0A4F4F9BD490A749D5437F821CF06DF1

Decree No. 2015-155 of 11 February, 2015: Public Health Code on Research on Embryos Article R2151-1 and Following Sections

https://www.legifrance.gouv.fr/affichCode.do?idArticle=LEGIARTI000030233469&idSectionTA=LEGISCTA000006190409&cidTexte=LEGITEXT000006072665&dateTexte=20151015

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Examining the file media/Synopses/D891178587F8CC0598F0213C5D0C756A.html:

This file was generated: 2020-07-14 08:37:00

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Motherhood/Family	family	2
Health	stem cells	stem cells	16
Social	Access to Social Goods	access	1
Social	Child	child	2
Social	Marital Status	single	1
Social	Property Ownership	home	2
Social	embryo	embryo	7
Social	philosophical differences/differences of opinion	opinion	2

Health / Motherhood/Family

Searching for indicator family:

Health / stem cells

Searching for indicator stem cells:

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p.002020: You are in: Home> Applicable codes> Public health code
p.002020: Public health code
p.002020: Hide the panel of << Previous block - Next block >> - -
p.002020: navigation Print
p.002020: Path Navigation:
p.002020: Public health code
p.002020: Public health code
p.002020: Regulatory part
p.002020: (Last modification: May 30 2020)
p.002020: Part Two: Family, Mother and Child Health
p.002020: Version in force on May 30, 2020
p.002020: Version to come on June 24, 2020 Book I: Protection and promotion of maternal and child health
p.002020: Version to come as of June 30, 2020 Title V: Research on the embryo and embryonic cells
p.002020: Version to come on July 12, 2020 Single Chapter
p.002020: Version to come on July 26, 2020
p.002020: Version coming September 1
p.002020: 2020
p.002020: Version to come on October 1, 2020 Section 1: Research implementation.
p.002020: Version coming January 1, 2021
p.002020: Version coming April 1, 2021
p.002020: Article R2151-1 Learn more about this article ...
p.002020: Version to come on July 1, 2021 Modified by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: Version coming January 1, 2022
p.002020: The Director General of the Biomedicine Agency may authorize, under the conditions laid down in Article L. 2151-5, a
p.002020: Version to come on March 1, 2022 research protocol on the embryo or on embryonic stem cells, after advice from the guidance council, for
p.002020: Version to come on: date not a fixed term which cannot exceed five years, renewable under the same conditions.
p.002020: specified
p.002020: Article R2151-2 Learn more about this article ...
p.002020: Consolidated version as of ...
p.002020: Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: Day month Year
p.002020: 2015 In addition to verifying the conditions set out in article L. 2151-5, the biomedicine agency ensures the feasibility of the
p.002020: October 15
p.002020: Ex: 2020 protocol and the sustainability of the organization and the research team. It takes into account titles, diplomas,
p.002020: experience and scientific work of the research manager and team members. In addition, the agency of the
p.002020: Consult biomedicine takes into account the premises, materials, equipment as well as the processes and techniques used
p.002020: by the applicant. It assesses the means and devices guaranteeing the safety, quality and traceability of embryos and
p.002020: embryonic stem cells.
p.002020: Hide code navigation
p.002020: Summary
p.002020: Legislative part Article R2151-3 Read more about this article ...
p.002020: Old legislative part Amended by Decree n ° 2012-467 of 11 April 2012 - art. 1
p.002020: Regulatory part I.-Only can obtain authorization to carry out research on the embryo:
p.002020: First part: 1 ° Public health establishments and medical biology laboratories authorized to store embryos in
p.002020: General protection of the application of article L. 2142-1, as well as establishments authorized to carry out preimplantation diagnosis in
p.002020: health application of article L. 2131-4;
p.002020: Second part :
p.002020: 2 ° Establishments and organizations having concluded an agreement with at least one of establishments or laboratories
p.002020: Family, mother health
p.002020: mentioned in 1 °. This agreement sets out the conditions under which the establishment or laboratory mentioned in 1 °
p.002020: Hide the search for canned items and provide embryos for the benefit of this establishment or organization. The provision
p.002020: within the embryo code is only allowed for the duration of the research.
p.002020: Enter a word from an article or a
p.002020: article number II.-Only the following can be authorized to carry out research on embryonic stem cells:
p.002020: Search in the entirety of 1 ° Establishments and organizations pursuing a research activity and holders of the conservation authorization
