79C3C34C52B45572883A05D425EB0F82
Ordinance of 20 September2013 on Organizational Aspectsof the Human Research Act(HRA Organisational Ordinance,OrgO-HRA), RS 810.308
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This file was generated: 2020-12-01 07:14:07
| 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 / political affiliation
Searching for indicator party:
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p.000001:
p.000001: Art. 2 Requirements for members
p.000001: 1Members of the ethics committee must, on commencing their service, attend a course on the duties of the ethics committee and the fundamentals of the
p.000001: assessment of research projects, and must regularly undergo further training in this area.
p.000001: 2 The members specified in Article 1 paragraph 1 letters a–c must have experience in the conduct of research projects.
p.000001:
p.000001: Art. 3 Scientific secretariat
p.000001: 1 Persons working for the scientific secretariat must have:
p.000001:
p.000001: a. a degree in medicine, pharmaceutics, natural sciences, psychology or law;
p.000001: b. adequate training in Good Clinical Practice;
p.000001: c. a knowledge of scientific methods for human research projects; and
p.000001: d. a knowledge of the legal requirements governing human research.
p.000001: 2 The scientific secretariat shall be staffed at a level that is sufficient:
p.000001:
p.000001: a. to ensure its availability for the committee and for applicants; and
p.000001: b. to guarantee that procedural deadlines are met.
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p.000001: Art. 4 Withdrawal from participation
p.000001: 1 Members of the ethics committee shall withdraw from participation in cases where:
p.000001:
p.000001: a. they are personally involved, or otherwise have a personal interest, in the research project;
p.000001: b. persons reporting to them, to whom they report, or with whom they have close personal ties, are involved in the research project; or
p.000001: c. they are an interested party for other reasons.
p.000001: 2 Members who are interested parties must not participate in deliberations or in decision-making on the matter in question.
p.000001:
p.000001: Art. 5 Regular procedure
p.000001: 1The ethics committee shall make decisions under the regular procedure with the participation of at least seven members. The composition of this group shall be
p.000001: such as to guarantee an expert and interdisciplinary assessment of the application.
p.000001: 2 Decisions shall be taken after oral deliberations. In justified exceptional cases, it is permissible for proceedings to be conducted in writing; a member may at any
p.000001: time request oral deliberations.
p.000001:
p.000001: 3 Decisions of the ethics committee shall be made by majority vote. In the event of a tie, the chair or vice-chair shall have a casting vote.
p.000001: 4 The provisions of Articles 6 and 7 are reserved.
p.000001:
p.000001: Art. 6 Simplified procedure
p.000001: 1 The ethics committee shall make decisions with the participation of three members on:
p.000001:
p.000001: a. Category A clinical trials, as specified in Article 19 paragraph 1, Article 20 paragraph 1, Article 49 paragraph 1 and Article 61 paragraph 1 of the
p.000001: Ordinance of 20 September 20131 on Clinical Trials (ClinO), provided that the trial does not raise any particular ethical, scientific or legal issues;
p.000001: b. Category A research projects involving persons, as specified in Article 7 paragraph 1 of the Human Research Ordinance of 20 September 20132;
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p.000001: e. It provides information for the public, preparing in particular a summary of the annual reports submitted by ethics committees and a statistical
p.000001: overview of the research projects authorised.
p.000001: 3It may, within the framework of the operation of the portal and the supplementary federal database in accordance with Article 67 ClinO1, enable the electronic
p.000001: exchange of documents relating to the authorisation and notification procedures between applicants and authorisation authorities.
p.000001: 4 It shall issue guidelines on the content of the reports to be submitted by ethics committees in accordance with Article 55 paragraph 2 HRA.
p.000001:
p.000001: 1
p.000001: SR 810.305
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p.000001: Chapter 3: Data Protection
p.000001: Art. 11 Disclosure of personal data
p.000001: 1Before the enforcement body discloses personal data to the authorities responsible in accordance with Article 59 paragraphs 1 and 2 HRA, it shall solicit
p.000001: comments from the data subject, providing information at the same time on:
p.000001: a. the purpose of the disclosure of data;
p.000001: b. the nature of the data to be disclosed; and
p.000001: c. the data recipient.
