In one way or another, we are all affected by the ongoing pandemic. It could be that we ourselves or someone we care about has been affected. Or we are affected in one way or another by the physical restrictions that exist. There is a lurking concern about whether this is the new normal. Many also work in professions that have been heavily burdened, not least in healthcare but also the research world has been affected. The challenge is to both deal with what is on the table today but also to find solutions so that fewer are affected or more can be cured. What can we do for them, to facilitate their important work?
High workload , staff shortages, competing tasks and pandemic restrictions have meant great strain on healthcare, laboratories and bio banks.
In order to give the operations better conditions and reduce unnecessary stress and strain, it is important to involve operational expertise from laboratories and biobanks at an early stage in the preparation of decisions that affect the operations. It has several positive effects, such as decision-makers gaining knowledge about which issues regarding priorities need to be resolved and / or what is required organizationally to enable the implementation of important decisions. But it also means that the operations are better equipped, receive support in important priorities and are given better conditions to carry out their important assignments.
The Biobanks Act’s consent rules mean that explicit consent is required for the sample donor’s sample to be preserved for his or her future care. The consent rules are complicated and set special requirements regarding samples taken within a care provider’s business. In the pandemic, however, it has not always been clear at the time of collection whether samples should be kept in a biobank and for what purposes. This means that there are also samples that due to the pandemic have been judged to need to be preserved, but for which consent routines for meeting the requirements regarding consent in the Biobanks Act have not been in place. In these cases, the regions have different options – in addition to getting consent procedures in place immediately – sending out information afterwards or throwing samples.
One way to solve this is to change the consent rules in the Biobanks Act in accordance with the proposal in the final report on the inquiry into the regulation of biobanks (Framtidens biobanker, SOU 2018: 4).
This does not mean that the right to decide on the preservation of one’s test is removed. Consent rules are found in the Patients Act (regulates information and consent in health care) and in the law on ethical review of research concerning people (regulates information and consent for tests to be used in research). Neither the Patients Act nor the Ethics Review Act existed when the Biobanks Act came into force, but no adjustment of the consent in the Biobanks Act was made in connection with its entry into force, which means that today there is a double regulation of information and consent requirements. The above-mentioned inquiry concluded that a special regulation in the Biobanks Act does not require consent to save samples in a biobank, neither for care nor for research.
Lack of national biobank register. It is not possible today at a national level to get an overview, search out or see which samples are preserved in biobank. It is also not possible to link information about which samples are preserved with other data sources. Without a biobank register, each question and issue needs to be resolved separately. Sometimes it is not possible to solve, despite the fact that both tests and information about tests are available, as well as committed employees and test providers who are positive that tests are used to increase knowledge for improved care.
The regions are working on a fresh start, to get a common IT support for information about tests and data about tests on site. It is important that resources are invested in completing the regions’ joint biobank registers and that local decision are made to deliver data from the Laboratory Information System (LIS) for this.