Difference between revisions of "Report:29d1a7fc-0809-484c-b91b-f7b02f9dad5c"
From The Embassy of Good Science
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|Title=Spain | |Title=Spain | ||
|Has Location=Spain | |Has Location=Spain | ||
| − | |Research Infrastructure=In 2019 there were 135,331 full-time researchers in Spain | + | |Research Infrastructure=In 2019 there were 135,331 full-time researchers in Spain <ref>Eurostat. [cited 2020 Jan 7]. Available from: |
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| + | https://ec.europa.eu/eurostat/tgm/refreshTableAction.do?tab=table&plugin=1&pcode=tsc00004&language=en</ref>. Spanish National Research Council, a State Agency with the consideration of a Public Research Organization of the Spanish General State Administration, has 120 research institutes out of which 51 are of joint centres with other institutions, primarily universities <ref name=":0">Institutes, Centres & Units. CSIC. [cited 2020 Jan 7]. Available from: https://www.csic.es/en/investigation/institutes-centres-units</ref>. There are also 8 centres functioning as research support units that provide technical and administrative support to two or more institutes <ref name=":0" />. Spain has 75 universities – 50 public and 25 private <ref>Estudios y Universidades en España. Listado de todas Universidades Españolas [Studies and Universities in Spain. List of All Spanish Universities]. [cited 2020 Jan 12]. Available from: http://www.estudiosyuniversidades.com/universidades/universidades-publicas-espana.html</ref>. | ||
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{{!}} width="366" valign="top"{{!}}Zaragoza | {{!}} width="366" valign="top"{{!}}Zaragoza | ||
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| − | |Research Funding=In 2019, the gross expenditures on research and development were €15.572 million, which comprises 1.25% of the country’s GDP | + | <references /> |
| − | |Research Strategy=The Spanish Strategy on Science, Technology and Innovation 2013-2020 was launched by the General State Administration and the Regional Administrations in 2012. Since it was created at the time when country was experiencing serious economic difficulties which led to decreasing of funding with respect to public and company investment, the Strategy promotes the capacities of the Spanish Science, Technology and Innovation System and enables collaboration between all the stakeholders of the System while increasing the social and economic returns from investment in Research Development and Innovation (RDI). With regard to this, the Strategy defends the importance of scientific and technological progress as an indisputable element of social progress | + | |Research Funding=In 2019, the gross expenditures on research and development were €15.572 million, which comprises 1.25% of the country’s GDP <ref>Instituto Nacional de Estadística. [cited 2020 Jan 7]. Available from: https://www.ine.es/dyngs/INEbase/en/operacion.htm?c=Estadistica_C&cid=1254736176754&menu=ultiDatos&idp=1254735576669</ref>. Most funding was spent in the corporate sector (56.1%), followed by the higher education sector (26.6%), general government sector (17.0%) and the private non-profit sector (0.3%) <ref>Statistics on R&D Activities. Year 2019. Final data. Instituto Nacional de Estadística. Press Release 27 November 2020. [cited 2020 Jan 7]. Available from: |
| + | |||
| + | https://www.ine.es/en/prensa/imasd_2019_en.pdf</ref>. Spain had 8.137 signed grants receiving €5.82 billion in H2020 <ref name=":0">H2020 Projects. [cited 2020 Feb 19]. Available from: | ||
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| + | https://webgate.ec.europa.eu/dashboard/sense/app/93297a69-09fd-4ef5-889f-b83c4e21d33e/sheet/erUXRa/state/analysis</ref> and 491 ERC signed grants receiving €664.8 million in H2020 <ref name=":0" />. | ||
| + | <references /> | ||
| + | |Research Strategy=The Spanish Strategy on Science, Technology and Innovation 2013-2020 was launched by the General State Administration and the Regional Administrations in 2012. Since it was created at the time when country was experiencing serious economic difficulties which led to decreasing of funding with respect to public and company investment, the Strategy promotes the capacities of the Spanish Science, Technology and Innovation System and enables collaboration between all the stakeholders of the System while increasing the social and economic returns from investment in Research Development and Innovation (RDI). With regard to this, the Strategy defends the importance of scientific and technological progress as an indisputable element of social progress <ref name=":0">Gobierno de España. Ministerio de Economía y Competitividad [Government of Spain. Ministry of Economy and Competitiveness]. Spanish Strategy for Science and Technology and Innovation 2013-2020. [cited 2020 Jan 7]. Available from: https://www.ciencia.gob.es/stfls/MICINN/Investigacion/FICHEROS/Spanish_Strategy_Science_Technology.pdf</ref>. One of the Strategy’s aims is to define a strategic framework for RDI policies to promote structural reforms, establish incentives and determine the objectives and efforts required to create the RDI capacities that will make Spain a country of innovation, contribute to social and economic progress and reinforce their international leadership in a global setting <ref name=":0" />. | ||
| + | <references /> | ||
|Research Governance=Spain has several bodies for RI – the Ethics Committee of the Spanish National Research Council (CSIC), the Spanish Research Ethics Committee (CEEI), the National Commission on Assisted Human Reproduction and the Commission for the Donation and Use of Human Cells and Tissues. | |Research Governance=Spain has several bodies for RI – the Ethics Committee of the Spanish National Research Council (CSIC), the Spanish Research Ethics Committee (CEEI), the National Commission on Assisted Human Reproduction and the Commission for the Donation and Use of Human Cells and Tissues. | ||
