The Guidelines for Derivation and Utilization of Human Embryonic Stem Cells
(SectionI.)
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Preface
  Although derivation and utilization of human embryonic stem (ES) cells has the potential to bring to us great progress in medicine and biology, we need to give careful consideration to these activities because ethical issues do exist: a human embryo, which is the beginning of a human life, is required for deriving human ES cells; human ES cells are capable of differentiating into any type of human cell, and so on. Based upon the 'Report on the Human Embryo Research Focusing on the Human Embryonic Stem Cells' (March 6, 2000, the Subcommittee of Human Embryo Research, Bioethics Committee, Council for Science and Technology), the Minister of Education, Culture, Sports, Science and Technology has established the Guidelines in attempt to appropriately promote research on human ES cells, by providing fundamental rules to be observed from bioethical points of view so that human dignity may never be violated in association with derivation or utilization of human ES cells.


Section I . General Rules
(Definitions)
Article 1

In the Guidelines, those terms stated in the following paragraphs have their meanings as defined therein:
1 . Embryo
A cell (except for a germ cell) or cells which has/have the potential to grow into an individual through the process of development in utero of a human or an animal and has/have not yet begun the formation of a placenta;
2 . Human embryo
An embryo of a human being, including an embryo with genetic information as a human being;
3 . Human fertilized embryo
An embryo produced by fertilization between a human spermatozoon and a human
unfertilized egg;
4 . Human embryonic stem (ES) cell
A cell collected from an embryo or a cell produced by division of such a cell, (excluding the embryo), which has pluripotency and retains ability to proliferate by itself, or is considered to have such ability;
5 . Pluripotency
Capability to differentiate into ectodermal, endodermal and mesodermal cells;
6 . Derivation
Production of cells with a specific property;
7 . Differentiated cell
A cell differentiated from the ES cell, which results in not having the property of an ES cell;
8 . Deriving institute (DI)
An institute where human ES cells are derived;
9 . Donating Medical facilities (DMFs)
Medical facilities that receive donation of human fertilized embryos used for deriving human ES cells and then transfer them to DI ;
10 . Utilizing institute (UI)
An institute where human ES cells are utilized;
11 . Derivation director (DD)
A person in charge directing derivation of human ES cells;
12 . Utilization director (UD)
A person in charge directing utilization of human ES cells; and
13 . Informed consent (IC)
A consent given out of one's own free will based upon sufficient explanation provided.

(Range of Application)
Article 2
(1) Derivation and utilization of human ES cells shall always be carried out appropriately in accordance with the Guidelines.
(2) Derivation and utilization of ES cells shall be limited to basic research for the present.

Again, the following activities shall not be carried out, until specific criteria other than the Guidelines have been established: i.e., clinical research applying human ES cells or cells originated from them to the human body, and utilization of them in medicine and in its related fields.



(Respect for Human Embryo and ES Cells)
Article 3

Human embryos and ES cells shall be handled carefully and conscientiously without violating human dignity, taking it into consideration that a human embryo is the beginning of a human life and that human ES cells have the potential to differentiate into any type of human cell.

(Gratuitous Donation of a Human Embryo)
Article 4
A human embryo shall be donated for derivation of human ES cells gratuitously, except for necessary expenses.


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