p.002020: code of embryonic stem cells for research purposes mentioned in article L. 2151-7;
p.002020: Limit search to 'Party
p.002020: 2 ° Public and private establishments and organizations pursuing a research activity having concluded an agreement
p.002020: Legislative ''
p.002020: with an establishment or organization mentioned in 1 ° in which the latter undertakes to supply and keep
p.002020: Limit search to 'Party
p.002020: embryonic stem cells for carrying out the research of the former.
p.002020: Regulatory ''
p.002020: Word or phrase within
p.002020: articles Article R2151-4 Read more about this article ...
p.002020: Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: The provision of prior information and the collection in writing of the free and informed consent of each member of the
p.002020: Number
p.002020: couple or of the surviving member of the couple, provided for in the last paragraph of article L. 2131-4 and in articles L. 2141-3, L. 2141-
p.002020: 4 and L. 2151-5, are carried out, in the case of a pre-implantation diagnosis, by the practitioner approved in application of article L.
p.002020: 2131-4-2 and, in other cases, by the intervening practitioner, in accordance with the fifth paragraph of article L. 2142-1,
p.002020: in an establishment, laboratory or body authorized under the same article.
p.002020: Search Information on the different categories of research likely to be carried out within the framework of the article
p.002020: L. 2151-5 is issued. It is specified to the couple or the surviving member of the couple that the embryos having been the subject of a
p.002020: research cannot be transferred for gestation and they are destroyed during the research. When he is
p.002020: applies II of article L. 2141-4, the couple or the surviving member is also informed that, if necessary, the
p.002020: cells derived from embryos can enter a cell therapy preparation for purposes
p.002020: exclusively therapeutic.
p.002020: The person responsible for the research must be able to justify at any time during the research of the collection of consents
p.002020: mentioned in the first paragraph.
p.002020: Article R2151-5 Read more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: Embryos can only be handed over to the research manager mentioned in article R. 2151-8 only by the holder of
p.002020: the authorization provided for in article L. 2151-7, by the practitioner approved in application of article L. 2131-4-2 or by the practitioner
p.002020: intervening, in accordance with the fifth paragraph of article L. 2142-1, in an establishment, laboratory or organism
p.002020: authorized under the same article. The research manager must produce the authorization of the research protocol.
p.002020: research. The authorization holder or the practitioner gives him the document attesting to the collection of consents
p.002020: mentioned in article R. 2151-4.
p.002020: The delivery of embryonic stem cells to the research manager by the holder of the import authorization
p.002020: provided for in article L. 2151-6 or for the storage authorization provided for in article L. 2151-7 is carried out on production of
p.002020: documents mentioned in the previous paragraph. If the embryonic stem cells have been imported, the holder of
p.002020: the authorization gives the research manager the documents attesting to their obtaining in compliance with the principles
p.002020: mentioned in articles 16 to 16-8 of the civil code and the collection of consents mentioned in article R. 2151-13.
p.002020: No information likely to allow the identification of the couple or of the surviving member of the couple at the origin of the
p.002020: embryos being researched cannot be communicated to the research manager.
p.002020: Article R2151-6 Learn more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: The request for authorization of a research protocol on the embryo or on embryonic stem cells is
p.002020: addressed to the director general of the biomedicine agency by registered post with request for acknowledgment of receipt or
p.002020: deposited against receipt with the agency under the same conditions. This request is accompanied by a file
p.002020: which includes all the elements allowing to verify that the legal conditions are met and whose form and
p.002020: contents are set by decision of the agency's director general.
p.002020: The Director General also sets the periods during which request files may be filed
p.002020: authorization. The closing date for these periods runs the four-month period provided below for requests
p.002020: accompanied by a complete file.
p.002020: When the documents essential to the processing of the request are lacking, the advice of delivery fixes the period within which
p.002020: these parts must be provided.
