79C3C34C52B45572883A05D425EB0F82
Federal Act on Research involving Human Beings
https://www.admin.ch/opc/en/classified-compilation/20061313/201401010000/810.30.pdf
http://leaux.net/URLS/ConvertAPI Text Files/04F5AF6DC3CBC755246F75AD90F04CB4.en.txt
Examining the file media/Synopses/04F5AF6DC3CBC755246F75AD90F04CB4.html:
This file was generated: 2020-12-01 07:11:21
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator felony:
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p.000015: registration, as well as notification requirements and the notification
p.000015:
p.000016: 16
p.000016:
p.000016: Human Research Act
p.000016: 810.30
p.000016:
p.000016: procedure. In doing so, it shall have regard to recognised international regulations and if possible take existing
p.000016: registries into consideration.
p.000016: 3 It may:
p.000016: a. entrust public- or private-law organisations with the establishment and man- agement of the registry;
p.000016: b. specify that the results of registered research projects are to be published in such registries.
p.000016:
p.000016: Art. 57 Duty of confidentiality
p.000016: Persons responsible for the enforcement of this Act have a duty to maintain confi- dentiality.
p.000016:
p.000016: Art. 58 Processing of personal data
p.000016: In discharging their duties, ethics committees and the other enforcement bodies are entitled to process personal data.
p.000016: Sensitive personal data may be processed, insofar as this is necessary.
p.000016:
p.000016: Art. 59 Disclosure of data
p.000016: 1 Where no conflicting private interest of overriding importance exists, data may be disclosed to:
p.000016: a. the federal and cantonal agencies responsible for enforcement of this Act, and to public- or
p.000016: private-law organisations and persons if they require the data to fulfil the duties assigned to them under this
p.000016: Act;
p.000016: b. criminal investigation authorities if the data is required to prosecute or pre- vent a felony or an offence
p.000016: under this Act.
p.000016: 2 Where no conflicting private interest of overriding importance exists, data may, in individual cases, following a
p.000016: written request, be disclosed to:
p.000016: a. civil courts if the data is required to judge a court case;
p.000016: b. criminal courts and criminal investigation authorities if the data is required to investigate a felony or
p.000016: misdemeanour.
p.000016: 3 Data which is of general interest and relates to the application of this Act may be published. The data subjects must
p.000016: not be identifiable.
p.000016: 4 In other cases, data may be disclosed to third parties as follows:
p.000016: a. data not relating to specific persons, provided that there is an overriding in- terest in this data being made
p.000016: available;
p.000016: b. personal data, provided that the data subject has given written consent in each case.
p.000016: 5 Only the data which is required for the purpose in question may be disclosed.
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: 810.30 Medicine and Human Dignity
p.000017:
p.000017: 6 The Federal Council shall regulate the details of the disclosure of data and the notification of the
p.000017: persons concerned.
p.000017:
p.000017: Art. 60 Transmission of data to foreign authorities and international organisations
p.000017: 1 Confidential data may only be transmitted to foreign authorities and institutions or to international organisations
p.000017: if:
p.000017: a. this is required by agreements under international law or resolutions passed by international organisations;
p.000017: b. this is necessary to avert an imminent danger to life or health; or
p.000017: c. this would enable serious offences under this Act to be exposed.
p.000017: 2 The Federal Council shall regulate responsibilities and the procedures for exchang- ing data with foreign
p.000017: authorities and institutions and with international organisa- tions.
p.000017:
p.000017: Art. 61 Evaluation
p.000017: 1 The FOPH is responsible for assessing the effectiveness of this Act.
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Searching for indicator prisoners:
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p.000008: carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not
p.000008: disproportionate to the expected benefits.
p.000008: 2 A research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be
p.000008: carried out if:
p.000008: a. it entails no more than minimal risks and burdens for the embryo or foetus; and
p.000008: b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women
p.000008: or for embryos or foetuses.
p.000008:
p.000008: Art. 27 Research projects concerning methods of induced abortion
p.000008: 1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning
p.000008: methods of induced abortion after she has decided to undergo an abortion.
p.000008: 2 Article 26 does not apply.
p.000008:
p.000008:
p.000008: Section 3 Research involving Prisoners
p.000008:
p.000008: Art. 28 Research projects involving prisoners
p.000008: 1 For research projects with an expected direct benefit which involve prisoners, the general requirements for
p.000008: research involving persons apply; however, Article 11 paragraph 2 does not apply.
p.000008: 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no
p.000008: more than minimal risks and burdens.
p.000008:
p.000008: Art. 29 Prohibition of a relaxation of conditions
p.000008: Participation in a research project must not be associated with relaxing the condi- tions of imprisonment.
p.000008:
p.000008:
p.000008: Section 4 Research in Emergency Situations
p.000008:
p.000008: Art. 30 Research projects in emergency situations
p.000008: 1 A research project with an expected direct benefit may be carried out in emergency situations if:
p.000008: a. the necessary measures have been taken so that the wishes of the person concerned can be determined
p.000008: as soon as possible;
p.000008:
p.000009: 9
p.000009:
p.000009: 810.30 Medicine and Human Dignity
p.000009:
p.000009: b. the person concerned does not visibly express opposition to the research in- tervention through either verbally
p.000009: or by his or her behaviour; and
p.000009: c. a physician who is not participating in the research project is called in to safeguard the
p.000009: interests of the person concerned before he or she is involved in the project; in exceptional cases, where there are
p.000009: good reasons for doing so, the physician may be called in at a later stage.
p.000009: 2 A research project with no expected direct benefit may be carried out in emergency situations if, in addition to the
p.000009: requirements specified in paragraph 1:
p.000009: a. it entails no more than minimal risks and burdens; and
...
Political / criminal
Searching for indicator criminal:
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p.000015: 2 It shall designate the registry, provide information on access thereto and specify the content of
p.000015: registration, as well as notification requirements and the notification
p.000015:
p.000016: 16
p.000016:
p.000016: Human Research Act
p.000016: 810.30
p.000016:
p.000016: procedure. In doing so, it shall have regard to recognised international regulations and if possible take existing
p.000016: registries into consideration.
p.000016: 3 It may:
p.000016: a. entrust public- or private-law organisations with the establishment and man- agement of the registry;
p.000016: b. specify that the results of registered research projects are to be published in such registries.
p.000016:
p.000016: Art. 57 Duty of confidentiality
p.000016: Persons responsible for the enforcement of this Act have a duty to maintain confi- dentiality.
p.000016:
p.000016: Art. 58 Processing of personal data
p.000016: In discharging their duties, ethics committees and the other enforcement bodies are entitled to process personal data.
p.000016: Sensitive personal data may be processed, insofar as this is necessary.
p.000016:
p.000016: Art. 59 Disclosure of data
p.000016: 1 Where no conflicting private interest of overriding importance exists, data may be disclosed to:
p.000016: a. the federal and cantonal agencies responsible for enforcement of this Act, and to public- or
p.000016: private-law organisations and persons if they require the data to fulfil the duties assigned to them under this
p.000016: Act;
p.000016: b. criminal investigation authorities if the data is required to prosecute or pre- vent a felony or an offence
p.000016: under this Act.
p.000016: 2 Where no conflicting private interest of overriding importance exists, data may, in individual cases, following a
p.000016: written request, be disclosed to:
p.000016: a. civil courts if the data is required to judge a court case;
p.000016: b. criminal courts and criminal investigation authorities if the data is required to investigate a felony or
p.000016: misdemeanour.
p.000016: 3 Data which is of general interest and relates to the application of this Act may be published. The data subjects must
p.000016: not be identifiable.
p.000016: 4 In other cases, data may be disclosed to third parties as follows:
p.000016: a. data not relating to specific persons, provided that there is an overriding in- terest in this data being made
p.000016: available;
p.000016: b. personal data, provided that the data subject has given written consent in each case.
p.000016: 5 Only the data which is required for the purpose in question may be disclosed.
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: 810.30 Medicine and Human Dignity
p.000017:
p.000017: 6 The Federal Council shall regulate the details of the disclosure of data and the notification of the
p.000017: persons concerned.
p.000017:
p.000017: Art. 60 Transmission of data to foreign authorities and international organisations
p.000017: 1 Confidential data may only be transmitted to foreign authorities and institutions or to international organisations
p.000017: if:
p.000017: a. this is required by agreements under international law or resolutions passed by international organisations;
p.000017: b. this is necessary to avert an imminent danger to life or health; or
p.000017: c. this would enable serious offences under this Act to be exposed.
p.000017: 2 The Federal Council shall regulate responsibilities and the procedures for exchang- ing data with foreign
p.000017: authorities and institutions and with international organisa- tions.
p.000017:
p.000017: Art. 61 Evaluation
p.000017: 1 The FOPH is responsible for assessing the effectiveness of this Act.
p.000017: 2 The Federal Department of Home Affairs shall report to the Federal Council on the results of the evaluation and
p.000017: submit proposals for further action.
p.000017:
p.000017:
p.000017: Chapter 11 Criminal Provisions
p.000017:
p.000017: Art. 62 Misdemeanours
p.000017: 1 Unless a more serious offence has been committed under the Criminal Code8, any person who wilfully:
p.000017: a. conducts a research project without the authorisation of an ethics committee or deviating from an authorised
p.000017: protocol (Art. 45) and thereby endangers the health of the participants;
p.000017: b. conducts a research project as defined in Chapter 2, 3, 5 or 6 without obtain- ing the consent required under
p.000017: this Act (Arts. 16, 17, 18 para. 3, Art. 22 pa- ras. 1, 3 let. a and 4, Arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39
p.000017: para. 1, 40);
p.000017: c. disposes of or acquires a human body or parts thereof in return for payment or other non-cash advantage (Art.
p.000017: 9);
p.000017: d. conducts a research project designed to modify properties of the embryo or foetus for non-disease-related
p.000017: reasons (Art. 25);
p.000017:
p.000017:
p.000017:
p.000017: 8 SR 311.0
p.000017:
p.000018: 18
p.000018:
p.000018: Human Research Act
p.000018: 810.30
p.000018:
p.000018: e. uses embryos or foetuses from induced or spontaneous abortions for a re- search project before death
p.000018: has been determined (Art. 39 para. 3, Art. 40 pa- ra. 2)
p.000018: shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.
p.000018: 2 If the act is committed for commercial gain, the penalty shall be a custodial sen- tence not exceeding three years;
p.000018: this shall be combined with a monetary penalty.
p.000018: 3 If the act is committed through negligence, the penalty shall be a monetary penalty not exceeding 180 daily penalty
p.000018: units.
p.000018:
p.000018: Art. 63 Contraventions
p.000018: 1 Any person who wilfully or negligently:
p.000018: a. commits an offence as specified in Article 62 paragraph 1 letter a without the participants' health being
p.000018: endangered;
p.000018: b. makes a payment or provides any other non-cash advantage to a person for participation in a research project
p.000018: with an expected direct benefit, or de- mands or accepts payment or any other non-cash advantage from a person
p.000018: for participation in a research project (Art. 14);
p.000018: c. makes further use of biological material or health-related personal data without the informed consent
p.000018: required under this Act (Arts. 32, 33), in cases where the conditions specified in Article 34 are not met and
p.000018: appropriate au- thorisation has not been obtained from the responsible ethics committee;
p.000018: d. transfers biological material or health-related personal data for non-research- related purposes in the absence
p.000018: of a legal basis or without the requisite con- sent (Art. 41)
p.000018: shall be liable to a fine.
p.000018: 2 A contravention and the penalty for a contravention become time-barred after five years.
p.000018:
p.000018: Art. 64 Jurisdiction and administrative criminal law
p.000018: 1 The cantons have jurisdiction for the prosecution and judgement of offences.
p.000018: 2 Articles 6, 7 (offences committed within a business) and 15 (forgery of documents, obtaining a false certificate
p.000018: by fraud) of the Federal Act of 22 March 19749 on Administrative Criminal Law apply.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: 9 SR 313.0
p.000018:
p.000019: 19
p.000019:
p.000019: 810.30
p.000019:
p.000019:
p.000019: Chapter 12 Final Provisions
p.000019: Medicine and Human Dignity
p.000019:
p.000019: Art. 65 Implementing provisions
p.000019: 1 The Federal Council shall enact the implementing provisions.
p.000019: 2 In doing so, it shall consider the different extents to which individual research areas and methods
p.000019: involve risks to dignity and privacy, in particular when specify- ing:
p.000019: a. the scientific requirements (Art. 10);
p.000019: b. any exemptions from liability (Art. 19) and liability coverage requirements (Art. 20);
p.000019: c. the requirements for insurance and other forms of coverage (Art. 20);
p.000019: d. the procedural requirements (Art. 49).
p.000019:
p.000019: Art. 66 Amendment of current legislation
p.000019: Current legislation shall be amended as specified in the Annex.
p.000019:
p.000019: Art. 67 Transitional provisions
p.000019: 1 Authorisations granted by cantonal ethics committees for the conduct of research projects remain valid for the term
p.000019: of the authorisation.
p.000019: 2 If no authorisation, as defined in paragraph 1, has been granted for a research project which is already
p.000019: under way when this Act comes into effect, an application for authorisation in accordance with Article 45 paragraph 1
p.000019: letter a shall be submit- ted to the responsible ethics committee within six months after the commencement of this Act.
p.000019: 3 Authorisations for the waiver of professional confidentiality in medical research remain valid for the term
...
