"Enabling Good Medical Research Is a Highly Ethical Principle"

2nd National Biobank Symposium 2013: While ensuring that research projects are feasible and of the highest quality, protection of personal rights is absolutely essential.

"Enabling Good Medical Research Is a Highly Ethical Principle"

December 12, 2013. Biobanks are currently regarded as the most important resource for achieving scientific progress in medicine. Biomaterials such as blood or tissue and the associated clinical data are increasingly being collected in large, long-term biobanks, where they are available for present and future research issues and analyses. Biomedical researchers and ethics specialists agree that in light of this background the hitherto acknowledged concepts of informed consent given by sample donors must be subjected to a process of further development. "It is important to be able to realize practical concordance between absolutely essential protection of the personal rights of donors of biomaterials and the indispensable and legitimate research interests of biobank users. Enabling good medical research is a highly ethical principle." That is how it was formulated by Matthias Brumhard, representative of the the ethics committee of the Department of Human Medicine at the University of Giessen, at the 2nd National Biobank Symposium, which took place in Berlin on December 11 and 12, 2013

Within the scope of the symposium, researchers and ethics specialists debated how this "practical concordance" could be established. Citizens are just as entitled to protection of their personal rights as – when they are patients – they are entitled to treatment options, especially if they are affected by diseases that have so far been impossible or scarcely possible to treat. The present concept of informed consent, that is, the patient gives consent, based on information and briefing, to the use of biological samples obtained from him, assumes that the materials are collected and stored for specific research purposes.

Initial approaches to broad consent

The first biobanks, like the Interdisciplinary Bank of Biomaterials and Data Würzburg (ibdw) headed by Prof. Dr. Roland Jahns for example, have, in recent years, developed new, broadly worded patient information sheets and consent declarations and coordinated them with the competent ethics committees. These approaches were also incorporated in a specimen text for patient and trial volunteer information sheets and a suitable consent declaration, which was prepared in the Working Party of Medical Ethics Committees. Matthias Brumhard, who is chair of the biobanking working group within the Working Party of Medical Ethics Committees, presented the specimen text at the symposium.

Involving citizens as active partners

As was explained by the deputy chairman of the German Ethics Council, Prof. Dr. Peter Dabrock (University of Erlangen-Nuremberg), it is absolutely essential for biobank infrastructures to be highly dynamic, both scientifically and technologically, and to be highly networked, both nationally and internationally. At the same time, biobank research is not possible without cooperation from patients and trial volunteers in their capacity as sample donors. That is why he regards informed consent as a necessary but inadequate precondition for this branch of research.

For this reason he advocated involving citizens in the research process as active partners and establishing firm confidence in biomaterials research with open, interactive discourse. In his view, "biobanks create confidence and interest when they regard and treat trial volunteers as cohort managers of their data." Trial volunteers must have an opportunity to check the use of their data to a certain degree, Dabrock emphasized.

It is important to conduct debates now

Prof. Dr. Nils Hoppe from the Centre for Ethics and Law in the Life Sciences at the University of Hanover said it was necessary to completely revise the concept of informed consent: "The real purpose of this concept is to provide a tool to protect the autonomy of patients and trial volunteers and not primarily to reduce the liability risk of researchers. If you keep that in mind, you can develop different constructs that respect the autonomy of the patient or trial volunteer and at the same time do not unreasonably hinder research with new resources and infrastructures, e.g. biobanks. It is important to conduct these debates now and not unnecessarily cling to rigid procedures if equivalent protection can also be achieved by different means."

There are various ways of developing the established concept further, for example in the dynamic consent model chiefly developed in Oxford, in which material donors are linked to the biobank via social networks and each one can individually give consent to or prohibit use of their materials in certain projects. However, he said it was an extremely complex and elaborate procedure so it could not be accomplished by every biobank. Moreover, not every patient and patient volunteer has the same need for information so the effort does not always seem justified. Instead of macro-level regulation it might therefore be more useful for the various biobanks to agree on individual arrangements with donors. Hoppe added that if the model of the particular biobank is transparent and the trial volunteer knowingly decides in favor of that model, the autonomy of the individual is maintained.

Quality assurance also important for ethical reasons

In the symposium it also became clear that quality assurance for the samples is not only in the interests of researchers and their scientific work: It is also required for ethical reasons because only if the results of analyses are reliable does it seem justified to ask patients or trial volunteers to donate samples. Various scientific projects that were also discussed at the symposium are currently investigating the stability of biomarkers at various temperatures and periods of storage and their impact on analysis results. The biobanking working group of the Working Party of Medical Ethics Committees too will be addressing quality criteria for biobanks in the very near future.