79C3C34C52B45572883A05D425EB0F82
Law 14/2007 onBiomedical Research
https://www.isciii.es/QueHacemos/Financiacion/solicitudes/Documents/SpanishLawonBiomedicalResearchEnglish.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
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p.000007: time looking after the interests of the subject source.
p.000007: In close relation with the use of samples of human origin, this Law defines and clears up the
p.000007: legal status of biobanks and differentiates them from other collections of biological samples that could
p.000007: exist for biomedical research purposes, notwithstanding that in both cases these must be registered in
p.000007: the National Biobank Registry. A sole system of registry is set up, whichever the finality of
p.000007: the bank,
p.000007:
p.000007: including those for clinical use in patients, in an exclusive or shared manner with those of research, and
p.000007: notwithstanding the specific measures that must be developed by regulation for the functioning
p.000007: of each bank in accordance to its respective nature and purposes. It also establishes that
p.000007: the authorisation for the creation of biobanks shall correspond to the appropriate entities
p.000007: of the autonomous community, except for the initiatives that the Institute of Health Carlos III
p.000007: could take on the creation of national banks of biological samples for research in accordance
p.000007: with the general welfare, in which case the authorisation shall correspond to the Ministry of
p.000007: Health and Consumption. Title VI establishes a regime of administrative infractions and sanctions
p.000007: that are based on the principles of legality, minimum intervention, proportionality, and
p.000007: subsidiarity regarding the criminal infraction. The specific infractions included in this
p.000007: Law are complemented with those provisions that to this respect are found in Law 14/2006 of 26 May on
p.000007: Assisted Human Reproduction Techniques, notwithstanding those which might likewise be applicable by
p.000007: the General Health Law and others provided in the regulation of the autonomous communities and
p.000007: on the regulation on the protection of
p.000007: data of a personal nature.
p.000007: Likewise, this Law aims to provide response to the need to have available a State entity such as the
p.000007: Bioethics Committee, basically of a consulting nature on matters related with the ethical, legal and
p.000007: social implications on Medicine and Biology, which also represents Spain in the
p.000007: supranational and international forums and bodies that
p.000007:
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p.000008:
p.000008: are involved in Bioethics and that collaborates with other state and autonomous committees
p.000008: with counselling functions on these matters. Title VII of this Law establishes those
p.000008: provisions on its composition and functioning, which aims to guarantee its independence through the
p.000008: designation of its members from accredited qualified persons of the scientific, legal and bioethical
p.000008: world.
p.000008: Lastly, title VIII of this Law, which is particularly relevant, is aimed at the promotion and coordination of
p.000008: biomedical research within the National Health System regarding the elaboration of a sector
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p.000035: the source subject, or where appropriate, his legal representatives have
p.000035: provided their consent in these terms.
p.000035:
p.000035: Article 71. Closure or closing of a biobank.
p.000035:
p.000035: 1. The competent authority may decide the closure or closing of a biobank, on its own motion or as
p.000035: requested and through a motivated resolution, in those cases in which there is non-compliance with the
p.000035: requisites established in this Law for its creation, organisation and function, or when its
p.000035: owner
p.000035:
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p.000036:
p.000036:
p.000036: manifests his will not to continue with its activity.
p.000036: 2. This resolution shall likewise provide the destination of the stored samples of the biobank that is going
p.000036: to be closured or closed.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: TITLE VI
p.000036: Infractions, sanctions and compensations for damages
p.000036:
p.000036: Article 72. General Dispositions.
p.000036:
p.000036: 1. The infractions provided in this Law related with the obtaining and use of human cells and tissues,
p.000036: on the use of invasive procedures in biomedical research, as well as personal genetic data shall be
p.000036: the object of the corresponding administrative sanctions, after the charges are compiled in
p.000036: a case, notwithstanding the civil, criminal or other type of liability that may also arise.
p.000036: 2. The sanctioning authority regulated in this Law shall be exercised, in those cases
p.000036: not provided in this Law, it shall be in accordance with that provided in Law 30/1992 of the Legal
p.000036: regulation of Public Administrations and the Common Administrative Procedure, in Law 14/1986, of 25 April,
p.000036: General Law on Health, and Basic Law 15/1999, of 13 December, on the Protection of Data of a
p.000036: Personal Nature.
p.000036: 3. When, in the opinion of by the Administration, the infraction could be an offence or misdemeanour, the
p.000036: administrative entity shall pass it on to the Prosecutor’s Office,
p.000036:
p.000036: abstaining form continuing with the sanctioning procedure until the judicial authority has made
p.000036: a pronouncement.
p.000036: The criminal sanction shall exclude the imposition of an administrative sanction always when it
p.000036: is imposed for the same acts and in relation to the same protected public interests, though all other
p.000036: responsibilities that can be deduced from other acts or infractions that concur must be enforced.
p.000036: If the decision is that there hasn’t been an offence or misdemeanour, then the administration
p.000036: shall continue with its sanctioning proceeding, taking as its basis, where appropriate, those
p.000036: facts that the courts have considered as proven.
p.000036: 4. The administrative measures that would have been adopted in order to safe keep the right to the
p.000036: protection of health and safety of the people shall be kept as long as the judicial authority doesn’t make a
p.000036: pronouncement on such.
p.000036: 5. Very serious offences shall prescribe after three years, serious, after two and minor after six months.
p.000036: The sanctions imposed for very serious offences shall prescribe after three years, those for
p.000036: serious offences after two and those for minor offences after a year.
p.000036:
p.000036: Article 73. Responsibilities.
p.000036:
p.000036: 1. The author shall be responsible for the different infractions.
p.000036: 2. When in accordance with the obligations provided in this Law, the compliance of the
p.000036: obligations corresponds to several persons jointly, then they shall be held joint and severally liable
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Political / political affiliation
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p.000012: according to the criteria of the doctor in charge, is necessary in order to avoid serious damage to his
p.000012: health or that of his biological family members, a close family member or a representative shall be
p.000012: informed, after consulting with the clinical ethics committee, if it exists. In any case, the
p.000012: communication shall exclusively be limited to the necessary data for these ends.
p.000012:
p.000012: Article 5. Protection of personal data and guarantees of confidentiality.
p.000012:
p.000012: 1. The protection of personal privacy and the confidential treatment of personal data
p.000012: that are the result of the biomedical research shall be guaranteed protection, in accordance with that provided in
p.000012: the Basic Law 15/1999, of 13 December on the Protection of Data of a Personal Nature. The
p.000012: same guarantees shall be applicable to biological samples that are the source of information of a
p.000012: personal nature.
p.000012: 2. The conveyance of data of a personal nature to third parties outside the medical-assistance
p.000012: act or to a biomedical research shall require the express and written consent of the interested party.
p.000012: In the event that the data obtained from the subject source could reveal information of a personal nature about
p.000012: his family members, the conveyance to thirds shall require the express and written consent of all
p.000012: those concerned.
p.000012: 3. The use of data related to the health of persons with purposes
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p.000013:
p.000013:
p.000013: different to those for which the consent was given shall be forbidden.
p.000013: 4. Any person who has access to data of a personal nature, in the duty of their functions in relation with
p.000013: the providing of a medical health care service or biomedical research, whichever the reach of either, shall
p.000013: be subject to the duty of secrecy.
p.000013: 5. If the publication of the results of a research is not possible without identifying the person
p.000013: who participated or who provided biological samples, then these results shall only be published
p.000013: when there has been a previous and express consent of this person.
p.000013:
p.000013: Article 6. Non-discrimination.
p.000013:
p.000013: No one shall be the object of any type of discrimination on account of their genetic characteristics. Also, a
p.000013: person shall not be able to be discriminated on the basis of their refusal to undergo a
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p.000029: always when assuring that third parties may not be able to associate the source subject.
p.000029:
p.000029: Article 51. Duty of confidentiality and the right to the protection of genetic data.
p.000029:
p.000029: 1. The personnel who have access to genetic data in the exercise of
p.000029:
p.000029: their functions shall be subject to the duty of secrecy in a permanent manner. The disclosure of personal
p.000029: genetic data to third parties is only permitted with the express written consent of the person from whom
p.000029: these proceed.
p.000029: If the publishing of the results of a research is not possible without identifying the source subjects, then
p.000029: such results may only be published with their consent.
p.000029: 2. In case of genetic analysis to several members of a family, the results shall be filed
p.000029: and communicated to each of them in an individual manner. In case of disabled or minors, the
p.000029: information shall be provided to their tutors or legal representatives.
p.000029:
p.000029: Article 52. Conservation of data.
p.000029:
p.000029: 1. Personal genetic data shall be kept during a period of no less than five years from the date in which
p.000029: they were obtained, after which the interested party may solicit its cancellation.
p.000029: 2. If there is no request by the interested party, the data shall be kept during the time that
p.000029: may be necessary in order to preserve the health of the person from which it was obtained or of
p.000029: third parties related with him.
p.000029: 3. Outside these events, data shall only be kept, for research purposes, in an anonimised manner, without there
p.000029: being the possibility to identify the subject source.
p.000029:
p.000029: Article 53. Genetic analysis on pre-embryos, embryos or foetuses.
p.000029:
p.000029: The results of genetic analysis undertaken on embryonic or foetal material shall be subject to
p.000029: the principles of protection of data and
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p.000030:
p.000030:
p.000030: confidentiality provided in this Law. The same criteria shall be applicable in relation with any other
p.000030: biological samples that may contain genetic information of the person who provided his own biological
p.000030: material for the obtaining of such.
p.000030:
p.000030: Article 54. Genetic screening.
p.000030:
p.000030: 1. Genetic screenings are aimed at detecting a serious disease or health risk of the
p.000030: participating individual or in his descent, for the purpose of early treatment of a disease or to
p.000030: offer access to preventive measures.
p.000030: 2. The health authorities shall determine based on objective criteria, the relevance of the
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p.000038: one or more infractions against this Law.
p.000038: 3. In every case, when the amount of the fine is less than the benefit obtained due to the commission of
p.000038: the infraction, the sanction shall be increased up to double the amount in which the offender has
p.000038: been benefited.
p.000038: 4. If one act can be grounds for two or more classified infractions in this or other Laws, then only that which has
p.000038: the greatest sanction shall be taken into account.
p.000038: 5. The amounts of the fines shall be periodically revised and updated by the Government, taking into account the
p.000038: variation of the consumer price indexes.
p.000038: 6. Notwithstanding the sanctions provided in this article, the serious or very serious infractions
p.000038: shall entail the revocation of the authorisation granted for that research or activity.
p.000038:
p.000038: Likewise, in especially serious cases, the exclusion of the authorisation of any of the
p.000038: activities regulated in this Law may be accorded for a period of one to five years. For the
p.000038: imposition of this measure, the following shall be taken into account: the generated risk, the social
p.000038: repercussion of the infraction and the benefit obtained by the offender of the sanctioned behaviour
p.000038: and the previous commission of one or more infractions against this Law.
p.000038:
p.000038: Article 76.
p.000038:
p.000038: The competent authorities shall exercise the functions of control and inspection, ex officio or as requested
p.000038: by a party, as well as the bringing of charges and resolution of sanctioning cases.
p.000038:
p.000038: TITLE VII
p.000038: The Spanish Committee on Bioethics
p.000038:
p.000038: Article 77. Nature of the Committee.
p.000038:
p.000038: The Spanish Committee on Bioethics is created as an entity composed of several
p.000038: members, independent and of a consulting nature on matters related with the ethical and social
p.000038: implication of Biomedicine and the Health Sciences.
p.000038: It shall be assigned to the Ministry of Health and Consumption which in turn shall designate its seat.
p.000038:
p.000038: Article 78. Functions.
p.000038:
p.000038: 1. The functions of the Spanish Committee on Bioethics are:
p.000038: a) To issue reports, proposals and recommendations for the state and autonomous public powers in
p.000038:
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p.000039:
p.000039:
p.000039: matters with relevant ethical implications.
p.000039: b) To issue reports, proposals and recommendations on matters that the Committee considers
p.000039: relevant related with the ethical and social implications of Biomedicine and the Health Sciences.
p.000039: c) To establish the general principles for the drafting of good practices codes for
p.000039: scientific research that shall be developed by the Research Ethics Committees.
p.000039: d) Represent Spain in the supranational and international forums and organisations that
p.000039: deal with Bioethics.
p.000039: e) Draft an annual memory of activities.
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p.000039: 3rd) One by the Ministry of Industry, Tourism and Commerce.
p.000039: 4th) Three by the Ministry of Health and Consumption.
p.000039: 3. The President of the Committee shall be named from among its members by the Minister
p.000039: of Health and Consumption.
p.000039: 4. The Secretary of the Committee shall be a civil servant with the rank of vice-director General belonging to
p.000039: the Institute of Health Carlos III, who shall have say but no vote.
p.000039:
p.000039: Article 80. Duration of the mandate and the exercise of the post.
p.000039:
p.000039: 1. The members of the Committee shall have a mandate of four years, renewable only once, except if they
p.000039: substitute, before the expiration of the term of another previously designated member, in which
p.000039: case their mandate shall be for the time remaining until the completion of the four years from the time
p.000039: of the naming of the original member,
p.000039:
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p.000040:
p.000040:
p.000040: without prejudice to the possibility of renovation.
p.000040: 2. Half of the members shall be renewed every two years, except the first time, which shall be
p.000040: by draw.
p.000040: 3. The members of the Committee shall cease for the following reasons:
p.000040: a) Expiration of their mandate.
p.000040: b) Resignation, which shall take effect by the mere notification to the Minister of Health and Consumption.
p.000040: c) Accorded separation by the Minster of Health and Consumption, after meeting with the interested
p.000040: party, due to permanent incapacity for the exercise of their function, serious non-fulfilment of
p.000040: his obligations, unexpected incompatibility or the processing for a wilful offence. To these
p.000040: effects, the opening of the stage of trial during which testimony is given shall be similar to the bill of
p.000040: indictment.
p.000040: 4. The members of the Committee shall act with independence from the authorities who proposed or named them
p.000040: and shall not be able to belong to governing entities of the Administration of the State,
p.000040: of autonomous communities or of local governments as well as to the Spanish Parliament or
p.000040: the Legislative Assemblies of the Autonomous Communities.
p.000040:
p.000040: Article 81. Functioning.
p.000040:
p.000040: 1. The Committee shall act in banc and in Standing Committees. The composition and functions of both entities
p.000040: shall be determined by regulation.
p.000040: 2. The functioning in banc and in the Standing Committees shall be developed by an internal regulation
p.000040: that shall be approved by the Committee in banc.
p.000040:
p.000040: 3. This regulation shall include, at least, the following matters:
p.000040: a) Frequency of meetings, which shall be, at least, every three months.
p.000040: b) Procedures of deliberation and the taking of decisions.
p.000040: c) Extension and limits of the duty of confidentiality of its members.
p.000040: d) Independence of its members and conflicts of interest.
p.000040: e) Election procedure of its President.
p.000040:
p.000040: TITLE VIII
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Health / Mentally Disabled
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p.000004: efficacy and equality and the Biomedical Research Committees are created as fundamental tools for the
p.000004: evaluation and follow-up of research projects. Lastly, article 3 establishes a broad list of
p.000004: definitions, which based on scient
p.000004: ific, technical and legal knowledge, aim to delimit some relevant concepts of the Law.
p.000004: The first specific matter of the Law, compiled in Title II, is dedicated to biomedical
p.000004: research that involves invasive procedures on human beings, excluding those that are merely observational.
p.000004: This regulation completes the normative framework of our legal regulation on research in which human beings are
p.000004: direct participating subjects, which already has specific regulations on
p.000004:
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p.000005:
p.000005:
p.000005: clinical trials with medications and health products.
p.000005: Its five chapters regulate, firstly, the general principles of these research, with express references
p.000005: to the consent and to the precise information that must be provided to the participating subjects of
p.000005: the research; next, the systems of evaluation and authorisation and of assurance of potential damages
p.000005: are established, which aim to reduce to the outmost the damages that could be derived from the research that
p.000005: entails invasive procedures in human beings; thirdly, there is a regulation of the
p.000005: specificities of research during a pregnancy and lactation, in the event of minors or disabled and
p.000005: the scenario of research with persons unable to provide their consent due to clinical reasons.
p.000005: The fourth chapter of this title regulates the safety and supervision systems in the process of research,
p.000005: with specific references to the evaluation of the state of health of the participants in research,
p.000005: the non- interference in the clinical intervention of these and the system of verifications
p.000005: that, under the supervision of the Research Ethics Committee, must be performed throughout the
p.000005: research. The last chapter of the title, finally, sets out the obligation to inform the
p.000005: participants in research about the relevant data for their health that could be obtained throughout it as
p.000005: well as the obligation to publicise their results.
p.000005: Title III, with its two chapters, compiles the regulation on the donation and use of human
p.000005: embryos and foetuses, of their cells, tissues or organs, with two main objectives. The first of these is to
p.000005: revise and update the legal regime that was in effect before the entry of this Law,
p.000005:
p.000005: specifically Law 42/1988, of 28 December, on the donation and use of human embryos or foetuses or their
p.000005: cells, tissues or organs; and secondly, to incorporate this matter to the global approach of this new
p.000005: Law, in order to eliminate unnecessary normative dispersions related with biomedical
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p.000011: procedures that allow the collection, storage, use and conveyance of genetic data of a personal nature or
p.000011: biological samples.
p.000011: x. “Traceability”: capacity to associate a specific biological material with registered
p.000011: information that makes reference to any step in the chain of its collection as well as through all the process of
p.000011: research.
p.000011:
p.000011: Article 4. Informed consent and the right to information.
p.000011:
p.000011: 1. The free will of persons that may participate in biomedical research or that could provide their
p.000011: biological samples shall be respected. Their previous express and written consent must be provided once
p.000011: the adequate information has been provided.
p.000011: The information provided shall be written and shall encompass the nature, importance, implications and
p.000011: risks of the research in the terms provided for in this Law.
p.000011: People with disabilities shall be provided this information in accessible manners and
p.000011: formats that are appropriate to their needs.
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p.000012:
p.000012:
p.000012: If the subject of research is unable to write, the consent may be granted through any means admitted by law that allows
p.000012: the stating of a record of his or her will.
p.000012: 2. When a person is legally disabled or is a minor, their consent shall be granted
p.000012: through representation, provided that there are no other alternatives to the research.
p.000012: The conveyance of the consent through representation shall be proportionate to the research to be
p.000012: undertaken and shall be done in accordance with the respect of the dignity of a person and for
p.000012: the benefit of their health.
p.000012: The disabled and minors shall participate, in so far as it is possible and in accordance to their age and
p.000012: capacities, in the decision making process throughout the research.
p.000012: 3. Those persons who participate in biomedical research shall be able to revoke their consent at any moment,
p.000012: notwithstanding the limitations provided in this Law. Those persons or entities that
p.000012: have received this consent shall have available those measures that are necessary for the effective
p.000012: exercise of this right.
p.000012: 4. The lack of consent or the revocation of consent that has been previously granted shall not entail
p.000012: any damages in the health care assistance of the subject.
p.000012: 5. Every person has the right to be informed of his or her genetic data and other data of a personal nature
p.000012: that are obtained in the course of a biomedical research, in accordance to the terms that he or
p.000012: she assented. The same right is recognised to the person who has provided, with the
p.000012: aforementioned purpose, biological samples or when other biological materials are obtained from these.
p.000012:
p.000012: There shall be an observance of the right of the person not to know that data, which is referred to in the
p.000012: former paragraph, including unexpected findings that could arise. Nonetheless, when this information,
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p.000015:
p.000015: The carrying out of research on a person shall require the express, specific and written consent of
p.000015: the person, or their legal representative, in accordance with the general principles set out in article 4 of
p.000015: this Law.
p.000015:
p.000015: Article 14. General Principles.
p.000015:
p.000015:
p.000015: 1. Research on human beings shall only take place in the absence of another alternative with
p.000015: a comparable efficacy.
p.000015: 2. Research shall not involve disproportionate risks or discomforts for the human being in relation with
p.000015: the potential benefits that may be obtained.
p.000015: 3. Notwithstanding what was previously established in the earlier paragraph, when the
p.000015: research doesn’t have the possibility to produce results that directly benefit the health of
p.000015: the participating subject, then the research can only begin in case that it entails a minimum risk
p.000015: and burden for the subject, in accordance with the decision of the Research Ethics Committee that
p.000015: must evaluate this research.
p.000015:
p.000015: Article 15. Information to the subjects participating in the research.
p.000015:
p.000015: 1. Those persons who have been asked to participate in a research project shall previously receive the
p.000015: necessary information, duly documented and in a comprehensible manner, and
p.000015: when dealing with disabled people, in a manner suited to their circumstances.
p.000015: 2. The information shall include the purpose, detailed plan, burdens and possible risks and benefits of the
p.000015: research. This information shall specify the following matters:
p.000015: a) Nature, extent and duration of the procedures that are going to be used, particularly those that affect the
p.000015: participation of the subject.
p.000015: b) Available preventive, diagnostic and therapeutic procedures.
p.000015: c) Measures to fight against adverse events that bear upon the
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p.000016:
p.000016:
p.000016: subjects who participate in the research.
p.000016: d) Measures to assure the respect towards private life and the confidentiality of personal data
p.000016: in accordance with the demands established in the legislation on the protection of data of a
p.000016: personal nature.
p.000016: e) Measures to access, in the terms provided in article 4.5, to the information that is relevant for
p.000016: the subject that may arise in the research or the total results.
p.000016: f) Measures to assure an adequate compensation in the event that the subject is damaged.
p.000016: g) Identity of the professional who is responsible for the research.
p.000016: h) Any potential future use of the results of the research, including those that are commercial.
p.000016: i) Financing source of the research project.
p.000016: In the event that these matters are not known, there is an explicit compromise to complete this
p.000016: information when available.
