Acronyms & Glossary

The process of a disclosure certification being reviewed for any conflicts of interest.

Investigator’s response to Management Plan. There are two options:
1. Accept
2. Request Clarification

An actual or potential interest that could directly and substantially (as determined
by the VPRS and/or his/her designee, acting on behalf of the Provost) affect the design, conduct, or reporting of funded research, or of scholarly and/or educational activities funded under external grants, contracts or cooperative agreements. COIs can be financial (FCOI) or obligatory (OCOI) innature.

Committee that meets to review disclosures and determine if there is a COI. The COIC also determines Management Plans for COIs

An entity providing property or services under contract for the direct benefit or use of an
awarding component.

Covered person means those individuals subject to the disclosure and other requirements specified in this Policy, which includes but is not limited to: 

• University Officials: Trustees, president and president's chief of staff; senior vice president, vice president, associate and assistant vice president, provost, vice provost, associate vice provost, and assistant vice provost; dean, vice dean, associate and assistant dean, associate and assistant vice-dean. 

• All faculty and other academic appointees of the University, including voluntary, full-time and part-time, and visiting scholars. 

• Graduate students, foreign students, postdoctoral associates, and volunteers. 

• Employees in key stakeholder departments. 

• All UMMG Faculty and all UHealth Clinical Providers, all UHealth/Miller School of Medicine Deans, Assistant/Associate Deans, Vice Presidents, Assistant/Associate Vice Presidents, and Vice Provosts , regardless of faculty status. UHealth includes Miller School of Medicine faculty or employees, a clinical provider who performs clinical services at UHealth, an affiliated volunteer who provides services to UHealth, or a full-time or part-time employee of a third party contracted with UHealth to provide temporary staffing services. 

• Individuals responsible for the design, conduct, or reporting of scholarly activities; this may include individuals that are not employees of the University and who do not have their own COI policy. 

A submission in the UDisclose System that confirms a set of a discloser’s interests
and other information at a certain point in time. Certifications can be “annual” or “research” based.

• Annual Certification - A Disclosure Certification that is required to be submitted once each year. A Disclosure Update is created/submitted any time a discloser’s interests change during the year and counts as the Investigator’s new Annual Certification for the next 11 months.
• Research Certification - A Disclosure Certification that is required to be submitted for each funded project and IRB study in which the discloser is involved. Research Certific

A “real-time” account of the review of a disclosure certification.

• Draft - The certification process has begun but has not been submitted.
• In Review - Certification has been submitted and is being reviewed for a possibleCOI.
• Under Management Plan - An agreed-upon plan put in place to manage a conflict ofinterest. ***If there are no conflicts of interest found in a review, the status will go from “In Review”to “Complete.”
• Complete - The certification process is complete, and the project is released from the DRM.

An Investigator’s (collectively, an educator, researcher, etc.; see
below) disclosure of financial interests to the University.

DSAM is the unit within the Office of the Vice Provost for Research and Scholarship (OVPRS) responsible for administering the disclosure system, process for disclosures to the University, and managing personal and institutional conflicts of interest related to scholarly activities. 

For the purposes of disclosure within this Policy means the spouse and dependent child of a Covered Person. If required for an incoming award or contract, this definition is expanded to include close family members, or of other members of the covered employee’s household. 

 

Anything of monetary value, whether or not the quantitative value is
readily ascertainable.

• With regard to any publicly traded entity, a financial interest exists if the value of any remuneration received from the entity in the twelve (12) months preceding the disclosure or the value of any equity interest in the entity as of the date of disclosure exceeds $600. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, travel). For purposes of this definition, 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; 
• With regard to any non-publicly traded entity, a financial interest exists if the value of any remuneration received from the entity in the twelve (12) months preceding the disclosure exceeds $600, or when the Covered Person (or the Covered Person's spouse or dependent children) holds any equity interest in the entity (e.g., stock, stock options (vested or unvested), or other ownership interest); or 
• With regard to Intellectual property (I.P.) rights and interests (e.g., patents, copyrights), a financial interest is considered to be present as soon as protection is sought (e.g., filing an invention disclosure, patent application, etc.). 

The term financial interest does not include the following types of interests: salary, royalties, or other remuneration paid by the University of Miami to the Investigator if the Investigator is currently employed or otherwise appointed by the University of Miami, including intellectual property rights assigned to the University of Miami 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; income from seminars, lectures, teaching engagements, service on advisory committees or review panels for, or sponsored by a United States 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

A financial interest that could directly and substantially affect the design, conduct, or reporting of funded research or scholarly and/or educational activities funded under external grants, contracts, or cooperative agreements.

