The Guidelines for Derivation and Utilization of Human Embryonic Stem Cells
(SectionIV.)
Section IV. Utilization of Human ES Cells
  - Paragraph I. Requirements for Utilization (Article 26. Article 29)
  - Paragraph II. Organization for Utilization (Article 30 - Article 33)
  - Paragraph III. Procedure of Utilizations(Article 34 - Article 38)


Paragraph I. Requirements for Utilization
(Requirements for Utilization)
Article 26
(1) Utilization of human ES cells shall be allowed only when the following requirements are satisfied:
1. Its purpose is basic research contributing to
(a) clarification of the function of human development, differentiation and regeneration, and
(b) development of a new method to diagnose, prevent or treat diseases or of medicines, drugs and so on; and
2. The utilization of human ES cells in the research prescribed in 1 above is both scientifically necessary and rational.
(2) The human ES cells to be utilized shall be limited to the cells derived in accordance with the Guidelines.
(3) Regardless of the provision in (2) above, the UI shall be able to utilize the human ES cells distributed from institutes in foreign countries, when the Minister recognizes that such cells have been appropriately derived on the basis of the Guidelines.

(Prohibitions)
Article 27
The person who handles human ES cells shall not perform the following acts:
1. Creation of an individual from human ES cells with such methods as implantation of an embryo created using human ES cells into the uterus of a human or an animal;
2. Introduction of human ES cells into a human embryo;
3. Introduction of human ES cells into a human fetus; and
4. Production of germ cells from human ES cells.

(Distribution of Human ES Cells)
Article 28  
(1) No UI shall distribute or assign human ES cells.
(2) The provision in (1) above shall not be applied in the following cases:
1. The case that it is necessary to distribute the human ES cells processed in the UI to another UI for the purpose of confirming reproducibility of research results; and
2. The case that it is necessary to assign the human ES cells processed in the UI to DI for the purpose of developing basic research.

(Handling of Differentiated Cells)
Article 29
(1) Utilization of differentiated cells shall be regarded as part of the utilization of human ES cells for the present.
(2) Distribution of differentiated cells shall be allowed only when the Minister recognizes it to be in accordance with the fundamental principles shown in the Guidelines.
  - Paragraph I. - Paragraph II. - Paragraph III.
Paragraph II. Organization for Utilization
(Criteria for Utilizing Institute)
Article 30
(1) The UI shall satisfy the following requirements:
1. It has equipment, facilities, staffs and technical ability sufficient for utilizing human ES cells;
2. Rules on ethical and technical matters to be observed in utilization of human ES cells are established; and
3. An IRB is set in it.
(2) The UI shall prepare and keep records on utilization of human ES cells.
(3) The UI shall cooperate in presentation of data on utilization, arrangement for accepting investigations and any other measures recognized necessary by the Minister.

(President of Utilizing Institute)
Article 31
The president of the UI shall have the obligation to
1. confirm the propriety of the submitted utilization protocol and approve it for undertaking,
2. survey and grasp the progress and/or results of the utilization of human ES cells and, if necessary, give to the UD directions on any items to be paid attention to, improved and so on,
3. supervise utilization of human ES cells, and
4. inform of the Guidelines widely and thoroughly within the UI and make certain the Guidelines are to be observed there.

(Utilization Director)
Article 32
(1) The UD shall have the obligation to
1. examine ethical and scientific propriety of the utilization protocol based upon the information and materials available on utilizing human ES cells at home and/or abroad,
2. prepare a document on the utilization protocol (DUP) based upon the results of the examination prescribed in 1 above,
3. direct utilization of human ES cells and give any necessary directions to researchers,
4. confirm on occasion that the utilization of human ES cells is appropriately carried out in accordance with the DUP,
5. report to the president of the UI and the IRB in the UI on any items necessary to mention on the progress and the results of utilization of human ES cells, and
6. take any measures necessary to direct the utilization protocol, in addition to the measures prescribed in 1 to 5 above.
(2) One UD shall be assigned to each utilization protocol, and he/she shall have sufficient expert skills and knowledge on utilizing human ES cells, and ability to carry out precisely the tasks set forth in (1)1 to 6 above.

