July 11, 2016 (updated)
The following changes and documents are acknowledged by the Swiss cantonal ethics committees by means of a „Silent Approval“:
- Non-substantial amendment (ClinO Art.29 Abs. 6),
N.B. non-substantial amendments for HRO projects don’t need to be submitted at all)
- Annual Safety Report (ClinO Art.43)
- Clinical Investigator’s Brochure (IB) (ClinO Annex 3)
- 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.
- 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.
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.
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, email@example.com).
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:
- the revised wizard ('categoriser') to help categorise research projects
- some real examples of trials,
- and a glossary in four languages.
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.
- coordinate and standardize working processes (leading committees)
- manage external representation: Swissmedic, FOPH (federal office of public health), industry
- inform about and organize training and further education for members of ethics committees