p.002020: Within four months of the end of the period during which the complete file was submitted,
p.002020: the director general of the biomedicine agency notifies the requesting establishment or body of the decision
p.002020: authorization or refusal of authorization. At the end of this period, the absence of a decision by the Director General constitutes a decision
p.002020: implied refusal of authorization.
p.002020: The Director General's decision granting the search authorization mentions the name of the person responsible for
p.002020: the research. This decision is published in the Official Journal of the French Republic.
p.002020: The director general of the agency may request, by registered letter with request for acknowledgment of receipt, any
p.002020: additional information, which he considers necessary for the processing of the authorization file. It indicates to the applicant the
p.002020: deadline within which he must provide these elements. This request for additional information suspends the deadline mentioned in
p.002020: fourth paragraph.
p.002020: Article R2151-7 Learn more about this article ...
p.002020: Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: Any decision of the director general of authorization or refusal of research and the opinion of the orientation council are transmitted
p.002020: simultaneously with the ministers responsible for health and research, who have one month to request
p.002020: jointly a new examination of the authorization request file, in application of 1 ° and 2 ° of III of article L.
p.002020: 2151-5.
p.002020: When a request for review of an authorized protocol is made by the ministers, the director general suspends
p.002020: the authorization issued for a period of two months. The suspension decision is notified to the authorization holder.
p.002020: At the end of the thirty-day period during which the agency proceeds to re-examine the request, the silence of
p.002020: the administration is worth confirmation of the initial decision of the director general of the agency.
p.002020: Article R2151-8 Learn more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: Any research authorized under article L. 2151-5 is placed under the direction of a designated responsible person
p.002020: by the request mentioned in article R. 2151-6.
p.002020: The person responsible for the research sends an annual report to the director general of the biomedicine agency.
p.002020: She sends him the final research report as soon as it is completed. These reports contain in particular the
p.002020: information on the destination of the embryos and embryonic stem cells covered by the protocol.
p.002020: The director general of the agency may at any time ask the person responsible for the research to report
p.002020: account of the progress of works.
p.002020: Article R2151-9 Read more about this article ...
p.002020: Created by Decree n ° 2006-121 of February 6, 2006 - art. 1 JORF February 7, 2006
p.002020: The establishment or organization that wishes to modify a substantial element of the protocol authorized under article L.
p.002020: 2151-5 must file a new authorization request file. The latter is instructed under the same conditions as
p.002020: the initial request.
p.002020: Article R2151-10 Learn more about this article ...
p.002020: Created by Decree n ° 2006-121 of February 6, 2006 - art. 1 JORF February 7, 2006
p.002020: In the event of violation of the laws or regulations or prescriptions fixed by the authorization, this
p.002020: the latter can be suspended at any time for a maximum of three months by the agency's director general
p.002020: of biomedicine, which informs the orientation council as soon as possible. The authorization can also be
p.002020: withdrawn after advice from the orientation council. The Director General's decision is notified to the authorization holder and
p.002020: communicated to ministers responsible for health and research.
p.002020: Before any decision to suspend or withdraw an authorization, the authorization holder is given notice to terminate
p.002020: failures or to submit observations within a time limit set by the Director General.
p.002020: Article R2151-11 Learn more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: I.-The establishments and organizations authorized under the first and third sections of this chapter maintain a
p.002020: registry of embryos and embryonic stem cells they hold.
p.002020: This register mentions:
p.002020: 1 ° The organization that supplied the embryos or embryonic stem cells and their identification code after
p.002020: anonymization;
p.002020: 2 ° The title of the research protocol;
p.002020: 3 ° The name of the person responsible for research or conservation activity;
p.002020: 4 ° The number of embryos and embryonic stem cell lines being researched;
