THE EXPERTS SPEAK
BIOPRESERVATION AND BIOBANKING Volume 9, Number 3, 2011 ª Mary Ann Liebert, Inc. DOI: 10.1089/bio.2011.9340
What Are the Main Roadblocks to Transnational Biobank Collaboration, and How Can We Overcome Them? Peter H. Watson, Rivka Ravid, Chon Boon Eng, Jan-Eric Litton, Jim Vaught, and Anita Matusan
T
he question is concise but the answer depends both on the interpretation of the sometimes awkward word ‘‘transnational’’ and on the perspective on two assumptions that underlie the question. I will cover these in turn and then address the question. What does transnational mean? It means across regions that host groups of people with a unifying government, frequently but not always associated with a specific geographical area. The word therefore applies to biobank collaboration between countries but equally can apply to collaboration across diverse nations (e.g., indigenous peoples), provinces/states/territories, and ‘‘distinct societies’’ that all exist for example within a country such as Canada. Distinct governance for each group is reflected in laws, ethics perspectives, and attitudes that relate to the activities of biobanking. Experience in building collaboration between regional biobanks that exist within or interface with all of these frames my answer. Are there reasons for biobanks to want to collaborate across regional and/or national borders? Relative to the biobank, there are ‘‘internal’’ reasons to collaborate regionally, nationally, and internationally to share ideas and information on biobank models, processes and operations to build better biobanks. There are also ‘‘external’’ reasons to collaborate to expand the capability of the biobank to support research users to address the same questions on comparable biospecimens, broader questions on a larger scale or narrower questions with a rare focus. These two categories of reasons frame my answer. Are there roadblocks to overcome at all? Collaborations for internal reasons once faced roadblocks mostly because of the relative isolation of biobanks in the absence of recognition of the discipline, but also because of funding models that created competition. But the growth of national (e.g. CTRNet), and international (p3G) networks, forums (e.g. Marble Arch Working Group), societies and meetings (e.g. ISBER), and a biobanking journal (Biopreservation and Biobanking) has essentially dismantled the first barrier. And the competitive funding models that had some merits a decade ago to stimulate new ideas for biobanks are also a diminishing roadblock, as competitive grant funding for biobanks is so rare in practice. But roadblocks to internal and external collaboration still persist.
So, to address the question. The main roadblock to transnational collaboration to address internal values has changed and is diminished. It is no longer the ability or will to communicate, it is the relatively poor recognition of the value of biobanking which still significantly restricts the effort that is or can be dedicated to biobank leadership, activities, and productive collaboration within our health and research organizations to build these values. The solutions lie in recent efforts to develop tools to classify biobank activities, track intermediate products, and measure overall impact of biobanks. Collaborations between biobanks to address external values face several different and more significant roadblocks. These relate to privacy laws, ethics policies, funding models, and also to practical issues of local medical terminology and definitions and sometimes ownership perceptions fostered by organizations. But among these the most significant are privacy laws. Privacy laws are very important to most of us, but have largely been designed with a focus on issues that are unrelated to medical research, by minds that favor the pendulum swing away from the rights of societies, and have been enacted without sufficient consideration and debate on the collateral damage to other societal objectives such as better health. This roadblock might once have been mitigated by field testing to enable modifications to harmonize these across regions and strategies to be developed to minimize negative impact, but the latter opportunity is long gone and the barrier remains significant and threatens to grow because of the way our political systems function. However the solutions lie in raising these complex issues for balanced and public opinion rather than lobby driven and representative debate, through tools such as deliberative democracy and by establishment of better governance, transparent engagement of donors and education of oversight bodies.