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p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
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p.000018:
p.000018:
p.000018: undertaken if the following conditions are met:
p.000018: a) That the results of the research can produce real or direct benefits for his health.
p.000018: b) That a research of comparable efficacy can not be carried out in persons capable of providing their
p.000018: consent.
p.000018: c) That the person who is going to participate in the research has been provided written information about his
p.000018: rights and the limits provided in this Law and in the regulation that further develops it for his
p.000018: protection, unless that person is not in a state to receive that information.
p.000018: d) That the legal representatives of the person who is going to participate in the research have
p.000018: provided their written consent, after having received the information established in article 15. The
p.000018: legal representative shall take into account the desires and objections that are previously expressed
p.000018: by the affected person. Additionally, in these cases, actions must be accordance with that
p.000018: provided in section 1 of article 4 of this Law.
...
p.000021: members of the research team shall leave written record of this matter, as well as the absence of a
p.000021: conflict of interests with the medical team.
p.000021: 3. The foetuses that are prematurely and spontaneously expelled shall be clinically
p.000021: treated while they remain biologically viable with the sole purpose to favour their development and vital autonomy.
p.000021: 4. Before proceeding to any intervention on human embryos that have lost their capacity of biological
p.000021:
p.000021: development or on dead embryos or foetuses, a record shall be made by the corresponding medical
p.000021: personnel that such circumstances have taken place.
p.000021:
p.000021: Article 29. Requisites on donation.
p.000021:
p.000021: 1. Besides that established in the previous article, the donation of human embryos or foetuses or their
p.000021: biological structures for the purposes provided in this Law shall meet the following requisites:
p.000021: a) That the donor or donors of the embryos or foetuses have previously granted their express and
p.000021: written consent. If any of them is a non-emancipated minor or is disabled, then the consent of
p.000021: their legal representatives shall also be necessary.
p.000021: b) That the donor or donors or, where appropriate, their legal representatives, have been provided
p.000021: written information before the granting of their consent in relation to the purposes that
p.000021: might be achieved with the donation, its consequences, as well as the interventions
p.000021: that may be undertaken to extract embryologic or foetal cells or structures, from the placenta or
p.000021: casings, and of the risks that may be derived from these interventions.
p.000021: c) That the expulsion, spontaneous or induced, of these embryos or foetuses has been made in
p.000021: the gestating woman and that it has not been possible to maintain its vital autonomy as provided in article 28.3
p.000021: 2. In the event that the persons from whom the embryos or foetuses come from are deceased, it is
p.000021: necessary that there is no record of their express opposition. If the deceased is a minor or
p.000021: disabled
p.000021:
p.000021: © Inter-University Chair in Law and the Human Genome
p.000022: 22
p.000022:
p.000022:
p.000022: person, then the donation shall take place unless there is a record of an express opposition by those that
p.000022: exercised, in the life of the former, their legal representation.
p.000022:
p.000022:
p.000022: CHAPTER II
p.000022: Conditions for biomedical research with human embryos and foetuses
p.000022:
p.000022: Article 30. Limitations on research with live embryos and foetuses in the uterus.
p.000022:
p.000022: Interventions on the live embryo or foetus in the uterus shall be exclusively authorised when
p.000022: their purpose is diagnostic or therapeutic in its own interest, notwithstanding what is legally established on
p.000022: the voluntary interruption of a pregnancy.
p.000022:
p.000022: Article 31. Requisites on the use.
p.000022:
p.000022: 1. Research on human embryos or foetuses or their biological structures must comply with
p.000022: the following requisites:
p.000022: a) That the embryos or foetuses fit within any of the situations established in section 1 of article 28
p.000022: of this Law.
p.000022: b) That the conditions provided in article 29 on the donation of the embryos and foetuses that are going
p.000022: to be used are taken into account.
...
p.000029: consent or when this data has been previously anonimised.
p.000029: 3. In exceptional cases and of general health interest, the corresponding authority,
p.000029: after a favourable report by the authority on data protection, may authorise the use of codified genetic data,
p.000029: always when assuring that third parties may not be able to associate the source subject.
p.000029:
p.000029: Article 51. Duty of confidentiality and the right to the protection of genetic data.
p.000029:
p.000029: 1. The personnel who have access to genetic data in the exercise of
p.000029:
p.000029: their functions shall be subject to the duty of secrecy in a permanent manner. The disclosure of personal
p.000029: genetic data to third parties is only permitted with the express written consent of the person from whom
p.000029: these proceed.
p.000029: If the publishing of the results of a research is not possible without identifying the source subjects, then
p.000029: such results may only be published with their consent.
p.000029: 2. In case of genetic analysis to several members of a family, the results shall be filed
p.000029: and communicated to each of them in an individual manner. In case of disabled or minors, the
p.000029: information shall be provided to their tutors or legal representatives.
p.000029:
p.000029: Article 52. Conservation of data.
p.000029:
p.000029: 1. Personal genetic data shall be kept during a period of no less than five years from the date in which
p.000029: they were obtained, after which the interested party may solicit its cancellation.
p.000029: 2. If there is no request by the interested party, the data shall be kept during the time that
p.000029: may be necessary in order to preserve the health of the person from which it was obtained or of
p.000029: third parties related with him.
p.000029: 3. Outside these events, data shall only be kept, for research purposes, in an anonimised manner, without there
p.000029: being the possibility to identify the subject source.
p.000029:
p.000029: Article 53. Genetic analysis on pre-embryos, embryos or foetuses.
p.000029:
p.000029: The results of genetic analysis undertaken on embryonic or foetal material shall be subject to
p.000029: the principles of protection of data and
p.000029:
p.000029: © Inter-University Chair in Law and the Human Genome
p.000030: 30
p.000030:
p.000030:
p.000030: confidentiality provided in this Law. The same criteria shall be applicable in relation with any other
p.000030: biological samples that may contain genetic information of the person who provided his own biological
p.000030: material for the obtaining of such.
p.000030:
p.000030: Article 54. Genetic screening.
p.000030:
...
p.000031: the obtaining of this consent is not possible or it entails a non- reasonable effort to
p.000031: the effects provided in article 3.i) of this Law. In these cases, the favourable opinion of the
p.000031: corresponding Research Ethics Committee shall be necessary, which must take into account,
p.000031: at least, the following requisites:
p.000031: a) That the research is of general interest.
p.000031: b) That the research is undertaken by the same institution that requested the consent for
p.000031: the obtaining of samples.
p.000031: c) That the research is less effective or not possible without the identifying data of the
p.000031: subject source.
p.000031: d) That there is no record of an express objection of the subject source.
p.000031: e) That personal data is guaranteed confidentiality.
p.000031: 3. Notwithstanding that provided in article 7, an economic compensation may be established for the
p.000031: physical discomforts, expenses and other inconveniences that may be derived from the taking of the
p.000031: sample.
p.000031: 4. For health reasons, the subject source or his family may use the samples when in need, always that these are
p.000031: available and are not anonimised.
p.000031: 5. The obtaining of biological samples from minors or the disabled for biomedical research shall be
p.000031: subject to the following conditions:
p.000031: a) That the necessary measures are adopted in order to guarantee that the risk of the intervention is minimal
p.000031: for the subject source.
p.000031: b) That relevant knowledge on a disease or on the situation that is object of research and which are of vital
p.000031: importance to understand, palliate or heal it may be obtained from the research.
p.000031:
p.000031: © Inter-University Chair in Law and the Human Genome
p.000032: 32
p.000032: c) That this knowledge may not beappropriate, shall in turn entail the
p.000032: obtained in another manner. compliance with the requirements
p.000032: d) That the authorisation is obtained fromprovided in this Law. In case that the legal representatives of the
p.000032: minor or thethese extremes are not known at disabled person or that, where appropriatet,hat moment, the
p.000032: compromise to there are guarantees on the correct consenitnform about it as soon as is known
p.000032: of the subject source. shall be established.
p.000032: 6. Studies of genetic diversity shall g) Right to know genetic data that
p.000032: always respect the local and ethnicis obtained from the analysis of traditions, always
p.000032: avoiding practices odf onated samples.
p.000032:
p.000032: stigmatisation and discrimination.
p.000032:
p.000032: Article 59. Information prior to the use of a biological sample.
p.000032:
p.000032: 1. Notwithstanding that provided in the legislation on the protection of data of a personal nature,
p.000032: and particularly, in article 45 of this Law, before providing the consent for the use of a biological sample
p.000032: for biomedical research that is not going to be subject to an anonimisation process, the
p.000032: subject source shall receive the following written information:
p.000032: a) Purpose of the research or the line of research for which he is providing the consent.
p.000032: b) Expected benefits.
p.000032: c) Possible inconveniences linked to the donation and obtaining of the sample, including the possibility of being
p.000032: contacted at a later time in order to collect new data or obtain other samples.
p.000032: d) Identity of the person responsible for the research.
p.000032: e) Right to revoke the consent and its effects, including the possibility of the
...
Searching for indicator disability:
(return to top)
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
p.000017:
p.000017: © Inter-University Chair in Law and the Human Genome
p.000018: 18
p.000018:
p.000018:
p.000018: undertaken if the following conditions are met:
p.000018: a) That the results of the research can produce real or direct benefits for his health.
p.000018: b) That a research of comparable efficacy can not be carried out in persons capable of providing their
p.000018: consent.
p.000018: c) That the person who is going to participate in the research has been provided written information about his
p.000018: rights and the limits provided in this Law and in the regulation that further develops it for his
p.000018: protection, unless that person is not in a state to receive that information.
p.000018: d) That the legal representatives of the person who is going to participate in the research have
p.000018: provided their written consent, after having received the information established in article 15. The
p.000018: legal representative shall take into account the desires and objections that are previously expressed
p.000018: by the affected person. Additionally, in these cases, actions must be accordance with that
p.000018: provided in section 1 of article 4 of this Law.
p.000018: 2. When it is foreseeable that the research is not going to produce results for the direct health benefit
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000012: capacities, in the decision making process throughout the research.
p.000012: 3. Those persons who participate in biomedical research shall be able to revoke their consent at any moment,
p.000012: notwithstanding the limitations provided in this Law. Those persons or entities that
p.000012: have received this consent shall have available those measures that are necessary for the effective
p.000012: exercise of this right.
p.000012: 4. The lack of consent or the revocation of consent that has been previously granted shall not entail
p.000012: any damages in the health care assistance of the subject.
p.000012: 5. Every person has the right to be informed of his or her genetic data and other data of a personal nature
p.000012: that are obtained in the course of a biomedical research, in accordance to the terms that he or
p.000012: she assented. The same right is recognised to the person who has provided, with the
p.000012: aforementioned purpose, biological samples or when other biological materials are obtained from these.
p.000012:
p.000012: There shall be an observance of the right of the person not to know that data, which is referred to in the
p.000012: former paragraph, including unexpected findings that could arise. Nonetheless, when this information,
p.000012: according to the criteria of the doctor in charge, is necessary in order to avoid serious damage to his
p.000012: health or that of his biological family members, a close family member or a representative shall be
p.000012: informed, after consulting with the clinical ethics committee, if it exists. In any case, the
p.000012: communication shall exclusively be limited to the necessary data for these ends.
p.000012:
p.000012: Article 5. Protection of personal data and guarantees of confidentiality.
p.000012:
p.000012: 1. The protection of personal privacy and the confidential treatment of personal data
p.000012: that are the result of the biomedical research shall be guaranteed protection, in accordance with that provided in
p.000012: the Basic Law 15/1999, of 13 December on the Protection of Data of a Personal Nature. The
p.000012: same guarantees shall be applicable to biological samples that are the source of information of a
p.000012: personal nature.
p.000012: 2. The conveyance of data of a personal nature to third parties outside the medical-assistance
p.000012: act or to a biomedical research shall require the express and written consent of the interested party.
p.000012: In the event that the data obtained from the subject source could reveal information of a personal nature about
p.000012: his family members, the conveyance to thirds shall require the express and written consent of all
p.000012: those concerned.
p.000012: 3. The use of data related to the health of persons with purposes
p.000012:
p.000012: © Inter-University Chair in Law and the Human Genome
p.000013: 13
p.000013:
p.000013:
p.000013: different to those for which the consent was given shall be forbidden.
p.000013: 4. Any person who has access to data of a personal nature, in the duty of their functions in relation with
p.000013: the providing of a medical health care service or biomedical research, whichever the reach of either, shall
p.000013: be subject to the duty of secrecy.
p.000013: 5. If the publication of the results of a research is not possible without identifying the person
p.000013: who participated or who provided biological samples, then these results shall only be published
p.000013: when there has been a previous and express consent of this person.
p.000013:
p.000013: Article 6. Non-discrimination.
p.000013:
p.000013: No one shall be the object of any type of discrimination on account of their genetic characteristics. Also, a
p.000013: person shall not be able to be discriminated on the basis of their refusal to undergo a
p.000013: genetic analysis to provide their consent to participate in a biomedical research or to donate biological
p.000013: material, particularly in relation with the conveyance of medical health care assistance that
...
p.000027: to a specific treatment.
p.000027:
p.000027: Article 47. Information previous to the undertaking of a genetic analysis for research purposes in the
p.000027: health sector.
p.000027:
p.000027: Notwithstanding what is provided on the legislation on the protection of data of a personal nature, before the
p.000027: subject provides his consent in the
p.000027:
p.000027: © Inter-University Chair in Law and the Human Genome
p.000028: 28
p.000028:
p.000028:
p.000028: terms provided in article 48, he must receive the following written information:
p.000028: 1st. Purpose of the genetic analysis for which he is consenting.
p.000028: 2nd. Place of the undertaking of the analysis and the destination of the biological sample at the end of
p.000028: it, whether it is the disassociation of the identifying data of the sample, its destruction or other destinations,
p.000028: for which the consent of the subject source must be requested in the terms provided in this Law.
p.000028: 3rd. Persons who will have access to the results of the analysis when those are not going to undergo
p.000028: a process of disassociation or anonimisation.
p.000028: 4th. A warning about the possibility of unexpected findings and its possible transcendence for
p.000028: the subject, as well as his faculty to take a stance in relation to receiving this communication.
p.000028: 5th. Warning about the implication that the information that could be obtained can have for his
p.000028: family members and the convenience for that person, where appropriate, to convey that information to them.
p.000028: 6th. Compromise to provide genetic counselling, once the results of the analysis are obtained
p.000028: and evaluated.
p.000028:
p.000028: Article 48. Consent.
p.000028:
p.000028: 1. The express and specific written consent shall be necessary for the undertaking of a genetic analysis.
p.000028: 2. In the health ambit, samples of deceased persons may be obtained and analysed always when it may be of
p.000028: interest for the protection of health, except when the deceased has expressly prohibited it during his life
p.000028: and can be proven. To this effect, the documents of previous instructions and, for lack of, the
p.000028:
p.000028: criteria of the closest family members of the deceased shall be consulted.
p.000028: The access by the biological family members to information derived from the genetic analysis of the
p.000028: deceased shall be limited to the genetic data relevant for the protection of their health.
p.000028: 3. In order to have access to a genetic screening, there must be an explicit and written consent of the
p.000028: person interested. The Research Ethics Committee shall determine the situations in which the consent
p.000028: may be expressed verbally. In any case, when the screening includes non-curable diseases or the benefits are
p.000028: scarce or uncertain, the consent shall always be written.
p.000028: 4. The undertaking of genetic analysis on in vivo pre-embryos or on embryos and foetuses in
p.000028: the uterus shall require the written consent of the gestating woman.
p.000028: The genetic analysis of an in vitro pre-embryo that has not been transferred shall be subject to that
p.000028: provided in the Law on Assisted Human Reproduction.
p.000028:
p.000028: Article 49. Right to Information and right not to know.
p.000028:
p.000028: 1. The subject source shall be informed on the genetic data of a personal nature that are obtained in
p.000028: the genetic analysis according to the terms in which he manifested his volition, notwithstanding the right to
p.000028: access that is established in the legislation on the protection of data of a personal nature, which
p.000028: could entail the revocation of the previously granted manifestation of free volition.
p.000028: 2. When the subject source has exercised his right not to know the results of a genetic analysis,
p.000028: then only that information that is
p.000028:
p.000028: © Inter-University Chair in Law and the Human Genome
p.000029: 29
p.000029:
p.000029:
p.000029: necessary for the follow up of a prescribed treatment by the doctor and that has been accepted by the
p.000029: patient shall be provided. When this information is necessary to avoid a serious damage for the health of his
p.000029: biological family, then the affected or their legally authorised representative may be
p.000029: informed. In every case, the communication shall be exclusively limited to the data necessary for these ends.
p.000029:
p.000029: Article 50. Access to genetic data by health personnel.
p.000029:
p.000029: 1. Health professionals of the centre or the establishment that stores the clinical history
p.000029: of the patient shall have access to the data recorded in it in so far as it is relevant for the
p.000029: assistance that is being provided to the patient, notwithstanding the duties of secrecy and
p.000029: confidentiality to which they are subject.
p.000029: 2. Genetic data of a personal nature can only be used for epidemiological, public
p.000029: health, research or education purposes when the interested subject has expressly provided his
p.000029: consent or when this data has been previously anonimised.
p.000029: 3. In exceptional cases and of general health interest, the corresponding authority,
p.000029: after a favourable report by the authority on data protection, may authorise the use of codified genetic data,
p.000029: always when assuring that third parties may not be able to associate the source subject.
p.000029:
p.000029: Article 51. Duty of confidentiality and the right to the protection of genetic data.
p.000029:
p.000029: 1. The personnel who have access to genetic data in the exercise of
p.000029:
p.000029: their functions shall be subject to the duty of secrecy in a permanent manner. The disclosure of personal
p.000029: genetic data to third parties is only permitted with the express written consent of the person from whom
p.000029: these proceed.
p.000029: If the publishing of the results of a research is not possible without identifying the source subjects, then
p.000029: such results may only be published with their consent.
p.000029: 2. In case of genetic analysis to several members of a family, the results shall be filed
p.000029: and communicated to each of them in an individual manner. In case of disabled or minors, the
p.000029: information shall be provided to their tutors or legal representatives.
p.000029:
p.000029: Article 52. Conservation of data.
p.000029:
p.000029: 1. Personal genetic data shall be kept during a period of no less than five years from the date in which
p.000029: they were obtained, after which the interested party may solicit its cancellation.
p.000029: 2. If there is no request by the interested party, the data shall be kept during the time that
p.000029: may be necessary in order to preserve the health of the person from which it was obtained or of
p.000029: third parties related with him.
p.000029: 3. Outside these events, data shall only be kept, for research purposes, in an anonimised manner, without there
p.000029: being the possibility to identify the subject source.
p.000029:
p.000029: Article 53. Genetic analysis on pre-embryos, embryos or foetuses.
p.000029:
p.000029: The results of genetic analysis undertaken on embryonic or foetal material shall be subject to
p.000029: the principles of protection of data and
p.000029:
p.000029: © Inter-University Chair in Law and the Human Genome
p.000030: 30
p.000030:
p.000030:
p.000030: confidentiality provided in this Law. The same criteria shall be applicable in relation with any other
...
p.000031: irrespective of whether there is an anonimisation.
p.000031: Notwithstanding this, in an exceptional manner, codified or
p.000031:
p.000031: identified samples for biomedical research may be used without the consent of the subject source when
p.000031: the obtaining of this consent is not possible or it entails a non- reasonable effort to
p.000031: the effects provided in article 3.i) of this Law. In these cases, the favourable opinion of the
p.000031: corresponding Research Ethics Committee shall be necessary, which must take into account,
p.000031: at least, the following requisites:
p.000031: a) That the research is of general interest.
p.000031: b) That the research is undertaken by the same institution that requested the consent for
p.000031: the obtaining of samples.
p.000031: c) That the research is less effective or not possible without the identifying data of the
p.000031: subject source.
p.000031: d) That there is no record of an express objection of the subject source.
p.000031: e) That personal data is guaranteed confidentiality.
p.000031: 3. Notwithstanding that provided in article 7, an economic compensation may be established for the
p.000031: physical discomforts, expenses and other inconveniences that may be derived from the taking of the
p.000031: sample.
p.000031: 4. For health reasons, the subject source or his family may use the samples when in need, always that these are
p.000031: available and are not anonimised.
p.000031: 5. The obtaining of biological samples from minors or the disabled for biomedical research shall be
p.000031: subject to the following conditions:
p.000031: a) That the necessary measures are adopted in order to guarantee that the risk of the intervention is minimal
p.000031: for the subject source.
p.000031: b) That relevant knowledge on a disease or on the situation that is object of research and which are of vital
p.000031: importance to understand, palliate or heal it may be obtained from the research.
p.000031:
p.000031: © Inter-University Chair in Law and the Human Genome
p.000032: 32
p.000032: c) That this knowledge may not beappropriate, shall in turn entail the
p.000032: obtained in another manner. compliance with the requirements
p.000032: d) That the authorisation is obtained fromprovided in this Law. In case that the legal representatives of the
p.000032: minor or thethese extremes are not known at disabled person or that, where appropriatet,hat moment, the
p.000032: compromise to there are guarantees on the correct consenitnform about it as soon as is known
p.000032: of the subject source. shall be established.
p.000032: 6. Studies of genetic diversity shall g) Right to know genetic data that
p.000032: always respect the local and ethnicis obtained from the analysis of traditions, always
p.000032: avoiding practices odf onated samples.
p.000032:
...
p.000032: subject source shall receive the following written information:
p.000032: a) Purpose of the research or the line of research for which he is providing the consent.
p.000032: b) Expected benefits.
p.000032: c) Possible inconveniences linked to the donation and obtaining of the sample, including the possibility of being
p.000032: contacted at a later time in order to collect new data or obtain other samples.
p.000032: d) Identity of the person responsible for the research.
p.000032: e) Right to revoke the consent and its effects, including the possibility of the
p.000032: destruction or the anonimisation of the sample and that to this end it shall not be applicable
p.000032: to the rest of the research data that has already taken place.
p.000032: f) Location of the undertaking of the analysis and the destination of the sample at the end of
p.000032: the research: disassociation, destruction or other research, and where
p.000032: h) Guarantee of confidentiality of the information obtained, indicating the identity of the persons who shall
p.000032: have access to the data of a personal nature of the subject source.
p.000032: i) Warning on the possibility that information relative to their health may be obtained as derived from the
p.000032: genetic analysis that are undertaken on their biological sample, as well as on their faculty to take a stance in
p.000032: relation to its communication.
p.000032: j) Warning on the implication of the information that could be obtained for his family members and
p.000032: the convenience that the person, where appropriate, transmit this information to them.
p.000032: k) Indication on the possibility to get in contact with him-her, for which information on the way to do so may be
p.000032: solicited.
p.000032: 2. In the event of the use of samples that are going to be anonimised, the subject
p.000032: source shall receive the information contained in sections a), b), c) and d) of this article.
p.000032:
p.000032: Article 60. Consent on the use of a biological sample.
p.000032:
p.000032: 1. The consent on the use of the biological sample shall be granted either in the act of obtaining
p.000032: the sample or later in a specific manner for a specific research.
p.000032: 2. The specific consent may provide for the use of a sample for
p.000032:
p.000032: © Inter-University Chair in Law and the Human Genome
p.000033: 33
p.000033:
p.000033:
p.000033: other lines of research related with that initially proposed, including those undertaken by third
p.000033: parties. If this is not the case, the subject source shall be requested to grant, if deemed appropriate, a
p.000033: new consent.
p.000033: 3. The consent may be revoked, totally or for specific purposes, at any time. When the revocation
p.000033: makes reference to any use of the sample, then it shall be immediately destroyed, notwithstanding the
p.000033: keeping of the resulting data of the research that would have been previously undertaken.
p.000033:
...
