Human Research Act (HRA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Research involving Children, Adolescents
Art. 21 Involvement of persons lacking capacity in the consent procedure
1 Children, adolescents and adults lacking capacity must be involved as far as possible in the consent procedure. 2 Increasing weight must be accorded to the views of children and adolescents lacking capacity the older and more mature they are.
Art. 22 Research projects involving children
1 A research project with an expected direct benefit may only be carried out in children who are capable of judgement if: a. the child has given informed consent; and b. the legal representative has given informed consent in writing. 2 A research project with no expected direct benefit may only be carried out in children who are capable of judgement if, in addition to paragraph 1: a. it entails no more than minimal risks and burdens; and b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation. 3 A research project with an expected direct benefit may only be carried out in children who lack capacity if: a. the legal representative has given informed consent in writing; and b. the child does not visibly express opposition to the research intervention either verbally or by his or her behaviour. 4 A research project with no expected direct benefit may only be carried out in childr
Art. 23 Research projects involving adolescents
1 A research project with or without an expected direct benefit may only be carried out in adolescents who are capable of judgement if: a. the adolescent has given informed consent in writing; and b. the legal representative has given informed consent in writing if the research project entails more than minimal risks and burdens. 2 A research project with an expected direct benefit may only be carried out in adolescents who lack capacity if: a. the legal representative has given informed consent in writing; and b. the adolescent does not visibly express opposition to the research intervention either verbally or by his or her behaviour. 3 A research project with no expected direct benefit may only be carried out in adolescents who lack capacity if, in addition to the requirements specified in paragraph 2: a. it entails no more than minimal risks and burdens; and b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disea
Art. 24 Research projects involving adults lacking capacity
1 A research project with an expected direct benefit may only be carried out in adults who lack capacity if: a. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly documented; b. informed consent has been given in writing by the legal representative, a designated trusted person or the next of kin, if no documented consent is available; and c. the person concerned does not visibly express opposition to the research intervention either verbally or by his or her behaviour. 2 A research project with no expected direct benefit may only to be carried out in adults who lack capacity if, in addition to the requirements specified in paragraph 1: a. it entails no more than minimal risks and burdens; and b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.
Section 2 Research involving Pregnant Women and Em
Art. 25 Prohibited research projects
Research projects designed to modify properties of an embryo or foetus for non‑disease-related reasons are prohibited.
Art. 26 Research projects involving pregnant women and embryos and foetuses in vivo
1 A research project with an expected direct benefit for a pregnant woman or for an embryo or foetus may only be carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not disproportionate to the expected benefits. 2 A research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be carried out if: a. it entails no more than minimal risks and burdens for the embryo or foetus; and b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women or for embryos or foetuses.
Art. 27 Research projects concerning methods of induced abortion
1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning methods of induced abortion after she has decided to undergo an abortion. 2 Article 26 does not apply.
Section 3 Research involving Prisoners
Art. 28 Research projects involving prisoners
1 For research projects with an expected direct benefit which involve prisoners, the general requirements for research involving persons apply; however, Article 11 paragraph 2 does not apply. 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no more than minimal risks and burdens.
Art. 29 Prohibition of a relaxation of conditions
Participation in a research project must not be associated with relaxing the conditions of imprisonment.
Section 4 Research in Emergency Situations
Art. 30 Research projects in emergency situations
1 A research project with an expected direct benefit may be carried out in emergency situations if: a. the necessary measures have been taken so that the wishes of the person concerned can be determined as soon as possible; b. the person concerned does not visibly express opposition to the research intervention through either verbally or by his or her behaviour; and c. a physician who is not participating in the research project is called in to safeguard the interests of the person concerned before he or she is involved in the project; in exceptional cases, where there are good reasons for doing so, the physician may be called in at a later stage. 2 A research project with no expected direct benefit may be carried out in emergency situations if, in addition to the requirements specified in paragraph 1: a. it entails no more than minimal risks and burdens; and b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease
Art. 31 Post hoc or proxy consent
1 The person concerned must be duly informed about the research project as soon as this becomes possible. He or she may subsequently give or withhold consent. 2 If the person concerned refuses to give post hoc consent, the biological material and data may no longer be used for the research project. 3 The Federal Council shall specify the procedure for the procurement of post hoc or proxy consent, in particular with regard to the involvement of children, adolescents and adults lacking capacity.