Biobank Act sets new standards on research use of samples of human origin
The importance of biobanks, which store tissue and cell samples of human origin, in boosting innovative research, especially in the development of pharmaceuticals and to hone disease prevention strategies, is being increasingly appreciated at national, EU and other international levels. They are also used increasingly for broad epidemiological research on genetic and environmental causes of diseases.
The numbers of biobanks worldwide is rapidly growing. In the EU area, the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) is working to connect biobanks across Europe. The BBMRI aims to enhance EU research and development on medical research and to expand European competitiveness globally in the field of medicine and biology.
This increased interest in the potential offered by biobanks is prompting activity to renew the rules governing the use of sample collections. Though biobanks are by no means a new phenomenon, their growing importance necessitates clearer and more standardized practices concerning their use. This is the setting for work carried out at the MSAH in recent years to look at how biobanks could best be regulated. The result is the new Biobank Act, which is intended to come into force at the beginning of 2012.Optimized use
The point of the new law is to optimize the rational use of biobank sample collections for new and follow-up research purposes, while safeguarding ethical standards. The notion of broad approval attached to the use of biobank samples, which is articulated by the new law, means that samples that are kept in biobanks will be available for use in all research related to a biobank's area of activity.
"Broader informed consent approach will facilitate biomedical research. At the same time, care will be taken so that the risks associated with biobanks do not pose a threat to individual protection," says Päivi Kaartamo, Ministerial Counsellor at the MSAH.
Allowing samples to be more easily available for research purposes means that biobanks could play a stronger role in the development of drugs that are better targeted at disease characteristics. The standardization of sample collections into biobanks will make this easier. In Finland, as in the other Nordic countries, sample collections tend to be somewhat scattered among small research sample collections at universities.
There is no common registry for these collections of cell and tissue samples. The largest research sample collection is held by the National Institute for Health and Welfare, inherited from the former National Public Health Institute. The pathology institutes of Finland's various hospital districts have amassed diagnostic samples for this collection.
Päivi Kaartamo reckons that the collection contains a million or so samples. But it may be the case that some of them are of bad quality, or are so insufficiently documented or in trace amounts that they can no longer be used for biobank research.
According to the Biobank Act, collections of samples should comprise a biobank if they are being preserved for future research. A biobank will not need to be established, however, if samples are collected only for a single research project.
Päivi Kaartamo estimates that fewer than ten biobanks will be created. It is unlikely that all hospital districts will establish their own biobanks, but instead will set up regional biobanks pertaining to each special area of medical responsibility, which will comprise samples from hospitals. There will be no additional funding for hospital districts to establish biobanks, nor will they be obliged to create them.
It will be possible for an institution other than a hospital district - for instance a private research establishment - to create a biobank. Biobanks will be obliged to provide their samples for research community. This may affect the desire of private bodies to set up their own biobanks, as it may be that they would not want to submit the samples they have collected for their own research purposes for use by others. Research groups that have collected samples would retain the right to use them for the time required by their research project.Informed Consent - Donor approval
When a biobank is established, it will be necessary to determine its area of operation. The National Supervisory Authority for Welfare and Health (known as VALVIRA), together with the National Committee on Medical Research Ethics (known as TUKIJA), will assess whether the planned activity meets the requirements concerning the protection of privacy and rights to individual autonomy, and whether it is ethically acceptable in other respects. If the area of activity in some way alters, a biobank will have to apply for a new ethical evaluation.
The new law will allow samples to be collected for biobanks for the purposes for which each of them has been established. Samples will, subject to approval, be able to be used for research carried out within a particular biobank's sphere of activity without needing fresh informed consent.
Under the new law, there will be a sample and data registry, an informed consent registry and code registry. Researchers will be entitled to be informed about whether a biobank has samples that are applicable for use in their research work. However, they will not be able to access the personal data of donors of individual samples without obtaining separate approval.
Samples will be linked to the personal data of donors using coding. ID numbers will be needed in follow-up research in order to be able to combine the data held by different registries. But samples that are submitted for research purposes will be unidentified.Old samples in new biobanks
Older cell and tissue samples held by healthcare facilities will be transferred to biobanks. Municipal residents will be informed about such transfers, and if they do not want their samples to be stored in biobanks, they can request that their samples be excluded from them.
Some sample donors are dead or unaware that their samples are being preserved. TUKIJA acts to oversee their interests. Before being transferred to a biobank, health care facilities will obtain a statement from the relevant regional ethics committee concerning the purposes for which the in their possession can be used and to which biobanks the samples can be transferred. The registry and supervising authority and the data Protection Ombudsman will monitor biobank compliance with existing regulations and act in accordance with their quality assurance system.
Päivi Kaartamo believes that biobanks will greatly help to promote biomedical research. They will speed up the research process, and human sample collections will have a broader research application than is currently the case. At the same time, the new Act will provide donors with the necessary assurance that the use of the samples will be appropriate and justified.Merja Moilanen and Mark Waller