Compliance → Conflict of Interest
encourages faculty and staff interactions with government agencies and
industry. External corporate relationships enrich teaching and research,
expand career opportunities for students, and provide a mechanism for
the translation of university developed intellectual property into
UMSL has policies and procedures related to potential conflict of interest related to GRANTS and for that related to TECHNOLOGY TRANSFER (e.g., licenses, startup companies, etc.).
Financial Conflict of Interest: Grants
The FCOI guidelines and forms discussed here are applicable to all research funding by the Public Health Service (PHS) and the National Science Foundation (NSF). See a list of PHS agencies in the right-hand column of this page.
In response to increased public scrutiny and concern about conflicts of interest at research institutions, the Public Health Service (PHS) has redrafted its conflict of interest regulations (42 CFR Part 50 Subpart F
and 45 CFR Part 94
). This increased public scrutiny is a result of both the increase in relationships between researchers and industry and the increased rate at which research is brought from the bench to the market place. Strengthening the existing regulation on managing financial conflicts of interest is key to assuring the public that the institutions PHS supports are taking a rigorous approach to managing the essential relationships between the government, federally funded research institutions, and the private sector. These revised regulations are effective as of August 24, 2012. Submissions on or after 8/24/12 or awards with an issue date of 8/24/12 or later are subject to the following:
- All Investigators are required to complete CITI Conflict of Interest training every four (4) years.
- An annual FINANCIAL DISCLOSURE FOR SPONSORED PROJECTS PHS & NSF form FCOI-1 is required to be on file (IRBNet) and dated within the 12 months preceding a proposal. If not within the 12 month period or a change in status has occurred, an update filing is required.
- INVESTIGATOR FORM FCOI-2 is required for all submissions identifying all investigators. It is the responsibility of the Principal Investigator to insure that all “investigators” have completed Conflict of Interest training and have an active Financial Disclosure for Sponsored Project form FCOI-1 on file before submission of grant. Note that Collaborators and Consultants are also required to complete an annual Financial Disclosure for Sponsored Projects PHS & NIH form FCOI-1.
PHS has provided the following guide for determining who is an investigator.
§50.603 Definitions: Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
PHS comments about the Investigator definition:
“…the definition of “investigator” has been revised in the final rule to emphasize that Institutions should consider the roles of those involved in research and the degree of independence with which those individuals work.”
“…we note that the definition refers to the function of the individual on the PHS-funded project; i.e. his/her responsibility for the design, conduct or reporting of the PHS-funded research, and not to his/her title or the amount and /or source of remuneration.” This broad definition may include post-doctoral associates, graduate students, etc.
Prior to Submission for all Federal and Federal Flow-Through Funding from PHS and NSF:STEP 1: CITI Training, Conflict of Interest Mini Course
Required for all investigators identified on the UMSL Investigator Form. Training is required prior to submission of the proposal and every four (4) years thereafter. Instructions to Access and Complete the CITI Mini CourseSTEP 2: UMSL Financial Disclosure for Sponsored Projects Form (FCOI-1)
Required for all investigators identified on the UMSL Investigator Form. Must be on file in IRBNet and dated within 12 months preceding a proposal. If not dated within the 12-month period prior to submission or a change in status has occurred, an updated filing is required. Instructions to Access, Complete and Submit FCOI-1STEP 3: UMSL Investigator Form (FCOI-2)
Must be included with the your signature page and PeopleSoft submission pages. NOTE: The ORA will ask you to review the Investigator Form at time of award and update the form whenever changes occur throughout the life of the project. UMSL Investigator Form (FCOI-2)Prior to Submission for Funding from Non-Federal and Other Sponsors Not Adopting the New FCOI Regulations:STEP 1: UMSL Financial Disclosure for Sponsored Projects Form (FCOI-1)
Required for all investigators identified on the UMSL Investigator Form. Must be on file in IRBNet and dated within 12 months preceding a proposal. If not dated within the 12-month period prior to submission or a change in status has occurred, an updated filing is required. Instructions to Access, Complete and Submit FCOI-1
Financial Conflict of Interest: Technology Transfer
interactions with the private sector carry potential for conflict of
interest, or the perception of such conflicts. To address the issue, the
University of Missouri System has developed conflict of interest
policies (see Collected Rules & Regulations 330.015
Faculty and staff engaged in activities involving external entities that may trigger conflicts of interest are required to submit a potential conflict of interest disclosure (see IRBNet for instructions and submission). A case that often arises in technology transfer regarding potential conflict of interest is when the University is negotiating a license with a faculty startup company. In such situations, the faculty members involved must submit and have reviewed/resolved a potential conflict of interest disclosure (and such disclosure must be available for public review for 10 days) before a license can be signed.
If you have any questions on conflict of interest related to technology transfer (licensing, startup companies, etc.) or the related COI Committee at UMSL, please contact Tamara Wilgers (314-516-6884).