The Guidelines for Derivation and Utilization of Human Embryonic Stem Cells
(SectionII.)
Section II . Derivation of Human ES Cells
  - Paragraph I. Requirements for Derivation and Distribution (Article 5 - Article 8)
  - Paragraph II. Derivation System (Article 9 - Article 13)
  - Paragraph III. Procedure of Derivation (Article 14 - Article 19)

Paragraph I. Requirements for Derivation and Distribution
(Requirements for Derivation of Human ES Cells)
Article 5 
Derivation of human ES cells shall be allowed only when the following requirements are satisfied:
1 A plan for utilization of human ES cells in accordance with the requirements for the utilization prescribed in Article 26(1) is explicitly indicated; and
2 The plan of utilization prescribed in 1 above is both scientifically necessary and rational.

(Requirements for Human Embryos Used for Derivation of Human ES Cells)
Article 6
A human embryo used for derivation of human ES cells shall
1 be the human fertilized embryo which has initially been created for the purposes of fertility treatment, but is planned not to be used any longer for the purposes, and, hence, is surely intended to be discarded by its donors,
2 be accompanied by an appropriate IC concerning its use for the derivation of human ES cells,
3 have been stored frozen, and
4 be used within 14 days after the fertilization, not counting any time during which it has
been stored frozen.

(Handling of Human Fertilized Embryos in Deriving Institute)
Article 7
The human fertilized embryo shall be appropriately handled in the DI by a medical doctor or under his/her guidance.

(Requirements for Distribution)
Article 8
(1) Distribution of human ES cells shall be allowed
1 when limited to the UI which undertakes the utilization protocol accepted by the Minister of Education, Culture, Sports, Science and Technology (hereinafter referred to as the"Minister") in accordance with the provisions in Article 36, and
2 when distributed gratuitously, except for necessary expenses.
(2) The DI shall distribute human ES cells at request of the UI which undertakes the utilization protocol accepted by the Minister in accordance with the provisions in Article 36, except under unavoidable circumstances.

  - Paragraph I. - Paragraph II. - Paragraph III.
Paragraph II. Derivation System
(Criteria for Deriving Institute)
Article 9
The DI shall satisfy the following requirements:
1 It has equipment, facilities, financial foundation, staffs and technical ability sufficient for deriving and distributing human ES cells;
2 Rules on ethical and technical matters to be observed in derivation and distribution of human ES cells are established; and
3 An institutional review board (IRB) is set in it.

(Tasks of Deriving Institute)
Article 10
(1) The DI shall have the obligation to
1 derive and distribute human ES cells, and
2 get assigned and distribute the human ES cells, which was once distributed to and then processed in the UI (restricted to the cases reasonable for development of research utilizing human ES cells).
(2) The DI shall prepare and keep records on derivation, maintenance and distribution of human ES cells.
(3) The DI shall cooperate in presenting data on derivation, maintenance and distribution, arranging for accepting investigations and any other measures recognized necessary by the Minister.

(President of Deriving Institute)
Article 11
The president of the DI shall have the obligation to
1 confirm the propriety of the submitted derivation protocol and approve it for undertaking,
2 survey and grasp the progress and/or results of the derivation of human ES cells and, if necessary, provide the DD appropriate directions on any items to be paid attention to, improved and so on,
3 supervise derivation and distribution of human ES cells, and
4 inform of the Guidelines widely and thoroughly within the DI and make certain the Guidelines are to be observed there.

(Derivation Director)
Article 12
(1) The DD shall have the obligation to
1 examine ethical and scientific propriety of the derivation protocol based upon the information and materials available on deriving human ES cells at home and/or abroad,
2 prepare a document on the derivation protocol (DDP) based upon the results of the examination prescribed in 1 above,
3 direct derivation of human ES cells, and give any necessary directions to researchers,
4 confirm on occasion that the derivation of human ES cells is appropriately carried out in accordance with the DDP,
5 report to the president of the DI and the IRB in the DI on any items necessary to mention on the progress and the results of derivation of human ES cells, and
6 take any measures necessary to direct the derivation protocol, in addition to the measures prescribed in 1 to 5 above.
(2) One DD shall be assigned to each derivation protocol, and he/she shall have experience in deriving ES cells from an animal embryo, sufficient expert skills and knowledge on deriving human ES cells, and ability to carry out precisely the tasks set forth in (1)1 to 6 above.

