Rs 810.311 Order Of February 2, 2005 Relating To Research On Embryonic Stem Cells (Research On Stem Cells, Orcs Ordinance)

Original Language Title: RS 810.311 Ordonnance du 2 février 2005 relative à la recherche sur les cellules souches embryonnaires (Ordonnance relative à la recherche sur les cellules souches, ORCS)

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810.311 order for research on embryonic stem cells (research on stem cells, ORCS Ordinance) of 2 February 2005 (status 1 April 2012) the federal Council Swiss, view of art. 17 of the Act of December 19, 2003 (Bill) stem cell research, stop: Section 1 Information and consent of the couple concerned art. 1 existence of an embryo supernumerary if an embryo can be used to induce pregnancy, the doctor explains to the couple treats it as part of a medically assisted reproduction procedure: a. that the embryo is supernumerary; (b) why it is, etc. will be destroyed if it is not used in accordance with the conditions laid down by the law, for the production of embryonic stem cells for the purpose of a research project (production of stem cells) or for a research project aimed at improving the production process of embryonic stem cells.

Art. 2 information of the couple concerned before the consent if a project of production of embryonic stem cells or a research project to improve the production process of embryonic stem cells has been authorized, the doctor informed the couple orally and understandably: a. the nature and the purpose of the research project considered, and of the date scheduled for the beginning of the project; b. rights referred to in art. 5, al. 3, of the Act and the al. 3 and 4 of this article; c. free under art. 4 of the Act; (d) the measures provided for in art. 27 to protect the personal data of the couple; e. that third parties can acquire rights on embryonic stem cells or products obtained from embryonic stem cells, in accordance, for example, with the provisions of the law of 25 June 1954 on patents, without the couple can assert any right; f. embryonic stem cells or products obtained from embryonic stem cells can be used in research and practice clinical without that the couple can assert any right; g. than embryonic stem cells, in accordance with art. 9, al. 1, let. c of the Act, may be transmitted to other research projects; ETH. the content of the consent referred to in art form. 3. the doctor back to the couple an information sheet and consent form provided by the person responsible for the research project (project management).
The couple has the right to ask or be asked questions at the direction of the project.
A reasonable reflection period must be granted to the advent couple that it made its decision.

RS 232.14 art. 3 content of consent by signing the consent form, the couple declare having been informed in accordance with art. 2 and allows the use of supernumerary embryo for stem cell production or to a research project aimed at improving the production process of embryonic stem cells.

Art. 4 consequences of a refusal or withdrawal of consent the refusal or withdrawal of consent by the couple or by one of the two partners may no prejudice to the couple in the rest of the treatment.

Section 2 authorisation to produce art. embryonic stem cells 5 request anyone who wants permission to produce embryonic stem cells to carry out a research project (art. 7 of the Act) must submit to the federal Office of public health (office) the documents below to review: a. the complete record of the project of production of embryonic stem cells, including proof of the adequacy of the laboratory facilities; (b) the complete record of the research project for which embryonic stem cells will be used as it was submitted to the commission of Ethics Committee in application of art. 17; c. the favourable opinion of the commission of Ethics Committee on research project; d. a score from one extracted from the registry referred to in art. 18 of the Act, explaining why embryonic stem cells available in Switzerland are not suitable for the research project in question; (e) an indication of the number of embryos that will likely be needed.

Art. 6 review the Agency verifies: a. that the supplied file is complete;
(b) the licensing requirements established by law are met.
He may apply to the management of the project to provide additional documents.

Art. 7 delay the office decided in 60 days.
If the agency asks management to the project of the additional documents, the period begins to run from the day of receipt of the required documents; the Agency notes the project management the date on which the period begins to run.

Section 3 authorisation of research projects aimed at improving the production process of Art. embryonic stem cells 8 request anyone who wants permission to carry out a research project aimed at improving the production process of embryonic stem cells (art. 8 of the Act) must submit to the office the documents below to review: a. the complete record of the research project, including a certificate of adequacy of the laboratory facilities; b. a note explaining what the research project could provide essential knowledge for the improvement of production processes; c. one notes explaining why it is not possible to get another way of knowledge of equal value, including by experiments on animal embryos; (d) the indication of the number of embryos that will likely be needed; (e) the information sheet and consent form.

