F.A.Q.
Does a company which runs clinical trials (in Sweden) follow the Swedish biobank law or are there any exceptions?
No there are no exceptions, during clinical trials even healthy volunteers every company would need a biobank process on how samples handles, stores and destroys.
Which personal identity number e.g. name is allowed to file at the company?
None of this information is allowed to be filed at a company. This information needs to be coded in some way.
Can a company which deals with biological samples get an inspection from Socialstyrelsen?
Yes.
If a company in some way has shown a neglect able way dealing with their biological material or some actions which is in conflict with the Swedish biobank law could there be consequences?
Yes.
How many months before analyse could a biological sample be kept before the sample is included of the biobank law?
It depends on the ethics approval but maximum 6 months.
That samples could be tracked (chain of custodian) is mentioned many times in the biobank law, how is chain of custodian defined?
For each donor’s biological samples there must be a full chain of custody through the samples entire life cycle.
If the informed consent is withdrawn, when must the sample be destroyed?
As soon as possible.