213
Peter H. Watson BC Cancer Agency 2410 Lee Avenue Victoria, British Columbia V8R 6V5, Canada E-mail: [email protected] Website: http://www.bccrc.ca/dept/ttr
214
THE EXPERTS SPEAK
B
iobanks and post-mortem brain banks are a prospective source of adequately collected and preserved tissues and fluids of the central nervous system (CNS), which are used in basic and clinical research. Efforts to create a transnational biobank / brain bank collaboration have been only partly successful. Currently, most banks are in the process of standardizing their local standard operating procedures (SOPs) and trying to harmonize the methodological /legal/ethical guidelines to be used in the procurement and dissemination of the specimens. Furthermore, the application of proteomics/genomics /neuronal cultures and adult stem cells creates additional hurdles for trans-national collaboration because of the huge variety in local legislation and ethical codes of conduct of the national brain banks. The absence of international uniformity of clinical and neuropathological diagnostic criteria of central nervous system (CNS) disorders creates an additional road block in the global sharing and exchange of specimens. A well-functioning international network of biobanks and brain banks for CNS disorders should be recognized as an entity that possesses the legal and ethical approach needed for the procurement and distribution of donated tissues for scientific research. Local brain banks should abide by the international discussions being considered with respect to informed consent, genetic testing, and custody of collected specimens and use of post-mortem tissues for scientific research by end-users. It took me 15 years to formalize the overall ethical Code of Conduct for the Netherlands Brain Bank and 5 more years to discuss this within Brain-Net Europe before a European Ethical Code of Conduct has been accepted by 19 European brain banks. There is also need for an internationally acceptable code of conduct for the remuneration in the supply of human specimens by biobanks and brain banks to the commercial pharmaceutical and biomedical sector. A small portion of biobanks operate on the basis of cost recovery model for the acquisition of data and specimens. Researchers at nonprofit institutions obtain specimens by covering the basic handling and shipment costs; the forprofit sector is being charged on the basis of availability/ numbers of the annotated specimens. The present diversity of the material transfer agreements (MTAs), shipment protocols, and cost recovery policies used by biobanks / brain banks worldwide adds a serious hurdle in the sharing/exchange of specimens and the progress of global biobanking practices. Dr. Rivka Ravid Brain Bank Consultants Royal Dutch Academy of Sciences Amsterdam The Netherlands E-mail: [email protected]
T
he new exciting era of personalized medicine is accompanied by the rise in the importance of biobanks. However, there are numerous roadblocks that need to be addressed.
1. Lack of well-defined benefits sharing framework This problem is often manifested when biobanks of developing countries and developed countries enters into an agreement prematurely. A well-defined framework, developed with consultation from both parties, is necessary to manage expectations. This negotiation process is important to limit frustration that might occur during the collaborative process. For example, in the recent H1N1 pandemic, several developing countries who provided the viral materials from their local populations expressed their dissatisfaction when they were not benefiting from the treatment options developed. These options are either costly or not made readily available to them. The problem is made worse with the stockpiling of vaccine for developed nations.
2. Specimen quality and funding inequality The amount of funds made available varies for different biobanks. These variants in resources between biobanks could precipitate into downstream analytical artifacts. An example is the well-documented issue of ischemia time in the collection of tissue specimens. Gene expression is influenced by this factor and it is recommended to freeze the specimen as quickly as possible after excision. Better funded biobanks may have the resources to engage a dedicated staff for this purpose while others might requires their staff to multitask and thus compromise on ischemia timing. Downstream analysis of specimens collected from different biobanks might thus reflect the difference in the tissue collection process rather than the underlying mechanism of disease progression. Best practices or minimal standards needs to be developed with this issue in mind. Otherwise, it might be advisable to evaluate the practice of the collaborating biobank before entering into an agreement.