Political / political affiliation
Searching for indicator party:
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p.000004: collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they
p.000004: must be informed of their right to dissent.
p.000004:
p.000004: Art. 18 Incomplete information
p.000004: 1 In exceptional cases, the persons concerned may be given incomplete information regarding individual aspects of a
p.000004: research project before it begins:
p.000004: a. insofar as this is essential for methodological reasons; and
p.000004: b. if the research project entails no more than minimal risks and burdens.
p.000004: 2 The participants must subsequently be duly informed as soon as possible.
p.000004:
p.000005: 5
p.000005:
p.000005: 810.30 Medicine and Human Dignity
p.000005:
p.000005: 3 Once they have been informed in accordance with paragraph 2, they may give or withhold their consent to the use of
p.000005: their biological material or their data. Only when such consent has been given is the biological material or
p.000005: data to be used for the research project.
p.000005:
p.000005:
p.000005: Section 3 Liability and Coverage
p.000005:
p.000005: Art. 19 Liability
p.000005: 1 Any person who carries out a research project involving persons shall be liable for damage suffered by them in
p.000005: connection with the project. The Federal Council may specify exemptions from liability.
p.000005: 2 Compensation claims become time-barred three years after the injured party has become aware of the damage
p.000005: and of the liable party, but no later than ten years after the completion of the research project. The Federal
p.000005: Council may specify a longer limitation period for particular research areas.
p.000005: 3 The provisions of the Code of Obligations4 on tort are otherwise applicable; in the exercise of official duties,
p.000005: the Government Liability Act of 14 March 19585, or cantonal government liability law, is applicable.
p.000005:
p.000005: Art. 20 Coverage
p.000005: 1 Liability must be appropriately covered through insurance or in some other man- ner. The Federal Government and
p.000005: its public-law institutions and corporations are exempt from the liability coverage requirements.
p.000005: 2 The Federal Council may:
p.000005: a. specify requirements for insurance and other forms of coverage;
p.000005: b. exempt research areas or classes of damage from the liability coverage re- quirements.
p.000005: 3 For the protection of the injured party, it may:
p.000005: a. grant this party a direct claim against the party providing liability coverage;
p.000005: b. restrict the cancellation rights and objections of the party providing liability coverage, while granting
p.000005: appropriate rights of recourse.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 4 SR 220
p.000005: 5 SR 170.32
p.000005:
p.000006: 6
p.000006:
p.000006: Human Research Act
p.000006: 810.30
p.000006:
p.000006: Chapter 3
p.000006: Additional Requirements for Research involving Particularly Vulnerable Persons
p.000006: Section 1
p.000006: Research involving Children, Adolescents and Adults lacking Capacity
p.000006:
p.000006: Art. 21 Involvement of persons lacking capacity in the consent procedure
p.000006: 1 Children, adolescents and adults lacking capacity must be involved as far as possi- ble in the consent procedure.
p.000006: 2 Increasing weight must be accorded to the views of children and adolescents lack- ing capacity the older and more
p.000006: mature they are.
p.000006:
p.000006: Art. 22 Research projects involving children
p.000006: 1 A research project with an expected direct benefit may only be carried out in children who are capable
p.000006: of judgement if:
...
p.000013: authorisation or make the continuation of the research project subject to additional conditions.
p.000013: 2 The ethics committee may request information or documentation from the holder of the authorisation. This must be
p.000013: provided or made available free of charge.
p.000013: 3 The competent federal and cantonal authorities retain the right to take measures.
p.000013: 4 The authorities and ethics committees shall keep each other informed and coordi- nate their measures.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: Human Research Act
p.000014: 810.30
p.000014:
p.000014: Art. 49 Procedure
p.000014: 1 The Federal Council shall specify requirements for the authorisation procedure so as to ensure consistent enforcement
p.000014: and the implementation of national and interna- tional regulations.
p.000014: 2 In particular for research projects involving biological material and genetic data in accordance with Article 32,
p.000014: or non-genetic health-related personal data in accord- ance with Article 33, it may specify less stringent
p.000014: procedural requirements.
p.000014: 3 Cantonal procedural law otherwise applies.
p.000014:
p.000014: Art. 50 Right of appeal
p.000014: 1 The procedure for appeals against ethics committee decisions is governed by cantonal procedural law and
p.000014: the general provisions concerning the administration of federal justice.
p.000014: 2 The appealing party may not file an appeal based on substantive inappropriateness.
p.000014:
p.000014:
p.000014: Chapter 9 Research Ethics Committees
p.000014:
p.000014: Art. 51 Duties
p.000014: 1 Within the framework of their responsibilities under Chapter 8, ethics committees shall assess whether research
p.000014: projects and the conduct thereof comply with the ethical, legal and scientific requirements of this Act. In
p.000014: particular, they shall assess whether the protection of the persons concerned is guaranteed.
p.000014: 2 They may advise researchers in particular on ethical questions and, if so requested by the researchers, comment on
p.000014: research projects not subject to this Act, and specifi- cally projects carried out abroad.
p.000014:
p.000014: Art. 52 Independence
p.000014: 1 Ethics committees shall exercise their duties in a professionally independent man- ner, without being subject to
p.000014: instructions from the supervisory authority in this regard.
p.000014: 2 The members of ethics committees shall disclose their interests. Each ethics com- mittee shall maintain a publicly
p.000014: accessible register of interests.
p.000014: 3 Members who are interested parties shall not participate in the assessment and decision procedures.
p.000014:
p.000014: Art. 53 Composition
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Political / vulnerable
Searching for indicator vulnerable:
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p.000002: communicated in an appropriate manner. The persons concerned may choose to forgo such information.
p.000002: 2 They are entitled to be informed about all the personal data held in relation to them.
p.000002:
p.000002: Art. 9 Prohibition of commercialisation
p.000002: The human body or parts thereof may not be disposed of or acquired as such for research purposes in
p.000002: return for payment or other non-cash advantage.
p.000002:
p.000002: Art. 10 Scientific requirements
p.000002: 1 Research involving human beings may only be carried out if:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 810.30 Medicine and Human Dignity
p.000003:
p.000003: a. the recognised regulations concerning scientific integrity are complied with, in particular with regard to the
p.000003: handling of conflicts of interest;
p.000003: b. scientific quality requirements are met;
p.000003: c. the recognised international Good Practice guidelines for research involving human beings are complied with; and
p.000003: d. the persons responsible have appropriate professional qualifications.
p.000003: 2 The Federal Council shall specify which national and international regulations must be complied with.
p.000003:
p.000003:
p.000003: Chapter 2 General Requirements for Research involving Persons Section 1 Protection of Participants
p.000003:
p.000003: Art. 11 Subsidiarity
p.000003: 1 A research project involving persons may only be carried out if equivalent findings cannot be obtained by other
p.000003: means.
p.000003: 2 A research project involving particularly vulnerable persons may only be carried out if equivalent findings cannot be
p.000003: obtained by other means.
p.000003:
p.000003: Art. 12 Risks and burdens
p.000003: 1 In every research project, the risks and burdens for the participants must be mini- mised as far as possible.
p.000003: 2 The likely risks and burdens for the participants must not be disproportionate to the expected benefits of the
p.000003: research project.
p.000003:
p.000003: Art. 13 Placebo
p.000003: In research projects with an expected direct benefit, the use of a placebo or non-treatment is only
p.000003: permissible if no additional risk of serious or irreversible harm is to be expected for the persons concerned and:
p.000003: a. no standard treatment is available; or
p.000003: b. the use of a placebo is required for compelling, scientifically sound method- ological reasons, in order to
p.000003: establish the efficacy or safety of a treatment method.
p.000003:
p.000003: Art. 14 Non-remunerative participation
p.000003: 1 No person may receive payment or any other non-cash advantage for participation in a research project with an
p.000003: expected direct benefit. Participation in a research project with no expected direct benefit may be appropriately
p.000003: remunerated.
p.000003: 2 No person may demand or accept payment or any other non-cash advantage from another in return for the latter’s
p.000003: participation in a research project.
p.000003:
p.000004: 4
p.000004:
p.000004: Human Research Act
p.000004: 810.30
p.000004:
p.000004: Art. 15 Safety and protective measures
...
p.000005: Council may specify a longer limitation period for particular research areas.
p.000005: 3 The provisions of the Code of Obligations4 on tort are otherwise applicable; in the exercise of official duties,
p.000005: the Government Liability Act of 14 March 19585, or cantonal government liability law, is applicable.
p.000005:
p.000005: Art. 20 Coverage
p.000005: 1 Liability must be appropriately covered through insurance or in some other man- ner. The Federal Government and
p.000005: its public-law institutions and corporations are exempt from the liability coverage requirements.
p.000005: 2 The Federal Council may:
p.000005: a. specify requirements for insurance and other forms of coverage;
p.000005: b. exempt research areas or classes of damage from the liability coverage re- quirements.
p.000005: 3 For the protection of the injured party, it may:
p.000005: a. grant this party a direct claim against the party providing liability coverage;
p.000005: b. restrict the cancellation rights and objections of the party providing liability coverage, while granting
p.000005: appropriate rights of recourse.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 4 SR 220
p.000005: 5 SR 170.32
p.000005:
p.000006: 6
p.000006:
p.000006: Human Research Act
p.000006: 810.30
p.000006:
p.000006: Chapter 3
p.000006: Additional Requirements for Research involving Particularly Vulnerable Persons
p.000006: Section 1
p.000006: Research involving Children, Adolescents and Adults lacking Capacity
p.000006:
p.000006: Art. 21 Involvement of persons lacking capacity in the consent procedure
p.000006: 1 Children, adolescents and adults lacking capacity must be involved as far as possi- ble in the consent procedure.
p.000006: 2 Increasing weight must be accorded to the views of children and adolescents lack- ing capacity the older and more
p.000006: mature they are.
p.000006:
p.000006: Art. 22 Research projects involving children
p.000006: 1 A research project with an expected direct benefit may only be carried out in children who are capable
p.000006: of judgement if:
p.000006: a. the child has given informed consent; and
p.000006: b. the legal representative has given informed consent in writing.
p.000006: 2 A research project with no expected direct benefit may only be carried out in children who are capable
p.000006: of judgement if, in addition to paragraph 1:
...
Health / Pregnant
Searching for indicator pregnant:
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p.000007: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007: Art. 24 Research projects involving adults lacking capacity
p.000007: 1 A research project with an expected direct benefit may only be carried out in adults who lack capacity if:
p.000007: a. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly
p.000007: documented;
p.000007: b. informed consent has been given in writing by the legal representative, a designated trusted person
p.000007: or the next of kin, if no documented consent is available; and
p.000007: c. the person concerned does not visibly express opposition to the research in- tervention either verbally or by
p.000007: his or her behaviour.
p.000007: 2 A research project with no expected direct benefit may only to be carried out in adults who lack capacity if, in
p.000007: addition to the requirements specified in paragraph 1:
p.000007: a. it entails no more than minimal risks and burdens; and
p.000007: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007:
p.000007: Section 2
p.000007: Research involving Pregnant Women and Embryos and Foetuses in vivo
p.000007:
p.000007: Art. 25 Prohibited research projects
p.000007: Research projects designed to modify properties of an embryo or foetus for non-disease-related reasons are
p.000007: prohibited.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: Human Research Act
p.000008: 810.30
p.000008:
p.000008: Art. 26 Research projects involving pregnant women and embryos and foetuses in vivo
p.000008: 1 A research project with an expected direct benefit for a pregnant woman or for an embryo or foetus may only be
p.000008: carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not
p.000008: disproportionate to the expected benefits.
p.000008: 2 A research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be
p.000008: carried out if:
p.000008: a. it entails no more than minimal risks and burdens for the embryo or foetus; and
p.000008: b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women
p.000008: or for embryos or foetuses.
p.000008:
p.000008: Art. 27 Research projects concerning methods of induced abortion
p.000008: 1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning
p.000008: methods of induced abortion after she has decided to undergo an abortion.
p.000008: 2 Article 26 does not apply.
p.000008:
p.000008:
p.000008: Section 3 Research involving Prisoners
p.000008:
p.000008: Art. 28 Research projects involving prisoners
p.000008: 1 For research projects with an expected direct benefit which involve prisoners, the general requirements for
p.000008: research involving persons apply; however, Article 11 paragraph 2 does not apply.
p.000008: 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no
p.000008: more than minimal risks and burdens.
p.000008:
p.000008: Art. 29 Prohibition of a relaxation of conditions
p.000008: Participation in a research project must not be associated with relaxing the condi- tions of imprisonment.
p.000008:
p.000008:
p.000008: Section 4 Research in Emergency Situations
p.000008:
p.000008: Art. 30 Research projects in emergency situations
p.000008: 1 A research project with an expected direct benefit may be carried out in emergency situations if:
p.000008: a. the necessary measures have been taken so that the wishes of the person concerned can be determined
p.000008: as soon as possible;
p.000008:
p.000009: 9
p.000009:
...
p.000010: it may not be carried out.
p.000010:
p.000010:
p.000010: 6 SR 810.21
p.000010:
p.000011: 11
p.000011:
p.000011: 810.30 Medicine and Human Dignity
p.000011:
p.000011: Art. 37 Additional requirements
p.000011: 1 A research project may be carried out in deceased persons when their death has been determined.
p.000011: 2 A research project may be carried out in deceased persons undergoing artificial respiration if, in
p.000011: addition to the requirement specified in paragraph 1, equivalent findings cannot be obtained with deceased
p.000011: persons not undergoing artificial respira- tion. The Federal Council may specify further conditions.
p.000011: 3 Anyone who carries out a research project in accordance with paragraph 2 must not have been involved in the
p.000011: determination of death or be authorised to issue instruc- tions to the persons involved in this procedure.
p.000011:
p.000011: Art. 38 Research in connection with an autopsy or transplantation
p.000011: Small quantities of bodily substances removed in the course of an autopsy or trans- plantation may be anonymised for
p.000011: research purposes without consent, in the absence of a documented refusal of the deceased person.
p.000011:
p.000011:
p.000011: Chapter 6
p.000011: Research involving Embryos and Foetuses from Induced Abortions and from Spontaneous Abortions including Stillbirths
p.000011:
p.000011: Art. 39 Requirements for research in embryos and foetuses from induced abortions
p.000011: 1 A pregnant woman may only be asked whether she wishes to make her embryo or foetus available for research purposes
p.000011: after she has decided to undergo an abortion. For consent, Articles 16 and 22–24 apply mutatis mutandis.
p.000011: 2 The time and method of induced abortion must be chosen without regard to the research project.
p.000011: 3 Embryos and foetuses from induced abortions may be used for a research project when death has been determined.
p.000011: 4 Anyone who carries out a research project in accordance with paragraph 3 must not be involved in the abortion or
p.000011: be authorised to issue instructions to the persons involved in this procedure.
p.000011:
p.000011: Art. 40 Requirements for research in embryos and foetuses from spontaneous abortions including stillbirths
p.000011: 1 Embryos and foetuses from spontaneous abortions including stillbirths may only be used for research purposes
p.000011: with the consent of the couple concerned. For consent, Article 16 applies mutatis mutandis.
p.000011: 2 Embryos and foetuses from spontaneous abortions may be used for a research project when death has been
p.000011: determined.
