Law And Regulation

⧼EGS Law And Regulation Desc⧽

⧼SA Foundation Data Type⧽: Text

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Showing 16 pages using this property.

A

Austria +

The Austrian government officially instated several laws regarding RE and RI. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="376" valign="top"|'''Law''' | width="376" valign="top"|'''Scope''' |- | width="376" valign="top"|[https://www.ris.bka.gv.at/Dokumente/Erv/ERV_1999_1_165/ERV_1999_1_165.html Federal Act concerning the Protection of Personal Data] | width="376" valign="top"|Protects fundamental right to data protection. |- | width="376" valign="top"|[https://www.ris.bka.gv.at/Dokumente/Erv/ERV_2002_1_120/ERV_2002_1_120.html Federal Act on the Organisation of Universities and their Studies (University Act)] | width="376" valign="top"|Ensures autonomous development and integration of individual universities into an overall system. |- | width="376" valign="top"|[https://bch.cbd.int/database/record.shtml?documentid=26 Genetic Engineering Act] | width="376" valign="top"|Regulates the main aspects of biotechnology and genetic engineering and lays down the rules for the installation and work of an Advisory Board on Gene Technology and its three scientific committees. |- | width="376" valign="top"|[https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20008142 Federal Act on Experiments on Live Animals] | width="376" valign="top"|Protects the life and well-being of animals based on man’s special responsibility for the animal as a fellow creature. |- | width="376" valign="top"|[https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10010285 Hospitals and Health Resorts Act] | width="376" valign="top"|Lays down general principles concerning hospitals and health resorts. |- | width="376" valign="top"|[https://www.bmbwf.gv.at/Themen/Forschung/Forschung-in-%C3%96sterreich/Services/Forschungsstatistik.html R & D Statistics Regulation] | width="376" valign="top"|Aims to compile statistics on research and experimental development. |}

B

Bulgaria +

A number of laws regarding RE and RI are officially instated in Bulgaria '"`UNIQ--ref-00000068-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="304" valign="top"|'''Law''' | width="466" valign="top"|'''Scope''' |- | width="304" valign="top"|[https://www.tandfonline.com/doi/pdf/10.2478/V10133-010-0091-6 Law on Drugs and Pharmacies in Human Medicine (1995)] | width="466" valign="top"|Regulates clinical trial activity in Bulgaria. |- | width="304" valign="top"|[https://pubmed.ncbi.nlm.nih.gov/17511405/ Health Law (2005)] | width="466" valign="top"|Organizes and finances healthcare, patients’ rights, accessibility and quality of health care, mental health, alternative medical services, medical education, medical profession and medical science as well as administrative-punitive measures. |- | width="304" valign="top"|[https://www.bda.bg/images/stories/documents/legal_acts/ZLPHM_en.pdf Medicinal Products in Human Medicine Act] | width="466" valign="top"|Governs the procedures for placing pharmaceutical products on the market, clinical trials, manufacture and import of pharmaceutical products as well as active substances, their packing, classification, safety, sale, retail trade and export, advertisement and state control. |- | width="304" valign="top"|[https://www.bda.bg/images/stories/documents/legal_acts/ZMI_en_20160308.pdf Medical Devices Act (2007)] | width="466" valign="top"|Regulates advertising medicines and medical devices. |- | width="304" valign="top"|[https://blsbg.eu/en/site/htm/filename/LAW+ON+THE+PROFESSIONAL+ORGANIZATIONS+OF+PHYSICIANS+AND+DENTISTS.pdf Law on the professional organizations of physicians and dentists (2007)] | width="466" valign="top"|Regulates the structure, organization and activities of the professional organizations of physicians and dentists, the conditions for practicing the medical and dental professions and the liability for breaching professional ethics. |- | width="304" valign="top"|[http://www.aegle-uhealth.eu/imagem/AEGLEinyourcountry_Bulgaria.pdf Ordinance No. 31 of August 12th, 2007 establishing rules for good clinical practice] | width="466" valign="top"|Governs the principles and guidance for good clinical practice with regard to pharmaceutical products for human use intended for research. |- | width="304" valign="top"|[https://www.bda.bg/images/stories/documents/legal_acts/Ordinance_Essential_requirements_MD_EN.pdf Ordinance on the essential requirements and the procedures for conformity assessment to the essential requirements for medical devices referred to in article 2, paragraph 1 (3) of the law on medical devices] | width="466" valign="top"|Defines essential requirements for the medical devices; the procedures for conformity assessment to the essential requirements and the technical documentation; the requirements for the notified bodies and for a risk analysis and risk management procedures for medical devices containing animal tissue which is rendered non-viable. It also defines the rules for classification of medical devices. |- | width="304" valign="top"|[https://www.tma-bulgaria.com/en/translations-of-pharma-legislation-in-english.html Ordinance No. 2 of February 5th, 2008 on the requirements for collection, validation and provision of information on unwanted side effects and on the content and format of emergency reports for adverse drug reactions and periodic safety reports] | width="466" valign="top"|Specifies the procedures for collecting, verifying and reporting adverse drug reactions. |- | width="304" valign="top"|[https://blsbg.com/bg/kodeks-za-profesionalna-etika-na-lekarite-v-blgariia_p2719.html Code of professional ethics of doctors in Bulgaria (2000)] | width="466" valign="top"|Defines the rules of professional medical ethics binding on every physician. |- | width="304" valign="top"|[https://www.mh.government.bg/media/filer_public/2015/04/17/naredba27-ot-15-06-2007g-razreshavane-upotreba-lekarstveni-produkti.pdf Ordinance No. 27 of June 15th, 2007 on the data requirements and the documentation for the authorization and the registration of medicinal products.] | width="466" valign="top"|Determines the requirements for the data and documentation submitted for authorization or registration, extension, modification and renewal of the marketing authorization or registration under a national procedure, under mutual recognition procedure and decentralized procedure for all kinds of medical products. Medicinal products that fall within the scope of Regulation (EC) are not subject to this Ordinance. |- | width="304" valign="top"|[https://www.mh.government.bg/bg/ministerstvo/komisii/komisiya-po-etika/ Rules and Regulations of the Central Ethics Commission to the Council of Ministers on the Law of Medicinal Products in Human Medicine (2007)] | width="466" valign="top"|Determine the conditions and the order for work of the Central Ethics Commission to the Council of Ministers under the Law on Medical Products in Human Medicine. |- | width="304" valign="top"|[https://blsbg.com/bg/pravilnik-za-deinostta-na-komisiiata-po-profesionalna-etika_p2660.html Rules for the procedure of the commission for professional ethics of Bulgarian Medical Association (2015)] | width="466" valign="top"|Provides rules on the observance of professional-medical, moral and deontological issues related to the exercise of the profession. |- | width="304" valign="top"|[https://www.global-regulation.com/translation/bulgaria/3357084/law-for-the-development-of-academic-staff-in-the-republic-of-bulgaria.html Law for the Development of the Academic Staff in the Republic of Bulgaria] | width="466" valign="top"|Regulates development of academic staff from the acquisition of degrees “doctor” and “doctor of sciences” to academic positions. |- | width="304" valign="top"|[https://lex.bg/en/laws/ldoc/2135680028%20%20Law%20on%20the%20development%20of%20the%20academic%20staff%20in%20the%20Republic%20of%20Bulgaria Rules for the Application of the Act for the Development of the Academic Staff in the Republic of Bulgaria] | width="466" valign="top"|Regulates the public relations related to the acquisition of scientific digress and for holding academic positions in the republic of Bulgaria. |- | width="304" valign="top"|[https://eacea.ec.europa.eu/national-policies/eurydice/content/national-reforms-higher-education-9_en Rules for the Activity of the Commission for Academic Ethics] | width="466" valign="top"|Examines cases of violations in the procedures for the award of academic degrees or academic positions, signals of plagiarism in doctoral dissertations, unreliability of scientific data or conflicts of interest in the formation of the scientific jury under the terms of Development of the Academic Staff in the Republic of Bulgaria. |} '"`UNIQ--references-00000069-QINU`"'