p.000001: 2 The obligations specified in paragraph 1 do not apply if:
p.000001:
p.000001: a. the data subject has already been adequately informed;
p.000001: b. the disclosure of data is evident from the circumstances of the particular case;
p.000001: c. there is an immediate risk of legal claims or important third-party interests being prejudiced, or the fulfilment of legal duties being prevented; or
p.000001: d. the data subject cannot be traced.
p.000001: 3If data is to be published under Article 59 paragraph 3 HRA, all items which, when combined, would enable the data subject to be identified without
p.000001: disproportionate effort, must be masked or deleted. These include in particular the name, address, date of birth and unique identification numbers.
p.000001:
p.000001: Art. 12 Exchange of data with foreign authorities and institutions
p.000001: 1 The following are empowered to exchange confidential data with foreign authorities and institutions or international organisations:
p.000001:
p.000001: a. the responsible ethics committee;
p.000001: b. the cantonal supervisory authority;
p.000001: c. the Swiss Agency for Therapeutic Products (Agency); and
p.000001: d. the FOPH.
p.000001: 2If the confidential data includes personal data, this may only be transmitted to foreign authorities and institutions or to international organisations if the privacy
p.000001: of the data subject is not seriously endangered thereby, in particular due to the absence of legislation that guarantees adequate protection.
p.000001: 3 In the absence of legislation that guarantees adequate protection, personal data may only be transmitted abroad if:
p.000001:
p.000001: a. disclosure is required in order to protect the life or the physical integrity of the data subject;
p.000001: b. disclosure is essential in order to avert an imminent danger to public health;
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Social / Linguistic Proficiency
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p.000001: CC 810.308 Ordinance of 20 September 2013 on Organisational Aspects of the Human Research Act (HRA Organisation Ordinance, OrgO-HRA) DE FR IT RM EN
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p.000001: The federal Council m S
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p.000001: > Sub-navigation
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p.000001: v Additional informations
p.000001:
p.000001: 810.308 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 Organisational Aspects of the Human Research Act
p.000001: (HRA Organisation Ordinance, OrgO-HRA)
p.000001: of 20 September 2013 (Status as of 1 January 2014)
p.000001:
p.000001: The Swiss Federal Council,
p.000001:
p.000001: on the basis of Article 49 paragraphs 1 and 2, Article 53 paragraph 3, Article 59 paragraph 6, Article 60 paragraph 2 and Article 65 of the Human Research Act of
p.000001: 30 September 20111 (HRA),
p.000001:
p.000001: ordains:
p.000001:
p.000001:
p.000001: Chapter 1: Research Ethics Committee
p.000001: Art. 1 Composition
p.000001: 1 The research ethics committee (ethics committee) shall be composed at least of persons possessing expertise in the following disciplines:
p.000001:
p.000001: a. medicine;
p.000001: b. psychology;
p.000001: c. nursing;
p.000001: d. pharmaceutics or pharmaceutical medicine;
p.000001: e. biology;
p.000001: f. biostatistics;
p.000001: g. ethics; and
p.000001: h. law, including data protection.
p.000001: 2 It shall be of balanced composition as regards gender and professional groups.
p.000001: 3 The ethics committee must be able to draw on knowledge of local conditions in the various areas of responsibility.
