SUNY Downstate Medical Center
Conflicts of Interest
Filing an Electronic Disclosure with COI SMART
A conflict of interest can jeopardize the integrity, objectivity, and viability of DMC research projects. In addition, State, Federal and sponsor scrutiny leave little room for error in identifying and managing these conflicts.
COI SMART is a web-based application that automates and organizes the process of conflict of interest disclosure. Its automated interface features a 'smart form' that enables users to quickly and conveniently submit the DMC Financial Disclosure Form. COI SMART will maintain electronic copies of all Investigators' Form submissions, and, for your convenience, COI SMART will auto-populate previously submitted information / answers so they will not have to be re-entered year after year. COI SMART has security controls that enable disclosures to be maintained securely and privately.
COI Electronic Disclosures - Who Must File
Conflicts of Interest Disclosure Forms must be submitted by all funded and unfunded Investigators.
Investigator: The project director, Principal Investigator, co-Principal Investigator, personnel who are considered to be essential to work performance or any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research. The PI is responsible for identifying all Investigators involved in their research activities. If the role of an individual is unclear and that individual is listed as an Investigator, compliance with all training and filing requirements will be expected.
Note - Transient staff and trainees, such as medical students, residents and fellows, who may recruit patients and/or collect and handle data under supervision, but are not key to the design, conduct or reporting of research are not considered Investigators for purposes of COI. In addition, staff or trainees who merely implement a protocol developed by an Investigator or enter data into an electronic data capturing system are also not considered Investigators for purposes of COI.
Any individual who is required to submit a Conflicts of Interest Disclosure Form must also complete Conflicts of Interest Training
COI Electronic Disclosures - When and How to File
Disclosures are required in four instances:
- Annual Disclosures: The DMC Financial Disclosure form for all Investigators must be submitted on an annual basis.
- Submission of Application for Grant/Award: Investigators are required to submit the DMC Transactional Disclosure Form (Declaration of Research Project) at the time of an application for a sponsor grant or award.
- Submission of an IRB Protocol for Human Research: Investigators are required to submit the DMC Transactional Disclosure Form (Declaration of Research Project) at the time of submission of an IRB protocol for unfunded research, at the time of an amendment to be added to an IRB application and at the time of IRB Continuing Review.
- New Disclosures: An updated DMC Financial Disclosure Form must be submitted within thirty (30) days of a new Outside Activity or interest that falls under this policy.
Please note that Investigators who do not complete an annual disclosure and/or a required declaration of new research project transactional questionnaire will be restricted from study approval and will have holds placed on any award account expenditures. This pertains to all research staff who meet the COI definition of "Investigator" as identified by the Principal Investigator for each particular study
|Reason for Filing a Disclosure:||Instructions:|
|Annual Disclosure||To File your annual disclosure use the link at the bottom of this page to log on to COI SMART. Then select the "2017 DMC Financial Disclosure Form" and answer all questions.|
|Revising an Annual Disclosure||To File a revision to your annual disclosure - if there has been a material change to the interests you disclosed in your annual questionnaire - use the link at the bottom of this page to log on to COI SMART. From there, please select the "2017 DMC Financial Disclosure Form," then click submitted to revise your 2017 DMC Financial Disclosure Form.|
|Declaration of Research Project||To Submit a "DECLARATION OF RESEARCH PROJECT" TRANSACTIONAL QUESTIONNAIRE use the link at the bottom of this page to log on to COI SMART. From the home screen find the button "Click here to access a new Transactional Questionnaire." Then select "Declaration of Research Project" from your Transactional Questionnaires queue and complete all questions. NOTE - your DMC Financial Disclosure Form (Annual Disclosure) must be submitted and up-to-date prior to your submission of a Declaration of Research Project (transactional questionnaire).|