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Terms and Definitions Terms and Definitions Business Entity

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Terms and Definitions Terms and Definitions Business Entity Powered By Docstoc
					Terms and Definitions

Business Entity: Any corporation, partnership, sole proprietorship,
firm, franchise, association, organization, holding company, joint stock
company, receivership, business or real estate trust or other legal
entity organized for profit as well as nonprofit entities that may
provide support to Investigators as salary, consulting, or board
compensation. The term does not include LSUHSC-S or any other
entity controlled by LSUHSC-S. For Investigators, a Business Entity
does not include a client to whom they provide professional services as
an individual and outside of their LSUHSC-S duties.

Compelling Circumstances: Those facts that when presented
convince the Conflict of Interest Committee that a financially
interested individual should be permitted to participate in a sponsored
project or conduct human subjects research. When considering a
request by a financially interested individual to participate in a
sponsored project or conduct human subjects research, the COI
Committee will evaluate:
   1. the nature of the research
   2. the magnitude of the interest and the degree to which it is
      related to the research
   3. the extent to which the interest could be directly and
      substantially affected by the research
   4. the degree of risk to the institution or to a human subject
      involved that is inherent in the research protocol.

The COI Committee will also consider the extent to which the interest
is amenable to effective oversight and management.

Compensation: Income or monetary value given in return for
services. All compensation (i.e., dollar value equal to or greater than
$1.00) must be reported.

Conducting Research: With respect to research protocols, is defined
as designing research, directing research or serving as the principal
investigator, enrolling research subjects (including obtaining 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.

Conflict of Commitment: Whenever an individual's outside activities
exceed the permitted limits, or whenever a researcher's (or a member
of the research staff) primary professional loyalty is not to LSUHSC-
Shreveport a conflict of commitment exists.

Conflict of Interest: A conflict of interest or “COI” arises when an
employee is involved in a particular matter as part of his/her official
duties with an outside organization with which he/she also has a
financial interest, or one which is imputed to him/her, (i.e., the
employee's spouse, minor children, an organization in which the
employee serves as officer, director, trustee, partner, or employee, or
a person or organization with which the employee is negotiating for
prospective or has an arrangement for prospective employment).
Conflicts of interest can arise out of the fact that a mission of the
university includes faculty consulting and the commercialization of
technologies derived from faculty research.

Some situations where a potential individual conflict of interest may
arise include:
   1. A consulting relationship with the organization sponsoring the
       investigator’s research.
   2. A management role or equity holdings in an outside entity that is
       sponsoring research or selling goods or services to the
       university.
   3. Ownership interest in technology that is the subject or result of
       the research.
   4. Dual supervisory roles – an investigator supervises trainees as a
       faculty mentor and as employees of his or her company

Conflict of Interest Committee: The Conflict of Interest Committee
consists of LSUHSC-Shreveport faculty, employees and community
representatives appointed to review potential conflict of interest
disclosures and other related issues brought to the attention of the
COI Committee. The COI Committee meets regularly to review
disclosures, reviews Management Plans submitted to the COI
Committee to manage, reduce or eliminate identified conflicts of
interest, ensures the approved Management Plans are being adhered
to, and makes recommendations to the Associate Dean for Research.

Covered Individual: All faculty (full, partial, or non-salaried),
employees, members of institutional research review-related
committees, and staff members who negotiate or execute research
agreements or conducts/participates in research on behalf of LSUHSC-
Shreveport.
Disclosure: The release of relevant information about Significant
Financial or Nonfinancial Interests to parties outside the institution’s
conflict of interest review and management processes (e.g. to research
participants, journal editors or potential sponsors).

Equity: Any stock or similar security, certificate of interest, or
participation in any profit sharing agreement, pre-organization
certificate or subscription, transferable share, voting trust certificate or
certificate of deposit for an equity security, limited partnership
interest, interest in a joint venture, or certificate of interest in an
business trust; any security future on any such security; or any
security convertible, with or without consideration into such a security,
or carrying any warrant or right to subscribe to or purchase such a
security; or any such warrant or right; or any put, call, straddle or
other option or privilege of buying such a security from or selling such
a security to another without being bound to do so.

Family: A person's spouse, domestic partner, children, parents,
siblings, equivalents by marriage, or other individuals residing in the
person's household.

Fiduciary Role: A special relationship of trust, confidence, and
responsibility to others, such as that created by serving as an officer,
trustee or member of the governing board of a business entity.

