79C3C34C52B45572883A05D425EB0F82
Ordinance of 20 September2013 on Clinical Trials inHuman Research with theException of Clinical Trials(Human Research Ordinance,HRO), RS 810.301
https://www.admin.ch/opc/en/classified-compilation/20121177/index.html
http://leaux.net/URLS/ConvertAPI Text Files/7544D6ABC9FC5C1B79F9DE44CAAD7F00.en.txt
Examining the file media/Synopses/7544D6ABC9FC5C1B79F9DE44CAAD7F00.html:
This file was generated: 2020-12-01 07:12:46
| 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 / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000001: 3 The liability coverage must cover damage occurring up to 10 years after the completion of the research project.
p.000001: 4 In addition, Article 11, Article 13 paragraph 1 and Article 14 ClinO1 apply mutatis mutandis.
p.000001:
p.000001: 1 SR 810.305
p.000001:
p.000001:
p.000001: Section 2 Authorisation Procedure
p.000001: Art. 14 Application
p.000001: 1 The project leader shall submit the application documents specified in Annex 2 to the responsible ethics committee for review.
p.000001: 2 The ethics committee may request additional information.
p.000001: 3The sponsor may submit the application instead of the project leader. In this case, the sponsor assumes the obligations of the project leader as specified in
p.000001: Articles 17–23. The application documents must be co-signed by the project leader.
p.000001:
p.000001: Art. 15 Review areas
p.000001: The responsible ethics committee shall review:
p.000001:
p.000001: a. the completeness of the application;
p.000001: b. the categorisation requested;
p.000001: c. the research project with regard to:
p.000001: 1. scientific quality, in the case of a research project as specified in Article 6 letter a,
p.000001: 2. the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA),
p.000001: 3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (Art. 15 HRA), including
p.000001: precautionary measures in the handling of personal data,
p.000001: 4. the need to involve persons, and in particular persons who are particularly vulnerable (Art. 11 HRA),
p.000001: 5. the criteria for the selection of participants,
p.000001: 6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,
p.000001: 7. the appropriateness of the remuneration for participants and compliance with the prohibition of commercialisation (Art. 9 HRA),
p.000001: 8. compliance with scientific integrity requirements;
p.000001: d. the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible
p.000001: involvement of particularly vulnerable persons;
p.000001: e. for Category B research projects: the guaranteeing of the right to compensation in the event of damage (Art. 20 HRA);
p.000001: f. for investigations involving radiation sources1: additionally, compliance with radiological protection legislation and the dose estimation, in cases
p.000001: where an opinion does not have to be sought from the Federal Office of Public Health (FOPH) in accordance with Article 19 paragraph 2;
p.000001: g. the professional qualifications of the project leader and the other researchers;
p.000001: h. compliance with the requirements concerning the storage of biological material or health-related personal data specified in Article 5;
p.000001: i. the suitability of the infrastructure at the research site;
p.000001: j. the financing of the research project and the agreements between the sponsor, third parties and the project leader concerning the allocation of tasks,
p.000001: remuneration and publication;
p.000001: k. other areas, where this is necessary to assess the protection of participants.
p.000001: 1
p.000001: Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This modification has been made throughout the
p.000001: text.
p.000001:
p.000001: Art. 16 Procedure and deadlines
p.000001: 1The ethics committee shall acknowledge receipt of the application within 7 days and notify the project leader of any formal deficiencies in the application
p.000001: documents.
...
Searching for indicator vulnerability:
(return to top)
p.000001: b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data;
p.000001: c. document all processing operations which are essential to ensure traceability.
p.000001: 2 Any person who stores biological material for research must, in particular:
p.000001:
p.000001: a. comply with the principles set out in paragraph 1 mutatis mutandis;
p.000001: b. ensure that the technical requirements are met for appropriate storage of the biological material;
p.000001: c. make available the resources required for storage.
p.000001:
p.000001:
p.000001: Chapter 2 Research Involving Measures for Sampling of Biological Material or
p.000001: Collection of Health-Related Personal Data from Persons
p.000001: Section 1 General Provisions
p.000001: Art. 6 Research project
p.000001: For the purposes of this Chapter, a research project is any project in which biological material is sampled or health-related personal data is collected from a person
p.000001: in order to:
p.000001:
p.000001: a. answer a scientific question; or
p.000001: b. make further use for research purposes of the biological material or the health-related personal data.
p.000001:
p.000001: Art. 7 Categorisation
p.000001: 1A research project comes under Category A if the planned measures for sampling biological material or collecting personal data entail only minimal risks and
p.000001: burdens.
p.000001: 2 A research project comes under Category B if the planned measures entail more than only minimal risks and burdens.
p.000001: 3 Sampling biological material or collecting health-related personal data entails minimal risks and burdens if the measures, in terms of intensity and quality, and
p.000001: taking into account the vulnerability of the participants and the specific circumstances, have only a slight and temporary impact on the participants’ health. In
p.000001: particular, minimal risks and burdens may be associated with:
p.000001:
p.000001: a. surveys and observations;
p.000001: b. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent;
p.000001: c. removing or collecting bodily substances without invasive interventions (in particular, saliva, urine and stool samples);
p.000001: d. taking swabs;
p.000001: e. magnetic resonance imaging scans without a contrast medium, ultrasound examinations or electrograms;
p.000001: f. examinations using medical devices bearing conformity markings without a contrast medium, or using authorised medicinal products capable of
p.000001: emitting ionising radiation, provided that the effective dose1 is below 5 mSv per research project and per participant.
p.000001: 1 The correction (replacement of expressions) of 24 April 2018 relates to the French and Italian texts only ( AS 2018 1653).
p.000001:
p.000001: Art. 8 Information
p.000001: 1 In addition to the points specified in Article 16 paragraph 2 HRA, the persons concerned must receive information on:
p.000001:
p.000001: a. the effort involved and the obligations arising from participation;
p.000001: b. their right to withhold or to revoke their consent without giving reasons;
p.000001: c. the consequences of revoking consent to further use of the biological material and personal data collected up to this point;
p.000001: d. their right to receive information at any time in response to further questions;
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000001: g. the main sources of financing for the research project;
p.000001: h. other points relevant to their decision on participation.
p.000001: 2If the intention exists to make further use for research of the biological material sampled or the health-related personal data collected, the persons concerned
p.000001: must also receive information on the points specified in Articles 28-32.
p.000001: 3 The information may be provided in stages. It may be additionally presented in a non-textual form.
p.000001: 4 Appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.
p.000001:
p.000001: Art. 9 Exceptions to written form
p.000001: 1 Information and consent may be provided and documented in a non—written form if:
p.000001:
p.000001: a. the research project in question comes under Category A, as defined in this Ordinance, and involves adults with capacity;
p.000001: b. provision of written information and consent would be disproportionate, given the project design; and
p.000001: c. reference is made to the departure from written form in the application to the responsible research ethics committee (ethics committee).
p.000001: 2 In individual cases, information may be provided and consent granted in a non—written form if:
p.000001:
p.000001: a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; and
p.000001: b. the project leader furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a
p.000001: recording of verbal consent.
p.000001: 3 In individual cases, the requirement to provide information in written form may be waived if:
p.000001:
p.000001: a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; and
p.000001: b. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.
p.000001:
p.000001: Art. 10 Consequences of revocation of consent
p.000001: 1If consent is revoked, the biological material and health—related personal data of the person concerned must be anonymised after data evaluation has been
p.000001: completed.
p.000001: 2 Anonymisation of the biological material and personal data may be dispensed with if:
p.000001:
p.000001: a. the person concerned expressly renounces this right when revoking consent; or
p.000001: b. it is established at the beginning of the research project that anonymisation is not possible and the person concerned, having been adequately
p.000001: informed of this fact, consented to participate.
p.000001: 3 Persons revoking consent must be offered any follow-up care required to protect their health.
p.000001:
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000001: 4 The ethics committee shall grant authorisation if:
p.000001:
p.000001: a. the requirements covered by Article 15 are met; and
p.000001: b. the FOPH has raised no objections to the research project.
p.000001: 5 It shall reach a decision in this case within 45 days after acknowledgement of receipt of the formally correct application documents. It shall inform the FOPH of
p.000001: its decision.
p.000001:
p.000001: 1 Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This modification has been made throughout the
p.000001: text.
p.000001:
p.000001:
p.000001: Section 3 Notifications and Reporting
p.000001: Art. 20 Notification of safety and protective measures
p.000001: If immediate safety and protective measures have to be taken during the conduct of a research project, the project leader shall notify the ethics committee of
p.000001: these measures, and of the circumstances necessitating them, within 7 days.
p.000001:
p.000001: Art. 21 Serious events
p.000001: 1 If, in the course of a research project, serious events occur in participants, the research project must be interrupted.
p.000001: 2A serious event is defined as any adverse event where it cannot be excluded that the event is attributable to the sampling of biological material or the collection
p.000001: of health-related personal data, and which:
p.000001:
p.000001: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;
p.000001: b. results in permanent or significant incapacity or disability; or
p.000001: c. is life-threatening or results in death.
p.000001: 3 If necessary in order to guarantee participants’ safety and health, further events are to be designated as serious in the protocol or at the request of the
p.000001: responsible ethics committee.
p.000001: 4The project leader shall notify the ethics committee of a serious event within 7 days. In addition, the project leader shall report to the committee on the
p.000001: connection between the event and the collection of health-related personal data or the sampling of biological material. At the same time, he or she shall submit
p.000001: proposals concerning the next steps to be taken.
