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RS 810.30 Federal Act of September 30, 2011 on Human Research (Human Research Act, HR)

Original Language Title: RS 810.30 Loi fédérale du 30 septembre 2011 relative à la recherche sur l’être humain (Loi relative à la recherche sur l’être humain, LRH)

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810.30

Federal Act On human research

(Human Research Act, HRL)

On 30 September 2011 (State 1 Er January 2014)

The Swiss Federal Assembly,

See art. 118 B , para. 1, of the Constitution 1 , given the message of the Federal Council of 21 October 2009 2 ,

Stops:

Chapter 1 General provisions

Section 1 Purpose, scope and definitions

Art. 1 Purpose

1 The purpose of this Act is to protect the dignity, personality and health of the human being in the course of research.

2 In addition, it has the following goals:

A.
Develop favourable conditions for human research;
B.
To help ensure the quality of human research;
C.
To ensure transparency in human research.
Art. 2 Scope of application

1 This Law shall apply to research on human diseases and on the structure and functioning of the human body, practised:

A.
On individuals;
B.
On deceased persons;
C.
On embryos and fetuses;
D.
Biological material;
E.
On personal health data.

2 It does not apply to research performed:

A.
On embryos In vitro As defined in the Federal Act of 19 December 2003 on research on embryonic stem cells 1 ;
B.
On anonymized biological material;
C.
Health data that have been collected anonymously or anonymized.

Art. 3 Definitions

For the purposes of this Law:

A.
Search: Methodological research aimed at obtaining generalizable knowledge;
B.
Disease research: Research into the causes, prevention, diagnosis, treatment and epidemiology of physical and mental health disorders;
C.
Research on the structure and functioning of the human body: Basic research, particularly in the fields of anatomy, physiology and genetics of the human body, as well as non-disease-related research on the human body;
D.
Research project with expected direct benefit: Any research project that results in an improvement in the health status of the participants;
E.
Biological material: Substances in the body from living persons;
F.
Personal health data: Information about a specific or determinable person who has a link to his or her health or disease, including genetic data;
G.
Genetic data: Information on a person's genetic heritage, obtained through genetic analysis;
H.
Coded biological material and health-related personal data: Biological material and data that can only be related to a specified person using a key;
I.
Anonymized biological material and health-related anonymized data: Biological material and health-related data that cannot be linked to or cannot be linked to a particular person without incurrable efforts;
J.
Child: Minors under 14 years of age;
K.
Adolescent: Minors who are at least 14 years of age;
L.
Clinical trial: A research project on individuals in which participants are initially assigned to health-related interventions to assess their health effects or the structure and functioning of the human body.

Section 2 Principles

Art. 4 Primacy of human interests

The interests, health and well-being of the human being take precedence over the interests of science and society.

Art. 5 Relevant scientific issue

Human research can only be carried out if the relevant scientific problem is relevant in one of the following areas:

A.
Understanding of human diseases;
B.
The structure and functioning of the human body;
C.
Public health.
Art. 6 Non-discrimination

1 No one shall be discriminated against in the course of research.

2 In particular when selecting research subjects, no group of people should be overrepresented or dismissed without valid reasons.

Art. 7 Consent

1 Research on human beings may be carried out only if the person concerned has given informed consent or has not exercised his right of opposition after being informed in accordance with this Law.

2 The person concerned may at any time refuse to participate in a research project or revoke his consent without having to justify his decision.

Art. 8 Right of information

1 The data subject has the right to be informed of the results of the research relating to his or her health. The transmission of information must be carried out in an appoprized form. The data subject may waive this information.

2 The data subject has the right to consult all the data collected concerning him.

Art. Prohibition of marketing

The human body and parts of the human body may not be ceded or acquired as such for research purposes against remuneration or other material benefits.