Health / Pregnant
Searching for indicator pregnant:
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p.000017: previous assurance of the general and special damages that could be derived for the person in whom it
p.000017: has been carried out.
p.000017: 3. When, for whatever reason, the insurance policy doesn’t fully cover the caused damages, the promoter
p.000017: of the research, the researcher in charge and the hospital or centre in which it was carried out shall be joint
p.000017: and severally liable for them, even if there is no fault, thereby being responsible to bear the burden
p.000017: of proof. Neither the administrative authority nor the report of the Research Ethics Committee
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
p.000017:
p.000017: © Inter-University Chair in Law and the Human Genome
p.000018: 18
p.000018:
p.000018:
p.000018: undertaken if the following conditions are met:
p.000018: a) That the results of the research can produce real or direct benefits for his health.
p.000018: b) That a research of comparable efficacy can not be carried out in persons capable of providing their
p.000018: consent.
...
Health / of childbearing age/fertile
Searching for indicator fertile:
(return to top)
p.000019: when the patient is in a condition to provide it.
p.000019:
p.000019: CHAPTER IV
p.000019: Safety and Supervision Article 22. Risk Prevention.
p.000019: 1. Besides that provided in article 18, necessary measures shall be taken in order to guarantee the
p.000019: safety of the research and to reduce the risks and discomforts for the individuals who participate.
p.000019: Medical decisions related with the health of the participating subjects in research belong to the doctor in
p.000019: charge of their assistance.
p.000019: 2. The researcher in charge of the project must accredit that the members who are part of
p.000019: the research team have the adequate qualification and experience in the ambit of the proposed research.
p.000019:
p.000019: Article 23. Evaluation of the state of health.
p.000019:
p.000019: 1. Those persons who are going to participate in the research have the duty to provide real data about their physical
p.000019: state or their health. In any case, the researcher shall take the necessary measures, which shall include,
p.000019: where appropriate, the consultation to the doctors responsible for the medical
p.000019: assistance of the participants, to
p.000019:
p.000019: verify such extremes before the beginning of the research, in order to assure that the persons for whom
p.000019: the research entails a special risk are excluded from it.
p.000019: 2. When research involves women in a fertile age, the possible adverse impact on an unknown existing
p.000019: pregnancy or a later one, as well as on the health of the embryos, foetuses or child shall be taken into
p.000019: account.
p.000019:
p.000019: Article 24. Non-interference with necessary clinical interventions.
p.000019:
p.000019: 1. Research must not delay or deprive the participants of the preventive, diagnostic or
p.000019: therapeutic medical procedures that are necessary for their state of health.
p.000019: 2. In research associated with the prevention, diagnosis or treatment of diseases, there must be
p.000019: an assurance that the participants who are assigned to the control groups receive proven procedures of
p.000019: prevention, diagnosis or treatment.
p.000019: The researcher must place on record the extremes which are referred to in the previous section in
p.000019: the protocol of the trial that she is going to submit for evaluation and authorisation.
p.000019: 3. A placebo may be used only if there are no methods of proven efficacy or when the withdrawal
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
...
Health / patients in emergency situations
Searching for indicator emergency situation:
(return to top)
p.000018: 2. When it is foreseeable that the research is not going to produce results for the direct health benefit
p.000018: of the subjects referred to in section 1 of this article, the research may be authorised in an exceptional manner
p.000018: if in addition to the requisites established in subsections b), c) and
p.000018: d) of the earlier section, the following conditions are met:
p.000018: a) That the object of the research is to contribute, through meaningful improvements of the
p.000018: understanding of the disease or the condition of the individual, to a beneficial result for other persons of
p.000018: the same age or with the same disease or conditions, within a reasonable time frame.
p.000018:
p.000018: b) That the research entails a minimum risk and burden to the participating individual.
p.000018: c) That the authorisation of the research is made known to the Ministry of the Public Prosecutor.
p.000018:
p.000018: Article 21. Research on persons unable to consent due to their clinical situation.
p.000018:
p.000018: 1. For undertaking research in situations of clinical emergency, in which the person involved may
p.000018: not provide their consent, the following specific conditions must be met:
p.000018: a) That research of comparable efficacy is not possible to be undertaken on persons who are not
p.000018: in that emergency situation.
p.000018: b) That in the event that it is not foreseeable that the research is going to produce beneficial
p.000018: results for the health of the patient, that it has the purpose to contribute in a meaningful manner
p.000018: to the understanding of the disease or the condition of the patient, with the purpose of
p.000018: benefiting other persons with the same disease or condition, always that it entails a minimum risk and discomfort for
p.000018: him.
p.000018: c) That the authorisation of the research is made known to the Ministry of the Public Prosecutor.
p.000018: 2. Any previously expressed objection by the patient that is known by the doctor in charge
p.000018: of providing assistance, by the researcher or by the Research Ethics Committee of the centre
p.000018: shall be observed.
p.000018: 3. In reference to section one of this article, research in emergency situations are considered to
p.000018: be those in which the person is not in condition to provide his consent and that, due to their state
p.000018: and the emergency of the situation, the authorisation of the legal
p.000018:
p.000018: © Inter-University Chair in Law and the Human Genome
p.000019: 19
p.000019:
p.000019:
p.000019: representatives of the patient or if there are none, of the persons who live with him is impossible to obtain on
p.000019: time.
p.000019: 4. Persons who participate in a research in an emergency situation, or where appropriate, their legal
p.000019: representatives, shall be informed in the shortest time possible of the terms provided in article 4 of
p.000019: this Law. Likewise, the consent to continue participating in the research must be obtained
p.000019: when the patient is in a condition to provide it.
p.000019:
p.000019: CHAPTER IV
p.000019: Safety and Supervision Article 22. Risk Prevention.
p.000019: 1. Besides that provided in article 18, necessary measures shall be taken in order to guarantee the
p.000019: safety of the research and to reduce the risks and discomforts for the individuals who participate.
p.000019: Medical decisions related with the health of the participating subjects in research belong to the doctor in
p.000019: charge of their assistance.
p.000019: 2. The researcher in charge of the project must accredit that the members who are part of
p.000019: the research team have the adequate qualification and experience in the ambit of the proposed research.
p.000019:
p.000019: Article 23. Evaluation of the state of health.
p.000019:
p.000019: 1. Those persons who are going to participate in the research have the duty to provide real data about their physical
p.000019: state or their health. In any case, the researcher shall take the necessary measures, which shall include,
p.000019: where appropriate, the consultation to the doctors responsible for the medical
p.000019: assistance of the participants, to
p.000019:
p.000019: verify such extremes before the beginning of the research, in order to assure that the persons for whom
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000003: from the principles of quality, efficacy and equal opportunity and in order to favour that the results of
p.000003: research are transformed into efficient therapies to combat different pathologies.
p.000003: Notably, the implantation of research in health centres as a routine practice is made easier,
p.000003: the collaboration among basic biomedical research centres and hospitals and other centres of
p.000003: the National Health System are encouraged and there is a fostering of the ties between the
p.000003:
p.000003: public and private sector through research in networks and the mobility of researchers
p.000003: and practitioners.
p.000003: From an organizational perspective, the Law creates different professional entities
p.000003: that are recognised with a specially qualified function based on its impartiality, independence,
p.000003: technical capacity and professional competency that are required to its members. On the
p.000003: one hand, Research Ethics Committees shall guarantee that each research centre that intervenes on human beings or
p.000003: biological samples of human origin does so in accordance with methodological, ethical and
p.000003: legal aspects. The Commission for the Guarantees on the Donation and Use of Human Cells and Tissues
p.000003: shall be responsible for the compulsory evaluation and providing of information of those with
p.000003: a favourable report of those research projects that require the obtaining or use of tissues, embryonic stem cells
p.000003: or other similar of human origin that are obtained through diverse techniques of cell reprogramming
p.000003: that already exist or that could be discovered in the future, as well as the development of other
p.000003: functions on scientific, ethical or legal aspects. Finally, the Spanish Bioethics Committee is
p.000003: created as the authority for the consultation of all aspects with ethical and social
p.000003: implications in the field of Medicine and Biology and is called upon to set guidelines and general
p.000003: principles for the drafting of codes of good practices in scientific research that are developed by the
p.000003: Research Ethics Committees.
p.000003:
p.000003: III
p.000003:
p.000003: © Inter-University Chair in Law and the Human Genome
p.000004: 4
p.000004:
p.000004:
p.000004: The Law expressly prohibits the creation of human pre-embryos and embryos exclusively for the purpose of
p.000004: experimentation, in accordance with the gradualist perspective on the protection of human life set out
p.000004: by our Constitutional Court in rulings such as 53/1985, 212/1996 and 116/1999, but allows the use of any
p.000004: technique for the obtaining of embryonic stem cells for therapeutic or research purposes that does not
p.000004: entail the creation of a pre-embryo or of an embryo exclusively for this purpose and in the terms provided in
p.000004: this Law.
p.000004: In reference to the use of supernumerary embryos from assisted human
p.000004: reproduction techniques, the starting point is that established by Law 14/2006, of 26 May, on Assisted
p.000004: Human Reproduction Techniques, which expressly forbids the so-called reproductive human cloning.
p.000004:
p.000004: IV
p.000004:
p.000004: This Law regulates such a broad and complex set of matters, compiled in ninety articles,
p.000004: fifteen chapters, eight titles, three additional dispositions, one repealing and five
p.000004: final dispositions.
p.000004: The general dispositions of Title I are the regulating and integrating axis of the Law. The object and
p.000004: scope of application of this Law are set out and it establishes a set of principles and guarantees for
p.000004: the protection of the rights of persons and of the legal goods involved in biomedical research.
p.000004: Regarding the object and scope of the regulation, there is clarification that the biomedical research that is
p.000004: made reference to by the regulation covers basic and clinical research and excludes clinical trials with
p.000004: medication and the implantation of
p.000004:
p.000004: organs, tissues and cells, which shall be regulated in a specific regulation.
...
p.000005: second chapter imposes that the research with live embryos and foetuses in the uterus shall only
p.000005: be undertaken for a diagnostic or therapeutic purpose in its own interest and
p.000005: establishes the requisites for the authorisation of the research projects with embryos, foetuses and
p.000005: their biological structures.
p.000005: In Title IV, the regulation on the donation, use and research with human embryonic cells and tissues
p.000005: and other similar cells is done in full accordance to that provided in Law 14/2006 on Assisted Human
p.000005:
p.000005: © Inter-University Chair in Law and the Human Genome
p.000006: 6
p.000006:
p.000006: Reproduction Techniques which already regulates the donation of surplus ovocites and pre-embryos in
p.000006: vitro, the application of assisted reproduction techniques as well as the requisites on the use of
p.000006: these pre-embryos or their biological structures for research or experimentation.
p.000006: This is notwithstanding the compulsory favourable report which the Guarantees
p.000006: Commission for the Donation and Use of Human Cells and Tissues must issue and to the conditions,
p.000006: guarantees and requisites that are imposed to these effects in the first two chapters of Title IV.
p.000006: The first chapter of this title expressly prohibits the creation of human pre-embryos or embryos
p.000006: for experimentation and authorises the use of any technique for obtaining human stem cells for therapeutic or
p.000006: research purposes, including the activation of ovocites through nuclear transfer which doesn’t entail
p.000006: the creation of a pre-embryo or embryo in the terms defined in this Law. Chapter two regulates
p.000006: the conditions which must be met when researching with biological samples of an embryonic nature. The third
p.000006: chapter establishes the composition and function of the aforementioned Guarantees Commission, which also has the
p.000006: responsibility to provide information on researches that are listed in the Law on stem tissues and
p.000006: cells or others functionally similar or to procedures or techniques for obtaining
p.000006: these, including embryonic stem cell lines from third countries. Lastly, within chapter four, a system for
p.000006: promotion and coordination is established in this ambit of research with human embryonic cells and
p.000006: tissues, highlights the regulation of the National Bank of Cell Lines, which is
p.000006:
p.000006: afforded a structure as a network with a central node and its appointment to the Institute
p.000006: of Health Carlos III.
p.000006: Title V regulates other emerging matters related with the current expansive tendency of biomedical
p.000006: research, such as, the undertaking of genetic analysis, the access and use of its results, as well as
p.000006: the obtaining and use of human biological samples. In spite of the enormous difficulties to
...
p.000023: c) The written compromise to provide the corresponding public authority the data that permit
p.000023: to identify and to know the conservation of the cell lines that could be obtained
p.000023: as a consequence of the development of the research.
p.000023: d) The compromise of the gratuitous conveyance of cell lines that could be obtained in
p.000023: the development of research for its use by other researchers.
p.000023: e) Where ovocites or pre- embryos are used, the indication and justification of their number
p.000023: and origin and the document of the informed consent, signed by the donor, or progenitors,
p.000023: respectively.
p.000023:
p.000023: © Inter-University Chair in Law and the Human Genome
p.000024: 24
p.000024:
p.000024:
p.000024: Article 35. Report of the Guarantees Commission for the Donation and Use of Human Cells and Tissues.
p.000024:
p.000024: 1. The previous favourable report of the Guarantees Commission for the Donation and Use of Human Cells and
p.000024: Tissues shall be required for those research projects that deal, in whole or in part, with the following
p.000024: matters:
p.000024: a) Research with human pre- embryos for the derivation of cell lines, for embryologic research and for
p.000024: other research purposes, except for those related with the development and application of
p.000024: assisted reproduction techniques.
p.000024: b) Research with human embryonic stem cells
p.000024: c) The activation of ovocites through nuclear transfer for therapeutic or research purposes.
p.000024: d) Any other technique, that using in whole or in part, human biological samples, can lead to the obtaining of
p.000024: stem cells
p.000024: e) Research with embryonic cells or tissues obtained through any of the procedures mentioned in article
p.000024: 33.2.
p.000024: f) Any other line of research that includes cell material of human embryonic origin or
p.000024: other functionally similar.
p.000024: g) Research with embryonic stem cell lines that come from another country, within the EU countries or
p.000024: those outside the EU. This origin shall be specified in the project submitted for authorisation.
p.000024: 2. The authority that granted the authorisation to the research project mentioned in the earlier section,
p.000024: shall annually forward its results to the Guarantees Commission for the Donation and use of Human Cells and
p.000024: Tissues.
p.000024:
p.000024: Article 36. Access to cryopreserved ovocites and pre- embryos.
p.000024:
p.000024: The Institute of Health Carlos III shall guarantee the access to surplus cryopreserved
p.000024: pre-embryos from assisted reproduction techniques that have been donated for research purposes.
p.000024: The same criteria shall be followed with ovocites donated for research.
p.000024:
p.000024: CHAPTER III
p.000024: On the Guarantees Commission for the Donation and use of Human Cells and Tissues
p.000024:
p.000024: Article 37. Creation of the Commission.
p.000024:
p.000024: 1. A Guarantees Commission for the Donation and Use of Human Cells and Tissues is created as the association
...
p.000045: nature of the functions that it is going to undertake. These units shall be considered as units
p.000045: of this Institute. The finance contributions granted globally to these centres for their functioning shall
p.000045: not be understood as included within the ambit of application of Law 38/2003 of 17 November, on
p.000045: General Subsidies.
p.000045: Three. Virtual Research Centres as a network.
p.000045: The Institute of Health Carlos III shall establish the mechanisms so that the networks to which article
p.000045: 51 of Law 16/2003 of 28 May makes reference, after being duly evaluated and surpassing the criteria of quality
p.000045: and suitability, may become virtual centres of research in a network with their own legal personality.
p.000045:
p.000045: Additional Third Disposition. Post-graduate training in Health within the European Space for Higher
p.000045: Learning.
p.000045:
p.000045: The National Health School shall be able to teach post-graduate courses in health within
p.000045: the Framework of the European Space for Higher Learning.
p.000045:
p.000045: © Inter-University Chair in Law and the Human Genome
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: First Transitory Disposition. Commission of Follow-Up and Control on the Donation and Use of Human
p.000046: Cells and Tissues.
p.000046:
p.000046: The Commission on the Follow-Up and Control on the Donation and Use of Human Cells and Tissues, which is
p.000046: referred to in Royal Decree 2132/2004 of 29 October, establishing the requisites and
p.000046: procedures to solicit the undertaking of research projects with stem cells obtained from surplus embryos,
p.000046: shall assume the functions of the Commission for the Guarantees in the Donation and Use of Human Cells
p.000046: and Tissues provided in article 38 while the latter is being created and in accordance with article 37 and
p.000046: ff of this Law. The former shall look after the compliance of the guarantees and requisites
p.000046: established in article 34 and 35 of this legal regulation.
p.000046:
p.000046: Second Transitory Disposition.
p.000046: Previously stored samples.
p.000046:
p.000046: Those biological samples obtained previous to the entry into effect of this Law may be used for biomedical
p.000046: research purposes when the subject source has provided his consent or when the samples have been
p.000046: previously anonymised. Nonetheless, codified samples or those identified for
p.000046: biomedical research purposes may be used without the consent of the subject source when the obtaining
p.000046: of this consent entails a unreasonable effort as provided in section i) of article 3 of this Law or
p.000046: when it is not possible due to the death of the subject source or when they can not
p.000046:
p.000046: be found. These cases shall require the favourable ruling of the appropriate Research
p.000046: Ethics Committee, which must take into account, at least, the following requisites:
p.000046: a) That it is a research of general interest.