(Institutional Review Board in Utilizing Institute)
Article 33
(1) The IRB in the UI shall have the obligation to
1. review the overall ethical and scientific propriety of the submitted utilization protocol and advise the president of the UI on the approval/disapproval of the protocol and any related items to be paid attention to, improved and so on, together with preparing and keeping records on the process of the review, in conformity with the Guidelines, and
2. receive a report on the progress and the results of utilization, investigate if necessary and advise the president of the UI on any related items to be paid attention to, improved and so on.
(2) The provisions in Article 13(2) shall be applied as the requirements for the IRB in the UI, with substituting 'UI' for 'DI' and 'utilization protocol' for 'derivation protocol', respectively.


  - Paragraph I. - Paragraph II. - Paragraph III.
Paragraph III. Procedure of Utilization
(Document on Utilization Protocol)
Article 34
(1) For utilizing human ES cells, the UD shall prepare a DUP in advance and request the president of the UI to approve it.
(2) The DUP in (1) above shall include the following items:
1. The name of the DUP;
2. The name of the UI and its address;
3. The name, the brief history, the achievement in research of the UD and researchers and their roles taken by each in the utilization protocol;
4. The purpose and necessity of utilization;
5. The method and term of the utilization;
6. The supplier of utilized human ES cells;
7. The process and procedures of handling of human ES cells and differentiated cells after completing the utilization;
8. Explanation concerning the criteria of the UI;
9. In case the utilized human ES cells are offered from abroad, explanation concerning derivation of such human ES cells and any conditions for offering those cells ;
10. In case the distribution of differentiated cells is planned, explanation concerning those differentiated cells and their distribution; and
11. Any other items necessary to mention.
(3) An executive summary of the DUP, which is mentioned in terms as simple as possible, shall be attached to the DUP.

(Procedure of Utilization)
Article 35
The president of the UI, when requested by the UD to give approval of undertaking the utilization protocol, shall consult the IRB in the UI on the propriety of the protocol and shall confirm the compliance of the protocol with the Guidelines based upon recommendations submitted by the IRB. (Acceptance of Utilization Protocol by the Minister)

Article 36
(1) Prior to the approval of undertaking the utilization protocol, the president of the UI shall be given by the Minister acceptance to the compliance of the protocol with the Guidelines.
(2) In the case of (1) above, the president of the UI shall present to the Minister the following documents:
1. The DUP;
2. The document representing the process and results of reviewing by the IRB in the UI; and
3. The document representing items on the IRB in the UI and a copy of the rules prescribed in Article 13(2)6applied with substituting a few terms in accordance with Article 33(2).
(3) The Minister shall consult the B&BC on the propriety of the utilization protocol, and shall accept the protocol based upon recommendations submitted by the B&BC.
(4) The Minister shall report on the results of acceptance of utilization protocols to the CSTP.

(Report)
Article 37
(1) The UD shall report on occasion to the president of the UI and the IRB in the UI on the progress and/or completion of the utilization of human ES cells.
(2) The UD shall prepare and present to the president of the UI a document representing the results of utilization (hereinafter referred to as a "Utilization Report (UR)") immediately after completing the utilization of human ES cells.
(3) When the UR has been presented to the president of the UI, he/she shall present a copy of the UR to the IRB in the UI and the Minister.
(4) The president of the UI shall notify the DI from which the utilized human ES cells were distributed of the completion of the utilization of the human ES cells and of the method of handling those cells thereafter.

(Public Disclosure of Outcomes of the Research)
Article 38
(1) In principle, the outcomes from the utilization of human ES cells shall be disclosed to the public.
(2) In disclosure to the public the outcomes from the utilization of human ES cells, the UI shall point it out clearly that the utilization of human ES cells has been carried out in accordance with the Guidelines.


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