The Guidelines for Derivation and Utilization of Human Embryonic Stem Cells
(SectionIII.)
Section III . Donation of Human Fertilized Embryos
  - Paragraph I. Donating Medical Facilities (Article 20. Article 21)
  - Paragraph II. Informed Consent (Article 22 - Article 25)


Paragraph I. Donating Medical Facilities
(Criteria for Donating Medical Facilities)
Article 20
DMFs shall satisfy the following requirements:
1. They have prior achievements in and sufficient ability for handling of a human fertilized embryo;
2. An IRB is set in them;
3. Measures are taken sufficiently for protecting personal information of the donors of a human fertilized embryo; and
4. There is clearly established methods to make sure of the will of the donors to discard their human fertilized embryo and, procedures concerning the handling of a human fertilized embryo as well.

(Institutional Review Board in Donating Medical Facilities)
Article 21
(1) The IRB in the DMFs shall have the obligation to review the overall ethical and scientific propriety of the submitted derivation protocol and advise the president of the DMFs on 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.
(2) The provisions in Article 13(2) shall be applied as the requirements for the IRB in the DMFs, with substituting 'DMFs' for 'DI'.

  - Paragraph I. - Paragraph II.
Paragraph II. Informed Consent
(Procedure of Informed Consent)
Article 22
(1) On using donated human fertilized embryos for the derivation of human ES cells, DMFs shall be given the IC by the donors of the human fertilized embryos necessary to derive human ES cells,who are a married couple (excluding common-law couples without registering their marriage ) donating gametes necessary to create these fertilized embryos (hereinafter referred to as the "donors").
(2) The IC in (1) above shall be expressed in writing.

(3)

DMFs shall satisfy the following requirements, out of sufficient regard for the feelings of the donors for receiving IC as prescribed in (1) above:
1. No situations of the donors is unfairly taken advantage of;
2. A person who does not have the capacity to consent is not requested to donate a human fertilized embryo;
3. The will of the donors to discard their human fertilized embryos is confirmed in advance;
4. There is sufficient time necessary to decide whether the donors donate a human fertilized embryo or not; and
5. Donated fertilized embryos are stored for at least one month after the IC is given.
(4) The donors shall be able to withdraw the IC as long as their donated human fertilized embryos are still being stored.
(Explanation on Informed Consent)
Article 23
(1) The explanation on IC shall be given by a member of the DI.
(2) The DI shall have the person, who is designated by the president of the DI from among persons belonging to the DI (excluding DD), give such explanation as prescribed in (1) above

(3)

The person designated by the president of the DI in accordance with the provision in (2) above shall present to the donors a document including the following items (hereinafter referred to as an "Explanation Document (ED)"), and shall explain simply when giving the explanation prescribed in (1) above:
1. The purposes and methods for deriving human ES cells;
2. Loss of the donated human fertilized embryos in derivation process and procedures of handling those embryos;
3. The anticipated method to utilize human ES cells and outcomes from it;
4. The fact that the compliance of the derivation protocol with the Guidelines is confirmed by the DI and the DMFs, and is accepted by the Government;
5. The process to remove personal information of the donors in the transfer of the human embryo to the DI, and other concrete measures taken for protecting personal information;
6. The fact that the donors are offered no compensation throughout the future because human fertilized embryos are donated gratuitously;
7. Likelihood that human ES cells may be analyzed genetically and the fact that those genetic analyses never intend to identify a specific person;
8. The fact that the outcomes from the research and information on the human ES cells cannot be shown to the donors because the donors are not identified from the human ES cells;
9. Likelihood that the process of deriving human ES cells and outcomes from the research utilizing the cells may be published in academic meetings and on other occasions;
10. The fact that human ES cells are maintained in the DI for a long time and are distributed to the UI gratuitously;
11. Likelihood that, in the case that a valuable outcome has been obtained from human ES cells, intangible rights such as a copyright and/or a patent right or economic benefits arise from the outcomes (including differentiated cells), and the fact that such rights and benefits do not belong to the donors;
12. The fact that expression of consent/dissent on the donation does not bring to the donors any advantage/disadvantage; and
13. The fact that donated human fertilized embryos are stored for at least one month after the consent has been given and that the consent can be withdrawn while those human fertilized embryos are still stored, and the method to withdraw the consent.
(4) The DI shall take appropriate measures to protect personal information of the donors, and shall provide an ED prescribed in (3) above and a certificate representing that such explanation has been given (hereinafter referred to as an "Explanation Certificate (EC)") to the donors and each copy of those two papers to the DMFs, respectively, when giving explanation as prescribed in (1) above.
(5) The DI shall give precise explanation as prescribed in (1) above based upon the latest scientific knowledge.

(Confirmation of Informed Consent)
Article 24
(1) The president of the DMFs shall confirm the document prescribed in Article 22(2), the ED and the EC, and shall consult the IRB in the DMFs, concerning the appropriate receipt of the IC based upon the derivation protocol.
(2) The president of the DMFs shall notify the DI in writing that he/she has carried out the confirmation prescribed in (1) above when human fertilized embryos have been transferred to the DI.

(3)

When the president of the DI receives the notice prescribed in (2) above, he/she shall present a copy of the notice to the Minister.

(Protection of Personal Information of Donors)
Article 25
(1) The person involved in the derivation or utilization of human ES cells shall make his/her best efforts in order to protect personal information of the donors.
(2) Taking the meaning of (1) above into consideration, DMFs shall take any necessary measures so that no one can relate the donated human fertilized embryos with personal information of the donors when human fertilized embryos are transferred to the DI.


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