New rules on health research and health data research projects
Among other things, the amendment act implements a number of changes to the Danish Act on Ethics Review of Health Research Projects and Health Data Research Projects ("the Committee Act").
According to the new Section 5a of the Committee Act, the competent research ethics committee can now allow that when reporting health research projects informed consent from the test subjects in accordance with Sections 3-5 of the Act is not obtained in the case of so-called low-risk clinical studies - provided that a number of conditions are met. This provision is therefore an exception to the general starting point of the Act, according to which all trials with 'wet' data - health research projects - that are notifiable under Section 14 require informed consent from the test subject (Section 3(1)) or consent from a representative (Section 3(2)). The exemption thus supports the bill's goal of creating a more flexible framework for health research. The provision does not change the legal position for studies with 'dry' data - health data research projects - which already before the amendment did not require consent.
The phrase "low-risk clinical studies" refers to cases where it is only a question of studying equivalent standard treatments already being used in Danish hospital departments, where the test subjects are not exposed to any other trial intervention and procedures. However, it is specified in the legislative history of the amending act that it is not a condition that the treatment in question is low-risk in itself.
In addition, the amendment means that the current conditions for the committees' assessment of research projects under Sections 18 and 21b are supplemented with a new provision in Section 21c, which is intended to make the rules more flexible for granting authorisation for hypothesis-generating research with large amounts of data. According to the explanatory notes to the bill, the provision has been introduced to ensure that the act keeps up with the technological development that has taken place in the use of health data, including the possibility of using new data-driven methods to analyse extensive amounts of data. It should be noted in this connection that Section 21c also contains a number of conditions that must be met in order for authorisation to be granted for the health research or health data research project. For example, it is a condition that access to data is limited in relation to the stated interest in the field of health research and that special consideration is given to the rights, integrity and privacy of the test subjects.
Before the Act came into force, Plesner also wrote an article about the amendments to the Act. You can read this article here.
Want to know more?
If you would like to learn more about these amendments, as well as the other changes to the Act, please contact Plesner's Life Science team.