TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER u: MISCELLANEOUS PROGRAMS AND SERVICES
PART 995 ILLINOIS REGENERATIVE MEDICINE INSTITUTE CODE
SECTION 995.10 DEFINITIONS


 

Section 995.10  Definitions

 

"Androgenetic human embryos" means embryos created from a male spermatozoon without genetic contribution from a female.

 

"Applicant" means an eligible institution that has submitted an application for an award of a grant pursuant to this Part for the purpose of conducting stem cell research in Illinois.

 

"Biotechnology start-up company" means a new company that makes use of microorganisms to achieve a result.

 

"Blastocyst" means a preimplantation embryo of 30-100 cells.  The blastocyst consists of a sphere made up of an outer layer of cells (the trophectoderm), a fluid-filled cavity (the blastocoel), and a cluster of cells on the interior (the inner cell mass).

 

"Cell division" means a method by which a single cell divides to create two cells.  This continuous process allows a population of cells to increase in number or maintain its numbers.

 

"Chimera" means an organism derived from more than one fertilized cell.

 

"Department" means the Illinois Department of Public Health.

 

"Differentiated cell" means a cell in which the level of organization or complexity has developed into a specialized function.

 

"Embryo" means a fertilized ovum from the time of fertilization until the end of the eighth week of gestation.

 

"Embryonic stem cell research" means research on embryonic stem cells.

 

"Embryonic stem cells" means pluripotent stem cells derived from the inner cell mass of a blastocyst that have the potential to become a wide variety of specialized cell types.

 

"ESCRO committee" means the Embryonic Stem Cell Research Oversight committee that provides ethical and legal oversight at institutions working with human embryonic stem cell lines.

 

"Experiment" means a test under controlled conditions that is made to demonstrate a known truth, to examine the validity of a hypothesis, or to determine the efficacy of something previously untried.

 

"FDA" means the United States Food and Drug Administration.

 

"Gamete" means a sperm or oocyte.

 

"Grant" means the award of funds under the Illinois Regenerative Medicine Institute (IRMI) program to an eligible applicant to conduct stem cell research in Illinois.

 

"Grant agreement" means the agreement entered into between the Department and a grantee setting forth the terms and conditions of a grant award.

 

"Grantee" means an institution receiving a grant.

 

"HIPAA" means the Health Insurance Portability and Accountability Act of 1996 and the Standards for Privacy of Individually Identified Health Information (Privacy Rule).

 

"Human embryonic stem cells" means embryonic stem cells derived from a human blastocyst.

 

"Human subject" means a living individual from whom an investigator, whether professional or student, conducting research obtains data or tissue through either intervention or interaction with the individual, or identifiable private information.

 

"Illinois Regenerative Medicine Institute" or "IRMI" or the "Institute" means a program of the Department to award research grants.

 

"Illinois Regenerative Medicine Institute Oversight Committee" or "Committee" means the group that determines the awards of the Institute's grant program, among other duties.

 

"Institution" means a corporation, association, partnership, nonprofit organization, governmental entity or other legal entity that conducts stem cell research.

 

"Institutional Animal Care and Use Committee" or "IACUC" means the committee providing oversight at an institution that uses animals as part of federally funded laboratory research.

 

"Institutional Research Committee" or "IRC" means the committee appointed by an institution to provide continuing oversight of the activities of an IRMI funded project.

 

"Institutional Review Board" or "IRB" means any board, committee or other group formally designated by an institution to conduct an initial review of, to approve the initiation of, and to conduct periodic review of all biomedical research involving human subjects.

 

"Intellectual property" means a creation of the mind that is unique, novel and unobvious, and has commercial value.

 

"Investigator" means a person conducting or assisting in the performance of stem cell research.

 

"In vitro" means a process or reaction occurring in an artificial environment such as a test tube or culture medium.

 

"In vitro fertilization" means a procedure in which fertilization of an egg with a sperm is accomplished outside the living organism.

 

"Lobbying" means any communication with the Governor, Lieutenant Governor, Secretary of State, Attorney General, State Treasurer or State Comptroller, their chiefs of staff, their cabinet members including Directors, Assistant Directors and Chief Legal Counsels or General Counsels, or Members of the General Assembly for the ultimate purpose of influencing executive, legislative or administrative action.

 

"Medical research" means basic or applied research conducted to aid the body of knowledge in the field of medicine.

 

"Nonprofit" means an institution exempt from taxation under section 501(c)(3) of the Internal Revenue Code.

 

"Nonprofit medical research institution" means a corporation, association, partnership, nonprofit organization, governmental entity or other legal entity that is exempt from taxation under section 501(c)(3) of the Internal Revenue Code and conducts basic or applied research to aid the body of knowledge in the field of medicine.

 

"Parthenogenetic human embryos" means embryos created soley from a female oocyte without genetic contribution from a male.

 

"Pluripotent" means the ability of a single stem cell to develop into many different cell types of the body.

 

"Principal investigator" means the person with primary responsibility for conducting a stem cell research project.

 

"Progenitor cell" means an early descendant of a stem cell that can differentiate, but cannot renew itself as a stem cell can.

 

"Project period" means the period in which a research project funded by a grant is to be completed.

 

"Reproductive cloning" means somatic cell nuclear transfer used for the production of a fetus and delivery of a live offspring that is genetically identical to the donor of the somatic cell DNA.

 

"Request for applications" or "RFA" means the announcement of the details of the application process for stem cell grants.

 

"Research donor" means an individual who donates to research any number of blastocysts that remain after clinical care at the time of the original harvesting.

 

"Scientific Review Panel" or "Panel" means a group of stem cell researchers from outside Illinois, chosen by the Department.

 

"Somatic cell nuclear transfer" means a technique in which the nucleus of a somatic cell is injected or transferred into an egg that has had its nucleus removed.

 

"Somatic stem cell", also called adult stem cell, means an undifferentiated cell that can become a specialized cell type of the tissue from which it came.

 

"Stem cell" means a cell with the ability to divide for indefinite periods in culture and to give rise to specialized cells, and includes, without limitation, somatic stem cells, cord blood stem cells, pluripotent stem cells, totipotent stem cells, progenitor cells, the product of somatic cell nuclear transfer, and any combination of these cells.

 

"Stem cell line" means a family of constantly dividing cells, the product of a single parent group of stem cells.

 

"Stem cell research" means scientific investigation and study into the nature and properties of stem cells, the transformation of stem cells into specialized cells, the development of stem cell lines, the growth of stem cells in vitro, or the possible uses of stem cells to cure or reduce the effects of disease, disabilities or physical conditions or maladies.

 

"TIN" means the nine-digit federal taxpayer identification number assigned to an institution by the Internal Revenue Service, also known as the federal employer identification number or governmental unit code.

 

"Totipotent stem cell" means a cell that can give rise to all cell types that are found in an embryo, fetus or developed organism, including the embryonic components of the trophoblast and placenta required to support development and birth.  The zygote and the cells at the very early stages following fertilization are considered totipotent.

 

"Undifferentiated cell" means a cell in which the level of organization or complexity has not yet developed into a specialized function.