text: 810.30 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Federal Acton Research involving Human Beings(Human Research Act, HRA)of 30 September 2011 (Status as of 26 May 2021)The Federal Assembly of the Swiss Confederation,on the basis of Article 118b paragraph 1 of the Federal Constitution1,and having considered the Dispatch of the Federal Council dated 21 October 20092,decrees:1 SR 1012 BBl 2009 8045Chapter 1 General Provisions  Section 1 Purpose, Scope and Definitions  Art. 1 Purpose  1 The purpose of this Act is to protect the dignity, privacy and health of human beings involved in research.2 It is also designed to:a. create favourable conditions for research involving human beings;b. help to ensure the quality of research involving human beings;c. ensure the transparency of research involving human beings.Art. 2 Scope  1 This Act applies to research concerning human diseases and concerning the structure and function of the human body, which involves:a. persons;b. deceased persons;c. embryos and foetuses;d. biological material;e. health-related personal data.2 It does not apply to research which involves:a. IVF embryos in accordance with the Stem Cell Research Act of 19 December 20033;b. anonymised biological material;c. anonymously collected or anonymised health-related data.3 SR 810.31Art. 3 Definitions  In this Act:a. Research means method-driven search for generalisable knowledge;b. Research concerning diseases means research on the causes, prevention, diagnosis, treatment and epidemiology of impairments of physical and mental health in human beings;c. Research concerning the structure and function of the human body means basic research, in particular on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and impacts on the human body;d. Research project with an expected direct benefit means a research project whose results can be expected to improve the health of the participants;e. Biological material means bodily substances derived from living persons;f. Health-related personal data means information concerning the health or disease of a specific or identifiable person, including genetic data;g. Genetic data means information on a person's genes, obtained by genetic testing;h. Coded biological material and coded health-related personal data means biological material and data linked to a specific person via a code;i. Anonymised biological material and anonymised health-related data means biological material and health-related data which cannot (without disproportionate effort) be traced to a specific person;j. Child means a legal minor under 14 years of age;k.  Adolescent means a legal minor aged 14 years or more;l.4 ...4 Repealed by Annex of the FA of 22 March 2019, with effect from 26 May 2021 (AS 2020 2961; BBl 2019 1).Section 2 Principles  Art. 4 Primacy of individual interests  The interests, health and welfare of the individual human being shall prevail over the interests of science and society.Art. 5 Scientifically relevant topic  Research involving human beings may only be carried out if it addresses a topic of scientific relevance concerning:the understanding of human diseases;the structure and function of the human body; orpublic health.Art. 6 Non-discrimination  1 Nobody is to be subjected to discrimination in connection with research.2 With regard to the selection of participants in particular, no group of persons shall be disproportionately included in or excluded from research without good reason.Art. 7 Consent  1 Research involving human beings may only be carried out if, in accordance with the provisions of this Act, the persons concerned have given their informed consent or, after being duly informed, have not exercised their right to dissent.2 The persons concerned may withhold or revoke their consent at any time, without stating their reasons.Art. 8 Right to receive information  1 The persons concerned are entitled to be informed of results relating to their health. The information is to be communicated in an appropriate manner. The persons concerned may choose to forgo such information.2 They are entitled to be informed about all the personal data held in relation to them.Art. 95 Prohibition of commercialisation  1 It is prohibited to offer, grant, demand or accept payment or any other non-cash advantage in exchange for the human body or parts thereof as such.2 It is also prohibited to use the human body or parts thereof if they have been subject to a prohibited act as specified in paragraph 1.5 Amended by Annex No 2 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971).Art. 10 Scientific requirements  1 Research involving human beings may only be carried out if:a. the recognised regulations concerning scientific integrity are complied with, in particular with regard to the handling of conflicts of interest;b. scientific quality requirements are met;c. the recognised international Good Practice guidelines for research involving human beings are complied with; andd. the persons responsible have appropriate professional qualifications.2 The Federal Council shall specify which national and international regulations must be complied with.Chapter 2 General Requirements for Research involving Persons  Section 1 Protection of Participants  Art. 11 Subsidiarity  1 A research project involving persons may only be carried out if equivalent findings cannot be obtained by other means.2 A research project involving particularly vulnerable persons may only be carried out if equivalent findings cannot be obtained by other means.Art. 12 Risks and burdens  1 In every research project, the risks and burdens for the participants must be minimised as far as possible.2 The likely risks and burdens for the participants must not be disproportionate to the expected benefits of the research project.Art. 13 Placebo  In research projects with an expected direct benefit, the use of a placebo or non‑treatment is only permissible if no additional risk of serious or irreversible harm is to be expected for the persons concerned and:no standard treatment is available; orthe use of a placebo is required for compelling, scientifically sound methodological reasons, in order to establish the efficacy or safety of a treatment method.Art. 14 Non-remunerative participation  1 No person may receive payment or any other non-cash advantage for participation in a research project with an expected direct benefit. Participation in a research project with no expected direct benefit may be appropriately remunerated.2 No person may demand or accept payment or any other non-cash advantage from another in return for the latter’s participation in a research project.Art. 15 Safety and protective measures  1 Anyone who conducts a research project must, before it begins, take all the measures required to protect the participants.2 If, during the research project, circumstances arise which could jeopardise the safety or health of the participants or lead to a disproportionate relationship between the risks and burdens and the benefits, all the measures required to ensure protection are to be taken without delay.Section 2 Information and Consent  Art. 16 Informed consent  1 Persons may only be involved in a research project if they have given their informed consent. Consent must be given in writing; the Federal Council may specify exemptions.2 The persons concerned must receive comprehensible oral and written information on:a. the nature, purpose and duration of, and procedure for, the research project;b. the foreseeable risks and burdens;c. the expected benefits of the research project, in particular for themselves or for other people;d. the measures taken to protect the personal data collected;e. their rights.3 Before a decision on consent is made by the persons concerned, they must be allowed an appropriate period for reflection.4 The Federal Council may specify further elements of the information to be provided.Art. 17 Consent to further use for research  If the intention exists to make further use for research of biological material sampled or health-related personal data collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they must be informed of their right to dissent.Art. 18 Incomplete information  1 In exceptional cases, the persons concerned may be given incomplete information regarding individual aspects of a research project before it begins:a. insofar as this is essential for methodological reasons; andb. if the research project entails no more than minimal risks and burdens.2 The participants must subsequently be duly informed as soon as possible.3 Once they have been informed in accordance with paragraph 2, they may give or withhold their consent to the use of their biological material or their data. Only when such consent has been given is the biological material or data to be used for the research project.Section 3 Liability and Coverage  Art. 19 Liability  1 Any person who carries out a research project involving persons shall be liable for damage suffered by them in connection with the project. The