Guideline and swissethics-template for drafting additional information (addendum) for study participants in line with the General Data Protection Regulation (GDPR)

October 2, 2018

In exchange and cooperation with data protection experts and representatives of the pharmaceutical industry, swissethics publishes a recommendation on the application (or non-application) and an addendum template to the patient information on the European General Data Protection Regulation (GDPR) within the framework of research in Switzerland. The document is available in German, French and Italian.

The latest on the application of the GDPR in Switzerland

July 19, 2018

At a joint exchange meeting with representatives of data protection and industry on 13 July, the jurists of the Swiss Ethics Committees have laid down the further procedure regarding the applicability of the general data protection regulation (GDPR) to the human research in Switzerland. In principle, it can be assumed that the principle of equivalence between the Swiss law and the EU regulation applies and that patients in Switzerland do not need to be additionally and newly informed about the European data protection rights. It is up to the sponsor and the hospital to determine in each individual case whether or not the GDPR is applicable or not to a clinical trial or a research project.

If the sponsor and the hospital should envisage to inform the study participants about the GDPR, then the information must be submitted in the form of an addendum to the informed consent. This addendum is only acknowledged by the study participants and is therefore not a consent from a legal point of view. Consequently, this addendum must be submitted to the ethics commissions for information only, but not for approval. However, the ethics commissions may request corrections to the documents before acknowledging them. Long and incomprehensible explanations or, for example, naming the Federal Data Protection Commissioner for questions or complaints are not accepted.

Summary report of the HRA working group with proposals for the revision of the law and the ordinances

July 17, 2018

In recent months, a swissethics working group has drawn up proposals to show where the ethics commissions believe the Human Research Act (HRA) and the ordinances need to be revised. The final summary report, written in German, can be accessed under the following link. This document is aimed at all stakeholders who are involved in research involving human beings and at the legislator. The proposals are to be considered as a basis for the further dialogue.

BASEC: Notification of safety events through a new dedicated Safety Form

June 6, 2018

The online-platform BASEC (Business Administration System for Ethics Committees) to submit research project has a new feature: there is now a dedicated separate form for notifications of safety events to Swiss Ethics Committees.

Starting June 11, 2018, all notifications of safety events (SE/SAEs, SUSARs, DSUR/ASR, urgent safety notifications, other safety notifications) must be done exclusively through the new Safety Form. This also includes the submission of documents that contain information which reveals treatment assignment in a double-blind study. The submission of safety reports by email or through the main application form will no longer be accepted.

Please see this FAQ for more detailed information on how to use the new Safety Form. Further complementary information are also available in BASEC. The new dedicated Safety Form has several advantages, among others:

  • One single dedicated Safety Form per project, used for the notification of all safety documents of that specific project.
  • The Safety Form will not be locked after a submission. Thus allowing multiple parallel notifications, without any constraints for the researchers, even during the review of the documents by the Ethics Committee.
  • The Safety Form can be owned and managed by a different person or team (e.g pharmacovigilance) other than the owner of the main application form. This allows the notification of safety documents that contain information which reveals treatment assignment in a double-blind study, without disclosing the treatment to unauthorized persons.
  • Access to the individual screens of the safety form (SE/SAE, SUSAR, …) can be managed per project by the owner of the Safety Form.
  • Simple structured screens and sections which allow the applicants to keep track of which safety document and version (first submission, follow-ups) has been submitted throughout the course of the study.

General Data Protection Regulation, GDPR

May 23, 2018

On 25.5.2018 the European Data Protection Regulation (GDPR) comes into force. swissethics has therefore updated the legal disclaimer (available in German and French).

RoPS (Registry of ongoing Projects in Switzerland)

May 11, 2018

RoPS (Registry of ongoing Projects in Switzerland) is the new registry of all research projects approved by the ethics committees and ongoing in Switzerland, for the general public.

To promote transparency of the research involving human beings, swissethics had regularly published a PDF list of all ongoing research projects on its webpage.

In line with this endeavor and to help the general public, researchers and institutions to navigate through the vast number of ongoing projects and take advantage of the available data, swissethics is releasing the web-based portal RoPS.