The University’s report of a financial conflict of interest to a funding component.

This means a Covered Person who is an executive officer of or has a legal interest to act in the best interest of an entity or individual.

This means (regardless of amount) direct or indirect support for a student, postdoc for other visiting scholar to enroll in, train, conduct scholarly activities, or to otherwise visit the University. 

 

Foreign affiliation means a professional affiliation with a Foreign Source. "Professional affiliations" include, but are not limited to, extra-institutional titles and affiliations, activities, relationships, professional or academic appointments (paid or unpaid), regardless of the effort (full-time, part-time, or voluntary), including but not limited to, a foreign institution of higher education, a foreign public or private entity, the government of another country, or a foreign talent programs (e.g., Thousand Talents Program, National High-End Foreign Expert Recruitment Plan, Yangtze River Scholars). 

This includes, but is not limited to, income received for any publication, presentation or speaking engagement (such as a conference, symposium or presentation). "Income" also includes, but is not limited to, income that is unrelated to University institutional responsibilities, as well as income for events that took place within the U.S. 

This is any circumstance involving a Financial or Obligatory Interest in or with a non-US entity; monetary or non-monetary foreign support for scholarly activities, or any form of Financial Support (as defined above) received from a non-US entity that could influence the activities of a Covered Person at the University. 

 

This is 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 an individual, whether directly or indirectly stated in the arrangement, contract, or other documentation at issue, in exchange for that 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 a 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 a Federal research and development award. 

 

Any governmental agency that has promulgated regulations or policies requiring investigator financial disclosure or requiring institutional conflict of interest policies relating to the award of grants or contracts.

Funding is imminent when, for instance, a PD/PI

• Is informed that his/her funding proposal review received what appears to be a fundable score
• Wants to open a new account under guarantee of anticipated funding
• Receives a notice of grant award (NoGA)
• is prepared to execute a contract with an outside entity

Any situation in which the financial or fiduciary interests of the University or the personal financial or fiduciary interests of a Covered Person, either affect or to reasonably appear to affect the University's teaching, clinical care mission, or design, conduct, reporting, review, or oversight of scholarly activities. 

An Investigator’s professional responsibilities on behalf of the Institution. These may include, for example: activities such as research, research consultation, consulting, lecturing, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards, Data and Safety Monitoring Boards, or external advisory boards. Income from, or obligations arising from any outside activity that is related to the Investigator’s institutional responsibilities must be disclosed to the University. 

Means patentable or un-patentable inventions, discoveries, processes, compositions, research tools, data, ideas, databases, know-how, copyrightable works, and tangible property, including biological organisms, engineering prototypes, drawings, and software created, conceived, or made by Covered Persons within their normal duties (including clinical duties), course of studies, field of research or scholarly expertise or making more than incidental use of University's resources.

This means patent applications and patents, copyright registrations and renewals, trade secrets and trademarks. 

The project director (PD), principal investigator (PI), co-principal investigators, and any other
person who could be responsible for the design, conduct, or reporting of:

• Research irrespective of funding source
• Scholarly and/or educational activities funded under external grants, contracts or cooperative
  agreements. 

“Investigator” is used to collectively indicate individuals whose role could be described as an educator, researcher or investigator. This includes sub-awardees, sub-contractor(s), consultants and “to be appointed” positions as well as any individual whose biographical sketch is included in the proposal or whose name appears in the budget (including subcontract budgets). The Investigator also includes the investigator’s spouse and dependent children. The phrase “team member” is used interchangeably with Investigator

The PD/PI and any other person identified as senior/key personnel in the grant application, progress report, or any other report submitted to the funding agency by theUniversity

Taking action to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

This means a Foreign Source provided monetary resources that supports University scholarly activities. "Monetary resources" does not include grants, contracts, or gifts awarded/given to University "Scholarly activities" includes, but is not limited to, consulting on a research study; serving as a Principal Investigator for another institution; and teaching and/or mentoring graduate students, publications, presentations, and speaking engagements, such as at a conference or symposium. 

This means a Foreign Source provided any non-monetary resources that support University scholarly activities. "Non-monetary resources" includes, but is not limited to, equipment, materials, or personnel provided or made available for scholarly activities. "Non-monetary resources" do not include resources arranged through the University as Unfunded Agreements (UFAs), such as material transfer agreements and/or data use agreements, library access at another institution generally provided to external academics or faculty members, resources included in the proposal of a funded sponsored award managed through the University. 

A relationship (regardless of compensation) that involves a responsibility or commitment to an external entity, including but not limited to being a founding member of that entity, or holding scientific advisory or governing board membership.