p.002020: 5 ° The number, designation and characteristics of the embryonic stem cell lines preserved or
p.002020: obtained during research;
p.002020: 6 ° The results of analyzes concerning biological markers of infection;
p.002020: 7 ° The place (s) of research and conservation;
p.002020: 8 ° The destination of embryos and embryonic stem cells.
p.002020: The person responsible for research or conservation is responsible for keeping this register. She ensures
p.002020: the accuracy of the information which is recorded in this register as well as its conservation under conditions of
p.002020: security to guarantee its integrity and confidentiality.
p.002020: II.-The biomedicine agency maintains a national registry of embryos and embryonic stem cells, which includes
p.002020: especially :
p.002020: 1 ° The authorization numbers and the names of the establishments or organizations authorized to carry out research or to
p.002020: store embryos or embryonic stem cells;
p.002020: 2 ° For each authorization, the information mentioned in 2 ° to 5 ° and to 7 ° and 8 ° of I, with, for embryos and
p.002020: embryonic stem cell lines under investigation, their identification code.
p.002020: The person responsible for research or conservation on the occasion of the annual report provided for in article R. 2151-8
p.002020: communicate to the director general of the biomedicine agency the information necessary for the latter to keep up to date
p.002020: this national register.
p.002020: The identification code assigned to each embryo, listed in the registers mentioned above, and to each line
p.002020: stem cells derived from them, established and made anonymous according to the coding system defined by
p.002020: decision of the director general of the agency, after opinion of the National Data Protection Commission.
p.002020: The anonymization of this code has a reversible character in order, if necessary, to access data allowing to identify
p.002020: the people at the origin of the embryo when a medical or health security purpose requires it.
p.002020: Article R2151-12 Read more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: Any establishment or organization that researches embryos or stem cells
p.002020: embryonic is required to keep for ten years from the end of this research the protocol provided for in article
p.002020: L. 2151-5, the documents attesting to the collection of consents mentioned in articles R. 2151-4 and R. 2151-13 as well
p.002020: than the final research report and the register mentioned in I of article R. 2151-11.
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p.002020: the accuracy of the information which is recorded in this register as well as its conservation under conditions of
p.002020: security to guarantee its integrity and confidentiality.
p.002020: II.-The biomedicine agency maintains a national registry of embryos and embryonic stem cells, which includes
p.002020: especially :
p.002020: 1 ° The authorization numbers and the names of the establishments or organizations authorized to carry out research or to
p.002020: store embryos or embryonic stem cells;
p.002020: 2 ° For each authorization, the information mentioned in 2 ° to 5 ° and to 7 ° and 8 ° of I, with, for embryos and
p.002020: embryonic stem cell lines under investigation, their identification code.
p.002020: The person responsible for research or conservation on the occasion of the annual report provided for in article R. 2151-8
p.002020: communicate to the director general of the biomedicine agency the information necessary for the latter to keep up to date
p.002020: this national register.
p.002020: The identification code assigned to each embryo, listed in the registers mentioned above, and to each line
p.002020: stem cells derived from them, established and made anonymous according to the coding system defined by
p.002020: decision of the director general of the agency, after opinion of the National Data Protection Commission.
p.002020: The anonymization of this code has a reversible character in order, if necessary, to access data allowing to identify
p.002020: the people at the origin of the embryo when a medical or health security purpose requires it.
p.002020: Article R2151-12 Read more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: Any establishment or organization that researches embryos or stem cells
p.002020: embryonic is required to keep for ten years from the end of this research the protocol provided for in article
p.002020: L. 2151-5, the documents attesting to the collection of consents mentioned in articles R. 2151-4 and R. 2151-13 as well
p.002020: than the final research report and the register mentioned in I of article R. 2151-11.
p.002020: << Previous block - Next block >> - -
p.002020: To print
p.002020: About the French legal system Licenses What's new on the site?
...