p.000001: 5If a serious event occurs in connection with an investigation involving a radiation source on which the FOPH has delivered an opinion in accordance with Article
p.000001: 19, this must be additionally reported to the FOPH within 7 days.
p.000001:
p.000001: 6 The ethics committee shall reach a decision on the continuation of the research project within 30 days after receipt of the report.
p.000001:
p.000001: Art. 22 Notification upon completion or discontinuation of a research project
p.000001: The project leader shall notify the ethics committee of the discontinuation or completion of a research project within 90 days.
p.000001:
p.000001: Art. 23 1Assessment, notification and reporting on the use of radiation sources
p.000001: 1In the case of investigations using radiation sources, the project leader shall assess compliance with the dose guidance value under Article 45 of the Radiological
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000002: e. compliance with the requirements for the storage of biological material or health-related personal data;
p.000002: f. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: g. the professional qualifications of the project leader and the other researchers.
p.000002:
p.000002: Art. 42 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17.
p.000002:
p.000002: Art. 43 Notifications
p.000002: 1 The project leader must notify the ethics committee in advance of the following changes to the research project:
p.000002:
p.000002: a. change of project leader;
p.000002: b. for research projects involving deceased persons undergoing artificial respiration: significant changes to the protocol.
p.000002: 2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
p.000002:
p.000002:
p.000002: Chapter 5 Research involving Embryos and Foetuses from Induced Abortions and
p.000002: from Spontaneous Abortions including Stillbirths
p.000002: Art. 44 Informed consent
p.000002: 1For research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths, the pregnant woman or the
p.000002: couple concerned must receive written and oral information on:
p.000002:
p.000002: a. the use of the embryo or foetus for research purposes;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. measures to protect the biological material and the personal data;
p.000002: d. the handling of the embryo or foetus after completion of the research.
p.000002: 2 The information may be additionally presented in a non-textual form.
p.000002: 3 Consent must be given in writing. The consequences of revocation of consent are governed by Article 10.
p.000002: 4 The exceptions to written form are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 45 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for informed consent;
p.000002: d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1,
p.000002: 2 and 4 HRA;
p.000002: e. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: f. compliance with the requirements concerning the storage of biological material or health-related personal data;
p.000002: g. the professional qualifications of the project leader and the other researchers;
p.000002: h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
p.000002:
p.000002: Art. 46 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17;
p.000002: d. for notification requirements: Article 36.
p.000002:
p.000002:
p.000002: Chapter 6 Final Provisions
p.000002: Art. 47 Updating of Annexes
p.000002: The Federal Department of Home Affairs may update the Annexes in accordance with international or technical developments. It shall undertake updates which
p.000002: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000002:
p.000002: Art. 48 Transitional provisions
p.000002: 1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.
p.000002: 2On request, the authority which authorised the research project before 1 January 2014 may assign the research project to Category A. In this case, the liability,
p.000002: coverage and notification requirements are governed by the new law.
p.000002: 3The ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in Article 6 of the HRA Organisation
p.000002: Ordinance of 20 September 20131.
p.000002: 4 The provisions of this Ordinance are applicable:
p.000002:
p.000002: a. to the assessment of significant changes to research projects as specified in Chapter 2;
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000001: requirements.
p.000001:
p.000001: 1
p.000001: Amended by Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261).
p.000002: 2
p.000002: SR 814.501
p.000002:
p.000002:
p.000002:
p.000002: Chapter 3 Further Use of Biological Material and Health-related Personal Data for
p.000002: Research
p.000002: Section 1 General Provisions
p.000002: Art. 24 Further use
p.000002: Further use of biological material and health-related personal data is defined as any handling, for research purposes, of biological material already sampled or
p.000002: data already collected, and in particular:
p.000002:
p.000002: a. procuring, bringing together or collecting biological material or health—related personal data;
p.000002: b. registration or cataloguing of biological material or health-related personal data;
p.000002: c. storage or inclusion in biobanks or databases;
p.000002: d. making accessible or available or transferring biological material or health—related personal data.
p.000002:
p.000002: Art. 25 Anonymisation
p.000002: 1For the anonymisation of biological material and health-related personal data, all items which, when combined, would enable the data subject to be identified
p.000002: without disproportionate effort, must be irreversibly masked or deleted.
p.000002: 2 In particular, the name, address, date of birth and unique identification numbers must be masked or deleted.
p.000002:
p.000002: Art. 26 Coding
p.000002: 1Biological material and health-related personal data are considered to be correctly coded in accordance with Article 32 paragraph 2 and Article 33 paragraph 2
p.000002: HRA if, from the perspective of a person who lacks access to the key, they are to be characterised as anonymised.
p.000002: 2The key must be stored separately from the material or data collection and in accordance with the principles of Article 5 paragraph 1, by a person to be
p.000002: designated in the application who is not involved in the research project.
p.000002:
p.000002: Art. 27 Conditions for breaking the code
p.000002: For coded biological material and coded health-related personal data, the code may only be broken if:
p.000002:
p.000002: a. breaking the code is necessary to avert an immediate risk to the health of the person concerned;
p.000002: b. a legal basis exists for breaking the code; or
p.000002: c. breaking the code is necessary to guarantee the rights of the person concerned, and in particular the right to revoke consent.
p.000002:
p.000002:
p.000002: Section 2 Informed Consent and Information
p.000002: Art. 28 Informed consent for further use of biological material and genetic personal data in uncoded form for a research project
p.000002: 1 The persons concerned must receive written and oral information on:
p.000002:
p.000002: a. the nature, purpose and duration of, and procedure for, the research project;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. the consequences of revocation of consent for the biological material and personal data used up to this point;
p.000002: d. their right to receive information at any time in response to further questions relating to the research project;
...
p.000002: data.
p.000002:
p.000002: Art. 35 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: Article 17.
p.000002:
p.000002: Art. 36 Notification requirements
p.000002: 1 The project leader shall notify the ethics committee of a change of project leader in advance.
p.000002: 2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
p.000002:
p.000002:
p.000002: Section 4 Authorisation Procedure and Notification Requirements for further Use of Biological Material and Health-Related
p.000002: Personal Data for Research in the Absence of Informed Consent in accordance with Article 34 HRA
p.000002: Art. 37 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the reasons, as specified in Article 34 letters a and b HRA;
p.000002: c. the interests of the proposed research which outweigh the interests of the person concerned in deciding on the further use of his or her biological
p.000002: material and health-related personal data;
p.000002: d. the group of persons entitled to pass on the biological material and the personal data;
p.000002: e. compliance with the requirements concerning the storage of biological material or health-related personal data and the group of persons with access
p.000002: rights;
p.000002: f. the professional qualifications of the persons entitled to receive the biological material and the personal data;
p.000002: g. other areas, where this is necessary to assess the protection of the persons concerned.
p.000002:
p.000002: Art. 38 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for further use or collection according to a standard protocol, but in different cantons: the procedure specified in Article 17.
p.000002:
p.000002: Art. 39 Authorisation
p.000002: The authorisation shall include at least the following information:
p.000002: a. the purpose for which further use may be made of the biological material and the health-related personal data;
p.000002: b. the designation of the biological material and health-related personal data covered by the authorisation;
p.000002: c. the group of persons entitled to pass on the biological material and the health-related personal data;
p.000002: d. the group of persons entitled to receive the biological material and the personal data.
p.000002:
p.000002: Art. 40 Notifications
p.000002: 1 The project leader must notify the ethics committee in advance of any changes to the information given in the authorisation.
p.000002: 2 The project leader must notify the ethics committee of the completion or discontinuation of the collection process within 90 days.
p.000002:
p.000002:
p.000002: Chapter 4 Research Involving Deceased Persons
p.000002: Art. 41 Review areas
...
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 4.7 information on the infrastructure available at the research site;
p.000002: 4.8 any authorisations granted by ethics committees in Switzerland for the sampling of biological material or the collection of health-related personal
p.000002: data.
p.000002:
p.000002:
p.000002: 5 Application documents for further use of biological material or health-related personal data in the absence of informed
p.000002: consent in accordance with Article 34 HRA
p.000002: 5.1 Basic form, including a summary of the project in the national language of the research site;
p.000002: 5.2 planned procedure;
p.000002: 5.3 description of the proposed research purposes for which further use is to made of the biological material or health-related personal data, including an
p.000002: explanation of how the research interests outweigh the interests of the persons concerned;
p.000002: 5.4 designation of the biological material or health-related personal data of which further use is to be made;
p.000002: 5.5 designation of the group of persons who are to be entitled to pass on the biological material or the health-related personal data;
p.000002: 5.6 designation of the persons who are to be entitled to receive the biological material or the health-related personal data;
p.000002: 5.7 designation of the persons responsible for protection of the data disclosed;
p.000002: 5.8 designation of the group of persons who are to have access rights for the biological material or the health-related personal data;
p.000002: 5.9 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 5.10 information on the duration of storage;
p.000002: 5.11 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 5.12 information on the infrastructure available at the research site.
p.000002:
p.000002:
p.000002: 6 Application documents for research projects involving deceased persons
p.000002: 6.1 Basic form, including a summary of the protocol in the national language of the research site;
p.000002: 6.2 protocol;
p.000002: 6.3 proof of compliance with the requirements for consent specified in Article 36 HRA;
p.000002: 6.4 proof of compliance with the requirement for prior determination of death specified in Article 37 paragraph 1 HRA;
p.000002: 6.5 for research projects involving deceased persons undergoing artificial respiration: statement of the reasons why such persons need to be involved in
p.000002: the research project, and proof of the independence of the persons determining death;
p.000002: 6.6 documents concerning any remuneration;
p.000002: 6.7 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 6.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000002:
p.000002: Art. 42 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17.
p.000002:
p.000002: Art. 43 Notifications
p.000002: 1 The project leader must notify the ethics committee in advance of the following changes to the research project:
p.000002:
p.000002: a. change of project leader;
p.000002: b. for research projects involving deceased persons undergoing artificial respiration: significant changes to the protocol.
p.000002: 2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
p.000002:
p.000002:
p.000002: Chapter 5 Research involving Embryos and Foetuses from Induced Abortions and
p.000002: from Spontaneous Abortions including Stillbirths
p.000002: Art. 44 Informed consent
p.000002: 1For research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths, the pregnant woman or the
p.000002: couple concerned must receive written and oral information on:
p.000002:
p.000002: a. the use of the embryo or foetus for research purposes;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. measures to protect the biological material and the personal data;
p.000002: d. the handling of the embryo or foetus after completion of the research.
p.000002: 2 The information may be additionally presented in a non-textual form.
p.000002: 3 Consent must be given in writing. The consequences of revocation of consent are governed by Article 10.
p.000002: 4 The exceptions to written form are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 45 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for informed consent;
p.000002: d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1,
p.000002: 2 and 4 HRA;
p.000002: e. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: f. compliance with the requirements concerning the storage of biological material or health-related personal data;
p.000002: g. the professional qualifications of the project leader and the other researchers;
p.000002: h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
p.000002:
p.000002: Art. 46 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
...
