harmonization of biobanking operational procedures and best practices is an essential 
 element that enables biobanks to exchange and pool data and samples . this so - called 
 interoperability is the foundation of successful global biobanking . rather than demanding 
 complete uniformity among biobanks , harmonization is a more flexible approach aimed at 
 ensuring the effective interchange of valid information and samples . one critical task of the 
 harmonization process is to articulate those situations in which true standardization is 
 required . standardization implies that precisely the same protocols / standard operating 
 procedures ( sops ) are used by all biobanks . for example , if data are to be passed between 
 biobank databases then there needs to be agreement on standard ontologies and exchange 
 formats . likewise , comparison of high - throughput - technology - derived data requires that 
 platforms and operational details be identical . harmonization is context - specific and 
 pertains to the compatibility of methodologies and approaches to facilitate synergistic 
 work . it thereby relates to the critical areas of generating , sharing , pooling , and 
 analyzing data and biological samples to allow combining resources and comparing results 
 obtained from different biobanks . harmonization encompasses enabling technologies and 
 procedures for phenotype characterization , sample handling , in vitro assays , 
 computational biology analytical tools and algorithms , data - coding and 
 electronic - communication protocols that enable biobanks to network together within 
 compatible ethico - legal frameworks . in recognition of the necessity to synchronize efforts and build upon previous 
 achievements , a host of consortia - based initiatives , project teams and agencies ( table 1 ) have been working to optimize the establishment , operation , 
 and use of interoperative biobank resources globally as demonstrated by the public 
 population project in genomics and society . 
 toward this end , the fundamental principles guiding 
 these efforts include transparency , complementarity , and the sharing of relevant knowledge 
 and tools to enable cutting - edge and translational science for the benefit of all . harmonization initiatives have brought together individuals with diverse expertise . on the 
 basis of consensus , they have developed standards,10 , 
 11 tools , technologies , and resources , which are 
 widely available to the biobanking community today . indeed , the science of biobanking has 
 emerged as a field in its own right , providing an ever - growing armamentarium of tools , 
 information , compatible bioinformatics , and sops . however , progress in unraveling the 
 complexities of disease etiology and developing successful treatments will require a far 
 greater degree of knowledge and data integration than currently exists . thus , how we 
 structure and harmonize our biobanks today will have important impact on the future of 
 biomedicine . a typology of biobanks includes : ( 1 ) 
 residual specimens collected during routine clinical care for therapeutic or diagnostic 
 purposes , including collections of tumor samples with associated histopathologic , 
 demographic , clinical , and outcome data ; ( 2 ) specimens collected during clinical trials ; 
 ( 3 ) specimens collected as part of specific research projects ; and ( 4 ) specimens collected 
 as part of population - based biobanks , which often contain longitudinal components . these 
 diverse types of biobanks have different roles in the generation and translation of 
 knowledge into public health and clinical medicine , and technological plus conceptual 
 evolution may make it impossible or undesirable to harmonize completely their practices , 
 policies , and operations . nonetheless , some baseline level of harmonization should be 
 fostered for two main reasons . first , harmonization increases the quantity of usable data 
 and numbers of biospecimens to achieve levels of statistical power necessary to detect 
 effects underlying complex disease etiology.12 , 
 13 , 14 , 15 second , translational science will rely on fundamental 
 biological data to ( re)classify human disease on the basis of causality and to identify 
 relevant drug targets and biomarkers . effective planning of studies will use targeted investigations of specific groups 
 classified on their individual , detailed biological  as well as socio - cultural 
  profiles . such designs will enrich our analytical repertoire and may help overcome 
 some of the historical boundaries between clinical and nonclinical research . accordingly , 
 our ability to correlate data and biospecimens from different biobanks will be pivotal to 
 accelerating the pace of translational research . a meta - model to describe information 
 about a biobank is already under construction as a first - step data sharing among biobanks 
 that exhibit tremendous heterogeneities . this work is being conducted internationally to 
 help harmonize the national biobanks participating in the biobanking and biomolecular 
 resources research infrastructures initiative ( bbmri ) . information about the participating biobanks is captured by a 
 common set of attributes ( minimum data set ) designed to adopt different kinds of 
 collections . the latest interoperability and semantic web technologies can be used for 
 building resource description frameworks for data and services providing flexible 
