Biobanks
Since the late 1990s, interest in the collection and analysis of human materials for medical research has increased due to advances in diagnostics, genetics, cellular techniques, and information technology. Human biological material such as DNA, blood, tumor and other cells, tissues, etc. are stored in so-called biobanks at hospitals, research institutes, and private companies.
There is no universally accepted definition of a “biobank”; however, all definitions essentially recognize the importance of establishing and maintaining a link between stored biological samples and well-documented data obtained from patient medical records and healthy individuals. In this topic, we will use the following definition formulated in 2006 by the Royal Netherlands Academy of Arts and Sciences (in Dutch: Koninklijke Nederlandse Akademie van Wetenschappen, or KNAW):
"“A biobank is a repository of biological samples for the use of research or treatment in which the samples are linked with medical, genetic or other data of the donors.”"
In addition to the enthusiasm arising from the use of biobanks and biobanked materials for medical research, there is also controversy regarding the issues associated with donor consent (specifically, informed, broad, versus open consent), the protection of donor privacy (including the issue of anonymized or coded samples), control of the biological samples, and the commercial use of these samples.
In some countries (for example, the United Kingdom) many of these issues are regulated by the government; however, this is currently not the case in the Netherlands. For a brief introduction to biobanks and examples in the Netherlands, read the article below.
In the Netherlands, the Dutch Medical Scientific Societies (in Dutch: Federa) has developed a Code of Conduct for the Responsible Use of Human Tissue in the Context of Medical Research (in Dutch: Verantwoord omgaan met lichaamsmateriaal ten behoeve van wetenschappelijk onderzoek). This self-regulatory code of professional biomedical conduct covers the secondary use of tissues and cells, as well as de novo biobanking. The English version of this Code can be found on the Federa website.
There are three general categories of biobanks.
- Secondary use biobanks
These biobanks contain collections of stored biological materials originally collected from patients for diagnosis or treatment, from which the residual biological material can be used for biomedical research. - Population biobanks (or de novo biobanks)
These biobanks contain stored biological materials obtained from healthy individuals specifically for use in scientific research. - Clinical biobanks
These biobanks contain stored biological materials consisting of additional samples obtained from patients with a particular condition or disease specifically obtained for use in scientific research designed to gain insight in the condition/disease.
In April 2017, former Dutch Minister of Health Edith Schipper announced a bill to be discussed entitled the Dutch Tissue Act (in Dutch: Wet Zeggenschap Lichaamsmateriaal), in which donor privacy, the access and use of human biological specimens, and review by accredited MRECs
would be regulated.
The current version of this bill contains a paragraph in which the biological materials can be used — albeit under very extreme circumstances— for criminal investigation without the donor’s consent. This paragraph has evoked considerable debate among medical and legal professionals in the Netherlands.
The consultation period for this bill closed on June 23, 2017. The Dutch government is now evaluating all reactions to this proposed bill and will obtain a recommendation from the Dutch Council of State (in Dutch: Raad van State), after which the bill (either in its current form or in a modified form) will be send to the Dutch Parliament.
This topic will be revised and/or updated after the Dutch Tissue Act has been approved by the Dutch Parliament or as other significant developments occur.