Glossary & FAQ
For each of the employee types listed below, the corresponding authority to receive the disclosure is listed.
·Faculty - Department Chair and, as required by the Dean/Director, to the Dean/Director
·Faculty Member without a Dept. Chair- Dean or Director
·Department Chair- Dean
·Executive Committee Member- Officer to whom he or she is accountable.
·President- Chair of the Board of Directors
·Any employee not mentioned above- The Director (or middle management equivalent) unless the Executive Committee member to which the employee's unit is accountable designates someone else.
Business - (verb, e.g., to do business): Any patient care, research, teaching, or similar OHSU activities; purchasing of goods and/or services for the provision of OHSU activities; contracting or attempting to contract for the provision of goods and/or services to be used in OHSU activities.
Business (noun, e.g., a business):
Any corporation, partnership, sole proprietorship, limited liability company, limited liability partnership, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes, but excluding OHSU, any affiliated hospital, any private medical practice, or any other entity controlled by, controlling, or under common control with OHSU.
Conflict of Interest: A conflict of interest exists when an employee's financial interests or other obligations interfere, or appear to interfere, with the employee's obligations to act in the best interest of the University and without improper bias. The mere appearance of a conflict may be as serious and potentially damaging to the public trust as an actual conflict. Therefore, potential conflicts must be disclosed, evaluated, and managed with the same thoroughness as actual conflicts.
Conflict of Interest in Research (CoIR) - A determination by the designated official that a significant financial interest (SFI) might affect, or reasonably appear to affect, the design, conduct, or reporting of research. Such situations may require management, but may not be found to constitute a FCoI as defined below.
Entity- Any corporation, partnership, sole proprietorship, limited liability company, limited liability partnership, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes, but excluding OHSU, any affiliated hospital, any private medical practice, or any other entity controlled by, controlling, or under common control with OHSU.
Executive Position - Any position which includes responsibilities for a material segment of the operation or management of a business. This would include a position on a Board of Directors.
Exempt Outside Activity- Pro-bono professional activities by any employee or faculty member; participation in an approved practice plan (a faculty practice plan approved by the President or adopted by OHSUMG); joint or dual appointments with OHSU and the VAMC (with prior approval by Department Chair); unpaid (other than expense reimbursements and modest honoraria -defined as $5,000 or less annually) service for or on governmental or not-for-profit entities, committees, or professional associations.
Family: A spouse, registered domestic partner, and dependent child/children.
Financial Conflict of Interest (FCoI): A determination by the designated official that a significant financial interest (SFI) could directly and significantly affect the design, conduct or reporting of the PHS-funded research.
Financially Interested Business: Any business with financial interests that would reasonably appear to be affected by the conduct or outcome of any of your current or proposed research projects (including the sponsor of the research and/or the manufacturer, owner, assignee, or licensee of an investigational product or technology used in the research). This term includes businesses that compete with the sponsor or the manufacturer/licensee of an investigational product, if the covered individual actually knows that the financial interests of such a business would reasonably appear to be affected by the research. This term also includes any entity acting as the agent of a financially interested business (e.g., a contract research organization).
Financial Interest- Any equity interest (e.g. stocks, stock options, warrants, contractual rights to acquire or receive ownership interests other than interests in a diversified mutual fund); compensation (anything of monetary value); or intellectual property rights.
Institutional Responsibilities: Investigator's professional responsibilities on behalf of OHSU, which include, but are not limited to, activities such as research, teaching, professional practice, committee memberships, and service on panels such as Institutional Review Boards or Data And Safety Monitoring Boards.
Intellectual Property- Intellectual property includes any invention or improvement in technology, whether patentable or not, conceived or developed using the expertise for which an employee is employed by OHSU, OHSU facilities, personnel, information, or other resources; educational professional or tangible materials, whether or not registered for copyright or trademark, that result from the instructional, research, or public service activities of OHSU; and data developed using OHSU facilities, personnel, or other resources or resulting from the instructional, research, or public service activities of OHSU.