Searching for indicator foetuses:
(return to top)
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for consent (Art. 36 HRA);
p.000002: d. for research projects involving deceased persons undergoing artificial respiration: the need to involve them in the research project (Art. 37 para. 2
p.000002: HRA) and compliance with the requirement for independence of the persons involved in the determination of their death (Art. 37 para. 3 HRA);
p.000002: e. compliance with the requirements for the storage of biological material or health-related personal data;
p.000002: f. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: g. the professional qualifications of the project leader and the other researchers.
p.000002:
p.000002: Art. 42 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17.
p.000002:
p.000002: Art. 43 Notifications
p.000002: 1 The project leader must notify the ethics committee in advance of the following changes to the research project:
p.000002:
p.000002: a. change of project leader;
p.000002: b. for research projects involving deceased persons undergoing artificial respiration: significant changes to the protocol.
p.000002: 2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
p.000002:
p.000002:
p.000002: Chapter 5 Research involving Embryos and Foetuses from Induced Abortions and
p.000002: from Spontaneous Abortions including Stillbirths
p.000002: Art. 44 Informed consent
p.000002: 1For research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths, the pregnant woman or the
p.000002: couple concerned must receive written and oral information on:
p.000002:
p.000002: a. the use of the embryo or foetus for research purposes;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. measures to protect the biological material and the personal data;
p.000002: d. the handling of the embryo or foetus after completion of the research.
p.000002: 2 The information may be additionally presented in a non-textual form.
p.000002: 3 Consent must be given in writing. The consequences of revocation of consent are governed by Article 10.
p.000002: 4 The exceptions to written form are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 45 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for informed consent;
p.000002: d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1,
p.000002: 2 and 4 HRA;
p.000002: e. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: f. compliance with the requirements concerning the storage of biological material or health-related personal data;
p.000002: g. the professional qualifications of the project leader and the other researchers;
p.000002: h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
p.000002:
p.000002: Art. 46 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17;
p.000002: d. for notification requirements: Article 36.
p.000002:
p.000002:
p.000002: Chapter 6 Final Provisions
p.000002: Art. 47 Updating of Annexes
p.000002: The Federal Department of Home Affairs may update the Annexes in accordance with international or technical developments. It shall undertake updates which
p.000002: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000002:
p.000002: Art. 48 Transitional provisions
p.000002: 1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.
...
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 5.12 information on the infrastructure available at the research site.
p.000002:
p.000002:
p.000002: 6 Application documents for research projects involving deceased persons
p.000002: 6.1 Basic form, including a summary of the protocol in the national language of the research site;
p.000002: 6.2 protocol;
p.000002: 6.3 proof of compliance with the requirements for consent specified in Article 36 HRA;
p.000002: 6.4 proof of compliance with the requirement for prior determination of death specified in Article 37 paragraph 1 HRA;
p.000002: 6.5 for research projects involving deceased persons undergoing artificial respiration: statement of the reasons why such persons need to be involved in
p.000002: the research project, and proof of the independence of the persons determining death;
p.000002: 6.6 documents concerning any remuneration;
p.000002: 6.7 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 6.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 6.9 information on the infrastructure available at the research site;
p.000002: 6.10 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the
p.000002: project leader and publication.
p.000002:
p.000002:
p.000002: 7 Application documents for research projects involving embryos and foetuses from induced abortions and from
p.000002: spontaneous abortions including stillbirths
p.000002: 7.1 Basic form, including a summary of the protocol in the national language of the research site;
p.000002: 7.2 protocol;
p.000002: 7.3 recruitment documents, including the wording of any advertisements, and the information sheet and informed consent form;
p.000002: 7.4 description of measures to ensure compliance with the requirements for consent specified in Article 39 paragraph 1 or Article 40 paragraph 1 HRA;
p.000002: 7.5 description of measures to ensure compliance with the requirement for prior determination of death specified in Article 39 paragraph 3 or Article 40
p.000002: paragraph 2 HRA;
p.000002: 7.6 for research projects involving embryos and foetuses from induced abortions: proof of compliance with the requirements specified in Article 39
p.000002: paragraphs 2 and 4 HRA;
p.000002: 7.7 documents concerning any remuneration;
p.000002: 7.8 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 7.9 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 7.10 information on the infrastructure available at the research site;
p.000002: 7.11 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the
p.000002: project leader and publication.
p.000002:
p.000002:
p.000002: 8 Application documents for the ethics committees concerned in multicentre research projects
p.000002: 8.1 Basic form, including a summary of the research project in the national language of the research site;
p.000002: 8.2 protocol;
p.000002: 8.3 for research projects involving persons or research projects involving embryos and foetuses from induced abortions and from spontaneous abortions
p.000002: including stillbirths: information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or
p.000002: advertisements, used at the research site in question;
p.000002: 8.4 for research projects involving deceased persons: proof of compliance with the requirements for consent specified in Article 36 HRA and proof of
p.000002: compliance with the requirement for prior determination of death specified in Article 37 paragraph 1 HRA at the research site in question;
p.000002: 8.5 the CV of the person responsible at the research site in question, including evidence of his or her knowledge and experience, and a list of the other
p.000002: persons involved in the research project at the site concerned, indicating their responsibilities and relevant professional knowledge;
p.000002: 8.6 proof of the suitability and availability of the infrastructure at the research site in question;
p.000002: 8.7 agreements between the sponsor and the person responsible at the research site in question, in particular with regard to his or her remuneration;
p.000002: 8.8 for Category B research projects involving persons: certificate of insurance or other proof of coverage for possible damage at the research site in
p.000002: question, including any agreements on this matter between the sponsor and the person responsible at the research site.
p.000002: 1 SR 814.50
p.000002: 2 This form can be obtained [in French/German] from the Federal Office of Public Health, Radiological Protection Division, CH-3003 Bern; it can also be accessed online at: www.bag.admin.ch
p.000002: > Themen > Strahlung, Radioaktivität und Schall.
p.000002:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000001: CC 810.301 Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO) DE FR IT RM EN
p.000001:
p.000001:
p.000001:
p.000001: The federal Council m S
p.000001:
p.000001:
p.000001: > Sub-navigation
p.000001:
p.000001:
p.000001:
p.000001: v Additional informations
p.000001:
p.000001: 810.301 expand all | article overview | collapse all | P
p.000001:
p.000001:
p.000001: English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
p.000001:
p.000001:
p.000001: Ordinance on Human Research with the Exception of Clinical Trials
p.000001: (Human Research Ordinance, HRO)
p.000001: of 20 September 2013 (Status as of 24 April 2018)
p.000001:
p.000001: The Swiss Federal Council,
p.000001:
p.000001: on the basis of the Human Research Act of 30 September 20111 (HRA),
p.000001:
p.000001: ordains:
p.000001:
p.000001:
p.000001: Chapter 1 General Provisions
p.000001: Art. 1 Purpose
p.000001: This Ordinance regulates:
p.000001:
p.000001: a. the requirements for the conduct of human research projects with the exception of clinical trials; and
p.000001: b. the authorisation and notification procedures for research projects as specified in letter a.
p.000001:
p.000001: Art. 2 Applicable provisions
p.000001: The provisions concerning scientific integrity and scientific quality set out in Articles 3 and 4 of the Ordinance of 20 September 20131 on Clinical Trials (ClinO)
p.000001: apply mutatis mutandis.
p.000001:
p.000001: 1
p.000001: SR 810.305
p.000001:
p.000001: Art. 3 Responsibilities of project leader and sponsor
p.000001: 1 The project leader is responsible for the conduct of the research project in Switzerland and for protection of the participants at the research site.
p.000001: 2The project leader is also responsible for organising the research project, and in particular for the initiation, management and financing of the project in
p.000001: Switzerland, provided that no other person or institution headquartered or represented in Switzerland takes responsibility for this (sponsor).
p.000001:
p.000001: Art. 4 Professional qualifications
p.000001: 1 The project leader responsible for a research project must:
p.000001:
...
p.000001: 4 Appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.
p.000001:
p.000001: Art. 9 Exceptions to written form
p.000001: 1 Information and consent may be provided and documented in a non—written form if:
p.000001:
p.000001: a. the research project in question comes under Category A, as defined in this Ordinance, and involves adults with capacity;
p.000001: b. provision of written information and consent would be disproportionate, given the project design; and
p.000001: c. reference is made to the departure from written form in the application to the responsible research ethics committee (ethics committee).
