Concept↦Ethics and Laws↦Study Categorisation↦Risk Categories
What is it? Why is it important?
The HRA ordinances (ClinO, ClinO-MD, HRO) define three possible risk-categories, namely A, B, or C, with category A resenting a low risk and category C a high risk. Based on study type, either three, two or no category apply.
- Based on ClinO, risk-categories of the following study types are set as follows:
- Investigational Medicinal Product (IMP) = A, B, C
- A combination of IMP and an Investigational-Medical-Device (IMD) = A, B, C
- Standardized transplants = A, C
- Gene therapy, genetically modified or pathogenic organisms = A, B, C
- Transplantation = A, C
- Ionising radiation = B,C
- Other clinical studies = A, B
- Based in ClinO-MD, risk-categories for Medical Device (MD) studies are either:
- A, which are further subdivided into A1 and A2
- C, which are further subdivided into C1, C2 and C3
- Based on HRO, risk categories of research projects are set as follows:
- Projects with patients or healthy volunteers = A, B
- Further-us of health-related personal data (HRpD) and biological material (BM): = none
- Deceased persons, Embryos, and Foetuses = none
What do I need to do?
As a SP-INV:
- Select the Ordinance (e.g. ClinO, ClinO-MD or HRO) that applies to your study
- Use the KOFAM risk-calculator to support you in defining the risk-category of your study (e.g. A has the lowest and C the highest risk)
- If still in doubt, submit your questions to the Ethics Committee (EC) through BASEC portal. They can provide you with useful advice
- Upon EC submission, include the defined risk-category of your study and its rational
The EC reviews the defined risk-category of your study, and can decide to change its category to a higher or lower risk level.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
External Links
Swissethics – see in particular
- BASEC: the portal for EC submission
References
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
Swiss Law
ClinO – see in particular articles and annex
- Art. 19 Categorisation of clinical trials of medicinal products
- Art. 20 Categorisation of clinical trials of products under Article 2a paragraph 2 TPA
- Art. 21 Categorisation of clinical trials of transplant products
- Art. 22 Categorisation of clinical trials of gene therapy and genetically modified or pathogenic organisms
- Art. 49 Categorisation of clinical trials of transplantation of human organs, tissues and cells
- Art. 61 Categorisation of other clinical studies
ClinO-MD – see in particular article
- Art. 6 Categorisation of
- investigations
HRO – see in particular article
- Art. 7 Categorisation
IvDO – see in particular
- Art. 14 Classification