University of Miami >> Research >> Office of Research >> Disclosure Profile System (DPS) >> Glossary and Acronyms

Glossary and Acronyms

Acronyms

COIConflict of Interest
DPDisclosure Profile
DPSDisclosure Profile System
FCOIFinancial Conflict of Interest
FDFFaculty Disclosure Form
FIFinancial Interest
FOIFinancial/Obligatory Interest (definition Financial Interest or Obligatory interest)
HHSDepartment of Health and Human Services
IRInstitutional Responsibilities
IPIntellectual Property
NIH National Institutes of Health
OCOIObligatory Conflict of Interest
OIObligatory Interest
OPAOutside Professional Activities
ORAOffice of Research Administration
ORCOffice of Research Compliance
PDProject Director
PHSPublic Health Service
PIPrincipal Investigator
SFISignificant Financial Interest
TMTeam member
VPRVice Provost of Research










 

Glossary

Conflict of interest (COI) - An actual or potential interest that could directly and substantially (as determined by the Vice Provost for Research 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) in nature.

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

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

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

 

A.With regard to any publicly traded entity, a financial interest exists if the value of any remuneration received from the entity in the twelve 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); 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;


B.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 months preceding the disclosure exceeds $600, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock options (vested or unvested), or other ownership interest); or


C.With regard to Intellectual property (IP) 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.


Financial conflict of interest (FCOI) - 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.

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

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

Imminent - 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), or
  • is prepared to execute a contract with an outside entity.

Institutional responsibilities (IRs)- 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.

Intellectual Property - The filing of a thought or idea that could be protected. 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.

Investigator - 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

1) research irrespective of funding source, or

2) 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.

Key (Senior) personnel - 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 the University.

Manage - 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.

Obligatory interest - 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.

Obligatory conflict of interest (OCOI) - 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.

Outside professional activities (OPAs) - All non-University professional activities performed for remuneration, including lecturing, delivering professional advice, expert witness testimony, arbitration, government services, corporate board activities, royalties, and private practice (which is only allowed for services that do not violate UMMG by-laws or compete with services that are or could be offered by the University).

Public Health Service (PHS) – Federal government agency comprising the below agencies:
  • National Institutes of Health (NIH)
  • Food and Drug Administration (FDA)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)

PHS funded Investigator– Any Investigator who is paid from a University sponsored account funded by a PHS agency listed below:
  • National Institutes of Health (NIH)
  • Food and Drug Administration (FDA)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)

Research - A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic “bench,” “clinical” or applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term also includes any scholarly or educational activity for which external funding is available through a contract, grant or cooperative agreement.

Senior (Key) personnel - 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 the University.
(1) 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:

A.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;

B. 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 dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

C. 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.


(2) 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.

(3) For PHS funded Investigators this also includes any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to an Investigator’s institutional responsibilities that the Vice Provost for Research and/or his/her designee determines constitutes an FCOI with the Investigator’s funded research.

Sponsored activities - Externally-funded research or educational activities.

Team Member- Used interchangeaby with 'Investigator'. Any other person who could be responsible for the design, conduct, or reporting of
A) research (irrespective of funding source) and/or
B) scholarly or educational activities funded under external grants, contracts or cooperative agreements.
 
 
Additional DPS Pages
 
DPS Login
 
Overview
 
Instructions
 
FAQs
 
Glossary and Acronyms
 
CITI COI Training
 
UM COI Policy
 
RRS Compliance Status Tools
 
Contact Us
If you have questions or would like to arrange a presentation, please call the DPS help line (305-243-0877).
 
Office of Research
305-243-1790
Site Map
Emergency Preparedness
Employment
Privacy Statement and Legal Notices
Send Technical Feedback
Copyright 2014 University of Miami. All Rights Reserved.