In a recent paper, Somiari and Somiari (2015) offered insight into the requirements for future biobanking, focusing on a research-ready hospital (RRH) model and recommendations for enhanced sustainability.1 According to the authors, future biobankers will need novel strategies to address the confluence of scarce biospecimens (good-quality, well-annotated specimens as well as specimens that are racially/ethnically diverse or associated with rare conditions) and high costs associated with ensuring adherence to best practices.
The authors indicate that future biobanking strategies will need to prioritize affordable, on-demand biospecimen acquisition. These strategies must provide:
- Greater numbers of samples
- A wide variety of biospecimens
- Samples pertaining to rare diseases and conditions
- Increased centers for procuring samples
The authors offer the RRH conceptual model as a novel response to these requirements. The RRH network would consist of member hospitals operating under the auspices of a centralized, governing body capable of integrating biobanking activities with current hospital standards with no reduction in quality patient care. According to the authors, a functioning RRH should be able to meet administrative, technical and regulatory requirements; provide multiple types of samples; store biospecimens short term; and transport samples to end users or centralized biobanks for long-term storage.
The authors indicate that a project of this scope will require considerable partnership, ideally across both the public and private sector. Further to this, the RRH hospitals must be recognized as true partners rather than mere suppliers, requiring clearly defined intellectual property rights. Somiari and Somiari suggest this division of responsibilities:
- Technical and operational biobanking activities should be overseen by an established, College of American Pathologists (CAP)-accredited biobanking organization. Since CAP already accredits hospitals in the United States, the process to certify an RRH should be familiar.
- The coordinating biobank should train hospital staff on standard operating procedures (SOPs) related to sample collection, storage and distribution. Each member hospital should maintain its own quality assurance using coordinated SOPs.
- RRH staff should also receive specific training on recognizing rare conditions to ensure the acquisition of relevant samples.
- The overseeing biobank should maintain communication with researchers and coordinate sample collection and distribution; a secondary workflow funneling unclaimed samples from the RRH to the biobank should also operate.
Notably, this RRH model would allow the scientific community to access biospecimens acquired from rural hospitals, an as yet underutilized source. The authors cite a Swiss pilot study demonstrating that small regional hospitals without an integrated pathology unit can, with proper planning, funnel biospecimens without compromising patient care on modest budgets ($35,662 setup, $1,250 yearly).2 They further indicate that this local infrastructure could increase community participation in research activities, reducing disparities in rural representation in research and clinical trials. Ultimately, greater access via RRH partnerships could improve translational medicine, including the search for novel biomarkers and drug development.
Future biobanks will also need to address sustainability issues, increasing supply value while minimizing storage and distribution costs. The authors offer this model grading system for ranking biospecimens in order to objectively weigh the value and cost of particular specimens:
Table: Conceptual Grading System1
|1||No clinical annotation. Not scarce. Easily collected. No limitations in size and number.||Low||Freely distribute.|
|2||No clinical annotation. Not scarce. Not easily collected. No limitations in size and number.||Low||Freely distribute.|
|3||Poor clinical annotation. Not scarce. Easily collected. No limitations in size and number.||Low||Freely distribute.|
|4||Very poor clinical annotation. Relatively scarce. Not easily donated. Some size and number limitations.||Medium||Distribute based on project importance.|
|5||Poor clinical annotation. Relatively scarce. Easily collected. No limitations in size and number.||Medium||Distribute based on project importance.|
|6||Poor clinical annotation. Relatively scarce. Not easily collected. No limitations in size and number.||Medium||Distribute based on project importance.|
|7||Poor clinical annotation. Relatively scarce. Not easily collected. Some limitations in size and number.||Medium||Distribute based on project importance.|
|8||Good clinical annotation. Not scarce. Easily collected. No limitations in size and number.||High||Distribute with caution.|
|9||Very good clinical annotation. Not scarce. Not easily collected. No limitations in size and number.||Very high||Distribute with caution.|
|10||Extensive clinical annotation. Very rare specimen, difficult to find and collect. Very limited in size and number.||Extremely high||Distribute with highest scrutiny.|
Further to this, the team recommends tightened protocols for the distribution of required samples only (e.g., a DNA aliquot rather than a tissue section) or the use of alternative methods of distribution like “touch preparations” and dry state, ambient temperature storage. This would reduce space requirements, energy usage and operations costs.
As the requirements of translational medicine and the various related -omics research fields place novel demands on the biobanking system, flexible responses like those presented here by Somiari and Somiari may be key to preserving and extending the impact of the biobanking industry.
1. Somiari, S.B. & Somiari, R.I. (2015) “The future of biobanking: A conceptual look at how biobanks can respond to the growing human biospecimen needs of researchers,” Biobanking in the 21st Century: Advances in Experimental Medicine and Biology, 864. doi: 10.1007/978-3-319-20579-3_2
2. von Strauss und Torney, M., et al. (2012) “Tissue banking in a regional hospital: A promising future concept? First report on fresh frozen tissue banking in a hospital without an integrated institute of pathology,” World Journal of Surgery, 36 (pp. 2300–2304).