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Create a human fertilized embryo
Ethical Guidelines for Assisted Reproductive Technology Research

December 17, 2010
(Partially revised on April 1, 2013)
(Partially revised on March 31, 2015)
(Partially revised on February 28, 2017)

Ministry of education
Ministry of Health, Labor and Welfare

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table of contents
Chapter 1 General Rules ........................................................ ......... 1
First purpose ..................................................... ........ 1
Second scope of application ........................................................ ..... 1
Third definition ..................................................... ........ 1
Chapter 2 Obtaining Gametes ..................................................... .... 3
Obtaining the first gamete ...................................................... ... 3
Second informed consent .................................. 4
Chapter 3 Handling of fertilized human embryos ..................................... 5
1st Creation Restriction ....................................................... .... Five
Second handling period ........................................................ ..... Five
Prohibition of transplantation into the third womb .................................. 5
4th Transfer to another institution ..................................... . Five
Disposal at the end of the 5th research ..................................... 5
Chapter 4 Research System ...................................................... ..... 6
First Research Institute ........................................................ ..... 6
Second provider .................................................................. ..... 7
When the third research institution and the providing institution are the same, the head of the institution, etc.
Requirements ................................................. ...... 9
Chapter 5 Research Procedures ...................................................... ..... 9
Implementation of the first research plan ...................................................... . 9
Second research plan change ...................................................... Ten
Report on the progress of the third research ................................................ 11
End of the 4th research ........................................................ ... 11
Fifth protection of personal information ...................................................... 11 11
6th Research Results Disclosure ...................................................... 12
Chapter 6 Miscellaneous Provisions ........................................................ ........ 12
Announcement of nonconformity with the 1st guideline ..................................... 12
Second review ..................................................... ..... 12
Third enforcement date ........................................................ .... 12
Supplementary Provisions ................................................. ............. 12

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Chapter 1 General Rules
1st purpose
This guideline takes into account the importance of research that contributes to the improvement of assisted reproductive technology.
Among the studies that contribute to the improvement of assisted reproductive technology, those that create fertilized human embryos
Involved in the research from the viewpoint of respect for human fertilized embryos and other ethical points of view.
To ensure proper implementation by stipulating the matters to be observed by the person
With the goal.
Second scope of application
This guideline is for research on fertilization, embryonic development and development, and implantation, and mating.
Research on improving preservation techniques for offspring and human fertilized embryos Other assisted reproductive technology
Among the studies that contribute to the improvement of human fertilized embryos (hereinafter referred to as "research")
That is. ).

