Operating principle of the Act
The HRA works as follows: Research on human beings is categorically prohibited unless a research project is approved by an independent supervisory body in accordance with the statutory requirements. In certain clearly regulated exceptional cases, human research projects may also be conducted without authorisation.
In its substance, the HRA defines the principles which need to be complied with for any human research project. The Act also has special provisions for specific types of research, for example research on persons lacking capacity, research involving prisoners or research involving deceased persons.
The classification of research projects according to the risks involved for the participants is also crucial. The research project category is pivotal in determining the authorisation procedure as well as for the restrictions concerning the project’s execution and reporting.