Date Established: 3/25/2013
Date Last Revised: –
Vice President for Research and Economic Development
Vice President for Research and Economic Development
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The University at Buffalo recognizes its obligation to protect the rights and welfare of human subject research participants and to ensure research integrity. Accordingly, all potential Institutional Conflicts of Interest in human subjects research require disclosure, evaluation, and management or elimination.
The University at Buffalo (UB, university) strives to ensure that its research, teaching, public service, and other activities are not compromised or perceived as biased by business and financial considerations. The breadth of university activities and the variety of its relationships may lead to an actual or perceived institutional conflict of interest that must be resolved appropriately.
Potential institutional conflicts of interest (ICOI) must be identified promptly and managed or eliminated before any contract, sponsored project, dedicated gift, or transaction is executed; any contractual relationship is initiated; or any action is taken that might be influenced or appear to be influenced by the conflict of interest.
An ICOI may occur in human subjects research when a business and financial interest of UB affects or appears to affect the design, conduct, reporting, review, or oversight of human subjects research. ICOIs are of significant concern when they create the potential for inappropriate influence over a human subjects research project, particularly to the integrity of the research and the safety and care of subjects enrolled in the research. All potential ICOIs in human subjects research require disclosure, evaluation, and either management or elimination.
An ICOI may exist in human subjects research when:
Covered individuals with direct responsibility for human subjects research are required to complete a Disclosure Statement annually, and within 30 days of discovering or acquiring a new significant financial interest (SFI) that includes information pertaining to the following SFIs of the covered individual and their immediate family members:
The following offices will report semi-annually to the COI Officer:
An ICOI may involve any university activity carried out in the pursuit of the university’s mission. Of significant concern are conflicts that create the potential for inappropriate influence over human subjects research, particularly to the safety and care of subjects enrolled in the research and the integrity of the research. An ICOI exists when:
An individual who has concerns about the permissibility of any relationship or activity on the part of the University or its personnel involving an external relationship should promptly consult the COI Officer. If, after examination of the situation, the COI Officer determines that a potential ICOI exists or poses significant potential for public perception of an ICOI, the COI Officer will refer the matter to the Conflict of Interest Committee (COI Committee). The COI Committee will review the matter and recommend a plan to manage or eliminate the potential ICOI.
Employees making good faith reports of suspected conflicts of interest are protected from retaliation. Acts of retaliation or reprisal against an individual for reporting in good faith a potential ICOI is a violation of this policy.
This policy applies to all university personnel with direct responsibility for human subjects research including administrators, faculty, and staff (covered individuals), who are in a position to make decisions, including those delegated such authority, for all university entities.
Persons with direct responsibility for human subjects research who have, or have been delegated, the authority to make decisions on behalf of the university including, but not limited to:
• Vice President for Research and Economic Development
• University official identified in federal-wide assurance for the protection of human research subjects
• Deans, department chairs, and directors.
Immediate Family Members
Includes an individual’s spouse, domestic partner, or person in a civil union or similar relationship, dependent children, or any other family members residing in the same household.
Institutional Conflict of Interest (ICOI)
Exists where a business and financial relationship between the university and an external entity compromises the integrity of institutional decision-making. Such conflicts may arise in situations:
• when covered individuals who act on behalf of the university have personal business and financial interests that may be affected by their administrative decisions; in these situations, an individual’s business and financial relationship also implicates the university’s interests
• where the university enters into a business and financial relationship at the institutional level with an external entity that may bring financial gain to the University or any of its units, such as:
· intellectual property
rights owned by SUNY/RF which has been licensed to an outside
entity in exchange for equity royalties or other forms of financial
· public or private equity held by the university in an outside entity that is a sponsor of human subjects research overseen by the Institutional Review Board (IRB)
· stock or other equity holdings included as part of SUNY/RF’s investment and endowment portfolio
· money or other non-monetary resources provided to SUNY/RF by an external entity or individual.
An ICOI may involve any university activity carried out in the pursuit of the university’s mission. Of significant concern are conflicts that create the potential for inappropriate influence over human subjects research, particularly to the safety and care of subjects enrolled in the research and the integrity of the research.
Principal Investigator (PI)
A UB faculty or staff member who bears responsibility for the intellectual leadership of a project. The PI accepts overall responsibility for directing the research, financial oversight, and compliance with relevant university policies and sponsor terms and conditions.
Significant Financial Interest
A financial interest consisting of one or more of the following interests of a covered individual (and those of their immediate family members) that reasonably appears to be related to the individual’s institutional responsibilities:
• ownership of more than 10% of the voting interest
• ownership of more than 10% of the fair market value
• service as a member of the board of directors or other governing body, including a trustee or advisory director
• service as an officer
• service as an employee.
Annually, and within 30 days of discovering or acquiring a new SFI, covered individuals must submit a Disclosure Statement that includes information pertaining to their and their immediate family members’ SFIs.
Using the semi-annual reports submitted by STOR and UBF, the COI Officer will develop a list of UB business and financial interests and provide it to the IRB.
The IRB will review all protocols to determine if the project’s sponsor is included on the UB business and financial interests list. If the sponsor is found on the list, the IRB will forward the protocol to the COI Officer to determine if an ICOI exists.
The review, evaluation, and approval of the ICOI management plan must be completed prior to the commencement of the project (including enrollment of research subjects).
The COI Officer will annually report all ICOIs to the Vice President for Research and Economic Development.