Third definition
In this guideline, the definitions of the following terms are as follows:
To do.
(1) Gamete
Refers to a human egg or sperm.
(2) Provider
A gamete provider used in research.
(3) Informed consent
The provider receives sufficient explanation about the research from researchers in advance,
Significance, purpose and method of the research, expected results and disadvantages, etc.
Providing gametes to be given based on free will and its
Consent regarding handling.
(4) Research institute
An institution that conducts research using the provided gametes.
(5) Provider
An institution that receives a gamete for research from a provider.
(6) Principal Investigator
At a research institution, carry out research and work related to the research
A person who supervises affairs.
(7) Researcher
At the research institution, those who are involved in the research under the direction of the principal investigator
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Say.
(8) Representatives of the organization, etc.
Businesses such as representatives of corporations that have providing organizations and heads of administrative organizations
A representative of an organization.
(9) Ethics Review Committee
Appropriateness of conducting, continuing or changing research and other necessary matters regarding research
To deliberate from an ethical and scientific point of view
A collegial body set up in each body as an advisory body to the head of the provider
To say.
(10) Personal information
Information about the donor of a living individual, any of the following:
It means something that corresponds to.
① Name, date of birth and other descriptions included in the information (documents, figures)
Image or electromagnetic recording (electromagnetic method (electronic method, magnetic method)
A method that cannot be recognized by the perception of others.
(11) Same as in ②. ) Is a record made. ), Young
Or recorded or represented using voice, action or other methods
All matters (excluding personal identification code). same as below. ) By
What can identify the provider (it can be collated with other information
What can, and thereby identify the provider
including. In addition, information on the dead will be sent to surviving individuals such as bereaved families at the same time.
If it is related information, the individual related to the provider of the living individual
It becomes human information.
② Those that include a personal identification code
(11) Personal identification code
Characters, numbers, symbols and other codes that fall under any of the following
Of these, the Law Enforcement Ordinance on the Protection of Personal Information (Cabinet Order No. 507 of 2003)
No.) Refers to other matters stipulated by laws and regulations.
① To use some characteristics of a specific individual's body for use in a computer
Characters, numbers, symbols and other codes converted to the specific
What can identify an individual
② Use of services provided to individuals or products sold to individuals
Cards and other items assigned or issued to individuals regarding purchases
Characters and numbers written on documents or recorded by electromagnetic means
No., symbol or other code, its user or purchaser, or
It is assigned to be different for each person who receives the issue, and
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Is described or recorded by a specific user
Or something that can identify the purchaser or the person who receives the issue
(12) Anonymization
Identify a specific individual from the personal information that accompanies the provided gamete
All descriptions (including personal identification codes) that can be written
Or delete a part (all or part of the description etc. is the specific
Includes replacement with descriptions that are not related to individuals. ).
(13) Correspondence table
From the anonymized information, it is possible to identify the provider when necessary
To be able to do so, check the provider and the description etc. that was replaced at the time of anonymization.
A table or similar that allows you to match.
Chapter 2 Obtaining Gametes
Obtaining the first gamete
1 Basic principle
(1) Providers shall be limited to those who have sufficient consent ability.
Do not receive gametes from minors or other incapacitated persons
Not.
(2) The provision of gametes is free of charge, except for the amount equivalent to the actual costs incurred in connection with the provision.
And shall.
2 Eggs that can be donated
For the time being, eggs will be provided only if they are listed below.
It shall be possible.
(1) Frozen for use in assisted reproductive technology (including future assisted reproductive technology)
Eggs that have been preserved and are no longer used for assisted reproductive technology
What.
(2) Non-frozen eggs listed below.
① Eggs used for assisted reproductive technology that have not been fertilized
(2) Eggs collected for the purpose of assisted reproductive technology, listed below
Things to do
B. As a result, it is used for assisted reproductive technology due to morphological abnormalities, etc.
Eggs that cannot be
Eggs other than Roy, spontaneously provided by the donor to the research
What was offered
③ From the ovary (including its section) removed for the treatment of diseases, etc.
Collected eggs that are not planned to be used for assisted reproductive technology
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Second informed consent
1 Informed consent
(1) Gametes are given informed consent written by the provider.
After being obtained, it shall be provided. Informed consent
The person who obtains the outlet shall be the head of the provider.
(2) Informed consent related to the provision of gametes is a specific study.
It must not be acquired when the research plan has not been finalized.
2 Explanation of informed consent
The explanation regarding informed consent is given in the purpose and method of research.
By handling and donation of gametes provided and human fertilized embryos produced
Possible disadvantages (Receiving the donation of eggs listed in (2) (2) -b of the first 2 (2)
In that case, it can be used for the original treatment (assisted reproductive technology).
As the number of eggs decreases, it may lead to a decrease in the treatment results.
Including that there is sex. ), How to protect personal information and other necessary matters
Document using as simple terms as possible so that you can get a good understanding
It shall be done more.
3 Donation of eggs from donors in the medical process
Offering in the process of treating assisted reproductive technology or diseases other than assisted reproductive technology
If the egg is donated by a person, the principal investigator shall give informed consent.
Ten without psychological pressure on the provider when acquiring an outlet
The necessary environment so that you can make free decisions with a good understanding
In addition to striving to secure informed consent, give an explanation regarding informed consent.
As a person to assist, a person other than the attending physician, and all the following important points
The one that satisfies the matter shall be placed.
① Not directly involved in the medical care of the provider.
② Have deep knowledge about assisted reproductive technology and research on assisted reproductive technology
That.
4 Withdrawal of informed consent
(1) The provider is the provided gamete or a person created from the gamete.
Informed consent to the donor while the fertilized embryo is preserved
The outlet can be withdrawn.
(2) The head of the provider will conduct research if the provider requests withdrawal.
The head of the institution shall be notified to that effect.
(3) When the head of the research institution receives the notification in (2), the gamete who received the donation
(Excluding those that the donor wishes to use for his / her assisted reproductive technology
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Ku. ) Or the human fertilized embryo produced from the gamete is discarded, and
A written notice to that effect shall be given to the head of the provider. However,
This does not apply in any of the following cases.
① When the gamete or human fertilized embryo is anonymized (a specific individual)
If it cannot be identified, the correspondence table has not been created.
Only when there is. )
(2) The ethics review committee of the research institution approves the continuation of research.
If approved and approved by the director of the research institution
Chapter 3 Handling of fertilized human embryos
1st creation restriction
Creation of fertilized human embryos is limited to the minimum necessary and minimal for conducting research
To
Second handling period
The created human fertilized embryo is taken only until the primitive streak appears.
Can be handled. However, starting from the day when the human fertilized embryo was created 14
About human fertilized embryos in which primitive streak does not appear within the period until the day passes
Will not be handled after 14 days have passed. In addition, human reception
When the embryos are cryopreserved, the cryopreservation period is included in the handling period.
Make it not exist.
Prohibition of transplantation into the third womb
(1) The prepared human fertilized embryo must not be transplanted into the womb of a human or animal.
I.
(2) Studies can transplant human fertilized embryos into human or animal wombs
Do not go in a room with equipment.
4th Transfer to another institution
Research institutes must not transfer the produced human fertilized embryos to other institutions.
However, when conducting joint research at multiple research institutes, these
Human fertilized embryos prepared can be transferred only between research institutes.
Disposal at the end of the 5th research
The research institute has completed the research plan or has a second human fertilized embryo handling period.
When the lapse has passed, the human fertilized embryo produced shall be immediately discarded.
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Chapter 4 Research System
1st Research Institute
1 Standards of research institutes, etc.
(1) The research institution shall meet the following criteria.
(1) Sufficient facilities and equipment for creating and culturing human fertilized embryos