Art. 10 Scientific Requirements

1 Human research can only be carried out under the following conditions:

A.
Meets recognized standards of scientific integrity, including conflict of interest management;
B.
It meets the scientific quality criteria;
C.
It complies with the international rules of good accepted practice in the field of human research;
D.
Those responsible have sufficient professional qualifications.

2 The Federal Council shall specify the national and international regulations which must be complied with.

Chapter 2 People research: general requirements

Section 1 Protection of participants

Art. 11 Subsidiarity

1 A research project can only be carried out on individuals if equivalent results cannot be obtained otherwise.

2 A research project can only be carried out on people who are particularly vulnerable if equivalent results cannot be obtained otherwise.

Art. 12 Risks and Constraints

1 The risks and constraints faced by people involved in a research project must be kept to a minimum.

2 The risks and foreseeable constraints faced by those involved in a research project should not be disproportionate to the expected utility of the project.

Art. 13 Placebo

In a research project with expected direct benefit, the use of a placebo or waiver of treatment is permitted only if there is no expectation of any additional risk of serious or irreversible harm to the person concerned; In addition, at least one of the following conditions must be met:

A.
No treatment consistent with the current state of science is available;
B.
The use of a placebo is necessary for both compelling and scientific methodological reasons to determine the efficacy or safety of a therapeutic method.
Art. 14 Free participation

1 No person shall receive remuneration or other material benefit for his or her participation in a research project with direct benefit. Participation in a research project without an expected direct benefit can result in equitable remuneration.

2 No person shall require or accept any remuneration or other material benefit of a person for his or her participation in a research project.

Art. 15 Safety and security measures

1 Every person who carries out a research project must, before undertaking the research, take all necessary measures to ensure the protection of the persons involved.

2 If events that jeopardize the safety or health of the persons involved in the research project or are likely to result in an imbalance between the risks and constraints on the one hand and the usefulness of the project on the other hand During this period, all measures necessary for the protection of participants must be taken without delay.

Section 2 Information and consent

Art. 16 Informed consent

1 A person may only be associated with a research project if he or she has consented to it after being sufficiently informed (informed consent). It must give its consent in writing; the Federal Council may provide for exceptions.

2 The following information shall be provided to the person concerned orally and in writing, in a comprehensible form:

A.
The nature, purpose, duration and conduct of the research project;
B.
Foreseeable risks and constraints;
C.
The expected benefit of the research project, in particular for itself or others;
D.
Measures to ensure the protection of personal data;
E.
Its rights.

3 A reasonable period of reflection must be given to the data subject before deciding on his or her consent.

4 The Federal Council can identify other elements to be provided in the information framework.

Art. 17 Consent to reuse of material or data

If, during the collection of biological material or the collection of personal data relating to health, their reuse is considered for research purposes, the consent of the person concerned must be collected at that time and The person concerned must be informed that they have the right to oppose them.

Art. 18 Partial Information

1 Exceptionally, the data subject may be informed in part on certain elements of a research project before the start of the research project if the following conditions are met:

A.
Methodological reasons;
B.
The risks and constraints inherent in the research project are minimal.

2 The person involved in the project must be informed A posteriori In a sufficient and timely manner.

3 If the participant is informed in accordance with para. 2, it may consent to the use of its biological material or data or refuse its consent. Biological material and data may only be used in the research project if the participant consents.

Section 3 Liability and security

Art. 19 Liability

1 Anyone who initiates a research project on individuals responds to the damage they are experiencing in relation to the project. The Federal Council may lay down exceptions to civil liability.

2 The right to compensation for damages shall be prescribed for three years from the day on which the person concerned is aware of the damage and the person responsible and no later than ten years from the end of the research project. The Federal Council may set a higher deadline for certain areas of research.

3 Moreover, the provisions of the Code of Obligations 1 Relating to unlawful acts shall apply; the exercise of an official function shall be governed by the law of 14 March 1958 on liability 2 Or by the provisions of the cantonal law relating to the liability of public authorities.


