Just like before, the purpose of the new Act is to regulate how traceable biological samples from humans may be collected, stored and used for certain purposes.
“But the new Act also involves some changes. These changes include an expanded scope,” says Linda Paavilainen, research coordinator at Uppsala Biobank.
In short, this means that the purpose determines the application of the law. The current legislation applies to traceable samples obtained from patients in the healthcare system, while the new Act will apply to all traceable biological samples from humans, regardless of the context in which they were obtained.
“This means that samples obtained outside the healthcare system may also be covered by the new Biobank Act,” says Linda Paavilainen.
The new Act aims to facilitate research and clinical trials while maintaining respect for people’s privacy, and address the shortcomings identified in the current legislation. A national implementation project will produce guidelines, document templates, new application forms, training courses, etc.
Training already underway
Uppsala Biobank is holding four webinars this June, two for researchers and two for other staff who take samples from people, in order to inform them about the changes in the legislation. The course Biobank Samples in Medical Research (1.5 credits) will also be offered on 20–24 November 2023. (Note that this course is offered in Swedish only, see link below for details.)
“During the course week in November, participants will receive information about the legislation and rules, how to apply for access to biobank samples, the sample collections that exist, and much more. The course targets doctoral students and researchers as well as other staff who work with biobank samples,” says Linda Paavilainen.
More information about both the webinars and the dates for the course and how to register can be found on the Uppsala Biobank website.