To have.
② Handling of gametes and human fertilized embryos and animal fertilized embryos or human fertilized embryos
Have a sufficient track record in producing sperm embryos.
③ Rules and management system for handling gametes and fertilized human embryos have been established.
Be prepared.
④ An ethics review committee has been established.
⑤ Maintain and improve technical ability and ethical awareness of research
The necessary education and training plan has been established.
⑥ At least one doctor must participate in the research.
(2) The research institute creates records regarding the handling of gametes and fertilized human embryos.
And save this.
(3) Research institutes submit materials related to research, accept surveys, and other Ministry of Education, Culture, Sports, Science and Technology.
Cooperate with measures deemed necessary by the Minister of Science and the Minister of Health, Labor and Welfare
To
2 Head of research institute
(1) The head of the research institution shall perform the following tasks.
① Confirm the validity of the research plan and its changes, and approve its implementation.
thing.
(2) Research progress and results, and handling of prepared human fertilized embryos
Understand the situation, and if necessary, give notes to the principal investigator and make improvements
Give instructions regarding items, etc.
③ Formulate an education and training plan for 1 (1) and ⑤, and provide education and training based on this.
To carry out.
(2) The head of the research institution can also serve as the principal investigator and the researcher.
Absent. However, according to the rule of 1 (1) ③, the work of the head of the research institution is performed on behalf of the research institute.
This does not apply if a person has been appointed.
3 Principal Investigator, etc.
(1) The principal investigator has a sufficient ethical awareness of assisted reproductive technology research.
In addition, sufficient expertise in the production of fertilized animal or human fertilized embryos
Must have knowledge and experience.
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(2) Researchers are proficient in handling animal or human gametes or fertilized embryos.
Must be the one who did.
(3) The principal investigator has sufficient experience in producing fertilized human embryos.
If not, at least one of the study practitioners has the experience
Must be the one who does.
4 Ethics review committee of research institute
(1) The ethics review committee of the research institution meets all of the following requirements:
Shall be.
① Comprehensively examine the scientific and ethical validity of the research plan
To biology, reproductive medicine and legal experts, bioethics
Those who have the insight to express their opinions and the general public
Each person must be able to stand and express their opinions.
(2) Two or more persons other than those who belong to the research institution are included.
③ Two or more men and two women are included.
(4) Persons who have an interest in the principal investigator and the researcher, and
Relatives within the third degree of the principal investigator must not participate in the examination.
⑤ Appropriate to ensure freedom and independence of the activities of the Ethics Review Board
The operating procedure is stipulated.
(2) The content of the proceedings will hinder the protection of intellectual property rights and personal information.
Except in cases, it shall be made public.
Second provider
1 Standards of the provider, etc.
(1) Gamete provider
Gamete providers shall meet the following criteria:
(1) Provided in Article 1-5, Paragraph 1 of the Medical Care Act (Act No. 205 of 1948)
Being a hospital or a clinic specified in Paragraph 2 of the same Article.
(2) An ethics review committee has been established.
③ Sufficient measures have been taken to protect the personal information of the provider.
thing.
(2) Egg donor organization
Egg donors are suitable for the following criteria in addition to the criteria listed in (1).
It shall match.
① Have an egg collection room that meets the following requirements. However, the first of Chapter 2
This is not the case when receiving the eggs listed in 2 (2) ③.
I.
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B. Medical Law Enforcement Regulations (Ministry of Health and Welfare Ordinance No. 50 of 1948) Article 20 No. 3
Must have the same level of structural equipment as the operating room specified in.
(B) For oxygen inhalers, aspirators, biological monitoring monitors and other emergency resuscitation
Have the necessary medical equipment.
(2) Rules and management systems for egg collection and storage are in place.
That.
③ An obstetrician or gynecologist with sufficient clinical experience belongs to the department.
thing.
(3) Sperm donor
Sperm donors are suitable for the following criteria in addition to the criteria listed in (1).
It shall match.
① Rules and management system for sperm collection and storage are in place
That.
② Obstetrics, gynecology or urology doctors with sufficient clinical experience
Belonging.
2 Head of the provider
The head of the provider shall perform the following operations.
(1) Regarding the research plan, procedures related to informed consent
Also, from the standpoint of the provider, confirm the validity of the research plan and implement it.
To understand.
(2) Understand the situation regarding the provision of gametes, and if necessary, the attending physician and others
To provide guidance and supervision to those involved in the provision of gametes.
3 Ethics review committee of the provider
(1) The ethics review committee of the provider will give informed consent.
Confirmation that the profit is being carried out properly (Chapter 2, 1st, 2nd, 2nd, 2nd)
If you receive the eggs listed in (b), the original treatment (reproduction)
Along with the fact that the eggs necessary for (auxiliary medical care) are not used for research, the original
Pre- and post-confirmation that no more invasion than the invasion associated with treatment will be added
including. ), And from the standpoint of the provider, the research total conducted by the research institution
The scientific and ethical validity of the painting shall be examined.
(2) The ethics review committee of the provider meets all of the following requirements:
Shall be.
① Comprehensively examine the scientific and ethical validity of the research plan
To biology, reproductive medicine and legal experts, bioethics
Those who have the insight to express their opinions and the general public
Each person must be able to stand and express their opinions.
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(2) Two or more persons other than those who belong to the providing organization are included.
③ Two or more men and two women are included.
④ Persons who have an interest in the principal investigator and the researcher, research
To provide relatives within the third degree of the person in charge, as well as the attending physician and other gametes
The person concerned does not participate in the examination.
⑤ Appropriate to guarantee the freedom and independence of the activities of the ethics review committee
Careful management procedures are established.
(3) The content of the proceedings will hinder the protection of intellectual property rights and personal information.
Except in cases, it shall be made public.
When the third research institution and the providing institution are the same, the head of the institution, etc.
Requirements
If the research institution and the providing institution are the same, the head of the institution and the research responsibility
The person and the researcher shall not also serve as the attending physician of the donor.
Chapter 5 Research Procedures
Implementation of the first research plan
1 Approval of the director of the research institution
(1) The principal investigator prepares a research plan and conducts the research.
The director of the institution shall be requested to approve the implementation of the research plan.
(2) The director of the research institution, who was asked to approve (1), is appropriate to implement the research plan.
The opinion of the ethics review committee of the research institution is sought, and the relevant
Based on the opinion, the conformity of the research plan to this guideline should be confirmed.
To do.
(3) The head of the research institute confirmed the conformity with this guideline by (2).
The consent of the head of the provider shall be obtained for the implementation of the research plan. Ta
However, this does not apply if the research institution and the providing institution are the same.
(4) The head of the providing institution acknowledges the implementation of the research plan in (3).
The opinion of the ethics review committee of the provider shall be heard. In addition, the providing machine
If the head of the Seki approves the implementation of the research plan, the ethics committee of the provider will
Research machine with documents showing the process and results of the examination by the inspection committee
The chief of Seki shall be notified.
2 Confirmation by the Minister of Education, Culture, Sports, Science and Technology and the Minister of Health, Labor and Welfare
(1) The head of the research institution should conduct research when approving the implementation of the research plan.
Conformity of the plan to this guideline Minister of Education, Culture, Sports, Science and Technology and Ministry of Health, Labor and Welfare
It shall be confirmed by the Minister.
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(2) The head of the research institution requests the confirmation of (1) from the following documents.
Shall be submitted.
① Research plan
(2) A copy of the rules regarding the handling of gametes and human fertilized embryos at research institutions
③ Show the process and results of the examination by the ethics examination committee of the research institution.
Documents and documents describing matters related to the Ethics Review Board
④ A copy of the rules regarding the collection and preservation of gametes of the providing organization
⑤ Show the process and results of the examination by the ethics examination committee of the provider.