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Human Research Act
p.000012: 810.30
p.000012:
p.000012:
p.000012: Chapter 7 Transfer, Export and Storage
p.000012:
...
Health / injured
Searching for indicator injured:
(return to top)
p.000004: If the intention exists to make further use for research of biological material sampled or health-related personal data
p.000004: collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they
p.000004: must be informed of their right to dissent.
p.000004:
p.000004: Art. 18 Incomplete information
p.000004: 1 In exceptional cases, the persons concerned may be given incomplete information regarding individual aspects of a
p.000004: research project before it begins:
p.000004: a. insofar as this is essential for methodological reasons; and
p.000004: b. if the research project entails no more than minimal risks and burdens.
p.000004: 2 The participants must subsequently be duly informed as soon as possible.
p.000004:
p.000005: 5
p.000005:
p.000005: 810.30 Medicine and Human Dignity
p.000005:
p.000005: 3 Once they have been informed in accordance with paragraph 2, they may give or withhold their consent to the use of
p.000005: their biological material or their data. Only when such consent has been given is the biological material or
p.000005: data to be used for the research project.
p.000005:
p.000005:
p.000005: Section 3 Liability and Coverage
p.000005:
p.000005: Art. 19 Liability
p.000005: 1 Any person who carries out a research project involving persons shall be liable for damage suffered by them in
p.000005: connection with the project. The Federal Council may specify exemptions from liability.
p.000005: 2 Compensation claims become time-barred three years after the injured party has become aware of the damage
p.000005: and of the liable party, but no later than ten years after the completion of the research project. The Federal
p.000005: Council may specify a longer limitation period for particular research areas.
p.000005: 3 The provisions of the Code of Obligations4 on tort are otherwise applicable; in the exercise of official duties,
p.000005: the Government Liability Act of 14 March 19585, or cantonal government liability law, is applicable.
p.000005:
p.000005: Art. 20 Coverage
p.000005: 1 Liability must be appropriately covered through insurance or in some other man- ner. The Federal Government and
p.000005: its public-law institutions and corporations are exempt from the liability coverage requirements.
p.000005: 2 The Federal Council may:
p.000005: a. specify requirements for insurance and other forms of coverage;
p.000005: b. exempt research areas or classes of damage from the liability coverage re- quirements.
p.000005: 3 For the protection of the injured party, it may:
p.000005: a. grant this party a direct claim against the party providing liability coverage;
p.000005: b. restrict the cancellation rights and objections of the party providing liability coverage, while granting
p.000005: appropriate rights of recourse.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 4 SR 220
p.000005: 5 SR 170.32
p.000005:
p.000006: 6
p.000006:
p.000006: Human Research Act
p.000006: 810.30
p.000006:
p.000006: Chapter 3
p.000006: Additional Requirements for Research involving Particularly Vulnerable Persons
p.000006: Section 1
p.000006: Research involving Children, Adolescents and Adults lacking Capacity
p.000006:
p.000006: Art. 21 Involvement of persons lacking capacity in the consent procedure
p.000006: 1 Children, adolescents and adults lacking capacity must be involved as far as possi- ble in the consent procedure.
p.000006: 2 Increasing weight must be accorded to the views of children and adolescents lack- ing capacity the older and more
p.000006: mature they are.
p.000006:
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000015: publicly accessible in by-laws.
p.000015: 5 The canton shall assure the financing of the ethics committee. It may make provi- sion for the charging of fees.
p.000015:
p.000015: Art. 55 Coordination and information
p.000015: 1 The Federal Office of Public Health (FOPH) is responsible for coordination be- tween ethics committees and
p.000015: with other supervisory authorities. It may delegate this responsibility to third parties.
p.000015: 2 Ethics committees shall report annually to the FOPH on their activities, in particu- lar on the type and number
p.000015: of research projects assessed and on the processing periods.
p.000015: 3 The FOPH shall publish a list of ethics committees and inform the public regularly about their activities.
p.000015: 4 In consultation with the ethics committees and other supervisory authorities con- cerned, it may issue
p.000015: recommendations for appropriate harmonisation of procedures and of assessment practice.
p.000015:
p.000015:
p.000015: Chapter 10 Transparency and Data Protection
p.000015:
p.000015: Art. 56 Registration
p.000015: 1 Authorised clinical trials must be recorded in a public registry. The Federal Coun- cil may specify exemptions
p.000015: from mandatory registration; in doing so, it shall be guided by recognised international regulations.
p.000015: 2 It shall designate the registry, provide information on access thereto and specify the content of
p.000015: registration, as well as notification requirements and the notification
p.000015:
p.000016: 16
p.000016:
p.000016: Human Research Act
p.000016: 810.30
p.000016:
p.000016: procedure. In doing so, it shall have regard to recognised international regulations and if possible take existing
p.000016: registries into consideration.
p.000016: 3 It may:
p.000016: a. entrust public- or private-law organisations with the establishment and man- agement of the registry;
p.000016: b. specify that the results of registered research projects are to be published in such registries.
p.000016:
p.000016: Art. 57 Duty of confidentiality
p.000016: Persons responsible for the enforcement of this Act have a duty to maintain confi- dentiality.
p.000016:
p.000016: Art. 58 Processing of personal data
p.000016: In discharging their duties, ethics committees and the other enforcement bodies are entitled to process personal data.
p.000016: Sensitive personal data may be processed, insofar as this is necessary.
p.000016:
p.000016: Art. 59 Disclosure of data
p.000016: 1 Where no conflicting private interest of overriding importance exists, data may be disclosed to:
p.000016: a. the federal and cantonal agencies responsible for enforcement of this Act, and to public- or
p.000016: private-law organisations and persons if they require the data to fulfil the duties assigned to them under this
p.000016: Act;
p.000016: b. criminal investigation authorities if the data is required to prosecute or pre- vent a felony or an offence
p.000016: under this Act.
...
Social / Age
Searching for indicator age:
(return to top)
p.000001: c. anonymously collected or anonymised health-related data.
p.000001:
p.000001: Art. 3 Definitions In this Act:
p.000001: a. Research means method-driven search for generalisable knowledge;
p.000001: b. Research concerning diseases means research on the causes, prevention, di- agnosis, treatment and epidemiology
p.000001: of impairments of physical and mental health in human beings;
p.000001: c. Research concerning the structure and function of the human body means basic research, in particular
p.000001: on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and
p.000001: impacts on the human body;
p.000001: d. Research project with an expected direct benefit means a research project whose results can be
p.000001: expected to improve the health of the participants;
p.000001: e. Biological material means bodily substances derived from living persons;
p.000001: f. Health-related personal data means information concerning the health or disease of a specific or
p.000001: identifiable person, including genetic data;
p.000001: g. Genetic data means information on a person's genes, obtained by genetic testing;
p.000001: h. Coded biological material and coded health-related personal data means biological material and data
p.000001: linked to a specific person via a code;
p.000001: i. Anonymised biological material and anonymised health-related data means biological material and health-related
p.000001: data which cannot (without dispropor- tionate effort) be traced to a specific person;
p.000001: j. Child means a legal minor under 14 years of age;
p.000001: k. Adolescent means a legal minor aged 14 years or more;
p.000001: l. Clinical trial means a research project in which persons are prospectively assigned to a
p.000001: health-related intervention in order to investigate its effects on health or on the structure and function of the human
p.000001: body.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 3 SR 810.31
p.000001:
p.000002: 2
p.000002:
p.000002: Human Research Act
p.000002: 810.30
p.000002:
p.000002: Section 2 Principles
p.000002:
p.000002: Art. 4 Primacy of individual interests
p.000002: The interests, health and welfare of the individual human being shall prevail over the interests of science and
p.000002: society.
p.000002:
p.000002: Art. 5 Scientifically relevant topic
p.000002: Research involving human beings may only be carried out if it addresses a topic of scientific relevance concerning:
p.000002: a. the understanding of human diseases;
p.000002: b. the structure and function of the human body; or
p.000002: c. public health.
p.000002:
p.000002: Art. 6 Non-discrimination
p.000002: 1 Nobody is to be subjected to discrimination in connection with research.
p.000002: 2 With regard to the selection of participants in particular, no group of persons shall be disproportionately included
p.000002: in or excluded from research without good reason.
p.000002:
p.000002: Art. 7 Consent
p.000002: 1 Research involving human beings may only be carried out if, in accordance with the provisions of this Act, the
...
Social / Child
Searching for indicator child:
(return to top)
p.000001: a. IVF embryos in accordance with the Stem Cell Research Act of 19 December 20033;
p.000001: b. anonymised biological material;
p.000001: c. anonymously collected or anonymised health-related data.
p.000001:
p.000001: Art. 3 Definitions In this Act:
p.000001: a. Research means method-driven search for generalisable knowledge;
p.000001: b. Research concerning diseases means research on the causes, prevention, di- agnosis, treatment and epidemiology
p.000001: of impairments of physical and mental health in human beings;
p.000001: c. Research concerning the structure and function of the human body means basic research, in particular
p.000001: on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and
p.000001: impacts on the human body;
p.000001: d. Research project with an expected direct benefit means a research project whose results can be
p.000001: expected to improve the health of the participants;
p.000001: e. Biological material means bodily substances derived from living persons;
p.000001: f. Health-related personal data means information concerning the health or disease of a specific or
p.000001: identifiable person, including genetic data;
p.000001: g. Genetic data means information on a person's genes, obtained by genetic testing;
p.000001: h. Coded biological material and coded health-related personal data means biological material and data
p.000001: linked to a specific person via a code;
p.000001: i. Anonymised biological material and anonymised health-related data means biological material and health-related
p.000001: data which cannot (without dispropor- tionate effort) be traced to a specific person;
p.000001: j. Child means a legal minor under 14 years of age;
p.000001: k. Adolescent means a legal minor aged 14 years or more;
p.000001: l. Clinical trial means a research project in which persons are prospectively assigned to a
p.000001: health-related intervention in order to investigate its effects on health or on the structure and function of the human
p.000001: body.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 3 SR 810.31
p.000001:
p.000002: 2
p.000002:
p.000002: Human Research Act
p.000002: 810.30
p.000002:
p.000002: Section 2 Principles
p.000002:
p.000002: Art. 4 Primacy of individual interests
p.000002: The interests, health and welfare of the individual human being shall prevail over the interests of science and
p.000002: society.
p.000002:
p.000002: Art. 5 Scientifically relevant topic
p.000002: Research involving human beings may only be carried out if it addresses a topic of scientific relevance concerning:
p.000002: a. the understanding of human diseases;
p.000002: b. the structure and function of the human body; or
p.000002: c. public health.
p.000002:
p.000002: Art. 6 Non-discrimination
p.000002: 1 Nobody is to be subjected to discrimination in connection with research.
p.000002: 2 With regard to the selection of participants in particular, no group of persons shall be disproportionately included
p.000002: in or excluded from research without good reason.
p.000002:
p.000002: Art. 7 Consent
...
p.000005:
p.000006: 6
p.000006:
p.000006: Human Research Act
p.000006: 810.30
p.000006:
p.000006: Chapter 3
p.000006: Additional Requirements for Research involving Particularly Vulnerable Persons
p.000006: Section 1
p.000006: Research involving Children, Adolescents and Adults lacking Capacity
p.000006:
p.000006: Art. 21 Involvement of persons lacking capacity in the consent procedure
p.000006: 1 Children, adolescents and adults lacking capacity must be involved as far as possi- ble in the consent procedure.
p.000006: 2 Increasing weight must be accorded to the views of children and adolescents lack- ing capacity the older and more
p.000006: mature they are.
p.000006:
p.000006: Art. 22 Research projects involving children
p.000006: 1 A research project with an expected direct benefit may only be carried out in children who are capable
p.000006: of judgement if:
p.000006: a. the child has given informed consent; and
p.000006: b. the legal representative has given informed consent in writing.
p.000006: 2 A research project with no expected direct benefit may only be carried out in children who are capable
p.000006: of judgement if, in addition to paragraph 1:
p.000006: a. it entails no more than minimal risks and burdens; and
p.000006: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000006: same disease or disorder, or in the same situation.
p.000006: 3 A research project with an expected direct benefit may only be carried out in children who lack capacity
p.000006: if:
p.000006: a. the legal representative has given informed consent in writing; and
p.000006: b. the child does not visibly express opposition to the research intervention ei- ther verbally or by his or her
p.000006: behaviour.
p.000006: 4 A research project with no expected direct benefit may only be carried out in children who lack capacity
p.000006: if the requirements specified in paragraphs 2 and 3 are met.
p.000006:
p.000006: Art. 23 Research projects involving adolescents
p.000006: 1 A research project with or without an expected direct benefit may only be carried out in adolescents who are capable
p.000006: of judgement if:
p.000006: a. the adolescent has given informed consent in writing; and
p.000006: b. the legal representative has given informed consent in writing if the research project entails more than minimal
p.000006: risks and burdens.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: 810.30 Medicine and Human Dignity
p.000007:
p.000007: 2 A research project with an expected direct benefit may only be carried out in adolescents who lack
p.000007: capacity if:
p.000007: a. the legal representative has given informed consent in writing; and
p.000007: b. the adolescent does not visibly express opposition to the research interven- tion either verbally or by his or
p.000007: her behaviour.
p.000007: 3 A research project with no expected direct benefit may only be carried out in adolescents who lack
...
