New Rules On Health Research And Health Data Research Projects

• Published date: 13 February 2024
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Privacy, Privacy Protection
• Law Firm: Plesner
• Author: Mette-Marie Buch Henrichsen

On 1 January 2024, an amending act on the ethical conduct of health research and health data research projects came into force.

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...