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000002: other legal goods related with them which have been established in our legal regulation, notably within the Spanish
p.000002: Constitution and the Convention for the Protection of Human rights and Dignity of the Human
p.000002: Being with regard to the Application of Biology and Medicine of the Council of Europe, signed in
p.000002: Oviedo, April 4, 1997 and which entered into effect in Spain on 1, January 2000. Consequently,
p.000002: the Law proclaims that the health, interest and well-being of the human being that participates in
p.000002: biomedical research shall prevail over the interest of society or science.
p.000002: In particular, the Law is built on the principles of the integrity of the persons and the protection of
p.000002: the dignity and identity of the human being in any biomedical research that involves the intervention
p.000002: on human beings as well as in the undertaking of genetic analysis, the processing of genetic data
p.000002: of a personal nature and of human biological samples used in research. Along these lines,
p.000002: the Law establishes the free will of a person as the foundation from which the specific rights to
p.000002: consent and to obtain previous information is derived. Likewise, it establishes the right to not
p.000002: be discriminated, the duty of confidentiality by any person that in the exercise of their duties has access to
p.000002: personal information,
p.000002:
p.000002: © Inter-University Chair in Law and the Human Genome
p.000003: 3
p.000003:
p.000003: the principle of gratuity of the donations of biological material and it sets the standards of
p.000003: quality and safety, which include the traceability of human cells and tissues and the strict compliance
p.000003: of the precautionary principle in the different activities that it regulates. In regulating
p.000003: all these matters, Basic Law 41/2002, of 14 November, on the Autonomy of the Patient and the Rights and
p.000003: Obligations in Matters of Clinical Information and Documentation and Basic Law 15/1999,
p.000003: of 13 December, on the Protection of Data of a Personal Nature have been taken into account,
p.000003: both of which are established as subsidiary in those matters that are not regulated by this Law.
p.000003: From a research point of view, the Law guarantees the freedom of research and of scientific production in the
p.000003: terms provided in article 20 of our Constitution. Furthermore, such an ambitious legal framework on advanced
p.000003: research in the field of biomedicine could not stop from bearing in mind the human,
p.000003: scientific, structural and social context in which it must develop in its daily practice, whereby
p.000003: this Law regulates the mechanisms to foster and promote, plan, evaluate and coordinate biomedical research
p.000003: from the principles of quality, efficacy and equal opportunity and in order to favour that the results of
...
p.000006: for experimentation and authorises the use of any technique for obtaining human stem cells for therapeutic or
p.000006: research purposes, including the activation of ovocites through nuclear transfer which doesn’t entail
p.000006: the creation of a pre-embryo or embryo in the terms defined in this Law. Chapter two regulates
p.000006: the conditions which must be met when researching with biological samples of an embryonic nature. The third
p.000006: chapter establishes the composition and function of the aforementioned Guarantees Commission, which also has the
p.000006: responsibility to provide information on researches that are listed in the Law on stem tissues and
p.000006: cells or others functionally similar or to procedures or techniques for obtaining
p.000006: these, including embryonic stem cell lines from third countries. Lastly, within chapter four, a system for
p.000006: promotion and coordination is established in this ambit of research with human embryonic cells and
p.000006: tissues, highlights the regulation of the National Bank of Cell Lines, which is
p.000006:
p.000006: afforded a structure as a network with a central node and its appointment to the Institute
p.000006: of Health Carlos III.
p.000006: Title V regulates other emerging matters related with the current expansive tendency of biomedical
p.000006: research, such as, the undertaking of genetic analysis, the access and use of its results, as well as
p.000006: the obtaining and use of human biological samples. In spite of the enormous difficulties to
p.000006: establish the limits between research and diagnosis in the ambit of genetic analysis, due to
p.000006: substantive and systematic coherence and in view of the important rights of persons which might be
p.000006: involved in these type of analysis, this Law could not renounce to establish a legal framework in which
p.000006: we must take a stance in the undertaking of genetic analysis for any purpose, including diagnostic.
p.000006: To this respect, the Law, at the same time that it prescribes a set of guarantees in relation with genetic
p.000006: analysis and biological samples within the ambit of the protection of data of a personal nature, it creates a
p.000006: set of norms in order to provide trust and safety to researches, and the public and private institutions
p.000006: in their acts within the sector, eliminating the current legal uncertainties.
p.000006: Besides other normative principles already mentioned, the guiding principles set are those of
p.000006: accessibility, equity and quality in the processing of data, it requires the previous consent and foresees
p.000006: the scenario of anonimised biological samples. Lastly, specific rules are established in relation with the deceased
p.000006: and with pre-embryos, embryos and foetuses, in respect to which the protection of data is also guaranteed and
...
p.000012:
p.000012: 1. The protection of personal privacy and the confidential treatment of personal data
p.000012: that are the result of the biomedical research shall be guaranteed protection, in accordance with that provided in
p.000012: the Basic Law 15/1999, of 13 December on the Protection of Data of a Personal Nature. The
p.000012: same guarantees shall be applicable to biological samples that are the source of information of a
p.000012: personal nature.
p.000012: 2. The conveyance of data of a personal nature to third parties outside the medical-assistance
p.000012: act or to a biomedical research shall require the express and written consent of the interested party.
p.000012: In the event that the data obtained from the subject source could reveal information of a personal nature about
p.000012: his family members, the conveyance to thirds shall require the express and written consent of all
p.000012: those concerned.
p.000012: 3. The use of data related to the health of persons with purposes
p.000012:
p.000012: © Inter-University Chair in Law and the Human Genome
p.000013: 13
p.000013:
p.000013:
p.000013: different to those for which the consent was given shall be forbidden.
p.000013: 4. Any person who has access to data of a personal nature, in the duty of their functions in relation with
p.000013: the providing of a medical health care service or biomedical research, whichever the reach of either, shall
p.000013: be subject to the duty of secrecy.
p.000013: 5. If the publication of the results of a research is not possible without identifying the person
p.000013: who participated or who provided biological samples, then these results shall only be published
p.000013: when there has been a previous and express consent of this person.
p.000013:
p.000013: Article 6. Non-discrimination.
p.000013:
p.000013: No one shall be the object of any type of discrimination on account of their genetic characteristics. Also, a
p.000013: person shall not be able to be discriminated on the basis of their refusal to undergo a
p.000013: genetic analysis to provide their consent to participate in a biomedical research or to donate biological
p.000013: material, particularly in relation with the conveyance of medical health care assistance that
p.000013: corresponds to the person.
p.000013:
p.000013:
p.000013: Article 7. Non profit.
p.000013:
p.000013: The donation and use of human biological samples shall be gratuitous, whichever its
p.000013: specific origin, and the compensations that are provided for in this Law can in no way entail a
p.000013: lucrative or commercial nature.
p.000013: Likewise, the donation implies the waiver by the donor to any right, of an economic nature or other, on the results
p.000013: that could be directly or indirectly obtained through the
p.000013:
...
p.000015: and burden for the subject, in accordance with the decision of the Research Ethics Committee that
p.000015: must evaluate this research.
p.000015:
p.000015: Article 15. Information to the subjects participating in the research.
p.000015:
p.000015: 1. Those persons who have been asked to participate in a research project shall previously receive the
p.000015: necessary information, duly documented and in a comprehensible manner, and
p.000015: when dealing with disabled people, in a manner suited to their circumstances.
p.000015: 2. The information shall include the purpose, detailed plan, burdens and possible risks and benefits of the
p.000015: research. This information shall specify the following matters:
p.000015: a) Nature, extent and duration of the procedures that are going to be used, particularly those that affect the
p.000015: participation of the subject.
p.000015: b) Available preventive, diagnostic and therapeutic procedures.
p.000015: c) Measures to fight against adverse events that bear upon the
p.000015:
p.000015: © Inter-University Chair in Law and the Human Genome
p.000016: 16
p.000016:
p.000016:
p.000016: subjects who participate in the research.
p.000016: d) Measures to assure the respect towards private life and the confidentiality of personal data
p.000016: in accordance with the demands established in the legislation on the protection of data of a
p.000016: personal nature.
p.000016: e) Measures to access, in the terms provided in article 4.5, to the information that is relevant for
p.000016: the subject that may arise in the research or the total results.
p.000016: f) Measures to assure an adequate compensation in the event that the subject is damaged.
p.000016: g) Identity of the professional who is responsible for the research.
p.000016: h) Any potential future use of the results of the research, including those that are commercial.
p.000016: i) Financing source of the research project.
p.000016: In the event that these matters are not known, there is an explicit compromise to complete this
p.000016: information when available.
p.000016: 3. In the event that the future or simultaneous use of genetic data or biological samples would
p.000016: be foreseen, then the provisions of Chapters II and III of Title V of this Law shall be applicable.
p.000016: 4. Furthermore, the persons that are asked to participate in research shall be informed of the rights and
p.000016: safeguards that are provided in this Law for their protection and specifically, on their right to
p.000016: refuse to consent or to revoke it at any moment without this affecting their right to health
p.000016: assistance.
p.000016:
p.000016: CHAPTER II
p.000016: Evaluation, authorisation and assurance of the damage
p.000016:
p.000016: Article 16. Evaluation and authorisation.
p.000016:
p.000016:
p.000016: Every biomedical research that entails an invasive procedure in the human being shall be previously
p.000016: evaluated by the Research Ethics Committee with oversight of the submitted research project and
p.000016: authorised by the corresponding autonomous authority. The evaluation must be previous to the
p.000016: authorisation, favourable, duly motivated and shall take into account the scientific
p.000016: suitability of the project, its relevance, feasibility and the suitability of the main researcher and
p.000016: the research team.
p.000016: In the event that the partial results that are obtained advise a modification of the
p.000016: project, this modification shall require a favourable report by the Research Ethics Committee
p.000016: and shall be notified to the competent autonomic authority for all practical purposes.
p.000016: In the case of research projects that are undertaken in several centres, the unity of criteria and
p.000016: the existence of a sole report shall be guaranteed.
p.000016:
p.000016: Article 17. Control and Follow up Guarantees.
p.000016:
p.000016: 1. The carrying out of research shall, in every case, abide by the content of the project which
p.000016: has been granted authorisation.
p.000016: 2. The health authorities shall have at all times faculty to inspect the research, being able to have access to
p.000016: the individual clinical histories of the subjects of the study, which, in every case, they must keep
p.000016: its confidential nature.
p.000016: 3. The autonomous authority shall proceed, on its own instance or on behalf of the Research
p.000016: Ethics Committee, to the temporary suspension of the authorised research in the cases where
p.000016: the
p.000016:
p.000016: © Inter-University Chair in Law and the Human Genome
p.000017: 17
p.000017:
p.000017:
p.000017: requisites provided by this Law aren’t met and when necessary to protect the rights of citizens.
p.000017:
p.000017: Article 18. Compensation for damages and its assurance.
p.000017:
p.000017: 1. Those persons, who have suffered damages as a consequence of their participation
p.000017: in a research project, shall receive a compensation that corresponds in accordance with that provided in the
p.000017: following sections.
p.000017: 2. The undertaking of a research that entails an invasive procedure in human beings shall require the
p.000017: previous assurance of the general and special damages that could be derived for the person in whom it
p.000017: has been carried out.
p.000017: 3. When, for whatever reason, the insurance policy doesn’t fully cover the caused damages, the promoter
p.000017: of the research, the researcher in charge and the hospital or centre in which it was carried out shall be joint
p.000017: and severally liable for them, even if there is no fault, thereby being responsible to bear the burden
...
p.000024: matters:
p.000024: a) Research with human pre- embryos for the derivation of cell lines, for embryologic research and for
p.000024: other research purposes, except for those related with the development and application of
p.000024: assisted reproduction techniques.
p.000024: b) Research with human embryonic stem cells
p.000024: c) The activation of ovocites through nuclear transfer for therapeutic or research purposes.
p.000024: d) Any other technique, that using in whole or in part, human biological samples, can lead to the obtaining of
p.000024: stem cells
p.000024: e) Research with embryonic cells or tissues obtained through any of the procedures mentioned in article
p.000024: 33.2.
p.000024: f) Any other line of research that includes cell material of human embryonic origin or
p.000024: other functionally similar.
p.000024: g) Research with embryonic stem cell lines that come from another country, within the EU countries or
p.000024: those outside the EU. This origin shall be specified in the project submitted for authorisation.
p.000024: 2. The authority that granted the authorisation to the research project mentioned in the earlier section,
p.000024: shall annually forward its results to the Guarantees Commission for the Donation and use of Human Cells and
p.000024: Tissues.
p.000024:
p.000024: Article 36. Access to cryopreserved ovocites and pre- embryos.
p.000024:
p.000024: The Institute of Health Carlos III shall guarantee the access to surplus cryopreserved
p.000024: pre-embryos from assisted reproduction techniques that have been donated for research purposes.
p.000024: The same criteria shall be followed with ovocites donated for research.
p.000024:
p.000024: CHAPTER III
p.000024: On the Guarantees Commission for the Donation and use of Human Cells and Tissues
p.000024:
p.000024: Article 37. Creation of the Commission.
p.000024:
p.000024: 1. A Guarantees Commission for the Donation and Use of Human Cells and Tissues is created as the association
p.000024: composed of several persons, assigned to the Institute of Health Carlos III, of a permanent and
p.000024: consultative nature, aimed at providing counsel and guidance on the research and experimentation with
p.000024: human embryonic biological samples and to contribute to the updating and dissemination of the scientific
p.000024: and technical knowledge in this matter.
p.000024: 2. The counterpart commissions that are created in the Autonomous Communities shall be considered as
p.000024: commissions to provide support and reference to the Guarantees Commission for the Donation and use of
p.000024: Human Cells and Tissues and shall collaborate with it in the exercise of its functions.
p.000024:
p.000024: Article 38. Functions of the Commission.
p.000024:
p.000024: 1. The Commission shall have the following assigned functions:
p.000024:
p.000024: © Inter-University Chair in Law and the Human Genome
p.000025: 25
p.000025:
p.000025:
p.000025: a) To assure the scientific, ethical and legal guarantees that may be demanded in relation
p.000025: with the research mentioned in article 35 and to annually evaluate their results.
...
p.000025: 2. The Commission shall issue its compulsory report on the research projects that have been submitted
p.000025: within a maximum time period of three months.
p.000025:
p.000025: Article 39. Composition of the Commission.
p.000025:
p.000025: 1. The Commission shall be made up of twelve members. All shall be specialists of well-known prestige in
p.000025: research on cell therapy or regenerative medicine, in bioethics and law related to
p.000025: bioethical matters.
p.000025: 2. The members of the Commission shall act at all times with criteria of independence and impartiality.
p.000025: 3. The members shall be named by the Minister of Health and Consumption for three year terms,
p.000025: with the following distribution:
p.000025:
p.000025: a) Six representatives designated by the Inter-territory Council of the National
p.000025: Health System as proposed by the autonomous communities.
p.000025: b) Six representatives of the General Administration of the State, two by the Ministry of Health and
p.000025: Consumption, two by the Ministry of Justice and two by the Ministry of Education and Science.
p.000025: 4. The President of the Commission shall be named by the Minister of Health and Consumption from
p.000025: among its members.
p.000025: 5. The Secretary of the Commission shall be a civil servant with the rank of vice-director
p.000025: general who belongs to the Institute of Health Carlos III, who will have a say but no vote.
p.000025: 6. The members of the Commission shall have access to the detailed information on the research project on
p.000025: cells and tissues that are referred to in this title, on the National Registry of Activity and
p.000025: Results of the Assisted Reproduction Centres and Services which are referred to in Law 14/2006, of 26
p.000025: May, on Assisted Human Reproduction Techniques and on the National Registry of Cell Lines.
p.000025:
p.000025: CHAPTER IV
p.000025: On the promotion and coordination of research with human embryonic cells and tissues
p.000025:
p.000025: Article 40. Promotion and coordination.
p.000025:
p.000025: 1. The promotion and coordination of research with embryonic biological samples shall be
p.000025: the responsibility of the Ministry of Health and Consumption, through the Institute of Health
p.000025: Carlos III, notwithstanding the powers that may
p.000025:
p.000025: © Inter-University Chair in Law and the Human Genome
p.000026: 26
p.000026:
p.000026:
p.000026: correspond to the autonomous communities.
p.000026: 2. The corresponding authority, via the Institute of Health Carlos III, through the procedure that
p.000026: may be established by regulations, shall forward those research projects that must have a report issued
p.000026: by the Guarantees Commission for the Donation and Use of Human Cells and Tissues.
p.000026:
p.000026: Article 41. Registry of projects.
p.000026:
p.000026: The Institute of Health Carlos III shall be responsible for the maintenance of the
p.000026: registry of research projects, whose data shall be based on that provided by the corresponding
...
p.000026: c) The report of the Guarantees Commission for the Donation and Use of Human Cells and Tissues.
p.000026: d) The certification of the authorisation to undertake research granted by the
p.000026: corresponding authority with power to do so.
p.000026: e) At the end of the authorised research, an evaluation report by the Guarantees Commission for the
p.000026: Donation and Use of Human Cells and Tissues.
p.000026:
p.000026: Article 42. National Bank of Cell Lines.
p.000026:
p.000026: 1. The National Bank of Cell Lines shall be structured as a network, with a central node responsible
p.000026: for its coordination and shall be assigned to the Institute of Health Carlos III.
p.000026: 2. The National Bank of Cell Lines shall promote the quality and safety of the procedures over which it
p.000026: exercises its competence, shall keep the confidentiality of the data and other demands in reference
p.000026: to those acts that it carries out, in accordance with that established in Law 14/2006, of 26
p.000026: May, on Assisted Human Reproduction Techniques, and Basic Law 15/1999, of 13 December,
p.000026: on the Protection of Data of a Personal Nature, and shall act in accordance with the principles of
p.000026: precaution, proportionality and non-profit.
p.000026: 3. The Technical Commission of the National Bank of Cell Lines, whose composition and functions
p.000026: shall be determined by an order of the Minister of Health and Consumption, shall see to it that
p.000026: the access to cell lines for the execution of research projects is undertaken within those scientifically,
p.000026: ethical and legal principles in force and must have available updated information on the
p.000026: registry of embryos and cell lines that are available in the centres for in vitro fertilisation and
p.000026: in the banks of cell lines.
p.000026:
p.000026: Article 43. Use of cell lines.
p.000026:
p.000026: The use of cell lines or of biological samples that are derived from the research that is referred to in
p.000026: this title shall comply with that provided in this Law and, where appropriate, in the regulation on clinical
p.000026: trials and
p.000026:
p.000026: © Inter-University Chair in Law and the Human Genome
p.000027: 27
p.000027:
p.000027:
p.000027: on the clinical use of cells and tissues.
p.000027:
p.000027: TITLE V
p.000027: Genetic analysis, biological samples and biobanks
p.000027:
p.000027: CHAPTER I
p.000027: General Dispositions
p.000027:
p.000027: Article 44. Object.
p.000027: The object of this title is:
p.000027: 1st. To establish the requirements that must be followed by institutions and persons that carry out genetic
p.000027: analysis and that process or store genetic data of a personal nature and biological samples.
p.000027: 2nd. To see to the correct use of biological samples for biomedical research.
p.000027: 3rd. To establish the requirements that must be followed by biobanks for their creation and functioning.
p.000027: 4th. To assure the gratuity throughout the process of donation, assignment, storage and use of
p.000027: biological samples, both for source subjects as well as for those who deposit, notwithstanding
p.000027: the compensation for the costs.
p.000027:
p.000027: Article 45. Specific guiding principles.
p.000027:
p.000027: Besides those guarantees established in title I of this Law, the following principles shall
p.000027: be applicable:
p.000027: a) Accessibility and equity: equal access to genetic analysis must be guaranteed
p.000027: without economic considerations and without previous requisites related to possible personal options.
p.000027: b) Protection of data: the right to privacy and to the respect of the will of a subject shall be guaranteed
p.000027: in matters of information, as well as
p.000027:
p.000027: the confidentiality of genetic data of a personal nature.
p.000027: c) Gratuity: all the process of donation, assignment, storage and use of biological samples, both for
p.000027: the source subjects as well as for those who deposit, shall be devoid of a financial gain or profit.
p.000027: Personal genetic data shall not be used for commercial purposes.
p.000027: d) Consent: the written consent of the subject source, or where appropriate, of his
p.000027: legal representatives must be obtained previous to the treatment of samples for research purposes of
p.000027: personal genetic data.
p.000027: e) Quality of the data: the data obtained from the genetic analysis shall neither be handled
p.000027: nor assigned for purposes other than those provided for in this Law.
p.000027:
p.000027: CHAPTER II
p.000027: Genetic analysis and the treatment of personal genetic data
p.000027:
p.000027: Article 46. Indication of genetic analysis.
p.000027:
p.000027: In the terms provided in article 1.2, genetic analysis shall be undertaken for the identification
p.000027: of an individual’s condition as affected, non- affected or as carrier of a genetic
p.000027: variable that could predispose to the development of a specific disease or to condition his response
p.000027: to a specific treatment.
p.000027:
p.000027: Article 47. Information previous to the undertaking of a genetic analysis for research purposes in the
p.000027: health sector.
p.000027:
p.000027: Notwithstanding what is provided on the legislation on the protection of data of a personal nature, before the
p.000027: subject provides his consent in the
p.000027:
p.000027: © Inter-University Chair in Law and the Human Genome
p.000028: 28
p.000028:
p.000028:
p.000028: terms provided in article 48, he must receive the following written information:
p.000028: 1st. Purpose of the genetic analysis for which he is consenting.
p.000028: 2nd. Place of the undertaking of the analysis and the destination of the biological sample at the end of
p.000028: it, whether it is the disassociation of the identifying data of the sample, its destruction or other destinations,
p.000028: for which the consent of the subject source must be requested in the terms provided in this Law.
p.000028: 3rd. Persons who will have access to the results of the analysis when those are not going to undergo
p.000028: a process of disassociation or anonimisation.
p.000028: 4th. A warning about the possibility of unexpected findings and its possible transcendence for
p.000028: the subject, as well as his faculty to take a stance in relation to receiving this communication.
p.000028: 5th. Warning about the implication that the information that could be obtained can have for his
p.000028: family members and the convenience for that person, where appropriate, to convey that information to them.
