Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 11 - CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS › Chapter 701 - POLICIES AND PROCEDURES › Section 701.3 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
The following words and terms, when used in this chapter,
				  shall have the following meanings, unless the context clearly indicates
				  otherwise.
(1) Advisory Committee--a
				committee of experts, including practitioners and patient advocates, created by
				the Oversight Committee to advise the Oversight Committee on issues related to
				cancer.
(2) Allowable Cost--a cost
				that is reasonable, necessary for the proper and efficient performance and
				administration of the project, and allocable to the project.
(3) Annual Public Report--the report issued
				by the Institute pursuant to Texas Health and Safety Code §
									102.052
				outlining Institute activities, including Grant Awards, research
				accomplishments, future Program directions, compliance, and Conflicts of
				Interest actions.
(4) Approved
				Budget--the financial expenditure plan for the Grant Award, including revisions
				approved by the Institute and permissible revisions made by the Grant
				Recipient. The Approved Budget may be shown by Project Year and detailed budget
				categories.
(5) Authorized
				Expense--cost items including honoraria, salaries and benefits, consumable
				supplies, other operating expenses, contracted research and development,
				capital equipment, construction or renovation of state or private facilities,
				travel, and conference fees and expenses.
(6) Authorized Signing Official (ASO)--the
				individual, including designated alternates, named by the Grant Applicant, who
				is authorized to act for the Grant Applicant or Grant Recipient in submitting
				the Grant Application and executing the Grant Contract and associated documents
				or requests.
(7) Bylaws--the rules
				established by the Oversight Committee to provide a framework for its
				operation, management, and governance.
(8) Cancer Prevention--a reduction in the
				risk of developing cancer, including early detection, control and/or mitigation
				of the incidence, disability, mortality, or post-diagnosis effects of
				cancer.
(9) Cancer Prevention and
				Control Program--effective strategies and interventions for preventing and
				controlling cancer designed to reduce the incidence and mortality of cancer and
				to enhance the quality of life of those affected by cancer.
(10) Cancer Prevention and Research Fund--the
				dedicated account in the general revenue fund consisting of legislative
				appropriations, gifts, grants, other donations, and earned interest.
(11) Cancer Research--research into the
				prevention, causes, detection, treatments, and cures for all types of cancer in
				humans, including basic mechanistic studies, pre-clinical studies, animal model
				studies, translational research, and clinical research to develop preventative
				measures, therapies, protocols, medical pharmaceuticals, medical devices or
				procedures for the detection, treatment, cure or substantial mitigation of all
				types of cancer and its effects in humans.
(12) Chief Compliance Officer--the individual
				employed by the Institute to monitor and report to the Oversight Committee
				regarding compliance with the Institute's statute and administrative rules. The
				term may also apply to an individual designated by the Chief Compliance Officer
				to fulfill the duty or duties described herein, unless the context clearly
				indicates otherwise.
(13) Chief
				Executive Officer--the individual hired by the Oversight Committee to perform
				duties required by the Institute's Statute or designated by the Oversight
				Committee. The term may apply to an individual designated by the Chief
				Executive Officer to fulfill the duty or duties described herein, unless the
				context clearly indicates otherwise.
(14) Chief Prevention Officer--the individual
				hired by the Chief Executive Officer to oversee the Institute's Cancer
				Prevention program, including the Grant Review Process, and to assist the Chief
				Executive Officer in collaborative outreach to further Cancer Research and
				Cancer Prevention. The term may also apply to an individual designated by the
				Chief Prevention Officer to fulfill the duty or duties described herein, unless
				the context clearly indicates otherwise.
(15) Chief Product Development Officer--the
				individual hired by Chief Executive Officer to oversee the Institute's Product
				Development program for drugs, biologicals, diagnostics, or devices arising
				from Cancer Research, including the Grant Review Process, and to assist the
				Chief Executive Officer in collaborative outreach to further Cancer Research
				and Cancer Prevention. The term may apply to an individual designated by the
				Chief Product Development Officer to fulfill the duty or duties described
				herein, unless the context clearly indicates otherwise.
(16) Chief Scientific Officer--the individual
				hired by the Chief Executive Officer to oversee the Institute's Cancer Research
				program, including the Grant Review Process, and to assist the Chief Executive
				Officer in collaborative outreach to further Cancer Research and Cancer
				Prevention. The term may apply to an individual designated by the Chief
				Scientific Officer to fulfill the duty or duties described herein, unless the
				context clearly indicates otherwise.
(17) Code of Conduct and Ethics--the code
				adopted by the Oversight Committee pursuant to Texas Health and Safety Code
				§
									102.109 to
				provide guidance related to the ethical conduct expected of Oversight Committee
				Members, Program Integration Committee Members, and Institute
				Employees.
