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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">INTRODUCTION</span></p><p class="elsevierStylePara">Biobank is an establishment containing biological samples that are associated with clinical information&#46; These samples are collected&#44; processed&#44; stored and managed according to quality criteria in order to make them available to serve society in a non-profit way with the aim of promoting biomedical investigation&#46;</p><p class="elsevierStylePara">As we infer from that definition&#44; biobanks are not the active agent for a single centre&#8217;s research&#59; rather&#44; they are complementary tools to facilitate the research of others&#46; Biobanks have come to be in the last five years&#59; their origin lies in the enormous growth of scientific production in biomedicine&#44; the need to coordinate basic and clinical studies by fostering cooperative models&#44; and the possibility of increasing the efficiency of informed consent so that the same biological material may serve for different studies&#46; Naturally&#44; all of this must be done according to criteria ensuring the quality and suitability of the stored samples&#44; and the ethical and legal requirements that guarantee citizens&#8217; rights&#46; Although these factors were already being taken into account be researchers&#44; they were not precisely regulated&#46; The combination of all of the above aspects led to the development of biobanks being considered a top-priority strategic need by both the EEC and&#44; at the Spanish national level&#44; the Carlos III Health Institute&#46;</p><p class="elsevierStylePara">Biobanks are intended to produce wealth through creating a mass of human <span class="elsevierStyleItalic">biological capital</span> intended to foster biomedical research and the promotion of health&#46; Samples must have an <span class="elsevierStyleItalic">overall quality</span> that is not only associated with their collection and storage conditions&#44; but also to their traceability and the precision and reliability of the clinical data associated with those samples&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Present and future of biobanks</span></p><p class="elsevierStylePara">At this time&#44; few biobanks are present in Spain&#46; Due to strategic initiatives by health authorities in this country&#44; an important development is foreseen in the near future&#46; The development of a biobank passes through the following phases&#58; defining its purpose&#44; predicting necessities&#44; obtaining funding&#44; installing infrastructure and preparing techniques&#44; preparing documentation&#44; implementing a management system&#44; and beginning operations&#46; In the medium term&#44; biobanks will begin to function as a network&#44; to maximise their potential on both the national and European levels&#46;</p><p class="elsevierStylePara">Biobanks could be intended to manage the biological material that would be necessary to develop a large project&#44; which would become increasingly associated with a high degree of specialisation &#40;National DNA Bank&#41;&#46; They could also attend to the needs of an institution - a hospital&#44; for example - or they could study a disease&#44; as is the case of the Spanish HIV BioBank&#46; These purposes would not be exclusive&#44; although in the future we would expect a tendency towards a certain degree of specialisation&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Bases for guaranteeing the effectiveness of biobanks</span></p><p class="elsevierStylePara">As mentioned previously&#44; biobanks are a very effective tool at the service of the scientific community&#46; When storing samples on a large scale&#44; complex technical procedures must necessarily be used for sample collection&#44; transport&#44; identification&#44; traceability maintenance&#44; storage at the proper temperature&#44; and for computerised data processing&#44; etc&#46; The bases that will guarantee the effectiveness of biobanks will comprise&#58;</p><p class="elsevierStylePara">- <span class="elsevierStyleItalic">Standardisation of procedures</span>&#58; the use of homogeneous&#44; well-defined protocols for sample collection&#44; processing&#44; conservation and storage will guarantee sample quality&#46; Well-defined standard notation of associated data will also create quality clinical information&#46; This will reflect the sample&#8217;s importance as biological capital&#44; since a sample with no associated information lacks value&#46; On the other hand&#44; the fact that the collection and storage of samples and associated clinical data will not be scattered among different groups&#44; centres&#44; collections&#44; etc&#46; will mean that all samples will share the same conditions and will be able to be compared with each other in different studies&#46;</p><p class="elsevierStylePara">- <span class="elsevierStyleItalic">Guaranteed sample traceability</span>&#44; by drawing on proper methodology for sample coding and identification&#44; which will guarantee its traceability at all times&#46;</p><p class="elsevierStylePara">- A <span class="elsevierStyleItalic">dynamic</span> and <span class="elsevierStyleItalic">effective management</span> by means of computer applications that allow us to list all of the processes to which samples and associated data have been submitted&#46;</p><p class="elsevierStylePara">- <span class="elsevierStyleItalic">The implementation of a quality management system</span> to make the organisation function effectively&#44; improving biobank customer satisfaction&#46;</p><p class="elsevierStylePara">- <span class="elsevierStyleItalic">Employment of qualified personnel</span> who will be exclusively dedicated to the operation of the biobank&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Bases for managing biobanks in Spain</span></p><p class="elsevierStylePara">The entire process that takes place from collecting the samples up to their use by researchers must be in accordance with applicable legislation&#44; which for biobanks is principally composed of&#58;</p><p class="elsevierStylePara">- Spanish Law 14&#47;2007 of 3 July regarding biomedical research&#44;<span class="elsevierStyleSup">1</span> which contemplates its origins and regulates its organisation&#44; functioning