What Are the Next Steps to Overcoming Roadblocks to Transnational Biobank Collaboration?

There is a great need for transnational biobank collaboration for a multitude of reasons—the very large sample size required in genome-wide association studies, the collation of sufficient number of cases to investigate rare diseases, and personalized medicine where comparative studies in different populations becomes increasingly important. Furthermore, collaboration reduces costs and increases speed of research. An example of successful collaboration has recently been demonstrated by the ENGAGE consortium (http://www.euengage.org/).

Although there is a clear need and the benefits are obvious, there are several roadblocks to be overcome before transnational biobank collaboration becomes routine.

The roadblocks can be attributed to three major issues:

1. Scientific and technical issues: A prerequisite for efficient collaboration is that biological samples and associated data collected by biobanks in different countries fulfill similar quality criteria so that they can be jointly analyzed. However samples are collected under different conditions and there are currently no evidence-based quality criteria that can be used to assess the quality of a given sample. This is even more difficult since the quality of a sample is not an absolute feature but has to be defined in the context of the scientific question to be addressed and the analytical technology employed. There are now major initiatives in the United States and Europe that aim at providing evidence-based quality criteria for sample pre-analytics and biobanking (http://www.spidia.eu/; http://biospecimens.cancer.gov/researchnetwork/default.asp).

2. Ethical and legal issues: The ethical and legal frameworks that have to be applied for biobanking in different countries vary markedly. Some countries even have legal restrictions on transnational sample exchange. For individual scientists, it is almost impossible to know all pertinent regulations and to understand how they are practically implemented. Several European Union-funded research projects have assessed this complex situation and provide useful tools, such as the WIKI Legal Platform of BBMRI (http://www.bbmri.eu/index.php/wiki-legal-platform) or the Human Sample Exchange Regulation Navigator (http://www.hsern.eu/). The Organization for Economic Co-operation and Development (OECD) has set a common international basis for transnational biobanking collaboration with the concept of establishing a Global Biological Resources Centres Network (GBRCN) and the best practice guidelines for biological resource centers as well as guidelines for human biobanks and genetic research databases. However the implementation of the guidelines in OECD member states will be a long process.

3. Psychological issues: There are many stakeholders that have directly or indirectly contributed to the collection of a biological sample and the related data. It is understandable that these stakeholders expect some benefits in case their samples are shipped to other countries and used by others. In case of a true research collaboration that results in joint publications this has generally been no problem. However, often the multitude of stakeholders cannot become coauthors and other rewarding systems are missing.

Several of the issues mentioned above will be addressed by the pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) by the establishment of Expert Centres that are linked to biobanks and perform sample analysis under internationally standardized conditions. This allows analysis of samples in their country of origin thereby avoiding sample shipment. Expert Centres will promote the implementation of an internationally harmonized quality management scheme for molecular analysis of human biological samples to facilitate data integration from multinational studies. High-quality data generated by Expert Centres will be made publicly available, resulting in better usage of finite biological resources. Furthermore, Expert Centres can also be established as public-private partnerships in the field of pre-competitive research facilitating collaboration with industry.