| − | From 2011 the Ethics Committee of the Spanish National Research Council (CSIC) has been a member of European Network of Research Integrity Office (ENRIO) and responsible for raising awareness of researchers about the importance of research integrity ( | + | From 2011 the Ethics Committee of the Spanish National Research Council (CSIC) has been a member of European Network of Research Integrity Office (ENRIO) and responsible for raising awareness of researchers about the importance of research integrity <ref name=":0">Ethics Committee of the Spanish National Research Council (CSIC). Enrio. [cited 2020 Jan 5]. Available from: http://www.enrio.eu/news-activities/members/spain/</ref>. Its aim is also to prevent research misconduct and unacceptable research practices <ref name=":0" />. To that end, the Committee has created the [http://enacti2ng-itn.cbm.uam.es/images/Documentation/CBP_CSIC_en.pdf Code of Good Scientific Practices of CSIC], the [https://www.cnb.csic.es/documents/ConflictosInteresCSIC.pdf CSIC Manual of Conflicts of Interest] and the [http://icmab.es/images/gender/Declaracion-nacional-integridad-cientifica.pdf Spanish National Statement of Research Integrity]. CSIC is also responsible for dealing with ethical conflicts. Any individual or institution can bring a case to the attention of the Committee, whose field of competence is limited to CSIC and its employees <ref name=":0" /><ref>CSIC’s Ethics Committee. CSIC. [cited 2020 Jan 7]. Available from: https://www.csic.es/en/csic/scientific-integrity-and-ethics-csic/csic-ethics-committee</ref>. |
| − | There are also a number of Spanish national associations for ethics assessment of research, centred mainly in bioethics and biomedical research. They include the National Association of Research Ethics Committees, the Network of Ethics Committees in Universities and Public Research Centres in Spain and the Spanish Association of Bioethics | + | There are also a number of Spanish national associations for ethics assessment of research, centred mainly in bioethics and biomedical research. They include the National Association of Research Ethics Committees, the Network of Ethics Committees in Universities and Public Research Centres in Spain and the Spanish Association of Bioethics <ref name=":1">Arias Díaz J, de Sola Perea L, Martin-Arrbias M C. Ethics Assessment in Different Countries. Spain. SATORI. 2015 June. [cited 2020 Jan 5]. Available from: https://satoriproject.eu/media/4.i-Country-report-Spain.pdf</ref>. |
| − | All the autonomous communities have Research Ethics Committees and Research Ethics Committees for drugs that perform the ethical assessment of research projects performed in the region. These committees have a special accreditation regulated by the Royal Decree 1090/2015 | + | All the autonomous communities have Research Ethics Committees and Research Ethics Committees for drugs that perform the ethical assessment of research projects performed in the region. These committees have a special accreditation regulated by the Royal Decree 1090/2015 <ref>Ministerio de Sanidad, Servicios Sociales e Igualdad, Agencia Española de Medicamentos y Productos Sanitarios. [Ministry of Health, Social Policy and Equality, The Spanish Agency of Medicines and Medical Devices]. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry. [cited 2020 Jan 7]. Available from: https://www.aemps.gob.es/legislacion/espana/investigacionClinica/docs/Royal-Decree-1090-2015_4-December.pdf</ref>. The Research Ethics Committees and ad hoc commissions are in charge of settling scientific integrity problems. They are independent and their decisions can be binding, although there is a right of appeal. The official list of proven misconduct regulated by authorities is not publicly available at the moment <ref name=":2">European Commission. Mutual Learning Exercise (MLE) on Research Integrity. Dialogue and Communication Thematic Report No 3. 2019 May. [cited 2020 Jan 7]. Available from: https://rio.jrc.ec.europa.eu/sites/default/files/report/MLE%20RI%20-%20Thematic%20Report%20No%203.pdf</ref>. |
| − | Spanish policies and initiatives to support ethics practices in the private industry mostly concern corporate social responsibility. Any industry can create an independent Research Ethics Committee or ascribe to any existent Research Ethics Committee, but each Research Ethics Committee must be authorized by the regional autonomies through an accreditation process strictly controlled by the health authorities. Large companies may have their own good practices codes, especially in the pharmaceutical sector | + | Spanish policies and initiatives to support ethics practices in the private industry mostly concern corporate social responsibility. Any industry can create an independent Research Ethics Committee or ascribe to any existent Research Ethics Committee, but each Research Ethics Committee must be authorized by the regional autonomies through an accreditation process strictly controlled by the health authorities. Large companies may have their own good practices codes, especially in the pharmaceutical sector <ref name=":1" />. |
| − | Aside from Research Ethics Committees, professional organizations can also sanction research misconducts. For example, deontological commissions related to the professional organizations act independently to sanction the professionals involved in research misconducting | + | Aside from Research Ethics Committees, professional organizations can also sanction research misconducts. For example, deontological commissions related to the professional organizations act independently to sanction the professionals involved in research misconducting <ref name=":2" />. If misconduct affects human beings, Justice system starts a process of investigation <ref name=":2" />. |
| − | The protection of whistle-blowers is not addressed in regulations related to RI. There is no specific law on whistle-blower protection for employees in Spain so citizens must personally come forward in order for their claim to be investigated. The only legislative regulation loosely related to whistleblowing is a provision allowing citizens to anonymously report conflicts of interest of high-ranking officials and members of Parliament and a whistle-blower e-mail hotline that allows anonymous reporting of anticompetitive behaviour | + | The protection of whistle-blowers is not addressed in regulations related to RI. There is no specific law on whistle-blower protection for employees in Spain so citizens must personally come forward in order for their claim to be investigated. The only legislative regulation loosely related to whistleblowing is a provision allowing citizens to anonymously report conflicts of interest of high-ranking officials and members of Parliament and a whistle-blower e-mail hotline that allows anonymous reporting of anticompetitive behaviour <ref>Briefing Paper. Whistleblower Protection in Spain. [cited 2020 Jan 7]. Available from: https://www.changeofdirection.eu/assets/briefings/EU%20briefing%20paper%20-%20Spain%20-%20english.pdf</ref>. |
| − | < | ||
{{{!}} class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" width="642" | {{{!}} class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" width="642" | ||
| − | {{!}} width="302" valign="top" {{!}}'''Bodies for RE+RI''' | + | {{!}} width="302" valign="top"{{!}}'''Bodies for RE+RI''' |
| − | {{!}} width="340" valign="top" {{!}}'''Scope''' | + | {{!}} width="340" valign="top"{{!}}'''Scope''' |
{{!}}- | {{!}}- | ||