p.000028: 6th. Compromise to provide genetic counselling, once the results of the analysis are obtained
p.000028: and evaluated.
p.000028:
p.000028: Article 48. Consent.
p.000028:
p.000028: 1. The express and specific written consent shall be necessary for the undertaking of a genetic analysis.
p.000028: 2. In the health ambit, samples of deceased persons may be obtained and analysed always when it may be of
p.000028: interest for the protection of health, except when the deceased has expressly prohibited it during his life
p.000028: and can be proven. To this effect, the documents of previous instructions and, for lack of, the
p.000028:
p.000028: criteria of the closest family members of the deceased shall be consulted.
p.000028: The access by the biological family members to information derived from the genetic analysis of the
p.000028: deceased shall be limited to the genetic data relevant for the protection of their health.
p.000028: 3. In order to have access to a genetic screening, there must be an explicit and written consent of the
p.000028: person interested. The Research Ethics Committee shall determine the situations in which the consent
p.000028: may be expressed verbally. In any case, when the screening includes non-curable diseases or the benefits are
p.000028: scarce or uncertain, the consent shall always be written.
p.000028: 4. The undertaking of genetic analysis on in vivo pre-embryos or on embryos and foetuses in
p.000028: the uterus shall require the written consent of the gestating woman.
p.000028: The genetic analysis of an in vitro pre-embryo that has not been transferred shall be subject to that
p.000028: provided in the Law on Assisted Human Reproduction.
p.000028:
p.000028: Article 49. Right to Information and right not to know.
p.000028:
p.000028: 1. The subject source shall be informed on the genetic data of a personal nature that are obtained in
p.000028: the genetic analysis according to the terms in which he manifested his volition, notwithstanding the right to
p.000028: access that is established in the legislation on the protection of data of a personal nature, which
p.000028: could entail the revocation of the previously granted manifestation of free volition.
p.000028: 2. When the subject source has exercised his right not to know the results of a genetic analysis,
p.000028: then only that information that is
p.000028:
p.000028: © Inter-University Chair in Law and the Human Genome
p.000029: 29
p.000029:
p.000029:
p.000029: necessary for the follow up of a prescribed treatment by the doctor and that has been accepted by the
p.000029: patient shall be provided. When this information is necessary to avoid a serious damage for the health of his
p.000029: biological family, then the affected or their legally authorised representative may be
p.000029: informed. In every case, the communication shall be exclusively limited to the data necessary for these ends.
p.000029:
p.000029: Article 50. Access to genetic data by health personnel.
p.000029:
p.000029: 1. Health professionals of the centre or the establishment that stores the clinical history
p.000029: of the patient shall have access to the data recorded in it in so far as it is relevant for the
p.000029: assistance that is being provided to the patient, notwithstanding the duties of secrecy and
p.000029: confidentiality to which they are subject.
p.000029: 2. Genetic data of a personal nature can only be used for epidemiological, public
p.000029: health, research or education purposes when the interested subject has expressly provided his
p.000029: consent or when this data has been previously anonimised.
p.000029: 3. In exceptional cases and of general health interest, the corresponding authority,
p.000029: after a favourable report by the authority on data protection, may authorise the use of codified genetic data,
p.000029: always when assuring that third parties may not be able to associate the source subject.
p.000029:
p.000029: Article 51. Duty of confidentiality and the right to the protection of genetic data.
p.000029:
p.000029: 1. The personnel who have access to genetic data in the exercise of
p.000029:
p.000029: their functions shall be subject to the duty of secrecy in a permanent manner. The disclosure of personal
p.000029: genetic data to third parties is only permitted with the express written consent of the person from whom
p.000029: these proceed.
p.000029: If the publishing of the results of a research is not possible without identifying the source subjects, then
p.000029: such results may only be published with their consent.
p.000029: 2. In case of genetic analysis to several members of a family, the results shall be filed
p.000029: and communicated to each of them in an individual manner. In case of disabled or minors, the
p.000029: information shall be provided to their tutors or legal representatives.
p.000029:
p.000029: Article 52. Conservation of data.
p.000029:
p.000029: 1. Personal genetic data shall be kept during a period of no less than five years from the date in which
p.000029: they were obtained, after which the interested party may solicit its cancellation.
p.000029: 2. If there is no request by the interested party, the data shall be kept during the time that
p.000029: may be necessary in order to preserve the health of the person from which it was obtained or of
p.000029: third parties related with him.
p.000029: 3. Outside these events, data shall only be kept, for research purposes, in an anonimised manner, without there
p.000029: being the possibility to identify the subject source.
p.000029:
p.000029: Article 53. Genetic analysis on pre-embryos, embryos or foetuses.
p.000029:
p.000029: The results of genetic analysis undertaken on embryonic or foetal material shall be subject to
p.000029: the principles of protection of data and
p.000029:
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p.000030: 30
p.000030:
p.000030:
p.000030: confidentiality provided in this Law. The same criteria shall be applicable in relation with any other
p.000030: biological samples that may contain genetic information of the person who provided his own biological
p.000030: material for the obtaining of such.
p.000030:
p.000030: Article 54. Genetic screening.
p.000030:
p.000030: 1. Genetic screenings are aimed at detecting a serious disease or health risk of the
p.000030: participating individual or in his descent, for the purpose of early treatment of a disease or to
p.000030: offer access to preventive measures.
p.000030: 2. The health authorities shall determine based on objective criteria, the relevance of the
p.000030: genetic screening in accordance with the diseases to be prevented or treated. Likewise, they shall
p.000030: ensure a universal and equitable access of the screening to the population for which it is
p.000030: indicated, for the organisation and planning of the program as well as the quality of the screening
p.000030: tests, diagnostic tests of a second level and the preventive and therapeutic services that are offered.
p.000030: 3. For the undertaking of the screening, the psycho-social aspects and its integration
p.000030: into the health system shall be taken into account. Likewise, the specific program of screening
p.000030: shall be evaluated by the ethics committee of the centre that performs it.
p.000030: 4. Appropriate procedures shall be established for the continuous follow-up and evaluation of
p.000030: the program.
p.000030: 5. The participation in a genetic screening shall be offered to all members of the population to
p.000030: which it is aimed, for which the previous written consent of each subject affected in the terms
p.000030: provided in
p.000030:
p.000030: articles 4 and 48.3 shall be necessary.
p.000030: 6. The information prior to this consent shall be written and shall make reference to:
p.000030: a) The sought characteristics and objectives of the screening.
p.000030: b) The voluntary nature of the participation.
p.000030: c) The validity and reliability of the screening tests and of the diagnostic tests of a second
p.000030: level.
p.000030: d) The possibility to obtain false positives and, in turn, the need to confirm or discard the diagnosis.
...
p.000032:
p.000032: 1. Notwithstanding that provided in the legislation on the protection of data of a personal nature,
p.000032: and particularly, in article 45 of this Law, before providing the consent for the use of a biological sample
p.000032: for biomedical research that is not going to be subject to an anonimisation process, the
p.000032: subject source shall receive the following written information:
p.000032: a) Purpose of the research or the line of research for which he is providing the consent.
p.000032: b) Expected benefits.
p.000032: c) Possible inconveniences linked to the donation and obtaining of the sample, including the possibility of being
p.000032: contacted at a later time in order to collect new data or obtain other samples.
p.000032: d) Identity of the person responsible for the research.
p.000032: e) Right to revoke the consent and its effects, including the possibility of the
p.000032: destruction or the anonimisation of the sample and that to this end it shall not be applicable
p.000032: to the rest of the research data that has already taken place.
p.000032: f) Location of the undertaking of the analysis and the destination of the sample at the end of
p.000032: the research: disassociation, destruction or other research, and where
p.000032: h) Guarantee of confidentiality of the information obtained, indicating the identity of the persons who shall
p.000032: have access to the data of a personal nature of the subject source.
p.000032: i) Warning on the possibility that information relative to their health may be obtained as derived from the
p.000032: genetic analysis that are undertaken on their biological sample, as well as on their faculty to take a stance in
p.000032: relation to its communication.
p.000032: j) Warning on the implication of the information that could be obtained for his family members and
p.000032: the convenience that the person, where appropriate, transmit this information to them.
p.000032: k) Indication on the possibility to get in contact with him-her, for which information on the way to do so may be
p.000032: solicited.
p.000032: 2. In the event of the use of samples that are going to be anonimised, the subject
p.000032: source shall receive the information contained in sections a), b), c) and d) of this article.
p.000032:
p.000032: Article 60. Consent on the use of a biological sample.
p.000032:
p.000032: 1. The consent on the use of the biological sample shall be granted either in the act of obtaining
p.000032: the sample or later in a specific manner for a specific research.
p.000032: 2. The specific consent may provide for the use of a sample for
p.000032:
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p.000033: 33
p.000033:
p.000033:
p.000033: other lines of research related with that initially proposed, including those undertaken by third
...
p.000034: 34
p.000034:
p.000034:
p.000034: Article 66. Organisation of the biobank.
p.000034:
p.000034: 1. The biobank shall have a scientific director, a person responsible for the files and shall
p.000034: be assigned to two external committees, a science and an ethics, respectively that
p.000034: will assist the director of the biobank in her functions.
p.000034: 2. The director of the biobank shall have the following obligations:
p.000034: a) To enforce the existing legislation.
p.000034: b) To keep a registry of activities of the biobank.
p.000034: c) To guarantee the quality, safety and traceability of stored biological data and samples and
p.000034: of the procedures associated with the functioning of the biobank.
p.000034: d) To draft an annual report of activities, this shall be made available to the authority
p.000034: that granted the authorisation for the creation of the biobank.
p.000034: e) To attend the consultations or complaints that could be addressed to the biobank.
p.000034: f) To draft a document of good practices of the biobank.
p.000034: g) To draft a descriptive memory that compiles the characteristics of the collections, the criteria for the
p.000034: inclusion and the purposes for which the collection is created, the manner in which the historic collection has
p.000034: been compiled and the information that can be associated to the samples.
p.000034: 3. The person responsible for the files shall attend all requests in the exercise of the rights to
p.000034: access, rectification, cancellation or opposition that are made by the subject source, in
p.000034: accordance with that provided in the existing legislation on the protection of data of a personal
p.000034: nature.
p.000034:
p.000034:
p.000034: Article 67. National Registry of Biobanks.
p.000034:
p.000034: 1. Once the biobank is constituted in accordance with the previous procedure, the
p.000034: corresponding authority shall proceed to register it in the National Registry of Biobanks for Biomedical
p.000034: Research, which shall be dependent of the Institute of Health Carlos III. Before that, they must register in
p.000034: the Spanish Agency for the Protection of Data in accordance with existing legislation. The data in
p.000034: this Registry shall be based in that provided by the competent authorities to authorise biobanks.
p.000034: 2. Any person or entity, public or private that has one or more ordered collections of human samples or
p.000034: biological material that come from identified or identifiable persons, must likewise register in the National
p.000034: Registry of Biobanks. This requisite shall be independent of its registration in the registries of
p.000034: other institutions due to their special nature or purpose.
p.000034: 3. Once registered, The Ministry of Health and Consumption shall certify the nature and scope of
p.000034: the collection.
p.000034: 4. The following shall not be subject to the aforementioned registration: those collections kept by physical
...
p.000035: stated in the request. It must contain the approval by the scientific and ethical committees of
p.000035: the bank.
p.000035: 3. The costs of obtaining, maintenance, handling, shipping and other costs of a similar
p.000035: nature related with the samples may be passed on with the assignment of each sample. In every case,
p.000035: the quantity of the assigned samples shall be the minimum necessary for the undertaking of the project.
p.000035: 4. The obtaining, transportation, storage, handling and shipping of samples shall be done in conditions of
p.000035: biosafety in accordance with applicable legislation.
p.000035: 5. The total or partial refusal of the biobank to deliver samples which are solicited for biomedical research
p.000035: shall require a reasoned decision by
p.000035:
p.000035: the person in charge, who shall take into account the previous respective reports of the scientific director and the
p.000035: scientific and ethical committees that are mentioned in article 66.1
p.000035: 6. The assignment of samples may be accompanied by the associated clinical information, in which case the
p.000035: data shall be protected in accordance with that provided in the Law of the Autonomy of the Patient and the
p.000035: Law for the Protection of Personal Data.
p.000035:
p.000035: Article 70. Rights of the source subjects.
p.000035:
p.000035: 1. That provided in the articles of Chapter III of this title in relation with the obtaining, previous
p.000035: information, consent, confidentiality, assignment, conservation of data and samples, access to data and the
p.000035: right not to know shall be applicable to biological samples deposited in biobanks.
p.000035: 2. Notwithstanding that provided in the previous section, those biological samples that are added
p.000035: to biobanks may be used for any biomedical research, in the terms provided in this Law, always when
p.000035: the source subject, or where appropriate, his legal representatives have
p.000035: provided their consent in these terms.
p.000035:
p.000035: Article 71. Closure or closing of a biobank.
p.000035:
p.000035: 1. The competent authority may decide the closure or closing of a biobank, on its own motion or as
p.000035: requested and through a motivated resolution, in those cases in which there is non-compliance with the
p.000035: requisites established in this Law for its creation, organisation and function, or when its
p.000035: owner
p.000035:
p.000035: © Inter-University Chair in Law and the Human Genome
p.000036: 36
p.000036:
p.000036:
p.000036: manifests his will not to continue with its activity.
p.000036: 2. This resolution shall likewise provide the destination of the stored samples of the biobank that is going
p.000036: to be closured or closed.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: TITLE VI
p.000036: Infractions, sanctions and compensations for damages
p.000036:
p.000036: Article 72. General Dispositions.
p.000036:
p.000036: 1. The infractions provided in this Law related with the obtaining and use of human cells and tissues,
...
p.000044: Health Carlos III or by the autonomous communities through the procedure that is established by
p.000044: regulation.
p.000044: In accordance with that provided in article 42.2 of Law 30/1992, of 26 November, of the Legal Regime of
p.000044: Public Administrations and the Common Administrative Procedure, the term for the resolution and
p.000044: notification in the process of certification to which this article makes reference to shall
p.000044: be of twelve months.
p.000044:
p.000044: Article 89. Cooperation among the public and private sectors.
p.000044:
p.000044: 1. In order to increase the involvement of the private sector in the Biomedical and Health
p.000044: Sciences Sector, procedures for the participation in private entities that develop activities
p.000044: of research or technological development in the execution of the research actions of the National Health
p.000044: System shall be established.
p.000044: 2. To comply with the objective of this first section, the centres of the National Health System, the
p.000044: public institutions and entities that research in biomedicine and the health sciences and the
p.000044: universities, may reach agreements with private entities that undertake activities of scientific research
p.000044: and technological development. These agreements may establish the possibility that the personnel of these
p.000044: private entities participate in the execution of research programs or projects of the National Health
p.000044: System. In no case shall this participation generate the right to access the public function or the service
p.000044: in the Public Administration through work ties or through any other means.
p.000044:
p.000044: 3. The public Administrations shall promote a favourable environment for the development of private
p.000044: initiatives and shall foster the creation of new business opportunities that arise
p.000044: in the National Health System, including the creation of risk-capital entities aimed at the
p.000044: investment in biomedical research.
p.000044: 4. Likewise, measures shall be taken that contribute to promote adequate returns to the
p.000044: National Health System in relation to the investments undertaken in the ambit of biomedical research.
p.000044:
p.000044: Article 90. Financing.
p.000044:
p.000044: 1. The Ministry of Health and Consumption, in its management of the activities mentioned in
p.000044: the previous articles, shall finance them through those instruments of finance provided in the National Plan
p.000044: of Scientific Research and Technological Development and Innovation. This financing
p.000044: shall be provided by the budget of this Ministry, notwithstanding the co- financing agreements that
p.000044: exist or that are established in the future with public or private entities.
p.000044: 2. The financing of the activities mentioned in the previous article that are managed by the Ministry
p.000044: of Health and Consumption shall fit that provided to the national plan of Research & Development
p.000044: & Innovation, even when the funds come from legally set tariffs and shall be charged to the
...
Social / Age
Searching for indicator age:
(return to top)
p.000011: the adequate information has been provided.
p.000011: The information provided shall be written and shall encompass the nature, importance, implications and
p.000011: risks of the research in the terms provided for in this Law.
p.000011: People with disabilities shall be provided this information in accessible manners and
p.000011: formats that are appropriate to their needs.
p.000011:
p.000011: © Inter-University Chair in Law and the Human Genome
p.000012: 12
p.000012:
p.000012:
p.000012: If the subject of research is unable to write, the consent may be granted through any means admitted by law that allows
p.000012: the stating of a record of his or her will.
p.000012: 2. When a person is legally disabled or is a minor, their consent shall be granted
p.000012: through representation, provided that there are no other alternatives to the research.
p.000012: The conveyance of the consent through representation shall be proportionate to the research to be
p.000012: undertaken and shall be done in accordance with the respect of the dignity of a person and for
p.000012: the benefit of their health.
p.000012: The disabled and minors shall participate, in so far as it is possible and in accordance to their age and
p.000012: capacities, in the decision making process throughout the research.
p.000012: 3. Those persons who participate in biomedical research shall be able to revoke their consent at any moment,
p.000012: notwithstanding the limitations provided in this Law. Those persons or entities that
p.000012: have received this consent shall have available those measures that are necessary for the effective
p.000012: exercise of this right.
p.000012: 4. The lack of consent or the revocation of consent that has been previously granted shall not entail
p.000012: any damages in the health care assistance of the subject.
p.000012: 5. Every person has the right to be informed of his or her genetic data and other data of a personal nature
p.000012: that are obtained in the course of a biomedical research, in accordance to the terms that he or
p.000012: she assented. The same right is recognised to the person who has provided, with the
p.000012: aforementioned purpose, biological samples or when other biological materials are obtained from these.
p.000012:
p.000012: There shall be an observance of the right of the person not to know that data, which is referred to in the
p.000012: former paragraph, including unexpected findings that could arise. Nonetheless, when this information,
p.000012: according to the criteria of the doctor in charge, is necessary in order to avoid serious damage to his
...
p.000018: consent.
p.000018: c) That the person who is going to participate in the research has been provided written information about his
p.000018: rights and the limits provided in this Law and in the regulation that further develops it for his
p.000018: protection, unless that person is not in a state to receive that information.
p.000018: d) That the legal representatives of the person who is going to participate in the research have
p.000018: provided their written consent, after having received the information established in article 15. The
p.000018: legal representative shall take into account the desires and objections that are previously expressed
p.000018: by the affected person. Additionally, in these cases, actions must be accordance with that
p.000018: provided in section 1 of article 4 of this Law.
p.000018: 2. When it is foreseeable that the research is not going to produce results for the direct health benefit
p.000018: of the subjects referred to in section 1 of this article, the research may be authorised in an exceptional manner
p.000018: if in addition to the requisites established in subsections b), c) and
p.000018: d) of the earlier section, the following conditions are met:
p.000018: a) That the object of the research is to contribute, through meaningful improvements of the
p.000018: understanding of the disease or the condition of the individual, to a beneficial result for other persons of
p.000018: the same age or with the same disease or conditions, within a reasonable time frame.
p.000018:
p.000018: b) That the research entails a minimum risk and burden to the participating individual.
p.000018: c) That the authorisation of the research is made known to the Ministry of the Public Prosecutor.
p.000018:
p.000018: Article 21. Research on persons unable to consent due to their clinical situation.
p.000018:
p.000018: 1. For undertaking research in situations of clinical emergency, in which the person involved may
p.000018: not provide their consent, the following specific conditions must be met:
p.000018: a) That research of comparable efficacy is not possible to be undertaken on persons who are not
p.000018: in that emergency situation.
p.000018: b) That in the event that it is not foreseeable that the research is going to produce beneficial
p.000018: results for the health of the patient, that it has the purpose to contribute in a meaningful manner
p.000018: to the understanding of the disease or the condition of the patient, with the purpose of
p.000018: benefiting other persons with the same disease or condition, always that it entails a minimum risk and discomfort for
p.000018: him.
p.000018: c) That the authorisation of the research is made known to the Ministry of the Public Prosecutor.
...
p.000019: when the patient is in a condition to provide it.
p.000019:
p.000019: CHAPTER IV
p.000019: Safety and Supervision Article 22. Risk Prevention.
p.000019: 1. Besides that provided in article 18, necessary measures shall be taken in order to guarantee the
p.000019: safety of the research and to reduce the risks and discomforts for the individuals who participate.
p.000019: Medical decisions related with the health of the participating subjects in research belong to the doctor in
p.000019: charge of their assistance.
p.000019: 2. The researcher in charge of the project must accredit that the members who are part of
p.000019: the research team have the adequate qualification and experience in the ambit of the proposed research.
p.000019:
p.000019: Article 23. Evaluation of the state of health.
p.000019:
p.000019: 1. Those persons who are going to participate in the research have the duty to provide real data about their physical
p.000019: state or their health. In any case, the researcher shall take the necessary measures, which shall include,
p.000019: where appropriate, the consultation to the doctors responsible for the medical
p.000019: assistance of the participants, to
p.000019:
p.000019: verify such extremes before the beginning of the research, in order to assure that the persons for whom
p.000019: the research entails a special risk are excluded from it.
p.000019: 2. When research involves women in a fertile age, the possible adverse impact on an unknown existing
p.000019: pregnancy or a later one, as well as on the health of the embryos, foetuses or child shall be taken into
p.000019: account.
p.000019:
p.000019: Article 24. Non-interference with necessary clinical interventions.
p.000019:
p.000019: 1. Research must not delay or deprive the participants of the preventive, diagnostic or
p.000019: therapeutic medical procedures that are necessary for their state of health.
p.000019: 2. In research associated with the prevention, diagnosis or treatment of diseases, there must be
p.000019: an assurance that the participants who are assigned to the control groups receive proven procedures of
p.000019: prevention, diagnosis or treatment.
p.000019: The researcher must place on record the extremes which are referred to in the previous section in
p.000019: the protocol of the trial that she is going to submit for evaluation and authorisation.
p.000019: 3. A placebo may be used only if there are no methods of proven efficacy or when the withdrawal
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
p.000019: project is justified in light of new knowledge that is reached throughout its execution.
p.000019:
...
