Research projects involving persons that require authorisation
Research projects involving persons can basically be divided into two groups that differ in terms of the effect they have on participants.
Clinical trials actively induce an effect among research participants – using medicinal products, medical devices or other health-related interventions – to investigate their impact on participants’ health or the structure and functioning of the human body.
Non-clinical trials don’t actively induce an effect among research participants – either just the health-related personal data are collected or else biological samples (such as saliva or blood) are taken.
Research projects involving persons can be divided into two groups – the type of effect they have on participants determines the assigned category.
The kofam website provides a categorizer to assist in assigning and categorising research projects. Further information is available here.
Research projects are categorised depending on the type of effect induced among, and the risk to, participants. The categorisation, in turn, will determine the authorisations that are required and the authorisation authorities that need to be contacted.
Clinical trials can be assigned to the following categories:
The impact on participants in Category A research projects entails minor or known risks. This may involve, for example, authorised medicinal products, CE-compliant medical devices or other previously established health-related interventions.
The impact on participants in Category B research projects entails slightly higher risks. This may involve, for example, off-label use of medicinal products or interventions. The associated risks are not yet known, which is why the research project as a whole is assigned to a higher risk category.
A research project falls into Category C if it involves, for example, use of a medicinal product that is not authorised in Switzerland or a medical device that is not CE compliant.
Categories A and B exist for non-clinical trials as well – Category A projects entail minimal risks and burdens for participants, Category B projects entail more than minimal risks and burdens.