Art. 9 review the Agency verifies: a. that the supplied file is complete;
(b) the information sheet and the consent form are comprehensible and complete;
(c) licensing requirements set by law are met.
He may apply to the management of the project to provide additional documents.

Art. 10 delay the office decided in 60 days.
If the agency asks management to the project of the additional documents, the period begins to run from the day of receipt of the required documents; the Agency notes the project management the date on which the period begins to run.

Section 4 authorization to keep supernumerary embryos art. 11 request anyone who wants permission to keep supernumerary embryos (art. 10 of the law) must submit to the office the documents below to review: a. the authorization issued in application of art. 7 or 8 of the Act; b. a note explaining why the retention of supernumerary embryos is absolutely essential; c. a certificate of qualifications of staff; d. proof of the adequacy of the laboratory facilities.

Art. 12 review the Agency verifies: a. that the supplied file is complete; b. that the licensing requirements established by law are met.

Section 5 permission to import art. embryonic stem cells 13 request anyone who wants permission to import of embryonic stem cells (art. 15 of the law) must provide to the Agency the documents below to review: a. the complete record of the research project for which embryonic stem cells will be used, as submitted to the commission of Ethics Committee in application of art. 17; b. the favourable opinion of the commission of Ethics Committee on research project; (c) the indication of the number of embryonic stem cells with necessary embryonic stem cell lines, and their characterization, in accordance with art. 29, al. 1, let. b; d. the certificate supplied by the competent body under the law in force in the country concerned or by another body recognized by that country, according to which: 1. embryonic stem cells were obtained from embryos, 2. the couple concerned, after having been informed, has consented to the use of the embryo for research purposes freely, 3. the couple receive no remuneration.

Art. 14 review the Agency verifies: a. that the supplied file is complete; b. that the licensing requirements established by law are met.

Section 6 authorization to export art. embryonic stem cells 15 application for leave anyone who is seeking approval to export (art. 15 of the law) embryonic stem cells must provide to the Agency the documents below to review: a. the title, purpose and place of realization of the project of research for which cells embryonic stem will be used; (b) the name and address of the project management; (c) the indication of the number of embryonic stem cells and embryonic export stem cell lines , and their characterization, in accordance with art. 29, al. 1, let. b; d. the certificate supplied by the competent body under the law in force in the country concerned or by another body recognized by that country, according to which: 1. the project allows for the knowledge on the diagnosis, treatment or prevention of serious diseases or on the biology of the development of the human being, 2. the project has been approved from the ethical point of view by a body independent of the direction of the project.

Art. 16 review of the office folder checks:

a. the records provided is complete; b. that the licensing requirements established by law are met.

Section 7 opinion of the Ethics Committee and authorization to launch the research project art. 17 request anyone who needs an opinion from the ethics commission to carry out a research project for which cells embryonic stem will be used (art. 11 of the law) must submit the documents below to review: a. a complete record of the research project; (b) a note explaining why it is not possible to get another way of knowledge of equal value; c. the information sheet and consent form If it is required for the research project involved embryonic stem cells.

Art. 18 review the ethics commission verifies: a. that the supplied file is complete; (b) that the conditions laid down by law for the realization of the research project for which stem cells will be used are met.

If the research project is on several sites, just for the first site competent ethics commission has rendered a favorable opinion in ordinary proceedings; the other ethics committees concerned will be able to make their decision at a summary trial. Management of the project must present the favourable opinion of the commission of Ethics Committee of the first site.
To evaluate the research project, the ethics commission can appeal to experts and ask management to the project of the additional documents.

Art. 19 time the ethics commission shall deliver its opinion within 30 days.
If it appeals to experts or she asked management to the project to provide additional documents, the period begins to run from the day of receipt of the opinion of experts or the required documents; project management, it indicates the date on which the period begins to run.

