Regulation of stem cell research in Denmark
I- Research on human stem cells
A) Current legal position
Cells and tissues may be collected and stored for research without explicit consent since Danish law has an opt-out system. Indeed, patients who do not wish their cells and tissues to be used for other purposes besides diagnosis and treatment of themselves may notify the Registry for the Use of Tissues of their decision.
When stored cells and tissues are used for research purposes an informed consent is required under the Act on Biomedical Research Ethical Evaluation of medical research projects. However, the regional Research Ethics Committee may derogate from the requirement in cases of registry based research and does not involve any health risk or other strain on the research subject, or it is impossible or a burden to obtain consent.
If a researcher would like a donor to donate cells directly to a specific research project an informed consent is required under the Act on Biomedical Research Ethical Evaluation of medical research projects.
If collected cells, that can be linked to the donor (not anonymised cells), are to be used in a research project a notification to the Regional Biomedical Research Ethics Committee (For instance Greater Copenhagen Regional Biomedical Research Ethics Committee) is necessary and the research cannot commence until the Committee has issued an approval. As stated above an informed consent is required unless the regional research ethics committee find that the requirements for derogation are met, in which case research may be carried out without obtaining an informed consent.
In some instances the Data Protection Authority must be notified of the research project.
If the cells to be used in research are anonymous or anonymized no notification is necessary. Research on cell lines or cell cultures need not to be notified to the Committee if the underlying material came from research using collected cells/tissues that had already gained approval.
If the cells are intended for use in the human body the requirements of the Human Tissues Act must be followed: Storage, quality assurance, traceability etc. The Act implements the European Union Tissues and Cells Directive 2004/23/EC. In some cases an authorisation from the Danish Medicines Agency is required. In case of experimental treatment, authorisation is also required from the regional Biomedical Research Ethics Committee.
B) Ethical and regulatory oversight
Registry for the use of tissues and cells (responsible authority for the Registry is the Health Data Board): to be notified if patients do not want their tissues and cells to be used beyond therapeutic purposes, such as for research.
Regional Biomedical Research Ethics Committee: to approve the research project in which collected cells are not anonymised. Also approves experimental treatment research projects. (List of regional committees )
The National Biomedical Research Ethics Committee functions as the appellate body and as first instance reviewer of research within complex areas (including research concerning medicines for advanced therapies and research involving whole-genome-sequencing if informed consent derogation is requested)
Data Protection Authority: To be notified of the research project in which collected cells are not anonymised.
Danish Medicines Agency authorizes clinical trials in humans using medicines
II- Research on human embryonic stem cells
Special rules apply for human embryonic stem cells and cell lines. Approval must always be obtained from regional Biomedical Research Ethics Committee. If the research falls within the so-called complex areas (including research concerning medicines for advanced therapies and research involving whole-genome-sequencing if informed consent derogation is requested) then the National Biomedical Research Ethics Committee must give an authorisation for research
A) Current legal position
According to the Act on Assisted Reproduction human embryonic stem cells can only be derived from embryos that are surplus in the fertility clinic and only for the purpose of:
1) improving IVF-technologies,
2) improving techniques used to genetic testing of embryos to diagnose serious genetic disease or chromosomal anomaly, or
3) to generate new knowledge that improves treatment of disease in humans (Act on Assisted Reproduction).
Imported embryonic stem cell lines must have been derived from surplus embryos.
Approval for research must be obtained from the regional or National Biomedical Research Ethics Committee. The committee must consider the requirements both in the Act on Assisted Reproduction (surplus embryos, consent from donating couple, aim of research using embryos) and the general requirements in the Act on Biomedical Research Ethical Evaluation of medical research projects. For that reason the research protocol must besides the regular information on purpose, methodology, literature, grants and publication strategy also document that the donating couple consented to the storage of the embryo and to the use of the embryo for the research. In case of imported embryonic stem cell lines the same requirements must be met and documented.
B) Ethical and regulatory oversight
Biomedical Research Ethics Committee: to approve the research protocols on human embryonic stem cells and cell lines. As stated above it can be the regional or National Biomedical Research Ethics Committee depending on whether or not the research falls under the so-called complex area.
III- Selected bibliography
A) Laws, regulations, guidelines
Act on Biomedical Research Ethical Evaluation of medical research projects
Ministerial Order on Use of Tissue Registry
B) Literature
Hartlev, Mette. Banks, Repositories and Registries of Stem Cell Lines: The Challenges to Legal Regulation. Translational Stem Cell Research: Issues Beyond the Debate on the Moral Status of the Human Embryo. ed. / Kristina Hug; Göran Hermeren. New York, Dordrecht, Heidelberg, London : Springer Publishing Company, 2011. p. 251-264.
Herrmann, Janne Rothmar. Retsbeskyttelsen af fostre og befrugtede æg : om håndteringen af retlige hybrider. København : Djøf / Jurist- og Økonomforbundet, 2008. p. 1-385.
Hartlev, Mette. Legitimering af stamcelleforskning : Samspil mellem lovgivning og teknologi. Håbets teknologi: Samfundsvidenskabelige perspektiver på stamcelleforskning i Danmark. ed. / Lene Koch; Klaus Høyer. København : Handelshøjskolens Forlag, 2007. p. 45-66.