p.000001: 2 In individual cases, information may be provided and consent granted in a non—written form if:
p.000001:
p.000001: a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; and
p.000001: b. the project leader furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a
p.000001: recording of verbal consent.
p.000001: 3 In individual cases, the requirement to provide information in written form may be waived if:
p.000001:
p.000001: a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; and
p.000001: b. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.
p.000001:
p.000001: Art. 10 Consequences of revocation of consent
p.000001: 1If consent is revoked, the biological material and health—related personal data of the person concerned must be anonymised after data evaluation has been
p.000001: completed.
p.000001: 2 Anonymisation of the biological material and personal data may be dispensed with if:
p.000001:
p.000001: a. the person concerned expressly renounces this right when revoking consent; or
p.000001: b. it is established at the beginning of the research project that anonymisation is not possible and the person concerned, having been adequately
p.000001: informed of this fact, consented to participate.
p.000001: 3 Persons revoking consent must be offered any follow-up care required to protect their health.
p.000001:
p.000001: Art. 11 Research projects in emergency situations
p.000001: For research projects in emergency situations, Articles 15–17 ClinO1 apply mutatis mutandis.
p.000001:
p.000001: 1 SR 810.305
p.000001:
p.000001: Art. 12 Exemptions from liability
p.000001: Any person who proves that:
p.000001:
p.000001: a. the damage is only slight and temporary; and
p.000001: b. the extent of the damage is no greater than would be expected in the current state of scientific knowledge
p.000001: shall be exempt from liability under Article 19 paragraph 1 HRA.
...
p.000002: Ordinance of 20 September 20131.
p.000002: 4 The provisions of this Ordinance are applicable:
p.000002:
p.000002: a. to the assessment of significant changes to research projects as specified in Chapter 2;
p.000002: b. to notifications concerning research projects as specified in Chapters 3–5.
p.000002: 5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted
p.000002: in accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.
p.000002:
p.000002: 1 SR 810.308
p.000002:
p.000002: Art. 49 Commencement
p.000002: This Ordinance comes into force on 1 January 2014.
p.000002:
p.000002:
p.000002:
p.000002: Annex 1
p.000002: (Art. 13)
p.000002:
p.000002:
p.000002: Policy values for liability coverage
p.000002: For Category B research projects involving persons, the policy value shall be at least:
p.000002:
p.000002: a. per person: 250 000 Swiss francs;
p.000002: b. for damage to property: 20 000 Swiss francs;
p.000002: c. for the entire research project: 3 million Swiss francs.
p.000002:
p.000002:
p.000002: Annex 2
p.000002: (Art. 14, 17–19)
p.000002:
p.000002:
p.000002: Application documents to be submitted to the responsible ethics committee for the procedure
p.000002:
p.000002: 1 Application documents for research projects involving the sampling of biological material or the collection of health-related
p.000002: personal data from persons
p.000002: 1.1 Basic form, including a summary of the protocol in the national language of the research site and reasons for the requested categorisation;
p.000002: 1.2 protocol;
p.000002: 1.3 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000002: 1.4 other documents issued to participants;
p.000002: 1.5 information on the type and amount of remuneration for participants;
p.000002: 1.6 for Category B research projects: certificate of insurance or other proof of coverage for possible damage;
p.000002: 1.7 information on the secure handling of biological material and personal data, and in particular on the storage thereof;
p.000002: 1.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 1.9 information on the suitability and availability of infrastructure at the research site;
p.000002: 1.10 agreements between the project leader and the sponsor or third parties, in particular with regard to the financing of the research project,
p.000002: remuneration of the project leader and publication.
p.000002:
p.000002:
p.000002: 2 Additional application documents for research projects which include investigations involving radiation sources
p.000002: 2.1 Details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour
p.000002: doses;
p.000002: 2.2 the licences required under Article 28 of the Radiological Protection Act of 22 March 19911.
p.000002:
p.000002:
p.000002: 3 Additional application documents for research projects which include investigations involving radioactive sources and
p.000002: require an opinion from the FOPH in accordance with Article 19 paragraph 2
p.000002: 3.1 Information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and
p.000002: radionuclide purity;
p.000002: 3.2 for authorised radiopharmaceuticals: the prescribing information;
p.000002: 3.3 for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of
p.000002: the persons responsible for these processes and details of their professional qualifications;
p.000002: 3.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;
p.000002: 3.5 information specified in the FOPH form for research projects involving radiopharmaceuticals or radiolabelled compounds2.
p.000002:
p.000002:
p.000002: 4 Application documents for research projects involving further use of biological material or health-related personal data
p.000002: 4.1 Basic form, including a summary of the scientific question in the national language of the research site;
p.000002: 4.2 description of the scientific question;
p.000002: 4.3 proof of the origin of the biological material and health-related personal data, and of compliance with the requirements concerning informed consent
p.000002: and information on the right to dissent specified in Articles 32 and 33 HRA;
p.000002: 4.4 for further use of biological material and health-related personal data in coded form: proof of secure and correct coding;
p.000002: 4.5 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 4.6 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 4.7 information on the infrastructure available at the research site;
p.000002: 4.8 any authorisations granted by ethics committees in Switzerland for the sampling of biological material or the collection of health-related personal
p.000002: data.
p.000002:
p.000002:
p.000002: 5 Application documents for further use of biological material or health-related personal data in the absence of informed
p.000002: consent in accordance with Article 34 HRA
p.000002: 5.1 Basic form, including a summary of the project in the national language of the research site;
p.000002: 5.2 planned procedure;
p.000002: 5.3 description of the proposed research purposes for which further use is to made of the biological material or health-related personal data, including an
p.000002: explanation of how the research interests outweigh the interests of the persons concerned;
p.000002: 5.4 designation of the biological material or health-related personal data of which further use is to be made;
p.000002: 5.5 designation of the group of persons who are to be entitled to pass on the biological material or the health-related personal data;
p.000002: 5.6 designation of the persons who are to be entitled to receive the biological material or the health-related personal data;
p.000002: 5.7 designation of the persons responsible for protection of the data disclosed;
p.000002: 5.8 designation of the group of persons who are to have access rights for the biological material or the health-related personal data;
p.000002: 5.9 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 5.10 information on the duration of storage;
p.000002: 5.11 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 5.12 information on the infrastructure available at the research site.
p.000002:
p.000002:
p.000002: 6 Application documents for research projects involving deceased persons
p.000002: 6.1 Basic form, including a summary of the protocol in the national language of the research site;
p.000002: 6.2 protocol;
p.000002: 6.3 proof of compliance with the requirements for consent specified in Article 36 HRA;
p.000002: 6.4 proof of compliance with the requirement for prior determination of death specified in Article 37 paragraph 1 HRA;
p.000002: 6.5 for research projects involving deceased persons undergoing artificial respiration: statement of the reasons why such persons need to be involved in
p.000002: the research project, and proof of the independence of the persons determining death;
p.000002: 6.6 documents concerning any remuneration;
p.000002: 6.7 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 6.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 6.9 information on the infrastructure available at the research site;
p.000002: 6.10 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the
p.000002: project leader and publication.
p.000002:
p.000002:
p.000002: 7 Application documents for research projects involving embryos and foetuses from induced abortions and from
p.000002: spontaneous abortions including stillbirths
p.000002: 7.1 Basic form, including a summary of the protocol in the national language of the research site;
p.000002: 7.2 protocol;
p.000002: 7.3 recruitment documents, including the wording of any advertisements, and the information sheet and informed consent form;
p.000002: 7.4 description of measures to ensure compliance with the requirements for consent specified in Article 39 paragraph 1 or Article 40 paragraph 1 HRA;
p.000002: 7.5 description of measures to ensure compliance with the requirement for prior determination of death specified in Article 39 paragraph 3 or Article 40
p.000002: paragraph 2 HRA;
p.000002: 7.6 for research projects involving embryos and foetuses from induced abortions: proof of compliance with the requirements specified in Article 39
p.000002: paragraphs 2 and 4 HRA;
p.000002: 7.7 documents concerning any remuneration;
p.000002: 7.8 proof of secure handling of biological material and personal data, and in particular the storage thereof;
p.000002: 7.9 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 7.10 information on the infrastructure available at the research site;
p.000002: 7.11 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the
p.000002: project leader and publication.
p.000002:
p.000002:
p.000002: 8 Application documents for the ethics committees concerned in multicentre research projects
p.000002: 8.1 Basic form, including a summary of the research project in the national language of the research site;
p.000002: 8.2 protocol;
p.000002: 8.3 for research projects involving persons or research projects involving embryos and foetuses from induced abortions and from spontaneous abortions
p.000002: including stillbirths: information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or
p.000002: advertisements, used at the research site in question;
p.000002: 8.4 for research projects involving deceased persons: proof of compliance with the requirements for consent specified in Article 36 HRA and proof of
p.000002: compliance with the requirement for prior determination of death specified in Article 37 paragraph 1 HRA at the research site in question;
p.000002: 8.5 the CV of the person responsible at the research site in question, including evidence of his or her knowledge and experience, and a list of the other
p.000002: persons involved in the research project at the site concerned, indicating their responsibilities and relevant professional knowledge;
p.000002: 8.6 proof of the suitability and availability of the infrastructure at the research site in question;
p.000002: 8.7 agreements between the sponsor and the person responsible at the research site in question, in particular with regard to his or her remuneration;
p.000002: 8.8 for Category B research projects involving persons: certificate of insurance or other proof of coverage for possible damage at the research site in
p.000002: question, including any agreements on this matter between the sponsor and the person responsible at the research site.