Documents and documents describing matters related to the ethics review committee of the institution
Kind
3 Research plan
The following matters shall be stated in the research plan.
① Name of research plan
(2) Name of research institution, its location, and name of the head of the research institution
③ Names, biographies, research achievements, education and training of the principal investigator and the researcher
Attendance history and role to play in research
④ How to obtain gametes used for research
⑤ Purpose and necessity of research
⑥ Research method and period
⑦ Explanation of research institution standards
⑧ Explanation of informed consent
⑨ Name of the provider, its location, and the name of the head of the provider
⑩ Explanation about the standards of the provider
⑪ Other necessary matters
Second research plan change
(1) The principal investigator is the research plan (matters listed in ②, ⑨ and ⑪ of 1-3).
except for. ), Change the research plan in advance.
A book shall be prepared and the approval of the director of the research institution shall be sought. Provider
The same shall apply to changes related to the addition of.
(2) When the head of a research institution is asked to approve the change in (1), it is appropriate.
We seek the opinion of the ethics review committee of the institution regarding sex, and we
Confirming the suitability of the change for this guideline based on that opinion
And.
(3) The head of the research institution should confirm the conformity with this guideline by (2).
In this case, if the content of the change in the research plan is related to the provider,
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The consent of the head of the provider concerned shall be obtained for the change.
(4) The head of the providing institution, in understanding (3), ethics of the institution.
The opinion of the judging committee shall be heard.
(5) When the head of the research institution approves the change in (1), the change is made.
Minister of Education, Culture, Sports, Science and Technology and Minister of Health, Labor and Welfare
Must be confirmed.
(6) The head of the research institution seeking confirmation of (5) writes the following documents.
It shall be submitted to the Minister of Education, Culture, Sports, Science and Technology and the Minister of Health, Labor and Welfare.
① Research plan change
(2) Examination process by the ethics examination committee of the research institution related to the change
And documents showing the results
③ If (3) applies, the ethics review committee of the provider related to the change
Documents showing the process and results of the examination by the committee
(7) The head of the research institution changes the matters listed in (1), (2), (9), or (11).
If so, notify the Minister of Education, Culture, Sports, Science and Technology and the Minister of Health, Labor and Welfare to that effect.
And.
Report on the progress of the third research
(1) The principal investigator shall be at least once a year while conducting the research.
The progress of the research (including the handling status of gametes and fertilized human embryos) is described.
Create a research progress report and submit it to the director of the research institution
And.
(2) When the head of the research institution receives the submission of the report of (1), he / she promptly
A copy of the copy is made by the ethics review committee of the research institution, the Minister of Education, Culture, Sports, Science and Technology and the welfare.
It shall be submitted to the Minister of Labor.
End of 4th research
(1) When the principal investigator completes the research, he / she will promptly inform that fact and the research.
Prepare a research completion report that describes the results of the research and submit it to the director of the research institution.
It shall be.
(2) When the head of the research institution receives the submission of the report of (1), he / she promptly
A copy shall be submitted to the Minister of Education, Culture, Sports, Science and Technology and the Minister of Health, Labor and Welfare.
Fifth protection of personal information
(1) The representatives of the organization, etc., regarding measures related to the protection of the personal information of the provider.
Ethical Guidelines for Medical Research for Humans (2014, Ministry of Education, Culture, Sports, Science and Technology)
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Ministry of Education, Ministry of Health, Labor and Welfare Notification No. 3) (Regarding Human Genome / Gene Analysis Research)