3. Cataloging of the biobank collection for specimen sharing A well-defined catalogue of the biobank collection is imperative for specimen sharing. Biobanks often underestimate the importance of this issue, which can result in the underutilization of their collection. Progress has been made in this area with the establishment of the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) catalogue of European biobanks and the National Cancer Institute (NCI) specimen resource locator. These factors are not exhaustive but biobanks may well resolve these roadblocks before embarking onto active collaborations. Chon Boon ENG, Ph.D. Head, NUHS Tissue Repository & Hospital-based Cancer Registry Yong Loo Lin School of Medicine National University Health System, Singapore 5 Lower Kent Ridge Road Singapore 119074 E-mail: [email protected] http://medicine.nus.edu.sg/tissue
THE EXPERTS SPEAK
B
iobanks are the biological back end of data-driven medicine but lack generic solutions for database interoperability and information harmonization. So far, most biobank infrastructure initiatives have developed as organizational networking, pure harmonization efforts in terms of specific data sets, or standardizing operational procedures for material collection. While this is important, the full potential of a biobank infrastructure will only be realized if a biobank e-infrastructure is constructed. Biobank collections often suffer from fragmentation and underutilization due to lack of commonly applied standards and limited access by investigators. As a result, merely retrieving high quality data on clinically annotated human samples is a time-consuming bottleneck for biomedical research. Compounding the problem is the fact that biobanks contain sensitive data from human donors. The resultant uncertainty over the legality of data access and exchange poses yet another roadblock to medical progress. In transnational biobank studies, data have often been collected into one centralized repository, using strict data submission protocols. In BBMRI, a complementary approach was suggested where data is accessed on demand from participating centers, using direct database connections. Each system has its own proprietary semantic meaning but is mapped to a logical data model that can be instantiated as a physical federated model or a canonical message model. Semantic interoperability is achieved within an enterprise via a hub-and-spoke topology, which reduces the redundancy and maintenance cost of pointto-point integration. As biobank data become more abundant, the main problem is no longer finding the information as such. What is needed is information about (biobank-) information, or (biobank) metadata. At the national level in Europe, in the wake of the BBMRI Preparatory Phase, a number of member states are in the process of establishing national hubs. A Meta model for biobank hubs is a first step towards data sharing among biobanks that exhibit tremendous heterogeneities. A common set of attributes defines the minimum dataset. A minimum data set for biobanks and a metadata model for biobank hubs have been developed during the BBMRI Preparatory Phase. The meta model is designed to adopt different kinds of collections and biobanks by using different schemas for study types and as such allowing to achieve integration with high information content while still permitting as many biobanks as possible to participate. 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. In order to obtain a unified view of the semantics of the attributes, each attribute can be defined in a multilingual vocabulary. For rights/intellectual property, a disclosure filter can be be used. The disclosure filter is a software component that helps the hosts to answer the following question: Who is allowed to receive what from whom under which circumstances, for what purposes and under which conditions? Implementation of the disclosure model would help remove an important obstacle, i.e., the legal uncertainty that currently blocks, complicates and delays cross border med-
215 ical research. Moreover, the disclosure model will be designed so as to enhance statutory control rights of individual biobank participants. This will promote transparency, trust and, hence, the sustainability of the proposed e-infrastructure for biobanks, which depend primarily on the trust of their participants. Prof. Jan-Eric Litton, Ph.D. Department of Medical Epidemiology and Biostatistics Karolinska Institutet Stockholm, Sweden Head, Database harmonization and IT infrastructure BBMRI EU Director, The Nordic Biobank Initiative Director, BBMRI.se E-mail: [email protected]
B
iobanking has truly become an international endeavor. The number of international conferences and organizations addressing various biobanking issues has increased over the past five years. However, there are a number of serious ‘‘roadblocks’’ to transnational collaboration and cooperation among biobanks. The major obstacles are: 1) a lack of coordination of ‘‘specimen locator’’ databases on an international basis; 2) few comprehensive specimen and data access policies; 3) legal, cultural and political restrictions to sharing specimens with collaborators in other countries; 4) differences in ethical and regulatory policies involving, for example, informed consent and material transfer between countries; and 5) a lack of widely used best practices or uniform SOPs, resulting in inconsistent quality of specimens. These roadblocks can be overcome by harmonization and widespread adoption of international standards for