Introduction
Scope and definition
Recommendations
R1: The working group recommends developing a published reference framework for “organizing and managing a tissue bank” in clinical practice, defining standards that distinguish “archive” from ‘tissue bank”. |
R2: In the accreditation process of a pathology laboratory, the quality and compliance to standard of the tissue archive/tissue banks must be taken into consideration. |
Tissue banking: critical role in articulating translational research and personalized medicine
Recommendations
R3: Contributing to medical progress through participation in tissue banking should be offered to the largest possible number of patients. |
R4: Tissue banking should take into consideration the need for collecting appropriate reference samples. Whenever possible and appropriate, the reference sample may consist of corresponding tissue not affected by the disease process. |
R5: Clinical practice should evolve to take into account the most effective way to exploit new molecular validated biomarkers and therapeutic targets. This requires technical innovation on evidence-based protocols for tissue procurement, preservation and processing. Innovation should also aim at better using archived collections. |
R6: Given that specimens collected in clinical practice are critical for research, rules of patient information and consent should be compatible with the broad use of such specimens in conditions fulfilling strict criteria of protection of persons and data. The working group recommends that further work is developed to increase awareness on these issues and to develop ethical and legal procedures at the national and European level. |
Role of the pathologist
Recommendations
R7: No tissue banking for research should take place without proper pathology documentation. All specimens used within research programs must have been reviewed and assessed by a pathologist. |
R8: The standard for tissue banking is a tissue sample and not derived products or isolated molecules. |
R9: The pathologist should have an active participation in decisions of access to banked specimens. |
R10: Efforts should be made to better communicate the role of pathology in tissue banking. |
Role of institutions
Recommendations
R11: Institutions should commit adequate resources and staff dedicated to acquisition, processing and proper distribution of both data and specimens and assisting the pathologist in all tasks that do not require a qualification in pathology. The basic requirements are (1) daily and technical management, (2) data and specimen collection management and (3) expertise in biobanking ethics and law, and (4) networking biobanks. Biobank staff, depending on the size of the pathology department should include at least a tissue bank manager and a technician in addition to the pathologist. The institution should commit adequate resources for pathologists to be involved, in addition to their clinical task, in tissue-banking activities. |
R12: Technical and pathology expertise should be provided by the pathology department; the added scientific value should be recognized. |
R13: Institutional commitment and appropriateness of the level of resources dedicated to tissue banks should be considered as critical elements in the process of tissue bank accreditation, which could be part of a general hospital or pathology accreditation. |
R14: The institution should be responsible for setting and publicizing the rules of access to tissue banks. |
R15: The rights of the patients should be taken into account in the procedures and rules for access and use of the tissue bank. |
R16: In granting access to tissue-banked specimens, a general principle of “minimal sample amount of tissue necessary for the project” is recommended. |
R17: Each procurement of banked tissue for research should be formalized through a Material Transfer Agreement (the scope and content of this MTA is a matter for further elaboration at the European level). |
R18: Funding agencies should be aware of the requirements of tissue banking before granting funds for a research project. Projects using banked specimens should specifically (1) provide assurance of the participation and support of the tissue banks; (2) consider the costs of specimen procurement and processing in relation with their specific research application. |
R19: A European framework for the professionalization of tissue banking should be developed, e.g., through a teaching program at master level. |
Tissue banking in clinical trials
Recommendations
R20: As a rule, tissue banking should be considered as an option in every clinical trial. |
R21: The need for biomarker application and the possibility of using trials for biomarker validation should be taken into account in the statistical and logistical design of the trial. |
R22: Pathologists should be involved in trial design. |
R23: There should be a comprehensive registry in the tissue bank (ideally coupled to an institutional clinical trial registry system) of the tissue samples collected in the context of clinical trials. |
Improving standards for tissue banking within clinical practice
R24: Innovation in tissue banking should focus on reducing gaps between standards for clinical practice and for research, and on the development of biomarkers for the quality control of tissue-banking procedures |
R25: The development of evidence-based protocols supported by published data should be a priority. Journal editors should be made aware of this priority and should solicit contributions to support this effort. Scientific journals should develop proper expert reviewing for the correct collection, handling and processing of human tissues forming the basis of published data. |
R26: It is recommended that current European initiatives and programs that develop technical platforms for large-scale specimen analysis are duly reviewed, assessed, and “harvested” for developing models for future network development. |
Incentives for increasing the participation of pathologists
R27: Efforts should be made to increase the awareness of the pathology community that (1) participating in research through tissue banking is part of their professional duties; (2) tissue banking is an instrument for managing the evolution of pathology work towards integration of biomarker analysis in clinical practice. |
R28: Pathologists should be involved as scientists in developing the design of studies using banked specimens and in interpreting their results. |
R29: The scientific involvement of pathologists should be acknowledged in publication authorship. This involvement may consist of specific diagnostic procedures and annotations at the time of specimen acquisition and/or pathology review before specimen processing for specific research purposes. |
R30: Contributing to tissue banking should not compete with the performance of clinical pathology duties; therefore, sufficient time and resources should be committed by institutions to the performance of tissue-banking activities. |
R31: In developing research on banked specimens, researchers should take into account the costs of the tissue-banking operation and should include these costs in grant applications. |