Soini Sirpa
Sirpa Soini, LL.M. works as senior legal adviser in Helsinki, and specializes in biomedical law and regulation. Alongside legal practice, she is engaged in various research and collaboration projects. She is a member of the National Medical Research Ethics Committee of Finland (TUKIJA), Senior legal adviser Academic Medical Center of Helsinki Biobank, and National Biobanking Steering Group (Ministry of Health and Social Affairs). Her pending doctoral dissertation at the Faculty of Law, Helsinki, studies legal pluralism in biomedical regulation.
J Law Med Ethics. 2016 Mar;44(1):24-34. doi: 10.1177/1073110516644187.
Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues.In terms of privacy protection, anonymization is generally not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research.
芬兰旨在成为基因组研究及相关业务的国际领先者，并为此目标颁布了生物样本库立法。《生物样本库法案》要求生物样本库获得批准、接受监管并在国家层面进行登记。在任何特定的研究环境中，许多其他法律也可能适用，例如《个人数据法》、《医学研究法》以及《人体器官和组织医学使用法》。在隐私保护方面，根据芬兰法律，匿名化一般不被允许，因此大多数生物样本库对数据和样本进行假名化处理。然而，芬兰对可识别数据的宽泛理解给与非欧盟国家共享数据带来了困难。此外，对生物样本库研究的同意仅适用于样本及相关数据，不适用于存储在其他健康相关登记处的数据，并且同意仅针对该特定生物样本库的研究领域。这些限制阻碍了用于研究的样本和数据的共享。