biobanking. There are several international organizations that are facilitating the development and adoption of such standards, including ISBER, the Forum for International Biobanking Organizations and the Global Biological Resource Center Network. However, arriving at a single set of standards is extremely difficult since ISBER, the Organisation for Economic Cooperation and Development, the U.S. National Cancer Institute (NCI), the International Agency for Research on Cancer, among others, have all developed excellent ‘‘best practice’’ documents that address biobanking standardization from different viewpoints and with varying levels of detail. In addition, although there is a proliferation of conferences that address these issues on a regular basis, there is little international cooperation and coordination that has any lasting effect. We believe that one effort that will be extremely useful and achievable over the next couple of years is being coordinated in close collaboration with the ISBER Informatics Working Group. That is the recent effort to coordinate specimen resource locators internationally. Currently many organizations sponsor such locators, including for example the U.S. NCI’s Specimen Resource Locator, the Canadian Tumour Repository Network’s Available Materials database, and the Australasian Biospecimen Network’s Tissue Specimen Locator. The ISBER International Repository Locator
216 working group includes ISBER members from 9 countries: Australia; France; Germany; Italy; The Netherlands; Qatar; Switzerland; the United Kingdom and the United States. As the working group notes in its initial mission statement: ‘‘The availability of a repository/specimen locator, searchable online, is considered critical research infrastructure. To maximize the value of a specimen or collection, a researcher requires the ability to locate it. In addition, researchers may need to locate and access specimens from multiple repositories to generate data that contains statistical rigor. An international repository locator would increase the profile of individual repositories amongst key stakeholders including: ISBER; researchers; funding bodies; governments and private industry.’’ Although there are other important efforts to overcome these transnational roadblocks, this ‘‘simple’’ step of sharing information about the specimen inventories and availability is a rational beginning toward removing one of the critical obstacles to international biobanking cooperation.
THE EXPERTS SPEAK Jim Vaught, Ph.D. Deputy Director Office of Biorepositories and Biospecimen Research http://biospecimens.cancer.gov/ National Cancer Institute 11400 Rockville Pike Bethesda, MD 20892 E-mail: [email protected] Anita Matusan, Ph.D. Project Manager Australasian Biospecimen Network – Oncology www.abrn.net Peter MacCallum Cancer Centre Locked Bag 1 A’Beckett St Melbourne VICTORIA 8006 Australia
BIOPRESERVATION AND BIOBANKING Volume 9, Number 3, 2011 ª Mary Ann Liebert, Inc. DOI: 10.1089/bio.2011.9340
What Are the Main Roadblocks to Transnational Biobank Collaboration, and How Can We Overcome Them? Peter H. Watson, Rivka Ravid, Chon Boon Eng, Jan-Eric Litton, Jim Vaught, and Anita Matusan
T
he question is concise but the answer depends both on the interpretation of the sometimes awkward word ‘‘transnational’’ and on the perspective on two assumptions that underlie the question. I will cover these in turn and then address the question. What does transnational mean? It means across regions that host groups of people with a unifying government, frequently but not always associated with a specific geographical area. The word therefore applies to biobank collaboration between countries but equally can apply to collaboration across diverse nations (e.g., indigenous peoples), provinces/states/territories, and ‘‘distinct societies’’ that all exist for example within a country such as Canada. Distinct governance for each group is reflected in laws, ethics perspectives, and attitudes that relate to the activities of biobanking. Experience in building collaboration between regional biobanks that exist within or interface with all of these frames my answer. Are there reasons for biobanks to want to collaborate across regional and/or national borders? Relative to the biobank, there are ‘‘internal’’ reasons to collaborate regionally, nationally, and internationally to share ideas and information on biobank models, processes and operations to build better biobanks. There are also ‘‘external’’ reasons to collaborate to expand the capability of the biobank to support research users to address the same questions on comparable biospecimens, broader questions on a larger scale or narrower questions with a rare focus. These two categories of reasons frame my answer. Are there roadblocks to overcome at all? Collaborations for internal reasons once faced roadblocks mostly because of the relative isolation of biobanks in the absence of recognition of the discipline, but also because of funding models that created competition. But the growth of national (e.g. CTRNet), and international (p3G) networks, forums (e.g. Marble Arch Working Group), societies and meetings (e.g. ISBER), and a biobanking journal (Biopreservation and Biobanking) has essentially dismantled the first barrier. And the competitive funding models that had some merits a decade ago to stimulate new ideas for biobanks are also a diminishing roadblock, as competitive grant funding for biobanks is so rare in practice. But roadblocks to internal and external collaboration still persist.
