www.snf.ch
Wildhainweg 3, P.O. Box 8232, CH-3001 Berne
Phone +41 (0)31 308 22 22 / Fax +41 (0)31 301 30 09
Research on humans
The federal office of public health1 (BAG) and the Swiss Ethic Commissions for clinical research2 provide a comprehensive overview of the legal basis of science on humans (in G,F,I).
As part of the public health sector, research on humans is however in the sovereignty of the Cantons.
Therefore please note that some Cantons have own additional laws and regulations concerning science
on humans.
Clinical trials have to be conducted following the Guidelines for good clinical practice by the ICH3.
The project contains the collection of samples and data from human subjects5,6
The project accesses existing samples or data from human subjects7
The project contains clinical trials of medicaments, medical products or immuno-biological substances (i.e. Heilmittel8,9).
The respective authorization by Swissmedic4
will be filed subsequently
is enclosed
The project contains clinical trials using somatic gene therapy in vivo or using medical products
that contain genetically modified micro-organisms8,9
The respective authorization by Swissmedic
will be filed subsequently
is enclosed
The project contains clinical trials with genetically modified grafts (i.e. ex vivo gene therapy; covered
by the Federal laws on transplantation10,11).
The respective authorization by the BAG
will be filed subsequently
is enclosed
The project contains clinical trials with human or animal grafts (covered by the Federal laws on
transplantation10,11).
The respective authorization the BAG
will be filed subsequently
is enclosed
BAG (G,F,I): http://www.bag.admin.ch/themen/medizin/00701/index.html?lang=de
2
CH Ethic commission: http://www.swissethics.ch
3
ICH-GCP: http://www.bag.admin.ch/themen/medizin/00701/00702/00703/index.html?lang=de
4
Swissmedic: http://www.swissmedic.ch/
Guidelines SAMS:
5
Scientific examinations in humans: http://www.samw.ch/docs/Richtlinien/e_Forschungsunters.pdf
6
Genetic examinations in humans:http://www.samw.ch/docs/Richtlinien/e_GenUnters.pdf
7
Guidelines for biobanks (G) : http://www.samw.ch/docs/Richtlinien/d_RL_Biobanken.pdf
Federal laws:
8
9
Law on Heilmittel (G,F,I): http://www.admin.ch/ch/d/sr/8/812.21.de.pdf
Ordinance on clinical trials with Heilmittel (G,F,I): http://www.admin.ch/ch/d/sr/8/812.214.2.de.pdf
10
Federal determination on transplantation: http://www.admin.ch/ch/d/sr/c818_111.html
11
Ordinance on transplatation: http://www.admin.ch/ch/d/sr/c818_111_3.html
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Patients’ data can generally only be used for scientific purposes if they are either in an anonymized form
or if the patient has given his/her informed consent. If neither case is feasible, the expert commission on
the professional secret in medical sciences11 has to be asked for an authorization.
The project requires the permission by the expert commission on the professional secret in medical
sciences, and the respective authorization
will be filed subsequently
is enclosed
In Switzerland, every scientific project involving research on humans has to be approved by an official
ethics commission2.
The approval by an ethics commission
will be filed subsequently
is enclosed
Declaration:
I hereby declare that I acknowledge the Swiss Acadamy of Medical Sciences’ ethical guidelines, which
apply to my research (SAMS; Scientific examinations in humans, genetic examinations, Biobanks). I
further assert that I will conduct my projects following these guidelines.
Applicant:
Datum:
12
Unterschrift:
Commission on the professional secret: http://www.bag.admin.ch/org/02329/index.html?lang=de