Conflict of Interests in Research

Policy Purpose

To set forth the rules governing the disclosure and management of conflicts of interest, financial conflicts of interest, foreign interests, and conflicts of commitment related to research activities. For conflicts that do not fit this definition please contact the Campus Ethics Officer at Compliance and Resources site. This policy does not replace or supplant an employee’s obligation to comply with NYS Ethics Rules which may have different definitions and requirements.

Responsible Office

Research and Economic Development
Enterprise Risk Management

Responsible Executive

Vice President of Research and Economic Development
Chief Enterprise Risk Management Officer

Policy History

Publication Date:
Date of Permanent Approval:

Policy Statement

The University at Albany (UAlbany) is committed to promoting objectivity in research and to establishing ethical standards for the design, conduct and reporting of research to ensure that it is not biased by the financial interests or outside obligations of individuals acting on behalf of the university and to ensure integrity, transparency, and fairness in its operations by addressing potential conflicts of interest among its employees, officers, and stakeholders. A researcher's responsibilities and obligations to the University must be clearly separate from any personal financial interests or obligations. Researchers may not have significant financial interests in or engage in outside activities that result in unmanaged or unmitigated conflicts of interest.

Persons Affected

This policy applies to all students, faculty and staff who apply for, receive, or plan to participate in external research funding.
Policy

Who must Disclose – all UAlbany personnel (Investigators) who apply for or participate in sponsored programs that will have responsibility for the design, conduct or reporting of a project. Additionally, any person who will have responsibility for the design, conduct or reporting of a UAlbany project that is not affiliated with UAlbany or another institution with an equivalent Conflict-of Interest policy and disclosure requirements. UAlbany reserves the right to request disclosure of any UAlbany personnel as determined by Sponsored Programs Administration or the Office of Regulatory and Research Compliance.
What to Disclose – individuals are required to disclose all financial, personal, and professional interests, activities, and external relationships held by an Investigator or any member of their immediate family that may be reasonably related to the Investigator’s obligations to UAlbany, State University of New York (SUNY), or the Research Foundation for SUNY. This includes both foreign and domestic interests and obligations. Foreign interests include, but are not limited to, any foreign professional affiliations, compensation, grant support, in kind resources such as visiting scholars, laboratory space, materials or equipment, and any participation in talent programs.
How to Disclose – individuals are required to respond to requests for disclosure in Preaward And Compliance System (PACS). Upon receiving the request for conflict-of-interest disclosure, access PACS Portal, and answer all questions. Disclosures can be saved so that you can return to update them as needed. They are submitted by clicking finish.
When to Disclose – Disclosure is required upon initial application for external funding, annually each November, and whenever there is a change in significant financial interest, outside obligations, or foreign interests. Disclosures will be reviewed once received and if it is determined that a potential or actual conflict of interest or commitment exists, the Conflict-of-Interest Committee will review the details and develop a management plan to manage the risk. The management plan will be signed by the Investigator, Oversight Monitor and UAlbany representative, implemented and reviewed at least annually.
Training Requirements – all Investigators must complete, at least every four years, the CITI Program course: “Managing Conflict of Interest Training in Research Training” before submitting disclosures in PACS. The Conflict of Interest Committee (COIC) may require additional training, as appropriate, for the management of any actual or potential conflict of interest.
Contact: Office of Regulatory and Research Compliance [email protected] or (518) 437-3850
Effective Date This policy shall go into effect immediately upon approval.

Definitions

Conflict of Interest (COI) - occurs when the private interest of Investigators interferes with their responsibilities at UAlbany, either in practice or appearance. Relationships or activities with outside entities may impair an individual’s ability to be objective in the design, conduct, or reporting of sponsored research activities concerning their institutional responsibilities.

Equity Interest - includes any stock, stock option or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

Financial Conflict of Interest (FCOI) - exists when the institution's designated official(s) reasonably determines that an Investigators significant financial interest could affect the design, conduct, or reporting of the research.

Foreign government sponsored talent recruitment program - a foreign government sponsored talent recruitment program is an effort organized, managed, or funded be a foreign government, or a foreign government instrumentality or entity, to recruit science and technology professionals or students (regardless of citizenship or national origin, or whether having a full-time or part-time position).

NSPM-33 Implementation Guidance provides this definition and the following guidance: Some foreign government-sponsored talent recruitment programs operate with the intent to import or otherwise acquire from abroad, sometimes through illicit means, proprietary technology or software, unpublished data and methods, and intellectual property to further the military modernization goals and/or economic goals of a foreign government. Many, but not all, programs aim to incentivize the targeted individual to relocate physically to the foreign state for the above purpose. Some programs allow for or encourage continued employment at United States research facilities or receipt of Federal research funds while concurrently working at and/or receiving compensation from a foreign institution, and some direct participants not to disclose their participation to United States entities. Compensation could take many forms including cash, research funding, complimentary foreign travel, honorific titles, career advancement opportunities, promised future compensation, or other types of remuneration or consideration, including in-kind compensation.

Immediate Family Members - an individual’s spouse or domestic partner or person in a civil union or similar relationship, dependent children, or any other family members residing in the same household.

Institutional Responsibilities - an individual’s professional obligations on behalf of UAlbany, SUNY or the RF which include, but are not limited to, activities such as research, teaching, professional practice, and institutional committee memberships.

Investigator - the Project Director, Principal Investigator and any other person, regardless of title or position who is responsible for the design, conduct, or reporting of funded research, or proposed for such funding, and which may include for example, collaborators or consultants. Includes investigators who plan to participate in or who participate in funded research.

