of interest training at time of award and a refresher every four (4) years thereafter at the Collaborative Institutional Training Initiative (“CITI”). GGH and CGHPI employees are strongly encouraged to complete the CITI training prior to the start of the project. They are not permitted to work on the project nor be paid by the project prior to the completion of CITI training.
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.