Searching for indicator children:
(return to top)
p.000005: 3 The provisions of the Code of Obligations4 on tort are otherwise applicable; in the exercise of official duties,
p.000005: the Government Liability Act of 14 March 19585, or cantonal government liability law, is applicable.
p.000005:
p.000005: Art. 20 Coverage
p.000005: 1 Liability must be appropriately covered through insurance or in some other man- ner. The Federal Government and
p.000005: its public-law institutions and corporations are exempt from the liability coverage requirements.
p.000005: 2 The Federal Council may:
p.000005: a. specify requirements for insurance and other forms of coverage;
p.000005: b. exempt research areas or classes of damage from the liability coverage re- quirements.
p.000005: 3 For the protection of the injured party, it may:
p.000005: a. grant this party a direct claim against the party providing liability coverage;
p.000005: b. restrict the cancellation rights and objections of the party providing liability coverage, while granting
p.000005: appropriate rights of recourse.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 4 SR 220
p.000005: 5 SR 170.32
p.000005:
p.000006: 6
p.000006:
p.000006: Human Research Act
p.000006: 810.30
p.000006:
p.000006: Chapter 3
p.000006: Additional Requirements for Research involving Particularly Vulnerable Persons
p.000006: Section 1
p.000006: Research involving Children, Adolescents and Adults lacking Capacity
p.000006:
p.000006: Art. 21 Involvement of persons lacking capacity in the consent procedure
p.000006: 1 Children, adolescents and adults lacking capacity must be involved as far as possi- ble in the consent procedure.
p.000006: 2 Increasing weight must be accorded to the views of children and adolescents lack- ing capacity the older and more
p.000006: mature they are.
p.000006:
p.000006: Art. 22 Research projects involving children
p.000006: 1 A research project with an expected direct benefit may only be carried out in children who are capable
p.000006: of judgement if:
p.000006: a. the child has given informed consent; and
p.000006: b. the legal representative has given informed consent in writing.
p.000006: 2 A research project with no expected direct benefit may only be carried out in children who are capable
p.000006: of judgement if, in addition to paragraph 1:
p.000006: a. it entails no more than minimal risks and burdens; and
p.000006: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000006: same disease or disorder, or in the same situation.
p.000006: 3 A research project with an expected direct benefit may only be carried out in children who lack capacity
p.000006: if:
p.000006: a. the legal representative has given informed consent in writing; and
p.000006: b. the child does not visibly express opposition to the research intervention ei- ther verbally or by his or her
p.000006: behaviour.
p.000006: 4 A research project with no expected direct benefit may only be carried out in children who lack capacity
p.000006: if the requirements specified in paragraphs 2 and 3 are met.
p.000006:
p.000006: Art. 23 Research projects involving adolescents
p.000006: 1 A research project with or without an expected direct benefit may only be carried out in adolescents who are capable
p.000006: of judgement if:
p.000006: a. the adolescent has given informed consent in writing; and
p.000006: b. the legal representative has given informed consent in writing if the research project entails more than minimal
p.000006: risks and burdens.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: 810.30 Medicine and Human Dignity
p.000007:
p.000007: 2 A research project with an expected direct benefit may only be carried out in adolescents who lack
p.000007: capacity if:
p.000007: a. the legal representative has given informed consent in writing; and
p.000007: b. the adolescent does not visibly express opposition to the research interven- tion either verbally or by his or
p.000007: her behaviour.
p.000007: 3 A research project with no expected direct benefit may only be carried out in adolescents who lack
p.000007: capacity if, in addition to the requirements specified in para- graph 2:
p.000007: a. it entails no more than minimal risks and burdens; and
p.000007: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
...
p.000009:
p.000009: b. the person concerned does not visibly express opposition to the research in- tervention through either verbally
p.000009: or by his or her behaviour; and
p.000009: c. a physician who is not participating in the research project is called in to safeguard the
p.000009: interests of the person concerned before he or she is involved in the project; in exceptional cases, where there are
p.000009: good reasons for doing so, the physician may be called in at a later stage.
p.000009: 2 A research project with no expected direct benefit may be carried out in emergency situations if, in addition to the
p.000009: requirements specified in paragraph 1:
p.000009: a. it entails no more than minimal risks and burdens; and
p.000009: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000009: same disease or disorder, or in the same situation.
p.000009:
p.000009: Art. 31 Post hoc or proxy consent
p.000009: 1 The person concerned must be duly informed about the research project as soon as this becomes possible. He or she may
p.000009: subsequently give or withhold consent.
p.000009: 2 If the person concerned refuses to give post hoc consent, the biological material and data may no longer be used for
p.000009: the research project.
p.000009: 3 The Federal Council shall specify the procedure for the procurement of post hoc or proxy consent, in particular with
p.000009: regard to the involvement of children, adolescents and adults lacking capacity.
p.000009:
p.000009:
p.000009: Chapter 4
p.000009: Further Use of Biological Material and Health-Related Personal Data for Research
p.000009:
p.000009: Art. 32 Further use of biological material and genetic data
p.000009: 1 Further use may be made of biological material and genetic data in uncoded form for a research project if informed
p.000009: consent has been given by the person concerned, or by the legal representative or next of kin. For consent,
p.000009: Articles 16 and 22–24 apply mutatis mutandis.
p.000009: 2 Further use may be made of biological material and genetic data in coded form for research purposes if informed
p.000009: consent has been given by the person concerned, or by the legal representative or next of kin. For consent,
p.000009: Articles 16 and 22–24 apply mutatis mutandis.
p.000009: 3 Biological material and genetic data may be anonymised for research purposes if the person concerned or the legal
p.000009: representative or next of kin have been informed in advance and have not dissented to anonymisation. For dissent,
p.000009: Articles 22–24 apply mutatis mutandis.
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Human Research Act
p.000010: 810.30
p.000010:
p.000010: Art. 33 Further use of non-genetic health-related personal data
p.000010: 1 Further use may be made of non-genetic health-related personal data in uncoded form for research purposes if
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000007: a. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly
p.000007: documented;
p.000007: b. informed consent has been given in writing by the legal representative, a designated trusted person
p.000007: or the next of kin, if no documented consent is available; and
p.000007: c. the person concerned does not visibly express opposition to the research in- tervention either verbally or by
p.000007: his or her behaviour.
p.000007: 2 A research project with no expected direct benefit may only to be carried out in adults who lack capacity if, in
p.000007: addition to the requirements specified in paragraph 1:
p.000007: a. it entails no more than minimal risks and burdens; and
p.000007: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007:
p.000007: Section 2
p.000007: Research involving Pregnant Women and Embryos and Foetuses in vivo
p.000007:
p.000007: Art. 25 Prohibited research projects
p.000007: Research projects designed to modify properties of an embryo or foetus for non-disease-related reasons are
p.000007: prohibited.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: Human Research Act
p.000008: 810.30
p.000008:
p.000008: Art. 26 Research projects involving pregnant women and embryos and foetuses in vivo
p.000008: 1 A research project with an expected direct benefit for a pregnant woman or for an embryo or foetus may only be
p.000008: carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not
p.000008: disproportionate to the expected benefits.
p.000008: 2 A research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be
p.000008: carried out if:
p.000008: a. it entails no more than minimal risks and burdens for the embryo or foetus; and
p.000008: b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women
p.000008: or for embryos or foetuses.
p.000008:
p.000008: Art. 27 Research projects concerning methods of induced abortion
p.000008: 1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning
p.000008: methods of induced abortion after she has decided to undergo an abortion.
p.000008: 2 Article 26 does not apply.
p.000008:
p.000008:
p.000008: Section 3 Research involving Prisoners
p.000008:
p.000008: Art. 28 Research projects involving prisoners
p.000008: 1 For research projects with an expected direct benefit which involve prisoners, the general requirements for
p.000008: research involving persons apply; however, Article 11 paragraph 2 does not apply.
p.000008: 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no
p.000008: more than minimal risks and burdens.
p.000008:
p.000008: Art. 29 Prohibition of a relaxation of conditions
p.000008: Participation in a research project must not be associated with relaxing the condi- tions of imprisonment.
p.000008:
p.000008:
p.000008: Section 4 Research in Emergency Situations
p.000008:
...
p.000011:
p.000011: Art. 37 Additional requirements
p.000011: 1 A research project may be carried out in deceased persons when their death has been determined.
p.000011: 2 A research project may be carried out in deceased persons undergoing artificial respiration if, in
p.000011: addition to the requirement specified in paragraph 1, equivalent findings cannot be obtained with deceased
p.000011: persons not undergoing artificial respira- tion. The Federal Council may specify further conditions.
p.000011: 3 Anyone who carries out a research project in accordance with paragraph 2 must not have been involved in the
p.000011: determination of death or be authorised to issue instruc- tions to the persons involved in this procedure.
p.000011:
p.000011: Art. 38 Research in connection with an autopsy or transplantation
p.000011: Small quantities of bodily substances removed in the course of an autopsy or trans- plantation may be anonymised for
p.000011: research purposes without consent, in the absence of a documented refusal of the deceased person.
p.000011:
p.000011:
p.000011: Chapter 6
p.000011: Research involving Embryos and Foetuses from Induced Abortions and from Spontaneous Abortions including Stillbirths
p.000011:
p.000011: Art. 39 Requirements for research in embryos and foetuses from induced abortions
p.000011: 1 A pregnant woman may only be asked whether she wishes to make her embryo or foetus available for research purposes
p.000011: after she has decided to undergo an abortion. For consent, Articles 16 and 22–24 apply mutatis mutandis.
p.000011: 2 The time and method of induced abortion must be chosen without regard to the research project.
p.000011: 3 Embryos and foetuses from induced abortions may be used for a research project when death has been determined.
p.000011: 4 Anyone who carries out a research project in accordance with paragraph 3 must not be involved in the abortion or
p.000011: be authorised to issue instructions to the persons involved in this procedure.
p.000011:
p.000011: Art. 40 Requirements for research in embryos and foetuses from spontaneous abortions including stillbirths
p.000011: 1 Embryos and foetuses from spontaneous abortions including stillbirths may only be used for research purposes
p.000011: with the consent of the couple concerned. For consent, Article 16 applies mutatis mutandis.
p.000011: 2 Embryos and foetuses from spontaneous abortions may be used for a research project when death has been
p.000011: determined.
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Human Research Act
p.000012: 810.30
p.000012:
p.000012:
p.000012: Chapter 7 Transfer, Export and Storage
p.000012:
...
p.000017: c. this would enable serious offences under this Act to be exposed.
p.000017: 2 The Federal Council shall regulate responsibilities and the procedures for exchang- ing data with foreign
p.000017: authorities and institutions and with international organisa- tions.
p.000017:
p.000017: Art. 61 Evaluation
p.000017: 1 The FOPH is responsible for assessing the effectiveness of this Act.
p.000017: 2 The Federal Department of Home Affairs shall report to the Federal Council on the results of the evaluation and
p.000017: submit proposals for further action.
p.000017:
p.000017:
p.000017: Chapter 11 Criminal Provisions
p.000017:
p.000017: Art. 62 Misdemeanours
p.000017: 1 Unless a more serious offence has been committed under the Criminal Code8, any person who wilfully:
p.000017: a. conducts a research project without the authorisation of an ethics committee or deviating from an authorised
p.000017: protocol (Art. 45) and thereby endangers the health of the participants;
p.000017: b. conducts a research project as defined in Chapter 2, 3, 5 or 6 without obtain- ing the consent required under
p.000017: this Act (Arts. 16, 17, 18 para. 3, Art. 22 pa- ras. 1, 3 let. a and 4, Arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39
p.000017: para. 1, 40);
p.000017: c. disposes of or acquires a human body or parts thereof in return for payment or other non-cash advantage (Art.
p.000017: 9);
p.000017: d. conducts a research project designed to modify properties of the embryo or foetus for non-disease-related
p.000017: reasons (Art. 25);
p.000017:
p.000017:
p.000017:
p.000017: 8 SR 311.0
p.000017:
p.000018: 18
p.000018:
p.000018: Human Research Act
p.000018: 810.30
p.000018:
p.000018: e. uses embryos or foetuses from induced or spontaneous abortions for a re- search project before death
p.000018: has been determined (Art. 39 para. 3, Art. 40 pa- ra. 2)
p.000018: shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.
p.000018: 2 If the act is committed for commercial gain, the penalty shall be a custodial sen- tence not exceeding three years;
p.000018: this shall be combined with a monetary penalty.
p.000018: 3 If the act is committed through negligence, the penalty shall be a monetary penalty not exceeding 180 daily penalty
p.000018: units.
p.000018:
p.000018: Art. 63 Contraventions
p.000018: 1 Any person who wilfully or negligently:
p.000018: a. commits an offence as specified in Article 62 paragraph 1 letter a without the participants' health being
p.000018: endangered;
p.000018: b. makes a payment or provides any other non-cash advantage to a person for participation in a research project
p.000018: with an expected direct benefit, or de- mands or accepts payment or any other non-cash advantage from a person
p.000018: for participation in a research project (Art. 14);
p.000018: c. makes further use of biological material or health-related personal data without the informed consent
p.000018: required under this Act (Arts. 32, 33), in cases where the conditions specified in Article 34 are not met and
...