Federal Council may specify exemptions from liability.2 Compensation claims prescribe in accordance with Article 60 of the Swiss Code of Obligations.6 The Federal Council may specify a longer prescriptive period for particular research areas.7 3 The provisions of the Code of Obligations on tort are otherwise applicable; in the exercise of official duties, the Government Liability Act of 14 March 19588, or cantonal government liability law, is applicable.6 SR 2207 Amended by Annex No 17 of the FA of 15 June 2018 (Revision of the Law on Prescription), in force since 1 Jan. 2020 (AS 2018 5343; BBl 2014 235).8 SR 170.32Art. 20 Coverage  1 Liability must be appropriately covered through insurance or in some other manner. The Federal Government and its public-law institutions and corporations are exempt from the liability coverage requirements.2 The Federal Council may:a. specify requirements for insurance and other forms of coverage;b. exempt research areas or classes of damage from the liability coverage requirements.3 For the protection of the injured party, it may:a. grant this party a direct claim against the party providing liability coverage;b. restrict the cancellation rights and objections of the party providing liability coverage, while granting appropriate rights of recourse.Chapter 3  Additional Requirements for Research involving Particularly Vulnerable Persons Section 1 Research involving Children, Adolescents and Adults lacking Capacity 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; andb. 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; andb. 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; andb. 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 children who lack capacity if the requirements specified in paragraphs 2 and 3 are met.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; andb. 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; andb. 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; andb. 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.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; andc. 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; andb. 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 Embryos and Foetuses in vivo 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; andb. 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; andc. 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; andb. 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.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.Chapter 4  Further Use of Biological Material and Health-Related Personal Data for Research Art. 32 Further use of biological material and genetic data  1 Further use may be made of biological material and genetic data in uncoded form for a research project if informed consent has been given by the person concerned, or by the legal representative or next of kin. For consent, Articles 16 and 22–24 apply mutatis mutandis.2 Further use may be made of biological material and genetic data in coded form for research purposes if informed consent has been given by the person concerned, or by the legal representative or next of kin. For consent, Articles 16 and 22–24 apply mutatis mutandis.3 Biological material and genetic data may be anonymised for research purposes if the person concerned or the legal representative or next of kin have been informed in advance and have not dissented to anonymisation. For dissent, Articles 22–24 apply mutatis mutandis.Art. 33 Further use of non-genetic health-related personal data  1 Further use may be made of non-genetic health-related personal data in uncoded form for research purposes if informed consent has been given by the person concerned, or by the legal representative or next of kin. For consent, Articles 16 and 22–24 apply mutatis mutandis.2 Further use may be made of non-genetic health-related personal data in coded form for research purposes if the person concerned or the legal representative or next of kin have been informed in advance and have not dissented. For dissent, Articles 22–24 apply mutatis mutandis.Art. 34 Absence of informed consent  If the requirements for informed consent specified in Articles 32 and 33 are not met, further use may be made of biological material or health-related personal data for research purposes in exceptional cases if:a. it is impossible or disproportionately difficult to obtain consent or to provide information on the right to dissent, or this would impose an undue burden on the person concerned;b. no documented refusal is available; andc. the interests of research outweigh the interests of the person concerned in deciding on the further use of his or her biological material and data.Art. 35 Anonymisation and coding  The Federal Council shall specify the requirements for correct and secure anonymisation and coding and also the conditions for breaking the code.Chapter 5 Research involving Deceased Persons  Art. 36 Consent  1 Research may be carried out in deceased persons if, before their death, the persons concerned consented to the use of their body for research purposes.2 If no documented consent or refusal of the deceased person is available, the body or parts thereof may be used for research purposes if consent is given by the next of kin or by a trusted person designated during the lifetime of the deceased person.3 The consent of the next of kin or the trusted person is governed by Article 8 of the Transplantation Act of 8 October 20049.4 In the case of deceased persons whose death occurred more than 70 years previously, research may be carried out without consent being given as specified in paragraph 2. If such research is opposed by the next of kin, it may not be carried out.9 SR 810.21Art. 37 Additional requirements  1 A research project may be carried out in deceased persons when their death has been determined.2 A research project may be carried out in deceased persons undergoing artificial respiration if, in addition to the requirement specified in paragraph 1, equivalent findings cannot be obtained with deceased persons not undergoing artificial respiration. The Federal Council may specify further conditions.3 Anyone who carries out a research project in accordance with paragraph 2 must not have been involved in the determination of death or be authorised to issue instructions to the persons involved in this procedure.Art. 38 Research in connection with an autopsy or transplantation  Small quantities of bodily substances removed in the course of an autopsy or transplantation may be anonymised for research purposes without consent, in the absence of a documented refusal of the deceased person.Chapter 6  Research involving Embryos and Foetuses from Induced Abortions and from Spontaneous Abortions including Stillbirths Art. 39 Requirements for research in embryos and foetuses from induced abortions  1 A pregnant woman may only be asked whether she wishes to make her embryo or foetus available for research purposes after she has decided to undergo an abortion. For consent, Articles 16 and 22–24 apply mutatis mutandis.2 The time and method of induced abortion must be chosen without regard to the research project.3 Embryos and foetuses from induced abortions may be used for a research project when death has been determined.4 Anyone who carries out a research project in accordance with paragraph 3 must not be involved in the abortion or be authorised to issue instructions to the persons involved in this procedure.Art. 40 Requirements for research in embryos and foetuses from spontaneous abortions including stillbirths  1 Embryos and foetuses from spontaneous abortions including stillbirths may only be used for research purposes with the consent of the couple concerned. For consent, Article 16 applies mutatis mutandis.2 Embryos and foetuses from spontaneous abortions may be used for a research project when death has been determined.Chapter 7 Transfer, Export and Storage  Art. 41 Transfer for purposes other than research  Biological material or health-related personal data which has been sampled or collected or of which further use has been made for research purposes may only be passed on for purposes other than research if:a. a legal basis exists for such a transfer; orb. in the particular case, informed consent to the transfer has been given by the person concerned.Art. 42 Export  1 Biological material or genetic data may be exported for research purposes if informed consent has been given by the person concerned. For consent, Articles 16 and 22–24 and 32 apply mutatis mutandis.2 Non-genetic health-related personal data may be disclosed abroad for research purposes if the requirements specified in Article 6 of the Federal Act of 19 June 199210 on Data Protection are met.10 SR 235.1Art. 43 Storage  1 Anyone who stores biological material or health-related personal data for research purposes must take appropriate technical and organisational measures to prevent unauthorised use thereof, and fulfil the operational and professional requirements.2 The