19 July 2022

Human research is more than classic clinical trials can cover. A new DKF training explains the different legal requirements for the many types of research projects that can be conducted.

About 80 percent of human research projects submitted to ethics committees are based on the collection or reuse of health-related data or biological material. Research with data and samples covers a wide range of possible projects that are subject to different legal regulations. These are set out in the Human Research Ordinance (HRO), one of the accompanying legal texts to the Human Research Act (HRA), and are not always easy to interpret.

Orientation in the multitude of regulations

In a collaboration between the Training & Education and Regulatory Affairs teams, and with the expert support of Nienke Jones, Head of the Scientific Secretariat of the Ethics Committee Northwestern and Central Switzerland (EKNZ), the new online training course "Human Research Beyond Clinical Trials" was added to the DKF's course offering.

It is a low-threshold offering that explains to researchers in a short time and with little effort the principle differences between the individual project types under the Human Research Ordinance. The training presents the provisions of the HRA step by step and with the help of new didactic tools such as explanatory videos. The aim is to familiarize researchers with the requirements for a planned project and thus speed up the preparation phase and approval process.

"Human Research Beyond Clinical Trials: Conducting HRO Projects"

New online course from the Department of Clinical Research

Online course in 4 modules with integrated quizzes. The course can be interrupted at any time and continued at a later date.

Course language

Module 1
Key aspects of HRO projects - classification, guidelines, requirements

Module 2A
HRO projects based on the collection of biological samples and health-related data

Module 2B
Requirements for HRO projects involving further use of existing samples and data

Module 3
Conduct and completion of HRO projects in general

Target audience
All professional groups in clinical research; no prerequisites regarding previous knowledge

Confirmation of participation

Time required
Approximately 2 to 4 hours, depending on prior knowledge and requirements

CHF 200
Free of charge for members of DKF research groups