BASEC
BASEC (Business Administration System for Ethics Committees) is the portal for the submission to the ethics committees: clnical trials, research projects, amendments, notification of safety events, clarification of responsibilities, requests for temporary autorizations, general questions, etc.
BASEC is not an electronic repository (Archiv) for study documents. Consequently, drafts that are not submitted, are deleted after 6 months inactivity.
Therefore, it is required that the sponsors and investigators regularly save and archive the study documents, as well as the letters and emails received from the ethics committee, on their own IT-infrastrukcture.
Detailled information on how to use BASEC can be found in BASEC itself and on the page «Frequently Asked Questions».
Link to BASEC (log in page)
List of documents required for submissions
Note: The BASEC-submission-form will automatically ask for the documents required according to the selection of the project-type. This document is given here for reference only.
List of documents required for submissions of clinical trials
List of documents required for submissions of research projects
News
Implementation: guiding principles for registers in human research
02.06.2020
Advisory opinion of the ethics committees on registers, biobanks and research projects in accordance with Art. 51 HFG
The pure creation of data registries or biobanks is not formally subject to authorisation under the HRA. However, projects that re-use these data and biological samples must generally be approved by an ethics committee. The ethics committees now offer a preliminary examination of the data registries and biobanks.
Read moreNew submission Form available: Advice on ethical questions/comments on research projects not subject to the HRA.
02.06.2020
Use the form "Advice on ethical questions/comments on research projects not subjet to the HRA" to obtain an advice on a data registry or on a biobank (without a concomitant submission of a research project), or to obtain comments on a research project not subject to the HRA, and specifically projects carried out abroad. The research project must be close to the ethics committee’s area of expertise. The form fulfils the requirements set by Article 51 lit 2 HRA.
Information on the corona virus
24.03.2020
Please consult the dedicated COVID-19 website on swissethics.ch for news on the corona virus, guidance documents on the conduct of clinical trials and research projects in Switzerland, and other information. The COVID-19 website is updated regularly with new information, as it becomes available.
To promote transparency and facilitate the coordination of research on COVID-19, swissethics now publishes all approved and all submitted clinical trials and research projects on the dedicated COVID-19 website. Researchers are kindly asked to find out which projects are already underway in order to avoid national duplications. Should you oppose to that, please contact swissethics at info@swissethics.ch before you submit the project.
Information on the coronavirus
18.03.2020
Sponsors, investigators and project leaders of clinical trials and research projects in Switzerland must ensure that the studies are conducted in line with the COVID-19 Ordinance 2 (available in German (PDF), French (PDF) and Italian (PDF), issued by the federal government on 16 March 2020.
In particular, participants over the age of 65 and participants with underlying medical
Read moreInformation on the corona virus
16.03.2020
The corona virus also does not stop at the ethics commissions. Not all the scheduled committee meetings can be held regularly at the various locations. This means that there may be delays in the decision-making process and therefore deadlines cannot always be met. The ethics committees thank you for your understanding.
Nevertheless, the reviews and approvals of studies investigating the disease or investigational medicinal products for COVID-19 are of course treated with priority.
We thank you for your cooperation in this critical situation. In individual cases, the ethics committees are available to answer questions on this matter directly.