Searching for indicator foetuses:
(return to top)
p.000001: 810.30
p.000001:
p.000001: English is not an official language of the Swiss Confederation. This translation is provided for information purposes
p.000001: only and has no legal force.
p.000001:
p.000001: Federal Act
p.000001: on Research involving Human Beings
p.000001: (Human Research Act, HRA)
p.000001:
p.000001: of 30 September 2011 (Status as of 1 January 2014)
p.000001:
p.000001:
p.000001: The Federal Assembly of the Swiss Confederation,
p.000001: on the basis of Article 118b paragraph 1 of the Federal Constitution1,
p.000001: and having considered the Dispatch of the Federal Council dated 21 October 20092,
p.000001: decrees:
p.000001:
p.000001:
p.000001: Chapter 1 General Provisions
p.000001: Section 1 Purpose, Scope and Definitions
p.000001:
p.000001: Art. 1 Purpose
p.000001: 1 The purpose of this Act is to protect the dignity, privacy and health of human beings involved in
p.000001: research.
p.000001: 2 It is also designed to:
p.000001: a. create favourable conditions for research involving human beings;
p.000001: b. help to ensure the quality of research involving human beings;
p.000001: c. ensure the transparency of research involving human beings.
p.000001:
p.000001: Art. 2 Scope
p.000001: 1 This Act applies to research concerning human diseases and concerning the struc- ture and function of the human body,
p.000001: which involves:
p.000001: a. persons;
p.000001: b. deceased persons;
p.000001: c. embryos and foetuses;
p.000001: d. biological material;
p.000001: e. health-related personal data.
p.000001:
p.000001: AS 2013 3215
p.000001: 1 SR 101
p.000001: 2 BBl 2009 8045
p.000001:
p.000001: 1
p.000001:
p.000001: 810.30 Medicine and Human Dignity
p.000001:
p.000001: 2 It does not apply to research which involves:
p.000001: a. IVF embryos in accordance with the Stem Cell Research Act of 19 December 20033;
p.000001: b. anonymised biological material;
p.000001: c. anonymously collected or anonymised health-related data.
p.000001:
p.000001: Art. 3 Definitions In this Act:
p.000001: a. Research means method-driven search for generalisable knowledge;
p.000001: b. Research concerning diseases means research on the causes, prevention, di- agnosis, treatment and epidemiology
p.000001: of impairments of physical and mental health in human beings;
p.000001: c. Research concerning the structure and function of the human body means basic research, in particular
p.000001: on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and
p.000001: impacts on the human body;
p.000001: d. Research project with an expected direct benefit means a research project whose results can be
p.000001: expected to improve the health of the participants;
p.000001: e. Biological material means bodily substances derived from living persons;
p.000001: f. Health-related personal data means information concerning the health or disease of a specific or
p.000001: identifiable person, including genetic data;
p.000001: g. Genetic data means information on a person's genes, obtained by genetic testing;
...
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007: Art. 24 Research projects involving adults lacking capacity
p.000007: 1 A research project with an expected direct benefit may only be carried out in adults who lack capacity if:
p.000007: a. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly
p.000007: documented;
p.000007: b. informed consent has been given in writing by the legal representative, a designated trusted person
p.000007: or the next of kin, if no documented consent is available; and
p.000007: c. the person concerned does not visibly express opposition to the research in- tervention either verbally or by
p.000007: his or her behaviour.
p.000007: 2 A research project with no expected direct benefit may only to be carried out in adults who lack capacity if, in
p.000007: addition to the requirements specified in paragraph 1:
p.000007: a. it entails no more than minimal risks and burdens; and
p.000007: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007:
p.000007: Section 2
p.000007: Research involving Pregnant Women and Embryos and Foetuses in vivo
p.000007:
p.000007: Art. 25 Prohibited research projects
p.000007: Research projects designed to modify properties of an embryo or foetus for non-disease-related reasons are
p.000007: prohibited.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: Human Research Act
p.000008: 810.30
p.000008:
p.000008: Art. 26 Research projects involving pregnant women and embryos and foetuses in vivo
p.000008: 1 A research project with an expected direct benefit for a pregnant woman or for an embryo or foetus may only be
p.000008: carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not
p.000008: disproportionate to the expected benefits.
p.000008: 2 A research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be
p.000008: carried out if:
p.000008: a. it entails no more than minimal risks and burdens for the embryo or foetus; and
p.000008: b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women
p.000008: or for embryos or foetuses.
p.000008:
p.000008: Art. 27 Research projects concerning methods of induced abortion
p.000008: 1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning
p.000008: methods of induced abortion after she has decided to undergo an abortion.
p.000008: 2 Article 26 does not apply.
p.000008:
p.000008:
p.000008: Section 3 Research involving Prisoners
p.000008:
p.000008: Art. 28 Research projects involving prisoners
p.000008: 1 For research projects with an expected direct benefit which involve prisoners, the general requirements for
p.000008: research involving persons apply; however, Article 11 paragraph 2 does not apply.
p.000008: 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no
p.000008: more than minimal risks and burdens.
p.000008:
p.000008: Art. 29 Prohibition of a relaxation of conditions
p.000008: Participation in a research project must not be associated with relaxing the condi- tions of imprisonment.
p.000008:
p.000008:
p.000008: Section 4 Research in Emergency Situations
p.000008:
p.000008: Art. 30 Research projects in emergency situations
p.000008: 1 A research project with an expected direct benefit may be carried out in emergency situations if:
...
p.000010: 20046.
p.000010: 4 In the case of deceased persons whose death occurred more than 70 years previous- ly, research may be carried
p.000010: out without consent being given as specified in para- graph 2. If such research is opposed by the next of kin,
p.000010: it may not be carried out.
p.000010:
p.000010:
p.000010: 6 SR 810.21
p.000010:
p.000011: 11
p.000011:
p.000011: 810.30 Medicine and Human Dignity
p.000011:
p.000011: Art. 37 Additional requirements
p.000011: 1 A research project may be carried out in deceased persons when their death has been determined.
p.000011: 2 A research project may be carried out in deceased persons undergoing artificial respiration if, in
p.000011: addition to the requirement specified in paragraph 1, equivalent findings cannot be obtained with deceased
p.000011: persons not undergoing artificial respira- tion. The Federal Council may specify further conditions.
p.000011: 3 Anyone who carries out a research project in accordance with paragraph 2 must not have been involved in the
p.000011: determination of death or be authorised to issue instruc- tions to the persons involved in this procedure.
p.000011:
p.000011: Art. 38 Research in connection with an autopsy or transplantation
p.000011: Small quantities of bodily substances removed in the course of an autopsy or trans- plantation may be anonymised for
p.000011: research purposes without consent, in the absence of a documented refusal of the deceased person.
p.000011:
p.000011:
p.000011: Chapter 6
p.000011: Research involving Embryos and Foetuses from Induced Abortions and from Spontaneous Abortions including Stillbirths
p.000011:
p.000011: Art. 39 Requirements for research in embryos and foetuses from induced abortions
p.000011: 1 A pregnant woman may only be asked whether she wishes to make her embryo or foetus available for research purposes
p.000011: after she has decided to undergo an abortion. For consent, Articles 16 and 22–24 apply mutatis mutandis.
p.000011: 2 The time and method of induced abortion must be chosen without regard to the research project.
p.000011: 3 Embryos and foetuses from induced abortions may be used for a research project when death has been determined.
p.000011: 4 Anyone who carries out a research project in accordance with paragraph 3 must not be involved in the abortion or
p.000011: be authorised to issue instructions to the persons involved in this procedure.
p.000011:
p.000011: Art. 40 Requirements for research in embryos and foetuses from spontaneous abortions including stillbirths
p.000011: 1 Embryos and foetuses from spontaneous abortions including stillbirths may only be used for research purposes
p.000011: with the consent of the couple concerned. For consent, Article 16 applies mutatis mutandis.
p.000011: 2 Embryos and foetuses from spontaneous abortions may be used for a research project when death has been
p.000011: determined.
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Human Research Act
p.000012: 810.30
p.000012:
p.000012:
p.000012: Chapter 7 Transfer, Export and Storage
p.000012:
p.000012: Art. 41 Transfer for purposes other than research
p.000012: Biological material or health-related personal data which has been sampled or col- lected or of which further use
p.000012: has been made for research purposes may only be passed on for purposes other than research if:
p.000012: a. a legal basis exists for such a transfer; or
p.000012: b. in the particular case, informed consent to the transfer has been given by the person concerned.
p.000012:
p.000012: Art. 42 Export
p.000012: 1 Biological material or genetic data may be exported for research purposes if in- formed consent has
p.000012: been given by the person concerned. For consent, Articles 16 and 22–24 and 32 apply mutatis mutandis.
p.000012: 2 Non-genetic health-related personal data may be disclosed abroad for research purposes if the
p.000012: requirements specified in Article 6 of the Federal Act of 19 June 19927 on Data Protection are met.
p.000012:
p.000012: Art. 43 Storage
p.000012: 1 Anyone who stores biological material or health-related personal data for research purposes must take appropriate
p.000012: technical and organisational measures to prevent unauthorised use thereof, and fulfil the operational and
p.000012: professional requirements.
p.000012: 2 The Federal Council shall specify the requirements for storage.
p.000012:
p.000012: Art. 44 Deceased persons, embryos and foetuses including stillbirths
p.000012: Articles 41–43 apply mutatis mutandis to deceased persons, to embryos and foetuses including stillbirths and parts
p.000012: thereof, and to data collected in this connection.
p.000012:
p.000012:
p.000012: Chapter 8 Authorisation, Notifications and Procedure
p.000012:
p.000012: Art. 45 Mandatory authorisation
p.000012: 1 Authorisation from the responsible ethics committee is required for:
p.000012: a. conducting a research project; or
p.000012: b. making further use of biological material or health-related personal data for research purposes in cases
p.000012: where consent has not been obtained or infor- mation on the right to dissent has not been provided (Art. 34).
p.000012:
p.000012:
p.000012: 7 SR 235.1
p.000012:
p.000013: 13
p.000013:
p.000013: 810.30 Medicine and Human Dignity
p.000013:
p.000013: 2 Authorisation is granted if the ethical, legal and scientific requirements of this Act are met. The decision must
p.000013: be available within two months of submission of the application. The Federal Council may specify shorter,
p.000013: risk-adapted maximum limits for processing periods.
p.000013: 3 The Federal Council may make changes to research projects subject to authorisa- tion. In doing so, it shall have
p.000013: regard to recognised international regulations.
p.000013:
p.000013: Art. 46 Notification and information requirements
p.000013: 1 The Federal Council may specify notification or information requirements, in particular with regard to:
p.000013: a. the completion or discontinuation of a research project;
p.000013: b. adverse events observed in connection with a research project;
...
p.000017: 2 The Federal Department of Home Affairs shall report to the Federal Council on the results of the evaluation and
p.000017: submit proposals for further action.
p.000017:
p.000017:
p.000017: Chapter 11 Criminal Provisions
p.000017:
p.000017: Art. 62 Misdemeanours
p.000017: 1 Unless a more serious offence has been committed under the Criminal Code8, any person who wilfully:
p.000017: a. conducts a research project without the authorisation of an ethics committee or deviating from an authorised
p.000017: protocol (Art. 45) and thereby endangers the health of the participants;
p.000017: b. conducts a research project as defined in Chapter 2, 3, 5 or 6 without obtain- ing the consent required under
p.000017: this Act (Arts. 16, 17, 18 para. 3, Art. 22 pa- ras. 1, 3 let. a and 4, Arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39
p.000017: para. 1, 40);
p.000017: c. disposes of or acquires a human body or parts thereof in return for payment or other non-cash advantage (Art.
p.000017: 9);
p.000017: d. conducts a research project designed to modify properties of the embryo or foetus for non-disease-related
p.000017: reasons (Art. 25);
p.000017:
p.000017:
p.000017:
p.000017: 8 SR 311.0
p.000017:
p.000018: 18
p.000018:
p.000018: Human Research Act
p.000018: 810.30
p.000018:
p.000018: e. uses embryos or foetuses from induced or spontaneous abortions for a re- search project before death
p.000018: has been determined (Art. 39 para. 3, Art. 40 pa- ra. 2)
p.000018: shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.
p.000018: 2 If the act is committed for commercial gain, the penalty shall be a custodial sen- tence not exceeding three years;
p.000018: this shall be combined with a monetary penalty.
p.000018: 3 If the act is committed through negligence, the penalty shall be a monetary penalty not exceeding 180 daily penalty
p.000018: units.
p.000018:
p.000018: Art. 63 Contraventions
p.000018: 1 Any person who wilfully or negligently:
p.000018: a. commits an offence as specified in Article 62 paragraph 1 letter a without the participants' health being
p.000018: endangered;
p.000018: b. makes a payment or provides any other non-cash advantage to a person for participation in a research project
p.000018: with an expected direct benefit, or de- mands or accepts payment or any other non-cash advantage from a person
p.000018: for participation in a research project (Art. 14);
p.000018: c. makes further use of biological material or health-related personal data without the informed consent
p.000018: required under this Act (Arts. 32, 33), in cases where the conditions specified in Article 34 are not met and
p.000018: appropriate au- thorisation has not been obtained from the responsible ethics committee;
p.000018: d. transfers biological material or health-related personal data for non-research- related purposes in the absence
p.000018: of a legal basis or without the requisite con- sent (Art. 41)
p.000018: shall be liable to a fine.
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000001: 810.30
p.000001:
p.000001: English is not an official language of the Swiss Confederation. This translation is provided for information purposes
p.000001: only and has no legal force.
p.000001:
p.000001: Federal Act
p.000001: on Research involving Human Beings
p.000001: (Human Research Act, HRA)
p.000001:
p.000001: of 30 September 2011 (Status as of 1 January 2014)
p.000001:
p.000001:
p.000001: The Federal Assembly of the Swiss Confederation,
p.000001: on the basis of Article 118b paragraph 1 of the Federal Constitution1,
p.000001: and having considered the Dispatch of the Federal Council dated 21 October 20092,
p.000001: decrees:
p.000001:
p.000001:
p.000001: Chapter 1 General Provisions
p.000001: Section 1 Purpose, Scope and Definitions
p.000001:
p.000001: Art. 1 Purpose
p.000001: 1 The purpose of this Act is to protect the dignity, privacy and health of human beings involved in
p.000001: research.
p.000001: 2 It is also designed to:
p.000001: a. create favourable conditions for research involving human beings;
p.000001: b. help to ensure the quality of research involving human beings;
p.000001: c. ensure the transparency of research involving human beings.
p.000001:
p.000001: Art. 2 Scope
p.000001: 1 This Act applies to research concerning human diseases and concerning the struc- ture and function of the human body,
p.000001: which involves:
p.000001: a. persons;
p.000001: b. deceased persons;
p.000001: c. embryos and foetuses;
p.000001: d. biological material;
p.000001: e. health-related personal data.
p.000001:
p.000001: AS 2013 3215
p.000001: 1 SR 101
p.000001: 2 BBl 2009 8045
p.000001:
p.000001: 1
p.000001:
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000016: not be identifiable.
p.000016: 4 In other cases, data may be disclosed to third parties as follows:
p.000016: a. data not relating to specific persons, provided that there is an overriding in- terest in this data being made
p.000016: available;
p.000016: b. personal data, provided that the data subject has given written consent in each case.
p.000016: 5 Only the data which is required for the purpose in question may be disclosed.