Searching for indicator child:

Searching for indicator single:

Searching for indicator home:

Searching for indicator embryo:

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p.002020: Home French law European law International law Translations Databases
p.002020: You are in: Home> Applicable codes> Public health code
p.002020: Public health code
p.002020: Hide the panel of << Previous block - Next block >> - -
p.002020: navigation Print
p.002020: Path Navigation:
p.002020: Public health code
p.002020: Public health code
p.002020: Regulatory part
p.002020: (Last modification: May 30 2020)
p.002020: Part Two: Family, Mother and Child Health
p.002020: Version in force on May 30, 2020
p.002020: Version to come on June 24, 2020 Book I: Protection and promotion of maternal and child health
p.002020: Version to come as of June 30, 2020 Title V: Research on the embryo and embryonic cells
p.002020: Version to come on July 12, 2020 Single Chapter
p.002020: Version to come on July 26, 2020
p.002020: Version coming September 1
p.002020: 2020
p.002020: Version to come on October 1, 2020 Section 1: Research implementation.
p.002020: Version coming January 1, 2021
p.002020: Version coming April 1, 2021
p.002020: Article R2151-1 Learn more about this article ...
p.002020: Version to come on July 1, 2021 Modified by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: Version coming January 1, 2022
p.002020: The Director General of the Biomedicine Agency may authorize, under the conditions laid down in Article L. 2151-5, a
p.002020: Version to come on March 1, 2022 research protocol on the embryo or on embryonic stem cells, after advice from the guidance council, for
p.002020: Version to come on: date not a fixed term which cannot exceed five years, renewable under the same conditions.
p.002020: specified
p.002020: Article R2151-2 Learn more about this article ...
p.002020: Consolidated version as of ...
p.002020: Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: Day month Year
p.002020: 2015 In addition to verifying the conditions set out in article L. 2151-5, the biomedicine agency ensures the feasibility of the
p.002020: October 15
p.002020: Ex: 2020 protocol and the sustainability of the organization and the research team. It takes into account titles, diplomas,
p.002020: experience and scientific work of the research manager and team members. In addition, the agency of the
p.002020: Consult biomedicine takes into account the premises, materials, equipment as well as the processes and techniques used
p.002020: by the applicant. It assesses the means and devices guaranteeing the safety, quality and traceability of embryos and
p.002020: embryonic stem cells.
p.002020: Hide code navigation
p.002020: Summary
p.002020: Legislative part Article R2151-3 Read more about this article ...
p.002020: Old legislative part Amended by Decree n ° 2012-467 of 11 April 2012 - art. 1
p.002020: Regulatory part I.-Only can obtain authorization to carry out research on the embryo:
p.002020: First part: 1 ° Public health establishments and medical biology laboratories authorized to store embryos in
p.002020: General protection of the application of article L. 2142-1, as well as establishments authorized to carry out preimplantation diagnosis in
p.002020: health application of article L. 2131-4;
p.002020: Second part :
p.002020: 2 ° Establishments and organizations having concluded an agreement with at least one of establishments or laboratories
p.002020: Family, mother health
p.002020: mentioned in 1 °. This agreement sets out the conditions under which the establishment or laboratory mentioned in 1 °
p.002020: Hide the search for canned items and provide embryos for the benefit of this establishment or organization. The provision
p.002020: within the embryo code is only allowed for the duration of the research.
p.002020: Enter a word from an article or a
p.002020: article number II.-Only the following can be authorized to carry out research on embryonic stem cells:
p.002020: Search in the entirety of 1 ° Establishments and organizations pursuing a research activity and holders of the conservation authorization
p.002020: code of embryonic stem cells for research purposes mentioned in article L. 2151-7;
p.002020: Limit search to 'Party
p.002020: 2 ° Public and private establishments and organizations pursuing a research activity having concluded an agreement
p.002020: Legislative ''
p.002020: with an establishment or organization mentioned in 1 ° in which the latter undertakes to supply and keep
p.002020: Limit search to 'Party
p.002020: embryonic stem cells for carrying out the research of the former.
p.002020: Regulatory ''
p.002020: Word or phrase within
p.002020: articles Article R2151-4 Read more about this article ...
p.002020: Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: The provision of prior information and the collection in writing of the free and informed consent of each member of the
p.002020: Number
p.002020: couple or of the surviving member of the couple, provided for in the last paragraph of article L. 2131-4 and in articles L. 2141-3, L. 2141-
p.002020: 4 and L. 2151-5, are carried out, in the case of a pre-implantation diagnosis, by the practitioner approved in application of article L.
p.002020: 2131-4-2 and, in other cases, by the intervening practitioner, in accordance with the fifth paragraph of article L. 2142-1,
p.002020: in an establishment, laboratory or body authorized under the same article.
...