Art. Warranty

1 Responsibility must be adequately secured, in the form of insurance or in some other form. The Confederation, its institutions and its public law corporations are not subject to the obligation to guarantee.

2 The Federal Council may:

A.
Determine the requirements to be met by insurance and other forms of security;
B.
Exclude from the obligation to guarantee areas of research or categories of damage.

3 In order to protect the injured person, he may:

A.
Provide that the person shall have the right to assert an immediate right of claim to the person who guarantees the liability;
B.
Limit the rights of termination and the exceptions granted to the person who guarantees the liability, while giving the person appropriate rights of appeal.

Chapter 3 Research on particularly vulnerable persons: additional requirements

Section 1 Research on persons unable to discernment

Art. Involvement of persons unable to discernment in the consent procedure

1 Persons incapable of discernment must be involved as much as possible in the consent procedure.

2 The opinion of children and adolescents who are unable to discernment is all the more important in terms of age and maturity.

Art. Research Projects on Children

1 A research project with expected direct benefit can involve a child with the ability to discern only under the following conditions:

A.
Gave informed consent;
B.
His or her legal representative gave written informed consent.

2 A research project with no expected direct benefit can be carried out on children who are capable of discernment only if it meets the conditions set out in para. 1 and the following conditions are met:

A.
The risks and constraints inherent in the project are minimal;
B.
The project provides essential results that can provide long-term benefits to people with the same disease or disorder, or whose health status is comparable.

3 A research project with an expected direct benefit can only be carried out on a child incapable of discernment under the following conditions:

A.
His or her legal representative gave written informed consent;
B.
The child does not express, verbally or by any particular behaviour, his or her refusal of treatment related to the research project.

4 A research project without an expected direct benefit can only be carried out on children who are indiscriminately incapable if the requirements referred to in paras. 2 and 3 are completed.

Art. Adolescent Research Projects

1 A research project with or without the expected direct benefit can be carried out on adolescents capable of discernment only under the following conditions:

A.
The adolescent concerned has given informed consent in writing;
B.
The legal representative of the adolescent concerned has given informed consent in writing, since the risks and constraints inherent in the project are not insignificant.

2 A research project with expected direct benefit can only be carried out on adolescents who are indiscriminately blind to the following conditions:

A.
The legal representative of the adolescent concerned has given informed consent in writing;
B.
The adolescent does not express, orally or by any particular behaviour, his or her refusal of treatment related to the research project.

3 A research project without an expected direct benefit can only be carried out on adolescents who are incapable of discernment if it meets the conditions set out in para. 2 and the following conditions are met:

A.
The risks and constraints inherent in the project are minimal;
B.
The project provides essential results that can provide long-term benefits to people with the same disease or disorder, or whose health status is comparable.
Art. 24 Research projects on adults unable to discernment

1 A research project with expected direct benefit can only be carried out on adults who are indiscriminately blind to the following conditions:

A.
The person concerned has given his or her consent before losing his or her ability to discern and that consent is attested by a document;
B.
In the absence of a document attesting to the consent of the person concerned, his or her legal representative, a person of trust or his or her relatives have given their informed consent in writing;
C.
The person concerned does not express in an identifiable manner, verbally or by any particular conduct, his refusal of treatment related to the research project.

2 A research project without an expected direct benefit can only be carried out on adults who are indiscriminately incapable if it meets the conditions set out in para. 1 and the following conditions are met:

A.
The risks and constraints inherent in the project are minimal;
B.
The project provides essential results that can provide long-term benefits to people with the same disease or disorder, or whose health status is comparable.

Section 2 Research on pregnant women and on embryos and fetuses In vivo

Art. 25 Illicit research projects

Research projects aimed at modifying the characteristics of the embryo or fetus that are unrelated to a disease are illegal.

Art. 26 Research projects on pregnant women and on embryos and fetuses In vivo

1 A research project with expected direct benefit can only be carried out on a pregnant woman, an embryo or a fetus if the relationship between the risks and the foreseeable constraints for the pregnant woman, for the embryo or the fetus, on the one hand, And the expected benefit, on the other hand, is not disproportionate.