Ethical guidelines (2013 Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare, Ministry of Economy, Trade and Industry notification
When conducting human genome / gene analysis research based on No. 1), the same
Measures shall be taken in accordance with the guidelines).
(2) When receiving the provision of gametes based on this guideline, the representatives of the organization, etc.
When handling personal information, in order to protect personal information, within the organization concerned
A personal information manager shall be placed in.
(3) Before the personal information manager transfers the provided gamete to the research institution
(If the research institution and the providing institution are the same, the gamete who received the donation
Before the handling of the institution is done in the research department of the institution), anonymization
Measures shall be taken.
Disclosure of 6th research results
Research institutes may have problems with the protection of intellectual property rights and personal information.
Except, the research results shall be disclosed.
Chapter 6 Miscellaneous Rules
Announcement of nonconformity with the first guideline
The Minister of Education, Culture, Sports, Science and Technology and the Minister of Health, Labor and Welfare have adopted this guideline regarding the implementation of research.
If there is something that does not meet the specified standards, that fact
Shall be published.
Second review
This guideline is based on the progress of related research and the social situation regarding the handling of human embryos.
It will be reviewed as necessary in consideration of changes.
Third enforcement date
This guideline will come into effect on April 1, 2011.

Supplementary provisions
(February 28, 2017 Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare Notification No. 2)
This notification is a specific individual in the Law and Administrative Procedures Concerning the Protection of Personal Information.
Enforcement of the law to partially revise the law regarding the use of numbers to identify people
It will come into effect on the day of (May 30, 2017).

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