Investigator: The principal investigator, co-investigator and other OHSU employees or volunteers, or any OHSU research collaborator, including visiting scientists, responsible for the design, conduct or reporting of research or educational activities or responsible for preparing a proposal for research funding.
In the Report on Individual Financial Interest in Human Subjects Research, the Association of American Medical Colleges (AAMC) defines the conduct of research as: "Conducting Research means, with respect to a research protocol, designing research, directing research or serving as the principal investigator, enrolling research subjects (including obtaining subjects' informed consent) or making decisions related to eligibility to participate in research, analyzing or reporting research data, or submitting manuscripts concerning the research for publication."
Outside Activity- Any activity engaged in by an OHSU employee but not in the employee's job description and not reimbursed by OHSU.
Outside Business: Any business (see definition above: business-noun) that is not affiliated with or controlled by OHSU
Participate: To be part of the described activity in any capacity or position that may influence an outcome.
Related Outside Activity: Any Outside Activity (OA) that requires the employee to use the academic, professional, or institutional expertise for which he/she is employed by OHSU; an OA conducted at OHSU owned or controlled premises or that uses OHSU facilities or support; or an activity that interferes with the employee's duties to OHSU, including but not limited to his/her time commitments.
Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. As used in OHSU policies, the term "research" encompasses basic and applied research and product development.
Significant Financial Interest (SFI) includes the following interests of the discloser (and those of the discloser's spouse or registered domestic partner and dependent children
1) Compensation: i.e., anything of monetary value including, but not limited to, salary, gifts, consulting fees, honoraria or other payments for services that is more than five thousand US dollars ($5,000) in the aggregate over the last twelve (12) months;
2) Equity interests: e.g. stocks, stock options, warrants, contractual rights to acquire or receive ownership interests, or other ownership interests in a publicly-traded company that is more than five thousand US dollars ($5,000) in the aggregate over the last twelve (12) months or any amount in a non-publicly-traded company;
3) The aggregated value of equity interest and compensation, as defined above, that exceed $5000 over the last twelve (12) months in a publicly-traded company;
4) Intellectual property rights: e.g. patents, copyrights and royalty income or the right to receive future royalties under a patent license or copyright;
5) Non-royalty payments or entitlements to payments in connection with the research that are not directly related to the reasonable costs of the research (e.g. bonus or milestone payments to the investigators in excess of reasonable costs incurred);
6) Service as an officer, director, or in any other executive position in an outside business, whether or not remuneration is received for such service; and
7) Reimbursed or sponsored travel applies only to travel by investigators (and their spouses) if they are involved Public Health Service funded research. Disclosures shall include the purpose of the travel, the identity of the sponsor/organizer, the destination and the duration of the travel, and any other information as requested by the disclosure form or designated official. See exceptions in (6) below.
Exceptions: Significant financial interests do not include the following:
(1) Interests of any amount in publicly traded, diversified mutual funds or retirement accounts so long as the investigator does not directly control the investment decisions made in these vehicles.
(2) Payments to the institution, or via the institution to the individual, that are directly related to reasonable costs incurred in the conduct of research as specified in the research agreement(s) between the sponsor and the institution.
(3) Salary and other remuneration from OHSU, including approved faculty practice plan earnings and the distribution of those earnings that may be established by departmental or other similar agreements provided that those agreements and departmental/divisional group plans are approved by the President.
(4) Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
(5) Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
(6) Reimbursed or sponsored travel that does not exceed $5,000 from any one entity in a 12-month period AND/OR travel that is reimbursed by a federal, state or local government agency, an Institution of higher education, an academic teaching hospital, or a research institute that is affiliated with an Institution of higher education.
Student: Any person enrolled in an OHSU undergraduate or graduate program, postdoctoral fellows, interns, or other trainees