| − | {{!}} width="302" valign="top" {{!}}[https://www.csic.es/en/csic/scientific-integrity-and-ethics-csic/csic-ethics-committee Ethics Committee of the Spanish National Research Council] | + | {{!}} width="302" valign="top"{{!}}[https://www.csic.es/en/csic/scientific-integrity-and-ethics-csic/csic-ethics-committee Ethics Committee of the Spanish National Research Council] |
| − | {{!}} width="340" valign="top" {{!}}Investigates, trains and promotes RI. It also issues reports and formulates recommendations about ethical and deontological principles related to research activity. | + | {{!}} width="340" valign="top"{{!}}Investigates, trains and promotes RI. It also issues reports and formulates recommendations about ethical and deontological principles related to research activity. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="302" valign="top" {{!}}[https://eng.isciii.es/eng.isciii.es/Paginas/Inicio.html The Research Ethics Committee of the Carlos III Health Institute] | + | {{!}} width="302" valign="top"{{!}}[https://eng.isciii.es/eng.isciii.es/Paginas/Inicio.html The Research Ethics Committee of the Carlos III Health Institute] |
| − | {{!}} width="340" valign="top" {{!}}Contributes to improving the health of all citizens through the promotion of research and innovation in Health Sciences and Biomedicine and through the provision of groundbreaking scientific and technical services and educational programmes directed towards the National Health System. | + | {{!}} width="340" valign="top"{{!}}Contributes to improving the health of all citizens through the promotion of research and innovation in Health Sciences and Biomedicine and through the provision of groundbreaking scientific and technical services and educational programmes directed towards the National Health System. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="302" valign="top" {{!}}[http://www.comitedebioetica.es/ The Spanish Bioethics Committee] | + | {{!}} width="302" valign="top"{{!}}[http://www.comitedebioetica.es/ The Spanish Bioethics Committee] |
| − | {{!}} width="340" valign="top" {{!}}Issues reports, proposals and recommendations for public authorities at state and regional level on matters related to the ethical and social implications of Biomedicine and Health Sciences. It is also responsible for establishing the general principles for the production of codes of good practice in scientific research and for representing Spain in supranational and international forums and bodies involved in bioethics. | + | {{!}} width="340" valign="top"{{!}}Issues reports, proposals and recommendations for public authorities at state and regional level on matters related to the ethical and social implications of Biomedicine and Health Sciences. It is also responsible for establishing the general principles for the production of codes of good practice in scientific research and for representing Spain in supranational and international forums and bodies involved in bioethics. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="302" valign="top" {{!}}[https://www.global-regulation.com/translation/spain/1441251/royal-decree-42-2010-of-15-january%252c-which-regulates-the-national-commission-for-assisted-human-reproduction.html The National Commission on Assisted Human Reproduction] | + | {{!}} width="302" valign="top"{{!}}[https://www.global-regulation.com/translation/spain/1441251/royal-decree-42-2010-of-15-january%252c-which-regulates-the-national-commission-for-assisted-human-reproduction.html The National Commission on Assisted Human Reproduction] |
| − | {{!}} width="340" valign="top" {{!}}Provides guidance on the use of assisted human reproduction techniques and collaborates with public administrations with regard to this matter. | + | {{!}} width="340" valign="top"{{!}}Provides guidance on the use of assisted human reproduction techniques and collaborates with public administrations with regard to this matter. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="302" valign="top" {{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2010-18654 The Commission for the Donation and Use of Human Cells and Tissues] | + | {{!}} width="302" valign="top"{{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2010-18654 The Commission for the Donation and Use of Human Cells and Tissues] |
| − | {{!}} width="340" valign="top" {{!}}Advises and guides research with biological samples of human embryonic nature and contributes to the updating and dissemination of scientific and technical knowledge in this matter. | + | {{!}} width="340" valign="top"{{!}}Advises and guides research with biological samples of human embryonic nature and contributes to the updating and dissemination of scientific and technical knowledge in this matter. |
{{!}}} | {{!}}} | ||
<br /> | <br /> | ||
| − | |Law And Regulation=A number of laws regarding RE and RI are officially instated in Spain. | + | <references /> |
| − | <br /> | + | |Law And Regulation=A number of laws regarding RE and RI are officially instated in Spain.<br /> |
{{{!}} class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" width="642" | {{{!}} class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" width="642" | ||
| − | {{!}} width="301" valign="top" {{!}}'''Law''' | + | {{!}} width="301" valign="top"{{!}}'''Law''' |
| − | {{!}} width="342" valign="top" {{!}}'''Scope''' | + | {{!}} width="342" valign="top"{{!}}'''Scope''' |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.global-regulation.com/translation/spain/1451484/law-6-2001%252c-of-21-december%252c-on-universities.html Act on Universities (La Ley Orgánica 6/2001 de Universidades)] | + | {{!}} width="301" valign="top"{{!}}[https://www.global-regulation.com/translation/spain/1451484/law-6-2001%252c-of-21-december%252c-on-universities.html Act on Universities (La Ley Orgánica 6/2001 de Universidades)] |
| − | {{!}} width="342" valign="top" {{!}}Promotes the action of the General Administration of the State in the structuring and cohesion of the University system, deepens the competences of the autonomous communities in the field of higher education, increases the degree of autonomy of the universities and establishes the channels needed to strengthen relationships and reciprocal links between University and society. | + | {{!}} width="342" valign="top"{{!}}Promotes the action of the General Administration of the State in the structuring and cohesion of the University system, deepens the competences of the autonomous communities in the field of higher education, increases the degree of autonomy of the universities and establishes the channels needed to strengthen relationships and reciprocal links between University and society. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-2011-9617 Law for Science, Technology and Innovation (Ley 14/2011, de 1 de junio, de la Ciencia, la Tecnología y la Innovación)] | + | {{!}} width="301" valign="top"{{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-2011-9617 Law for Science, Technology and Innovation (Ley 14/2011, de 1 de junio, de la Ciencia, la Tecnología y la Innovación)] |
