Policy Approval Authority | President |
Responsible Division | Division of Research and Innovation Partnerships |
Responsible University Office | Office of Research Compliance Integrity and Safety |
Responsible Officer(s) | Director |
Contact Person | Shannon Stoker |
Primary Audience |
Faculty
|
Status | Active |
Last Review Date | 03-14-2024 |
Policy Category/Categories |
Research Ethics / Intellectual Property
|
Effective Date: 11/01/12
Update: 12/03/19; 12/14/2020; 03/2024
Revision No. 4
Approval: Vice President for RIPS
Introduction
Definitions
Requirements
Investigator Responsibilities
Institutional Responsibilities
Management Plan
Non-Compliance
Retrospective Review
Mitigation Report
Records
Public Accessibility
Northern Illinois University (NIU) strives for excellence in research. To reach this goal the public's trust is required. Maintaining public trust means ensuring NIU's research activities are not perceived as biased by financial and/or business relationships.
It is accepted NIU faculty members, and their families may have financial relationships outside the university. NIU must be aware of these relationships to make sure there is no room for perceived bias in PHS and DOE funded research. If there is a possibility of perceived bias, a financial conflict of interest (FCOI) exists and it is NIU's responsibility to eliminate, reduce, or manage the FCOI.
This policy expands upon NIU’s Academic Conflicts of Interest (COI) Policy. It is applicable to all PHS and DOE funded investigators and is in accordance with 42 CFR 50, Subpart F, and 45 CFR 94, and 2 CFR 200.112
NIU requires that any PHS and DOE sub-recipients at other institutions verify their institution has a FCOI policy equal to or more stringent than NIU's policy. If the sub-recipient institution does not have a FCOI policy they must agree to follow NIU's policy.
“Financial Conflict of Interest” means a significant financial interest that is related to a research program or project and could directly and significantly affect the design, conduct or reporting of that research.
“Institutional Responsibilities” means the Investigator’s professional responsibilities on behalf of the university including, but not limited to, activities such as research, consultation, teaching, professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring boards.
“Investigator(s)” means the principal investigator/project director, co-principal investigator, and any other person who is responsible or involved in the design, conduct, or reporting of research, instructional or service activities funded, or proposed for funding, by an external sponsor. For the purposes of the requirement relating to financial interest, investigator includes spouses and dependent children.
“Research” means any systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product testing and development. It includes any activity for which research funding is available from a Public Health Service component that awards funds under grants, cooperative agreements, or otherwise.
"Significant Financial Interest" A financial interest consisting of one or more of the following interest of the Investigator (and/or those of the Investigator's spouse and/or dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:
The term does not include the following:
In accordance with PHS and DOE regulations institutions must comply with the following requirements:
The principal investigator is responsible for:
The Office of Research Compliance, Integrity, and Safety (ORCIS) will collect and perform an initial review of all disclosed SFIs to determine if a FCOI exists. If a determination has been made that a FCOI does exist, the matter will be referred to the VPR for the final decision.
If a determination is made that there may be a potential or actual FCOI by the VPR, ORCIS will develop a management plan (see below) to address the FCOI. This can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
ORCIS will also report to the federal government funders if it believes an investigator’s significant financial interest could affect the research in accordance with 42 CFR 50, subpart F, 45 CFR 94, and 2 CFR 200.112.
When a Significant Financial Interest determined to constitute a Financial Conflict of Interest exists ORCIS may recommend a Conflict of Interest Management Plan. The plan is developed after discussion by the the Investigator, ORCIS, department, college and/or approval by the Institutional Review Board if human subjects are involved. The following steps are required when implementing a management plan:
An investigator may appeal the recommendation to the IRB for research pertaining to human subjects, or to the VPR itself for non-human subjects research. An investigator dissatisfied with his/her appeal may submit his/her disagreement in writing to the Provost for final resolution.
When an investigator is found to have violated this policy or the terms of the management plan, ORCIS may recommend sanctions be imposed consistent with NIU policy and collective bargaining agreements.. In cases of violation, the VPR will notify the appropriate funding agency.
Identification of untimely or any delayed disclosure of an SFI by an investigator requires the ORCIS’ review within 60 days of determination: if it’s related to the funded research, and if an FCOI exists. Such a determination requires:
As appropriate, the institution shall update the previously submitted FCOI report specifying the actions taken to manage the FCOI moving forward. If the institution determines there was bias it must notify the awarding component promptly and submit a mitigation report to that component. The mitigation report must include:
Records of the Investigator’s significant financial interests and NIU’s review and management of the SFI, will be retained by the university for (i) three years from the date of submission of the final expenditures report (in the case of grants and cooperative agreements); or (ii) three years from the final payment (in the case of research contracts), or (iii) resolution of any government action involving the records, or (iv) as otherwise required by law.
Prior to any expenditure of funds, NIU will ensure the FCOI information will be accessible to the public providing for written responses to requests within 5 business days based, on the following criteria, within reason:
NIU must make the following information available in writing (or on its website):
Policy Library
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