C

Croatia +

The National Committee for Ethics in Research and Higher Education created the national Ethics Code '"`UNIQ--ref-0000021F-QINU`"' which all higher education and research education institutions can, but are not obliged to implement. The Committee can initiate the procedure of revoking a doctoral degree based on its RI investigation findings. Research and higher education institutions also have their ethics codes and ethics committees which take on research integrity issues. There is rarely a separate body specific for research integrity. One of them is Croatian science foundation that has Committee for Research integrity '"`UNIQ--ref-00000220-QINU`"'. Croatian Digital Theses Repository also addresses Research integrity and contains codes of ethics from Croatian Universities '"`UNIQ--ref-00000221-QINU`"'. Some associations and professional bodies also have courts of honour that deal with ethics issues, including research integrity. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="376" valign="top"|'''Law ''' | width="376" valign="top"|'''Scope''' |- | width="376" valign="top"|[https://www.azvo.hr/images/stories/o_nama/Act_on_Scientific_Activity-UNOFFICIAL_TRANSLATION.pdf The Act on Scientific Activity and Higher Education] | width="376" valign="top"|Stipulates the system of research activity and higher education and indicates one of the pillars of research activity, which is ethics of researchers. |- | width="376" valign="top"|[https://www.pmda.go.jp/files/000152996.pdf Ministerial Ordinance on Good Clinical Practice for Drugs] | width="376" valign="top"|Provides standards which serve as the Good Clinical Practice for Drugs, including the registration of clinical trials. |} '"`UNIQ--references-00000222-QINU`"' +

D

Denmark +

A number of laws regarding RE and RI are officially instated in Denmark. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="376" valign="top"|'''Law''' | width="376" valign="top"|'''Scope''' |- | width="376" valign="top"|[https://en.nvk.dk/rules-and-guidelines/act-on-research-ethics-review-of-health-research-projects Act on Research Ethics Review of Health Research Projects] | width="376" valign="top"|Provides the legal framework for the research ethics evaluation of health research projects by the committees and lays down the tasks of the committee system on this basis. |- | width="376" valign="top"|[https://laegemiddelstyrelsen.dk/en/about/targets-and-tasks/legislation/the-danish-act-on-clinical-trials-of-medicinal-products/ Act on Clinical Trials of Medical products] | width="376" valign="top"|Regulates the Danish Medicines Agency’s and the medicinal research ethics committees’ assessment of and control with clinical trials of medicinal products in humans and animals. |- | width="376" valign="top"|[https://link.springer.com/article/10.1007/s10734-014-9814-1 University Act] | width="376" valign="top"|Determines universities’ obligations regarding research and education. It also describes third mission activities, the role of university boards and the organisation of universities. |- | width="376" valign="top"|[https://stip.oecd.org/stip/policy-initiatives/2019%2Fdata%2FpolicyInitiatives%2F15809 Research Misconduct Act] | width="376" valign="top"|Promotes RI and credibility in research by establishing up-to-date rules on handling of research misconduct and questionable research practice. |- | width="376" valign="top"|[https://ufm.dk/en/legislation/prevailing-laws-and-regulations/research-and-innovation/executive-order-on-the-danish-committees-on-scientific-dishonesty.pdf Executive Order on the Danish Committees on Scientific Dishonesty] | width="376" valign="top"|Defines the research dishonesty and aims at strengthening RI. |- | width="376" valign="top"|[http://europam.eu/data/mechanisms/FD/FD%20Laws/Denmark/Denmark%20Public%20Administration%20Act%202013%20webpage%20DK.html Public Administration Act] | width="376" valign="top"|Ensures transparency among authorities, focusing on freedom of information and expression, citizens’ participation in democracy, public control of public administration, media dissemination of information to the public and trust in public administration. |}