p.002020: Embryos can only be handed over to the research manager mentioned in article R. 2151-8 only by the holder of
p.002020: the authorization provided for in article L. 2151-7, by the practitioner approved in application of article L. 2131-4-2 or by the practitioner
p.002020: intervening, in accordance with the fifth paragraph of article L. 2142-1, in an establishment, laboratory or organism
p.002020: authorized under the same article. The research manager must produce the authorization of the research protocol.
p.002020: research. The authorization holder or the practitioner gives him the document attesting to the collection of consents
p.002020: mentioned in article R. 2151-4.
p.002020: The delivery of embryonic stem cells to the research manager by the holder of the import authorization
p.002020: provided for in article L. 2151-6 or for the storage authorization provided for in article L. 2151-7 is carried out on production of
p.002020: documents mentioned in the previous paragraph. If the embryonic stem cells have been imported, the holder of
p.002020: the authorization gives the research manager the documents attesting to their obtaining in compliance with the principles
p.002020: mentioned in articles 16 to 16-8 of the civil code and the collection of consents mentioned in article R. 2151-13.
p.002020: No information likely to allow the identification of the couple or of the surviving member of the couple at the origin of the
p.002020: embryos being researched cannot be communicated to the research manager.
p.002020: Article R2151-6 Learn more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: The request for authorization of a research protocol on the embryo or on embryonic stem cells is
p.002020: addressed to the director general of the biomedicine agency by registered post with request for acknowledgment of receipt or
p.002020: deposited against receipt with the agency under the same conditions. This request is accompanied by a file
p.002020: which includes all the elements allowing to verify that the legal conditions are met and whose form and
p.002020: contents are set by decision of the agency's director general.
p.002020: The Director General also sets the periods during which request files may be filed
p.002020: authorization. The closing date for these periods runs the four-month period provided below for requests
p.002020: accompanied by a complete file.
p.002020: When the documents essential to the processing of the request are lacking, the advice of delivery fixes the period within which
p.002020: these parts must be provided.
p.002020: Within four months of the end of the period during which the complete file was submitted,
p.002020: the director general of the biomedicine agency notifies the requesting establishment or body of the decision
p.002020: authorization or refusal of authorization. At the end of this period, the absence of a decision by the Director General constitutes a decision
p.002020: implied refusal of authorization.
p.002020: The Director General's decision granting the search authorization mentions the name of the person responsible for
p.002020: the research. This decision is published in the Official Journal of the French Republic.
p.002020: The director general of the agency may request, by registered letter with request for acknowledgment of receipt, any
p.002020: additional information, which he considers necessary for the processing of the authorization file. It indicates to the applicant the
...