Federal Council shall specify the requirements for storage.Art. 44 Deceased persons, embryos and foetuses including stillbirths  Articles 41–43 apply mutatis mutandis to deceased persons, to embryos and foetuses including stillbirths and parts thereof, and to data collected in this connection.Chapter 8 Authorisation, Notifications and Procedure  Art. 45 Mandatory authorisation  1 Authorisation from the responsible ethics committee is required for:a. conducting a research project; orb. making further use of biological material or health-related personal data for research purposes in cases where consent has not been obtained or information on the right to dissent has not been provided (Art. 34).2 Authorisation is granted if the ethical, legal and scientific requirements of this Act are met. The decision must be available within two months of submission of the application. The Federal Council may:a. specify shorter, risk-adapted maximum limits for processing periods;b. adjust the processing periods, if this is required by recognised international regulations.113 The Federal Council may make changes to research projects subject to authorisation. In doing so, it shall have regard to recognised international regulations.11 Amended by Annex of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).Art. 46 Notification and information requirements  1 The Federal Council may specify notification or information requirements, in particular with regard to:a. the completion or discontinuation of a research project;b. adverse events observed in connection with a research project;c. the occurrence of circumstances during the conduct of a research project which could affect the safety or health of the participants.2 In doing so, it shall have regard to recognised international regulations.Art. 47 Responsible ethics committee  1 The responsible ethics committee is that of the canton in whose territory the research is conducted.2 If a research project is carried out according to a standard protocol, but in different cantons (multicentre research project), authorisation is required from the ethics committee which is responsible at the site of activity of the project coordinator (the lead committee).3 In order to assess whether the professional and operational requirements are fulfilled in other cantons, the lead committee shall seek the opinion of the ethics committees concerned. It shall be bound by their opinion.4 Paragraphs 2 and 3 apply mutatis mutandis to authorisation for the use in accordance with Article 34 of biological material and health-related personal data of which further use is made or which are collected according to a standard protocol, but in different cantons.Art. 48 Official measures  1 If the safety or health of the persons concerned is at risk, the ethics committee may revoke or suspend its authorisation or make the continuation of the research project subject to additional conditions.2 The ethics committee may request information or documentation from the holder of the authorisation. This must be provided or made available free of charge.3 The competent federal and cantonal authorities retain the right to take measures.4 The authorities and ethics committees shall keep each other informed and coordinate their measures.Art. 49 Procedure  1 The documents for the authorisation and notification procedures, and for reporting and supervision, shall be submitted to the cantonal information system referred to in Article 56a.121bis The Federal Council shall specify requirements for the procedure so as to ensure consistent enforcement and the implementation of national and international regulations. It may stipulate that the submission of applications, correspondence and the publication of decisions must be effected electronically.132 In particular for research projects involving biological material and genetic data in accordance with Article 32, or non-genetic health-related personal data in accordance with Article 33, it may specify less stringent procedural requirements.3 Cantonal procedural law otherwise applies.12 Amended by Annex of the FA of 22 March 2019, in force since 26 May 2021  (AS 2020 2961; BBl 2019 1).13 Inserted by Annex of the FA of 22 March 2019, in force since 26 May 2021  (AS 2020 2961; BBl 2019 1).Art. 50 Right of appeal  1 The procedure for appeals against ethics committee decisions is governed by cantonal procedural law and the general provisions concerning the administration of federal justice.2 The appealing party may not file an appeal based on substantive inappropriateness.Chapter 9 Research Ethics Committees  Art. 51 Duties  1 Within the framework of their responsibilities under Chapter 8, ethics committees shall assess whether research projects and the conduct thereof comply with the ethical, legal and scientific requirements of this Act. In particular, they shall assess whether the protection of the persons concerned is guaranteed.2 They may advise researchers in particular on ethical questions and, if so requested by the researchers, comment on research projects not subject to this Act, and specifically projects carried out abroad.Art. 52 Independence  1 Ethics committees shall exercise their duties in a professionally independent manner, without being subject to instructions from the supervisory authority in this regard.2 The members of ethics committees shall disclose their interests. Each ethics committee shall maintain a publicly accessible register of interests.3 Members who are interested parties shall not participate in the assessment and decision procedures.Art. 53 Composition  1 Ethics committees must be composed in such a way that they have the professional skills and experience required to discharge their duties. The members must include:a. experts in various disciplines, in particular medicine, ethics and law; andb. at least one person representing patients.142 Ethics committees may call in external specialists to serve as experts.3 The Federal Council shall enact additional regulations concerning the composition of ethics committees and the requirements to be fulfilled by their members. In doing so, it shall have regard to recognised international regulations.14 Amended by Annex of the FA of 22 March 2019, in force since 26 May 2021  (AS 2020 2961; BBl 2019 1).Art. 54 Organisation and financing  1 Each canton shall designate the ethics committee responsible for its territory and appoint the members thereof. It shall oversee the activities of the ethics committee.2 Each canton has at most one ethics committee. Several cantons may appoint a joint ethics committee or agree that one canton's ethics committee is also to be responsible for other cantons.3 The Federal Council may issue guidelines concerning the minimum number of research projects to be assessed by an ethics committee per year. It shall first consult the cantons.4 Each ethics committee shall have a scientific secretariat. Details of the organisation and working methods are to be publicly accessible in by-laws.5 The canton shall assure the financing of the ethics committee. It may make provision for the charging of fees.Art. 55 Coordination and information  1 The Federal Office of Public Health (FOPH) is responsible for coordination between ethics committees and with other supervisory authorities. It may delegate this responsibility to third parties.2 Ethics committees shall report annually to the FOPH on their activities, in particular on the type and number of research projects assessed and on the processing periods.3 The FOPH shall publish a list of ethics committees and inform the public regularly about their activities.4 In consultation with the ethics committees and other supervisory authorities concerned, it may issue recommendations for appropriate harmonisation of procedures and of assessment practice.Chapter 10 Transparency and Data Protection  Art. 56 Registration  1 Authorised clinical trials must be recorded in a public registry. The Federal Council shall define the clinical trials in more detail and may specify exemptions from mandatory registration; in doing so, it shall be guided by recognised international regulations.152 It shall designate the registry, provide information on access thereto and specify the content of registration, as well as notification requirements and the notification procedure. In doing so, it shall have regard to recognised international regulations and if possible take existing registries into consideration.3 It may:a. entrust public- or private-law organisations with the establishment and management of the registry;b.16 specify that the results of registered research projects must be published on a recognised platform.15 Second sentence amended by Annex of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).16 Amended by Annex of the FA of 22 March 2019, in force since 26 May 2021  (AS 2020 2961; BBl 2019 1).Art. 56a17 Cantonal information system  1 The cantons shall operate a shared information system for the conduct of authorisation and notification procedures, the