| − | {{!}} width="342" valign="top" {{!}}Deepens the vertebration of relations and the dialogue between science, technology, innovation and society. | + | {{!}} width="342" valign="top"{{!}}Deepens the vertebration of relations and the dialogue between science, technology, innovation and society. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-2007-12945 The Law on Biomedical Research (Ley 14/2007, de 3 de julio, de Investigación biomédica)] | + | {{!}} width="301" valign="top"{{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-2007-12945 The Law on Biomedical Research (Ley 14/2007, de 3 de julio, de Investigación biomédica)] |
| − | {{!}} width="342" valign="top" {{!}}Establishes standards in areas that have not been regulated yet or that have been fragmentary or unrelated to the changes occurred in recent years, such as genetic analysis, research with human biological samples, in particular those of an embryonic nature, or biobanks. | + | {{!}} width="342" valign="top"{{!}}Establishes standards in areas that have not been regulated yet or that have been fragmentary or unrelated to the changes occurred in recent years, such as genetic analysis, research with human biological samples, in particular those of an embryonic nature, or biobanks. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.global-regulation.com/translation/spain/1448886/royal-decree-2132---2004%252c-of-29-october%252c-laying-down-the-requirements-and-procedures-for-the-development-of-research-projects-with-stem-cells-take.html Royal Decree 2132/2004, Of 29 October, Laying Down The Requirements And Procedures For The Development Of Research Projects With Stem Cells Taken From Surplus Pre-Embryos] | + | {{!}} width="301" valign="top"{{!}}[https://www.global-regulation.com/translation/spain/1448886/royal-decree-2132---2004%252c-of-29-october%252c-laying-down-the-requirements-and-procedures-for-the-development-of-research-projects-with-stem-cells-take.html Royal Decree 2132/2004, Of 29 October, Laying Down The Requirements And Procedures For The Development Of Research Projects With Stem Cells Taken From Surplus Pre-Embryos] |
<br /> | <br /> | ||
| − | {{!}} width="342" valign="top" {{!}}Regulates the use of the human pre-embryos for the research purposes. | + | {{!}} width="342" valign="top"{{!}}Regulates the use of the human pre-embryos for the research purposes. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.global-regulation.com/translation/spain/1446767/order-sco-393-2006%252c-of-8-february%252c-which-establishes-the-organization-and-functioning-of-the-national-stem-cell-bank.html Order SCO/393/2006, Of 8 February, Which Establishes The Organization And Functioning Of The National Stem Cell Bank] | + | {{!}} width="301" valign="top"{{!}}[https://www.global-regulation.com/translation/spain/1446767/order-sco-393-2006%252c-of-8-february%252c-which-establishes-the-organization-and-functioning-of-the-national-stem-cell-bank.html Order SCO/393/2006, Of 8 February, Which Establishes The Organization And Functioning Of The National Stem Cell Bank] |
| − | {{!}} width="342" valign="top" {{!}}Establishes the organization and operation of the National Bank of Cellular Lines. | + | {{!}} width="342" valign="top"{{!}}Establishes the organization and operation of the National Bank of Cellular Lines. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-1999-23750 Organic Law 15/1999, of December 13, on the Protection of Personal Data] | + | {{!}} width="301" valign="top"{{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-1999-23750 Organic Law 15/1999, of December 13, on the Protection of Personal Data] |
| − | {{!}} width="342" valign="top" {{!}}Guarantees and protects, with regard to the processing of personal data, the public freedoms and fundamental rights of natural persons, and in particular their personal and family honour and privacy. | + | {{!}} width="342" valign="top"{{!}}Guarantees and protects, with regard to the processing of personal data, the public freedoms and fundamental rights of natural persons, and in particular their personal and family honour and privacy. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2010-18654 Royal Decree 1527/2010, of November 15, regulating the Guarantees Commission for the Donation and Use of Human Cells and Tissues and the Registration of Research Projects] | + | {{!}} width="301" valign="top"{{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2010-18654 Royal Decree 1527/2010, of November 15, regulating the Guarantees Commission for the Donation and Use of Human Cells and Tissues and the Registration of Research Projects] |
<br /> | <br /> | ||
| − | {{!}} width="342" valign="top" {{!}}Regulates the use of human cells and tissues and the registry of research projects. | + | {{!}} width="342" valign="top"{{!}}Regulates the use of human cells and tissues and the registry of research projects. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-2011-18919 Royal Decree 1716/2011 of 18 November establishing the basic requirements for the authorization and operation of biobanks for biomedical research and the treatment of biological samples of human origin, and regulating the operation and organization of the National Register of Biobanks for biomedical research.] | + | {{!}} width="301" valign="top"{{!}}[https://www.boe.es/buscar/doc.php?id=BOE-A-2011-18919 Royal Decree 1716/2011 of 18 November establishing the basic requirements for the authorization and operation of biobanks for biomedical research and the treatment of biological samples of human origin, and regulating the operation and organization of the National Register of Biobanks for biomedical research.] |
<br /> | <br /> | ||
| − | {{!}} width="342" valign="top" {{!}}Establishes the basic requirements for authorization and operation of biobanks for biomedical research. | + | {{!}} width="342" valign="top"{{!}}Establishes the basic requirements for authorization and operation of biobanks for biomedical research. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2013-1337 Royal Decree 53/2013 of 1 February laying down the basic rules applicable for the protection of animals used in experimentation and other scientific purposes, including teaching.] | + | {{!}} width="301" valign="top"{{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2013-1337 Royal Decree 53/2013 of 1 February laying down the basic rules applicable for the protection of animals used in experimentation and other scientific purposes, including teaching.] |