Art. 20 launch of the research project before launching the research project, management project announced the project at the office and shall provide: a. the title of the research project, if the Agency has already received the dossier on the research project under the procedure of authorization referred to in art. 5 or 13; b. the complete record of the research project, as it was submitted to the commission of Ethics Committee in application of art. 17, and the favourable opinion of the Ethics Committee, if it is a project for which will be used for embryonic stem cells available in Switzerland.

The office may request from the direction of the project to provide additional documents.
If the project don't gives rise to no objection on his part, the agency assigns a reference number to research project within 15 days from the date of receipt of the announcement or the required documents. He communicates this number to the project management.
The research project may start as soon as the reference number was provided.

Art. 21 reassessment of a project and withdrawal of the favourable opinion the ethics commission can proceed to the re-evaluation of a research project and, where appropriate, withdraw its favourable opinion if new scientific developments and ethical re-evaluation resulting require.
It shall immediately notify the withdrawal of his favorable to the project management and the Board.
If she suspected irregularities in the implementation of the project, she informs the office without delay.

Section 8 changing a project art. 22 anyone who produces embryonic stem cells, directed a research project aimed at improving the production process of embryonic stem cells, supernumerary embryos preserved or matter or exports embryonic stem cells, must announce to the Agency any significant changes it intends to make to the project concerned.
Anyone who realizes a research project for which cells embryonic stem are used should announce to the ethics commission and the office any significant changes it intends to make to the research protocol.
The office or the ethics commission and the office pronounce within 30 days from the date of receipt of the announcement of the changes.
A project within the meaning of para. 1 cannot be sued according to the announced changes if the Board issues a new authorization.
A project of research within the meaning of para. 2 cannot be sued according to the announced changes unless the Ethics Committee issues a favorable review that the office and the restart of the project.

Section 9 Obligation to announce and reporting art. 23 announcement after interruption or completion of a project anyone who produces embryonic stem cells or realize a research project aimed at improving the production process of embryonic stem cells must announce to the Board, within 15 days, the interruption or completion of the project concerned.
Anyone who realizes a research project for which cells embryonic stem are used should announce to the Agency and to the ethics commission, within 15 days, the interruption or completion of the project.
The grounds for interruption must be specified in the announcement.

Art. 24 final report anyone who produces embryonic stem cells or realize a research project aimed at improving the production process of embryonic stem cells must report to the office within six months following the interruption or completion of the project concerned.
Anyone who realizes a research project for which cells embryonic stem are used must submit a report to the Agency and to the Ethics Committee within six months following the interruption or completion of the project.
The office may shorten this delay if important reasons; It may extend it in exceptional cases duly motivated by the project management.

Art. 25 content of any final report final report must document the process and the results of the production of embryonic stem cells, of the research project to improve the production process of embryonic stem cells or the research project for which stem cells were used.
The final report on a project to produce embryonic stem cells must in addition specify: a. the number of embryos which have been used; (b) the number of embryonic stem cells that have been produced and the number of lines of embryonic stem cells and their characterization, in accordance with art. 29, al. 1, let. (b) the final report on a research project aimed at improving the production process of stem cells must also: a. specify the number of embryos which have been used; (b) specify the number of embryonic stem cells that have been produced and the number of lines of embryonic stem cells and their characterization, in accordance with art. 29, al. 1, let. b, if such stem cells were produced in connection with the project; c. include a summary of the positive and negative results.

The final report on a research project for which cells embryonic stem have been used should also contain a summary of the positive and negative results.

Art. 26 embryonic stem cells anyone who maintains embryonic stem cells should indicate to the Agency, on July 1 of each year, the number of stem cells inputs and outputs, the number of stored stem cell lines and their characterization, in accordance with art. 29, al. 1, let. (b) Section 10 Protection of data art. 27. data allowing the identification of the couple concerned should not be made available to those involved in the production of embryonic stem cells or research projects.
Before putting a supernumerary embryo available to a project of production of stem cells or to a research project aimed at improving the production process of stem cells, the clinic where fertilization vitro has been carried anonymous data for the supernumerary embryo by assigning a code.
She keeps 10 years data to the couple concerned, the information sheet, the original of the signed consent form and the key to the code. The security measures for the data must match the current state of the art.