transmission of reports and the supervision of research projects.2 The system shall contain data, including personal data on administrative or criminal proceedings and sanctions or on health, which is necessary for the conduct of authorisation and notification procedures and for reporting and supervision in accordance with this Act.3 The cantons shall ensure that the information system is compatible with the Medical Devices Information System of the Swiss Agency for Therapeutic Products and with the European database on medical devices (Eudamed).4 The Federal Council may specify that:a. the data referred to in paragraph 2 concerning clinical trials with medical devices is to be automatically aligned with the Medical Devices Information System of the Swiss Agency for Therapeutic Products or with Eudamed;b. any data referred to in paragraph 2 which is not sensitive is to be published with due protection of professional confidentiality and trade secrets.17 Inserted by Annex of the FA of 22 March 2019, in force since 26 May 2021  (AS 2020 2961; BBl 2019 1).Art. 57 Duty of confidentiality  Persons responsible for the enforcement of this Act have a duty to maintain confidentiality.Art. 58 Processing of personal data  In discharging their duties, ethics committees and the other enforcement bodies are entitled to process personal data. Sensitive personal data may be processed, insofar as this is necessary.Art. 59 Disclosure of data  1 Where no conflicting private interest of overriding importance exists, data may be disclosed to:a. the federal and cantonal agencies responsible for enforcement of this Act, and to public- or private-law organisations and persons if they require the data to fulfil the duties assigned to them under this Act;b. criminal investigation authorities if the data is required to prosecute or prevent a felony or an offence under this Act.2 Where no conflicting private interest of overriding importance exists, data may, in individual cases, following a written request, be disclosed to:a. civil courts if the data is required to judge a court case;b. criminal courts and criminal investigation authorities if the data is required to investigate a felony or misdemeanour.3 Data which is of general interest and relates to the application of this Act may be published. The data subjects must not be identifiable.4 In other cases, data may be disclosed to third parties as follows:a. data not relating to specific persons, provided that there is an overriding interest in this data being made available;b. personal data, provided that the data subject has given written consent in each case.5 Only the data which is required for the purpose in question may be disclosed.6 The Federal Council shall regulate the details of the disclosure of data and the notification of the persons concerned.Art. 60 Transmission of data to foreign authorities and international organisations  1 Confidential data may only be transmitted to foreign authorities and institutions or to international organisations if:a. this is required by agreements under international law or resolutions passed by international organisations;b. this is necessary to avert an imminent danger to life or health; orc. this would enable serious offences under this Act to be exposed.2 The Federal Council shall regulate responsibilities and the procedures for exchanging data with foreign authorities and institutions and with international organisations.Art. 61 Evaluation  1 The FOPH is responsible for assessing the effectiveness of this Act.2 The Federal Department of Home Affairs shall report to the Federal Council on the results of the evaluation and submit proposals for further action.Chapter 11 Criminal Provisions  Art. 62 Misdemeanours  1 Unless a more serious offence has been committed under the Criminal Code18, any person who wilfully:a. conducts a research project without the authorisation of an ethics committee or deviating from an authorised protocol (Art. 45) and thereby endangers the health of the participants;b. conducts a research project as defined in Chapter 2, 3, 5 or 6 without obtaining the consent required under this Act (Arts. 16, 17, 18 para. 3, Art. 22 paras. 1, 3 let. a and 4, Arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39 para. 1, 40);c.19 offers, grants, demands or accepts payment or any other non-cash advantage in exchange for the human body or parts thereof as such;cbis.20 uses the human body or parts thereof if they have been subject to a prohibited act as specified in letter c;d. conducts a research project designed to modify properties of the embryo or foetus for non-disease-related reasons (Art. 25);e. uses embryos or foetuses from induced or spontaneous abortions for a research project before death has been determined (Art. 39 para. 3, Art. 40 para. 2)shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 If the act is committed for commercial gain, the penalty shall be a custodial sentence not exceeding three years; this shall be combined with a monetary penalty.3 If the act is committed through negligence, the penalty shall be a monetary penalty not exceeding 180 daily penalty units.18 SR 311.019 Amended by Annex No 2 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971).20 Inserted by Annex No 2 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971).Art. 63 Contraventions  1 Any person who wilfully or negligently:a. commits an offence as specified in Article 62 paragraph 1 letter a without the participants' health being endangered;b. makes a payment or provides any other non-cash advantage to a person for participation in a research project with an expected direct benefit, or demands or accepts payment or any other non-cash advantage from a person for participation in a research project (Art. 14);c. makes further use of biological material or health-related personal data without the informed consent required under this Act (Arts. 32, 33), in cases where the conditions specified in Article 34 are not met and appropriate authorisation has not been obtained from the responsible ethics committee;d. transfers biological material or health-related personal data for non-research-related purposes in the absence of a legal basis or without the requisite consent (Art. 41)shall be liable to a fine.2 A contravention and the penalty for a contravention become time-barred after five years.Art. 64 Jurisdiction and administrative criminal law  1 The cantons have jurisdiction for the prosecution and judgment of offences.2 Articles 6, 7 (offences committed within a business) and 15 (forgery of documents, obtaining a false certificate by fraud) of the Federal Act of 22 March 197421 on Administrative Criminal Law apply.3 The competent authorities shall inform the FOPH of all judgments passed in accordance with Article 62 paragraph 1 letters b–cbis or Article 63 paragraph 1 letter c on account of an offence involving the human body or parts thereof.2221 SR 313.022 Inserted by Annex No 2 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971).Chapter 12 Final Provisions  Art. 65  Implementing provisions  1 The Federal Council shall enact the implementing provisions.2 In doing so, it shall consider the different extents to which individual research areas and methods involve risks to dignity and privacy, in particular when specifying:the scientific requirements (Art. 10);b. any exemptions from liability (Art. 19) and liability coverage requirements (Art. 20);c. the requirements for insurance and other forms of coverage (Art. 20);d. the procedural requirements (Art. 49).Art. 66 Amendment of current legislation  Current legislation shall be amended as specified in the Annex.Art. 67 Transitional provisions  1 Authorisations granted by cantonal ethics committees for the conduct of research projects remain valid for the term of the authorisation.2 If no authorisation, as defined in paragraph 1, has been granted for a research project which is already under way when this Act comes into effect, an application for authorisation in accordance with Article 45 paragraph 1 letter a shall be submitted to the responsible ethics committee within six months after the commencement of this Act.3 Authorisations for the waiver of professional confidentiality in medical research remain valid for the term of the authorisation. If the authorisation has been granted for an unlimited term, an application for authorisation in accordance with Article 45 paragraph 1 shall be submitted to the responsible ethics committee within a year of the commencement of this Act.4 The Federal Council shall regulate the registration under Article 56 of research projects which are in progress when this Act comes into force.Art. 68 Referendum and commencement  1 This Act is subject to an optional referendum.2 The Federal Council shall determine the commencement date.Commencement Date: 1 January 20142323 FCD of 20 Sept. 2013.Annex (Art. 66)Amendment of current legislation The federal acts below are amended as follows:...2424 The amendments may be consulted under AS 2013 3215.