E

Estonia +

A number of laws address RE and RI in Estonia. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="283" valign="top"|'''Law''' | width="468" valign="top"|'''Scope''' |- | width="283" valign="top"|[https://www.riigiteataja.ee/en/eli/ee/529122020002/consolide/current Medicinal Products Act] | width="468" valign="top"|Ensures the safety, quality and efficacy of medicinal products in Estonia. It also promotes the use of medicinal products for their intended purposes. |- | width="283" valign="top"|[https://www.riigiteataja.ee/en/eli/ee/530102013045/consolide/current Animal Protection Act] | width="468" valign="top"|Regulates the protection of animals from human acts or omissions that may endanger their health and welfare. |- | width="283" valign="top"|[https://www.riigiteataja.ee/en/eli/ee/513042015012/consolide/current Organisation of Research and Development Act] | width="468" valign="top"|Provides the grounds for the organisation of research and development as a component of Estonian culture and the Estonian economy. |- | width="283" valign="top"|[https://www.riigiteataja.ee/en/eli/ee/Riigikogu/act/525062020001/consolide Higher Education Act] | width="468" valign="top"|Provides the bases of organisation of studies at the level of higher education; the rights and obligations upon studying at the level of higher education; and the bases of the operations of education institutions organising studies at the level of higher education. |- | width="283" valign="top"|[https://euraxess.ec.europa.eu/jobs/charter The European Charter & Code for Researchers] | width="468" valign="top"|The Charter and Code ensure that researchers can enjoy the same rights and obligations in any European country. |- | width="283" valign="top"|[https://www.riigiteataja.ee/en/eli/ee/530102013038/consolide/current Gender Equality Act] | width="468" valign="top"|Ensures and promotes equal treatment of men and women ss a fundamental human right and for the public good in all areas of social life. |- | width="283" valign="top"|[https://www.riigiteataja.ee/en/eli/ee/530102013066/consolide/current Equal Treatment Act] | width="468" valign="top"|Ensures the protection of persons against discrimination on grounds of nationality (ethnic origin), race, colour, religion or other beliefs, age, disability or sexual orientation. |}

F

Finland +

A number of laws regarding RE and RI are officially instated in Finland. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="271" valign="top"|'''Law''' | width="480" valign="top"|'''Scope''' |- | width="271" valign="top"|[https://finlex.fi/en/laki/kaannokset/2010/en20100820_20100820.pdf Decree on the National Committee on Medical Research Ethics] | width="480" valign="top"|Supports and coordinates the activities of the regional ethics committees in connection with the procedures regarding requesting opinions, participates in international cooperation regarding research ethics issues and collects and conveys information on research ethics issues. It also conveys information on the international discussion on ethics in the field of medical research and promotes the public discussion on medical and biomedical research. |- | width="271" valign="top"|[https://finlex.fi/en/laki/kaannokset/1999/en19990488_20100794.pdf Medical Research Act] | width="480" valign="top"|Provides basic rules for medical research with humans. |- | width="271" valign="top"|[https://finlex.fi/en/laki/kaannokset/1995/en19950377_20100955.pdf Gene Technology Act] | width="480" valign="top"|Promotes safe and ethical use and development of gene technology. It protects human and animal health and the environment when carrying out the contained use or deliberate release of genetically modified organisms into the environment. |- | width="271" valign="top"|[https://www.finlex.fi/en/laki/kaannokset/1992/en19920785 Act on the Status and Rights of Patients] | width="480" valign="top"|Regulates the patients’ status and rights in health care and medical care. |- | width="271" valign="top"|[https://www.finlex.fi/fi/laki/kaannokset/2006/en20060062.pdf Act on the Use of Animals for Experimental Purposes] | width="480" valign="top"|Ensures keeping and using animals in experimental animal activities only for necessary and important reasons. |- | width="271" valign="top"|[https://finlex.fi/en/laki/kaannokset/2001/en20010101_20130277.pdf Act on the Medical Use of Human Organs, Tissues and Cells] | width="480" valign="top"|Lays down provisions on the use of: - human organs, tissues and cells for the treatment of human disease or injury - organs intended for transplantation - human embryos for a purpose other than fertility treatment or medical research- - human organs, tissues, cells and tissue samples for a purpose other than that for which they were removed or retained - cadaver for medical teaching and research etc. |- | width="271" valign="top"|[https://finlex.fi/en/laki/kaannokset/1999/en19990523_20000986.pdf Personal Data Act] | width="480" valign="top"|Implements the protection of private life and other basic rights which safeguard the right to privacy and in the processing of personal data. It also promotes the development of and compliance with good processing practice. |- | width="271" valign="top"|[https://finlex.fi/en/laki/kaannokset/1999/en19990621_20150907.pdf Act on the Openness of Government Activities] | width="480" valign="top"|Defines objectives of the right of access and the duties of the authorities regarding openness and good practice on information management in government. |}

France +

A number of laws regarding RE and RI are officially instated in France. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="257" valign="top"|'''Law''' | width="494" valign="top"|'''Scope''' |- | width="257" valign="top"|[https://www.iforct.com/New-Jarde-decree-in-France-News/p/3/665/0/ New Jardé Decree Applying from 17 November 2016] | width="494" valign="top"|Specifies the methods of conducting research involving humans. |- | width="257" valign="top"|[https://www.legifrance.gouv.fr/loda/id/JORFTEXT000027038013/ Order on the ethical evaluation and authorization of projects involving the use of animals in procedures] | width="494" valign="top"|Specifies the methods of conducting research involving animals. |- | width="257" valign="top"|[https://www.legifrance.gouv.fr/codes/id/LEGITEXT000006071367/ Rural and Maritime Fishing Code, Articles R214-117 to R214-127] | width="494" valign="top"|Supports research, innovation and development, especially the bio-based products and plant chemistry sectors. It aims to develop added value in agricultural and food sectors, strengthen France's export capacity, contribute to the protection of the public health and health of farmers and employees in the agricultural sector, etc. |- | width="257" valign="top"|[https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000043136646/ Code of the Environment] | width="494" valign="top"|Provides rules concerning the preservation of natural resources, monitoring of hazardous activities, environmental assessment and public information on project. |- | width="257" valign="top"|[https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000036684330?r=cHTkWm5iJL Order of March 1, 2018 relating to the College of Ethics within the Ministry of Higher Education and Research] | width="494" valign="top"|Gives opinion on the general issues relating to the application of the obligations and ethical principles in the services and establishments within the Ministry of Higher Education and Research. It recommends measures for enforcing ethical obligations and preventing or stopping a conflict of interest situation. |}