<br /> | <br /> | ||
| − | {{!}} width="342" valign="top" {{!}}Establishes the basic rules applicable for the protection of animals used in experimentation and other scientific purposes, including teaching. | + | {{!}} width="342" valign="top"{{!}}Establishes the basic rules applicable for the protection of animals used in experimentation and other scientific purposes, including teaching. |
{{!}}- | {{!}}- | ||
| − | {{!}} width="301" valign="top" {{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2013-6271 Law 6/2013, of June 11, amending Law 32/2007, of November 7, for the care of animals, in their exploitation, transport, experimentation and slaughter.] | + | {{!}} width="301" valign="top"{{!}}[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2013-6271 Law 6/2013, of June 11, amending Law 32/2007, of November 7, for the care of animals, in their exploitation, transport, experimentation and slaughter.] |
<br /> | <br /> | ||
| − | {{!}} width="342" valign="top" {{!}}Establishes a set of principles regarding the care of animals and the regulation of the corresponding sanctioning regime in case of non-compliance with animal welfare regulations. | + | {{!}} width="342" valign="top"{{!}}Establishes a set of principles regarding the care of animals and the regulation of the corresponding sanctioning regime in case of non-compliance with animal welfare regulations. |
{{!}}} | {{!}}} | ||
|Measure=<u>RI training </u> | |Measure=<u>RI training </u> | ||
| − | There is no mandate for RI training but some universities and institutions have integrated a module about research integrity in their existing program about research ethics (Autonomous University of Madrid, University of Barcelona, University of Oviedo and National University of Distance Education). Several members of the CSIC Ethics Committee give lectures regarding research integrity and responsible conduct of research. Research Ethics and Research Integrity have been included as topics in the CSIC Management Training Course aimed to CSIC’s Directors and Managers ( | + | There is no mandate for RI training but some universities and institutions have integrated a module about research integrity in their existing program about research ethics (Autonomous University of Madrid, University of Barcelona, University of Oviedo and National University of Distance Education). Several members of the CSIC Ethics Committee give lectures regarding research integrity and responsible conduct of research. Research Ethics and Research Integrity have been included as topics in the CSIC Management Training Course aimed to CSIC’s Directors and Managers <ref>Ethics Committee of the Spanish National Research Council (CSIC). Enrio. [cited 2020 Jan 5]. Available from: http://www.enrio.eu/news-activities/members/spain/</ref>. |
<u>RI dialogue and communication</u> | <u>RI dialogue and communication</u> | ||
| − | In a Knowledge Transfer study 2010-2012, Spain positioning is about average (56%). Spain is one of the countries with a low level of innovation and weak knowledge translation policies. | + | In a Knowledge Transfer study 2010-2012, Spain positioning is about average (56%). Spain is one of the countries with a low level of innovation and weak knowledge translation policies <ref>Arundel A, Es-Sadki N, Barjak F, Perrett P, Samuel O, Lilischkis S. Knowledge Transfer Study 2010-2012. Final Report. 2013 June. [cited 2020 Jan 7]. Available from: https://ec.europa.eu/research/innovation-union/pdf/knowledge_transfer_2010-2012_report.pdf</ref>. Research Results Transfer Offices, that are part of each university, aim to promote and facilitate cooperation in Research and Development activities between researchers and companies <ref>RedOTRI. Research Results Transfer Offices (OTRI). [cited 2020 Jan 7]. Available from: http://www.redotriuniversidades.net/index.php/presentacion?id=272</ref>. |
| − | ( | + | The academic system is perceived corrupt. Academic corruption survey of 5,725 people who studied in 11 European countries showed the highest levels of perceived corruption in Ukraine and Spain <ref>Marušić A. Mutual Learning Exercise (MLE) on Research Integrity. Dialogue and Communication Thematic Report No 3. 2019 May. [cited 2020 Jan 7]. Available from: https://rio.jrc.ec.europa.eu/sites/default/files/report/MLE%20RI%20-%20Thematic%20Report%20No%203.pdf</ref>. Since 2002, the percentage of the population understanding science and technology as bringing more benefits than harms keeps growing every year <ref>Fundación Española para la Ciencia y la Tecnología [Spanish Foundation for Science and Technology]. Recruitment Opportunities for Researchers in Spain. 2016 March. [cited 2020 Jan 7]. Available from: |
| − | + | https://cdn2.euraxess.org/sites/default/files/recruitmentopportunities_vf4.pdf</ref>. The research integrity s occasionally discussed in the lay press. The most relevant newspapers at the national level (EL Pais and El Mundo) published several articles about cases of scientific misconduct in Spain. | |
<u>RI incentives</u> | <u>RI incentives</u> | ||
| − | Spain provides Research and Development tax relief through a hybrid tax credit and social security contributions exemption for qualified research staff. Both of these incentives are mutually exclusive in their use except for innovative small and medium-sized enterprises | + | Spain provides Research and Development tax relief through a hybrid tax credit and social security contributions exemption for qualified research staff. Both of these incentives are mutually exclusive in their use except for innovative small and medium-sized enterprises <ref>OECD. R&D Tax Incentives: Spain, 2019. [cited 2020 Jan 7]. Available from: https://www.oecd.org/sti/rd-tax-stats-spain.pdf</ref>. |
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Latest revision as of 10:43, 22 October 2021
Based on the document Report:29d1a7fc-0809-484c-b91b-f7b02f9dad5c which was published on 2021-10-22T09:43:01 on the website "Embassy of Good Science" under the URL https://embassy.science/wiki/Report:29d1a7fc-0809-484c-b91b-f7b02f9dad5c, the research ifrastructure of {{{Display_Title}}} is described as follows: In 2019 there were 135,331 full-time researchers in Spain [1]. Spanish National Research Council, a State Agency with the consideration of a Public Research Organization of the Spanish General State Administration, has 120 research institutes out of which 51 are of joint centres with other institutions, primarily universities [2]. There are also 8 centres functioning as research support units that provide technical and administrative support to two or more institutes [2]. Spain has 75 universities – 50 public and 25 private [3].