RoPS is a registry of all research projects ongoing in Switzerland. The users can run queries with free texts or by using predefined key terms, use the available filters to sort the lists, print the selections or export lists in .xlsx or .csv format, set display preferences for the data, and more.

The portal can be accessed at ongoingprojects.swissethics.ch or through the link on swissethics.ch.

More detailed information on clinical trials can be found on the SNCTP (Swiss National Clinical Trials Portal), operated by the FOPH.

General Data Protection Regulation (GDPR), also relevant for Switzerland

April 17, 2018

On 25 May 2018, the new General Data Protection Regulation (GDPR), will enter into force in the EU, which will also require immediate action in Switzerland for further, smooth international data traffic. In Switzerland, the Federal Act on the Data Protection (FADP, SR 235.1) is currently under revision. Various cantons will also adapt their data protection legislation.

In human research, this affects all internationally active institutions and companies that collect and process personal data from EU residents or send data from Swiss citizens abroad (EU). Internationally compatible solutions must therefore be found for data protection.

The required information to the patients regarding changes in the data protection is possible for example on a temporary basis by means of additional information documents. These must be submitted separately to the competent ethics committees. In the medium term, the chapter on the confidentiality in the template of swissethics will be adapted in such a way that no further use of additional information documents will be required. However, this will only be possible after the entry into force of the revised Federal Act on Data Protection (date still unknown). swissethics will provide more information in due course.

Amendment to Annex I of the Clinical Trials Ordinance (ClinO) as of 1 May 2017

May 1st, 2017

The ICH-GCP Guideline of 10 June 1996 was amended by the International Harmonization Conference on 9 November 2016.

As of 1 May 2017, Annex I of the Clinical Trials Ordinance (ClinO) refers to the amended Guideline ‘ICH E6(R2)’. Hence, as of 1 May 2017, the Guideline ‘ICH E6(R2)’ for clinical trials with medicinal products and transplant products is applicable in Switzerland.

Scale of fees

November 4, 2016, update: 1.1.2017

Silent Approval

July 11, 2016 (updated)

The following changes and documents are acknowledged by the Swiss cantonal ethics committees by means of a „Silent Approval“:

  1. Non-substantial amendment (ClinO Art.29 Abs. 6),
    N.B. non-substantial amendments for HRO projects don’t need to be submitted at all)
  2. Annual Safety Report (ClinO Art.43)
  3. Clinical Investigator’s Brochure (IB) (ClinO Annex 3)
  4. Completion of the clinical trial (ClinO Art. 38 Abs. 1) and of the research project (HRO Art. 22 Abs. 2, Art 36 Abs. 2 and Art. 40 Abs. 2).
    N.B. The “Silent Approval” does not apply to the discontinuation or interruption of the clinical trial or of the research project.
  5. Closing report (ClinO Art. 38 Abs. 3)

If the competent ethics committee has any comments or questions, it will contact the applicant. If there is no feedback within 15 days, or as soon as the project has been opened again in BASEC, the applicant can regard the documents as acknowledged by the ethics committee.

The EC St. Gallen merges with the EC Thurgau

June 1st, 2016

On June 1st 2016 the ethics committee of the Canton St. Gallen merges with the ethics committee of the Canton Thurgau. The new created Ethics Committee East Switzerland (EKOS) is so responsible for the cantons SG, TG, AR and AI. The EKOS has its office in the city of St. Gallen.

BASEC

December 17 2015

swissethics wishes to thank all applicants, who already used the new web portal BASEC to submit their new projects. All submissions were received without problems.

Starting from January 1st 2016 the online-submission to all Swiss Ethics Committees is mandatory. No submissions or updates outside of BASEC will be accepted. The check-lists and the "old" base-form will be obsolete and replaced entirely by the online-form in BASEC (Research Project Application Form).

Submission of updates and new documents for projects (amendments, safety-reports etc.):

  • Projects that were initially submitted before BASEC: As of January 1st 2016 there will be an additional simplified online-form in BASEC to submit updates to these projects.
  • Projects that were initially submitted through BASEC: Updates are submitted through the existing form of your project (see also this FAQ article)

From January 1st BASEC will also offer a form to submit "clarifications of responsibility" to Ethics Committees.