G

Greece +

A number of laws regarding RE and RI are officially instated in Greece. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="307" valign="top"|'''Law''' | width="445" valign="top"|'''Scope''' |- | width="307" valign="top"|[https://www.mindbank.info/item/2070 Act on the establishment of National Council of Medical Ethics and Deontology] | width="445" valign="top"|Addresses the rights of hospital patients and provides greater protection for people admitted compulsorily. |- | width="307" valign="top"|[https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679&from=EN Regulation (EU) 2016/679] | width="445" valign="top"|Aims to protect natural persons with regard to processing of personal data and on the free movement of such data. |- | width="307" valign="top"|[https://www.ey.com/en_gr/tax/tax-alerts/ey-law-alert-law-4624-2019-protection-of-personal-data-and-measures-for-the-implementation-of-the-gdpr Law 4624/2019: Protection of Personal Data and Measures for the Implementation of the GDPR] | width="445" valign="top"|Enacts supplemental measures for the application of the General Data Protection Regulation (GDPR) and incorporates Directive (EU) 2016/680. |- | width="307" valign="top"|[https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3295632 Act 2619/1998: ratification of the Oviedo Convention] | width="445" valign="top"|This act implemented the Oviedo Convention in Greece. |- | width="307" valign="top"|[http://www.ilo.org/dyn/natlex/natlex4.detail?p_lang=&p_isn=89616&p_classification=09 Law No. 4009 of 2011 concerning the Structure, Function, and Quality of Studies, and the Internationalization of Higher Educational Institutions] | width="445" valign="top"|Provides organizational structure for the universities. |} +

I

Ireland +

A number of laws regarding RE and RI are officially instated in Ireland. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="307" valign="top"|'''Law''' | width="445" valign="top"|'''Scope''' |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/1997/act/24/enacted/en/html?q=Universities Universities Act] | width="445" valign="top"|Sets out the objects and functions of the University, the structure and role of the Governing Authority, staffing arrangements, composition and role of the Academic Council and settings related to property, finance and reporting. |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/2006/act/25/enacted/en/html?q=institutes+of+technology Institutes of Technology Act] | width="445" valign="top"|Sets out the objects and functions of Institutes of Technology, the structure and role of the governing bodies, staffing arrangements, composition and role of the Academic Council and settings related to property, finance and reporting. |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/2018/act/3/enacted/en/html Technological Universities Act] | width="445" valign="top"|Allows for the merges of two or more Institutes of technology to create a new Technological University. |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/2014/act/30/section/6/enacted/en/html#part2 Freedom of Information Act] | width="445" valign="top"|Gives each individual legal rights to access both personal and non-personal (corporate) records, to have personal records amended or deleted where the information is incorrect or misleading and the right to seek reasons for decisions that affect them. |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/2018/act/7/enacted/en/html?q=data+protection+act Data Protection Act] | width="445" valign="top"|Confers rights on individuals in relation to the privacy of their personal data as well as responsibilities on those persons holding and processing such data. |- | width="307" valign="top"|[http://www.hpra.ie/homepage/medicines/regulatory-information/clinical-trials/clinical-trial-regulation-(regulation-(eu)-no-536-2014) Clinical Trial Regulation (Regulation (EU) No 536/2014)] | width="445" valign="top"|Regulates the clinical trials on medicinal products for human use. |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/2007/si/539/made/en/print Medicinal Products (Control of Manufacture) Regulations] | width="445" valign="top"|Provides regulatory framework for medicinal products in Ireland. |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/2018/si/314/made/en/pdf Data Protection Act 2018] [http://www.irishstatutebook.ie/eli/2018/si/314/made/en/pdf (Section 36(2)) (Health Research) Regulations 2018] | width="445" valign="top"|Provides regulatory framework for processing or further processing personal data for the purposes of health research. |- | width="307" valign="top"|[http://www.irishstatutebook.ie/eli/2014/act/14/enacted/en/html The Protected Disclosures Act 2014] | width="445" valign="top"|Aims to protect people who raise concerns about possible wrongdoing in the workplace. This Act is also known as the whistleblower legislation. |}

