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.

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.

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; and

c.

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.

The Federal Council shall specify the requirements for correct and secure anonymisation and coding and also the conditions for breaking the code.

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 2004¹².

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.

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.

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.

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.

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.

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; or

b.

in the particular case, informed consent to the transfer has been given by the person concerned.

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 Articles 16 and 17 of the Data Protection Act of 25 September 2020¹³ are met.¹⁴

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.

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.

¹ Authorisation from the responsible ethics committee is required for:

a.

conducting a research project; or

b.

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.¹⁵

³ The Federal Council may make changes to research projects subject to authorisation. In doing so, it shall have regard to recognised international regulations.

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.

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.

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.

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.¹⁶

^1bis 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.¹⁷

² 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.

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.

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.

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.

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; and

b.

at least one person representing patients.¹⁸

² 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.

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.

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.

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.¹⁹

² 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.²⁰

specify that the results of registered research projects must be published on a recognised platform.

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.

Persons responsible for the enforcement of this Act have a duty to maintain confidentiality.

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.

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.

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; or

c.

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.

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.

¹ Unless a more serious offence has been committed under the Criminal Code²², 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.²³

offers, grants, demands or accepts payment or any other non-cash advantage in exchange for the human body or parts thereof as such;

c^bis.²⁴

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 five years or a monetary penalty.²⁵

³ If the act is committed through negligence, the penalty shall be a monetary penalty not exceeding 180 daily penalty units.

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.

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 1974²⁶ 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-c^bis or Article 63 paragraph 1 letter c on account of an offence involving the human body or parts thereof.²⁷

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:

a.

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).

Current legislation shall be amended as specified in the Annex.

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.

¹ This Act is subject to an optional referendum.

² The Federal Council shall determine the commencement date.

Commencement Date: 1 January 2014²⁸