Pub Date : 2020-10-01DOI: 10.54920/scto.2021.rawatch.4.11
Pietro Gervasoni
{"title":"Advice from Switzerland’s ethics committees on registries, biobanks, and research projects in accordance with art. 51 of the Human Research Act","authors":"Pietro Gervasoni","doi":"10.54920/scto.2021.rawatch.4.11","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.11","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125370830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-01DOI: 10.54920/scto.2020.rawatch.3.23
S. Méance
To get an understanding of the patient perspective on the General Consent (GC), RA Watch Editor Séverine Méance met with Philipp do Canto from the Swiss Multiple Sclerosis Association (MSA).
为了了解患者对一般同意(GC)的看法，RA Watch编辑ssamverine msamance会见了瑞士多发性硬化症协会(MSA)的Philipp do Canto。
{"title":"A patient perspective: Talking about the Swiss General Consent","authors":"S. Méance","doi":"10.54920/scto.2020.rawatch.3.23","DOIUrl":"https://doi.org/10.54920/scto.2020.rawatch.3.23","url":null,"abstract":"To get an understanding of the patient perspective on the General Consent (GC), RA Watch Editor Séverine Méance met with Philipp do Canto from the Swiss Multiple Sclerosis Association (MSA).","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133444729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-01DOI: 10.54920/scto.2020.rawatch.3.19
J. Maurer, Sonia Carboni, Cindy Roth
The Swiss Personalized Health Network (SPHN), a national initiative funded by the State Secretariat for Education, Research and Innovation (SERI), was designed to promote the development of personalised medicine and personalised health in Switzerland. The SPHN aims to develop infrastructure projects that will make health-related data interoperable and shareable at the national level. Accordingly, certain projects related to informed consent (IC) were funded and are described in this article: the Electronic General Consent (e-GC), the Citizen Centered Consent: Shared, Transparent and Dynamic (the so-called C3-STuDY), and the proactive management tool of consent for research (in French so-called “Gestion Proactive des Consentements de Recherche”, GPCR).
瑞士个性化保健网络(SPHN)是由国家教育、研究和创新秘书处(SERI)资助的一项国家倡议，旨在促进瑞士个性化医疗和个性化保健的发展。SPHN旨在开发基础设施项目，使与健康有关的数据在国家一级可互操作和共享。因此，一些与知情同意(IC)相关的项目得到了资助，并在本文中进行了描述:电子一般同意(e-GC)，以公民为中心的同意:共享、透明和动态(所谓的c3研究)，以及研究同意的主动管理工具(法语称为“Gestion proactive des Consentements de Recherche”，GPCR)。
{"title":"Developing innovative procedures for obtaining informed consent: Three solutions underway","authors":"J. Maurer, Sonia Carboni, Cindy Roth","doi":"10.54920/scto.2020.rawatch.3.19","DOIUrl":"https://doi.org/10.54920/scto.2020.rawatch.3.19","url":null,"abstract":"The Swiss Personalized Health Network (SPHN), a national initiative funded by the State Secretariat for Education, Research and Innovation (SERI), was designed to promote the development of personalised medicine and personalised health in Switzerland. The SPHN aims to develop infrastructure projects that will make health-related data interoperable and shareable at the national level. Accordingly, certain projects related to informed consent (IC) were funded and are described in this article: the Electronic General Consent (e-GC), the Citizen Centered Consent: Shared, Transparent and Dynamic (the so-called C3-STuDY), and the proactive management tool of consent for research (in French so-called “Gestion Proactive des Consentements de Recherche”, GPCR).","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115068953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-01DOI: 10.54920/scto.2020.rawatch.3.4
A. Nienhaus
A journey of a thousand miles begins with a single step. This Chinese proverb comes to mind when one is considering the project of introducing a harmonised General Consent (GC) in Switzerland. Nobody knows where the journey will take us, but this much is certain – with the harmonised GC, adopted in 2019 by the university hospitals, the first step has been taken.
{"title":"Many steps make up the mile: Towards a harmonised General Consent within Switzerland","authors":"A. Nienhaus","doi":"10.54920/scto.2020.rawatch.3.4","DOIUrl":"https://doi.org/10.54920/scto.2020.rawatch.3.4","url":null,"abstract":"A journey of a thousand miles begins with a single step. This Chinese proverb comes to mind when one is considering the project of introducing a harmonised General Consent (GC) in Switzerland. Nobody knows where the journey will take us, but this much is certain – with the harmonised GC, adopted in 2019 by the university hospitals, the first step has been taken.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127571773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-01DOI: 10.54920/scto.2020.rawatch.3.8
Sonia Carboni
Informed consent (IC) is an ethical and legal requirement for research involving human participants. From a research perspective, interest in using health-related data and samples from large patient populations has intensified. In response, different forms of IC have been proposed, with a preference for the so-called General Consent (GC), via which donors agree to the further use of their data and samples for potential research projects that have not yet been defined. This article reviews: the legal basis of the GC in Switzerland; a short history about the process of reaching a harmonised GC at the national level; and the status quo of implementation in the five university hospitals in the country.
