Development↦Ethics and Laws↦Federal Office of Public Health↦Submission
Was betrifft es? Warum ist das wichtig?
Before Swissmedic and the Ethics Committee (EC) approve a study, they seek the opinion of the Federal Office of Public Health (FOPH).
Swissmedic seeks the opinion of the FOPH in:
- Studies on gene therapy and genetically modified pathogenic organisms (risk-categories B and C)
- IMP/MD combination (in vitro) studies capable of emitting ionising radiation (risk-category C)
- Studies using a radiation source exceeding 5mSv per year for participants (risk-category C)
The EC seeks the opinion of the FOPH in:
- Studies in transplantation of human organs, tissues and cells (risk-category C)
- Studies using a radiation source exceeding 5mSv per year for participants (risk-category C)
Regarding studies of gene therapy and genetically modified / pathogenic organisms, Swissmedic together with the FOPH and the FOEN jointly issue guidelines on risks to human health and the environment.
Was muss ich befolgen?
As a SP-INV, submit the following studies for approval to the FOPH:
- Transplantation of human organs, tissues and cells (risk-category C)
- Studies with radiation sources that exceed 5 mSv per year for participants (risk-category C)
As these studies are also submitted to EC and Swissmedic, they can be submitted in parallel.
Refer to the ClinO and its annexes regarding submission requirements to the FOPH.
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
FOPH – see in particular tabs
- Medicine & research / Research involving humans
- Medicine & research / Research involving human embryonic stem cells
- Laws & Licenses / Applications & Approvals / Biosafety: notifications & authorisations
- Laws & Licenses / Applications & Approvals / Exemption authorisations and authorisations banned narcotics
Swiss Law
ClinO – see in particular articles and annexes
- Art. 28 Procedure for investigation with radiation sources
- Art. 35 Procedure for gene therapy and genetically modified pathogenic organism
- Art. 36 Procedure for IMP and in vitro diagnostic MDs or combination capable of emitting ionising radiation
- Art. 50 Coordination in authorisation procedures for organ, tissue or cells transplantation
- Art. 52 Exemption from mandatory authorisation for organ, tissue or cells transplantation
- Annex 3 Submission requirements for investigation with radiation sources
- Annex 4 Submission requirements for transplantation, gene therapy, genetically modified/pathogenic organism
ClinO-MD – see in particular articles and annex
- Art. 14 Procedure for investigation with radiation sources
- Art. 18 Trials with MD capable of emitting ionising radiation
- Annex 1 Submission document list
HRO – see in particular article and annex
- Art. 19 Procedure for trials involving radiation sources
- Annex 2 Submission document list