Documentation relating to biobank samples and biobanking
Documentation relating to biobank samples and biobanking can be divided into two different categories: metadata connected to the samples themselves and biobank agreements connected to the study.
Metadata connected to the samples
It is very important to make sure that you have the right documentation coupled to your biobank samples, so that you ensure that you have all possible information when the samples should be used in the future. This means that you need to document all the steps pertaining to the samples right from the beginning. The consent tied to the study participant and the samples should be documented and you also need information about the sample taking procedures, type(s) of sample(s), which kind of tube/container was used, how the sample was transported to the biobank and keep track of other quality markers when available. This means that it is important to document the preanalytical steps when collecting samples, since they will affect the types of analysis and research that can be done.
Ensure that you have proper documentation on how you trace the samples, what coding system you use, if samples are barcoded and how the samples are linked to the donor. Furthermore, information on where and how samples are stored is important.
It is only quite recently that attempts have been made, both nationally and internationally, to standardise this documentation – especially its content and format. More information can be found on BioBanking and Molecular Resource Infrastructure of Sweden and International Society for Biological and Environmental Repositories (SPREC). Another useful standard is Minimum Information About BIobank data Sharing (MIABIS).
Biobank agreements regulate who (usually an organisation like Karolinska Institutet or Karolinska University Hospital) is legally responsible for the samples and what a recipient of samples is allowed to do or not. Every time samples leave the legally responsible organisation a Material Transfer Agreement (MTA) should be written that states the purpose of the research, who is responsible, who is the recipient of the samples and what the responsibilities of the recipient are. The transfer of legal responsibilities from one organisation (legal entity = huvudman) to another can be done at two different levels, depending also on the number of involved organisations – if the transfer occurs for example between Karolinska University Hospital and Karolinska Institutet one single normal agreement (a so called utlämningsavtal) is needed, but instead if the transfer was also from Uppsala University Hospital (Akademiska sjukhuset) and Umeå University Hospital to Karolinska Institutet it is usually better to use a so called multicentre agreement instead of having three separate utlämningsavtal, one with each hospital.