- ↑ Eurostat. [cited 2020 Jan 7]. Available from: https://ec.europa.eu/eurostat/tgm/refreshTableAction.do?tab=table&plugin=1&pcode=tsc00004&language=en
- ↑ 2.0 2.1 Institutes, Centres & Units. CSIC. [cited 2020 Jan 7]. Available from: https://www.csic.es/en/investigation/institutes-centres-units
- ↑ Estudios y Universidades en España. Listado de todas Universidades Españolas [Studies and Universities in Spain. List of All Spanish Universities]. [cited 2020 Jan 12]. Available from: http://www.estudiosyuniversidades.com/universidades/universidades-publicas-espana.html
Facts & FiguresSpain
Where
Research infrastructure
In 2019 there were 135,331 full-time researchers in Spain [1]. Spanish National Research Council, a State Agency with the consideration of a Public Research Organization of the Spanish General State Administration, has 120 research institutes out of which 51 are of joint centres with other institutions, primarily universities [2]. There are also 8 centres functioning as research support units that provide technical and administrative support to two or more institutes [2]. Spain has 75 universities – 50 public and 25 private [3].
- ↑ Eurostat. [cited 2020 Jan 7]. Available from: https://ec.europa.eu/eurostat/tgm/refreshTableAction.do?tab=table&plugin=1&pcode=tsc00004&language=en
- ↑ 2.0 2.1 Institutes, Centres & Units. CSIC. [cited 2020 Jan 7]. Available from: https://www.csic.es/en/investigation/institutes-centres-units
- ↑ Estudios y Universidades en España. Listado de todas Universidades Españolas [Studies and Universities in Spain. List of All Spanish Universities]. [cited 2020 Jan 12]. Available from: http://www.estudiosyuniversidades.com/universidades/universidades-publicas-espana.html
Research funding
In 2019, the gross expenditures on research and development were €15.572 million, which comprises 1.25% of the country’s GDP [1]. Most funding was spent in the corporate sector (56.1%), followed by the higher education sector (26.6%), general government sector (17.0%) and the private non-profit sector (0.3%) [2]. Spain had 8.137 signed grants receiving €5.82 billion in H2020 [3] and 491 ERC signed grants receiving €664.8 million in H2020 [3].
- ↑ Instituto Nacional de Estadística. [cited 2020 Jan 7]. Available from: https://www.ine.es/dyngs/INEbase/en/operacion.htm?c=Estadistica_C&cid=1254736176754&menu=ultiDatos&idp=1254735576669
- ↑ Statistics on R&D Activities. Year 2019. Final data. Instituto Nacional de Estadística. Press Release 27 November 2020. [cited 2020 Jan 7]. Available from: https://www.ine.es/en/prensa/imasd_2019_en.pdf
- ↑ 3.0 3.1 H2020 Projects. [cited 2020 Feb 19]. Available from: https://webgate.ec.europa.eu/dashboard/sense/app/93297a69-09fd-4ef5-889f-b83c4e21d33e/sheet/erUXRa/state/analysis
Research strategy
The Spanish Strategy on Science, Technology and Innovation 2013-2020 was launched by the General State Administration and the Regional Administrations in 2012. Since it was created at the time when country was experiencing serious economic difficulties which led to decreasing of funding with respect to public and company investment, the Strategy promotes the capacities of the Spanish Science, Technology and Innovation System and enables collaboration between all the stakeholders of the System while increasing the social and economic returns from investment in Research Development and Innovation (RDI). With regard to this, the Strategy defends the importance of scientific and technological progress as an indisputable element of social progress [1]. One of the Strategy’s aims is to define a strategic framework for RDI policies to promote structural reforms, establish incentives and determine the objectives and efforts required to create the RDI capacities that will make Spain a country of innovation, contribute to social and economic progress and reinforce their international leadership in a global setting [1].
- ↑ 1.0 1.1 Gobierno de España. Ministerio de Economía y Competitividad [Government of Spain. Ministry of Economy and Competitiveness]. Spanish Strategy for Science and Technology and Innovation 2013-2020. [cited 2020 Jan 7]. Available from: https://www.ciencia.gob.es/stfls/MICINN/Investigacion/FICHEROS/Spanish_Strategy_Science_Technology.pdf
Research governance, compliance and integrity
Spain has several bodies for RI – the Ethics Committee of the Spanish National Research Council (CSIC), the Spanish Research Ethics Committee (CEEI), the National Commission on Assisted Human Reproduction and the Commission for the Donation and Use of Human Cells and Tissues.