Malign Foreign Talent Recruitment Program - a Malign Foreign Talent Recruitment Program is defined as:

Any program, position, or activity that includes compensation in the form of cash, in-kind compensation, including research funding, promised future compensation, complimentary foreign travel, things of non de minimis value, honorific titles, career advancement opportunities, or other types of remuneration or consideration directly provided by a foreign country at any level (national, provincial, or local) or their designee, or an entity based in, funded by, or affiliated with a foreign country, whether or not directly sponsored by the foreign country, to the targeted individual, whether directly or indirectly stated in the arrangement, contract, or other documentation at issue, in exchange for the individual—
1. engaging in the unauthorized transfer of intellectual property, materials, data products, or other nonpublic information owned by a United States entity or developed with a Federal research and development award to the government of a foreign country or an entity based in, funded by, or affiliated with a foreign country regardless of whether that government or entity provided support for the development of the intellectual property, materials, or data products;
2. being required to recruit trainees or researchers to enroll in such program, position, or activity;
3. establishing a laboratory or company, accepting a faculty position, or undertaking any other employment or appointment in a foreign country or with an entity based in, funded by, or affiliated with a foreign country if such activities are in violation of the standard terms and conditions of a Federal research and development award;
4. being unable to terminate the foreign talent recruitment program contract or agreement except in extraordinary circumstances;
5. through funding or effort related to the foreign talent recruitment program, being limited in the capacity to carry out a research and development award or required to engage in work that would result in substantial overlap or duplication with a Federal research and development award;
6. being required to apply for and successfully receive funding from the sponsoring foreign government’s funding agencies with the sponsoring foreign organization as the recipient;
7. being required to omit acknowledgment of the recipient institution with which the individual is affiliated, or the Federal research agency sponsoring the research and development award, contrary to the institutional policies or standard terms and conditions of the Federal research and development award;
8. being required to not disclose to the Federal research agency or employing institution the participation of such individual in such program, position, or activity; or
9. having a conflict of interest or conflict of commitment contrary to the standard terms and conditions of the Federal research and development award; and
a program that is sponsored by:
1. a foreign country of concern or an entity based in a foreign country of concern, whether or not directly sponsored by the foreign country of concern;
  The list of “foreign countries of concern” includes the People's Republic of China, the Democratic People's Republic of Korea, the Russian Federation, the Islamic Republic of Iran, or any other country deemed to be a country of concern as determined by the Secretary of State. For questions as to whether a specific country or entity is “of concern” please contact the Office of Regulatory and Research Compliance at [email protected]
2. an academic institution or a foreign talent recruitment program on the list developed in the National Defense Authorization Act.
  The full reference for these lists can be found under section 1286(c)(8) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (10 U.S.C. 2358 note; Public Law 115-232).

Management Plan - an action plan that will reduce or eliminate an actual or potential conflict-of-interest and prevent or mitigate the harm that could arise from the conflict, and to the extent possible, ensure that the design, conduct, and reporting of research or other activities is free of bias.

Outside Activity - activity including ownership or investment in an outside business or enterprise, serving as a director, officer, partner, consultant, broker, agent, or representative of any outside enterprise, outside professional activity or other activity, or other employment.

Public Health Services (PHS) - A branch of the U.S. Department of Health and Human Service (HHS), and components of the PHS including but not limited to the: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).

Renumeration - salary and any payment for services not otherwise identified as salary.

Royalty - cash, equity, or other value received by UAlbany as consideration for license of rights to UAlbany intellectual property.

Significant Financial Interest (SFI) - A financial interest of the investigator (or their immediate family) that reasonably appears to be related to the investigator’s institutional responsibilities:

publicly traded entity remuneration, including travel, received in the twelve months preceding the disclosure; and the value of any aggregate equity interest exceeding $5,000
non-publicly traded entity remuneration, including travel, received in the twelve months preceding the disclosure if, when aggregated, exceeds $5,000, or when the investigator or his or her immediate family members hold any equity interest (e.g., stock, stock option, or other ownership interest)
intellectual property rights and interests (e.g., patents, copyrights), and royalties from such rights, upon receipt of income related to such rights and interest; royalties are included except when received by the investigator from SUNY or the Research Foundation for SUNY (RF) if the investigator is currently employed or otherwise appointed by the UAlbany, SUNY or RF
income received from foreign entities for seminars, lectures, teaching engagements, or service on advisory committees or review panels

SFI Exclusions:

Salary, royalty, or other remuneration paid to an investigator by UAlbany, SUNY or RF, when the investigator is currently employed or otherwise appointed by the UAlbany, SUNY or RF;
Intellectual property rights assigned to SUNY or the RF and agreements to share in royalties related to such rights;
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; and
Income received from U.S. based organizations for seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a federal; state; local government agency; an US institution of higher education; or an academic teaching hospital, a medical center, or a research institute that is affiliated with an US institution of higher education.

Significant Obligation - Positions held by an individual or his or her immediate family members as an officer, trustee, director, employee, or consultant of an outside entity whether or not the entity is for profit and whether or not the position is paid, that would reasonably appear to affect the individual’s institutional responsibilities.

Sponsored Project - Any externally funded research, training, evaluative testing, or public service project directed by UAlbany faculty or staff as part of their university work that requires the university to perform a specified program or deliver a specified product.

Sponsored Travel - Travel related to an investigator’s institutional responsibilities that is paid by a non-UAlbany entity on behalf of the investigator, and not reimbursed to the investigator so that the exact monetary value may not be readily available.