Social / Child
Searching for indicator child:
(return to top)
p.000017: of the research, the researcher in charge and the hospital or centre in which it was carried out shall be joint
p.000017: and severally liable for them, even if there is no fault, thereby being responsible to bear the burden
p.000017: of proof. Neither the administrative authority nor the report of the Research Ethics Committee
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
p.000017:
p.000017: © Inter-University Chair in Law and the Human Genome
p.000018: 18
p.000018:
p.000018:
p.000018: undertaken if the following conditions are met:
p.000018: a) That the results of the research can produce real or direct benefits for his health.
p.000018: b) That a research of comparable efficacy can not be carried out in persons capable of providing their
p.000018: consent.
p.000018: c) That the person who is going to participate in the research has been provided written information about his
p.000018: rights and the limits provided in this Law and in the regulation that further develops it for his
p.000018: protection, unless that person is not in a state to receive that information.
p.000018: d) That the legal representatives of the person who is going to participate in the research have
...
p.000019: safety of the research and to reduce the risks and discomforts for the individuals who participate.
p.000019: Medical decisions related with the health of the participating subjects in research belong to the doctor in
p.000019: charge of their assistance.
p.000019: 2. The researcher in charge of the project must accredit that the members who are part of
p.000019: the research team have the adequate qualification and experience in the ambit of the proposed research.
p.000019:
p.000019: Article 23. Evaluation of the state of health.
p.000019:
p.000019: 1. Those persons who are going to participate in the research have the duty to provide real data about their physical
p.000019: state or their health. In any case, the researcher shall take the necessary measures, which shall include,
p.000019: where appropriate, the consultation to the doctors responsible for the medical
p.000019: assistance of the participants, to
p.000019:
p.000019: verify such extremes before the beginning of the research, in order to assure that the persons for whom
p.000019: the research entails a special risk are excluded from it.
p.000019: 2. When research involves women in a fertile age, the possible adverse impact on an unknown existing
p.000019: pregnancy or a later one, as well as on the health of the embryos, foetuses or child shall be taken into
p.000019: account.
p.000019:
p.000019: Article 24. Non-interference with necessary clinical interventions.
p.000019:
p.000019: 1. Research must not delay or deprive the participants of the preventive, diagnostic or
p.000019: therapeutic medical procedures that are necessary for their state of health.
p.000019: 2. In research associated with the prevention, diagnosis or treatment of diseases, there must be
p.000019: an assurance that the participants who are assigned to the control groups receive proven procedures of
p.000019: prevention, diagnosis or treatment.
p.000019: The researcher must place on record the extremes which are referred to in the previous section in
p.000019: the protocol of the trial that she is going to submit for evaluation and authorisation.
p.000019: 3. A placebo may be used only if there are no methods of proven efficacy or when the withdrawal
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
p.000019: project is justified in light of new knowledge that is reached throughout its execution.
p.000019:
p.000019: © Inter-University Chair in Law and the Human Genome
p.000020: 20
p.000020:
p.000020:
p.000020: The main researchers must send to the Committee, without delay, any relevant information for the safety of the
p.000020: participating subjects.
...
Searching for indicator children:
(return to top)
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000010: identifiable person as the nexus with all information that identified the subject has been destroyed
p.000010: or because such association demands a non-reasonable effort, understood as the use of disproportionate
p.000010: amounts of time, expense and work.
p.000010: j. “Genetic data of a personal nature”: information on the hereditary characteristics of
p.000010: a person, identified or identifiable that is obtained through nucleic acid analysis or through other
p.000010: scientific analysis.
p.000010: k. “Codified or reversibly disassociated data”: data that is not associated to an identified
p.000010: or identifiable person as the information that identified that person has been
p.000010: substituted or detached using a code that permits the reverse operation.
p.000010: l. “Embryo”: phase of embryonic development from the moment in which the fertilised ovocite is found in
p.000010: the uterus of a woman until the beginning of organ genesis and which ends 56 days from the
p.000010: moment of fertilisation, with the exception of the computation of those days in which
p.000010: the development could have been stopped.
p.000010:
p.000010: © Inter-University Chair in Law and the Human Genome
p.000011: 11
p.000011:
p.000011:
p.000011: m. “Observation study”: study undertaken on individuals in reference to whom there is
p.000011: neither the modification of the treatment or intervention to which they could be subject nor a
p.000011: prescription of any other guideline that could affect their personal integrity.
p.000011: n. “Foetus”: embryo with human appearance and with its organs formed which is maturing from the 57th
p.000011: day after the moment of fertilising until the moment of birth, taking out of the computation those days
p.000011: in which the development could have been stopped.
p.000011: o. “Biological sample”: any biological material of human origin capable of conservation and
p.000011: that can hold information on the genetic endowment that is characteristic of a person.
p.000011: p. “Anonimised or irreversible disassociated biological sample”: sample which can not be associated to
p.000011: an identified or identifiable person as the nexus which had all the information that identifies the subject
p.000011: has been destroyed or because such association requires an unreasonable effort.
p.000011: q. “Non-identifiable or anonymous biological sample”: sample collected without a
p.000011: nexus with an identified or identifiable person which, as a result, its origin is unknown and is
p.000011: impossible to trace.
p.000011: r. “Codified or reversibly disassociated biological sample”: sample not associated to
p.000011: an identified or identifiable person as the information that identifies that person has been
p.000011: substituted or disassociated using a code that allows the reverse operation.
p.000011: s. “Pre-embryo”: embryo constituted in vitro that is formed by the group of cells that are the result
p.000011: of the progressive division of the
p.000011:
p.000011: ovocite from the time it is fertilised until 14 days after.
...
p.000017: 3. When, for whatever reason, the insurance policy doesn’t fully cover the caused damages, the promoter
p.000017: of the research, the researcher in charge and the hospital or centre in which it was carried out shall be joint
p.000017: and severally liable for them, even if there is no fault, thereby being responsible to bear the burden
p.000017: of proof. Neither the administrative authority nor the report of the Research Ethics Committee
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
p.000017:
p.000017: © Inter-University Chair in Law and the Human Genome
p.000018: 18
p.000018:
p.000018:
p.000018: undertaken if the following conditions are met:
p.000018: a) That the results of the research can produce real or direct benefits for his health.
p.000018: b) That a research of comparable efficacy can not be carried out in persons capable of providing their
...
p.000021: casings, and of the risks that may be derived from these interventions.
p.000021: c) That the expulsion, spontaneous or induced, of these embryos or foetuses has been made in
p.000021: the gestating woman and that it has not been possible to maintain its vital autonomy as provided in article 28.3
p.000021: 2. In the event that the persons from whom the embryos or foetuses come from are deceased, it is
p.000021: necessary that there is no record of their express opposition. If the deceased is a minor or
p.000021: disabled
p.000021:
p.000021: © Inter-University Chair in Law and the Human Genome
p.000022: 22
p.000022:
p.000022:
p.000022: person, then the donation shall take place unless there is a record of an express opposition by those that
p.000022: exercised, in the life of the former, their legal representation.
p.000022:
p.000022:
p.000022: CHAPTER II
p.000022: Conditions for biomedical research with human embryos and foetuses
p.000022:
p.000022: Article 30. Limitations on research with live embryos and foetuses in the uterus.
p.000022:
p.000022: Interventions on the live embryo or foetus in the uterus shall be exclusively authorised when
p.000022: their purpose is diagnostic or therapeutic in its own interest, notwithstanding what is legally established on
p.000022: the voluntary interruption of a pregnancy.
p.000022:
p.000022: Article 31. Requisites on the use.
p.000022:
p.000022: 1. Research on human embryos or foetuses or their biological structures must comply with
p.000022: the following requisites:
p.000022: a) That the embryos or foetuses fit within any of the situations established in section 1 of article 28
p.000022: of this Law.
p.000022: b) That the conditions provided in article 29 on the donation of the embryos and foetuses that are going
p.000022: to be used are taken into account.
p.000022: c) That a project is drafted on the expected use and that it has a favourable report by the Guarantees
p.000022: Commission for the Donation and use of Human Cells and Tissues.
p.000022: d) That the corresponding autonomous or State authority has provided an authorisation to its
p.000022: expected use.
p.000022: 2. The team responsible for the authorised project must
p.000022:
p.000022: communicate its result both to the entity that provided the authorisation to the submitted project, as well
p.000022: as to the Guarantees Commission for the Donation and use of Human Cells and Tissues.
p.000022:
p.000022:
p.000022:
...
Searching for indicator foetuses:
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p.000005: the research; next, the systems of evaluation and authorisation and of assurance of potential damages
p.000005: are established, which aim to reduce to the outmost the damages that could be derived from the research that
p.000005: entails invasive procedures in human beings; thirdly, there is a regulation of the
p.000005: specificities of research during a pregnancy and lactation, in the event of minors or disabled and
p.000005: the scenario of research with persons unable to provide their consent due to clinical reasons.
p.000005: The fourth chapter of this title regulates the safety and supervision systems in the process of research,
p.000005: with specific references to the evaluation of the state of health of the participants in research,
p.000005: the non- interference in the clinical intervention of these and the system of verifications
p.000005: that, under the supervision of the Research Ethics Committee, must be performed throughout the
p.000005: research. The last chapter of the title, finally, sets out the obligation to inform the
p.000005: participants in research about the relevant data for their health that could be obtained throughout it as
p.000005: well as the obligation to publicise their results.
p.000005: Title III, with its two chapters, compiles the regulation on the donation and use of human
p.000005: embryos and foetuses, of their cells, tissues or organs, with two main objectives. The first of these is to
p.000005: revise and update the legal regime that was in effect before the entry of this Law,
p.000005:
p.000005: specifically Law 42/1988, of 28 December, on the donation and use of human embryos or foetuses or their
p.000005: cells, tissues or organs; and secondly, to incorporate this matter to the global approach of this new
p.000005: Law, in order to eliminate unnecessary normative dispersions related with biomedical
p.000005: research. The repeal of Law 42/1988, of 28 December, that in its time was a noteworthy legislative novelty
p.000005: of our legal regulation and was a recognised as a reference in comparative law, is a
p.000005: consequence of this.
p.000005: The title is structured in two chapters. The first regulates the conditions for the donation of human
p.000005: embryos and foetuses, among which are the prohibitions that the interruption of a pregnancy can have as
p.000005: a final purpose a donation and that the professional members of a medical team that perform the
p.000005: interruption intervene in the use of the aborted embryos or foetuses, and establishes that for the donation to
p.000005: be valid there must be a concurrence of the informed consent of the donor and the expulsion in the
p.000005: gestating women of the embryos and foetuses without possibility of maintaining its vital autonomy. The
p.000005: second chapter imposes that the research with live embryos and foetuses in the uterus shall only
p.000005: be undertaken for a diagnostic or therapeutic purpose in its own interest and
p.000005: establishes the requisites for the authorisation of the research projects with embryos, foetuses and
p.000005: their biological structures.
p.000005: In Title IV, the regulation on the donation, use and research with human embryonic cells and tissues
p.000005: and other similar cells is done in full accordance to that provided in Law 14/2006 on Assisted Human
p.000005:
p.000005: © Inter-University Chair in Law and the Human Genome
p.000006: 6
p.000006:
p.000006: Reproduction Techniques which already regulates the donation of surplus ovocites and pre-embryos in
p.000006: vitro, the application of assisted reproduction techniques as well as the requisites on the use of
p.000006: these pre-embryos or their biological structures for research or experimentation.
p.000006: This is notwithstanding the compulsory favourable report which the Guarantees
p.000006: Commission for the Donation and Use of Human Cells and Tissues must issue and to the conditions,
p.000006: guarantees and requisites that are imposed to these effects in the first two chapters of Title IV.
p.000006: The first chapter of this title expressly prohibits the creation of human pre-embryos or embryos
p.000006: for experimentation and authorises the use of any technique for obtaining human stem cells for therapeutic or
p.000006: research purposes, including the activation of ovocites through nuclear transfer which doesn’t entail
p.000006: the creation of a pre-embryo or embryo in the terms defined in this Law. Chapter two regulates
...
p.000006: research, such as, the undertaking of genetic analysis, the access and use of its results, as well as
p.000006: the obtaining and use of human biological samples. In spite of the enormous difficulties to
p.000006: establish the limits between research and diagnosis in the ambit of genetic analysis, due to
p.000006: substantive and systematic coherence and in view of the important rights of persons which might be
p.000006: involved in these type of analysis, this Law could not renounce to establish a legal framework in which
p.000006: we must take a stance in the undertaking of genetic analysis for any purpose, including diagnostic.
p.000006: To this respect, the Law, at the same time that it prescribes a set of guarantees in relation with genetic
p.000006: analysis and biological samples within the ambit of the protection of data of a personal nature, it creates a
p.000006: set of norms in order to provide trust and safety to researches, and the public and private institutions
p.000006: in their acts within the sector, eliminating the current legal uncertainties.
p.000006: Besides other normative principles already mentioned, the guiding principles set are those of
p.000006: accessibility, equity and quality in the processing of data, it requires the previous consent and foresees
p.000006: the scenario of anonimised biological samples. Lastly, specific rules are established in relation with the deceased
p.000006: and with pre-embryos, embryos and foetuses, in respect to which the protection of data is also guaranteed and
p.000006: the duty of confidentiality is established. It is
p.000006:
p.000006: © Inter-University Chair in Law and the Human Genome
p.000007: 7
p.000007:
p.000007:
p.000007: also noteworthy, that the Law sets out the need to accredit the centres and persons capable to undertake
p.000007: genetic analysis.
p.000007: The regulation on the obtaining, conservation, use and assignment of biological samples is likewise
p.000007: object of a detailed regulation in chapter three of this title. As is logical, the legal
p.000007: framework turns once again on the consent of the subject source of the samples and on the previous
p.000007: information that must be provided to this respect. In so far as the disjunctive on the possibility to
p.000007: grant a completely generic or a specific consent on the use or latter uses of the sample, the Law has chosen
p.000007: an intermediate and flexible regulation, in that the initial consent may provide coverage, if
p.000007: in the information previously provided to the subject source there has been a provision about later
p.000007: researches related with the initial, including the researches that may be undertaken by third parties
p.000007: and the assignment of the data or of identified or identifiable samples to them. Anyways, a
p.000007: transitory regulation has been established in respect to biological samples obtained for any
...
p.000008: additional second, which revises and updates the regulation of the Institute of Health Carlos III as a basic
p.000008: instrument of the General Administration of the State for fostering biomedical research.
p.000008: The diverse provisions and regulations established in this Law offer an innovative normative set,
p.000008: which is complete and, to a great extent, capable of adapting to circumstances and situations
p.000008: to which biomedical research is foreseeable headed to in the coming years. It is a normative
p.000008: instrument that while at the same time it complies with its aim to guarantee the legal rights and
p.000008: goods involved in biomedical research, it also constitutes a decisive support for the development of
p.000008: public policies and private initiatives that must provide thrust to a biomedical research that is progressive and
p.000008: competitive in our scientific environment and in a clear legal framework that allows the efficiency and quality
p.000008: in research.
p.000008:
p.000008:
p.000008:
p.000008: TITLE I
p.000008: General Provisions Article 1. Object and Scope.
p.000008:
p.000008: © Inter-University Chair in Law and the Human Genome
p.000009: 9
p.000009:
p.000009:
p.000009: 1. The object of this Law, with full respect towards human dignity and identity and the inherent rights
p.000009: of a person, is the regulation of biomedical research, and in particular:
p.000009: a. Researches related with human health that imply invasive procedures.
p.000009: b. The donation and use of human ovocites, sperm, pre- embryos, embryos and foetuses or
p.000009: of their cells, tissues or organs for biomedical research purposes and its possible clinical applications.
p.000009: c. The handling of biological samples.
p.000009: d. The storage and movement of biological samples.
p.000009: e. Biobanks.
p.000009: f. The Spanish Committee on Bioethics and other entities with competence on biomedical research
p.000009: matters.
p.000009: g. The mechanisms for fostering and promotion, planning, evaluation and coordination of biomedical
p.000009: research.
p.000009: 2. Likewise and exclusively within the health ambit, this Law regulates the undertaking of genetic analysis
p.000009: and the processing of genetic data of a personal nature.
p.000009: 3. The biomedical research to which this Law makes reference to includes basic and clinical research,
p.000009: with the exception of clinical trials with medication and sanitary products, which shall be
p.000009: regulated by its specific regulation.
p.000009: a. The implantation of organs, tissues or cells of any origin shall be regulated by that established in Law
p.000009: 30/1979 of 27 October, on the Extraction and Transplantation of Organs and other applicable
p.000009: legislation, and are excluded from the scope of application of this Law.
p.000009:
p.000009: Article 2. Principles and guarantees of biomedical research.
p.000009:
p.000009: The undertaking of any activity of biomedical research within this Law shall be subject to compliance with
p.000009: the following guarantees:
p.000009: a. The protection of the dignity and identity of the human being shall be protected in relation
...
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
...
p.000019: 1. Besides that provided in article 18, necessary measures shall be taken in order to guarantee the
p.000019: safety of the research and to reduce the risks and discomforts for the individuals who participate.
p.000019: Medical decisions related with the health of the participating subjects in research belong to the doctor in
p.000019: charge of their assistance.
p.000019: 2. The researcher in charge of the project must accredit that the members who are part of
p.000019: the research team have the adequate qualification and experience in the ambit of the proposed research.
p.000019:
p.000019: Article 23. Evaluation of the state of health.
p.000019:
p.000019: 1. Those persons who are going to participate in the research have the duty to provide real data about their physical
p.000019: state or their health. In any case, the researcher shall take the necessary measures, which shall include,
p.000019: where appropriate, the consultation to the doctors responsible for the medical
p.000019: assistance of the participants, to
p.000019:
p.000019: verify such extremes before the beginning of the research, in order to assure that the persons for whom
p.000019: the research entails a special risk are excluded from it.
p.000019: 2. When research involves women in a fertile age, the possible adverse impact on an unknown existing
p.000019: pregnancy or a later one, as well as on the health of the embryos, foetuses or child shall be taken into
p.000019: account.
p.000019:
p.000019: Article 24. Non-interference with necessary clinical interventions.
p.000019:
p.000019: 1. Research must not delay or deprive the participants of the preventive, diagnostic or
p.000019: therapeutic medical procedures that are necessary for their state of health.
p.000019: 2. In research associated with the prevention, diagnosis or treatment of diseases, there must be
p.000019: an assurance that the participants who are assigned to the control groups receive proven procedures of
p.000019: prevention, diagnosis or treatment.
p.000019: The researcher must place on record the extremes which are referred to in the previous section in
p.000019: the protocol of the trial that she is going to submit for evaluation and authorisation.
p.000019: 3. A placebo may be used only if there are no methods of proven efficacy or when the withdrawal
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
p.000019: project is justified in light of new knowledge that is reached throughout its execution.
p.000019:
p.000019: © Inter-University Chair in Law and the Human Genome
p.000020: 20
p.000020:
p.000020:
p.000020: The main researchers must send to the Committee, without delay, any relevant information for the safety of the
...
p.000020: which provided its conformity to the research.
p.000020:
p.000020: CHAPTER V
p.000020: Management of Information Article 26. Duty to inform.
p.000020: According to that provided in article 4.5, if research would provide relevant information for the health of
p.000020: the participants, then this must be made available to them, which shall done within the framework of
p.000020: assistance that is underway, or for lack of, by providing a specific counselling.
p.000020:
p.000020: Article 27. Information on the results.
p.000020:
p.000020: 1. Once the research has concluded, the researcher in charge shall forward a summary of it to the
p.000020: corresponding authority that provided the authorisation and to the corresponding Research Ethics
p.000020: Committee.
p.000020: 2. The research results shall be communicated to the participants, always when these request so.
p.000020: 3. The researchers shall make public the general results of their research once these
p.000020: have concluded, taking into account the requirements related to data of a personal nature that are
p.000020: mentioned in article 5.5 of this Law and without detriment to the corresponding rights of intellectual and
p.000020: industrial property that could be derived from this research.
p.000020:
p.000020:
p.000020: TITLE III
p.000020:
p.000020: © Inter-University Chair in Law and the Human Genome
p.000021: 21
p.000021:
p.000021:
p.000021: On the donation and use of human embryos and foetuses, their cells, tissues or organs.