L

Lithuania +

A number of laws address RE and RI in Lithuania. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" width="604" | width="217" valign="top"|'''Law''' | width="387" valign="top"|'''Scope''' |- | width="217" valign="top"|[https://vaspvt.gov.lt/files/EN/LAW%20ON%20HEALTH%20SYSTEM.pdf The Republic of Lithuania Law on Health System] | width="387" valign="top"|Regulates the national health system in Lithuania, its structure, limits of legal regulation of health care, health strengthening and health recovery, fundamentals of establishment of the scope of health activities, organization and management of individual and public health care, health promotion, conclusion of contracts regarding health activities, fundamentals of the liability for violations of legal norms of health activities, rights and duties of the residents and subjects of health activities. |- | width="217" valign="top"|[https://e-seimas.lrs.lt/portal/legalActPrint/lt?jfwid=5w7avz05m&documentId=TAIS.377604&category=TAD Law on Health Care Institutions] | width="387" valign="top"|Establishes the classification of healthcare institutions, principles of their founding, reorganisation, liquidation, operation, state regulation thereof, control measures, special features of administration and financing thereof, the nomenclature of institutions of the National Healthcare System of Lithuania, relations between healthcare institutions and patients and the principles of liability for violations of this Law. |- | width="217" valign="top"|[https://vaspvt.gov.lt/files/EN/LAW%20ON%20MEDICAL%20PRACTICE.pdf Law on Medical Practice of the Republic of Lithuania] | width="387" valign="top"|Regulates conditions related to the medical practice of doctor of medicine, doctor resident, family physician and a doctor specialist in the Republic of Lithuania. |- | width="217" valign="top"|[https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/76582f93e9c811e59b76f36d7fa634f8?jfwid=-ji9gt0req Law on Ethics of Biomedical Research] | width="387" valign="top"|Establishes requirements for biomedical research, terms and conditions of processing of human biological samples and managing personal health information for the purposes of biomedical research and activities of biobanks, terms and conditions of issuance of approvals to conduct biomedical research, supervision of conducting of biomedical research and liability of sponsors of biomedical research and investigators for damage resulting from the subject’s health impairment or death. |- | width="217" valign="top"|[https://e-seimas.lrs.lt/rs/legalact/TAD/TAIS.296798/format/ISO_PDF/ Pharmaceutical Law (2006, last amended in 2017)] | width="387" valign="top"|Regulates pharmaceutical and other activity related to medicinal investigational products, veterinary pharmaceuticals, active and other medicinal substances as well as medicinal purpose products, veterinary pharmaceutical activity and also state management and control of the activity. |- | width="217" valign="top"|[https://e-seimas.lrs.lt/rs/legalact/TAD/TAIS.39603/ Republic of Lithuania Law on Dental Care (Assistance)] | width="387" valign="top"|Regulates the right to engage in practice of doctor of dentistry, dental technician, oral hygienist and dental assistant professions, the procedure and control of performance of dental care (rendering of assistance), obligations and rights of dentists and dentist specialists, state regulation measures and grounds of liability. |- | width="217" valign="top"|[https://vaspvt.gov.lt/files/EN/THE%20LAW%20ON%20NURSING%20PRACTICE%20AND%20MIDWIFERY%20PRACTICE.pdf The Law on Nursing Practice and Midwifery Practice of the Republic of Lithuania] | width="387" valign="top"|Establishes the acquisition of professional qualification of the nurses responsible for general care and midwives, their practice conditions, rights, duties, and responsibilities. |- | width="217" valign="top"|[https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/81a7b822444a11e68f45bcf65e0a17ee Republic of Lithuania Law on Higher Education and Research] | width="387" valign="top"|Establishes state regulation of higher education and research, principles of quality assurance in higher education and research, legal basis of establishment, termination and restructuring of higher education and research institutions, awarding and recognition of higher education qualifications and scientific degrees, management of higher education and research institutions, organization and supervision of their activities, rights and duties of the academic staff, research staff and students of higher education and research institutions, funding of higher education and research, principles of management, use and disposal of the assets of state higher education institutions. |- | width="217" valign="top"|[https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/5f13b560b2b511e59010bea026bdb259?jfwid=9tq147ogj Republic of Lithuania Law on Copyright and Related Rights] | width="387" valign="top"|Regulates copyright in literary, scientific, and artistic works (copyright), the rights of performers, producers of phonograms, broadcasting organisations and producers of the first fixation of an audio-visual work (film) (related rights), the rights of makers of databases (sui generis rights), exercise, collective administration, and enforcement of copyright and related rights, as well as the exercise and enforcement of sui generis rights. |- | width="217" valign="top"|[https://europam.eu/data/mechanisms/PF/PF%20Laws/Lithuania/Lithuania_Code%20of%20administrative%20offences_1985_amended2016_eng.pdf The Republic of Lithuania Code of Administrative Offences] | width="387" valign="top"|Protects the Republic of Lithuania social order, property, social, economic, political, and individual citizens' rights, and freedoms, as well as companies, institutions and organizations rights and legitimate interests of the established order of administration, the state and public order. It also focuses on contract cheating. |}

Luxembourg +

A number of laws address RE and RI in Luxembourg are transposing EU Law. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" width="608" | width="236" valign="top"|'''Law''' | width="372" valign="top"|'''Scope''' |- | width="236" valign="top"|[http://legilux.public.lu/eli/etat/leg/rgd/2002/10/17/n1/jo Grand-Ducal Regulation:] [http://legilux.public.lu/eli/etat/leg/rgd/2002/10/17/n1/jo Contained use of genetically modified organisms (transposing EU Directive 1998/81)] | width="372" valign="top"|It sets the criteria for classifying genetically modified organisms and their uses. It also defines the security measures and the containment procedures relating to these uses. |- | width="236" valign="top"|[http://legilux.public.lu/eli/etat/leg/rgd/2005/05/30/n5/jo Clinical trials in human medicines (transposing EU Directive 2001/20/CE)] | width="372" valign="top"|Lays down specific provisions concerning the conduct of clinical trials, including multicentre trials, carried out on human being and relating to medicinal products as defined by the law of 1993 regulating the placing on the market and advertising of medicinal products. |- | width="236" valign="top"|[http://legilux.public.lu/eli/etat/leg/rgd/2013/01/11/n2/jo Protection of animals used in scientific research (transposing EU Directive 2010/63/UE)] | width="372" valign="top"|Establishes measures for the protection of animals used for scientific or educational purposes. |- | width="236" valign="top"|[https://deiereschutzgesetz.lu/la-loi/chapitre-8-protection-des-animaux-utilises-a-des-fins-scientifiques/ Law on the protection of animal life, security and welfare (Chapter 8, Article 13)] | width="372" valign="top"|Limits animal experiments and experiences which can cause pain, aliments or damage to animals to what is strictly necessary. |- | width="236" valign="top"|[http://legilux.public.lu/eli/etat/leg/loi/2001/04/18/n2/jo Law of 18 April 2001 on copyright, neighboring rights and databases (transposing EU Directive 2001/84)] | width="372" valign="top"|Establishes rules on copyright, neighbouring rights and databases. |- | width="236" valign="top"|[http://legilux.public.lu/eli/etat/leg/loi/2002/08/02/n2/jo Law of 2 August 2002 on the protection of individuals with regard to the processing of personal data (transposing EU Directive 1995/46/CE)] | width="372" valign="top"|Establishes rules for protection of personal data. |}