p.000002: 1 SR 814.50
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000002: 4 The exceptions to written form are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 45 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for informed consent;
p.000002: d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1,
p.000002: 2 and 4 HRA;
p.000002: e. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: f. compliance with the requirements concerning the storage of biological material or health-related personal data;
p.000002: g. the professional qualifications of the project leader and the other researchers;
p.000002: h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
p.000002:
p.000002: Art. 46 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17;
p.000002: d. for notification requirements: Article 36.
p.000002:
p.000002:
p.000002: Chapter 6 Final Provisions
p.000002: Art. 47 Updating of Annexes
p.000002: The Federal Department of Home Affairs may update the Annexes in accordance with international or technical developments. It shall undertake updates which
p.000002: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000002:
p.000002: Art. 48 Transitional provisions
p.000002: 1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.
p.000002: 2On request, the authority which authorised the research project before 1 January 2014 may assign the research project to Category A. In this case, the liability,
p.000002: coverage and notification requirements are governed by the new law.
p.000002: 3The ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in Article 6 of the HRA Organisation
p.000002: Ordinance of 20 September 20131.
p.000002: 4 The provisions of this Ordinance are applicable:
p.000002:
p.000002: a. to the assessment of significant changes to research projects as specified in Chapter 2;
p.000002: b. to notifications concerning research projects as specified in Chapters 3–5.
p.000002: 5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted
p.000002: in accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.
p.000002:
p.000002: 1 SR 810.308
p.000002:
p.000002: Art. 49 Commencement
p.000002: This Ordinance comes into force on 1 January 2014.
p.000002:
p.000002:
...
Searching for indicator property:
(return to top)
p.000002: 1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.
p.000002: 2On request, the authority which authorised the research project before 1 January 2014 may assign the research project to Category A. In this case, the liability,
p.000002: coverage and notification requirements are governed by the new law.
p.000002: 3The ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in Article 6 of the HRA Organisation
p.000002: Ordinance of 20 September 20131.
p.000002: 4 The provisions of this Ordinance are applicable:
p.000002:
p.000002: a. to the assessment of significant changes to research projects as specified in Chapter 2;
p.000002: b. to notifications concerning research projects as specified in Chapters 3–5.
p.000002: 5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted
p.000002: in accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.
p.000002:
p.000002: 1 SR 810.308
p.000002:
p.000002: Art. 49 Commencement
p.000002: This Ordinance comes into force on 1 January 2014.
p.000002:
p.000002:
p.000002:
p.000002: Annex 1
p.000002: (Art. 13)
p.000002:
p.000002:
p.000002: Policy values for liability coverage
p.000002: For Category B research projects involving persons, the policy value shall be at least:
p.000002:
p.000002: a. per person: 250 000 Swiss francs;
p.000002: b. for damage to property: 20 000 Swiss francs;
p.000002: c. for the entire research project: 3 million Swiss francs.
p.000002:
p.000002:
p.000002: Annex 2
p.000002: (Art. 14, 17–19)
p.000002:
p.000002:
p.000002: Application documents to be submitted to the responsible ethics committee for the procedure
p.000002:
p.000002: 1 Application documents for research projects involving the sampling of biological material or the collection of health-related
p.000002: personal data from persons
p.000002: 1.1 Basic form, including a summary of the protocol in the national language of the research site and reasons for the requested categorisation;
p.000002: 1.2 protocol;
p.000002: 1.3 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000002: 1.4 other documents issued to participants;
p.000002: 1.5 information on the type and amount of remuneration for participants;
p.000002: 1.6 for Category B research projects: certificate of insurance or other proof of coverage for possible damage;
p.000002: 1.7 information on the secure handling of biological material and personal data, and in particular on the storage thereof;
p.000002: 1.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 1.9 information on the suitability and availability of infrastructure at the research site;
p.000002: 1.10 agreements between the project leader and the sponsor or third parties, in particular with regard to the financing of the research project,
...
Social / education
Searching for indicator education:
(return to top)
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for informed consent;
p.000002: d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1,
p.000002: 2 and 4 HRA;
p.000002: e. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: f. compliance with the requirements concerning the storage of biological material or health-related personal data;
p.000002: g. the professional qualifications of the project leader and the other researchers;
p.000002: h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
p.000002:
p.000002: Art. 46 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17;
p.000002: d. for notification requirements: Article 36.
p.000002:
p.000002:
p.000002: Chapter 6 Final Provisions
p.000002: Art. 47 Updating of Annexes
p.000002: The Federal Department of Home Affairs may update the Annexes in accordance with international or technical developments. It shall undertake updates which
p.000002: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000002:
p.000002: Art. 48 Transitional provisions
p.000002: 1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.
p.000002: 2On request, the authority which authorised the research project before 1 January 2014 may assign the research project to Category A. In this case, the liability,
p.000002: coverage and notification requirements are governed by the new law.
p.000002: 3The ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in Article 6 of the HRA Organisation
p.000002: Ordinance of 20 September 20131.
p.000002: 4 The provisions of this Ordinance are applicable:
p.000002:
p.000002: a. to the assessment of significant changes to research projects as specified in Chapter 2;
p.000002: b. to notifications concerning research projects as specified in Chapters 3–5.
p.000002: 5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted
p.000002: in accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.
p.000002:
p.000002: 1 SR 810.308
p.000002:
p.000002: Art. 49 Commencement
p.000002: This Ordinance comes into force on 1 January 2014.
p.000002:
p.000002:
p.000002:
p.000002: Annex 1
p.000002: (Art. 13)
p.000002:
p.000002:
p.000002: Policy values for liability coverage
p.000002: For Category B research projects involving persons, the policy value shall be at least:
p.000002:
p.000002: a. per person: 250 000 Swiss francs;
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000002: f. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: g. the professional qualifications of the project leader and the other researchers.
p.000002:
p.000002: Art. 42 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17.
p.000002:
p.000002: Art. 43 Notifications
p.000002: 1 The project leader must notify the ethics committee in advance of the following changes to the research project:
p.000002:
p.000002: a. change of project leader;
p.000002: b. for research projects involving deceased persons undergoing artificial respiration: significant changes to the protocol.
p.000002: 2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
p.000002:
p.000002:
p.000002: Chapter 5 Research involving Embryos and Foetuses from Induced Abortions and
p.000002: from Spontaneous Abortions including Stillbirths
p.000002: Art. 44 Informed consent
p.000002: 1For research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths, the pregnant woman or the
p.000002: couple concerned must receive written and oral information on:
p.000002:
p.000002: a. the use of the embryo or foetus for research purposes;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. measures to protect the biological material and the personal data;
p.000002: d. the handling of the embryo or foetus after completion of the research.
p.000002: 2 The information may be additionally presented in a non-textual form.
p.000002: 3 Consent must be given in writing. The consequences of revocation of consent are governed by Article 10.
p.000002: 4 The exceptions to written form are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 45 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for informed consent;
p.000002: d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1,
p.000002: 2 and 4 HRA;
p.000002: e. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: f. compliance with the requirements concerning the storage of biological material or health-related personal data;
p.000002: g. the professional qualifications of the project leader and the other researchers;
p.000002: h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
p.000002:
p.000002: Art. 46 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000001: 1. scientific quality, in the case of a research project as specified in Article 6 letter a,
p.000001: 2. the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA),
p.000001: 3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (Art. 15 HRA), including
p.000001: precautionary measures in the handling of personal data,
p.000001: 4. the need to involve persons, and in particular persons who are particularly vulnerable (Art. 11 HRA),
p.000001: 5. the criteria for the selection of participants,
p.000001: 6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,
p.000001: 7. the appropriateness of the remuneration for participants and compliance with the prohibition of commercialisation (Art. 9 HRA),
p.000001: 8. compliance with scientific integrity requirements;
p.000001: d. the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible
p.000001: involvement of particularly vulnerable persons;
p.000001: e. for Category B research projects: the guaranteeing of the right to compensation in the event of damage (Art. 20 HRA);
p.000001: f. for investigations involving radiation sources1: additionally, compliance with radiological protection legislation and the dose estimation, in cases
p.000001: where an opinion does not have to be sought from the Federal Office of Public Health (FOPH) in accordance with Article 19 paragraph 2;
p.000001: g. the professional qualifications of the project leader and the other researchers;
p.000001: h. compliance with the requirements concerning the storage of biological material or health-related personal data specified in Article 5;
p.000001: i. the suitability of the infrastructure at the research site;
p.000001: j. the financing of the research project and the agreements between the sponsor, third parties and the project leader concerning the allocation of tasks,
p.000001: remuneration and publication;
p.000001: k. other areas, where this is necessary to assess the protection of participants.
p.000001: 1
p.000001: Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This modification has been made throughout the
p.000001: text.
p.000001:
p.000001: Art. 16 Procedure and deadlines
p.000001: 1The ethics committee shall acknowledge receipt of the application within 7 days and notify the project leader of any formal deficiencies in the application
p.000001: documents.
p.000001: 2 It shall reach a decision within 30 days after acknowledgement of receipt of the formally correct application documents.
p.000001: 3 If the ethics committee requests additional information in accordance with Article 14 paragraph 2, the clock shall be stopped until this information has been
p.000001: received.
p.000001:
p.000001: Art. 17 Multicentre research projects
...
p.000001: b. in the case of a Category B research project, changes to the protocol which concern the goal or the central topic of the research project;
p.000001: c. a change of research site or conducting the research project at an additional site; or
p.000001: d. a change of project leader or sponsor.