From 2011 the Ethics Committee of the Spanish National Research Council (CSIC) has been a member of European Network of Research Integrity Office (ENRIO) and responsible for raising awareness of researchers about the importance of research integrity [1]. Its aim is also to prevent research misconduct and unacceptable research practices [1]. To that end, the Committee has created the Code of Good Scientific Practices of CSIC, the CSIC Manual of Conflicts of Interest and the Spanish National Statement of Research Integrity. CSIC is also responsible for dealing with ethical conflicts. Any individual or institution can bring a case to the attention of the Committee, whose field of competence is limited to CSIC and its employees [1][2].
There are also a number of Spanish national associations for ethics assessment of research, centred mainly in bioethics and biomedical research. They include the National Association of Research Ethics Committees, the Network of Ethics Committees in Universities and Public Research Centres in Spain and the Spanish Association of Bioethics [3].
All the autonomous communities have Research Ethics Committees and Research Ethics Committees for drugs that perform the ethical assessment of research projects performed in the region. These committees have a special accreditation regulated by the Royal Decree 1090/2015 [4]. The Research Ethics Committees and ad hoc commissions are in charge of settling scientific integrity problems. They are independent and their decisions can be binding, although there is a right of appeal. The official list of proven misconduct regulated by authorities is not publicly available at the moment [5].
Spanish policies and initiatives to support ethics practices in the private industry mostly concern corporate social responsibility. Any industry can create an independent Research Ethics Committee or ascribe to any existent Research Ethics Committee, but each Research Ethics Committee must be authorized by the regional autonomies through an accreditation process strictly controlled by the health authorities. Large companies may have their own good practices codes, especially in the pharmaceutical sector [3].
Aside from Research Ethics Committees, professional organizations can also sanction research misconducts. For example, deontological commissions related to the professional organizations act independently to sanction the professionals involved in research misconducting [5]. If misconduct affects human beings, Justice system starts a process of investigation [5].
The protection of whistle-blowers is not addressed in regulations related to RI. There is no specific law on whistle-blower protection for employees in Spain so citizens must personally come forward in order for their claim to be investigated. The only legislative regulation loosely related to whistleblowing is a provision allowing citizens to anonymously report conflicts of interest of high-ranking officials and members of Parliament and a whistle-blower e-mail hotline that allows anonymous reporting of anticompetitive behaviour [6].
| Bodies for RE+RI | Scope |
| Ethics Committee of the Spanish National Research Council | Investigates, trains and promotes RI. It also issues reports and formulates recommendations about ethical and deontological principles related to research activity. |
| The Research Ethics Committee of the Carlos III Health Institute | Contributes to improving the health of all citizens through the promotion of research and innovation in Health Sciences and Biomedicine and through the provision of groundbreaking scientific and technical services and educational programmes directed towards the National Health System. |
| The Spanish Bioethics Committee | Issues reports, proposals and recommendations for public authorities at state and regional level on matters related to the ethical and social implications of Biomedicine and Health Sciences. It is also responsible for establishing the general principles for the production of codes of good practice in scientific research and for representing Spain in supranational and international forums and bodies involved in bioethics. |
| The National Commission on Assisted Human Reproduction | Provides guidance on the use of assisted human reproduction techniques and collaborates with public administrations with regard to this matter. |
| The Commission for the Donation and Use of Human Cells and Tissues | Advises and guides research with biological samples of human embryonic nature and contributes to the updating and dissemination of scientific and technical knowledge in this matter. |
- ↑ 1.0 1.1 1.2 Ethics Committee of the Spanish National Research Council (CSIC). Enrio. [cited 2020 Jan 5]. Available from: http://www.enrio.eu/news-activities/members/spain/
- ↑ CSIC’s Ethics Committee. CSIC. [cited 2020 Jan 7]. Available from: https://www.csic.es/en/csic/scientific-integrity-and-ethics-csic/csic-ethics-committee
- ↑ 3.0 3.1 Arias Díaz J, de Sola Perea L, Martin-Arrbias M C. Ethics Assessment in Different Countries. Spain. SATORI. 2015 June. [cited 2020 Jan 5]. Available from: https://satoriproject.eu/media/4.i-Country-report-Spain.pdf
- ↑ Ministerio de Sanidad, Servicios Sociales e Igualdad, Agencia Española de Medicamentos y Productos Sanitarios. [Ministry of Health, Social Policy and Equality, The Spanish Agency of Medicines and Medical Devices]. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry. [cited 2020 Jan 7]. Available from: https://www.aemps.gob.es/legislacion/espana/investigacionClinica/docs/Royal-Decree-1090-2015_4-December.pdf
- ↑ 5.0 5.1 5.2 European Commission. Mutual Learning Exercise (MLE) on Research Integrity. Dialogue and Communication Thematic Report No 3. 2019 May. [cited 2020 Jan 7]. Available from: https://rio.jrc.ec.europa.eu/sites/default/files/report/MLE%20RI%20-%20Thematic%20Report%20No%203.pdf
- ↑ Briefing Paper. Whistleblower Protection in Spain. [cited 2020 Jan 7]. Available from: https://www.changeofdirection.eu/assets/briefings/EU%20briefing%20paper%20-%20Spain%20-%20english.pdf
Laws and regulations
A number of laws regarding RE and RI are officially instated in Spain.