p.000001:
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Social / gender
Searching for indicator gender:
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p.000001:
p.000001: 810.308 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 Organisational Aspects of the Human Research Act
p.000001: (HRA Organisation Ordinance, OrgO-HRA)
p.000001: of 20 September 2013 (Status as of 1 January 2014)
p.000001:
p.000001: The Swiss Federal Council,
p.000001:
p.000001: on the basis of Article 49 paragraphs 1 and 2, Article 53 paragraph 3, Article 59 paragraph 6, Article 60 paragraph 2 and Article 65 of the Human Research Act of
p.000001: 30 September 20111 (HRA),
p.000001:
p.000001: ordains:
p.000001:
p.000001:
p.000001: Chapter 1: Research Ethics Committee
p.000001: Art. 1 Composition
p.000001: 1 The research ethics committee (ethics committee) shall be composed at least of persons possessing expertise in the following disciplines:
p.000001:
p.000001: a. medicine;
p.000001: b. psychology;
p.000001: c. nursing;
p.000001: d. pharmaceutics or pharmaceutical medicine;
p.000001: e. biology;
p.000001: f. biostatistics;
p.000001: g. ethics; and
p.000001: h. law, including data protection.
p.000001: 2 It shall be of balanced composition as regards gender and professional groups.
p.000001: 3 The ethics committee must be able to draw on knowledge of local conditions in the various areas of responsibility.
p.000001:
p.000001: 4 If the ethics committee lacks the expertise required for the assessment of a research project, it must call in external specialists.
p.000001:
p.000001: Art. 2 Requirements for members
p.000001: 1Members of the ethics committee must, on commencing their service, attend a course on the duties of the ethics committee and the fundamentals of the
p.000001: assessment of research projects, and must regularly undergo further training in this area.
p.000001: 2 The members specified in Article 1 paragraph 1 letters a–c must have experience in the conduct of research projects.
p.000001:
p.000001: Art. 3 Scientific secretariat
p.000001: 1 Persons working for the scientific secretariat must have:
p.000001:
p.000001: a. a degree in medicine, pharmaceutics, natural sciences, psychology or law;
p.000001: b. adequate training in Good Clinical Practice;
p.000001: c. a knowledge of scientific methods for human research projects; and
p.000001: d. a knowledge of the legal requirements governing human research.
p.000001: 2 The scientific secretariat shall be staffed at a level that is sufficient:
p.000001:
p.000001: a. to ensure its availability for the committee and for applicants; and
p.000001: b. to guarantee that procedural deadlines are met.
p.000001:
p.000001: Art. 4 Withdrawal from participation
p.000001: 1 Members of the ethics committee shall withdraw from participation in cases where:
p.000001:
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General/Other / Relationship to Authority
Searching for indicator authority:
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p.000001: 3 The conduct of proceedings in writing is permissible if no members request oral deliberations.
p.000001: 4 The regular procedure shall be adopted if:
p.000001:
p.000001: a. unanimous agreement is not reached; or
p.000001: b. a request to this effect is made by a member of the group of three.
p.000001: 1 SR
p.000001: 2 SR
p.000001:
p.000001: Art. 7 Decisions to be made by the chair
p.000001: 1 The chair or vice-chair of the ethics committee shall make decisions on:
p.000001:
p.000001: a. research projects involving existing biological material or existing health-related personal data, with the exception of further use in accordance with
p.000001: Article 34 HRA;
p.000001: b. significant changes to authorised research projects which do not raise any particular ethical, scientific or legal issues;
p.000001: c. whether the requirements concerning local conditions in multicentre research projects are met;
p.000001: d. refusal to consider incomplete applications;
p.000001: e. the cancellation of applications which are no longer relevant or have been withdrawn;
p.000001: f. the fulfilment of conditions imposed;
p.000001: g. the ordering of official measures as specified in Article 48 HRA.
p.000001: 2 He or she may at any time order the adoption of the simplified or regular procedure.
p.000001:
p.000001: Art. 8 Obligation to retain documents and right of inspection
p.000001: 1Application documents submitted to the ethics committee, minutes of meetings and correspondence must be retained for ten years after the completion or
p.000001: discontinuation of a research project.
p.000001:
p.000001: 2 The cantonal supervisory authority may inspect these documents.
p.000001:
p.000001: Art. 9 Notification requirements
p.000001: The cantonal supervisory authority shall notify the coordination office as specified in Article 10 of the responsible ethics committee.
