Professor Michael Hummel is head of the BIH Biobank Core Facility as well as the German Biobank Node and was involved in the creation of a Guide for quality-promoting aspects in medicine and biomedicine. Mr. Hummel, how did this come about?
Michael Hummel: Biosamples and their associated data are of vital importance when it comes to ensuring research quality. Through my role as head of the German Biobank Node (GBN), the umbrella organization of the academic biobanks collaborating under the German Biobank Alliance (GBA), I have acquired a broad understanding of the national and European environment for biobanking. I am pleased that this prompted the German Research Foundation (DFG) to ask me to contribute my experience to the creation of the guidelines.
So what is the problem with the quality of DFG proposals in medicine and biomedicine? Or with the actual research results?
The scientific quality of DFG-funded projects is very high. Yet, often due to lack of awareness, existing infrastructures are not sufficiently included in project planning. In biobanking, this frequently leads to individual biosample collections being created for specific projects instead of using central biobanks that already exist locally. The result is sample collections whose quality does not always meet international standards and which do not have a “home” after completion of the respective project – therefore causing them not to be set up in a sustainable way. Not to mention the fact that new freezers have to be purchased unnecessarily for such collections, which often lack backup power for emergency situations. However, it is in the interest of the sample donors that we adhere to the highest quality standards when working with their samples, that we store them safely, and that we make them available to biomedical research on the widest possible scale. All of this is guaranteed by the central biobanks of the German Biobank Alliance.
The goal is to increase the quality of research projects and the reproducibility of the obtained results. How can this be achieved?
If researchers use biosamples of varying quality that lack consistent documentation and were not processed uniformly, then such samples will not be comparable and the research data obtained with them will not be reproducible. The central biobanks in Germany operate according to high quality standards and use precisely uniform specifications. The GBN and GBA regularly conduct proficiency tests to ensure the high quality of samples and associated data on a long-term basis. In addition, we continuously audit the biobanks in order to prepare them for accreditation according to a new international biobank standard. Not only does working with this biobanking infrastructure in Germany ensure the high quality and availability of biosamples used in research projects, but it also enables collaboration across sites and provides the basis for reproducible research results.
Who is the target audience of this guide?
MH: Anyone who uses – human – biosamples in their research. This includes both projects that require prospective sample collections and projects that seek access to existing samples. In both cases it pays off to work with a central biobank. Through their IT infrastructure, biobanks can also provide links to clinical data – while of course complying with data protection laws and ethical regulations in a tried-and-tested system. But in principle, central biobanks can also handle non-human biosamples.
How can reviewers tell from the application whether the quality of the proposed research project is ensured?
The decisive factor is whether the researchers submitting the application intend to collaborate with a central biobank. A copy of written approval from the biobank should be enclosed, and this should include a transparent overview of both feasibility and costs. If questions arise that the reviewers can’t clarify, the GBN will be glad to provide assistance as a neutral entity. Of course, it may happen that the central biobanks are unable to support a research project. In such cases, however, a corresponding explanation is required from the applicants and an appropriate statement from the biobank.
And what should applicants consider or take into account?
They should clearly describe the design of their biobanking activities. Whenever possible, researchers should use for this purpose the infrastructures that the existing local central biobanks have already put into place. They need to clearly outline the nature and scope of their envisaged collaboration with the central biobank, including the anticipated costs.
Do you expect the number of submitted applications and of approved applications to decrease as a result of this measure?
No, there is no reason why structured biobanking should have a reducing effect on the number of applications. Quite the contrary. During a transitional period, there may be requests regarding applications that central biobanks are unable to accommodate or that require adjustments to be made by the applicants. However, this will rarely happen after a “settling-in” period. The major advantage and long-term benefit will be a significantly higher quality and better availability of biosamples and data, as well as meaningful and reproducible research results.