p.002020: 3 ° The name of the person responsible for research or conservation activity;
p.002020: 4 ° The number of embryos and embryonic stem cell lines being researched;
p.002020: 5 ° The number, designation and characteristics of the embryonic stem cell lines preserved or
p.002020: obtained during research;
p.002020: 6 ° The results of analyzes concerning biological markers of infection;
p.002020: 7 ° The place (s) of research and conservation;
p.002020: 8 ° The destination of embryos and embryonic stem cells.
p.002020: The person responsible for research or conservation is responsible for keeping this register. She ensures
p.002020: the accuracy of the information which is recorded in this register as well as its conservation under conditions of
p.002020: security to guarantee its integrity and confidentiality.
p.002020: II.-The biomedicine agency maintains a national registry of embryos and embryonic stem cells, which includes
p.002020: especially :
p.002020: 1 ° The authorization numbers and the names of the establishments or organizations authorized to carry out research or to
p.002020: store embryos or embryonic stem cells;
p.002020: 2 ° For each authorization, the information mentioned in 2 ° to 5 ° and to 7 ° and 8 ° of I, with, for embryos and
p.002020: embryonic stem cell lines under investigation, their identification code.
p.002020: The person responsible for research or conservation on the occasion of the annual report provided for in article R. 2151-8
p.002020: communicate to the director general of the biomedicine agency the information necessary for the latter to keep up to date
p.002020: this national register.
p.002020: The identification code assigned to each embryo, listed in the registers mentioned above, and to each line
p.002020: stem cells derived from them, established and made anonymous according to the coding system defined by
p.002020: decision of the director general of the agency, after opinion of the National Data Protection Commission.
p.002020: The anonymization of this code has a reversible character in order, if necessary, to access data allowing to identify
p.002020: the people at the origin of the embryo when a medical or health security purpose requires it.
p.002020: Article R2151-12 Read more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: Any establishment or organization that researches embryos or stem cells
p.002020: embryonic is required to keep for ten years from the end of this research the protocol provided for in article
p.002020: L. 2151-5, the documents attesting to the collection of consents mentioned in articles R. 2151-4 and R. 2151-13 as well
p.002020: than the final research report and the register mentioned in I of article R. 2151-11.
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p.002020: contents are set by decision of the agency's director general.
p.002020: The Director General also sets the periods during which request files may be filed
p.002020: authorization. The closing date for these periods runs the four-month period provided below for requests
p.002020: accompanied by a complete file.
p.002020: When the documents essential to the processing of the request are lacking, the advice of delivery fixes the period within which
p.002020: these parts must be provided.
p.002020: Within four months of the end of the period during which the complete file was submitted,
p.002020: the director general of the biomedicine agency notifies the requesting establishment or body of the decision
p.002020: authorization or refusal of authorization. At the end of this period, the absence of a decision by the Director General constitutes a decision
p.002020: implied refusal of authorization.
p.002020: The Director General's decision granting the search authorization mentions the name of the person responsible for
p.002020: the research. This decision is published in the Official Journal of the French Republic.
p.002020: The director general of the agency may request, by registered letter with request for acknowledgment of receipt, any
p.002020: additional information, which he considers necessary for the processing of the authorization file. It indicates to the applicant the
p.002020: deadline within which he must provide these elements. This request for additional information suspends the deadline mentioned in
p.002020: fourth paragraph.
p.002020: Article R2151-7 Learn more about this article ...
p.002020: Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
p.002020: Any decision of the director general of authorization or refusal of research and the opinion of the orientation council are transmitted
p.002020: simultaneously with the ministers responsible for health and research, who have one month to request
p.002020: jointly a new examination of the authorization request file, in application of 1 ° and 2 ° of III of article L.
p.002020: 2151-5.
p.002020: When a request for review of an authorized protocol is made by the ministers, the director general suspends
p.002020: the authorization issued for a period of two months. The suspension decision is notified to the authorization holder.
p.002020: At the end of the thirty-day period during which the agency proceeds to re-examine the request, the silence of
p.002020: the administration is worth confirmation of the initial decision of the director general of the agency.
p.002020: Article R2151-8 Learn more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: Any research authorized under article L. 2151-5 is placed under the direction of a designated responsible person
p.002020: by the request mentioned in article R. 2151-6.
p.002020: The person responsible for the research sends an annual report to the director general of the biomedicine agency.
p.002020: She sends him the final research report as soon as it is completed. These reports contain in particular the
p.002020: information on the destination of the embryos and embryonic stem cells covered by the protocol.
p.002020: The director general of the agency may at any time ask the person responsible for the research to report
p.002020: account of the progress of works.
p.002020: Article R2151-9 Read more about this article ...
p.002020: Created by Decree n ° 2006-121 of February 6, 2006 - art. 1 JORF February 7, 2006
p.002020: The establishment or organization that wishes to modify a substantial element of the protocol authorized under article L.
...