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: 810.30 Medicine and Human Dignity
p.000017:
p.000017: 6 The Federal Council shall regulate the details of the disclosure of data and the notification of the
p.000017: persons concerned.
p.000017:
p.000017: Art. 60 Transmission of data to foreign authorities and international organisations
p.000017: 1 Confidential data may only be transmitted to foreign authorities and institutions or to international organisations
p.000017: if:
p.000017: a. this is required by agreements under international law or resolutions passed by international organisations;
p.000017: b. this is necessary to avert an imminent danger to life or health; or
p.000017: c. this would enable serious offences under this Act to be exposed.
p.000017: 2 The Federal Council shall regulate responsibilities and the procedures for exchang- ing data with foreign
p.000017: authorities and institutions and with international organisa- tions.
p.000017:
p.000017: Art. 61 Evaluation
p.000017: 1 The FOPH is responsible for assessing the effectiveness of this Act.
p.000017: 2 The Federal Department of Home Affairs shall report to the Federal Council on the results of the evaluation and
p.000017: submit proposals for further action.
p.000017:
p.000017:
p.000017: Chapter 11 Criminal Provisions
p.000017:
p.000017: Art. 62 Misdemeanours
p.000017: 1 Unless a more serious offence has been committed under the Criminal Code8, any person who wilfully:
p.000017: a. conducts a research project without the authorisation of an ethics committee or deviating from an authorised
p.000017: protocol (Art. 45) and thereby endangers the health of the participants;
p.000017: b. conducts a research project as defined in Chapter 2, 3, 5 or 6 without obtain- ing the consent required under
p.000017: this Act (Arts. 16, 17, 18 para. 3, Art. 22 pa- ras. 1, 3 let. a and 4, Arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39
p.000017: para. 1, 40);
p.000017: c. disposes of or acquires a human body or parts thereof in return for payment or other non-cash advantage (Art.
p.000017: 9);
p.000017: d. conducts a research project designed to modify properties of the embryo or foetus for non-disease-related
p.000017: reasons (Art. 25);
p.000017:
p.000017:
p.000017:
p.000017: 8 SR 311.0
p.000017:
p.000018: 18
p.000018:
p.000018: Human Research Act
p.000018: 810.30
p.000018:
p.000018: e. uses embryos or foetuses from induced or spontaneous abortions for a re- search project before death
p.000018: has been determined (Art. 39 para. 3, Art. 40 pa- ra. 2)
...
Social / Women
Searching for indicator women:
(return to top)
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007: Art. 24 Research projects involving adults lacking capacity
p.000007: 1 A research project with an expected direct benefit may only be carried out in adults who lack capacity if:
p.000007: a. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly
p.000007: documented;
p.000007: b. informed consent has been given in writing by the legal representative, a designated trusted person
p.000007: or the next of kin, if no documented consent is available; and
p.000007: c. the person concerned does not visibly express opposition to the research in- tervention either verbally or by
p.000007: his or her behaviour.
p.000007: 2 A research project with no expected direct benefit may only to be carried out in adults who lack capacity if, in
p.000007: addition to the requirements specified in paragraph 1:
p.000007: a. it entails no more than minimal risks and burdens; and
p.000007: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007:
p.000007: Section 2
p.000007: Research involving Pregnant Women and Embryos and Foetuses in vivo
p.000007:
p.000007: Art. 25 Prohibited research projects
p.000007: Research projects designed to modify properties of an embryo or foetus for non-disease-related reasons are
p.000007: prohibited.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: Human Research Act
p.000008: 810.30
p.000008:
p.000008: Art. 26 Research projects involving pregnant women and embryos and foetuses in vivo
p.000008: 1 A research project with an expected direct benefit for a pregnant woman or for an embryo or foetus may only be
p.000008: carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not
p.000008: disproportionate to the expected benefits.
p.000008: 2 A research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be
p.000008: carried out if:
p.000008: a. it entails no more than minimal risks and burdens for the embryo or foetus; and
p.000008: b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women
p.000008: or for embryos or foetuses.
p.000008:
p.000008: Art. 27 Research projects concerning methods of induced abortion
p.000008: 1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning
p.000008: methods of induced abortion after she has decided to undergo an abortion.
p.000008: 2 Article 26 does not apply.
p.000008:
p.000008:
p.000008: Section 3 Research involving Prisoners
p.000008:
p.000008: Art. 28 Research projects involving prisoners
p.000008: 1 For research projects with an expected direct benefit which involve prisoners, the general requirements for
p.000008: research involving persons apply; however, Article 11 paragraph 2 does not apply.
p.000008: 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no
p.000008: more than minimal risks and burdens.
p.000008:
p.000008: Art. 29 Prohibition of a relaxation of conditions
p.000008: Participation in a research project must not be associated with relaxing the condi- tions of imprisonment.
p.000008:
p.000008:
p.000008: Section 4 Research in Emergency Situations
p.000008:
p.000008: Art. 30 Research projects in emergency situations
p.000008: 1 A research project with an expected direct benefit may be carried out in emergency situations if:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000001: b. anonymised biological material;
p.000001: c. anonymously collected or anonymised health-related data.
p.000001:
p.000001: Art. 3 Definitions In this Act:
p.000001: a. Research means method-driven search for generalisable knowledge;
p.000001: b. Research concerning diseases means research on the causes, prevention, di- agnosis, treatment and epidemiology
p.000001: of impairments of physical and mental health in human beings;
p.000001: c. Research concerning the structure and function of the human body means basic research, in particular
p.000001: on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and
p.000001: impacts on the human body;
p.000001: d. Research project with an expected direct benefit means a research project whose results can be
p.000001: expected to improve the health of the participants;
p.000001: e. Biological material means bodily substances derived from living persons;
p.000001: f. Health-related personal data means information concerning the health or disease of a specific or
p.000001: identifiable person, including genetic data;
p.000001: g. Genetic data means information on a person's genes, obtained by genetic testing;
p.000001: h. Coded biological material and coded health-related personal data means biological material and data
p.000001: linked to a specific person via a code;
p.000001: i. Anonymised biological material and anonymised health-related data means biological material and health-related
p.000001: data which cannot (without dispropor- tionate effort) be traced to a specific person;
p.000001: j. Child means a legal minor under 14 years of age;
p.000001: k. Adolescent means a legal minor aged 14 years or more;
p.000001: l. Clinical trial means a research project in which persons are prospectively assigned to a
p.000001: health-related intervention in order to investigate its effects on health or on the structure and function of the human
p.000001: body.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 3 SR 810.31
p.000001:
p.000002: 2
p.000002:
p.000002: Human Research Act
p.000002: 810.30
p.000002:
p.000002: Section 2 Principles
p.000002:
p.000002: Art. 4 Primacy of individual interests
p.000002: The interests, health and welfare of the individual human being shall prevail over the interests of science and
p.000002: society.
p.000002:
p.000002: Art. 5 Scientifically relevant topic
p.000002: Research involving human beings may only be carried out if it addresses a topic of scientific relevance concerning:
p.000002: a. the understanding of human diseases;
p.000002: b. the structure and function of the human body; or
p.000002: c. public health.
p.000002:
p.000002: Art. 6 Non-discrimination
p.000002: 1 Nobody is to be subjected to discrimination in connection with research.
p.000002: 2 With regard to the selection of participants in particular, no group of persons shall be disproportionately included
p.000002: in or excluded from research without good reason.
p.000002:
p.000002: Art. 7 Consent
p.000002: 1 Research involving human beings may only be carried out if, in accordance with the provisions of this Act, the
p.000002: persons concerned have given their informed consent or, after being duly informed, have not exercised their right to
p.000002: dissent.
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000007: 1 A research project with an expected direct benefit may only be carried out in adults who lack capacity if:
p.000007: a. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly
p.000007: documented;
p.000007: b. informed consent has been given in writing by the legal representative, a designated trusted person
p.000007: or the next of kin, if no documented consent is available; and
p.000007: c. the person concerned does not visibly express opposition to the research in- tervention either verbally or by
p.000007: his or her behaviour.
p.000007: 2 A research project with no expected direct benefit may only to be carried out in adults who lack capacity if, in
p.000007: addition to the requirements specified in paragraph 1:
p.000007: a. it entails no more than minimal risks and burdens; and
p.000007: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000007: same disease or disorder, or in the same situation.
p.000007:
p.000007:
p.000007: Section 2
p.000007: Research involving Pregnant Women and Embryos and Foetuses in vivo
p.000007:
p.000007: Art. 25 Prohibited research projects
p.000007: Research projects designed to modify properties of an embryo or foetus for non-disease-related reasons are
p.000007: prohibited.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: Human Research Act
p.000008: 810.30
p.000008:
p.000008: Art. 26 Research projects involving pregnant women and embryos and foetuses in vivo
p.000008: 1 A research project with an expected direct benefit for a pregnant woman or for an embryo or foetus may only be
p.000008: carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not
p.000008: disproportionate to the expected benefits.
p.000008: 2 A research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be
p.000008: carried out if:
p.000008: a. it entails no more than minimal risks and burdens for the embryo or foetus; and
p.000008: b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women
p.000008: or for embryos or foetuses.
p.000008:
p.000008: Art. 27 Research projects concerning methods of induced abortion
p.000008: 1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning
p.000008: methods of induced abortion after she has decided to undergo an abortion.
p.000008: 2 Article 26 does not apply.
p.000008:
p.000008:
p.000008: Section 3 Research involving Prisoners
p.000008:
p.000008: Art. 28 Research projects involving prisoners
p.000008: 1 For research projects with an expected direct benefit which involve prisoners, the general requirements for
p.000008: research involving persons apply; however, Article 11 paragraph 2 does not apply.
p.000008: 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no
p.000008: more than minimal risks and burdens.
p.000008:
p.000008: Art. 29 Prohibition of a relaxation of conditions
p.000008: Participation in a research project must not be associated with relaxing the condi- tions of imprisonment.
p.000008:
p.000008:
...
p.000010:
p.000011: 11
p.000011:
p.000011: 810.30 Medicine and Human Dignity
p.000011:
p.000011: Art. 37 Additional requirements
p.000011: 1 A research project may be carried out in deceased persons when their death has been determined.
p.000011: 2 A research project may be carried out in deceased persons undergoing artificial respiration if, in
p.000011: addition to the requirement specified in paragraph 1, equivalent findings cannot be obtained with deceased
p.000011: persons not undergoing artificial respira- tion. The Federal Council may specify further conditions.
p.000011: 3 Anyone who carries out a research project in accordance with paragraph 2 must not have been involved in the
p.000011: determination of death or be authorised to issue instruc- tions to the persons involved in this procedure.
p.000011:
p.000011: Art. 38 Research in connection with an autopsy or transplantation
p.000011: Small quantities of bodily substances removed in the course of an autopsy or trans- plantation may be anonymised for
p.000011: research purposes without consent, in the absence of a documented refusal of the deceased person.
p.000011:
p.000011:
p.000011: Chapter 6
p.000011: Research involving Embryos and Foetuses from Induced Abortions and from Spontaneous Abortions including Stillbirths
p.000011:
p.000011: Art. 39 Requirements for research in embryos and foetuses from induced abortions
p.000011: 1 A pregnant woman may only be asked whether she wishes to make her embryo or foetus available for research purposes
p.000011: after she has decided to undergo an abortion. For consent, Articles 16 and 22–24 apply mutatis mutandis.
p.000011: 2 The time and method of induced abortion must be chosen without regard to the research project.
p.000011: 3 Embryos and foetuses from induced abortions may be used for a research project when death has been determined.
p.000011: 4 Anyone who carries out a research project in accordance with paragraph 3 must not be involved in the abortion or
p.000011: be authorised to issue instructions to the persons involved in this procedure.
p.000011:
p.000011: Art. 40 Requirements for research in embryos and foetuses from spontaneous abortions including stillbirths
p.000011: 1 Embryos and foetuses from spontaneous abortions including stillbirths may only be used for research purposes
p.000011: with the consent of the couple concerned. For consent, Article 16 applies mutatis mutandis.
p.000011: 2 Embryos and foetuses from spontaneous abortions may be used for a research project when death has been
p.000011: determined.