Financially Interested Entity: An entity that does business with
LSUHSC-Shreveport in the areas of research or education (e.g.,
sponsors research, donates to the university, or is involved with a
license agreement or LSUHSC-Shreveport held equity) or a business
entity with financial interests that would reasonably appear to be
affected by the conduct or outcome of the research or business at
LSUHSC-Shreveport. This term includes entities that compete with the
sponsor of the research or the manufacturer of the investigational
product, if the covered individual actually knows that the financial
interests of such an entity would reasonably appear to be affected by
the research or business at LSUHSC-Shreveport. This term also
includes any entity acting as the agent of a financially interested entity
(e.g., a contract research organization).

Gift: The transfer of an item of value (i.e., a trip, personal belongings,
or special concessions in connection with personal business) for less
than fair market value, including a personal discount. Business
dinners or other business outings are not considered “gifts” unless the
business component is not significant or the social component does not
behave in a manner that is fitting with the overall professional
standard of avoiding actual and perceived conflicts of interest.

Honoraria: A one time payment from another University or non-for-
profit entity made to a faculty member for a voluntary service (i.e., a
presentation or speech on an area of expertise). The intent of an
honorarium is to show appreciation for a service where custom or
propriety does not permit a price to be set. Federal regulations does
not require disclosure of income from seminars, lectures, or teaching
engagements sponsored by public or non-profit entities (42 CFR Part
50, Subpart F).

Human Subjects Research: All research meeting the definition of
“research” performed with “human subjects” as these terms are
defined in the federal Common Rule (45 CFR Part 46 and 21 CFR Part
56), regardless of the source of research funding or whether the
research is otherwise subject to federal regulation.

Institutional Conflict of Interest: Situations in which the financial
interests of the institution, or of an institutional official acting within
his or her authority on behalf of the institution, might affect, or
reasonably appear to affect, institutional processes for the conduct,
review, or oversight of research or for exercising any LSUHSC-
Shreveport duty or responsibility.

Some situations where a potential institutional conflict of interest may
arise include:
   1) A consulting relationship of a department or University official
       with an organization that sponsors research in his or her
       department.
   2) Stock owned by a department employee in a medical device
       company that is a vendor of goods or services utilized within his
       or her department.
   3) University resources (a grant award) proposed to be utilized to
       purchase goods or services from a company in which LSUHSC-
       Shreveport holds an equity position.

Institution: Refers to LSUHSC-Shreveport

Institutional Official (IO): The LSUHSC-S Associate Dean of
Research serves as the Institutional Official for carrying out the
Institution’s human research protections program. The IO is
responsible for ensuring that the Human Research Protection Program
(HRPP) at the facility has the resources and support necessary to
comply with all federal regulations and guidelines that govern human
subject research. The IO is legally authorized to represent the
institution, is the signatory official for all Assurances, and assumes the
obligations and responsibilities of the Institution’s Assurance.

Institutional Review Board (IRB): The entity with jurisdiction over
reviewing research as specified in the federal-wide assurance (FWA)
that the institution has provided to the U.S. Department of Health and
Human Services (DHHS), or as otherwise established under DHHS or
FDA regulation or policy. An IRB is an independent board designated
by the Institution to review, to approve the initiation of, and to
conduct periodic review of research involving human subjects. This
independent board is composed of medical, scientific, and non-
scientific members.

Intellectual Property: Legally protected works of the mind (e.g.,
technology, software, or scholarly or artistic works) including
inventions, plants, mask works, copyrightable works, trademarks, and
trade secrets. Intellectual property includes commercializable
biomaterials, such as transgenic animals or cells and viruses.

Investigator: An “Investigator” is defined as the Principal
Investigator and any other person who is responsible for the design,
conduct, or reporting of research. For NIH funded research, the
definition extends to the Investigator’s spouse and dependent children.

Management Plan: A set of actions to be taken by the individual or
institution, as designed and implemented to manage, reduce or
eliminate any potential or actual conflicts of interest.

Non-financial Conflict of Interest: Non-financial conflict of interest
may exist when an individual serves dual roles, such as health care
provider and investigator. Other interests such as publication,
promotion or tenure, can also become conflicts of interest that may
affect an individual’s judgment. Membership in oversight committees
such as the IRB as well as positions of authority may pose actual,
perceived, or potential conflicts of interest. Any position that includes
responsibilities for the review and approval of research projects or
contracts other than his or her own may potentially affect the design
of, decisions made and/or action taken involving a specific study.