p.000001: 4 The ethics committee shall reach a decision on significant changes within 30 days. Article 16 applies mutatis mutandis.
p.000001: 5 For the authorisation procedure in the case of significant changes to authorised multicentre research projects, Article 17 applies mutatis mutandis.
p.000001:
p.000001: Art. 19 Procedure for investigations involving radiation sources
p.000001: 1 In the case of investigations involving radiation sources, the project leader shall additionally submit to the responsible ethics committee the documents specified
p.000001: in Annex 2 number 2. Subject to the provisions of the following paragraphs, the authorisation procedure is governed by Articles 14–18.
p.000001: 2 The project leader shall additionally submit to the FOPH the application documents specified in Annex 2 number 3, informing the ethics committee at the same
p.000001: time if the effective dose per person, taking the uncertainty factor into account, is more than 5 mSv per year and:
p.000001:
p.000001: a. a radiopharmaceutical is used which is not authorised in Switzerland;
p.000001: b. a radiopharmaceutical is used which is authorised in Switzerland, and the intervention in question is not a routine nuclear medicine examination; or
p.000001: c. some other radioactive source1 is used.
p.000001: 3 The FOPH shall deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estimation.
p.000001: 4 The ethics committee shall grant authorisation if:
p.000001:
p.000001: a. the requirements covered by Article 15 are met; and
p.000001: b. the FOPH has raised no objections to the research project.
p.000001: 5 It shall reach a decision in this case within 45 days after acknowledgement of receipt of the formally correct application documents. It shall inform the FOPH of
p.000001: its decision.
p.000001:
p.000001: 1 Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This modification has been made throughout the
p.000001: text.
p.000001:
p.000001:
p.000001: Section 3 Notifications and Reporting
p.000001: Art. 20 Notification of safety and protective measures
p.000001: If immediate safety and protective measures have to be taken during the conduct of a research project, the project leader shall notify the ethics committee of
p.000001: these measures, and of the circumstances necessitating them, within 7 days.
p.000001:
p.000001: Art. 21 Serious events
p.000001: 1 If, in the course of a research project, serious events occur in participants, the research project must be interrupted.
p.000001: 2A serious event is defined as any adverse event where it cannot be excluded that the event is attributable to the sampling of biological material or the collection
p.000001: of health-related personal data, and which:
p.000001:
p.000001: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;
p.000001: b. results in permanent or significant incapacity or disability; or
p.000001: c. is life-threatening or results in death.
p.000001: 3 If necessary in order to guarantee participants’ safety and health, further events are to be designated as serious in the protocol or at the request of the
p.000001: responsible ethics committee.
p.000001: 4The project leader shall notify the ethics committee of a serious event within 7 days. In addition, the project leader shall report to the committee on the
p.000001: connection between the event and the collection of health-related personal data or the sampling of biological material. At the same time, he or she shall submit
p.000001: proposals concerning the next steps to be taken.
p.000001: 5If a serious event occurs in connection with an investigation involving a radiation source on which the FOPH has delivered an opinion in accordance with Article
p.000001: 19, this must be additionally reported to the FOPH within 7 days.
p.000001:
p.000001: 6 The ethics committee shall reach a decision on the continuation of the research project within 30 days after receipt of the report.
p.000001:
p.000001: Art. 22 Notification upon completion or discontinuation of a research project
p.000001: The project leader shall notify the ethics committee of the discontinuation or completion of a research project within 90 days.
p.000001:
p.000001: Art. 23 1Assessment, notification and reporting on the use of radiation sources
p.000001: 1In the case of investigations using radiation sources, the project leader shall assess compliance with the dose guidance value under Article 45 of the Radiological
p.000001: Protection Ordinance of 26 April 20172.
p.000001: 2 He or she shall give notify the competent ethics committee if the permitted dose guidance value within seven working days of the information coming to light.
p.000001:
p.000001: 3 The competent ethics committee may obtain technical advice from the FOPH in order to assess the dose calculation or the dose estimate and to decide what
p.000001: further measures are required.
p.000001: 4 Within a year of completing or discontinuing a research project which included investigations involving radioactive sources, the project leader shall submit to
p.000001: the FOPH a final report including all information of relevance for radiological protection, and in particular a retrospective dose estimation by the participants.
p.000001: 5 Routine nuclear medicine examinations involving authorised radiopharmaceuticals are exempt from the reporting requirement under paragraph 4.
p.000001: 6 Within the framework of the opinion delivered in accordance with Article 19, or on request, the FOPH may specify further exemptions from the reporting
p.000001: requirements.
p.000001:
p.000001: 1
p.000001: Amended by Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261).
p.000002: 2
p.000002: SR 814.501
p.000002:
p.000002:
p.000002:
p.000002: Chapter 3 Further Use of Biological Material and Health-related Personal Data for
p.000002: Research
p.000002: Section 1 General Provisions
p.000002: Art. 24 Further use
p.000002: Further use of biological material and health-related personal data is defined as any handling, for research purposes, of biological material already sampled or
p.000002: data already collected, and in particular:
p.000002:
p.000002: a. procuring, bringing together or collecting biological material or health—related personal data;
p.000002: b. registration or cataloguing of biological material or health-related personal data;
p.000002: c. storage or inclusion in biobanks or databases;
p.000002: d. making accessible or available or transferring biological material or health—related personal data.
p.000002:
p.000002: Art. 25 Anonymisation
p.000002: 1For the anonymisation of biological material and health-related personal data, all items which, when combined, would enable the data subject to be identified
p.000002: without disproportionate effort, must be irreversibly masked or deleted.
p.000002: 2 In particular, the name, address, date of birth and unique identification numbers must be masked or deleted.
p.000002:
p.000002: Art. 26 Coding
p.000002: 1Biological material and health-related personal data are considered to be correctly coded in accordance with Article 32 paragraph 2 and Article 33 paragraph 2
...
p.000002: 1.4 other documents issued to participants;
p.000002: 1.5 information on the type and amount of remuneration for participants;
p.000002: 1.6 for Category B research projects: certificate of insurance or other proof of coverage for possible damage;
p.000002: 1.7 information on the secure handling of biological material and personal data, and in particular on the storage thereof;
p.000002: 1.8 the project leader’s CV, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project,
p.000002: indicating their responsibilities and relevant professional knowledge;
p.000002: 1.9 information on the suitability and availability of infrastructure at the research site;
p.000002: 1.10 agreements between the project leader and the sponsor or third parties, in particular with regard to the financing of the research project,
p.000002: remuneration of the project leader and publication.
p.000002:
p.000002:
p.000002: 2 Additional application documents for research projects which include investigations involving radiation sources
p.000002: 2.1 Details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour
p.000002: doses;
p.000002: 2.2 the licences required under Article 28 of the Radiological Protection Act of 22 March 19911.
p.000002:
p.000002:
p.000002: 3 Additional application documents for research projects which include investigations involving radioactive sources and
p.000002: require an opinion from the FOPH in accordance with Article 19 paragraph 2
p.000002: 3.1 Information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and
p.000002: radionuclide purity;
p.000002: 3.2 for authorised radiopharmaceuticals: the prescribing information;
p.000002: 3.3 for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of
p.000002: the persons responsible for these processes and details of their professional qualifications;
p.000002: 3.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;
p.000002: 3.5 information specified in the FOPH form for research projects involving radiopharmaceuticals or radiolabelled compounds2.
p.000002:
p.000002:
p.000002: 4 Application documents for research projects involving further use of biological material or health-related personal data
p.000002: 4.1 Basic form, including a summary of the scientific question in the national language of the research site;
p.000002: 4.2 description of the scientific question;
p.000002: 4.3 proof of the origin of the biological material and health-related personal data, and of compliance with the requirements concerning informed consent
p.000002: and information on the right to dissent specified in Articles 32 and 33 HRA;
p.000002: 4.4 for further use of biological material and health-related personal data in coded form: proof of secure and correct coding;
p.000002: 4.5 proof of secure handling of biological material and personal data, and in particular the storage thereof;
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000001: 4 The ethics committee shall grant authorisation if:
p.000001:
p.000001: a. the requirements covered by Article 15 are met; and
p.000001: b. the FOPH has raised no objections to the research project.
p.000001: 5 It shall reach a decision in this case within 45 days after acknowledgement of receipt of the formally correct application documents. It shall inform the FOPH of
p.000001: its decision.
p.000001:
p.000001: 1 Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This modification has been made throughout the
p.000001: text.
p.000001:
p.000001:
p.000001: Section 3 Notifications and Reporting
p.000001: Art. 20 Notification of safety and protective measures
p.000001: If immediate safety and protective measures have to be taken during the conduct of a research project, the project leader shall notify the ethics committee of
p.000001: these measures, and of the circumstances necessitating them, within 7 days.
p.000001:
p.000001: Art. 21 Serious events
p.000001: 1 If, in the course of a research project, serious events occur in participants, the research project must be interrupted.
p.000001: 2A serious event is defined as any adverse event where it cannot be excluded that the event is attributable to the sampling of biological material or the collection
p.000001: of health-related personal data, and which:
p.000001:
p.000001: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;
p.000001: b. results in permanent or significant incapacity or disability; or
p.000001: c. is life-threatening or results in death.
p.000001: 3 If necessary in order to guarantee participants’ safety and health, further events are to be designated as serious in the protocol or at the request of the
p.000001: responsible ethics committee.
p.000001: 4The project leader shall notify the ethics committee of a serious event within 7 days. In addition, the project leader shall report to the committee on the
p.000001: connection between the event and the collection of health-related personal data or the sampling of biological material. At the same time, he or she shall submit
p.000001: proposals concerning the next steps to be taken.