 frameworks that can be used in different data - sharing scenarios . figure 1 depicts three major types of biobanks and their 
 niches in health - care research relative to population disease development . modern research 
 strategies should be able to draw on samples and data derived from these biobank 
 categories to capture the full range of biological variance associated with phenotypes 
 ranging from pre - disease states through response to treatment . to ensure scientific excellence while optimally leveraging the potential of biobanks , the 
 scientific frameworks within which biobanks operate will need to keep advancing in several 
 critical areas , including : ( 1 ) networking of multidisciplinary professionals ; ( 2 ) 
 development of comprehensive inventories , including listing of extant biobanks , their 
 holdings , and access procedures ; ( 3 ) establishment of standardized data - collection 
 protocols governed by appropriate quality management systems ; ( 4 ) continued innovation 
 that leads to improved technologies for preservation of biospecimens and pre - analytical 
 processes , ( 5 ) progress in information infrastructure to facilitate data sharing and 
 pooling , including new technical solutions for data management and analysis , as well as 
 for the protection of participant privacy and data confidentiality ; and ( 6 ) harmonization 
 of quality management systems to ensure consistency of materials . the science of biobanking itself is as important to develop and fund as the science that 
 uses biobanks . because the science of biobanking is very closely linked to the development 
 of an enabling infrastructure , it requires scientists to work more closely with each other 
 and with funders than has historically been the norm in biomedical science . in this , 
 biobanking resembles more the situation typical for large - scale physics , which is 
 characterized by close collaborative , pre - competitive relationships among workers in the 
 field to construct , develop , and maintain the necessary research infrastructures while 
 embracing healthy competition in the undertaking of both hypothesis - based and free 
 research using these infrastructures . developing this kind of culture and spirit will be 
 essential for the success of large , cross - institutional biobanking efforts . meeting these needs will require stable funding and new mechanisms to support the 
 coordination of infrastructure programs internationally . other elements essential to the successful nurturing of a vibrant 
 research community include frequent interchanges that will seed and foster relationships 
 among scientists in the field , non - risk - averse early funding for small exploratory 
 research projects , and the maintenance of registries of relevant professionals . several of 
 the major initiatives listed in table 1 are already helping to 
 meet these needs . however , they currently lack the kind of stable funding required not 
 only for the activities listed above , but importantly  also for the 
 development of networking among biobanking professionals that can lead to the development 
 of multidisciplinary research projects . training of the next generation of biobanking professionals is a critical aspect that 
 requires focused attention and investment , as is the establishment of communication and 
 publishing conduits for sharing resources and results . specific attention will also need 
 to be paid to career development and advancement aspects of biobanking scientists in an 
 effort to correct the current perception of the profession as mere infrastructure 
 providers . likewise , the field itself still needs to build reputation and recognition as a 
 scientific discipline as opposed to an  ancillary service ' . no less important than harmonization of specimens and data is the promotion and 
 implementation of shared ethical principles and procedures as they relate to biobanking . although the last decade has seen the emergence of principles reflecting shared ethical 
 principles that foster international scientific collaborations , the concepts of altruism , of solidarity , or of databases as global 
  public goods ' to promote data sharing , are still evolving . building trust , so that individuals will continue to donate to biobanks for the benefit of 
 all , is essential to ensure the advance of biomedical research . society must recognize its 
 role in this process and take steps to protect research participants against the possible 
 misuse of their information . this will require building governance mechanisms that operate 
 at a meta - level to enable accountable and responsible research . furthermore , we must 
 develop approaches to foster trust related to specific contexts with which biobanks will 
 interface , including , for example , industry and health care . the authors strongly advocate that the necessary procedural mechanisms for privacy 
 protection and the use of it software and biostatistical solutions to facilitate secure 
 use and transfer of data across 
 borders be adopted and implemented more 
 broadly by the global biobanking community as a matter of high priority . in addition , it 
 will be important to build the mutual trust that is required for the delegation of ethics 
 review across jurisdictions , where such delegation is feasible and 
 appropriate . the use of researcher 
 authentication techniques may provide additional protections and can be expected to 
 develop gradually . for example , the open researcher and contributor i d initiative enables 