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Human Research Act
p.000012: 810.30
p.000012:
p.000012:
p.000012: Chapter 7 Transfer, Export and Storage
p.000012:
p.000012: Art. 41 Transfer for purposes other than research
...
p.000017: c. this would enable serious offences under this Act to be exposed.
p.000017: 2 The Federal Council shall regulate responsibilities and the procedures for exchang- ing data with foreign
p.000017: authorities and institutions and with international organisa- tions.
p.000017:
p.000017: Art. 61 Evaluation
p.000017: 1 The FOPH is responsible for assessing the effectiveness of this Act.
p.000017: 2 The Federal Department of Home Affairs shall report to the Federal Council on the results of the evaluation and
p.000017: submit proposals for further action.
p.000017:
p.000017:
p.000017: Chapter 11 Criminal Provisions
p.000017:
p.000017: Art. 62 Misdemeanours
p.000017: 1 Unless a more serious offence has been committed under the Criminal Code8, any person who wilfully:
p.000017: a. conducts a research project without the authorisation of an ethics committee or deviating from an authorised
p.000017: protocol (Art. 45) and thereby endangers the health of the participants;
p.000017: b. conducts a research project as defined in Chapter 2, 3, 5 or 6 without obtain- ing the consent required under
p.000017: this Act (Arts. 16, 17, 18 para. 3, Art. 22 pa- ras. 1, 3 let. a and 4, Arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39
p.000017: para. 1, 40);
p.000017: c. disposes of or acquires a human body or parts thereof in return for payment or other non-cash advantage (Art.
p.000017: 9);
p.000017: d. conducts a research project designed to modify properties of the embryo or foetus for non-disease-related
p.000017: reasons (Art. 25);
p.000017:
p.000017:
p.000017:
p.000017: 8 SR 311.0
p.000017:
p.000018: 18
p.000018:
p.000018: Human Research Act
p.000018: 810.30
p.000018:
p.000018: e. uses embryos or foetuses from induced or spontaneous abortions for a re- search project before death
p.000018: has been determined (Art. 39 para. 3, Art. 40 pa- ra. 2)
p.000018: shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.
p.000018: 2 If the act is committed for commercial gain, the penalty shall be a custodial sen- tence not exceeding three years;
p.000018: this shall be combined with a monetary penalty.
p.000018: 3 If the act is committed through negligence, the penalty shall be a monetary penalty not exceeding 180 daily penalty
p.000018: units.
p.000018:
p.000018: Art. 63 Contraventions
p.000018: 1 Any person who wilfully or negligently:
p.000018: a. commits an offence as specified in Article 62 paragraph 1 letter a without the participants' health being
p.000018: endangered;
p.000018: b. makes a payment or provides any other non-cash advantage to a person for participation in a research project
p.000018: with an expected direct benefit, or de- mands or accepts payment or any other non-cash advantage from a person
p.000018: for participation in a research project (Art. 14);
p.000018: c. makes further use of biological material or health-related personal data without the informed consent
p.000018: required under this Act (Arts. 32, 33), in cases where the conditions specified in Article 34 are not met and
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000013: be available within two months of submission of the application. The Federal Council may specify shorter,
p.000013: risk-adapted maximum limits for processing periods.
p.000013: 3 The Federal Council may make changes to research projects subject to authorisa- tion. In doing so, it shall have
p.000013: regard to recognised international regulations.
p.000013:
p.000013: Art. 46 Notification and information requirements
p.000013: 1 The Federal Council may specify notification or information requirements, in particular with regard to:
p.000013: a. the completion or discontinuation of a research project;
p.000013: b. adverse events observed in connection with a research project;
p.000013: c. the occurrence of circumstances during the conduct of a research project which could affect the safety
p.000013: or health of the participants.
p.000013: 2 In doing so, it shall have regard to recognised international regulations.
p.000013:
p.000013: Art. 47 Responsible ethics committee
p.000013: 1 The responsible ethics committee is that of the canton in whose territory the re- search is conducted.
p.000013: 2 If a research project is carried out according to a standard protocol, but in different cantons (multicentre
p.000013: research project), authorisation is required from the ethics committee which is responsible at the site of
p.000013: activity of the project coordinator (the lead committee).
p.000013: 3 In order to assess whether the professional and operational requirements are ful- filled in other cantons, the lead
p.000013: committee shall seek the opinion of the ethics com- mittees concerned. It shall be bound by their opinion.
p.000013: 4 Paragraphs 2 and 3 apply mutatis mutandis to authorisation for the use in accord- ance with Article 34 of biological
p.000013: material and health-related personal data of which further use is made or which are collected according to a standard
p.000013: protocol, but in different cantons.
p.000013:
p.000013: Art. 48 Official measures
p.000013: 1 If the safety or health of the persons concerned is at risk, the ethics committee may revoke or suspend its
p.000013: authorisation or make the continuation of the research project subject to additional conditions.
p.000013: 2 The ethics committee may request information or documentation from the holder of the authorisation. This must be
p.000013: provided or made available free of charge.
p.000013: 3 The competent federal and cantonal authorities retain the right to take measures.
p.000013: 4 The authorities and ethics committees shall keep each other informed and coordi- nate their measures.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: Human Research Act
p.000014: 810.30
p.000014:
p.000014: Art. 49 Procedure
p.000014: 1 The Federal Council shall specify requirements for the authorisation procedure so as to ensure consistent enforcement
p.000014: and the implementation of national and interna- tional regulations.
p.000014: 2 In particular for research projects involving biological material and genetic data in accordance with Article 32,
p.000014: or non-genetic health-related personal data in accord- ance with Article 33, it may specify less stringent
p.000014: procedural requirements.
p.000014: 3 Cantonal procedural law otherwise applies.
p.000014:
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000008: b. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women
p.000008: or for embryos or foetuses.
p.000008:
p.000008: Art. 27 Research projects concerning methods of induced abortion
p.000008: 1 A pregnant woman may only be asked whether she wishes to participate in a research project concerning
p.000008: methods of induced abortion after she has decided to undergo an abortion.
p.000008: 2 Article 26 does not apply.
p.000008:
p.000008:
p.000008: Section 3 Research involving Prisoners
p.000008:
p.000008: Art. 28 Research projects involving prisoners
p.000008: 1 For research projects with an expected direct benefit which involve prisoners, the general requirements for
p.000008: research involving persons apply; however, Article 11 paragraph 2 does not apply.
p.000008: 2 A research project with no expected direct benefit which involves prisoners may only be carried out if it entails no
p.000008: more than minimal risks and burdens.
p.000008:
p.000008: Art. 29 Prohibition of a relaxation of conditions
p.000008: Participation in a research project must not be associated with relaxing the condi- tions of imprisonment.
p.000008:
p.000008:
p.000008: Section 4 Research in Emergency Situations
p.000008:
p.000008: Art. 30 Research projects in emergency situations
p.000008: 1 A research project with an expected direct benefit may be carried out in emergency situations if:
p.000008: a. the necessary measures have been taken so that the wishes of the person concerned can be determined
p.000008: as soon as possible;
p.000008:
p.000009: 9
p.000009:
p.000009: 810.30 Medicine and Human Dignity
p.000009:
p.000009: b. the person concerned does not visibly express opposition to the research in- tervention through either verbally
p.000009: or by his or her behaviour; and
p.000009: c. a physician who is not participating in the research project is called in to safeguard the
p.000009: interests of the person concerned before he or she is involved in the project; in exceptional cases, where there are
p.000009: good reasons for doing so, the physician may be called in at a later stage.
p.000009: 2 A research project with no expected direct benefit may be carried out in emergency situations if, in addition to the
p.000009: requirements specified in paragraph 1:
p.000009: a. it entails no more than minimal risks and burdens; and
p.000009: b. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the
p.000009: same disease or disorder, or in the same situation.
p.000009:
p.000009: Art. 31 Post hoc or proxy consent
p.000009: 1 The person concerned must be duly informed about the research project as soon as this becomes possible. He or she may
p.000009: subsequently give or withhold consent.
p.000009: 2 If the person concerned refuses to give post hoc consent, the biological material and data may no longer be used for
p.000009: the research project.
p.000009: 3 The Federal Council shall specify the procedure for the procurement of post hoc or proxy consent, in particular with
p.000009: regard to the involvement of children, adolescents and adults lacking capacity.
p.000009:
p.000009:
p.000009: Chapter 4
p.000009: Further Use of Biological Material and Health-Related Personal Data for Research
p.000009:
p.000009: Art. 32 Further use of biological material and genetic data
p.000009: 1 Further use may be made of biological material and genetic data in uncoded form for a research project if informed
p.000009: consent has been given by the person concerned, or by the legal representative or next of kin. For consent,
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000014: procedural requirements.
p.000014: 3 Cantonal procedural law otherwise applies.
p.000014:
p.000014: Art. 50 Right of appeal
p.000014: 1 The procedure for appeals against ethics committee decisions is governed by cantonal procedural law and
p.000014: the general provisions concerning the administration of federal justice.
p.000014: 2 The appealing party may not file an appeal based on substantive inappropriateness.
p.000014:
p.000014:
p.000014: Chapter 9 Research Ethics Committees
p.000014:
p.000014: Art. 51 Duties
p.000014: 1 Within the framework of their responsibilities under Chapter 8, ethics committees shall assess whether research
p.000014: projects and the conduct thereof comply with the ethical, legal and scientific requirements of this Act. In
p.000014: particular, they shall assess whether the protection of the persons concerned is guaranteed.
p.000014: 2 They may advise researchers in particular on ethical questions and, if so requested by the researchers, comment on
p.000014: research projects not subject to this Act, and specifi- cally projects carried out abroad.
p.000014:
p.000014: Art. 52 Independence
p.000014: 1 Ethics committees shall exercise their duties in a professionally independent man- ner, without being subject to
p.000014: instructions from the supervisory authority in this regard.
p.000014: 2 The members of ethics committees shall disclose their interests. Each ethics com- mittee shall maintain a publicly
p.000014: accessible register of interests.
p.000014: 3 Members who are interested parties shall not participate in the assessment and decision procedures.
p.000014:
p.000014: Art. 53 Composition
p.000014: 1 Ethics committees must be composed in such a way that they have the professional skills and experience required to
p.000014: discharge their duties. The members must include experts in various disciplines, in particular medicine, ethics and
p.000014: law. Cantons may specify the inclusion of patient representatives.
p.000014:
p.000015: 15
p.000015:
p.000015: 810.30 Medicine and Human Dignity
p.000015:
p.000015: 2 Ethics committees may call in external specialists to serve as experts.
p.000015: 3 The Federal Council shall enact additional regulations concerning the composition of ethics committees and the
p.000015: requirements to be fulfilled by their members. In doing so, it shall have regard to recognised international
p.000015: regulations.
p.000015:
p.000015: Art. 54 Organisation and financing
p.000015: 1 Each canton shall designate the ethics committee responsible for its territory and appoint the members thereof. It
p.000015: shall oversee the activities of the ethics committee.
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000002:
p.000002: Art. 10 Scientific requirements
p.000002: 1 Research involving human beings may only be carried out if:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 810.30 Medicine and Human Dignity
p.000003:
p.000003: a. the recognised regulations concerning scientific integrity are complied with, in particular with regard to the
p.000003: handling of conflicts of interest;
p.000003: b. scientific quality requirements are met;
p.000003: c. the recognised international Good Practice guidelines for research involving human beings are complied with; and
p.000003: d. the persons responsible have appropriate professional qualifications.
p.000003: 2 The Federal Council shall specify which national and international regulations must be complied with.
p.000003:
p.000003:
p.000003: Chapter 2 General Requirements for Research involving Persons Section 1 Protection of Participants
p.000003:
p.000003: Art. 11 Subsidiarity
p.000003: 1 A research project involving persons may only be carried out if equivalent findings cannot be obtained by other
p.000003: means.
p.000003: 2 A research project involving particularly vulnerable persons may only be carried out if equivalent findings cannot be
p.000003: obtained by other means.
p.000003:
p.000003: Art. 12 Risks and burdens
p.000003: 1 In every research project, the risks and burdens for the participants must be mini- mised as far as possible.
p.000003: 2 The likely risks and burdens for the participants must not be disproportionate to the expected benefits of the
p.000003: research project.
p.000003:
p.000003: Art. 13 Placebo
p.000003: In research projects with an expected direct benefit, the use of a placebo or non-treatment is only
p.000003: permissible if no additional risk of serious or irreversible harm is to be expected for the persons concerned and:
p.000003: a. no standard treatment is available; or
p.000003: b. the use of a placebo is required for compelling, scientifically sound method- ological reasons, in order to
p.000003: establish the efficacy or safety of a treatment method.
p.000003:
p.000003: Art. 14 Non-remunerative participation
p.000003: 1 No person may receive payment or any other non-cash advantage for participation in a research project with an
p.000003: expected direct benefit. Participation in a research project with no expected direct benefit may be appropriately
p.000003: remunerated.
p.000003: 2 No person may demand or accept payment or any other non-cash advantage from another in return for the latter’s
p.000003: participation in a research project.
p.000003:
p.000004: 4
p.000004:
p.000004: Human Research Act
p.000004: 810.30
p.000004:
p.000004: Art. 15 Safety and protective measures
p.000004: 1 Anyone who conducts a research project must, before it begins, take all the measures required to protect
p.000004: the participants.
p.000004: 2 If, during the research project, circumstances arise which could jeopardise the safety or health of the
p.000004: participants or lead to a disproportionate relationship between the risks and burdens and the benefits, all the
p.000004: measures required to ensure protection are to be taken without delay.
p.000004:
p.000004:
p.000004: Section 2 Information and Consent
p.000004:
p.000004: Art. 16 Informed consent
p.000004: 1 Persons may only be involved in a research project if they have given their in- formed consent. Consent
...
