Biobanks, Ethics and Regulations.

The Swedish Act on Biobanks (2002:297) applies as from January 1st, 2003. The stated purpose of the legislation is that "important knowledge that can be acquired from biobanks should be available for research, health care and treatment, while the material in the biobanks must not be used in any way that may harm the individual who has provided the sample or his genetic relatives". The National Board of Health and Welfare has issued additional regulations (SOSFS 2002:11).

The Swedish Act on Biobanks embraces all samples traceable to identifiable human beings that are stored for more than 2 months after analysis and are collected in the Swedish health care system. The providers of health care have a responsibility to inform the patient that a sample will be stored, why it is stored and the consequences of not storing the sample. The patient shall give his consent to the saving of the sample. The consent shall indicate for what purposes the patient allows the sample to be used. The patient shall have the possibility to change his consent at any time. Such change of consent may be a change in allowed purposes or the wish to have the sample destroyed.

The Swedish Act on Biobanks also regulates biobank security: The responsibilities of the biobank must be clarified. The National Board of Health and Welfare maintains a register of existing biobanks. This register contains information only on biobanks, however, not on the individual samples. Newly started biobanks shall be reported to the National Board of Health and Welfare (form is available on www.sos.se, SOSFS 2002:11). Biobanks existing before January 1st, 2003, shall be reported before December 31st, 2004.

The counties of Sweden are responsible for provision of medical care and are now developing national guidelines on clinical routines for information and consent in routine medical care.

 

More on Biobanks, Ethics and Regulations

• More on Purpose and Scope of The Swedish Biobanks Act
   
• More on The establishment of a biobank
   
• More on information and consent
   
• More on access to samples for new objectives
   
• More on delivery of samples
   
• More on Supervision, punishment, and the right to claim for damages
   
• Answers to common questions on biobanking

Other resources

Link to the Act on Biobanks.(Lag 2002:297)

Link to the regulations of the National Board of
Health and Welfare. (Sosfs 2002:11)

Power Point presentation: Juridik och etik kring biobanker.ppt