and records&#46; At present&#44; there is no developmental legislation to clarify it&#44; meaning that we must wait to know what conditions will be necessary for authorisation and for havinga national registry&#46; By law&#44; biobanks must guarantee the quality&#44; safety and traceability of the biological data and samples that they house&#46; Likewise&#44; they must guarantee protection of the rights of subjects who have donated biological material and who may be affected by the research&#46;</p><p class="elsevierStylePara">- <span class="elsevierStyleItalic">Organic Law 15&#47;1999 of 13 December regarding the Protection of Personal Data</span>&#46;<span class="elsevierStyleSup">2</span> This law must be applied to samples from identifiable subjects and to samples for which identification could be re-associated or decoded&#44; which are considered to be personal health-related data&#46; It requires guaranteeing confidentiality and the proper useof samples in the exclusive field of the approved research study&#46; The law does not apply to anonymous or irreversibly dissociated samples&#46;</p><p class="elsevierStylePara">Biobanks may be owned publicly or privately&#44; but for all cases they must be non-profit organisations&#46; Their organisational scheme must contain a scientific director and a file manager&#44; and in addition&#44; they must be attached to two external committees&#58; a scientific committee and an ethics committee&#46;</p><p class="elsevierStylePara">Legal considerations for using biological samples are different for biobanks and sample collections&#46; In both cases&#44; however&#44; the informed consent of the source subject is necessary in order to obtain the samples&#46; Given biobanks&#8217; mission of public service&#44; consent is granted in more wide-ranging terms&#46; This means it is not necessary to give details about the specific project in which the sample is to be used&#44; as would be the case for collections&#59; also&#44; there must be a clause regarding ceding the sample to third parties&#44; which is also impossible for normal data collecting without obtaining further consent&#46;</p><p class="elsevierStylePara">In this way&#44; samples can be kept indefinitely in a biobank and be at the scientific community&#8217;s disposal for future investigations that are not planned atthe moment the sample is taken&#46; The nature of the sample is respected in any case&#46;</p><p class="elsevierStylePara">Samples can be provided at no cost for use in research projects that have been approved by both the scientific and ethics sides&#46;</p><p class="elsevierStylePara">Only the minimum necessary quantity will be ceded&#46; Samples and associated data that are transferred will be kept anonymous or dissociated&#46; In the cession agreement&#44; the researcher will commit to not use the sample for any purpose other than that for which the sample was requested&#46; Likewise&#44; he&#47;she may not cede the sample to third parties&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Who benefits from biobank development&#63;</span></p><p class="elsevierStylePara">We expect that the benefits provided by biobanks will affect various segments of the population&#44; including the following&#58;</p><p class="elsevierStylePara">- Researchers&#58;</p><p class="elsevierStylePara">- Sample quality and organisation criteria allow them to carry out epidemiological studies under proper conditions&#46;<br></br>- Biobanks provide them with legal and ethical assessment and regulate the exchange of biological samples for investigation using standard procedures and transparent workings&#46;<br></br>- Biobanks act as an instrument for cooperative investigation that is multi-centre&#44; interdisciplinary and multi-sectorial&#46;<br></br>- Biobanks contribute to gaining new financing and patents for the Health System&#46;</p><p class="elsevierStylePara">- Patients&#58;</p><p class="elsevierStylePara">- By using biological samples&#44; researchers can develop biomarkers and target treatments that may lead to advances in prediction&#44; early diagnosis and disease treatment methods&#46;</p><p class="elsevierStylePara">- Society in general&#58;</p><p class="elsevierStylePara">- Biobanks may serve to develop diagnostic tools for preventing diseases&#46;<br></br>- They may identify risk factors if studies are carried out relating lifestyles or environmental factors with diseases&#46;<br></br>- The creation of <span class="elsevierStyleItalic">biological capital</span> will foster the creation of social wealth by acting as a factor promoting the development of the pharmaceutical industry&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Other considerations related to biobanks</span></p><p class="elsevierStylePara">Despite the positive aspects that biobanks can contribute&#44; summarised above&#44; their start-up is not free from difficulties&#44; some of which are shown in table 1&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Biobanks and Nephrology</span></p><p class="elsevierStylePara">Our speciality is not unaware of the need to have these tools at our disposal&#44; and in the future they will be completely necessary if we wish to deepen our study of the diseases that concern us&#46; In addition&#44; the possibility of real-time access to samples stored in biobanks will further increase nephrologists&#8217; capacity for research&#46; Given that the SEN &#40;Spanish Society of Nephrology&#41; has been a participative scientific society throughout its history&#44; we are certain that the development of biobanks will lead to better cooperation among us&#44; increasing our research potential&#44; and therefore our contribution to improving care for kidney disease patients&#46; Although we are still in a develop ment phase&#44;<span class="elsevierStyleSup">3</span> we are placing the Ramon y Cajal UH-CIFRA biobank at the disposal of Spanish nephrologists wishing to use it for their projects&#46;</p><p class="elsevierStylePara"><a href="grande&#47;16918078&#95;t1&#95;p195&#46;jpg" class="elsevierStyleCrossRefs"><img src="16918078_t1_p195.jpg" alt="Difficulties involved in starting up biobanks"></img></a></p><p class="elsevierStylePara">Table 1&#46; Difficulties involved in starting up biobanks</p>"
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