| Law | Scope |
| Act on Universities (La Ley Orgánica 6/2001 de Universidades) | Promotes the action of the General Administration of the State in the structuring and cohesion of the University system, deepens the competences of the autonomous communities in the field of higher education, increases the degree of autonomy of the universities and establishes the channels needed to strengthen relationships and reciprocal links between University and society. |
| Law for Science, Technology and Innovation (Ley 14/2011, de 1 de junio, de la Ciencia, la Tecnología y la Innovación) | Deepens the vertebration of relations and the dialogue between science, technology, innovation and society. |
| The Law on Biomedical Research (Ley 14/2007, de 3 de julio, de Investigación biomédica) | Establishes standards in areas that have not been regulated yet or that have been fragmentary or unrelated to the changes occurred in recent years, such as genetic analysis, research with human biological samples, in particular those of an embryonic nature, or biobanks. |
| Royal Decree 2132/2004, Of 29 October, Laying Down The Requirements And Procedures For The Development Of Research Projects With Stem Cells Taken From Surplus Pre-Embryos
|
Regulates the use of the human pre-embryos for the research purposes. |
| Order SCO/393/2006, Of 8 February, Which Establishes The Organization And Functioning Of The National Stem Cell Bank | Establishes the organization and operation of the National Bank of Cellular Lines. |
| Organic Law 15/1999, of December 13, on the Protection of Personal Data | Guarantees and protects, with regard to the processing of personal data, the public freedoms and fundamental rights of natural persons, and in particular their personal and family honour and privacy. |
| Royal Decree 1527/2010, of November 15, regulating the Guarantees Commission for the Donation and Use of Human Cells and Tissues and the Registration of Research Projects
|
Regulates the use of human cells and tissues and the registry of research projects. |
| Royal Decree 1716/2011 of 18 November establishing the basic requirements for the authorization and operation of biobanks for biomedical research and the treatment of biological samples of human origin, and regulating the operation and organization of the National Register of Biobanks for biomedical research.
|
Establishes the basic requirements for authorization and operation of biobanks for biomedical research. |
| Royal Decree 53/2013 of 1 February laying down the basic rules applicable for the protection of animals used in experimentation and other scientific purposes, including teaching.
|
Establishes the basic rules applicable for the protection of animals used in experimentation and other scientific purposes, including teaching. |
| Law 6/2013, of June 11, amending Law 32/2007, of November 7, for the care of animals, in their exploitation, transport, experimentation and slaughter.
|
Establishes a set of principles regarding the care of animals and the regulation of the corresponding sanctioning regime in case of non-compliance with animal welfare regulations. |
Measures to promote good scientific practices and open science
RI training
There is no mandate for RI training but some universities and institutions have integrated a module about research integrity in their existing program about research ethics (Autonomous University of Madrid, University of Barcelona, University of Oviedo and National University of Distance Education). Several members of the CSIC Ethics Committee give lectures regarding research integrity and responsible conduct of research. Research Ethics and Research Integrity have been included as topics in the CSIC Management Training Course aimed to CSIC’s Directors and Managers [1].
RI dialogue and communication
In a Knowledge Transfer study 2010-2012, Spain positioning is about average (56%). Spain is one of the countries with a low level of innovation and weak knowledge translation policies [2]. Research Results Transfer Offices, that are part of each university, aim to promote and facilitate cooperation in Research and Development activities between researchers and companies [3].
The academic system is perceived corrupt. Academic corruption survey of 5,725 people who studied in 11 European countries showed the highest levels of perceived corruption in Ukraine and Spain [4]. Since 2002, the percentage of the population understanding science and technology as bringing more benefits than harms keeps growing every year [5]. The research integrity s occasionally discussed in the lay press. The most relevant newspapers at the national level (EL Pais and El Mundo) published several articles about cases of scientific misconduct in Spain.
RI incentives
Spain provides Research and Development tax relief through a hybrid tax credit and social security contributions exemption for qualified research staff. Both of these incentives are mutually exclusive in their use except for innovative small and medium-sized enterprises [6].
| Initiatives | Scope |
| CSIC Management Training Course | Training |
| The National Accreditation Entity | Accreditation |
| The National Research Award | Support |
- ↑ Ethics Committee of the Spanish National Research Council (CSIC). Enrio. [cited 2020 Jan 5]. Available from: http://www.enrio.eu/news-activities/members/spain/
- ↑ Arundel A, Es-Sadki N, Barjak F, Perrett P, Samuel O, Lilischkis S. Knowledge Transfer Study 2010-2012. Final Report. 2013 June. [cited 2020 Jan 7]. Available from: https://ec.europa.eu/research/innovation-union/pdf/knowledge_transfer_2010-2012_report.pdf
- ↑ RedOTRI. Research Results Transfer Offices (OTRI). [cited 2020 Jan 7]. Available from: http://www.redotriuniversidades.net/index.php/presentacion?id=272
- ↑ Marušić A. Mutual Learning Exercise (MLE) on Research Integrity. Dialogue and Communication Thematic Report No 3. 2019 May. [cited 2020 Jan 7]. Available from: https://rio.jrc.ec.europa.eu/sites/default/files/report/MLE%20RI%20-%20Thematic%20Report%20No%203.pdf
- ↑ Fundación Española para la Ciencia y la Tecnología [Spanish Foundation for Science and Technology]. Recruitment Opportunities for Researchers in Spain. 2016 March. [cited 2020 Jan 7]. Available from: https://cdn2.euraxess.org/sites/default/files/recruitmentopportunities_vf4.pdf
- ↑ OECD. R&D Tax Incentives: Spain, 2019. [cited 2020 Jan 7]. Available from: https://www.oecd.org/sti/rd-tax-stats-spain.pdf
Guidelines
Spain
A total of 5 guidelines were found. Add a Guideline.
- Spanish Law on Science, Technology and Innovation (March 2022)
- Conflicts of Interest (CSIC, Spain) (January 2022)
- Good-Practice Guide for Scientific-Academic Publishing (CSIC, Spain) (January 2022)
- Code of Good Scientific Practices of the Spanish National Research Council (CSIS) (October 2021)
- Spanish National Statement on Scientific Integrity (October 2020)
Andrijana Perković Paloš, Elsa Amin contributed to this report. Latest contribution was Oct 22, 2021