The upload of documents on infrastructure and "staff list" is now optional to reduce the administrative burden for many projects. In special cases the Ethics Committees shall still have the right to ask for documentation on infrastructure and qualifications of staff members at the research site.

Office swissethics

December 17 2015

On December 1st 2015 Dr. Pietro Gervasoni began to work as managing director at the office of swissethics in Bern (phone: 031 306 93 95, pietro.gervasoni@swissethics.ch).

Online submission of research projects

October 6 2015

The online-platform BASEC (Buisness Administration System for Ethics Committees) to submit research project to Swiss Ethics Committees will be opened shortly.

The web-portal’s address is https://submissions.swissethics.ch. Logins can already be created, the submission form will be available on Monday, October 26 2015, and the submission function will be activated on November 2nd 2015.

The system is supposed to be self-explanatory and was tested by stakeholders from academy, industry and other interest groups.

Starting from November 2nd 2015 all new projects should be submitted through the web-portal. As of January 1st 2016 the online-submission is mandatory and replaces all former submission methods (paper, CD, other storage devices). Please use these former submission methods for amendments and additions to old projects until December 31 2015; from January 1st 2016 the web-portal will also be compulsory for old projects.

Updated information will be published on this webpage and through the newsletter.

This document offers answers to frequently asked questions related to the introduction of BASEC.

New chair/vice-chair elected

June 25 2015

On the last general assembly of swissethics (June 11 2015) Ms Dr. med. Susanne Driessen, chairwoman of the Ethics Committee St. Gallen, was elected new president of swissethics. Mr Prof. Dr. med. Patrick Francioli, president of the Ethics Committee Vaud, remains vice-president of swissethics, Dr. iur. Jürg Müller of EKNZ (past-president of swissethics) was elected second vice-president of swissethics.

Research based on registries

May 15 2015

For research (sub)projects using data from registries or other existing databases, ethical approval needs to be obtained from the ethics committee in the region where the Principle Investigator is located.

Redesign of www.kofam.ch

March 31 2015

The website kofam.ch has been completely revised. In addition to basic information on the regulation of human research in Switzerland, kofam.ch now offers several new tools for researchers:

Two short videos explain the most important aspects of research involving humans and provide information on the requirement for approval, selecting the right category and submitting applications for human research projects.
On the SNCTP trial portal you can search for clinical trials registered in Switzerland, and new clinical trials can be registered here until the introduction of BASEC, the application submission system of the ethics committees.

Human Research Act (HRA)

The new legislation on research involving humans goes into effect on January 1, 2014. The legislation will affect the work and workflow of ethics committees in Switzerland in the following ways:

  • The number of ethics committees will be reduced.
    Please visit the new directory of committees to find the committee competent for your canton or region.
  • Additional information will be published on the new webpage of the Coordination Office for Research Involving Humans (KOFAM)
  • Forms, templates and guidelines will be revised. The revisions are underway and will be published soon.
    Templates will be listed in the section Templates/recommendations upon ratification by the EC-presidents/Federal office of public health (BAG). The use of these forms and templates is mandatory for submissions.
  • Information on the new legislation and ordinances will be added to the section legislation/guidelines. This section is updated regularly.

Ethics committees for research involving humans (EC)

Swissethics.ch is the joint web site of the Swiss Association of Ethics Committees for research involving humans. A short list of what you will find here:

  • general information about the operation/activities of ethics committees
  • mandatory templates for committees and applicants
  • links to all cantonal or regional ethics committees
  • information about activities of swissethics and about training/further education

Swissethics is organised as an association (statutes, german text). Its members are all the recognised regional/cantonal ethics committees of Switzerland.

Swissethics is mandated by the Coordination office for research involving humans (KOFAM) and the conference of cantonal ministers of public health (GDK) to:

  • coordinate and standardize working processes
  • inform about and organize training and further education for members of ethics committees

Contact details

association's officechairwebsite

swissethics
Dr. Pietro Gervasoni
Haus der Akademien
Laupenstrasse 7
CH-3008 Bern
info@swissethics.ch
Tel.: +41 31 306 93 95 (Mon-Thu)

swissethics
Dr. med. Susanne Driessen
Scheibenackerstrasse 4
CH-9000 St. Gallen
susanne.driessen@swissethics.ch

Webmaster

Email