2 A research project without direct benefit to the pregnant woman or to the embryo or foetus can only be carried out under the following conditions:

A.
The risks and constraints inherent in the project are minimal for the embryo or fetus;
B.
The project has key results that can provide long-term benefits to other pregnant women or other embryos or fetuses.
Art. 27 Research Projects on Methods of Interruption of Pregnancy

1 A pregnant woman may not be asked to participate in a research project on methods of termination of pregnancy until her decision to interrupt her pregnancy is final.

2 Art. 26 is not applicable.

Section 3 Research on persons deprived of their liberty

Art. 28 Research projects on persons deprived of their liberty

1 Any research project with direct benefit to persons deprived of their liberty must meet the general requirements for research on persons; s. 11, para. 2, is not applicable.

2 A research project without the expected direct benefit can be carried out on persons deprived of their liberty only if the risks and constraints inherent in the project are minimal.

Art. Unlawful relief of the conditions of deprivation of liberty

Participation in a research project cannot be linked to relieving the conditions of deprivation of liberty.

Section 4 Emergency research

Art. Emergency research projects

1 A research project with an expected direct benefit can only be carried out in an emergency situation under the following conditions:

A.
The necessary arrangements have been made to establish the will of the data subject as soon as possible;
B.
The person concerned does not express in an identifiable manner, verbally or by any particular conduct, his refusal of treatment related to the research project;
C.
A doctor who is not involved in the research project is consulted before the integration of a person into the project in order to defend the interests of the project; exceptionally, it is possible to meet this requirement at a later date if there are valid reasons for this. Justify.

2 A research project without an expected direct benefit can only be carried out in an emergency situation if it meets the conditions set out in para. 1 and the following conditions are met:

A.
The risks and constraints inherent in the project are minimal;
B.
The project provides essential results that can provide long-term benefits to people with the same disease or disorder, or whose health status is comparable.
Art. Consent A posteriori Or by substitution

1 As soon as the person concerned is again able to express his or her will, she must be sufficiently informed of the research project. She can then give her consent A posteriori Or refuse it.

2 If the data subject refuses to give consent A posteriori , biological material and data can no longer be used in the research project.

3 The Federal Council regulates the procedure for collecting consent A posteriori Or by substitution, in particular with the participation of children or adolescents or adults who are incapable of discernment.

Chapter 4 Re-use of Biological Material and Personal Health Data

Art. 32 Re-use of biological material and genetic data

1 Biological material and genetic data may be reused for a research project in a non-coded form where the person concerned or, where appropriate, his or her legal representative or close relatives have given informed consent. Art. 16 and 22 to 24 apply by analogy to consent.

2 Biological material and genetic data may be reused for research purposes in coded form where the person concerned or, where appropriate, his or her legal representative or close relatives have given informed consent. Art. 16 and 22 to 24 apply by analogy to consent.

3 Biological material and genetic data may be anonymized for research purposes when the data subject or, where appropriate, his or her legal representative or family members have not objected to it after being informed. Art. 22 to 24 apply mutatis mutandis to the right of opposition.

Art. 33 Reus of non-genetic personal data related to health

1 Non-genetic personal data relating to health may be reused for research purposes in a non-coded form where the person concerned or, where appropriate, his or her legal representative or close relatives have given informed consent. Art. 16 and 22 to 24 apply by analogy to consent.

2 Non-genetic personal data relating to health may be reused for research purposes in a coded form where the person concerned or, where appropriate, his or her legal representative or family members have not objected to it after having been Informed. 22 to 24 shall apply mutatis mutandis to the right of opposition.