(18) Compliance
				Program--a process to assess and ensure compliance by the Oversight Committee
				Members and Institute Employees with applicable laws, rules, and policies,
				including matters of ethics and standards of conduct, financial reporting,
				internal accounting controls, and auditing.
(19) Conflict(s) of Interest--a financial,
				professional, or personal interest held by the individual or the individual's
				Relative that is contrary to the individual's obligation and duty to act for
				the benefit of the Institute.
(20)
				Encumbered Funds--funds that are designated by a Grant Recipient for a specific
				purpose.
(21) Financial Status
				Report--form used to report all Grant Award related financial expenditures
				incurred in implementation of the Grant Award. This form may also be referred
				to as "FSR" or "Form 269-A."
(22)
				Grant Applicant--the public or private institution of higher education, as
				defined by §
									61.003, Texas
				Education Code, research institution, government organization, non-governmental
				organization, non-profit organization, other public entity, private company,
				individual, or consortia, including any combination of the aforementioned, that
				submits a Grant Application to the Institute. Unless otherwise indicated, this
				term includes the Principal Investigator or Program Director.
(23) Grant Application--the written proposal
				submitted by a Grant Applicant to the Institute in the form required by the
				Institute that, if successful, will result in a Grant Award.
(24) Grant Award--funding, including a direct
				company investment, awarded by the Institute pursuant to a Grant Contract
				providing money to the Grant Recipient to carry out the Cancer Research or
				Cancer Prevention project in accordance with rules, regulations, and guidance
				provided by the Institute.
(25)
				Grant Contract--the legal agreement executed by the Grant Recipient and the
				Institute setting forth the terms and conditions for the Cancer Research or
				Cancer Prevention Grant Award approved by the Oversight Committee.
(26) Grant Management System--the electronic
				interactive system used by the Institute to exchange, record, and store Grant
				Application and Grant Award information.
(27) Grant Mechanism--the specific Grant
				Award type.
(28) Grant Program--the
				functional area in which the Institute makes Grant Awards, including research,
				prevention and product development.
(29) Grant Progress Report--the required
				report submitted by the Grant Recipient at least annually and at the close of
				the grant award describing the activities undertaken to achieve the Scope of
				Work of the funded project and including information, data and program metrics.
				Unless the context clearly indicates otherwise, the Grant Progress Report also
				includes other required reports such as a Historically Underutilized Business
				and Texas Supplier form, a single audit determination form, an inventory
				report, a single audit determination form, a revenue sharing form, and any
				other reports or forms designated by the Institute.
(30) Grant Recipient--the entire legal entity
				responsible for the performance or administration of the Grant Award pursuant
				to the Grant Contract. Unless otherwise indicated, this term includes the
				Principal Investigator, Program Director, or Company Representative.
(31) Grant Review Cycle--the period that
				begins on the day that the Request for Applications is released for a
				particular Grant Mechanism and ends on the day that the Oversight Committee
				takes action on the Grant Award recommendations.
(32) Grant Review Process--the Institute's
				processes for Peer Review, Program Review and Oversight Committee approval of
				Grant Applications.
(33) Indirect
				Costs--the expenses of doing business that are not readily identified with a
				particular Grant Award, Grant Contract, project, function, or activity, but are
				necessary for the general operation of the Grant Recipient or the performance
				of the Grant Recipient's activities.
(34) Institute--the Cancer Prevention and
				Research Institute of Texas or CPRIT.
(35) Institute Employee--any individual
				employed by the Institute, including any individual performing duties for the
				Institute pursuant to a contract of employment. Unless otherwise indicated, the
				term does not include an individual providing services to the Institute
				pursuant to a services contract.
(36) Intellectual Property Rights--any and
				all of the following and all rights in, arising out of, or associated
				therewith, but only to the extent resulting from the Grant Award:
(A) The United States and foreign patents and
				utility models and applications therefore and all reissues, divisions,
				re-examinations, renewals, extensions, provisionals, continuations and such
				claims of continuations-in-part as are entitled to claim priority to the
				aforesaid patents or patent applications, and equivalent or similar rights
				anywhere in the world in Inventions and discoveries;
(B) All trade secrets and rights in know-how
				and proprietary information;
(C)
				All copyrights, whether registered or unregistered, and applications therefore,
				and all other rights corresponding thereto throughout the world excluding
				scholarly and academic works such as professional articles and presentations,
				lab notebooks, and original medical records; and
(D) All mask works, mask work registrations
				and applications therefore, and any equivalent or similar rights in
				semiconductor masks, layouts, architectures or topography.