p.000001:
p.000001:
p.000001: Chapter 2: Coordination Office
p.000001: Art. 10
p.000001: 1 The Federal Office of Public Health (FOPH) shall manage the coordination office as specified in Article 55 HRA.
p.000001:
p.000001: 2 In particular, the coordination office has the following duties:
p.000001:
p.000001: a. It ensures regular exchanges between the supervisory authorities concerned.
p.000001: b. It ensures regular exchanges with research representatives and institutions.
p.000001: c. In cooperation with the ethics committees and, where appropriate, other supervisory authorities concerned, it issues recommendations on
p.000001: authorisation and notification procedures and on specific aspects of decision-making practice.
p.000001: d. It participates in the design and implementation of basic and further training for members of ethics committees.
p.000001: e. It provides information for the public, preparing in particular a summary of the annual reports submitted by ethics committees and a statistical
p.000001: overview of the research projects authorised.
p.000001: 3It may, within the framework of the operation of the portal and the supplementary federal database in accordance with Article 67 ClinO1, enable the electronic
p.000001: exchange of documents relating to the authorisation and notification procedures between applicants and authorisation authorities.
...
p.000001:
p.000001:
p.000001: Chapter 3: Data Protection
p.000001: Art. 11 Disclosure of personal data
p.000001: 1Before the enforcement body discloses personal data to the authorities responsible in accordance with Article 59 paragraphs 1 and 2 HRA, it shall solicit
p.000001: comments from the data subject, providing information at the same time on:
p.000001: a. the purpose of the disclosure of data;
p.000001: b. the nature of the data to be disclosed; and
p.000001: c. the data recipient.
p.000001: 2 The obligations specified in paragraph 1 do not apply if:
p.000001:
p.000001: a. the data subject has already been adequately informed;
p.000001: b. the disclosure of data is evident from the circumstances of the particular case;
p.000001: c. there is an immediate risk of legal claims or important third-party interests being prejudiced, or the fulfilment of legal duties being prevented; or
p.000001: d. the data subject cannot be traced.
p.000001: 3If data is to be published under Article 59 paragraph 3 HRA, all items which, when combined, would enable the data subject to be identified without
p.000001: disproportionate effort, must be masked or deleted. These include in particular the name, address, date of birth and unique identification numbers.
p.000001:
p.000001: Art. 12 Exchange of data with foreign authorities and institutions
p.000001: 1 The following are empowered to exchange confidential data with foreign authorities and institutions or international organisations:
p.000001:
p.000001: a. the responsible ethics committee;
p.000001: b. the cantonal supervisory authority;
p.000001: c. the Swiss Agency for Therapeutic Products (Agency); and
p.000001: d. the FOPH.
p.000001: 2If the confidential data includes personal data, this may only be transmitted to foreign authorities and institutions or to international organisations if the privacy
p.000001: of the data subject is not seriously endangered thereby, in particular due to the absence of legislation that guarantees adequate protection.
p.000001: 3 In the absence of legislation that guarantees adequate protection, personal data may only be transmitted abroad if:
p.000001:
p.000001: a. disclosure is required in order to protect the life or the physical integrity of the data subject;
p.000001: b. disclosure is essential in order to avert an imminent danger to public health;
p.000001: c. sufficient safeguards, in particular contractual clauses, ensure an adequate level of protection abroad; or
p.000001: d. the data subject has consented in the particular case.
p.000001:
p.000001:
p.000001: Chapter 4: Commencement
p.000001: Art. 13
p.000001: This Ordinance shall come into force on 1 January 2014.
p.000001:
p.000001: AS 2013 3455
p.000001:
p.000001: 1 SR 810.30
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p.000001:
p.000001: ^ Back to top
p.000001:
p.000001:
p.000001: Additional informations
p.000001:
p.000001: This text is in force.
p.000001:
p.000001: Decision 20 September 2013
p.000001:
p.000001: In force 1 January 2014
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p.000001: All versions of this law
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p.000001: 26.05.2021
p.000001:
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Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| gender | gender |
| language | Linguistic Proficiency |
| party | political affiliation |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input