M

Moldova +

A number of laws regarding RE and RI are officially instated in Moldova. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" width="604" | width="264" valign="top"|'''Law''' | width="340" valign="top"|'''Scope''' |- | width="264" valign="top"|[http://lex.justice.md/md/286236/ The Code on Science and Innovation] [http://lex.justice.md/md/286236/ of the Republic of Moldova] | width="340" valign="top"|Regulates activities in the fields of research and innovation, including the process of policy development and implementation, evaluation of organizations, confirmation and recognition of scientific and scientific-didactic titles. |- | width="264" valign="top"|[http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=356042 Government decision on the approval] [http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=356042 of the Research and Development Strategy of the] [http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=356042 Republic of Moldova until 2020] | width="340" valign="top"|Approves the Moldovan research-development strategy until 2020. |- | width="264" valign="top"|[https://mecc.gov.md/sites/default/files/pnci_engleza.pdf Government decision no. 381/2019 on the approval of the National Program in the fields research and innovation for the years 2020-2023 and the Plan of actions regarding its implementation] | width="340" valign="top"|Approves the National Program in the fields of research and innovation for the years 2020-2023 and the Plan of actions with regard to its implementation. |- | width="264" valign="top"|[http://lex.justice.md/md/356044/ Government decision for the approval] [http://lex.justice.md/md/356044/ of the Regulation on the organisation of the PhD studies] | width="340" valign="top"|Approves the Regulation on the organization of higher doctoral studies. |- | width="264" valign="top"|[https://mecc.gov.md/sites/default/files/national_roadmap_for_the_integration_of_the_republic_of_moldova_into_the_european_research_area_for_2019-2021_and_the_action_plan_for_its_implementation.pdf Government decision for the approval] [https://mecc.gov.md/sites/default/files/national_roadmap_for_the_integration_of_the_republic_of_moldova_into_the_european_research_area_for_2019-2021_and_the_action_plan_for_its_implementation.pdf of the National Roadmap of Integration of] [https://mecc.gov.md/sites/default/files/national_roadmap_for_the_integration_of_the_republic_of_moldova_into_the_european_research_area_for_2019-2021_and_the_action_plan_for_its_implementation.pdf Republic of Moldova in ERA Government decision no. 1081/2018] | width="340" valign="top"|Approves the National Roadmap of Integration of Republic Moldova in European Research Area (ERA) for the years 2019-2021. |- | width="264" valign="top"|[http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=375717 Government decision on the approval] [http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=375717 of the Regulation on the organization and conduct] [http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=375717 of postdoctoral programs] | width="340" valign="top"|Ensures the normative framework for organizing research, development and innovation activities through postdoctoral programs. |- | width="264" valign="top"| | width="340" valign="top"| |}