type: legislation

jurisdiction: Switzerland

text: 810.301English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Ordinanceon Human Research with the Exception of Clinical Trials(Human Research Ordinance, HRO)of 20 September 2013 (Status as of 26 May 2021)The Swiss Federal Council,on the basis of the Human Research Act of 30 September 20111 (HRA),ordains:1 SR 810.30Chapter 1 General Provisions  Art. 1 Purpose  This Ordinance regulates:a. the requirements for the conduct of human research projects with the exception of clinical trials; andb. the authorisation and notification procedures for research projects as specified in letter a.Art. 2 Applicable provisions  The provisions concerning scientific integrity and scientific quality set out in Articles 3 and 4 of the Ordinance of 20 September 20132 on Clinical Trials (ClinO) apply mutatis mutandis.2 SR 810.305Art. 3 Responsibilities of project leader and sponsor  1 The project leader is responsible for the conduct of the research project in Switzerland and for protection of the participants at the research site.2 The project leader is also responsible for organising the research project, and in particular for the initiation, management and financing of the project in Switzerland, provided that no other person or institution headquartered or represented in Switzerland takes responsibility for this (sponsor).Art. 4 Professional qualifications  1 The project leader responsible for a research project must:a. be entitled to practise independently the profession specifically qualifying him or her to conduct the research project in question;b. have the training and experience required to conduct the research project in question;c. be conversant with the legal requirements for research projects or be able to ensure compliance by calling in appropriate expertise.2 The other persons conducting the research project must have the professional knowledge and experience appropriate to the activities in question.Art. 5 Storage of health-related personal data and biological material  1 Any person who stores health-related personal data for research must take appropriate operational and organisational measures to protect it, and in particular:a. restrict the handling of the health-related personal data to those persons who require this data to fulfil their duties;b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data;c. document all processing operations which are essential to ensure traceability.2 Any person who stores biological material for research must, in particular:a. comply with the principles set out in paragraph 1 mutatis mutandis;b. ensure that the technical requirements are met for appropriate storage of the biological material;c. make available the resources required for storage.Chapter 2 Research Involving Measures for Sampling of Biological Material or Collection of Health-Related Personal Data from Persons Section 1 General Provisions  Art. 6 Research project  For the purposes of this Chapter, a research project is any project in which biological material is sampled or health-related personal data is collected from a person in order to:a. answer a scientific question; orb. make further use for research purposes of the biological material or the health-related personal data.Art. 7 Categorisation  1 A research project comes under Category A if the planned measures for sampling biological material or collecting personal data entail only minimal risks and burdens.2 A research project comes under Category B if the planned measures entail more than only minimal risks and burdens.3 Sampling biological material or collecting health-related personal data entails minimal risks and burdens if the measures, in terms of intensity and quality, and taking into account the vulnerability of the participants and the specific circumstances, have only a slight and temporary impact on the participants’ health. In particular, minimal risks and burdens may be associated with:a. surveys and observations;b. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent;c. removing or collecting bodily substances without invasive interventions (in particular, saliva, urine and stool samples);d. taking swabs;e. magnetic resonance imaging scans without a contrast medium, ultrasound examinations or electrograms;f.3 examinations using medical devices in accordance with Article 3 of the Medical Devices Ordinance of 1 July 20204 that bear a conformity marking and are used without a contrast medium, and examinations using authorised medicinal products capable of emitting ionising radiation, provided that the effective dose is below 5 mSv per research project and per participant.3 Amended by Annex 2 No 1 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033).4 SR 812.213Art. 8 Information  1 In addition to the points specified in Article 16 paragraph 2 HRA, the persons concerned must receive information on:a. the effort involved and the obligations arising from participation; b. their right to withhold or to revoke their consent without giving reasons;c. the consequences of revoking consent to further use of the biological material and personal data collected up to this point;d. their right to receive information at any time in response to further questions;e. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this decision for them;f. the measures envisaged to cover any damage arising from the research project, including the procedure in the event of a claim;g. the main sources of financing for the research project;h. other points relevant to their decision on participation.2 If the intention exists to make further use for research of the biological material sampled or the health-related personal data collected, the persons concerned must also receive information on the points specified in Articles 28−32.3 The information may be provided in stages. It may be additionally presented in a non-textual form.4 Appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.Art. 9 Exceptions to written form  1 Information and consent may be provided and documented in a non‑written form if:a. the research project in question comes under Category A, as defined in this Ordinance, and involves adults with capacity;b. provision of written information and consent would be disproportionate, given the project design; andc. reference is made to the departure from written form in the application to the responsible research ethics committee (ethics committee).2 In individual cases, information may be provided and consent granted in a non‑written form if:a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; andb. the project leader furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a recording of verbal consent.3 In individual cases, the requirement to provide information in written form may be waived if:a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; andb. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.Art. 10 Consequences of revocation of consent  1 If consent is revoked, the biological material and health‑related personal data of the person concerned must be anonymised after data evaluation has been completed.2 Anonymisation of the biological material and personal data may be dispensed with if:a. the person concerned expressly renounces this right when revoking consent; orb. it is established at the beginning of the research project that anonymisation is not possible and the person concerned, having been adequately informed of this fact, consented to participate.3 Persons revoking consent must be offered any follow-up care required to protect their health.Art. 11 Research projects in emergency situations  For research projects in emergency situations, Articles 15–17 ClinO5 apply mutatis mutandis.5 SR 810.305Art. 12 Exemptions from liability  Any person who proves that:a. the damage is only slight and temporary; andb. the extent of the damage is no greater than would be expected in the current state of scientific knowledgeshall be exempt from liability under Article 19 paragraph 1 HRA.Art. 13 Coverage  1 Category A research projects are exempt from the liability coverage requirements specified in Article 20 HRA.2 For Category B research projects, the policy value shall be set in accordance with Annex 1.3 The liability coverage must cover damage occurring up to 10 years after the completion of the research project.4 In addition, Article 11, Article 13 paragraph 1 and Article 14 ClinO6 apply mutatis mutandis.6 SR 810.305Section 2 Authorisation Procedure  Art. 14 Application  1 The project leader shall submit the application documents specified in Annex 2 to the responsible ethics committee for review.2 The ethics committee may request additional information.3 The sponsor may submit the application instead of the project leader. In this case, the sponsor assumes the obligations of the project leader as specified in Articles 17–23. The application documents must be co-signed by the project leader.Art. 15 Review areas  The responsible ethics committee shall review:a. the completeness of the application;b. the categorisation requested;c. the research project with regard to:1. scientific quality, in the case of a research project as specified in Article 6 letter a,2. the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA),3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (Art. 15 HRA), including precautionary measures in the handling of personal data,4. the need to involve persons, and in particular persons who are particularly vulnerable (Art. 11 HRA),5. the criteria for the selection of participants,6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,7. the appropriateness of the remuneration for participants and compliance with the prohibition of commercialisation (Art. 9 HRA),8. compliance with scientific integrity requirements;d. the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible involvement of particularly vulnerable persons;e. for Category B research projects: the guaranteeing of the right to compensation in the event of damage (Art. 20 HRA);f. for investigations involving radiation sources7: additionally, compliance