So, to address the question. The main roadblock to transnational collaboration to address internal values has changed and is diminished. It is no longer the ability or will to communicate, it is the relatively poor recognition of the value of biobanking which still significantly restricts the effort that is or can be dedicated to biobank leadership, activities, and productive collaboration within our health and research organizations to build these values. The solutions lie in recent efforts to develop tools to classify biobank activities, track intermediate products, and measure overall impact of biobanks. Collaborations between biobanks to address external values face several different and more significant roadblocks. These relate to privacy laws, ethics policies, funding models, and also to practical issues of local medical terminology and definitions and sometimes ownership perceptions fostered by organizations. But among these the most significant are privacy laws. Privacy laws are very important to most of us, but have largely been designed with a focus on issues that are unrelated to medical research, by minds that favor the pendulum swing away from the rights of societies, and have been enacted without sufficient consideration and debate on the collateral damage to other societal objectives such as better health. This roadblock might once have been mitigated by field testing to enable modifications to harmonize these across regions and strategies to be developed to minimize negative impact, but the latter opportunity is long gone and the barrier remains significant and threatens to grow because of the way our political systems function. However the solutions lie in raising these complex issues for balanced and public opinion rather than lobby driven and representative debate, through tools such as deliberative democracy and by establishment of better governance, transparent engagement of donors and education of oversight bodies.
213
Peter H. Watson BC Cancer Agency 2410 Lee Avenue Victoria, British Columbia V8R 6V5, Canada E-mail: [email protected] Website: http://www.bccrc.ca/dept/ttr
214
THE EXPERTS SPEAK
B
iobanks and post-mortem brain banks are a prospective source of adequately collected and preserved tissues and fluids of the central nervous system (CNS), which are used in basic and clinical research. Efforts to create a transnational biobank / brain bank collaboration have been only partly successful. Currently, most banks are in the process of standardizing their local standard operating procedures (SOPs) and trying to harmonize the methodological /legal/ethical guidelines to be used in the procurement and dissemination of the specimens. Furthermore, the application of proteomics/genomics /neuronal cultures and adult stem cells creates additional hurdles for trans-national collaboration because of the huge variety in local legislation and ethical codes of conduct of the national brain banks. The absence of international uniformity of clinical and neuropathological diagnostic criteria of central nervous system (CNS) disorders creates an additional road block in the global sharing and exchange of specimens. A well-functioning international network of biobanks and brain banks for CNS disorders should be recognized as an entity that possesses the legal and ethical approach needed for the procurement and distribution of donated tissues for scientific research. Local brain banks should abide by the international discussions being considered with respect to informed consent, genetic testing, and custody of collected specimens and use of post-mortem tissues for scientific research by end-users. It took me 15 years to formalize the overall ethical Code of Conduct for the Netherlands Brain Bank and 5 more years to discuss this within Brain-Net Europe before a European Ethical Code of Conduct has been accepted by 19 European brain banks. There is also need for an internationally acceptable code of conduct for the remuneration in the supply of human specimens by biobanks and brain banks to the commercial pharmaceutical and biomedical sector. A small portion of biobanks operate on the basis of cost recovery model for the acquisition of data and specimens. Researchers at nonprofit institutions obtain specimens by covering the basic handling and shipment costs; the forprofit sector is being charged on the basis of availability/ numbers of the annotated specimens. The present diversity of the material transfer agreements (MTAs), shipment protocols, and cost recovery policies used by biobanks / brain banks worldwide adds a serious hurdle in the sharing/exchange of specimens and the progress of global biobanking practices. Dr. Rivka Ravid Brain Bank Consultants Royal Dutch Academy of Sciences Amsterdam The Netherlands E-mail: [email protected]
T
he new exciting era of personalized medicine is accompanied by the rise in the importance of biobanks. However, there are numerous roadblocks that need to be addressed.
