Laws & ethics
Laws, ethics, consent & disposition
There are three laws related to biobanks and biobank research in Sweden. The Swedish Act on Biobanks (2002:297), The Act concerning the Ethical Review of Research involving Humans (2003:460), and The Personal Data Act (1998:204). There are also some additional regulations connected to these and other acts depending on the type of research and on the material.
According to The Personal Data Act (1998:204 § 26) a participant in a research study has the right, once a year, to obtain a register extract containing all information registered about him or her. A written request for a register extract must be sent to the registrator at KI.
Ethics is important in all biobank related research. Samples and associated data are only to be used for ethically and scientifically approved projects performed under individual informed consent. Safety precautions need to be taken to prevent unauthorized intrusion into sample collections or data.
The consent of participants to allow use of their information and samples is based on the information on the specific research study and the storage of material in biobanks.
Most sample collections in a biobank will be stored safely for many years (even decades) and form a unique resource to study the causes of disease and how to overcome them. Beyond the first intended studies, it isn’t possible to predict what future research may be possible and undertaken. For this reason strict ethical approvals are required for every new project proposing to use the samples.
Sample donors can at any time withdraw their consent and demand that the collected samples are destroyed. This is done by filling in an “Opt-Out” form. To withdraw the consent means that the samples will be withdrawn without delay. No further information will be collected, but the information already collected does not need to be erased from the register.
Disposition of research rights
Access to samples and information for research purposes is based on the service agreement between KI Biobank and the principal investigator for each sample collection. Sample collections at KI Biobank are published in the registry of BBMRI.se and are open for proposals for new scientific collaborations.