 institutionally verifiable and reliable disambiguation of one author from 
 another . the mandatory deposition of 
 certain data into the public domain and publication policies of journals enforcing 
 transparency on these issues constitute important steps in these directions . in order to build a global infrastructure involving high - quality specimens and data 
 collections to support a broad array of scientific projects , a highly supportive political 
 environment is also critical . strengthening relationships with governments , ministries , 
 industry , and the general public will be crucial to create and maintain such an 
 environment . developing a global biobanking infrastructure is expensive and relies on the 
 willingness of individual participants to act as  global citizens '  or 
 as  citizen scientists ' by 
 providing their specimens and data for the greater good of science and progress in 
 individual and public health . consideration should be given to working closely with 
 agencies that communicate effectively the importance of science to educate the media and 
 the general public . it is the responsibility of stakeholders to react sensitively and 
 responsively to public and political perceptions and to maintain transparent , accountable 
 information on their activities . in particular , general information on projects of researchers who have used the biobanks should be 
 publically available . an important element of infrastructural development involves substantial investment in 
 ensuring ethical , effective , and equitable access to banked data and samples . this often 
 involves overlapping , but sometimes competing interests of biobank scientists and 
 managers , secondary users of the biobank , study participants , funders , ethico - legal 
 experts , and the public at large . such a multiplicity of stakeholders means that some 
 issues can only be resolved at the highest level , with agreement on policy at an 
 international level after significant stakeholder input . solutions include recognizing 
 that data / samples funded from public funds are a shared resource for the promotion of 
 scientific research for the public good , with adequate funding / cooperation and 
 recognition of the contributions , which make these resources available , and with the 
 provision of sanctions for those that misuse biobanks and/or specimens and 
 data . to this end , the biobanking 
 community and funders must work together with policy makers on regional , national , and 
 international levels to provide legal and ethical frameworks or , at minimum , reciprocal 
  safe harbor ' recognition to encourage the use and sharing of data , samples , 
 and knowledge . this will require international consensus guidance and collaboration to 
 ensure equitable approaches to the governance of privacy and access and the development of 
 training programmes for members of ethics review boards and other data regulatory bodies . current challenges are often related to the application of existing regulations and 
 policies that were developed for patient safety and protection in interventional clinical 
 trials involving new , potentially harmful drugs , devices , or psychological interventions ; 
 we argue that these norms are ill - suited for application to observational studies such as 
 longitudinal population studies , with minimal risks ( related primarily to data 
 protection ) . obviously , there must be sufficient investment in the infrastructure , 
 personnel , and processes that enable data management , archiving and release under a 
 pragmatic , simplified , streamlined ethics review . a number of considerations 
 are critical to keeping biobanks and the research they support active and dynamic . the 
 need for long - term investments into biological resources is clearly evident when 
 longitudinal data are needed . prospective collections of data and samples from 
 asymptomatic individuals will allow future identification of premorbid and subclinical 
 periods of disease development and will identify prognostic and diagnostic biomarkers and 
 drug targets.13 , 33 , 
 34 treatment follow - up studies require sampling 
 and data collection over many years before substantive analysis can be performed . as 
 molecular approaches to health and translational medicine are still in nascent stages , the 
 value of already collected data will continue to grow as new knowledge and methodologies 
 are applied to biobanks . thus , preservation of today 's biobanks is critical for 
 realising the science and medicine of tomorrow . most conventional grant mechanisms with limited periods of funding are not sufficient for 
 such sustainability . alternative approaches to 
 providing long - term support , such as the nih contract model that has supported the 
 framingham study , a distinguished successful biobanking initiative ( nota bene , since long 
 before the term  biobanking ' was coined ) , must be developed and expanded . it 
 may well be that the answer will lie in the use of a combination of approaches that 
 includes long - term commitments from public and governmental sources ( eg , the estonian human genes act (  27 ) ) for 
 functions related to the collection , maintainance , and storage of samples and 
 information , as well as support from 
 private industry . embedding biobanks in health - care systems would help ensure reliable long - term funding 
 and establish biobanks as a key component of the public health infrastructure . both the 
