Considerations for the development of a biobank

The decision to establish a biobank as a service requires careful consideration. It really depends on how well a biobank fits as a service within the blood facility’s infrastructure and culture. 

Below is a list of considerations for the development of a biobank. See also the Management and Governance of a Plasma Biobank Framework page for further considerations.

Resources/Structure    

• Resource costs to develop, maintain and administer a biobank and database management system
• Quality assurance/control of the biobank, e.g. storage considerations, etc.    
• Decide what type of services the biobank will provide, e.g.
  • Data only,  e.g. the blood service performs testing
  • Provision of samples and data
• Development of a biobank governance committee
• Oversight or management of the biobank may be different depending on if it is created for Public Health use or academic or industry use
  • Consider donor consent nuances regarding use of the biobank for ‘emergency’ surveillance in a pandemic situation    
• Privacy/Ethics/Legal
• Security and safety of personal data and specimens    
  • Safeguards against secondary access
• Underutilization of biobanks and ethical concerns 
  • Reference: Singh et al (2021 J Med Ethics)
• Use of biobank material to develop diagnostic methods and/or assay evaluation of emerging pathogens 
  • Reference: Peeling et al (2020) Lancet Infect Dis
• Definition of Public Health partners
  • Available only to local/domestic PH or to national/international PH?
  • Concerns regarding inequitable transfer among LMIC and HIC 
  • Reference: Singh et al (2021) J Med Ethics

• The degree of personal identifiers that are included

  • Normally samples/data are anonymized but are linked to a donor ID/code

• Will data provision be aggregate or individual? 
• Will there be an allowance to contact individual participants to obtain further information?    
• Specimen provision considerations: 
  • Type of specimen in biobank (whole blood, plasma, serum, etc.); increased sample types may increase complexity of storage requirements
  • Storage/maintenance considerations (space for freezers; energy requirements; how many samples total can be stored; stability/turnover of samples, etc.)
• One-time aliquots provided to PH collaborator and then destroyed?
• Strict limits on usage/access (requires ethics/security agreement prior to work starting)
• Data collection considerations:
  • Age, gender, ethnicity, address (for linkage to socioeconomic strata)
  • Access to risk factor data (blood collection interview information)
  • The type of data desired by PH may change depending on the emerging pathogen or PH concern (i.e., pregnancy – Zika; Diet – HEV or biochemical marker study; travel – Lyme, etc.)

 

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