with radiological protection legislation and the dose estimation, in cases where an opinion does not have to be sought from the Federal Office of Public Health (FOPH) in accordance with Article 19 paragraph 2;g. the professional qualifications of the project leader and the other researchers;h. compliance with the requirements concerning the storage of biological material or health-related personal data specified in Article 5;i. the suitability of the infrastructure at the research site;j. the financing of the research project and the agreements between the sponsor, third parties and the project leader concerning the allocation of tasks, remuneration and publication;k. other areas, where this is necessary to assess the protection of participants.7 Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). This modification has been made throughout the text.Art. 16 Procedure and deadlines  1 The ethics committee shall acknowledge receipt of the application within 7 days and notify the project leader of any formal deficiencies in the application documents.2 It shall reach a decision within 30 days after acknowledgement of receipt of the formally correct application documents.3 If the ethics committee requests additional information in accordance with Article 14 paragraph 2, the clock shall be stopped until this information has been received.Art. 17 Multicentre research projects  1 The project leader shall submit the application for a multicentre research project to the lead committee in accordance with Article 47 paragraph 2 HRA.2 The lead committee shall acknowledge receipt of the application within 7 days and at the same time notify the project leader whether the application documents submitted are formally in order.3 At the request of the lead committee, the project leader shall submit the required number of copies of the application documents specified in Annex 2 to the ethics committees responsible at the other research sites (ethics committees concerned). These shall review the local conditions and inform the lead committee of their assessment within 15 days.4 The lead committee shall reach a decision within 45 days of acknowledging receipt of the formally correct application. It shall inform the ethics committees concerned of its decision.Art. 18 Changes  1 Significant changes to an authorised research project must be authorised by the ethics committee before being implemented. Exempt from this requirement are measures which have to be taken immediately in order to protect the participants.2 The project leader shall submit to the ethics committee any application documents specified in Annex 2 which are affected by the change. At the same time, the project leader shall provide information on the reasons for the change.3 The following are considered to be significant changes:a. changes affecting the participants’ safety and health, or their rights and obligations;b. in the case of a Category B research project, changes to the protocol which concern the goal or the central topic of the research project;c. a change of research site or conducting the research project at an additional site; ord. a change of project leader or sponsor.4 The ethics committee shall reach a decision on significant changes within 30 days. Article 16 applies mutatis mutandis.5 For the authorisation procedure in the case of significant changes to authorised multicentre research projects, Article 17 applies mutatis mutandis.Art. 19 Procedure for investigations involving radiation sources  1 In the case of investigations involving radiation sources, the project leader shall additionally submit to the responsible ethics committee the documents specified in Annex 2 number 2. Subject to the provisions of the following paragraphs, the authorisation procedure is governed by Articles 14–18.2 The project leader shall additionally submit to the FOPH the application documents specified in Annex 2 number 3, informing the ethics committee at the same time if the effective dose per person, taking the uncertainty factor into account, is more than 5 mSv per year and:a. a radiopharmaceutical is used which is not authorised in Switzerland;b. a radiopharmaceutical is used which is authorised in Switzerland, and the intervention in question is not a routine nuclear medicine examination; orc. some other radioactive source8 is used.3 The FOPH shall deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estimation.4 The ethics committee shall grant authorisation if:a. the requirements covered by Article 15 are met; andb. the FOPH has raised no objections to the research project.5 It shall reach a decision in this case within 45 days after acknowledgement of receipt of the formally correct application documents. It shall inform the FOPH of its decision.8 Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). This modification has been made throughout the text.Section 3 Notifications and Reporting  Art. 20 Notification of safety and protective measures  If immediate safety and protective measures have to be taken during the conduct of a research project, the project leader shall notify the ethics committee of these measures, and of the circumstances necessitating them, within 7 days.Art. 21 Serious events  1 If, in the course of a research project, serious events occur in participants, the research project must be interrupted.2 A serious event is defined as any adverse event where it cannot be excluded that the event is attributable to the sampling of biological material or the collection of health-related personal data, and which:a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;b. results in permanent or significant incapacity or disability; orc. is life-threatening or results in death.3 If necessary in order to guarantee participants’ safety and health, further events are to be designated as serious in the protocol or at the request of the responsible ethics committee.4 The project leader shall notify the ethics committee of a serious event within 7 days. In addition, the project leader shall report to the committee on the connection between the event and the collection of health-related personal data or the sampling of biological material. At the same time, he or she shall submit proposals concerning the next steps to be taken.5 If a serious event occurs in connection with an investigation involving a radiation source on which the FOPH has delivered an opinion in accordance with Article 19, this must be additionally reported to the FOPH within 7 days.6 The ethics committee shall reach a decision on the continuation of the research project within 30 days after receipt of the report.Art. 22 Notification upon completion or discontinuation of a research project  The project leader shall notify the ethics committee of the discontinuation or completion of a research project within 90 days.Art. 239 Assessment, notification and reporting on the use of radiation sources  1 In the case of investigations using radiation sources, the project leader shall assess compliance with the dose guidance value under Article 45 of the Radiological Protection Ordinance of 26 April 201710.2 He or she shall give notify the competent ethics committee if the permitted dose guidance value within seven working days of the information coming to light.3 The competent ethics committee may obtain technical advice from the FOPH in order to assess the dose calculation or the dose estimate and to decide what further measures are required. 4 Within a year of completing or discontinuing a research project which included investigations involving radioactive sources, the project leader shall submit to the FOPH a final report including all information of relevance for radiological protection, and in particular a retrospective dose estimation by the participants.5 Routine nuclear medicine examinations involving authorised radiopharmaceuticals are exempt from the reporting requirement under paragraph 4.6 Within the framework of the opinion delivered in accordance with Article 19, or on request, the FOPH may specify further exemptions from the reporting requirements.9 Amended by Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261).10 SR 814.501Chapter 3 Further Use of Biological Material and Health-related Personal Data for Research Section 1 General Provisions  Art. 24 Further use  Further use of biological material and health-related personal data is defined as any handling, for research purposes, of biological material already sampled or data already collected, and in particular:a. procuring, bringing together or collecting biological material or health‑related personal data;b. registration or cataloguing of biological material or health-related personal data;c. storage or inclusion in biobanks or databases;d. making accessible or available or transferring biological material or health‑related personal data.Art. 25 Anonymisation  1 For the anonymisation of biological material and health-related personal data, all items which, when combined, would enable the data subject to be identified without disproportionate effort, must be irreversibly masked or deleted.2 In particular, the name, address, date of birth and unique identification numbers must be masked or deleted.Art. 26 Coding  1 Biological material and health-related personal data are considered to be correctly coded in accordance with Article 32 paragraph 2 and Article 33 paragraph 2 HRA if, from the perspective of a person who lacks access to the key, they are to be characterised as anonymised.2 The key must be stored separately from the material or data collection and in accordance with the principles of Article 5 paragraph 1, by a person to be designated in the application who is not involved in the research project.Art. 27 Conditions for breaking the code  For coded biological material and coded health-related personal data, the code may only be broken if:a. breaking the code is necessary to avert an immediate risk to the health of the person concerned;b. a legal basis exists for breaking the code; orc. breaking the code is necessary to guarantee the rights of the person concerned, and in particular the right to revoke consent.Section 2 Informed Consent and Information  Art. 28 Informed consent for further use of biological material and genetic personal data in uncoded form for a research project   1 The persons concerned must receive written and oral information on:a. the nature, purpose and duration of, and procedure for, the research project;b. their right to withhold or to revoke their consent at any time without giving reasons;c. the consequences of revocation of consent for the biological material and personal data used up to this point;d. their right to receive information at any time in response to further questions relating to the research project;e. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this decision for them;f. measures to protect the biological material and the personal data;g. the main sources of financing for the research project;h. other points relevant to their decision.2 The information may be additionally presented in a non-textual form.3 Consent must be given in writing.4 The exceptions to written form are governed by Article 9 mutatis mutandis.Art. 29 Informed consent for further use of biological material and genetic personal data in coded form for research purposes  1 The persons concerned must receive written or oral information on:a. the proposed further use of the coded biological material and coded genetic personal data for research purposes;b. their right to withhold or to revoke their consent at any time without giving reasons;c. measures to protect the biological material and personal data, and in particular management of the key;d. the possibility of the biological material and the genetic personal data being passed on to third parties for research purposes.2 Consent must be given in writing; the exceptions are governed by Article 9 mutatis mutandis.Art. 30 Information on the proposed anonymisation of biological material and genetic personal data for research purposes  The persons concerned must receive written or oral information on:a. the proposed anonymisation of the biological material and genetic personal data for research purposes;b. their right to dissent;c.  the consequences of anonymisation with regard to results concerning their health;d. the possibility of the biological material and the data being passed on to third parties for research purposes.Art. 31 Informed consent for further use of non-genetic health-related personal data in uncoded form for research purposes  1 The persons concerned must receive written or oral information on:a. the proposed further use of the non-genetic health-related personal data for research purposes;b. their right to withhold or to revoke their consent at any time without giving reasons;c. their right to be informed of results concerning their health, and their right to forgo such information;d. measures to protect the personal data;e. the possibility of the personal data being passed on to third parties for research purposes.2 Consent must be given in writing; the exceptions are governed by Article 9 mutatis mutandis.Art. 32 Information on the proposed further use of non-genetic health-related personal data in coded form for research purposes  The persons concerned must receive written or oral information on:a. the proposed further use of the non-genetic health-related personal data in coded form for research purposes;b. their right to dissent;c. measures to protect the personal data, and in particular management of the key;d. the possibility of the personal data being passed on to third parties for research purposes.Section 3 Authorisation Procedure and Notification Requirements for Research Projects involving Biological Material and Health-Related Personal Data Art. 33 Research project  For the purposes of this Section, a research project is any project in which further use is made of biological material already sampled or health-related personal data already collected in order to answer a scientific question.Art. 34 Review areas  1 The ethics committee shall review:a. the completeness of the application;b. the fulfilment of the conditions specified in Articles 32 and 33 HRA;c. for research projects involving biological material and health-related personal data in coded form: correct and secure coding;d. compliance with the requirements for the storage of biological material or health-related personal data;e. the professional qualifications of the project leader and the other persons involved in the research project;f. other areas, where this is necessary to assess the protection of the persons concerned.2 In this process, it shall take into account existing authorisations from ethics committees with regard to the biological material or the health-related personal data.Art. 35 Applicable provisions  The following provisions apply mutatis mutandis:a. for the submission of the application: Article 14;b. for the procedure and deadlines: Article 16;c. for multicentre research projects: Article 17.Art. 36 Notification requirements  1 The project leader shall notify the ethics committee of a change of project leader in advance.2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.Section 4 Authorisation Procedure and Notification Requirements for further Use of Biological Material and Health-Related Personal Data for Research in the Absence of Informed Consent in accordance with Article 34 HRA Art. 37 Review areas  The ethics committee shall review:a. the completeness of the application;b. the reasons, as specified in Article 34 letters a and b HRA;c. the interests of the proposed research which outweigh the interests of the person concerned in deciding on the further use of his or her biological material and health-related personal data;d. the group of persons entitled to pass on the biological material and the personal data;e. compliance with the requirements concerning the storage of biological material or health-related personal data and the group of persons with access rights;f. the professional qualifications of the persons entitled to receive the biological material and the personal data;g. other areas, where this is necessary to assess the protection of the persons concerned.Art. 38 Applicable provisions  The following provisions apply mutatis mutandis:a. for the submission of the application: Article 14;b. for the procedure and deadlines: Article 16;c. for further use or collection according to a standard protocol, but in different cantons: the procedure specified in Article 17.Art. 39 Authorisation  The authorisation shall include at least the following information:a. the purpose for which further use may be made of the biological material and the health-related personal data;b. the designation of the biological material and health-related personal data covered by the authorisation;c. the group of persons entitled to pass on the biological material and the health-related personal data;d. the group of persons entitled to receive the biological material and the personal data.Art. 40 Notifications  1 The project leader must notify the ethics committee in advance of any changes to the information given in the authorisation.2 The project leader must notify the ethics committee of the completion or discontinuation of the collection process within 90 days.Chapter 4 Research Involving Deceased Persons  Art. 41 Review areas  The ethics committee shall review:a. the completeness of the application;b. the scientific quality;c. compliance with the requirements for consent (Art. 36 HRA);d. for research projects involving deceased persons undergoing artificial respiration: the need to involve them in the research project (Art. 37 para. 2 HRA) and compliance with the requirement for independence of the persons involved in the determination of their death (Art. 37 para. 3 HRA);e. compliance with the requirements for the storage of biological material or health-related personal data;f. compliance with the prohibition of commercialisation (Art. 9 HRA);g. the professional qualifications of the project leader and the other researchers.Art. 42 Applicable provisions  The following provisions apply mutatis mutandis:a. for the submission of the application: Article 14;b. for the procedure and deadlines: Article 16;c. for multicentre research projects: the procedure specified in Article 17.Art. 43 Notifications  1 The project leader must notify the ethics committee in advance of the following changes to the research project:a. change of project leader;b. for research projects involving deceased persons undergoing artificial respiration: significant changes to the protocol.2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.Chapter 5 Research involving Embryos and Foetuses from Induced Abortions and from Spontaneous Abortions including Stillbirths Art. 44 Informed consent  1 For research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths, the pregnant woman or the couple concerned must receive written and oral information on:a. the use of the embryo or foetus for research purposes;b. their right to withhold or to revoke their consent at any time without giving reasons;c. measures to protect the biological material and the personal data;d. the handling of the embryo or foetus after completion of the research.2 The information may be additionally presented in a non-textual form.3 Consent must be given in writing. The consequences of revocation of consent are governed by Article 10.4 The exceptions to written form are governed by Article 9 mutatis mutandis.Art. 45 Review areas  The ethics committee shall review:a. the completeness of the application;b. the scientific quality;c. compliance with the requirements for informed consent;d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1, 2 and 4 HRA;e. compliance with the prohibition of commercialisation (Art. 9 HRA);f. compliance with the requirements concerning the storage of biological material or health-related personal data;g. the professional qualifications of the project leader and the other researchers;h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.Art. 46 Applicable provisions  The following