p.000021:
p.000021: CHAPTER I
p.000021: Donation of human embryos and foetuses
p.000021:
p.000021: Article 28. Donation of human embryos and foetuses.
p.000021:
p.000021: 1. Human embryos that have lost their capacity for biological development, as well as
p.000021: dead human embryos or foetuses, may be donated for biomedical research or other diagnostic,
p.000021: therapeutic, pharmacological, clinical or surgical purposes
p.000021: 2. The interruption of a pregnancy shall never have as its purpose the donation and later use of embryos,
p.000021: foetuses or their biological structures. The procedure and manner of the practice
p.000021: of the interruption of the pregnancy shall be only subject to the legal demands and limitations
p.000021: and the characteristics and circumstances that surround it.
p.000021: The professionals who are part of the medical team that undertakes the interruption of the pregnancy shall
p.000021: not intervene in the use of the aborted embryos, foetuses or their biological structures. To this effect, the
p.000021: members of the research team shall leave written record of this matter, as well as the absence of a
p.000021: conflict of interests with the medical team.
p.000021: 3. The foetuses that are prematurely and spontaneously expelled shall be clinically
p.000021: treated while they remain biologically viable with the sole purpose to favour their development and vital autonomy.
p.000021: 4. Before proceeding to any intervention on human embryos that have lost their capacity of biological
p.000021:
p.000021: development or on dead embryos or foetuses, a record shall be made by the corresponding medical
p.000021: personnel that such circumstances have taken place.
p.000021:
p.000021: Article 29. Requisites on donation.
p.000021:
p.000021: 1. Besides that established in the previous article, the donation of human embryos or foetuses or their
p.000021: biological structures for the purposes provided in this Law shall meet the following requisites:
p.000021: a) That the donor or donors of the embryos or foetuses have previously granted their express and
p.000021: written consent. If any of them is a non-emancipated minor or is disabled, then the consent of
p.000021: their legal representatives shall also be necessary.
p.000021: b) That the donor or donors or, where appropriate, their legal representatives, have been provided
p.000021: written information before the granting of their consent in relation to the purposes that
p.000021: might be achieved with the donation, its consequences, as well as the interventions
p.000021: that may be undertaken to extract embryologic or foetal cells or structures, from the placenta or
p.000021: casings, and of the risks that may be derived from these interventions.
p.000021: c) That the expulsion, spontaneous or induced, of these embryos or foetuses has been made in
p.000021: the gestating woman and that it has not been possible to maintain its vital autonomy as provided in article 28.3
p.000021: 2. In the event that the persons from whom the embryos or foetuses come from are deceased, it is
p.000021: necessary that there is no record of their express opposition. If the deceased is a minor or
p.000021: disabled
p.000021:
p.000021: © Inter-University Chair in Law and the Human Genome
p.000022: 22
p.000022:
p.000022:
p.000022: person, then the donation shall take place unless there is a record of an express opposition by those that
p.000022: exercised, in the life of the former, their legal representation.
p.000022:
p.000022:
p.000022: CHAPTER II
p.000022: Conditions for biomedical research with human embryos and foetuses
p.000022:
p.000022: Article 30. Limitations on research with live embryos and foetuses in the uterus.
p.000022:
p.000022: Interventions on the live embryo or foetus in the uterus shall be exclusively authorised when
p.000022: their purpose is diagnostic or therapeutic in its own interest, notwithstanding what is legally established on
p.000022: the voluntary interruption of a pregnancy.
p.000022:
p.000022: Article 31. Requisites on the use.
p.000022:
p.000022: 1. Research on human embryos or foetuses or their biological structures must comply with
p.000022: the following requisites:
p.000022: a) That the embryos or foetuses fit within any of the situations established in section 1 of article 28
p.000022: of this Law.
p.000022: b) That the conditions provided in article 29 on the donation of the embryos and foetuses that are going
p.000022: to be used are taken into account.
p.000022: c) That a project is drafted on the expected use and that it has a favourable report by the Guarantees
p.000022: Commission for the Donation and use of Human Cells and Tissues.
p.000022: d) That the corresponding autonomous or State authority has provided an authorisation to its
p.000022: expected use.
p.000022: 2. The team responsible for the authorised project must
p.000022:
p.000022: communicate its result both to the entity that provided the authorisation to the submitted project, as well
p.000022: as to the Guarantees Commission for the Donation and use of Human Cells and Tissues.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: TITLE IV
p.000022: On the obtaining and use of cells and tissues of human embryonic origin and other
p.000022: similar cells
p.000022:
p.000022: CHAPTER I
p.000022: On the use of ovocites and pre- embryos
p.000022:
p.000022: Article 32. Donation of ovocites and pre-embryos.
p.000022:
p.000022: 1. Research with ovocites and pre- embryos must have the consent of the persons from whom they come from,
p.000022: who can revoke it at any moment without affecting the research undertaken.
p.000022: 2. The donation of ovocites and pre-embryos shall be governed according to that provided in Law
p.000022: 14/2006, of 26 May, on Assisted Human Reproduction Techniques.
p.000022: In the case of ovocites, the consent of the donors shall make express reference to
...
p.000028: 2. In the health ambit, samples of deceased persons may be obtained and analysed always when it may be of
p.000028: interest for the protection of health, except when the deceased has expressly prohibited it during his life
p.000028: and can be proven. To this effect, the documents of previous instructions and, for lack of, the
p.000028:
p.000028: criteria of the closest family members of the deceased shall be consulted.
p.000028: The access by the biological family members to information derived from the genetic analysis of the
p.000028: deceased shall be limited to the genetic data relevant for the protection of their health.
p.000028: 3. In order to have access to a genetic screening, there must be an explicit and written consent of the
p.000028: person interested. The Research Ethics Committee shall determine the situations in which the consent
p.000028: may be expressed verbally. In any case, when the screening includes non-curable diseases or the benefits are
p.000028: scarce or uncertain, the consent shall always be written.
p.000028: 4. The undertaking of genetic analysis on in vivo pre-embryos or on embryos and foetuses in
p.000028: the uterus shall require the written consent of the gestating woman.
p.000028: The genetic analysis of an in vitro pre-embryo that has not been transferred shall be subject to that
p.000028: provided in the Law on Assisted Human Reproduction.
p.000028:
p.000028: Article 49. Right to Information and right not to know.
p.000028:
p.000028: 1. The subject source shall be informed on the genetic data of a personal nature that are obtained in
p.000028: the genetic analysis according to the terms in which he manifested his volition, notwithstanding the right to
p.000028: access that is established in the legislation on the protection of data of a personal nature, which
p.000028: could entail the revocation of the previously granted manifestation of free volition.
p.000028: 2. When the subject source has exercised his right not to know the results of a genetic analysis,
p.000028: then only that information that is
p.000028:
p.000028: © Inter-University Chair in Law and the Human Genome
p.000029: 29
p.000029:
p.000029:
p.000029: necessary for the follow up of a prescribed treatment by the doctor and that has been accepted by the
p.000029: patient shall be provided. When this information is necessary to avoid a serious damage for the health of his
p.000029: biological family, then the affected or their legally authorised representative may be
...
p.000029: these proceed.
p.000029: If the publishing of the results of a research is not possible without identifying the source subjects, then
p.000029: such results may only be published with their consent.
p.000029: 2. In case of genetic analysis to several members of a family, the results shall be filed
p.000029: and communicated to each of them in an individual manner. In case of disabled or minors, the
p.000029: information shall be provided to their tutors or legal representatives.
p.000029:
p.000029: Article 52. Conservation of data.
p.000029:
p.000029: 1. Personal genetic data shall be kept during a period of no less than five years from the date in which
p.000029: they were obtained, after which the interested party may solicit its cancellation.
p.000029: 2. If there is no request by the interested party, the data shall be kept during the time that
p.000029: may be necessary in order to preserve the health of the person from which it was obtained or of
p.000029: third parties related with him.
p.000029: 3. Outside these events, data shall only be kept, for research purposes, in an anonimised manner, without there
p.000029: being the possibility to identify the subject source.
p.000029:
p.000029: Article 53. Genetic analysis on pre-embryos, embryos or foetuses.
p.000029:
p.000029: The results of genetic analysis undertaken on embryonic or foetal material shall be subject to
p.000029: the principles of protection of data and
p.000029:
p.000029: © Inter-University Chair in Law and the Human Genome
p.000030: 30
p.000030:
p.000030:
p.000030: confidentiality provided in this Law. The same criteria shall be applicable in relation with any other
p.000030: biological samples that may contain genetic information of the person who provided his own biological
p.000030: material for the obtaining of such.
p.000030:
p.000030: Article 54. Genetic screening.
p.000030:
p.000030: 1. Genetic screenings are aimed at detecting a serious disease or health risk of the
p.000030: participating individual or in his descent, for the purpose of early treatment of a disease or to
p.000030: offer access to preventive measures.
p.000030: 2. The health authorities shall determine based on objective criteria, the relevance of the
p.000030: genetic screening in accordance with the diseases to be prevented or treated. Likewise, they shall
p.000030: ensure a universal and equitable access of the screening to the population for which it is
p.000030: indicated, for the organisation and planning of the program as well as the quality of the screening
p.000030: tests, diagnostic tests of a second level and the preventive and therapeutic services that are offered.
p.000030: 3. For the undertaking of the screening, the psycho-social aspects and its integration
...
p.000037: Law on Assisted Human Reproduction Techniques, Basic Law on the Autonomy of the Patient and
p.000037: of the Rights and Obligations in Matters of Clinical Documentation and on other regulations passed by the
p.000037: autonomous communities, in accordance with this Law, the following infractions shall be
p.000037: considered as minor serious and very serious:
p.000037: A) Minor infractions are:
p.000037: Those that entail the non- compliance of any obligation or the violation of any prohibition
p.000037: that is provided in this Law, always when in accordance with the criteria provided in this section they
p.000037: can’t be classified as serious or very serious infractions.
p.000037: B) Serious infractions are:
p.000037: a) Non-observance of the prescriptions, conditions, requisites or previous authorisations that
p.000037: are provided in this Law for the functioning of the registries provided in this Law.
p.000037:
p.000037: b) The omission of data, consents and references required by this Law.
p.000037: c) The non-providing of data to the appropriate health authority responsible for the functioning
p.000037: of registries provided in this Law.
p.000037: d) The breach of the conditions of confidentiality of the data of the donors established in this Law.
p.000037: e) The non-fulfilment of the gratuity of the donation of pre- embryos, embryos and foetuses
p.000037: in the terms provided in this Law.
p.000037: f) The non-fulfilment of the norms and guarantees established for the transfer between countries of cells
p.000037: and tissues of human embryonic origin.
p.000037: C) Very serious infractions are:
p.000037: a) The carrying on of any intervention aimed at the introduction of a modification
p.000037: in the genome of the descent.
p.000037: b) To continue with the development in vitro of the pre- embryos beyond the limit of 14
p.000037: days after the fertilisation of the ovocite, taking away from that time that which in which it may
p.000037: have been cryopreserved.
p.000037: c) To keep living embryos and foetuses outside the uterus for any purpose other than procreation.
p.000037: d) The extraction of cells or tissues from embryos or foetuses in development of the placenta or
p.000037: casings for purposes other than diagnostic or therapeutic in the interest of these, except in
p.000037: those cases provided in Law 14/2006, of
p.000037: 26 May, on Assisted Human Reproduction Techniques.
p.000037: e) Non-fulfilment of that provided in article 33.
p.000037: f) The production of interspecific hybrids that use human genetic material, except that provided in the
p.000037: law on Assisted Human Reproduction Techniques.
p.000037:
p.000037: © Inter-University Chair in Law and the Human Genome
p.000038: 38
p.000038:
p.000038:
p.000038: g) The non-observance of the previous prescriptions, conditions, requisites or authorisations that
p.000038: are established in this Law for the obtaining and use of cells and tissues of human embryonic
p.000038: origin or other that is functionally similar.
p.000038:
p.000038: Article 75. Sanctions.
p.000038:
p.000038: 1. Minor infractions, as provided in this Law, shall be sanctioned with a fine of up to 600 euros, serious with a
p.000038: fine from 601 euros up to 10.000 euros, and the very serious from
p.000038: 10.001 up to 1.000.000 euros.
p.000038: 2. The amount of the sanction that is imposed, within the limits provided, shall be established
p.000038: taking into account the risk created, the social repercussion of the infraction, the benefit that has been
p.000038: provided to the offender of the sanctioned behaviour and the previous commission of
p.000038: one or more infractions against this Law.
...
p.000046: when it is not possible due to the death of the subject source or when they can not
p.000046:
p.000046: be found. These cases shall require the favourable ruling of the appropriate Research
p.000046: Ethics Committee, which must take into account, at least, the following requisites:
p.000046: a) That it is a research of general interest.
p.000046: b) That the research is less effective or not possible without the identifying data of the
p.000046: subject source.
p.000046: c) That there is no express objection by the subject source.
p.000046: d) That the confidentiality of the data of a personal nature is guaranteed.
p.000046:
p.000046: Third Transitory Disposition. Clinical Research Ethics Committees.
p.000046:
p.000046: Clinical Research Ethics Committees shall cease to exist from the moment in which
p.000046: the Research Ethics Committees are established. Until these Committees are established, the
p.000046: Clinical Research Ethics Committees that are working in the centres which undertake biomedical research
p.000046: shall be able to assume the competences of these.
p.000046:
p.000046: Sole Derogatory Disposition.
p.000046: Regulatory Derogation.
p.000046:
p.000046: Law 42/1988 of 28 December on the Donation and Use of Human Embryos and Foetuses or their Cells,
p.000046: Tissues or Organs and whichever dispositions, whichever their rank which are contrary to that established
p.000046: in this Law are derogated. Likewise, the following are derogated: Sections 5 and 6 of article
p.000046: 45, and articles 46, 47 and 50 of Law 16/2003 of 28 May on the Cohesion and Quality of the
p.000046: National Health System; Title VII
p.000046:
p.000046: © Inter-University Chair in Law and the Human Genome
p.000047: 47
p.000047:
p.000047:
p.000047: and Chapters II and III of title VI of Law 14/1986 of 25 April of the National Health Law;
p.000047: Additional Second Disposition of Law 14/2006 of 26 May, on Assisted Human Reproduction Techniques;
p.000047: and articles 10 and 11 of the Statute of the National Centre for Transplantation and
p.000047: Regenerative Medicine, approved by Royal Decree 176/2004 of 30 January.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: First Final Disposition.
p.000047: Competency Title.
p.000047:
p.000047: This Law is based on article
p.000047: 149.1.15 and 16 of the Spanish Constitution, which attributes to the State the exclusive competency
p.000047: in matters of promotion and general coordination of scientific and technical research and in matters of
p.000047: basis and general coordination of health matters.
p.000047: The State and the autonomous communities shall adopt, within the ambit of their
p.000047: respective competencies, those measures necessary to guarantee the effectiveness of this Law.
p.000047:
p.000047: Second Final Disposition.
p.000047: Suppletory Application.
p.000047:
...
Social / Occupation
Searching for indicator job:
(return to top)
p.000042: 53/1984, of 26 December, of Incompatibilities of the personnel at the service of the
p.000042: Public Administrations.
p.000042:
p.000042: Article 86. Mobility of Research Personnel.
p.000042:
p.000042: 1. The mobility and exchange of health researchers in the different centres within the
p.000042: national
p.000042:
p.000042: © Inter-University Chair in Law and the Human Genome
p.000043: 43
p.000043:
p.000043:
p.000043: framework, the European space of research and of the reciprocal cooperation agreements with other
p.000043: States shall be promoted.
p.000043: The civil servants who belong to research entities or registries may be authorised to undertake works
p.000043: related with scientific and technical research outside the organic ambit to which they are appointed, through
p.000043: mobility mechanisms established in the regulation of public functions.
p.000043: 2. Always when an enterprise of a technological basis is created through patents or results
p.000043: generated by research projects which are fully or partially financed with public funds and undertaken in
p.000043: research centres, the civil servants or statutory personnel who justify their participation in
p.000043: the mentioned project shall be able to solicit authorisation to join that enterprise, through a
p.000043: temporary leave of absence.
p.000043: The Government shall regulate the conditions and the procedures for the granting of this leave that, in
p.000043: every case, shall only be for a maximum time limit of five years. During this period, the person
p.000043: on leave shall have the right to have their job post reserved and to their computation for seniority
p.000043: purposes. If prior to the last month of the end of the period for which the leave has been granted to the civil
p.000043: servant or statutory personnel, he or she would not solicit the return to active service, then he or
p.000043: she shall be officially declared on its own motion in voluntary leave for private purposes.
p.000043:
p.000043: Article 87. Temporary appointment of specialists.
p.000043:
p.000043: The Ministry of Health and Consumption, after the authorisation by the corresponding entity, shall be
p.000043:
p.000043: able to temporarily appoint, full or part time, scientific personnel, experts in clinical
p.000043: research and technological development, who provide services in ministry departments,
p.000043: autonomous communities, universities, public centres of research and public entities. This
p.000043: appointment shall be drafted in accordance with the regulations of the legal system of the civil
p.000043: servants or labour personnel which is applicable, in each case.
p.000043: The part time appointment of the previously mentioned personnel shall be compatible with that
p.000043: undertaken, likewise in a part time manner, in the job post that they hold. They shall also be able to
p.000043: contract, for a time that is not greater to the duration of the Sectorial Initiative
p.000043: on Health Research, any type of personnel not appointed to the public sector, in accordance with that
p.000043: established in article 15.1, subsection a, of the Worker’s Statute and in conformance
p.000043: with that provided in the corresponding Offers for Public Job Posts.
p.000043:
p.000043: Article 88. Research Institutes and Networks.
p.000043:
p.000043: The National Health System shall collaborate with other institutions and organisations involved
p.000043: in research for the joint use of scientific infrastructures and the development of research projects. To this
p.000043: effect, the creation of institutes of biomedical research within the centres of the
p.000043: National Health System shall be promoted through the association of research groups. To the effects of
p.000043: participation in the convocations of the Ministry of Health and Consumption, the research
p.000043: capacity of these institutes
p.000043:
p.000043: © Inter-University Chair in Law and the Human Genome
p.000044: 44
p.000044:
p.000044:
p.000044: may be certified by the Ministry of Health and Consumption, as proposed by the Institute of
p.000044: Health Carlos III or by the autonomous communities through the procedure that is established by
p.000044: regulation.
p.000044: In accordance with that provided in article 42.2 of Law 30/1992, of 26 November, of the Legal Regime of
p.000044: Public Administrations and the Common Administrative Procedure, the term for the resolution and
p.000044: notification in the process of certification to which this article makes reference to shall
p.000044: be of twelve months.
p.000044:
p.000044: Article 89. Cooperation among the public and private sectors.
p.000044:
p.000044: 1. In order to increase the involvement of the private sector in the Biomedical and Health
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000020: 6. The researcher in charge shall report the reasons for the early
p.000020:
p.000020: termination of any research project to the Research Ethics Committee and to the corresponding authority
p.000020: which provided its conformity to the research.
p.000020:
p.000020: CHAPTER V
p.000020: Management of Information Article 26. Duty to inform.
p.000020: According to that provided in article 4.5, if research would provide relevant information for the health of
p.000020: the participants, then this must be made available to them, which shall done within the framework of
p.000020: assistance that is underway, or for lack of, by providing a specific counselling.
p.000020:
p.000020: Article 27. Information on the results.
p.000020:
p.000020: 1. Once the research has concluded, the researcher in charge shall forward a summary of it to the
p.000020: corresponding authority that provided the authorisation and to the corresponding Research Ethics
p.000020: Committee.
p.000020: 2. The research results shall be communicated to the participants, always when these request so.
p.000020: 3. The researchers shall make public the general results of their research once these
p.000020: have concluded, taking into account the requirements related to data of a personal nature that are
p.000020: mentioned in article 5.5 of this Law and without detriment to the corresponding rights of intellectual and
p.000020: industrial property that could be derived from this research.
p.000020:
p.000020:
p.000020: TITLE III
p.000020:
p.000020: © Inter-University Chair in Law and the Human Genome
p.000021: 21
p.000021:
p.000021:
p.000021: On the donation and use of human embryos and foetuses, their cells, tissues or organs.
p.000021:
p.000021: CHAPTER I
p.000021: Donation of human embryos and foetuses
p.000021:
p.000021: Article 28. Donation of human embryos and foetuses.
p.000021:
p.000021: 1. Human embryos that have lost their capacity for biological development, as well as
p.000021: dead human embryos or foetuses, may be donated for biomedical research or other diagnostic,
p.000021: therapeutic, pharmacological, clinical or surgical purposes
p.000021: 2. The interruption of a pregnancy shall never have as its purpose the donation and later use of embryos,
p.000021: foetuses or their biological structures. The procedure and manner of the practice
p.000021: of the interruption of the pregnancy shall be only subject to the legal demands and limitations
p.000021: and the characteristics and circumstances that surround it.
p.000021: The professionals who are part of the medical team that undertakes the interruption of the pregnancy shall
p.000021: not intervene in the use of the aborted embryos, foetuses or their biological structures. To this effect, the
...