p.000001: 5If a serious event occurs in connection with an investigation involving a radiation source on which the FOPH has delivered an opinion in accordance with Article
p.000001: 19, this must be additionally reported to the FOPH within 7 days.
p.000001:
p.000001: 6 The ethics committee shall reach a decision on the continuation of the research project within 30 days after receipt of the report.
p.000001:
p.000001: Art. 22 Notification upon completion or discontinuation of a research project
p.000001: The project leader shall notify the ethics committee of the discontinuation or completion of a research project within 90 days.
p.000001:
p.000001: Art. 23 1Assessment, notification and reporting on the use of radiation sources
p.000001: 1In the case of investigations using radiation sources, the project leader shall assess compliance with the dose guidance value under Article 45 of the Radiological
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000001: b. the project leader furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a
p.000001: recording of verbal consent.
p.000001: 3 In individual cases, the requirement to provide information in written form may be waived if:
p.000001:
p.000001: a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; and
p.000001: b. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.
p.000001:
p.000001: Art. 10 Consequences of revocation of consent
p.000001: 1If consent is revoked, the biological material and health—related personal data of the person concerned must be anonymised after data evaluation has been
p.000001: completed.
p.000001: 2 Anonymisation of the biological material and personal data may be dispensed with if:
p.000001:
p.000001: a. the person concerned expressly renounces this right when revoking consent; or
p.000001: b. it is established at the beginning of the research project that anonymisation is not possible and the person concerned, having been adequately
p.000001: informed of this fact, consented to participate.
p.000001: 3 Persons revoking consent must be offered any follow-up care required to protect their health.
p.000001:
p.000001: Art. 11 Research projects in emergency situations
p.000001: For research projects in emergency situations, Articles 15–17 ClinO1 apply mutatis mutandis.
p.000001:
p.000001: 1 SR 810.305
p.000001:
p.000001: Art. 12 Exemptions from liability
p.000001: Any person who proves that:
p.000001:
p.000001: a. the damage is only slight and temporary; and
p.000001: b. the extent of the damage is no greater than would be expected in the current state of scientific knowledge
p.000001: shall be exempt from liability under Article 19 paragraph 1 HRA.
p.000001:
p.000001: Art. 13 Coverage
p.000001: 1 Category A research projects are exempt from the liability coverage requirements specified in Article 20 HRA.
p.000001: 2 For Category B research projects, the policy value shall be set in accordance with Annex 1.
p.000001: 3 The liability coverage must cover damage occurring up to 10 years after the completion of the research project.
p.000001: 4 In addition, Article 11, Article 13 paragraph 1 and Article 14 ClinO1 apply mutatis mutandis.
p.000001:
p.000001: 1 SR 810.305
p.000001:
p.000001:
p.000001: Section 2 Authorisation Procedure
p.000001: Art. 14 Application
p.000001: 1 The project leader shall submit the application documents specified in Annex 2 to the responsible ethics committee for review.
p.000001: 2 The ethics committee may request additional information.
p.000001: 3The sponsor may submit the application instead of the project leader. In this case, the sponsor assumes the obligations of the project leader as specified in
p.000001: Articles 17–23. The application documents must be co-signed by the project leader.
p.000001:
p.000001: Art. 15 Review areas
p.000001: The responsible ethics committee shall review:
p.000001:
p.000001: a. the completeness of the application;
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: 2 and 4 HRA;
p.000002: e. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: f. compliance with the requirements concerning the storage of biological material or health-related personal data;
p.000002: g. the professional qualifications of the project leader and the other researchers;
p.000002: h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
p.000002:
p.000002: Art. 46 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17;
p.000002: d. for notification requirements: Article 36.
p.000002:
p.000002:
p.000002: Chapter 6 Final Provisions
p.000002: Art. 47 Updating of Annexes
p.000002: The Federal Department of Home Affairs may update the Annexes in accordance with international or technical developments. It shall undertake updates which
p.000002: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000002:
p.000002: Art. 48 Transitional provisions
p.000002: 1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.
p.000002: 2On request, the authority which authorised the research project before 1 January 2014 may assign the research project to Category A. In this case, the liability,
p.000002: coverage and notification requirements are governed by the new law.
p.000002: 3The ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in Article 6 of the HRA Organisation
p.000002: Ordinance of 20 September 20131.
p.000002: 4 The provisions of this Ordinance are applicable:
p.000002:
p.000002: a. to the assessment of significant changes to research projects as specified in Chapter 2;
p.000002: b. to notifications concerning research projects as specified in Chapters 3–5.
p.000002: 5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted
p.000002: in accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.
p.000002:
p.000002: 1 SR 810.308
p.000002:
p.000002: Art. 49 Commencement
p.000002: This Ordinance comes into force on 1 January 2014.
p.000002:
p.000002:
p.000002:
p.000002: Annex 1
p.000002: (Art. 13)
p.000002:
p.000002:
p.000002: Policy values for liability coverage
p.000002: For Category B research projects involving persons, the policy value shall be at least:
p.000002:
p.000002: a. per person: 250 000 Swiss francs;
p.000002: b. for damage to property: 20 000 Swiss francs;
p.000002: c. for the entire research project: 3 million Swiss francs.
p.000002:
p.000002:
p.000002: Annex 2
p.000002: (Art. 14, 17–19)
p.000002:
p.000002:
...
Orphaned Trigger Words
p.000001:
p.000001: Art. 2 Applicable provisions
p.000001: The provisions concerning scientific integrity and scientific quality set out in Articles 3 and 4 of the Ordinance of 20 September 20131 on Clinical Trials (ClinO)
p.000001: apply mutatis mutandis.
p.000001:
p.000001: 1
p.000001: SR 810.305
p.000001:
p.000001: Art. 3 Responsibilities of project leader and sponsor
p.000001: 1 The project leader is responsible for the conduct of the research project in Switzerland and for protection of the participants at the research site.
p.000001: 2The project leader is also responsible for organising the research project, and in particular for the initiation, management and financing of the project in
p.000001: Switzerland, provided that no other person or institution headquartered or represented in Switzerland takes responsibility for this (sponsor).
p.000001:
p.000001: Art. 4 Professional qualifications
p.000001: 1 The project leader responsible for a research project must:
p.000001:
p.000001: a. be entitled to practise independently the profession specifically qualifying him or her to conduct the research project in question;
p.000001: b. have the training and experience required to conduct the research project in question;
p.000001: c. be conversant with the legal requirements for research projects or be able to ensure compliance by calling in appropriate expertise.
p.000001: 2 The other persons conducting the research project must have the professional knowledge and experience appropriate to the activities in question.
p.000001:
p.000001: Art. 5 Storage of health-related personal data and biological material
p.000001: 1 Any person who stores health-related personal data for research must take appropriate operational and organisational measures to protect it, and in particular:
p.000001:
p.000001: a. restrict the handling of the health-related personal data to those persons who require this data to fulfil their duties;
p.000001: b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data;
p.000001: c. document all processing operations which are essential to ensure traceability.
p.000001: 2 Any person who stores biological material for research must, in particular:
p.000001:
p.000001: a. comply with the principles set out in paragraph 1 mutatis mutandis;
p.000001: b. ensure that the technical requirements are met for appropriate storage of the biological material;
p.000001: c. make available the resources required for storage.
p.000001:
p.000001:
p.000001: Chapter 2 Research Involving Measures for Sampling of Biological Material or
p.000001: Collection of Health-Related Personal Data from Persons
p.000001: Section 1 General Provisions
p.000001: Art. 6 Research project
p.000001: For the purposes of this Chapter, a research project is any project in which biological material is sampled or health-related personal data is collected from a person
p.000001: in order to:
p.000001:
p.000001: a. answer a scientific question; or
p.000001: b. make further use for research purposes of the biological material or the health-related personal data.
p.000001:
p.000001: Art. 7 Categorisation
p.000001: 1A research project comes under Category A if the planned measures for sampling biological material or collecting personal data entail only minimal risks and
p.000001: burdens.
p.000001: 2 A research project comes under Category B if the planned measures entail more than only minimal risks and burdens.
