What is it? Why is it important?
The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) “other clinical studies” which do not include the use of:
- A Medicinal Product (MP)
- In vitro diagnostic Medical Devices (MDs) or products
- Combination of MP and MD
- Combination of non-viable human tissue/cells and MD
- Transplantation and transplant products
These studies use or implement other types of medical, psychological, or physiological interventions or procedures (e.g. surgery, psychotherapy, physiotherapy, behavioural sciences, diet and nutrition).
Based on the study intervention, risk categories A or C apply, with A having a low and C a high risk.
Categorisation of health-related interventions in “other clinical studies”:
Category A: if the study
- Entails only minimal risks and burdens; or
- Is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria
Category B if the study:
- Entails more than minimal risks and burdens; and
- Is not recognised as standard as specified under category A
In particular, minimal risks and burdens may be associated with:
- Surveys and observations
- Peripheral venous or capillary blood sampling and skin punch biopsies of limited extent
- Non-invasive interventions removing or collecting bodily substances, in particular, saliva, urine and stool samples
- Taking swabs
- Magnetic resonance imaging scans without a contrast medium
- Ultra-sound examinations or electrograms
- Examinations using MDs which bear conformity markings and without using a contrast medium, or using authorised MP capable of emitting ionising radiation, provided that the effective dose is below 5 mSv per research project and per person concerned
What do I need to do?
For “other clinical studies” you are required to know and comply with the requirements defined in the ClinO ordinance:
- Familiarise yourself with the organisation of the various chapters and sections
- Focus on the articles that are relevant to your study
“Other clinical studies” must be submitted and approved by the EC prior to implementation.
Thus, submit your application dossier to EC, who provides a reply within:
- 30 days for monocentric studies
- 45 days for multi-centre studies
Studies that fall under the category of “other clinical studies” in ClinO, are exempt from submission and approval by regulatory authorities (e.g. Swissmedic, FOPH).
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
Swissethics – see in particular
- Templates and checklists
- Study protocols / Other clinical trials
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
FEDLEX – law is available online under number
- 810.305 ClinO
ClinO – see in particular articles
- Art. 2 Definition of minimal risks and burdens
- Art. 61 Categorisation of other clinical studies
- Art. 62 Procedures and deadlines EC