The federal law on human research clarifies the requirements of the Act in relation to the ethical, scientific and legal requirements that must be observed in research on humans. Here, the legal and administrative requirements depend on the extent of the risk to participating in the research person.
The legal regulation is structured as follows:
- Ordinance on Clinical Trials in Human Research (Ordinance on Clinical Trials, KlinV):
The KlinV regulates all research projects in accordance with Article 3 lit. l of the Human Research Act qualify as clinical trials. Objects of regulation, the regulation of the requirements for the conduct of clinical trials, the procedure regarding authorizations and notifications, as well as the registration of clinical trials.
- Regulation on Human Research, with the Exception of Clinical Trials (Human Research Regulation, HFV):
HFV regulates all research projects within the scope of the Human Research Act, with the exception of clinical trials. These include research projects that are associated with the removal of biological material or the collection of health-related data and research projects that do already use existing material or data.
- Law, for Human Research Act (Organisation Regulation HFG, OV-HFG):
The OV-HFG regulates the organization of ethics committees for research in terms of their composition and the procedural provisions. Furthermore, it defines the tasks of the Coordination Unit.
The Human Research Act and the regulations take effect on 1 January 2014 [read more…].
Impact on the Conduct of Non-Interventional Studies (NIS)
- No longer need to send documents to SwissMedic for classification
- Conduct of NIS governed by the Human Research Regulation (HFV)
- The Ethics Committees (ECs) have been reorganised (Refer to the Swiss Ethics Link)
- New EC submission requirements for NIS (Refer to the Swiss Ethics Templates)
- EC templates and forms have been updated (Refer to the Swiss Ethics Templates)
- Clear guidance on the requirements for the collection and use of biosamples (refer to the HFV)
- Clear guidance of the re-use of data where no consent is present (refer to HFV)
- Clear guidance on the use of data from deceased patients (refer to HFV)
- Newly established SNCTP (Swiss National Clinical Trials Portal – see image below) is also the subject of the currently ongoing design phase
- A new portal is being established for online ethics committee applications. The project BASEC (Business Administration System for Ethics Committees) is currently in the design phase and can be implemented at the earliest in the second half of 2014