...
p.000001: remuneration and publication;
p.000001: k. other areas, where this is necessary to assess the protection of participants.
p.000001: 1
p.000001: Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This modification has been made throughout the
p.000001: text.
p.000001:
p.000001: Art. 16 Procedure and deadlines
p.000001: 1The ethics committee shall acknowledge receipt of the application within 7 days and notify the project leader of any formal deficiencies in the application
p.000001: documents.
p.000001: 2 It shall reach a decision within 30 days after acknowledgement of receipt of the formally correct application documents.
p.000001: 3 If the ethics committee requests additional information in accordance with Article 14 paragraph 2, the clock shall be stopped until this information has been
p.000001: received.
p.000001:
p.000001: Art. 17 Multicentre research projects
p.000001: 1 The project leader shall submit the application for a multicentre research project to the lead committee in accordance with Article 47 paragraph 2 HRA.
p.000001: 2The lead committee shall acknowledge receipt of the application within 7 days and at the same time notify the project leader whether the application
p.000001: documents submitted are formally in order.
p.000001: 3 At the request of the lead committee, the project leader shall submit the required number of copies of the application documents specified in Annex 2 to the
p.000001: ethics committees responsible at the other research sites (ethics committees concerned). These shall review the local conditions and inform the lead committee of
p.000001: their assessment within 15 days.
p.000001: 4The lead committee shall reach a decision within 45 days of acknowledging receipt of the formally correct application. It shall inform the ethics committees
p.000001: concerned of its decision.
p.000001:
p.000001: Art. 18 Changes
p.000001: 1Significant changes to an authorised research project must be authorised by the ethics committee before being implemented. Exempt from this requirement are
p.000001: measures which have to be taken immediately in order to protect the participants.
p.000001: 2The project leader shall submit to the ethics committee any application documents specified in Annex 2 which are affected by the change. At the same time, the
p.000001: project leader shall provide information on the reasons for the change.
p.000001: 3 The following are considered to be significant changes:
p.000001:
p.000001: a. changes affecting the participants’ safety and health, or their rights and obligations;
p.000001: b. in the case of a Category B research project, changes to the protocol which concern the goal or the central topic of the research project;
p.000001: c. a change of research site or conducting the research project at an additional site; or
p.000001: d. a change of project leader or sponsor.
p.000001: 4 The ethics committee shall reach a decision on significant changes within 30 days. Article 16 applies mutatis mutandis.
p.000001: 5 For the authorisation procedure in the case of significant changes to authorised multicentre research projects, Article 17 applies mutatis mutandis.
p.000001:
p.000001: Art. 19 Procedure for investigations involving radiation sources
p.000001: 1 In the case of investigations involving radiation sources, the project leader shall additionally submit to the responsible ethics committee the documents specified
p.000001: in Annex 2 number 2. Subject to the provisions of the following paragraphs, the authorisation procedure is governed by Articles 14–18.
p.000001: 2 The project leader shall additionally submit to the FOPH the application documents specified in Annex 2 number 3, informing the ethics committee at the same
p.000001: time if the effective dose per person, taking the uncertainty factor into account, is more than 5 mSv per year and:
p.000001:
...
p.000002:
p.000002: Art. 27 Conditions for breaking the code
p.000002: For coded biological material and coded health-related personal data, the code may only be broken if:
p.000002:
p.000002: a. breaking the code is necessary to avert an immediate risk to the health of the person concerned;
p.000002: b. a legal basis exists for breaking the code; or
p.000002: c. breaking the code is necessary to guarantee the rights of the person concerned, and in particular the right to revoke consent.
p.000002:
p.000002:
p.000002: Section 2 Informed Consent and Information
p.000002: Art. 28 Informed consent for further use of biological material and genetic personal data in uncoded form for a research project
p.000002: 1 The persons concerned must receive written and oral information on:
p.000002:
p.000002: a. the nature, purpose and duration of, and procedure for, the research project;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. the consequences of revocation of consent for the biological material and personal data used up to this point;
p.000002: d. their right to receive information at any time in response to further questions relating to the research project;
p.000002: e. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this
p.000002: decision for them;
p.000002: f. measures to protect the biological material and the personal data;
p.000002: g. the main sources of financing for the research project;
p.000002: h. other points relevant to their decision.
p.000002: 2 The information may be additionally presented in a non-textual form.
p.000002: 3 Consent must be given in writing.
p.000002: 4 The exceptions to written form are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 29 Informed consent for further use of biological material and genetic personal data in coded form for research purposes
p.000002: 1 The persons concerned must receive written or oral information on:
p.000002:
p.000002: a. the proposed further use of the coded biological material and coded genetic personal data for research purposes;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. measures to protect the biological material and personal data, and in particular management of the key;
p.000002: d. the possibility of the biological material and the genetic personal data being passed on to third parties for research purposes.
p.000002: 2 Consent must be given in writing; the exceptions are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 30 Information on the proposed anonymisation of biological material and genetic personal data for research purposes
p.000002: The persons concerned must receive written or oral information on:
p.000002:
p.000002: a. the proposed anonymisation of the biological material and genetic personal data for research purposes;
p.000002: b. their right to dissent;
p.000002: c. the consequences of anonymisation with regard to results concerning their health;
p.000002: d. the possibility of the biological material and the data being passed on to third parties for research purposes.
p.000002: Art. 31 Informed consent for further use of non-genetic health-related personal data in uncoded form for research purposes
p.000002: 1 The persons concerned must receive written or oral information on:
p.000002:
p.000002: a. the proposed further use of the non-genetic health-related personal data for research purposes;
p.000002: b. their right to withhold or to revoke their consent at any time without giving reasons;
p.000002: c. their right to be informed of results concerning their health, and their right to forgo such information;
p.000002: d. measures to protect the personal data;
p.000002: e. the possibility of the personal data being passed on to third parties for research purposes.
p.000002: 2 Consent must be given in writing; the exceptions are governed by Article 9 mutatis mutandis.
p.000002:
p.000002: Art. 32 Information on the proposed further use of non-genetic health-related personal data in coded form for research purposes
p.000002: The persons concerned must receive written or oral information on:
p.000002:
p.000002: a. the proposed further use of the non-genetic health-related personal data in coded form for research purposes;
p.000002: b. their right to dissent;
p.000002: c. measures to protect the personal data, and in particular management of the key;
p.000002: d. the possibility of the personal data being passed on to third parties for research purposes.
p.000002:
p.000002:
p.000002: Section 3 Authorisation Procedure and Notification Requirements for Research Projects involving Biological Material and
p.000002: Health-Related Personal Data
p.000002: Art. 33 Research project
p.000002: For the purposes of this Section, a research project is any project in which further use is made of biological material already sampled or health-related personal
p.000002: data already collected in order to answer a scientific question.
p.000002:
p.000002: Art. 34 Review areas
p.000002: 1 The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the fulfilment of the conditions specified in Articles 32 and 33 HRA;
p.000002: c. for research projects involving biological material and health-related personal data in coded form: correct and secure coding;
p.000002: d. compliance with the requirements for the storage of biological material or health-related personal data;
p.000002: e. the professional qualifications of the project leader and the other persons involved in the research project;
p.000002: f. other areas, where this is necessary to assess the protection of the persons concerned.
p.000002: 2In this process, it shall take into account existing authorisations from ethics committees with regard to the biological material or the health-related personal
p.000002: data.
p.000002:
p.000002: Art. 35 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: Article 17.
p.000002:
p.000002: Art. 36 Notification requirements
p.000002: 1 The project leader shall notify the ethics committee of a change of project leader in advance.
p.000002: 2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
p.000002:
p.000002:
p.000002: Section 4 Authorisation Procedure and Notification Requirements for further Use of Biological Material and Health-Related
p.000002: Personal Data for Research in the Absence of Informed Consent in accordance with Article 34 HRA
p.000002: Art. 37 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the reasons, as specified in Article 34 letters a and b HRA;
p.000002: c. the interests of the proposed research which outweigh the interests of the person concerned in deciding on the further use of his or her biological
p.000002: material and health-related personal data;
p.000002: d. the group of persons entitled to pass on the biological material and the personal data;
p.000002: e. compliance with the requirements concerning the storage of biological material or health-related personal data and the group of persons with access
p.000002: rights;
p.000002: f. the professional qualifications of the persons entitled to receive the biological material and the personal data;
p.000002: g. other areas, where this is necessary to assess the protection of the persons concerned.
p.000002:
p.000002: Art. 38 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for further use or collection according to a standard protocol, but in different cantons: the procedure specified in Article 17.
p.000002:
p.000002: Art. 39 Authorisation
p.000002: The authorisation shall include at least the following information:
p.000002: a. the purpose for which further use may be made of the biological material and the health-related personal data;
p.000002: b. the designation of the biological material and health-related personal data covered by the authorisation;
p.000002: c. the group of persons entitled to pass on the biological material and the health-related personal data;
p.000002: d. the group of persons entitled to receive the biological material and the personal data.
p.000002:
p.000002: Art. 40 Notifications
p.000002: 1 The project leader must notify the ethics committee in advance of any changes to the information given in the authorisation.
p.000002: 2 The project leader must notify the ethics committee of the completion or discontinuation of the collection process within 90 days.
p.000002:
p.000002:
p.000002: Chapter 4 Research Involving Deceased Persons
p.000002: Art. 41 Review areas
p.000002: The ethics committee shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the scientific quality;
p.000002: c. compliance with the requirements for consent (Art. 36 HRA);
p.000002: d. for research projects involving deceased persons undergoing artificial respiration: the need to involve them in the research project (Art. 37 para. 2
p.000002: HRA) and compliance with the requirement for independence of the persons involved in the determination of their death (Art. 37 para. 3 HRA);
p.000002: e. compliance with the requirements for the storage of biological material or health-related personal data;
p.000002: f. compliance with the prohibition of commercialisation (Art. 9 HRA);
p.000002: g. the professional qualifications of the project leader and the other researchers.
p.000002:
p.000002: Art. 42 Applicable provisions
p.000002: The following provisions apply mutatis mutandis:
p.000002:
p.000002: a. for the submission of the application: Article 14;
p.000002: b. for the procedure and deadlines: Article 16;
p.000002: c. for multicentre research projects: the procedure specified in Article 17.
p.000002:
p.000002: Art. 43 Notifications
p.000002: 1 The project leader must notify the ethics committee in advance of the following changes to the research project:
p.000002:
p.000002: a. change of project leader;
p.000002: b. for research projects involving deceased persons undergoing artificial respiration: significant changes to the protocol.
p.000002: 2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
p.000002:
p.000002:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| cognitive | Cognitive Impairment |
| disability | Mentally Disabled |
| education | education |
| embryo | embryo |
| emergency | Public Emergency |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| home | Property Ownership |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| opinion | philosophical differences/differences of opinion |
| pregnant | Pregnant |
| property | Property Ownership |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| foetus | ['foetuses'] |
| foetuses | ['foetus'] |
| home | ['property'] |
| property | ['home'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input