1. Lack of well-defined benefits sharing framework This problem is often manifested when biobanks of developing countries and developed countries enters into an agreement prematurely. A well-defined framework, developed with consultation from both parties, is necessary to manage expectations. This negotiation process is important to limit frustration that might occur during the collaborative process. For example, in the recent H1N1 pandemic, several developing countries who provided the viral materials from their local populations expressed their dissatisfaction when they were not benefiting from the treatment options developed. These options are either costly or not made readily available to them. The problem is made worse with the stockpiling of vaccine for developed nations.
2. Specimen quality and funding inequality The amount of funds made available varies for different biobanks. These variants in resources between biobanks could precipitate into downstream analytical artifacts. An example is the well-documented issue of ischemia time in the collection of tissue specimens. Gene expression is influenced by this factor and it is recommended to freeze the specimen as quickly as possible after excision. Better funded biobanks may have the resources to engage a dedicated staff for this purpose while others might requires their staff to multitask and thus compromise on ischemia timing. Downstream analysis of specimens collected from different biobanks might thus reflect the difference in the tissue collection process rather than the underlying mechanism of disease progression. Best practices or minimal standards needs to be developed with this issue in mind. Otherwise, it might be advisable to evaluate the practice of the collaborating biobank before entering into an agreement.
3. Cataloging of the biobank collection for specimen sharing A well-defined catalogue of the biobank collection is imperative for specimen sharing. Biobanks often underestimate the importance of this issue, which can result in the underutilization of their collection. Progress has been made in this area with the establishment of the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) catalogue of European biobanks and the National Cancer Institute (NCI) specimen resource locator. These factors are not exhaustive but biobanks may well resolve these roadblocks before embarking onto active collaborations. Chon Boon ENG, Ph.D. Head, NUHS Tissue Repository & Hospital-based Cancer Registry Yong Loo Lin School of Medicine National University Health System, Singapore 5 Lower Kent Ridge Road Singapore 119074 E-mail: [email protected] http://medicine.nus.edu.sg/tissue
THE EXPERTS SPEAK
B
iobanks are the biological back end of data-driven medicine but lack generic solutions for database interoperability and information harmonization. So far, most biobank infrastructure initiatives have developed as organizational networking, pure harmonization efforts in terms of specific data sets, or standardizing operational procedures for material collection. While this is important, the full potential of a biobank infrastructure will only be realized if a biobank e-infrastructure is constructed. Biobank collections often suffer from fragmentation and underutilization due to lack of commonly applied standards and limited access by investigators. As a result, merely retrieving high quality data on clinically annotated human samples is a time-consuming bottleneck for biomedical research. Compounding the problem is the fact that biobanks contain sensitive data from human donors. The resultant uncertainty over the legality of data access and exchange poses yet another roadblock to medical progress. In transnational biobank studies, data have often been collected into one centralized repository, using strict data submission protocols. In BBMRI, a complementary approach was suggested where data is accessed on demand from participating centers, using direct database connections. Each system has its own proprietary semantic meaning but is mapped to a logical data model that can be instantiated as a physical federated model or a canonical message model. Semantic interoperability is achieved within an enterprise via a hub-and-spoke topology, which reduces the redundancy and maintenance cost of pointto-point integration. As biobank data become more abundant, the main problem is no longer finding the information as such. What is needed is information about (biobank-) information, or (biobank) metadata. At the national level in Europe, in the wake of the BBMRI Preparatory Phase, a number of member states are in the process of establishing national hubs. A Meta model for biobank hubs is a first step towards data sharing among biobanks that exhibit tremendous heterogeneities. A common set of attributes defines the minimum dataset. A minimum data set for biobanks and a metadata model for biobank hubs have been developed during the BBMRI Preparatory Phase. The meta model is designed to adopt different kinds of collections and biobanks by using different schemas for study types and as such allowing to achieve integration with high information content while still permitting as many biobanks as possible to participate. 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. In order to obtain a unified view of the semantics of the attributes, each attribute can be defined in a multilingual vocabulary. For rights/intellectual property, a disclosure filter can be be used. The disclosure filter is a software component that helps the hosts to answer the following question: Who is allowed to receive what from whom under which circumstances, for what purposes and under which conditions? Implementation of the disclosure model would help remove an important obstacle, i.e., the legal uncertainty that currently blocks, complicates and delays cross border med-