(Institutional Review Board in Deriving Institute)
Article 13
(1) The IRB in the DI shall have the obligation to
1 review the overall ethical and scientific propriety of the submitted derivation protocol and advise the president of the DI 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 derivation, investigate if necessary, and advise the president of the DI on any related items to be paid attention to, improved and so on.
(2) The IRB in the DI shall satisfy the following requirements:
1 It consists of an expert in biology, medicine and law, a person qualified to give his/her opinions on bioethics and a person able to give his/her opinions as a representative member for the general public;
2 Among members there are included two or more persons not belonging or relating to the DI;
3 There are included two or more men and two or more women;
4 The person who carries out the derivation protocol does not take part in its review;
5 There is an established appropriate procedure to manage the IRB so that independence and freedom in its activity will be guaranteed; and
6 There are established and disclosed to the public rules on management, organization and system of the IRB, public disclosure of its proceedings and procedures required in reviewing a derivation protocol.

  - Paragraph I. - Paragraph II. - Paragraph III.
Paragraph III. Procedure of Derivation
(Document on Derivation Protocol)
Article 14
(1) For deriving human ES cells, the DD shall prepare a DDP in advance and request the president of the DI to approve it.
(2) The DDP in (1) above shall include the following items:
1 The name of the DDP;
2 The name of the DI and its address;
3 The name, the brief history, the achievement in research of the DD and researchers and their roles taken by each in the derivation protocol;
4 Explanation concerning the human fertilized embryos used for the derivation;
5 A plan for utilization of human ES cells after the derivation;
6 The necessity of the derivation;
7 The method and term of the derivation;
8 Explanation concerning the distribution;
9 Explanation concerning the criteria of the DI;
10 Explanation concerning the IC;
11 Explanation concerning the DMFs;
12 Explanation concerning the IRB in the DMFs; and
13 Any other items necessary to mention.
(3) An executive summary of the DDP expressed in terms as simple as possible and the document explaining on the IC prescribed in Article 23(1) shall be attached to the DDP. 

(Procedure of Derivation)
Article 15
(1) The president of the DI, when requested by the DD to give approval of undertaking the derivation protocol, shall consult the IRB in the DI on the propriety of the protocol and shall confirm the compliance of the protocol with the Guidelines based upon recommendations submitted by the IRB.
(2) The president of the DI shall obtain agreement of the president of the DMFs to undertake the derivation protocol.
(3) The president of the DMFs shall consult the IRB in the DMFs for agreeing to undertake the derivation protocol.

(Acceptance of Derivation Protocol by the Minister)
Article 16
(1) Prior to the approval of undertaking the derivation protocol, the president of the DI 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 DI shall present to the Minister the following documents, concerning the derivation protocol upon which the president of the DMFs has agreed:
1 The DDP;
2 Each document representing the process and results of reviewing by the IRB in the DI or DMFs, respectively; and
3 Each document representing items on the IRB in the DI or the DMFs, respectively, and each copy of the rules prescribed in Article 13(2)6 and of those applied with substituting a few terms in accordance with Article 21(2).
(3) An executive summary of the DDP expressed in terms as simple as possible and the document explaining on the IC prescribed in Article 23(1) shall be attached to the DDP. 
(4) An executive summary of the DDP expressed in terms as simple as possible and the document explaining on the IC prescribed in Article 23(1) shall be attached to the DDP. 

(Report)
Article 17
(1) The DD shall report on occasion to the president of the DI and the IRB in the DI on the progress and/or completion of the derivation of human ES cells, and the situation of the distribution of the ES cells and of the donated human fertilized embryos as well.
(2) The DD shall prepare and present to the president of the DI a document representing the results of derivation (hereinafter referred to as a "Derivation Report (DR)") immediately after completing the derivation of human ES cells.
(3) When the DR has been presented to the president of the DI, he/she shall present a copy of the DR to the IRB in the DI and the Minister.
(4) While human ES cells are maintained after completing the derivation, the president of the DI shall report to the Minister on the situation of the distribution of these human ES cells at least once a year.

(Public Disclosure of Outcomes from the Research)
Article 18
(1) In principle, outcomes from the derivation of human ES cells shall be disclosed to the public.
(2) In disclosing to the public the outcomes from the derivation of human ES cells, the DI shall point it out clearly that the derivation of human ES cells has been carried out in accordance with the Guidelines.

(Special Case Concerning Deriving Institute)
Article 19
(1) Two or more institutes in cooperation shall be allowed to assume their obligation as one DI entity.
(2) In the case of (1) above, each institute shall prepare their DDP to mention the role share and the responsibility taken by each institute, and consult each IRB set in these institutes on their derivation protocol, respectively.


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