Orphaned Trigger Words
p.000001: health-related intervention in order to investigate its effects on health or on the structure and function of the human
p.000001: body.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 3 SR 810.31
p.000001:
p.000002: 2
p.000002:
p.000002: Human Research Act
p.000002: 810.30
p.000002:
p.000002: Section 2 Principles
p.000002:
p.000002: Art. 4 Primacy of individual interests
p.000002: The interests, health and welfare of the individual human being shall prevail over the interests of science and
p.000002: society.
p.000002:
p.000002: Art. 5 Scientifically relevant topic
p.000002: Research involving human beings may only be carried out if it addresses a topic of scientific relevance concerning:
p.000002: a. the understanding of human diseases;
p.000002: b. the structure and function of the human body; or
p.000002: c. public health.
p.000002:
p.000002: Art. 6 Non-discrimination
p.000002: 1 Nobody is to be subjected to discrimination in connection with research.
p.000002: 2 With regard to the selection of participants in particular, no group of persons shall be disproportionately included
p.000002: in or excluded from research without good reason.
p.000002:
p.000002: Art. 7 Consent
p.000002: 1 Research involving human beings may only be carried out if, in accordance with the provisions of this Act, the
p.000002: persons concerned have given their informed consent or, after being duly informed, have not exercised their right to
p.000002: dissent.
p.000002: 2 The persons concerned may withhold or revoke their consent at any time, without stating their reasons.
p.000002:
p.000002: Art. 8 Right to receive information
p.000002: 1 The persons concerned are entitled to be informed of results relating to their health. The information is to be
p.000002: communicated in an appropriate manner. The persons concerned may choose to forgo such information.
p.000002: 2 They are entitled to be informed about all the personal data held in relation to them.
p.000002:
p.000002: Art. 9 Prohibition of commercialisation
p.000002: The human body or parts thereof may not be disposed of or acquired as such for research purposes in
p.000002: return for payment or other non-cash advantage.
p.000002:
p.000002: Art. 10 Scientific requirements
p.000002: 1 Research involving human beings may only be carried out if:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 810.30 Medicine and Human Dignity
p.000003:
p.000003: a. the recognised regulations concerning scientific integrity are complied with, in particular with regard to the
p.000003: handling of conflicts of interest;
p.000003: b. scientific quality requirements are met;
p.000003: c. the recognised international Good Practice guidelines for research involving human beings are complied with; and
p.000003: d. the persons responsible have appropriate professional qualifications.
p.000003: 2 The Federal Council shall specify which national and international regulations must be complied with.
p.000003:
p.000003:
p.000003: Chapter 2 General Requirements for Research involving Persons Section 1 Protection of Participants
p.000003:
p.000003: Art. 11 Subsidiarity
...
p.000003: remunerated.
p.000003: 2 No person may demand or accept payment or any other non-cash advantage from another in return for the latter’s
p.000003: participation in a research project.
p.000003:
p.000004: 4
p.000004:
p.000004: Human Research Act
p.000004: 810.30
p.000004:
p.000004: Art. 15 Safety and protective measures
p.000004: 1 Anyone who conducts a research project must, before it begins, take all the measures required to protect
p.000004: the participants.
p.000004: 2 If, during the research project, circumstances arise which could jeopardise the safety or health of the
p.000004: participants or lead to a disproportionate relationship between the risks and burdens and the benefits, all the
p.000004: measures required to ensure protection are to be taken without delay.
p.000004:
p.000004:
p.000004: Section 2 Information and Consent
p.000004:
p.000004: Art. 16 Informed consent
p.000004: 1 Persons may only be involved in a research project if they have given their in- formed consent. Consent
p.000004: must be given in writing; the Federal Council may specify exemptions.
p.000004: 2 The persons concerned must receive comprehensible oral and written information on:
p.000004: a. the nature, purpose and duration of, and procedure for, the research project;
p.000004: b. the foreseeable risks and burdens;
p.000004: c. the expected benefits of the research project, in particular for themselves or for other people;
p.000004: d. the measures taken to protect the personal data collected;
p.000004: e. their rights.
p.000004: 3 Before a decision on consent is made by the persons concerned, they must be allowed an appropriate
p.000004: period for reflection.
p.000004: 4 The Federal Council may specify further elements of the information to be provid- ed.
p.000004:
p.000004: Art. 17 Consent to further use for research
p.000004: If the intention exists to make further use for research of biological material sampled or health-related personal data
p.000004: collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they
p.000004: must be informed of their right to dissent.
p.000004:
p.000004: Art. 18 Incomplete information
p.000004: 1 In exceptional cases, the persons concerned may be given incomplete information regarding individual aspects of a
p.000004: research project before it begins:
p.000004: a. insofar as this is essential for methodological reasons; and
p.000004: b. if the research project entails no more than minimal risks and burdens.
p.000004: 2 The participants must subsequently be duly informed as soon as possible.
p.000004:
p.000005: 5
p.000005:
p.000005: 810.30 Medicine and Human Dignity
p.000005:
p.000005: 3 Once they have been informed in accordance with paragraph 2, they may give or withhold their consent to the use of
p.000005: their biological material or their data. Only when such consent has been given is the biological material or
p.000005: data to be used for the research project.
p.000005:
p.000005:
p.000005: Section 3 Liability and Coverage
p.000005:
p.000005: Art. 19 Liability
...
p.000009:
p.000009:
p.000009: Chapter 4
p.000009: Further Use of Biological Material and Health-Related Personal Data for Research
p.000009:
p.000009: Art. 32 Further use of biological material and genetic data
p.000009: 1 Further use may be made of biological material and genetic data in uncoded form for a research project if informed
p.000009: consent has been given by the person concerned, or by the legal representative or next of kin. For consent,
p.000009: Articles 16 and 22–24 apply mutatis mutandis.
p.000009: 2 Further use may be made of biological material and genetic data in coded form for research purposes if informed
p.000009: consent has been given by the person concerned, or by the legal representative or next of kin. For consent,
p.000009: Articles 16 and 22–24 apply mutatis mutandis.
p.000009: 3 Biological material and genetic data may be anonymised for research purposes if the person concerned or the legal
p.000009: representative or next of kin have been informed in advance and have not dissented to anonymisation. For dissent,
p.000009: Articles 22–24 apply mutatis mutandis.
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Human Research Act
p.000010: 810.30
p.000010:
p.000010: Art. 33 Further use of non-genetic health-related personal data
p.000010: 1 Further use may be made of non-genetic health-related personal data in uncoded form for research purposes if
p.000010: informed consent has been given by the person con- cerned, or by the legal representative or next of kin. For consent,
p.000010: Articles 16 and 22– 24 apply mutatis mutandis.
p.000010: 2 Further use may be made of non-genetic health-related personal data in coded form for research purposes if the person
p.000010: concerned or the legal representative or next of kin have been informed in advance and have not dissented. For dissent,
p.000010: Articles 22– 24 apply mutatis mutandis.
p.000010:
p.000010: Art. 34 Absence of informed consent
p.000010: If the requirements for informed consent specified in Articles 32 and 33 are not met, further use may be made of
p.000010: biological material or health-related personal data for research purposes in exceptional cases if:
p.000010: a. it is impossible or disproportionately difficult to obtain consent or to provide information on the right to
p.000010: dissent, or this would impose an undue burden on the person concerned;
p.000010: b. no documented refusal is available; and
p.000010: c. the interests of research outweigh the interests of the person concerned in deciding on the further
p.000010: use of his or her biological material and data.
p.000010:
p.000010: Art. 35 Anonymisation and coding
p.000010: The Federal Council shall specify the requirements for correct and secure anony- misation and coding and
p.000010: also the conditions for breaking the code.
p.000010:
p.000010:
p.000010: Chapter 5 Research involving Deceased Persons
p.000010:
p.000010: Art. 36 Consent
p.000010: 1 Research may be carried out in deceased persons if, before their death, the persons concerned consented to the use of
p.000010: their body for research purposes.
p.000010: 2 If no documented consent or refusal of the deceased person is available, the body or parts thereof may be used for
p.000010: research purposes if consent is given by the next of kin or by a trusted person designated during the lifetime of the
p.000010: deceased person.
p.000010: 3 The consent of the next of kin or the trusted person is governed by Article 8 of the Transplantation Act of 8 October
p.000010: 20046.
p.000010: 4 In the case of deceased persons whose death occurred more than 70 years previous- ly, research may be carried
p.000010: out without consent being given as specified in para- graph 2. If such research is opposed by the next of kin,
p.000010: it may not be carried out.
p.000010:
p.000010:
p.000010: 6 SR 810.21
p.000010:
p.000011: 11
p.000011:
p.000011: 810.30 Medicine and Human Dignity
p.000011:
p.000011: Art. 37 Additional requirements
p.000011: 1 A research project may be carried out in deceased persons when their death has been determined.
p.000011: 2 A research project may be carried out in deceased persons undergoing artificial respiration if, in
p.000011: addition to the requirement specified in paragraph 1, equivalent findings cannot be obtained with deceased
p.000011: persons not undergoing artificial respira- tion. The Federal Council may specify further conditions.
p.000011: 3 Anyone who carries out a research project in accordance with paragraph 2 must not have been involved in the
p.000011: determination of death or be authorised to issue instruc- tions to the persons involved in this procedure.
p.000011:
p.000011: Art. 38 Research in connection with an autopsy or transplantation
p.000011: Small quantities of bodily substances removed in the course of an autopsy or trans- plantation may be anonymised for
p.000011: research purposes without consent, in the absence of a documented refusal of the deceased person.
p.000011:
p.000011:
p.000011: Chapter 6
...
p.000014: accessible register of interests.
p.000014: 3 Members who are interested parties shall not participate in the assessment and decision procedures.
p.000014:
p.000014: Art. 53 Composition
p.000014: 1 Ethics committees must be composed in such a way that they have the professional skills and experience required to
p.000014: discharge their duties. The members must include experts in various disciplines, in particular medicine, ethics and
p.000014: law. Cantons may specify the inclusion of patient representatives.
p.000014:
p.000015: 15
p.000015:
p.000015: 810.30 Medicine and Human Dignity
p.000015:
p.000015: 2 Ethics committees may call in external specialists to serve as experts.
p.000015: 3 The Federal Council shall enact additional regulations concerning the composition of ethics committees and the
p.000015: requirements to be fulfilled by their members. In doing so, it shall have regard to recognised international
p.000015: regulations.
p.000015:
p.000015: Art. 54 Organisation and financing
p.000015: 1 Each canton shall designate the ethics committee responsible for its territory and appoint the members thereof. It
p.000015: shall oversee the activities of the ethics committee.
p.000015: 2 Each canton has at most one ethics committee. Several cantons may appoint a joint ethics committee or agree that one
p.000015: canton's ethics committee is also to be responsi- ble for other cantons.
p.000015: 3 The Federal Council may issue guidelines concerning the minimum number of research projects to be assessed
p.000015: by an ethics committee per year. It shall first consult the cantons.
p.000015: 4 Each ethics committee shall have a scientific secretariat. Details of the organisation and working methods are to be
p.000015: publicly accessible in by-laws.
p.000015: 5 The canton shall assure the financing of the ethics committee. It may make provi- sion for the charging of fees.
p.000015:
p.000015: Art. 55 Coordination and information
p.000015: 1 The Federal Office of Public Health (FOPH) is responsible for coordination be- tween ethics committees and
p.000015: with other supervisory authorities. It may delegate this responsibility to third parties.
p.000015: 2 Ethics committees shall report annually to the FOPH on their activities, in particu- lar on the type and number
p.000015: of research projects assessed and on the processing periods.
p.000015: 3 The FOPH shall publish a list of ethics committees and inform the public regularly about their activities.
p.000015: 4 In consultation with the ethics committees and other supervisory authorities con- cerned, it may issue
p.000015: recommendations for appropriate harmonisation of procedures and of assessment practice.
p.000015:
p.000015:
p.000015: Chapter 10 Transparency and Data Protection
p.000015:
p.000015: Art. 56 Registration
p.000015: 1 Authorised clinical trials must be recorded in a public registry. The Federal Coun- cil may specify exemptions
...
p.000019: Medicine and Human Dignity
p.000019:
p.000019: Art. 65 Implementing provisions
p.000019: 1 The Federal Council shall enact the implementing provisions.
p.000019: 2 In doing so, it shall consider the different extents to which individual research areas and methods
p.000019: involve risks to dignity and privacy, in particular when specify- ing:
p.000019: a. the scientific requirements (Art. 10);
p.000019: b. any exemptions from liability (Art. 19) and liability coverage requirements (Art. 20);
p.000019: c. the requirements for insurance and other forms of coverage (Art. 20);
p.000019: d. the procedural requirements (Art. 49).
p.000019:
p.000019: Art. 66 Amendment of current legislation
p.000019: Current legislation shall be amended as specified in the Annex.
p.000019:
p.000019: Art. 67 Transitional provisions
p.000019: 1 Authorisations granted by cantonal ethics committees for the conduct of research projects remain valid for the term
p.000019: of the authorisation.
p.000019: 2 If no authorisation, as defined in paragraph 1, has been granted for a research project which is already
p.000019: under way when this Act comes into effect, an application for authorisation in accordance with Article 45 paragraph 1
p.000019: letter a shall be submit- ted to the responsible ethics committee within six months after the commencement of this Act.
p.000019: 3 Authorisations for the waiver of professional confidentiality in medical research remain valid for the term
p.000019: of the authorisation. If the authorisation has been granted for an unlimited term, an application for authorisation in
p.000019: accordance with Article 45 paragraph 1 shall be submitted to the responsible ethics committee within a year of the
p.000019: commencement of this Act.
p.000019: 4 The Federal Council shall regulate the registration under Article 56 of research projects which are in
p.000019: progress when this Act comes into force.
p.000019:
p.000019: Art. 68 Referendum and commencement
p.000019: 1 This Act is subject to an optional referendum.
p.000019: 2 The Federal Council shall determine the commencement date.
p.000019:
p.000019: Commencement Date: 1 January 201410
p.000019:
p.000019:
p.000019: 10 Federal Council Decree of 20 Sept. 2013
p.000019:
p.000020: 20
p.000020:
p.000020: Human Research Act
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: Amendment of current legislation
p.000020:
p.000020: …11
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: 11 The amendments may be consulted under AS 2013 3215.
p.000020: 810.30
p.000020:
p.000020:
p.000020: Annex
p.000020: (Art. 66)
p.000020:
p.000021: 21
p.000021:
p.000021: 810.30 Medicine and Human Dignity
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
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p.000021:
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...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| criminal | criminal |
| embryo | embryo |
| emergency | Public Emergency |
| felony | Criminal Convictions |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| home | Property Ownership |
| injured | injured |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| felony | ['prisoners'] |
| foetus | ['foetuses'] |
| foetuses | ['foetus'] |
| prisoners | ['felony'] |
Trigger Words
capacity
consent
ethics
harm
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input