provisions apply mutatis mutandis:a. for the submission of the application: Article 14;b. for the procedure and deadlines: Article 16;c. for multicentre research projects: the procedure specified in Article 17;d. for notification requirements: Article 36.Chapter 6 Final Provisions  Art. 47 Updating of Annexes  The Federal Department of Home Affairs may update the Annexes in accordance with international or technical developments. It shall undertake updates which may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.Art. 48 Transitional provisions  1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.2 On request, the authority which authorised the research project before 1 January 2014 may assign the research project to Category A. In this case, the liability, coverage and notification requirements are governed by the new law.3 The ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in Article 6 of the HRA Organisation Ordinance of 20 September 201311.4 The provisions of this Ordinance are applicable:a. to the assessment of significant changes to research projects as specified in Chapter 2;b. to notifications concerning research projects as specified in Chapters 3–5.5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted in accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.11 SR 810.308Art. 49 Commencement  This Ordinance comes into force on 1 January 2014.Annex 1 (Art. 13)Policy values for liability coverage For Category B research projects involving persons, the policy value shall be at least:a. per person: 250 000 Swiss francs;b. for damage to property: 20 000 Swiss francs;c. for the entire research project: 3 million Swiss francs.Annex 2 (Art. 14, 17–19)Application documents to be submitted to the responsible ethics committee for the procedure 1 Application documents for research projects involving the sampling of biological material or the collection of health-related personal data from persons  1.1 Basic form, including a summary of the protocol in the national language of the research site and reasons for the requested categorisation;1.2 protocol;1.3 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;1.4 other documents issued to participants;1.5 information on the type and amount of remuneration for participants;1.6 for Category B research projects: certificate of insurance or other proof of coverage for possible damage;1.7 information on the secure handling of biological material and personal data, and in particular on the storage thereof;1.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;1.9 information on the suitability and availability of infrastructure at the research site;1.10 agreements between the project leader and the sponsor or third parties, in particular with regard to the financing of the research project, remuneration of the project leader and publication.2 Additional application documents for research projects which include investigations involving radiation sources  2.1 Details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour doses;2.2 the licences required under Article 28 of the Radiological Protection Act of 22 March 199112.12 SR 814.503 Additional application documents for research projects which include investigations involving radioactive sources and require an opinion from the FOPH in accordance with Article 19 paragraph 2  3.1 Information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and radionuclide purity;3.2 for authorised radiopharmaceuticals: the prescribing information;3.3 for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of the persons responsible for these processes and details of their professional qualifications;3.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;3.5 information specified in the FOPH form for research projects involving radiopharmaceuticals or radiolabelled compounds13.13 This form can be obtained [in French/German] from the Federal Office of Public Health, Radiological Protection Division, CH-3003 Bern; it can also be accessed online at: www.bag.admin.ch > Themen > Strahlung, Radioaktivität und Schall.4 Application documents for research projects involving further use of biological material or health-related personal data  4.1 Basic form, including a summary of the scientific question in the national language of the research site;4.2 description of the scientific question;4.3 proof of the origin of the biological material and health-related personal data, and of compliance with the requirements concerning informed consent and information on the right to dissent specified in Articles 32 and 33 HRA;4.4 for further use of biological material and health-related personal data in coded form: proof of secure and correct coding;4.5 proof of secure handling of biological material and personal data, and in particular the storage thereof;4.6 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;4.7 information on the infrastructure available at the research site;4.8 any authorisations granted by ethics committees in Switzerland for the sampling of biological material or the collection of health-related personal data.5 Application documents for further use of biological material or health-related personal data in the absence of informed consent in accordance with Article 34 HRA  5.1 Basic form, including a summary of the project in the national language of the research site;5.2 planned procedure;5.3 description of the proposed research purposes for which further use is to made of the biological material or health-related personal data, including an explanation of how the research interests outweigh the interests of the persons concerned;5.4 designation of the biological material or health-related personal data of which further use is to be made;5.5 designation of the group of persons who are to be entitled to pass on the biological material or the health-related personal data;5.6 designation of the persons who are to be entitled to receive the biological material or the health-related personal data;5.7 designation of the persons responsible for protection of the data disclosed;5.8 designation of the group of persons who are to have access rights for the biological material or the health-related personal data;5.9 proof of secure handling of biological material and personal data, and in particular the storage thereof;5.10 information on the duration of storage;5.11 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;5.12 information on the infrastructure available at the research site.6 Application documents for research projects involving deceased persons  6.1 Basic form, including a summary of the protocol in the national language of the research site;6.2 protocol;6.3 proof of compliance with the requirements for consent specified in Article 36 HRA;6.4 proof of compliance with the requirement for prior determination of death specified in Article 37 paragraph 1 HRA;6.5 for research projects involving deceased persons undergoing artificial respiration: statement of the reasons why such persons need to be involved in the research project, and proof of the independence of the persons determining death;6.6 documents concerning any remuneration;6.7 proof of secure handling of biological material and personal data, and in particular the storage thereof;6.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;6.9 information on the infrastructure available at the research site;6.10 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the project leader and publication.7 Application documents for research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths  7.1 Basic form, including a summary of the protocol in the national language of the research site;7.2 protocol;7.3 recruitment documents, including the wording of any advertisements, and the information sheet and informed consent form;7.4 description of measures to ensure compliance with the requirements for consent specified in Article 39 paragraph 1 or Article 40 paragraph 1 HRA;7.5 description of measures to ensure compliance with the requirement for prior determination of death specified in Article 39 paragraph 3 or Article 40 paragraph 2 HRA;7.6 for research projects involving embryos and foetuses from induced abortions: proof of compliance with the requirements specified in Article 39 paragraphs 2 and 4 HRA;7.7 documents concerning any remuneration;7.8 proof of secure handling of biological material and personal data, and in particular the storage thereof;7.9 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;7.10 information on the infrastructure available at the research site;7.11 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the project leader and publication.8 Application documents for the ethics committees concerned in multicentre research projects  8.1 Basic form, including a summary of the research project in the national language of the research site;8.2 protocol;8.3 for research projects involving persons or research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths: information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements, used at the research site in question;8.4 for research projects involving deceased persons: proof of compliance with the requirements for consent specified in Article 36 HRA and proof of compliance with the requirement for prior determination of death specified in Article 37 paragraph 1 HRA at the research site in question;8.5 the CV of the person responsible at the research site in question, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project at the site concerned, indicating their responsibilities and relevant professional knowledge;8.6 proof of the suitability and availability of the infrastructure at the research site in question;8.7 agreements between the sponsor and the person responsible at the research site in question, in particular with regard to his or her remuneration;8.8 for Category B research projects involving persons: certificate of insurance or other proof of coverage for possible damage at the research site in question, including any agreements on this matter between the sponsor and the person responsible at the research site.