Art. 34 Failure to consent or information

Where the requirements for consent and information within the meaning of s. 32 and 33 are not fulfilled, biological material and personal health data may be reused as an exception for research purposes under the following conditions:

A.
The obtaining of consent or information on the right of opposition is impossible or poses disproportionate difficulties, or it cannot reasonably be expected of the person concerned;
B.
There is no record of a refusal by the data subject;
C.
The interest of science takes precedence over that of the person concerned to decide on the reuse of his biological material or data.
Art. 35 Anonymization and coding

The Federal Council specifies the requirements for the anonymization and coding of data and the conditions for their decoding.

Chapter 5 Research on Deceased Persons

Art. 36 Consent

1 Research on the body of a deceased person may be carried out if that person has consented to the use of his or her body for research purposes.

2 In the absence of a document attesting to the consent or refusal of the deceased person, the body or parts thereof may be used for research purposes with the consent of the relatives or a designated trusted person, Alive, by the deceased.

3 The consent of the relatives or the person of trust is governed by s. 8 of the Law of 8 October 2004 on Transplantation 1 .

4 Research on the body of a person who has died more than 70 years previously may be carried out without the consent referred to in para. 2. However, it cannot be practiced if there is disagreement between family members.


Art. Other conditions

1 A research project can only be carried out on deceased persons if the death has been noted.

2 A research project may be carried out on deceased persons who have been placed under artificial respiration only if, in addition to the condition laid down in para. 1, it is impossible to obtain equivalent results with deceased persons who have not been placed under artificial respiration. The Federal Council may lay down additional conditions.

3 Anyone who carries out a research project within the meaning of s. 2 cannot participate in the finding of death or be entitled to give instructions to those who are responsible for the death.

Art. 38 Research in an autopsy or transplant

If bodily substances are collected as part of an autopsy or transplantation, a minimal amount may be used anonymized for research purposes without the need for consent, as long as it does not exist No evidence of the deceased's refusal.

Chapter 6 Research on embryos and fetuses from interruptions in pregnancy and spontaneous abortions, including stillbirths

Art. 39 Requirements for research on embryos and fetuses from terminations of pregnancy

1 A pregnant woman cannot be asked to put her embryo or her fetus at the disposal of the research until her decision to interrupt her pregnancy is final. Art. 16 and 22 to 24 apply by analogy to consent.

2 The date of termination of pregnancy and the method used should not be selected based on a research project.

3 The research project can only be carried out on an embryo or foetus resulting from a termination of pregnancy if the death has been noted.

4 Anyone who carries out a research project within the meaning of s. 3 may not participate in the termination of pregnancy or be entitled to give instructions to the persons responsible for the intervention.

Art. 40 Requirements for research on embryos and fetuses from spontaneous abortions, including stillborn children

1 Research may be carried out on an embryo or foetus resulting from a spontaneous abortion, including a stillborn child, only with the consent of the couple concerned. Art. 16 shall apply mutatis mutandis to consent.

2 A research project can only be carried out on an embryo or fetus from a spontaneous abortion if the death has been noted.

Chapter 7 Transmission, Export and Conservation

Art. Transmission for purposes other than research

Biological material collected or reused and personal health data collected or reused for research purposes may not be transmitted for research purposes other than under one of the following conditions:

A.
A legal basis provides for it;
B.
The person concerned gave his or her informed consent in this case.
Art. Exporting

1 Biological material and genetic data may be exported for research purposes only with the informed consent of the data subject. Art. 16, 22 to 24 and 32 apply by analogy to consent.

2 Non-genetic personal data related to health may be disclosed outside Canada for research purposes only if the conditions under s. 6 of the Federal Law of 19 June 1992 on Data Protection 1 Are completed.


Art. 43 Conservation

1 Any person who maintains biological material or personal health data for research purposes must protect them from unlawful use through appropriate technical and organizational measures and meet the requirements Operating conditions techniques.

2 The Federal Council specifies the conservation requirements.

Art. 44 Deceased persons, embryos and fetuses, including stillborn children

Art. 41 to 43 apply by analogy to deceased persons, embryos and fetuses, including stillborn children, to parts thereof, and to data identified in this context.