N

Netherlands +

Research infrastructure In 1992 laws concerning higher education and research (WHW: Wet op het hoger onderwijs en wetenschappelijk onderzoek) were made to enhance quality, to innovate the capacity and targeting society.'"`UNIQ--ref-00000042-QINU`"' Governance In the Netherlands, there is a law which determines that the government has to act open. In other words, there are particular tasks which must be done in public.'"`UNIQ--ref-00000043-QINU`"' This is describes in detail in the ‘Wet openbaarheid van bestuur’.'"`UNIQ--ref-00000044-QINU`"' Research with hazardous materials It is important that research institutes/universities act transparent. In this way, the government can verify easily whether the research institute/university obey the law concerning hazardous materials. The goal of this law, The Nuclear Energy Act, is to protect employees, patients and other citizens against ionizing radiation.'"`UNIQ--ref-00000045-QINU`"''"`UNIQ--ref-00000046-QINU`"' Privacy The ‘Algemene verordening gegevensbescherming’ contains the most important rules for handling personal data in the Netherlands. It is important that it is clear and transparent how and why personal data are processed. The goal of processing the personal data must be clarified before using the data.'"`UNIQ--ref-00000047-QINU`"''"`UNIQ--ref-00000048-QINU`"' {| class="wikitable" border="1" cellspacing="0" cellpadding="0" width="767" | width="307" valign="top"|'''Law''' | width="461" valign="top"|'''Scope''' |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0005682/2021-10-01 Wet op het hoger onderwijs en wetenschappelijk onderzoek] | width="461" valign="top"|This law describes the following aspects of higher education and scientific research: planning and funding; consultation; personnel; supervision; accreditation in higher education; educational offer; education; collaboration of funded higher education institutions; management and organization of the universities, open university, academic hospitals and institutions for scientific research; appeal to the administrative judge; withholding of funding; compensation and penalties; transitional provisions, including in connection with the introduction of the law and regulations in connection with mergers, conversion, demergers, relocations and transfers of management; transitional and implementation provisions amending laws until 2002; transitional and implementation provisions amending laws from 2002. |- | width="307" valign="top"|[https://www.rug.nl/about-ug/organization/rules-and-regulations/general/gedragscodes-nederlandse-universiteiten/ Code goed bestuur universiteiten] | width="461" valign="top"|The goal of this code is to create transparency of universities. In the code, the universities clarify how they implement the assignment and the scope that the law gives in the field of governance of universities. The code is based on 9 principles on the basis of which the directors and regulators of the universities affiliated with the VSNU give substance to good board. |- | width="307" valign="top"|[https://www.knaw.nl/nl/actueel/publicaties/gedragscode-voor-gebruik-van-persoonsgegevens-in-wetenschappelijk-onderzoek Code voor het gebruik van persoonsgegevens in wetenschappelijk onderzoek] | width="461" valign="top"|The code of conduct is an elaboration for researchers of the 2001 Personal Data Protection Act, which protects the privacy of Dutch citizens. This code offers researchers who work with privacy-sensitive data practical instructions on how to handle it responsibly. According to the code, no more data may be collected than is necessary for the investigation, and the data must be anonymised as much as possible. The code of conduct provides important guidelines that researchers use personal data only for research, that is, for a scientific publication, and that individuals should never be recognizable in that publication. |- | width="307" valign="top"|[https://autoriteitpersoonsgegevens.nl/nl/over-privacy/wetten/algemene-verordening-gegevensbescherming-avg Algemene verordening gegevensbescherming] | width="461" valign="top"|This law describes the most important rules for handling personal data in the Netherlands. |- | width="307" valign="top"|[https://www.vsnu.nl/files/documenten/Nederlandse%20gedragscode%20wetenschappelijke%20integriteit%202018.pdf De Nederlandse Gedragscode wetenschappelijke Integriteit] | width="461" valign="top"|The code of conduct defines five principles of academic integrity, 61 standards for good research practices and the institutions' duties of care. The five principles are: honesty; accuracy; transparency; independency; accountability. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0009408/2020-01-01#Paragraaf6 Wet medisch-wetenschappelijk onderzoek met mensen] | width="461" valign="top"|This law described the following aspects of medical scientific research with humans: rules for scientific research with participants; liability and insurance; obligations of those who conduct or conduct scientific research; additional rules for scientific research with medicines; the committees. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0013797/2020-10-01#Paragraaf6 Embryowet] | width="461" valign="top"|The embyo law descibes the following aspects: rules on the control of germ cells and embryos; rules concerning scientific research with embryos outside the human body that do not induce pregnancy; rules regarding scientific research with embryos outside the human body with the aim of inducing pregnancy; rules regarding scientific research with fetuses; prohibited actions with germ cells and embryos. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0021505/2020-04-01#Hoofdstuk11 Geneesmiddelenwet] | width="461" valign="top"|The Medicines Act describes the following aspects: the board for the evaluation of medicines; the manufacturer's license and the wholesale license; manufacturers and wholesalers of active substances; the marketing authorization for medicines; classification of drugs; handing over and prescribing medicines; labeling and package insert; pharmacovigilance; pharmaceutical advertising; enforcement: supervision and investigation. |- | width="307" valign="top"|[https://www.knmp.nl/praktijkvoering/regelgeving/regelgeving-geneesmiddelen-en-grondstoffen/opiumwet Opiumwet] | width="461" valign="top"|The Opium Act prohibits the possession of certain substances listed on Lists l and ll of the Opium Act. Their manufacture, preparation, processing, processing, sale, delivery, provision and transportation are also prohibited. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0008974/2019-04-02 Wet op bijzondere medische verrichtingen] | width="461" valign="top"|Some medical procedures are so special that only licensed licensed hospitals are allowed to perform them. This applies, for example, to open heart operations and certain organ transplants. This is stated in the Special Medical Procedures Act. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0005699/2019-04-02 Wet op het bevolkingsonderzoek] | width="461" valign="top"|In certain cases, a permit is required to carry out population screening. This law describes in which cases the permit is needed. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0005252/2018-07-28 Wet openbaarheid van bestuur] | width="461" valign="top"|The government fulfills public disclosure in the performance of its task. This is determined in Article 110 of the Constitution. In other words, the government observes transparency in the performance of its duties. Article 110 also determines that a law must describe how the government must do this. For example, the Wet openbaarheid bestuur (Wob) determines which information is public and when it must be provided to an applicant for information. The core objective of the Wob is to regulate the public nature of the administration and the provision of information. This is for the benefit of good and democratic governance. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0002402/2018-10-16 De Kernenergiewet] | width="461" valign="top"|The Nuclear Energy Act lays the foundation for protection against the harmful effects of ionizing radiation. The rules of the Nuclear Energy Act protect employees, patients and other citizens against this radiation as much as possible. The Nuclear Energy Act does this by, among other things, requiring a permit for most activities involving sources of ionizing radiation. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0007850/2015-01-01 Kwaliteitswet zorginstellingen] | width="461" valign="top"|All healthcare institutions must provide care that meets certain quality requirements. This law describes these requirements, ho wit is enforced and what the sanctions are if the requirements are not met. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0040509/2019-02-15 Regeling basisveiligheidsnormen stralingsbescherming] | width="461" valign="top"|The Basic Safety Standards for Radiation Protection Regulation is a General Administrative Order (AMvB). It elaborates on the Nuclear Energy Act and aims to protect the population, employees and patients against the adverse effects of ionizing radiation. |- | width="307" valign="top"|[https://wetten.overheid.nl/BWBR0003081/2019-01-01 Wet op de dierproeven] | width="461" valign="top"|The goals of this law are: strengthen the protection of animals used for scientific purposes; restore a level playing field for industry and scientific research in the EU; the treatment and use of animals for scientific purposes should be subject to the Three Rs (replacement, reduction and refinement). |- | width="307" valign="top"|[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice Good clinical practice] | width="461" valign="top"|Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible. In addition, this standard ensures that the data obtained from clinical research is reliable. |} '"`UNIQ--references-00000049-QINU`"'

