Regulatory Environment for Biobanking in Estonia

The regulatory framework for biobanking in Estonia is fragmented. Whilst a specific law applies to the population-wide biobank, other entities engaged in biobanking are subject to rules stemming from various legal sources. In the case of the population biobank, participants give open consent for their data and tissue to be used in genetic research. Most other entities do not have the possibility to obtain open research consent for the use of personal data. However, national data protection law enables the use of personal data in research without the consent of individuals.

In contrast, since no stricter requirements are set, open consent can be used when tissue is obtained directly from individuals for research purposes. However, if tissue is initially obtained for other (research) purposes, further research use requires written consent in the case of blood, while due notification will suffice for most other types of tissue.

• Primary Source

• Alternative Source