{"title":"An update on the national general informed consent: what is the status quo of implementation at Swiss university hospitals?","authors":"Sonia Carboni","doi":"10.54920/scto.2020.rawatch.3.8","DOIUrl":"https://doi.org/10.54920/scto.2020.rawatch.3.8","url":null,"abstract":"Informed consent (IC) is an ethical and legal requirement for research involving human participants. From a research perspective, interest in using health-related data and samples from large patient populations has intensified. In response, different forms of IC have been proposed, with a preference for the so-called General Consent (GC), via which donors agree to the further use of their data and samples for potential research projects that have not yet been defined. This article reviews: the legal basis of the GC in Switzerland; a short history about the process of reaching a harmonised GC at the national level; and the status quo of implementation in the five university hospitals in the country.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"48 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115678543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-01DOI: 10.54920/scto.2020.rawatch.3.15
K. Posfay‐Barbe, J. Bielicki, Pascale Wenger
The general goal of the initiative launched by the Swiss Personalized Health Network (SPHN) is to establish the infrastructure needed to collect and provide data and samples from Swiss residents, to ultimately support personalised approaches to healthcare.
{"title":"Considerations on General Consent in paediatrics","authors":"K. Posfay‐Barbe, J. Bielicki, Pascale Wenger","doi":"10.54920/scto.2020.rawatch.3.15","DOIUrl":"https://doi.org/10.54920/scto.2020.rawatch.3.15","url":null,"abstract":"The general goal of the initiative launched by the Swiss Personalized Health Network (SPHN) is to establish the infrastructure needed to collect and provide data and samples from Swiss residents, to ultimately support personalised approaches to healthcare.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"387 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124795992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-01DOI: 10.54920/scto.2020.rawatch.3.3
C. Pauli-Magnus
{"title":"Editorial: Collaborating on the General Consent, the key success factor","authors":"C. Pauli-Magnus","doi":"10.54920/scto.2020.rawatch.3.3","DOIUrl":"https://doi.org/10.54920/scto.2020.rawatch.3.3","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"322 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133271399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-01DOI: 10.54920/scto.2019.rawatch.2.12
To provide our readers with a good forecast of the changes ahead, the RA Watch editorial team asked different representatives – of the ethics committees umbrella organisation, the industry, and the SCTO network of CTUs – their views about the two ordinances proposed for consultation by the Federal Office of Public Health (FOPH). Their views and opinions refer to the drafted versions of the Medical Devices Ordinance (MedDO) and the ordinance on clinical trials for medical devices (ClinO-MD) as open to comments on 15 May 2019.
{"title":"Stakeholders’ views on the Swiss draft ordinances on medical devices","authors":"","doi":"10.54920/scto.2019.rawatch.2.12","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.12","url":null,"abstract":"To provide our readers with a good forecast of the changes ahead, the RA Watch editorial team asked different representatives – of the ethics committees umbrella organisation, the industry, and the SCTO network of CTUs – their views about the two ordinances proposed for consultation by the Federal Office of Public Health (FOPH). Their views and opinions refer to the drafted versions of the Medical Devices Ordinance (MedDO) and the ordinance on clinical trials for medical devices (ClinO-MD) as open to comments on 15 May 2019.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"47 2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131648800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-01DOI: 10.54920/scto.2019.rawatch.2.9
O. Goarnisson, J. Sommer
Companies conducting clinical investigations with medical devices in Switzerland should be particularly aware of the following new requirements to become effective with the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), once adopted in its final form and applicable.This article comments on changes that lie ahead relating to: clinical evaluations, in particular exceptions for equivalence; and to clinical investigations (focusing on: pre-market, post-market, monitoring, protecting personal data, and Eudamed. The draft ClinO-MD is based on Chapter VI of the MDR. The text is largely in alignment with international standards for the conduct of clinical investigations with medical devices set out, inter alia, in ISO 14155:2011 and the Declaration of Helsinki. In the EU, the MDR leaves the Member States with a broad scope of discretion regarding the organisation of the assessment of clinical investigations and the applicable authorisation procedures. Companies conducting clinical investigations with medical devices in Switzerland should be particularly aware of the following new requirements to become effective with the ClinO-MD, once adopted in its final form and applicable. This article comments on changes that lie ahead relating to: clinical evaluations, in particular exceptions for equivalence; and to clinical investigations (focusing on: pre-market, post-market, monitoring, protecting personal data, and Eudamed.
{"title":"Clinical evaluations and investigations: Changes ahead in Swiss medical devices laws","authors":"O. Goarnisson, J. Sommer","doi":"10.54920/scto.2019.rawatch.2.9","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.9","url":null,"abstract":"Companies conducting clinical investigations with medical devices in Switzerland should be particularly aware of the following new requirements to become effective with the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), once adopted in its final form and applicable.This article comments on changes that lie ahead relating to: clinical evaluations, in particular exceptions for equivalence; and to clinical investigations (focusing on: pre-market, post-market, monitoring, protecting personal data, and Eudamed. The draft ClinO-MD is based on Chapter VI of the MDR. The text is largely in alignment with international standards for the conduct of clinical investigations with medical devices set out, inter alia, in ISO 14155:2011 and the Declaration of Helsinki. In the EU, the MDR leaves the Member States with a broad scope of discretion regarding the organisation of the assessment of clinical investigations and the applicable authorisation procedures. Companies conducting clinical investigations with medical devices in Switzerland should be particularly aware of the following new requirements to become effective with the ClinO-MD, once adopted in its final form and applicable. This article comments on changes that lie ahead relating to: clinical evaluations, in particular exceptions for equivalence; and to clinical investigations (focusing on: pre-market, post-market, monitoring, protecting personal data, and Eudamed.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"59 8","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114005773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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