Norway +

A number of laws regarding RE and RI are officially instated in Norway. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="212" valign="top"|'''Law''' | width="539" valign="top"|'''Scope''' |- | width="212" valign="top"|[https://lovdata.no/dokument/NL/lov/2018-06-15-38/*#& Personal Data Act] | width="539" valign="top"|Ensures the protection of natural persons in with regard to the processing of personal data, the free exchange of such information and the repeal of Directive 95/46/EC (General Data Protection Regulation) |- | width="212" valign="top"|[https://lovdata.no/dokument/NL/lov/2017-04-28-23 Research Ethics Act] | width="539" valign="top"|Contributes to ensuring that research under public and private auspices is conducted in accordance with recognized research ethics norms. |- | width="212" valign="top"|[https://lovdata.no/dokument/SF/forskrift/2018-03-05-321 Research Ethics Regulation] | width="539" valign="top"|Provides regulations on research ethics committees and commissions. |- | width="212" valign="top"|[https://lovdata.no/dokument/NL/lov/2005-04-01-15#KAPITTEL_1-1 University and Higher Education Act] | width="539" valign="top"|Makes possible for universities and university colleges to provide higher education at a high international level, conduct research and academic and artistic development work at a high international level, and disseminate knowledge about their activities and promote an understanding for the principle of academic freedom and the application of scientific and artistic methods and results, both in teaching students, in their other activities and in public administration, cultural life and business and industry. |- | width="212" valign="top"|[https://lovdata.no/dokument/NL/lov/2008-06-20-44#KAPITTEL_1 Health Research Act] | width="539" valign="top"|Promotes good and ethically sound medical and health research. It applies to medical and health research on humans, human biological material or health information. Such research also includes pilot studies and experimental treatment. |- | width="212" valign="top"|[https://lovdata.no/dokument/NL/lov/1999-07-02-64#KAPITTEL_1 Health Care Act] | width="539" valign="top"|Contributes to safety for patients and quality in the health and care service as well as trust in health personnel and the health and care service. The law applies to health personnel and companies that provide health care in the country. |- | width="212" valign="top"|[https://lovdata.no/dokument/NL/lov/2003-12-05-100#KAPITTEL_1 Biotechnology Act] | width="539" valign="top"|Ensures that the medical use of biotechnology is utilized for the benefit of people in a society where there is room for everyone. This shall be done in accordance with the principles of respect for human dignity, human rights and personal integrity and without discrimination on the basis of hereditary systems based on the ethical norms enshrined in our Western cultural heritage. The law applies to human medical use of biotechnology etc. and includes assisted reproduction, research on fertilized eggs and cloning, fetal diagnostics, genetic examinations of births and gene therapy etc. |- | width="212" valign="top"|[https://lovdata.no/dokument/LTI/forskrift/2003-03-14-349 Regulations of the capture and collection of game for scientific or other special purposes] | width="539" valign="top"|Ensures that the capture and collection of game for research, teaching, information, farming, etc., must be carried out without inflicting unnecessary suffering of animals and without reducing nature’s productivity. |- | width="212" valign="top"|[https://norecopa.no/files/statute.html Regulation on Animal Experimentation] | width="539" valign="top"|Ensures that animals governed by the Regulation receive correct treatment and are not subjected to unnecessary pain and suffering. Regulates experimentation with animals, and in addition the breeding, rearing and keeping of animals that are to be utilized in experiments. |- | width="212" valign="top"|[https://www.regjeringen.no/en/dokumenter/gene-technology-act/id173031/ Gene Technology Act] | width="539" valign="top"|Ensures that the production and use of genetically modified organisms and the production of cloned animals take place in an ethically justifiable and socially acceptable manner, in accordance with the principle of sustainable development and without adverse effects on health and the environment. |- | width="212" valign="top"|[https://www.regjeringen.no/en/dokumenter/animal-welfare-act/id571188/ Animal Welfare Act] | width="539" valign="top"|Promotes good animal welfare and respect for animals. It applies to conditions which affect welfare of or respect for mammals, birds, reptiles, amphibians, fish, decapods, squid, octopi and honey bees. The Act applies equally to the development stages of the animals referred to in cases where the sensory apparatus is equivalent to the developmental level in living animals. |}

S

Spain +

A number of laws regarding RE and RI are officially instated in Spain. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" width="642" | width="301" valign="top"|'''Law''' | 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="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="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="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="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="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="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="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="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="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="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. |}

Sweden +

A number of laws regarding RE and RI are officially instated in Sweden. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" | width="200" valign="top"|'''Law''' | width="551" valign="top"|'''Scope''' |- | width="200" valign="top"|[https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-2003460-om-etikprovning-av-forskning-som_sfs-2003-460 Ordinance No. 615 Concerning the Ethical Vetting of Research Involving Humans (2003)] | width="551" valign="top"|Protects the human dignity in research. The law provides for the ethical review of research involving human beings and biological material from humans. |- | width="200" valign="top"|[https://www.global-regulation.com/translation/sweden/2988473/regulation-%25282007%253a1069%2529-with-instruction-for-the-regional-ethical-review-board.html Regulation (2007:1069) With Instruction For Regional Ethical Review Boards] | width="551" valign="top"|Established regional ethics review boards with the purpose of examining applications for ethical review under the Act (SFS 2003:460) if the ethical review of research involving humans. |- | width="200" valign="top"|[https://www.wipo.int/edocs/lexdocs/laws/en/se/se097en.pdf The Personal Data Act] | width="551" valign="top"|Protects people against the violation of their personal integrity by processing of personal data. |- | width="200" valign="top"|[https://www.government.se/information-material/2009/09/public-access-to-information-and-secrecy-act/ The Public Access to Information and Secrecy Act] | width="551" valign="top"|Contains provisions that supplement the provisions contained in the Freedom of the Press Act on the right to obtain official documents, for example provisions on the obligation of public authorities to register official documents, appeals against decisions of authorities, etc. |- | width="200" valign="top"|[https://www.global-regulation.com/translation/sweden/2988365/patient-data-law-%25282008%253a355%2529.html The Patient Data Act] | width="551" valign="top"|Contains rules on the handling of personal data in the health and social care system. |- | width="200" valign="top"|[https://www.uhr.se/en/start/laws-and-regulations/Laws-and-regulations/The-Higher-Education-Ordinance/#chapter1 The Higher Education ordinance] | width="551" valign="top"|Contains regulations concerning higher education institutions for which the Government is the accountable authority. |- | width="200" valign="top"|[https://www.uhr.se/en/start/laws-and-regulations/Laws-and-regulations/act-on-responsibility-for-good-research-practice/ Act on responsibility for good research practice and the examination of research misconduct (2019:504)] | width="551" valign="top"|Contains provisions on the responsibility of conducting research in accordance with good research practice as well as provisions on the procedure for examining issues related to research misconduct. |}