Stem Cell Research Act (StRA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 5 Informed consent
1 A surplus embryo may only be used for the derivation of embryonic stem cells if written consent has been freely given by the couple concerned. Before such consent is given, the couple must be provided with adequate information, verbally and in writing, in a comprehensible form, concerning the use of the embryo. 2 A request may only be made to the couple after the determination of the surplus status of the embryo. 3 Consent may be revoked by the couple, or by the woman or man, at any time, without any statement of reasons, up until the initiation of stem cell derivation. 4 If consent is refused or revoked, the embryo must be destroyed immediately. 5 In the event of one partner’s death, the decision concerning the use of the embryo for stem cell derivation shall be taken by the surviving partner; he or she must have regard to the declared or presumed wishes of the deceased.
Art. 6 Independence of participants
It is not permissible for persons involved in the derivation of stem cells either to participate in the assisted reproduction procedure of the couple concerned or to have the authority to issue instructions to persons involved in this procedure.
Art. 7 Licensing requirement for stem cell derivation
1 Any person wishing to derive embryonic stem cells from surplus embryos with a view to conducting a research project shall require a licence from the Federal Office of Public Health (Federal Office). 2 A licence shall be granted if: a. the research project has received the approval of the ethics committee, as specified in Article 11; b. no suitable embryonic stem cells are available in this country; c. no more surplus embryos are used than are essential for the derivation of embryonic stem cells; and d. the technical and operational requirements are met.
Para. 2 let. a — Amended by Annex No 5 of the Human Research Act of 30 Sept. 2011, in force since 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045).
Art. 8 Licensing requirement for research projects aimed at improving derivation methods
1 Any person wishing to derive embryonic stem cells from surplus embryos in connection with a research project aimed at improving derivation methods shall require a licence from the Federal Office. 2 A licence shall be granted if: a. the project meets the scientific and ethical requirements specified in Paragraph 3; b. no more surplus embryos are used than are essential for the attainment of the research objective; and c. the technical and operational requirements are met. 3 The research project may only be carried out if: a. the project is designed to yield significant insights for the improvement of derivation methods; b. equivalent insights cannot also be gained in a different way; c. the project satisfies the scientific quality requirements; and d. the project is ethically acceptable. 4 For the scientific and ethical assessment of the project, the Federal Office shall consult independent experts.
Art. 9 Duties of the licensee
1 The holder of a licence granted under Article 7 or 8 is required: a. to destroy the embryo immediately after the derivation of embryonic stem cells; b. to report on the derivation of stem cells to the Federal Office; c. to pass on embryonic stem cells, with reimbursement possibly being provided as specified in Article 4, for research projects carried out in this country that have received the approval of an ethics committee as specified in Article 11. 2 In the case of a research project aimed at improving derivation methods, the licensee is additionally required: a. to notify the Federal Office of the completion or discontinuation of the project; b. within an appropriate period after the completion or discontinuation of the project, to make a summary of the results publicly available.
Para. 1 let. c — Amended by Annex No 5 of the Human Research Act of 30 Sept. 2011, in force since 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045).
Art. 10 Licensing requirement for the storage of surplus embryos
1 Any person wishing to store surplus embryos shall require a licence from the Federal Office. 2 A licence shall be granted if: a. stem cell derivation is licensed under Article 7 or 8; b. storage is essential for the purpose of stem cell derivation; and c. the technical and operational requirements for storage are met.