p.002020: 7 ° The place (s) of research and conservation;
p.002020: 8 ° The destination of embryos and embryonic stem cells.
p.002020: The person responsible for research or conservation is responsible for keeping this register. She ensures
p.002020: the accuracy of the information which is recorded in this register as well as its conservation under conditions of
p.002020: security to guarantee its integrity and confidentiality.
p.002020: II.-The biomedicine agency maintains a national registry of embryos and embryonic stem cells, which includes
p.002020: especially :
p.002020: 1 ° The authorization numbers and the names of the establishments or organizations authorized to carry out research or to
p.002020: store embryos or embryonic stem cells;
p.002020: 2 ° For each authorization, the information mentioned in 2 ° to 5 ° and to 7 ° and 8 ° of I, with, for embryos and
p.002020: embryonic stem cell lines under investigation, their identification code.
p.002020: The person responsible for research or conservation on the occasion of the annual report provided for in article R. 2151-8
p.002020: communicate to the director general of the biomedicine agency the information necessary for the latter to keep up to date
p.002020: this national register.
p.002020: The identification code assigned to each embryo, listed in the registers mentioned above, and to each line
p.002020: stem cells derived from them, established and made anonymous according to the coding system defined by
p.002020: decision of the director general of the agency, after opinion of the National Data Protection Commission.
p.002020: The anonymization of this code has a reversible character in order, if necessary, to access data allowing to identify
p.002020: the people at the origin of the embryo when a medical or health security purpose requires it.
p.002020: Article R2151-12 Read more about this article ...
p.002020: Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
p.002020: Any establishment or organization that researches embryos or stem cells
p.002020: embryonic is required to keep for ten years from the end of this research the protocol provided for in article
p.002020: L. 2151-5, the documents attesting to the collection of consents mentioned in articles R. 2151-4 and R. 2151-13 as well
p.002020: than the final research report and the register mentioned in I of article R. 2151-11.
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p.002020: To print
p.002020: About the French legal system Licenses What's new on the site?
...

Orphaned Trigger Words

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
child	Child
embryo	embryo
family	Motherhood/Family
home	Property Ownership
opinion	philosophical differences/differences of opinion
single	Marital Status
stem cells	stem cells

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers

Trigger Words

consent

protection

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Motherhood/Family	family	2
Health	stem cells	stem cells	16
Social	Access to Social Goods	access	1
Social	Child	child	2
Social	Marital Status	single	1
Social	Property Ownership	home	2
Social	embryo	embryo	7
Social	philosophical differences/differences of opinion	opinion	2

Decree No. 2015-155 of 11 February, 2015: Public Health Code on Research on Embryos Article R2151-1 and Following Sections

Applicable Type / Vulnerability / Indicator Overlay for this Input

Health / Motherhood/Family

Health / stem cells

Social / Access to Social Goods

Social / Child

Social / Marital Status

Social / Property Ownership

Social / embryo

Social / philosophical differences/differences of opinion

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input