A responsibility or commitment that could directly and substantially affect the design, conduct, or reporting of funded research, or of scholarly and/or educational activities funded under external grants, contracts or cooperative agreements.

Any non-University scholarly activities. Examples include, but are not limited to, consulting on a research study; serving as a Principal Investigator or investigator for another institution; and teaching and/or mentoring graduate students at an entity, irrespective of whether the scholarly activities took place inside or outside of the United States but does not include guest speaker engagements or collaborations that are included in the proposal of a funded sponsored award managed through the University. 

It means the United States Public Health Service, and refers to the agencies of the PHS. 

Any Investigator who is paid from a University sponsored account funded by a PHS agency listed above.

A funding entity whose policies require that UM abide by PHS regulation in order to accept their funding. 

Any discloser can designate a proxy who will be able to create and update that individual’s
disclosures. However, a proxy cannot submit disclosure certifications on behalf of someone else; these must be submitted by the actual discloser

This means an interest that involves the same or similar focus (academic discipline, disease or injury, molecular target, drug, or device, digital technologies, and platforms) as some aspect of the Covered Person's Institutional Responsibilities.  

To embrace inquiry, research, and creative professional performance, create and/or advance existing knowledge, and broaden the intellectual advancement in areas related to a Covered Person's discipline and the University community. Incorporating a Covered Person's Institutional Responsibilities, examples include, but are not limited to teaching, performing research, conducting clinical studies, participation in University service and administration, shaping public policy, editing journals, consulting, and writing or performing.  

This means the Project Director/Principal Investigator and any other person identified as senior/key personnel in a grant application, progress report, or any other report submitted to a funding or government agency by the University. 

A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be
related (associated with a common idea or practice) to the Investigator’s institutional responsibilities:

• With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, travel); 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;
• With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependentchildren) holds any equity interest (e.g., stock, stock option, or other ownership interest);or
• Intellectual property rights and interests (e.g., patents, copyrights) become SFIs when an individual receives an aggregated income of $5,000 or more from one entity for said rights and interests.

The term significant financial interest does not include the following types of interests: salary, travel, royalties, or other remuneration paid by the University of Miami to the Investigator if the Investigator is currently employed or otherwise appointed by the University of Miami, including intellectual property rights assigned to the University of Miami 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; income from seminars, lectures, teaching engagements, service on advisory committees or review panels for or sponsored by a United States 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. 

For DOE, PHS and PHS-like-funded Covered Persons this also includes any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Covered Person and not reimbursed to the Covered Person so that the exact monetary value may not be readily available), related to a Covered Person's Institutional Responsibilities that the Vice Provost for Research and Scholarship and/or their designees determines constitutes a financial conflict of interest with the Covered Person's scholarly activities. 

Externally-funded research or educational activities.

A State represents one step in the workflow process. As users execute activities in the system, a disclosure certification moves from one state to another.

Used interchangeably with ‘Investigator’. Any other person who could be responsible for the
design, conduct, or reporting of: 

• Research (irrespective of funding source) and/or
• Scholarly or educational activities funded under external grants, contracts or cooperativeagreements.

Within the UDisclose System, certifications are completed once (and updated when necessary) for a research project. The Project ID corresponds to the FP or IBIS number assigned to a funded research project at the time it was entered into the UDisclose System. 

A series of pages (such as Institutional Responsibilities, Disclosure Details) in a form with built-in logic that determines which pages need to be completed. By clicking the Continue button in a SmartForm, the discloser will be guided through the process of submitting his/her disclosures.  

In the DPS, team members were required to complete disclosure certifications for every year of awarded funding, designated by separate InfoEd numbers. Within the UDisclose System,
certifications are completed once (and updated when necessary) for a research project. The Project ID corresponds to the FPnumber assigned to a funded research project at the time it was entered into the UDisclose System.

A series of pages (such as Institutional Responsibilities, Disclosure Details) in a form with built-in logic that determines which pages need to be completed. By clicking the Continue button in a SmartForm, the discloser will be guided through the process of submitting his/her disclosures.

UHC is the department responsible for identifying and preventing criminal and unethical conduct, creating a centralized source of information on health care regulations, developing and monitoring mechanisms for reporting non-compliance, investigating alleged misconduct, initiating immediate and appropriate corrective action, and reducing UHealth's exposure to civil, criminal and administrative penalties. The department is comprised of the Office of Regulatory Compliance, Educational Initiatives, HIPPA and Privacy Compliance, and Billing Compliance.  

 

UCS is the central University office with the collaboration of the Office of the Secretary of the Board of Trustees, administers the system and processes for disclosures of conflicts by the Trustees, officers, and other key personnel.