Participate: To contribute the described activity in any capacity,
including but not limited to, serving as the principal investigator, co-
investigator, research, collaborator, expert witness, provider of direct
patient care, or a person in a position to influence the study’s results
or have privileged information as to the outcome.

Public Health Service (PHS): An operating division of the U.S.
Department of Health and Human Services, and any components of
the PHS to which the authority involved may be delegated.

Reasonable Circumstances: The circumstances that a reasonable,
prudent layperson would expect a covered individual to maintain given
the need to accomplish a specific task related to LSUHSC-Shreveport
activities but having a Significant Financial Interest. Reasonable
circumstances might include the extent of the conflict upon the
research or activity itself, the institution, and the sponsor or external
party.

Remuneration: Any form of compensation from an outside entity
including but not limited to ownership of stocks, bonds, stock options,
warrants, partnership interests, rights to patent or royalty payments,
receipt of consulting fees, honoraria, speaking fees, salary, loans,
gifts, lectureship fees, or payment for serving on boards of directors,
scientific and other advisory boards.

Reporting: The providing of information by a covered individual to the
appropriate institutional officials and to the COI Committee, or the
transmission of such information within institutional channels (e.g.,
from the COI Committee to the Institutional Review Board).

Research: A systematic investigation designed to develop or
contribute to generalizable knowledge. The term encompasses basic
and applied research and product development. The term includes,
but is not limited to, any such activity for which research funding is
available from an outside entity (federal or non-federal). Research
includes conducting clinical trials.

Royalty: Any and all consideration received for the grant of a license,
including but not limited to “running royalties” (those royalties paid
based on the sale of licensed products) and any fixed fees paid under
the license (e.g., up-front fees, milestone payments, minimum annual
royalties, etc.)

Significant Financial Interests: anything of monetary value
including, but not limited to:
   1) Compensation, consulting fees, honoraria (including honoraria
      from a third party, if the original source is a financially interested
      entity), intellectual property rights (e.g. patents, copyrights or
      other ownership interests), gifts or other emoluments, or “in
      kind” compensation from all financially interested entities (or
      entitlement to the same), whether for consulting, lecturing,
      travel, service on an advisory board, or for any other purpose
      not directly related to the reasonable costs of conducting the
      research or activity (as specified in the agreement), that when
      aggregated for the immediate family have in the current
      calendar year (12 months) met or exceeded $10,000, or are
      expected to meet or exceed $10,000 in the next calendar year
      (12 months).
   2) Equity interests when aggregated for the immediate family,
      including stock options, of any amount in a non-publicly-traded
      financially interested entity (or entitlement to the same).
   3) Equity interests when aggregated for the immediate family (or
      entitlement to the same) in a publicly-traded financially
      interested entity of either $10,000 or 5% equity ownership,
      whichever is less.
   4) Royalty income or the right to receive future royalties under a
      patent license or copyright, when aggregated for the immediate
      family where the research is directly related to the licensed
      technology or work, or any amount.

This term does not include:
   1. Salary, compensation, royalties, or other remuneration from
      LSUHSC-Shreveport;
   2. Income from seminars, lectures or teaching engagements
      sponsored by public agencies or non-profit entities;
   3. Income from service on advisory committees or review panels
      for public agencies or non-profit entities;
   4. Interest in mutual funds where the covered individual has no
      control over the selection of holdings.

Sponsor: An individual or entity (e.g., a family trust, charitable
organization, federal funding agency) which typically provides financial
support for mission related institution activities including but not
limited to support for research, service, patient care, or educational
activities.

Sponsored Research: Research, training, and instructional projects
involving funds, materials, or other compensation from outside sources
under agreements that contain any of the following:
   1) The agreement binds LSUHSC-Shreveport to a line of scholarly
      or scientific inquiry specified to a substantial level of detail.
     Such specificity may be indicated by a plan, by the stipulation of
     requirements for orderly testing or validation of particular
     approaches, or by the designation of performance targets.
  2) A line-item budget or modular budget is involved. A line-item
     budget details expenses by activity, function, or project period.
     The designation of overhead (or indirect costs) qualifies a budget
     as “line item.”

Stock/stock options: The shares of a particular company or
corporation, the certification of ownership of such stock.

Technology: Any process, method, product, compound, software,
drug, device, or any diagnostic, biomedical, or surgical procedure
developed using LSUHSC-Shreveport facilities, equipment, or funds,
whether intended for commercial use or not.

				
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