Chapter 8 Authorizations, Announcements and Procedures

Art. 45 Authorization system

1 The following activities are subject to the authorisation of the relevant Ethics Commission:

A.
Completion of a research project;
B.
The reuse of biological material or personal health data for research purposes in cases where consent or information on the right of opposition is lacking (s. 34).

2 The authorisation shall be granted if the ethical, legal and scientific requirements laid down in this Law are fulfilled. The decision must be taken within two months of the filing of the application. The Federal Council may shorten this period when the risks involved permit.

3 Any changes to a research project may be subject to authorization by the Federal Council. In so doing, it takes account of recognised international regulations.

Art. Obligation to advertise and inform

1 The Federal Council may provide for an obligation to announce and inform, in particular in the following cases:

A.
The research project is completed or discontinued;
B.
Adverse events occur as part of a research project;
C.
Events that occur during the conduct of a research project may affect the safety or health of the individuals involved.

2 In so doing, the Federal Council takes account of recognised international regulations.

Art. Competent Ethics Commission

1 The competent ethics committee shall be that of the canton in which the research is carried out.

2 Any research project carried out on the basis of a single protocol in several cantons (multicentre research project) is subject to the authorisation of the competent ethics committee for the place of activity of the project coordinator (committee Director).

3 The Steering Committee is seeking the opinion of the relevant ethics committees to assess the extent to which the requirements for professional qualifications and exploitation are met in the other cantons. It is bound by their opinion.

4 The s. 2 and 3 shall apply mutatis mutandis to the authorisation for the use of biological material and personal data relating to health referred to in Art. 34 which are reused or taken from different cantons according to uniform criteria.

Art. 48 Measures by the authorities

1 If the safety or health of the persons concerned is compromised, the Ethics Commission may revoke or suspend the authorization, or make the continuation of the research project subject to additional conditions.

2 The Ethics Commission may require all relevant information and documents from the authorization holder. These are to be communicated or provided free of charge.

3 The measures taken by the competent federal and cantonal authorities are reserved.

4 The authorities and ethics boards shall keep each other informed and coordinate their measures.

Art. Procedure

1 The Federal Council regulates the procedure to ensure uniformity in the implementation and implementation of national and international regulations.

2 It may provide for lower procedural requirements, in particular for research projects involving biological material and genetic data referred to in s. 32, as well as non-genetic personal data related to health referred to in s. 33.

3 Moreover, the procedure is governed by the cantonal law.

Art. 50 Lanes of law

1 The appeal against decisions of ethical commissions is governed by the cantonal rules of procedure and by the general provisions of the federal procedure.

2 The resort cannot invoke the lack of opportunity.

Chapter 9 Research Ethics Boards

Art. Tasks

1 Ethics commissions shall verify, within the framework of the powers assigned to them under Chapter 8, whether the research projects and their achievement are in conformity with the ethical, legal and scientific requirements of this Law. They shall, in particular, check whether the protection of the persons concerned is ensured.

2 They may advise researchers on ethical issues in particular and, at their request, take a position on projects not subject to this Law, in particular projects carried out abroad.

Art. Independence

1 Ethics commissions carry out their duties independently, without receiving instructions from the supervisory authority.

2 Members of ethics boards are required to indicate the interests that bind them. Each commission shall keep a register accessible to the public.

3 The members of the ethics committees shall refrain from participating in the assessment and decision-making procedure when they are concerned with a research project.

Art. Composition

1 Ethics commissions must be established in such a way as to have the necessary skills and experience to carry out their tasks. They are made up of experts from the medical, ethical and legal fields. The cantons may provide that patients will be represented in the committees.

2 Ethics commissions may use external experts.

3 The Federal Council shall lay down additional provisions, in particular as regards the composition of the ethics committees and the requirements imposed on their members. In so doing, it takes account of recognised international regulations.