215 ical research. Moreover, the disclosure model will be designed so as to enhance statutory control rights of individual biobank participants. This will promote transparency, trust and, hence, the sustainability of the proposed e-infrastructure for biobanks, which depend primarily on the trust of their participants. Prof. Jan-Eric Litton, Ph.D. Department of Medical Epidemiology and Biostatistics Karolinska Institutet Stockholm, Sweden Head, Database harmonization and IT infrastructure BBMRI EU Director, The Nordic Biobank Initiative Director, BBMRI.se E-mail: [email protected]
B
iobanking has truly become an international endeavor. The number of international conferences and organizations addressing various biobanking issues has increased over the past five years. However, there are a number of serious ‘‘roadblocks’’ to transnational collaboration and cooperation among biobanks. The major obstacles are: 1) a lack of coordination of ‘‘specimen locator’’ databases on an international basis; 2) few comprehensive specimen and data access policies; 3) legal, cultural and political restrictions to sharing specimens with collaborators in other countries; 4) differences in ethical and regulatory policies involving, for example, informed consent and material transfer between countries; and 5) a lack of widely used best practices or uniform SOPs, resulting in inconsistent quality of specimens. These roadblocks can be overcome by harmonization and widespread adoption of international standards for biobanking. There are several international organizations that are facilitating the development and adoption of such standards, including ISBER, the Forum for International Biobanking Organizations and the Global Biological Resource Center Network. However, arriving at a single set of standards is extremely difficult since ISBER, the Organisation for Economic Cooperation and Development, the U.S. National Cancer Institute (NCI), the International Agency for Research on Cancer, among others, have all developed excellent ‘‘best practice’’ documents that address biobanking standardization from different viewpoints and with varying levels of detail. In addition, although there is a proliferation of conferences that address these issues on a regular basis, there is little international cooperation and coordination that has any lasting effect. We believe that one effort that will be extremely useful and achievable over the next couple of years is being coordinated in close collaboration with the ISBER Informatics Working Group. That is the recent effort to coordinate specimen resource locators internationally. Currently many organizations sponsor such locators, including for example the U.S. NCI’s Specimen Resource Locator, the Canadian Tumour Repository Network’s Available Materials database, and the Australasian Biospecimen Network’s Tissue Specimen Locator. The ISBER International Repository Locator
216 working group includes ISBER members from 9 countries: Australia; France; Germany; Italy; The Netherlands; Qatar; Switzerland; the United Kingdom and the United States. As the working group notes in its initial mission statement: ‘‘The availability of a repository/specimen locator, searchable online, is considered critical research infrastructure. To maximize the value of a specimen or collection, a researcher requires the ability to locate it. In addition, researchers may need to locate and access specimens from multiple repositories to generate data that contains statistical rigor. An international repository locator would increase the profile of individual repositories amongst key stakeholders including: ISBER; researchers; funding bodies; governments and private industry.’’ Although there are other important efforts to overcome these transnational roadblocks, this ‘‘simple’’ step of sharing information about the specimen inventories and availability is a rational beginning toward removing one of the critical obstacles to international biobanking cooperation.
THE EXPERTS SPEAK Jim Vaught, Ph.D. Deputy Director Office of Biorepositories and Biospecimen Research http://biospecimens.cancer.gov/ National Cancer Institute 11400 Rockville Pike Bethesda, MD 20892 E-mail: [email protected] Anita Matusan, Ph.D. Project Manager Australasian Biospecimen Network – Oncology www.abrn.net Peter MacCallum Cancer Centre Locked Bag 1 A’Beckett St Melbourne VICTORIA 8006 Australia