Section 11 registry public art. 28 purpose of the register the register referred to in art. 18 of the Act must: a. be used for delivery of embryonic stem cells for research projects conducted in Switzerland within the meaning of art. 9, al. 1, let. c, of the Act; b. allow to assess whether appropriate embryonic stem cells are available in Switzerland for a research project given; c. give an overview of the research projects underway or completed in Switzerland.

Art. 29 contents of register anyone who produces embryonic stem cells, directed a research project aimed at improving the production process of embryonic stem cells or a project for which cells embryonic stem are used, or still embryonic stem cells, must provide the Agency: a. description of the project in which embryonic stem cells are produced or used specifying:

1. the title of the project, 2. his goal, 3. the name and address of the management of the project, 4. likely the date scheduled for the beginning of the project and its duration;

b. characterization of embryonic stem cells produced or used in the project as well as used embryonic stem cell lines; embryonic stem cell lines, refers to the pluripotent cells taken from cells of an embryo at an early stage, which can be grown and reproduced in vitro for several generations and which are characterized by stable a genotype and a phenotype.

The office registered in the register the information required in the al. 1, let. a, when it grants permissions referred to in art. 5, 8 or 13 or when it receives the announcement provided for in art. 20. He published in the register summaries provided in art. 25, al. 3, let. c, and al. 4. it can seek clarification on the information provided.

Section 12 fees art. 30 calculation of emoluments the emoluments are set within the limits of the ranges defined in art. 31. they are function of the time invested and the necessary technical knowledge.
For benefits that are not explicitly mentioned in art. 31, the amount of the fees is calculated based on the time invested. The hourly amount varies according to the technical knowledge and function of personnel running from 90 to 200 francs.

Art. 31 amount of fees the Agency collects including the following fees: in francs.

production of embryonic stem cells from supernumerary embryos: first authorization, renewal, suspension, withdrawal 500 to 10 000 b.

research project aimed at improving the production process of embryonic stem cells: first authorization, renewal, suspension, withdrawal 500 to 10 000 c.

conservation of surplus embryos: first authorization, renewal, suspension, withdrawal 250-5000 d.

import or export of embryonic stem cells: first authorization, renewal, suspension, withdrawal 500 to 10 000 e.

inspection (without preparation or report), a day of 1 000 to 20 000 f.

certificate, report of 200 to 2,000 new content according to ch. I of O of 2 March 2012, in force since April 1, 2012 (RO 2012 1201) new content according to ch. I of O of 2 March 2012, in force since April 1, 2012 (RO 2012 1201) new content according to ch. I of O of 2 March 2012, in force since April 1, 2012 (RO 2012 1201) new content according to c I of the O on March 2. 2012, in force since April 1, 2012 (2012 1201 RO) art. 32 supplement the Agency may require a supplement of up to 50% of fees if delivery: a. is, upon request, provided emergency or outside normal opening hours; b. is an unusually large or present particular difficulties.

Art. 33 disbursements in addition to fees, the Agency Bill disbursements in the present case. Are particularly considered in disbursements: a. fees of the members of the commissions, experts and agents; (b) the costs of looking for evidence, scientific analyses, examinations, or the need to procure documents; c. travel and transportation costs; d. the costs of analyses carried out in laboratories or in other laboratories; (e) the costs of the works he entrusts to a third party.

Section 13 forms art. 34. the office may prescribe forms: a. for the authorisation procedures referred to in art. 5, 8, 11, 13 and 15; b. for ads or the reports referred to in art. 20, 23 and 24; c. for the indications which must be entered into the register of embryonic stem cells.

Section 14 entry into force art. 35. this order comes into force on March 1, 2005.

RO 2005 959 RS 810.31 State on April 1, 2012

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