Art. Organization and financing

1 Each canton appoints the competent ethics committee on its territory and its members. He is monitoring it.

2 Each canton has a committee on ethics. Several cantons may designate a Joint Ethics Commission or may decide to declare the Ethics Commission of one canton to be competent for the others.

3 The Federal Council may define the minimum number of research projects that an ethics commission must evaluate each year. He auditioned the cantons in advance.

4 Each Ethics Commission has a Scientific Secretariat. An internal regulation accessible to the public determines its organisation and mode of operation.

5 The cantons provide funding for ethics commissions. They may provide for the collection of emoluments.

Art. Coordination and information

1 The Federal Office of Public Health (FOPH) coordinates ethics commissions and other supervisory authorities. It may entrust this task to third parties.

2 The Ethics Boards submit an annual activity report to the FOPH, indicating in particular the nature and number of research projects that have been the subject of a decision, as well as the duration of the respective procedures.

3 The FOPH publishes a list of ethics commissions and regularly informs the public about their activities.

4 It may make recommendations on the appropriate harmonisation of evaluation procedures and practice, after consultation with the Ethics Boards and other supervisory authorities concerned.

Chapter 10 Transparency and data protection

Art. 56 Registration

1 Authorized clinical trials must be listed in a public registry. The Federal Council may provide for exceptions to this obligation on the basis of recognised international regulations.

2 It defines the determining register, specifies the terms of access and specifies the data to be included, the obligation to announce and the procedure to be followed. To do so, it takes into account recognised international regulations and, to the extent possible, existing registers.

3 The Federal Council may:

A.
Entrust the establishment and management of the register to organisations of public law or private law;
B.
Provide for the publication of the results of registered research projects in the Register.
Art. 57 Obligation to keep secrecy

Persons responsible for the execution of this Law shall be kept secret.

Art. Processing of personal data

Ethics commissions and other implementing bodies are authorised to process personal data in the performance of their tasks. They can also process sensitive personal data if necessary.

Art. Data Communication

1 Unless there is a overriding private interest, data may be provided to the following bodies:

A.
Federal and cantonal services, as well as organizations and persons governed by public law or private law who are responsible for the implementation of this Law, if the data are necessary for the purpose of performing tasks which Be the responsibility of this Act;
B.
Criminal investigation authorities when it is a matter of denouncing or preventing a crime or an offence within the meaning of this Law.

2 Unless there is a overriding private interest, data may be provided in case of species, upon written request to the following bodies:

A.
Civil courts, where the data are necessary to judge a dispute;
B.
Criminal courts and criminal investigation authorities, where the data are necessary for the elucidation of a crime or crime.

3 Data of general interest relating to the application of this Law may be published. The persons concerned must not be able to be identified.

4 In addition, the following data may be communicated to third parties:

A.
Data that does not relate to individuals, provided that their communication is of overriding interest;
B.
Personal data, provided that the person concerned has given his or her consent in writing in the case in question.

5 Only the data necessary for the intended use can be communicated.

6 The Federal Council regulates the way in which data and information are communicated to the data subjects.

Art. 60 Transmission to foreign authorities and international organizations

1 Confidential data may be transmitted to foreign authorities and institutions or to international organisations only under one of the following conditions:

A.
International law agreements or decisions of international organizations;
B.
An imminent risk to life or health may be removed;
C.
This measure allows for the discovery of serious offences under this Act.

2 The Federal Council regulates the competences and the procedure for the exchange of data with foreign authorities or institutions as well as with international organisations.

Art. 61 Evaluation

1 The FOPH shall ensure that the effectiveness of this Act is assessed.

2 The Federal Department of the Interior shall submit a report to the Federal Council on the results of the evaluation and shall submit proposals to the Federal Council on the follow-up to the evaluation.