 long - term scientific benefits to be accrued from biobanking , and the personal 
 health - care - related benefits that individuals may gain from having objective 
 health - related information stored in biobanks , suggest that at least some types of 
 biobanks may become nested within the health - care system . indeed this trend is already evident in many nations as reflected 
 by the ever - growing number of national hubs associated with the bbmri . if we want to ensure 
 that the environment is right to support such nesting , it is critical that biobank 
 operators , biobanking scientists , and science funders work hand in hand with policy makers 
 and health - care strategists at all levels to ensure that the development of governance 
 systems and regulatory frameworks , mechanisms for quality management , and systems for data 
 storage , transfer , and integration are all harmonized and aligned to meet current and 
 future needs . if done properly , such a systematic integration may be the essential 
 foundation for future contributions that biobanks can make to human health . thus , the 
 design of approaches for data sharing across the spectrum of biobanks should dovetail with 
 national health information systems to ensure that these systems are capable of 
 interfacing ( in an appropriately controlled manner ) with the it systems that hold the bulk 
 of the detailed information in biobanks . obviously , funding is conditional on the level of ongoing benefit produced . thus it is 
 critical that biobanks are evaluated on an ongoing basis using well - defined 
 metrics . this implies the urgent need to 
 develop more formalized systems to objectively assess the value of biobanks or biobank 
 networks over time . no such monitoring system exists yet , though some ideas for measuring 
 a  bio - resource impact factor ' ( brif ) are being designed and 
 piloted . it will be necessary to record 
 simultaneously the impact of biobanks as infrastructures supporting research and the 
 scientific and operational contributions made by the  biobank researchers ' 
 ( principal investigators , managers , bioinformaticians so on ) . this will be assisted by the 
 development of systems that track the history of biobank collections and their 
 applications using digital ids for biobanks and researchers , and by a growing emphasis on 
 publishing infrastructure data , as well as discoveries made as a result of accessing them . this , in turn , requires continued improvements in the underlying controlled vocabularies , 
 databases , search systems , and guidelines addressing the ethical , legal , and social issues 
 related to biobanks . likewise , criteria should be established to terminate biobanks , which fail to meet the 
 established requirements and metrics . in 
 addition to quantitative metrics for assessing the utility of biobanks , it is essential to 
 also consider the less tangible , qualitative impact biobanks may have in fostering 
 scientific advances the development and use of such metrics also serve another purpose 
 that may affect sustainability needs : such metrics help to incentivize and justify the 
 field by providing objective criteria for unambiguously qualifying scientific 
 contributions by engaged investigators . biobanking has the potential to be the most powerful single platform for health 
 innovation and knowledge generation , provided that it is adequately resourced and 
 networked . maximizing the use , productivity , and value of biobanks worldwide will depend 
 on a transition of the way in which biobanking is perceived and conducted . harmonization 
 across biobanks is crucial in order to make investigations more robust , more targeted , and 
 more economical . building on fundamental principles that emphasize synergy of effort , 
 openness , and resource sharing for the benefit of all , international biobanking efforts 
 have already begun to lay the groundwork for such harmonization . to realize fully the 
 major public health benefits from the current patchwork of biobanking efforts , a 
 coordinated strategy is required that engages the diverse stakeholders and proceeds 
 through consensus building . we have articulated a vision and outlined a number of 
 strategies for building the scientific , social , and political framework for continued 
 progress . the key considerations underpinning the successful implementation of a road map 
 to develop biobanking globally for health are summarized in table 
 2 . drawing from the experience of an impressive number of harmonization 
 initiatives in the field , we propose working to establish an international biobanking 
 infrastructure and community . the collective output of these efforts includes guidance for 
 the design and management of biobanks , for the development of sops for sample handling 
 within a quality management system , cataloging and comparing data , and for coordinating 
 development of compatible bioinformatics and ethico - legal frameworks . in addition to 
 fostering biobank interoperability , with regard to the collection and exchange of data and 
 samples , it is critical to form strategic alliances between governmental bodies , funding 
 agencies , public and private science enterprises , and other stakeholders . the challenges we describe must be met , if we 
 are to realize , mobilize , and sustain the promise of major individual and public health 
 benefits through the application of biobanking to biomedical research .