What Are the Biggest Challenges and Opportunities for Biorepositories in the Next Three to Five Years?

One of the major challenges for modern biorepositories is gaining visibility and recognition as professional infrastructures and service providers, in front of national regulatory bodies, institutional review boards (IRB), data protection authorities, research funding organizations, and the diagnostic and pharmaceutical industries. This recognition is necessary to ensure biorepository-specific law texts and IRB and data protection guidelines are drawn up, and to attract public and private funding. All the above elements and especially the last are necessary for long term biorepository sustainability. There are two ways to ensure this:

By the development of rules for appropriate public institutional support and funding of biorepositories as long-term research infrastructures (and not as appendices of specific and finite research projects). Such rules can only be based on an objective assessment of each biorepository's organization by an independent third party, in the context of a certification mechanism. The opportunity lying ahead of us now is the development of an appropriate international certification scheme covering all human, animal, plant and microbial resources.

By the development of incentives for researchers and industry to use biospecimens from professional biorepositories. One opportunity here is the development of strict publication rules for authors about the disclosure of the origin of biospecimens used in the research studies. A second is the development of new rules for the regulatory approval of in vitro diagnostic tests and therapeutic agents, pertaining to the origin of biospecimens used for validation, where an appropriate, general certification mechanism as referred to above would be of immediate relevance.