Chapter 11 Criminal Provisions

S. 62 Delays

1 It shall be punishable by deprivation of liberty for up to three years or a pecuniary penalty, unless it has committed a more serious offence within the meaning of the Penal Code 1 , anyone, intentionally:

A.
Conducts a research project without the authorization of an ethics commission or by deviating from the authorized protocol (s. 45), putting the health of the participants at risk;
B.
Carries out a research project in accordance with chap. 2, 3, 5 or 6 without the consent required by this Act (s. 16, 17, 18, para. 3, 22, para. 1, 3, let. A, and 4, art. 23, 24, 26, 28, 30, 36, al. 1 and 2, 39, para. 1, and 40);
C.
Transfer or acquire against remuneration or in exchange for other material benefits a human body or parts of a human body (art. 9);
D.
Conducts a research project to modify the characteristics of an embryo or fetus that is unrelated to a disease (s. 25);
E.
Uses in a research project an embryo or foetus resulting from a termination of pregnancy or a spontaneous abortion before death is found (s. 39, para. 3, and 40, para. 2).

2 If the offender acts by profession, he shall be punished by deprivation of liberty for up to three years; the penalty shall be combined with a pecuniary penalty.

3 If the infringer acts by negligence, he shall be punished by a pecuniary penalty of 180 days maximum.


S. 63 Contraventions

1 A fine is imposed on anyone, either intentionally or negligently:

A.
Is guilty of an offence under s. 62, para. 1, let. A, without endangers the health of the persons participating in the research project;
B.
Remunerates or grants another material benefit to a person for his or her participation in a research project with direct benefit, or requires or accepts a financial benefit or other material benefit of a person for his or her participation in A research project (art. 14);
C.
Reuses biological material or personal health data without obtaining consent or giving the information required by this Act (art. 32 and 33), without the conditions under s. 34 have been completed and without the approval of the relevant Ethics Commission;
D.
Transmits biological material or personal health data for purposes other than research, without legal basis or without the need for consent (art. 41).

2 The contravention and sentence are prescribed by five years.

Art. 64 Jurisdiction and administrative criminal law

1 Prosecution and prosecution of offences is the responsibility of the cantons.

2 Art. 6 and 7 (infringement committed in a company) and 15 (false in securities, fraudulent obtaining of a false finding) of the Federal Act of 22 March 1974 on administrative criminal law 1 Are applicable.


Chapter 12 Final provisions

Art. Implementing provisions

1 The Federal Council shall issue the implementing provisions.

2 It takes into account, inter alia, the extent of the threat to dignity and personality, in relation to the various fields and research processes, in particular when it lays down the provisions concerning the following:

A.
Scientific requirements (s. 10);
B.
Possible exceptions to liability (Art. 19) and the obligation to guarantee (art. 20);
C.
The requirements for insurance and other forms of security (art. 20);
D.
Procedure (art. 49).
Art. 66 Amendment of the law in force

The amendment to the existing law is set out in the Annex.

Art. 67 Transitional provisions

1 Any authorisation issued by a cantonal ethics commission to carry out a research project remains valid until its expiry.

2 If no authority under para. 1 has not been issued for a research project during the coming into force of this Act, an application for an authorization within the meaning of s. 45, para. 1, let. A, shall be filed with the competent Ethics Commission within six months of the entry into force of this Law.

3 Any authorisation to lift the professional secrecy in the field of medical research shall remain valid until its expiry. In the case of unlimited authorization, an application for an authorization within the meaning of s. 45, para. 1, shall be filed with the relevant Ethics Commission within one year of the coming into force of this Act.

4 The Federal Council regulates the registration referred to in Art. 56 for any research project in progress upon the coming into force of this Act.

Art. 68 Referendum and entry into force

1 This Law shall be subject to the referendum.

2 The Federal Council shall fix the date of entry into force.

Annex

(art. 66)

Amendment of the law in force

The following laws are amended as follows:

... 1


1 The mod. Can be viewed at RO 2013 3215 .


State 1 Er January 2014