Social / Women
Searching for indicator women:
(return to top)
p.000005: embryos and foetuses, of their cells, tissues or organs, with two main objectives. The first of these is to
p.000005: revise and update the legal regime that was in effect before the entry of this Law,
p.000005:
p.000005: specifically Law 42/1988, of 28 December, on the donation and use of human embryos or foetuses or their
p.000005: cells, tissues or organs; and secondly, to incorporate this matter to the global approach of this new
p.000005: Law, in order to eliminate unnecessary normative dispersions related with biomedical
p.000005: research. The repeal of Law 42/1988, of 28 December, that in its time was a noteworthy legislative novelty
p.000005: of our legal regulation and was a recognised as a reference in comparative law, is a
p.000005: consequence of this.
p.000005: The title is structured in two chapters. The first regulates the conditions for the donation of human
p.000005: embryos and foetuses, among which are the prohibitions that the interruption of a pregnancy can have as
p.000005: a final purpose a donation and that the professional members of a medical team that perform the
p.000005: interruption intervene in the use of the aborted embryos or foetuses, and establishes that for the donation to
p.000005: be valid there must be a concurrence of the informed consent of the donor and the expulsion in the
p.000005: gestating women of the embryos and foetuses without possibility of maintaining its vital autonomy. The
p.000005: second chapter imposes that the research with live embryos and foetuses in the uterus shall only
p.000005: be undertaken for a diagnostic or therapeutic purpose in its own interest and
p.000005: establishes the requisites for the authorisation of the research projects with embryos, foetuses and
p.000005: their biological structures.
p.000005: In Title IV, the regulation on the donation, use and research with human embryonic cells and tissues
p.000005: and other similar cells is done in full accordance to that provided in Law 14/2006 on Assisted Human
p.000005:
p.000005: © Inter-University Chair in Law and the Human Genome
p.000006: 6
p.000006:
p.000006: Reproduction Techniques which already regulates the donation of surplus ovocites and pre-embryos in
p.000006: vitro, the application of assisted reproduction techniques as well as the requisites on the use of
p.000006: these pre-embryos or their biological structures for research or experimentation.
p.000006: This is notwithstanding the compulsory favourable report which the Guarantees
p.000006: Commission for the Donation and Use of Human Cells and Tissues must issue and to the conditions,
p.000006: guarantees and requisites that are imposed to these effects in the first two chapters of Title IV.
...
p.000017: of proof. Neither the administrative authority nor the report of the Research Ethics Committee
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
p.000017:
p.000017: © Inter-University Chair in Law and the Human Genome
p.000018: 18
p.000018:
p.000018:
...
p.000019: this Law. Likewise, the consent to continue participating in the research must be obtained
p.000019: when the patient is in a condition to provide it.
p.000019:
p.000019: CHAPTER IV
p.000019: Safety and Supervision Article 22. Risk Prevention.
p.000019: 1. Besides that provided in article 18, necessary measures shall be taken in order to guarantee the
p.000019: safety of the research and to reduce the risks and discomforts for the individuals who participate.
p.000019: Medical decisions related with the health of the participating subjects in research belong to the doctor in
p.000019: charge of their assistance.
p.000019: 2. The researcher in charge of the project must accredit that the members who are part of
p.000019: the research team have the adequate qualification and experience in the ambit of the proposed research.
p.000019:
p.000019: Article 23. Evaluation of the state of health.
p.000019:
p.000019: 1. Those persons who are going to participate in the research have the duty to provide real data about their physical
p.000019: state or their health. In any case, the researcher shall take the necessary measures, which shall include,
p.000019: where appropriate, the consultation to the doctors responsible for the medical
p.000019: assistance of the participants, to
p.000019:
p.000019: verify such extremes before the beginning of the research, in order to assure that the persons for whom
p.000019: the research entails a special risk are excluded from it.
p.000019: 2. When research involves women in a fertile age, the possible adverse impact on an unknown existing
p.000019: pregnancy or a later one, as well as on the health of the embryos, foetuses or child shall be taken into
p.000019: account.
p.000019:
p.000019: Article 24. Non-interference with necessary clinical interventions.
p.000019:
p.000019: 1. Research must not delay or deprive the participants of the preventive, diagnostic or
p.000019: therapeutic medical procedures that are necessary for their state of health.
p.000019: 2. In research associated with the prevention, diagnosis or treatment of diseases, there must be
p.000019: an assurance that the participants who are assigned to the control groups receive proven procedures of
p.000019: prevention, diagnosis or treatment.
p.000019: The researcher must place on record the extremes which are referred to in the previous section in
p.000019: the protocol of the trial that she is going to submit for evaluation and authorisation.
p.000019: 3. A placebo may be used only if there are no methods of proven efficacy or when the withdrawal
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000011: p. “Anonimised or irreversible disassociated biological sample”: sample which can not be associated to
p.000011: an identified or identifiable person as the nexus which had all the information that identifies the subject
p.000011: has been destroyed or because such association requires an unreasonable effort.
p.000011: q. “Non-identifiable or anonymous biological sample”: sample collected without a
p.000011: nexus with an identified or identifiable person which, as a result, its origin is unknown and is
p.000011: impossible to trace.
p.000011: r. “Codified or reversibly disassociated biological sample”: sample not associated to
p.000011: an identified or identifiable person as the information that identifies that person has been
p.000011: substituted or disassociated using a code that allows the reverse operation.
p.000011: s. “Pre-embryo”: embryo constituted in vitro that is formed by the group of cells that are the result
p.000011: of the progressive division of the
p.000011:
p.000011: ovocite from the time it is fertilised until 14 days after.
p.000011: t. “Invasive procedure”: any intervention undertaken for research purposes that involves a physical or
p.000011: psychic risk for the affected subject
p.000011: u. “Minimum risk and burden”: health impacts and discomforts that could be borne by the participating
p.000011: subject in a research and whose effects can only be of a minor and temporary nature.
p.000011: v. “Source subject”: living being, no matter his or her state of health, or deceased from whom the
p.000011: biological sample is obtained.
p.000011: w. “Processing of genetic data of a personal nature or of biological samples”: operations and
p.000011: procedures that allow the collection, storage, use and conveyance of genetic data of a personal nature or
p.000011: biological samples.
p.000011: x. “Traceability”: capacity to associate a specific biological material with registered
p.000011: information that makes reference to any step in the chain of its collection as well as through all the process of
p.000011: research.
p.000011:
p.000011: Article 4. Informed consent and the right to information.
p.000011:
p.000011: 1. The free will of persons that may participate in biomedical research or that could provide their
p.000011: biological samples shall be respected. Their previous express and written consent must be provided once
p.000011: the adequate information has been provided.
p.000011: The information provided shall be written and shall encompass the nature, importance, implications and
p.000011: risks of the research in the terms provided for in this Law.
p.000011: People with disabilities shall be provided this information in accessible manners and
p.000011: formats that are appropriate to their needs.
p.000011:
p.000011: © Inter-University Chair in Law and the Human Genome
p.000012: 12
p.000012:
p.000012:
p.000012: If the subject of research is unable to write, the consent may be granted through any means admitted by law that allows
p.000012: the stating of a record of his or her will.
p.000012: 2. When a person is legally disabled or is a minor, their consent shall be granted
p.000012: through representation, provided that there are no other alternatives to the research.
p.000012: The conveyance of the consent through representation shall be proportionate to the research to be
p.000012: undertaken and shall be done in accordance with the respect of the dignity of a person and for
p.000012: the benefit of their health.
p.000012: The disabled and minors shall participate, in so far as it is possible and in accordance to their age and
p.000012: capacities, in the decision making process throughout the research.
p.000012: 3. Those persons who participate in biomedical research shall be able to revoke their consent at any moment,
p.000012: notwithstanding the limitations provided in this Law. Those persons or entities that
p.000012: have received this consent shall have available those measures that are necessary for the effective
p.000012: exercise of this right.
p.000012: 4. The lack of consent or the revocation of consent that has been previously granted shall not entail
p.000012: any damages in the health care assistance of the subject.
p.000012: 5. Every person has the right to be informed of his or her genetic data and other data of a personal nature
...
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
p.000017:
p.000017: © Inter-University Chair in Law and the Human Genome
p.000018: 18
p.000018:
p.000018:
p.000018: undertaken if the following conditions are met:
p.000018: a) That the results of the research can produce real or direct benefits for his health.
p.000018: b) That a research of comparable efficacy can not be carried out in persons capable of providing their
p.000018: consent.
p.000018: c) That the person who is going to participate in the research has been provided written information about his
p.000018: rights and the limits provided in this Law and in the regulation that further develops it for his
p.000018: protection, unless that person is not in a state to receive that information.
p.000018: d) That the legal representatives of the person who is going to participate in the research have
p.000018: provided their written consent, after having received the information established in article 15. The
p.000018: legal representative shall take into account the desires and objections that are previously expressed
p.000018: by the affected person. Additionally, in these cases, actions must be accordance with that
...
p.000021: not intervene in the use of the aborted embryos, foetuses or their biological structures. To this effect, the
p.000021: members of the research team shall leave written record of this matter, as well as the absence of a
p.000021: conflict of interests with the medical team.
p.000021: 3. The foetuses that are prematurely and spontaneously expelled shall be clinically
p.000021: treated while they remain biologically viable with the sole purpose to favour their development and vital autonomy.
p.000021: 4. Before proceeding to any intervention on human embryos that have lost their capacity of biological
p.000021:
p.000021: development or on dead embryos or foetuses, a record shall be made by the corresponding medical
p.000021: personnel that such circumstances have taken place.
p.000021:
p.000021: Article 29. Requisites on donation.
p.000021:
p.000021: 1. Besides that established in the previous article, the donation of human embryos or foetuses or their
p.000021: biological structures for the purposes provided in this Law shall meet the following requisites:
p.000021: a) That the donor or donors of the embryos or foetuses have previously granted their express and
p.000021: written consent. If any of them is a non-emancipated minor or is disabled, then the consent of
p.000021: their legal representatives shall also be necessary.
p.000021: b) That the donor or donors or, where appropriate, their legal representatives, have been provided
p.000021: written information before the granting of their consent in relation to the purposes that
p.000021: might be achieved with the donation, its consequences, as well as the interventions
p.000021: that may be undertaken to extract embryologic or foetal cells or structures, from the placenta or
p.000021: casings, and of the risks that may be derived from these interventions.
p.000021: c) That the expulsion, spontaneous or induced, of these embryos or foetuses has been made in
p.000021: the gestating woman and that it has not been possible to maintain its vital autonomy as provided in article 28.3
p.000021: 2. In the event that the persons from whom the embryos or foetuses come from are deceased, it is
p.000021: necessary that there is no record of their express opposition. If the deceased is a minor or
p.000021: disabled
p.000021:
p.000021: © Inter-University Chair in Law and the Human Genome
p.000022: 22
p.000022:
p.000022:
p.000022: person, then the donation shall take place unless there is a record of an express opposition by those that
p.000022: exercised, in the life of the former, their legal representation.
p.000022:
p.000022:
p.000022: CHAPTER II
p.000022: Conditions for biomedical research with human embryos and foetuses
p.000022:
p.000022: Article 30. Limitations on research with live embryos and foetuses in the uterus.
p.000022:
p.000022: Interventions on the live embryo or foetus in the uterus shall be exclusively authorised when
p.000022: their purpose is diagnostic or therapeutic in its own interest, notwithstanding what is legally established on
p.000022: the voluntary interruption of a pregnancy.
p.000022:
p.000022: Article 31. Requisites on the use.
p.000022:
p.000022: 1. Research on human embryos or foetuses or their biological structures must comply with
p.000022: the following requisites:
p.000022: a) That the embryos or foetuses fit within any of the situations established in section 1 of article 28
p.000022: of this Law.
p.000022: b) That the conditions provided in article 29 on the donation of the embryos and foetuses that are going
p.000022: to be used are taken into account.
...
p.000031: subject source.
p.000031: d) That there is no record of an express objection of the subject source.
p.000031: e) That personal data is guaranteed confidentiality.
p.000031: 3. Notwithstanding that provided in article 7, an economic compensation may be established for the
p.000031: physical discomforts, expenses and other inconveniences that may be derived from the taking of the
p.000031: sample.
p.000031: 4. For health reasons, the subject source or his family may use the samples when in need, always that these are
p.000031: available and are not anonimised.
p.000031: 5. The obtaining of biological samples from minors or the disabled for biomedical research shall be
p.000031: subject to the following conditions:
p.000031: a) That the necessary measures are adopted in order to guarantee that the risk of the intervention is minimal
p.000031: for the subject source.
p.000031: b) That relevant knowledge on a disease or on the situation that is object of research and which are of vital
p.000031: importance to understand, palliate or heal it may be obtained from the research.
p.000031:
p.000031: © Inter-University Chair in Law and the Human Genome
p.000032: 32
p.000032: c) That this knowledge may not beappropriate, shall in turn entail the
p.000032: obtained in another manner. compliance with the requirements
p.000032: d) That the authorisation is obtained fromprovided in this Law. In case that the legal representatives of the
p.000032: minor or thethese extremes are not known at disabled person or that, where appropriatet,hat moment, the
p.000032: compromise to there are guarantees on the correct consenitnform about it as soon as is known
p.000032: of the subject source. shall be established.
p.000032: 6. Studies of genetic diversity shall g) Right to know genetic data that
p.000032: always respect the local and ethnicis obtained from the analysis of traditions, always
p.000032: avoiding practices odf onated samples.
p.000032:
p.000032: stigmatisation and discrimination.
p.000032:
p.000032: Article 59. Information prior to the use of a biological sample.
p.000032:
p.000032: 1. Notwithstanding that provided in the legislation on the protection of data of a personal nature,
p.000032: and particularly, in article 45 of this Law, before providing the consent for the use of a biological sample
p.000032: for biomedical research that is not going to be subject to an anonimisation process, the
p.000032: subject source shall receive the following written information:
p.000032: a) Purpose of the research or the line of research for which he is providing the consent.
p.000032: b) Expected benefits.
p.000032: c) Possible inconveniences linked to the donation and obtaining of the sample, including the possibility of being
p.000032: contacted at a later time in order to collect new data or obtain other samples.
p.000032: d) Identity of the person responsible for the research.
...
p.000036: Personal Nature.
p.000036: 3. When, in the opinion of by the Administration, the infraction could be an offence or misdemeanour, the
p.000036: administrative entity shall pass it on to the Prosecutor’s Office,
p.000036:
p.000036: abstaining form continuing with the sanctioning procedure until the judicial authority has made
p.000036: a pronouncement.
p.000036: The criminal sanction shall exclude the imposition of an administrative sanction always when it
p.000036: is imposed for the same acts and in relation to the same protected public interests, though all other
p.000036: responsibilities that can be deduced from other acts or infractions that concur must be enforced.
p.000036: If the decision is that there hasn’t been an offence or misdemeanour, then the administration
p.000036: shall continue with its sanctioning proceeding, taking as its basis, where appropriate, those
p.000036: facts that the courts have considered as proven.
p.000036: 4. The administrative measures that would have been adopted in order to safe keep the right to the
p.000036: protection of health and safety of the people shall be kept as long as the judicial authority doesn’t make a
p.000036: pronouncement on such.
p.000036: 5. Very serious offences shall prescribe after three years, serious, after two and minor after six months.
p.000036: The sanctions imposed for very serious offences shall prescribe after three years, those for
p.000036: serious offences after two and those for minor offences after a year.
p.000036:
p.000036: Article 73. Responsibilities.
p.000036:
p.000036: 1. The author shall be responsible for the different infractions.
p.000036: 2. When in accordance with the obligations provided in this Law, the compliance of the
p.000036: obligations corresponds to several persons jointly, then they shall be held joint and severally liable
p.000036: in accordance with that provide in article 130.3 of Law 30/1992, of 26 November, of the Legal Regulation
p.000036: of the Public
p.000036:
p.000036: © Inter-University Chair in Law and the Human Genome
p.000037: 37
p.000037:
p.000037:
p.000037: Administrations and the Common Administrative Procedure. The same norm shall be applicable to the
p.000037: directors of the centres or services for the non-compliance with the aforementioned obligations by the
p.000037: biomedical professionals who are under their responsibility.
p.000037:
p.000037: Article 74. Infractions.
p.000037:
p.000037: 1. Infractions shall be classified as minor, serious or very serious in accordance with the harmfulness of
p.000037: the act, the quantity of the eventual benefit obtained, the health and social alteration produced and its
p.000037: degree of intent.
p.000037: 2. Besides that provided in the General Health Law, the Law on the Protection of Personal Data, the
p.000037: Law on Assisted Human Reproduction Techniques, Basic Law on the Autonomy of the Patient and
p.000037: of the Rights and Obligations in Matters of Clinical Documentation and on other regulations passed by the
p.000037: autonomous communities, in accordance with this Law, the following infractions shall be
p.000037: considered as minor serious and very serious:
p.000037: A) Minor infractions are:
p.000037: Those that entail the non- compliance of any obligation or the violation of any prohibition
p.000037: that is provided in this Law, always when in accordance with the criteria provided in this section they
p.000037: can’t be classified as serious or very serious infractions.
p.000037: B) Serious infractions are:
p.000037: a) Non-observance of the prescriptions, conditions, requisites or previous authorisations that
p.000037: are provided in this Law for the functioning of the registries provided in this Law.
p.000037:
p.000037: b) The omission of data, consents and references required by this Law.
p.000037: c) The non-providing of data to the appropriate health authority responsible for the functioning
p.000037: of registries provided in this Law.
p.000037: d) The breach of the conditions of confidentiality of the data of the donors established in this Law.
p.000037: e) The non-fulfilment of the gratuity of the donation of pre- embryos, embryos and foetuses
p.000037: in the terms provided in this Law.
p.000037: f) The non-fulfilment of the norms and guarantees established for the transfer between countries of cells
p.000037: and tissues of human embryonic origin.
p.000037: C) Very serious infractions are:
p.000037: a) The carrying on of any intervention aimed at the introduction of a modification
p.000037: in the genome of the descent.
p.000037: b) To continue with the development in vitro of the pre- embryos beyond the limit of 14
p.000037: days after the fertilisation of the ovocite, taking away from that time that which in which it may
p.000037: have been cryopreserved.
p.000037: c) To keep living embryos and foetuses outside the uterus for any purpose other than procreation.
p.000037: d) The extraction of cells or tissues from embryos or foetuses in development of the placenta or
p.000037: casings for purposes other than diagnostic or therapeutic in the interest of these, except in
p.000037: those cases provided in Law 14/2006, of
p.000037: 26 May, on Assisted Human Reproduction Techniques.
p.000037: e) Non-fulfilment of that provided in article 33.
p.000037: f) The production of interspecific hybrids that use human genetic material, except that provided in the
p.000037: law on Assisted Human Reproduction Techniques.
p.000037:
p.000037: © Inter-University Chair in Law and the Human Genome
p.000038: 38
p.000038:
p.000038:
p.000038: g) The non-observance of the previous prescriptions, conditions, requisites or authorisations that
p.000038: are established in this Law for the obtaining and use of cells and tissues of human embryonic
p.000038: origin or other that is functionally similar.
p.000038:
p.000038: Article 75. Sanctions.
p.000038:
p.000038: 1. Minor infractions, as provided in this Law, shall be sanctioned with a fine of up to 600 euros, serious with a
p.000038: fine from 601 euros up to 10.000 euros, and the very serious from
p.000038: 10.001 up to 1.000.000 euros.
p.000038: 2. The amount of the sanction that is imposed, within the limits provided, shall be established
p.000038: taking into account the risk created, the social repercussion of the infraction, the benefit that has been
p.000038: provided to the offender of the sanctioned behaviour and the previous commission of
p.000038: one or more infractions against this Law.
p.000038: 3. In every case, when the amount of the fine is less than the benefit obtained due to the commission of
p.000038: the infraction, the sanction shall be increased up to double the amount in which the offender has
p.000038: been benefited.
p.000038: 4. If one act can be grounds for two or more classified infractions in this or other Laws, then only that which has
p.000038: the greatest sanction shall be taken into account.
p.000038: 5. The amounts of the fines shall be periodically revised and updated by the Government, taking into account the
p.000038: variation of the consumer price indexes.
p.000038: 6. Notwithstanding the sanctions provided in this article, the serious or very serious infractions
p.000038: shall entail the revocation of the authorisation granted for that research or activity.
p.000038:
p.000038: Likewise, in especially serious cases, the exclusion of the authorisation of any of the
p.000038: activities regulated in this Law may be accorded for a period of one to five years. For the
...
Social / education
Searching for indicator education:
(return to top)
p.000025: of embryonic material. In case of research project with embryonic stem cell lines from non-EU
p.000025: member countries, the Commission shall only issue its report when the project incorporates the documentation
p.000025: that accredits the origin, procedures and guarantees in the obtaining and treatment of stem cell lines and the
p.000025: regulation of the country of origin on this matter.
p.000025: 2. The Commission shall issue its compulsory report on the research projects that have been submitted
p.000025: within a maximum time period of three months.
p.000025:
p.000025: Article 39. Composition of the Commission.
p.000025:
p.000025: 1. The Commission shall be made up of twelve members. All shall be specialists of well-known prestige in
p.000025: research on cell therapy or regenerative medicine, in bioethics and law related to
p.000025: bioethical matters.
p.000025: 2. The members of the Commission shall act at all times with criteria of independence and impartiality.
p.000025: 3. The members shall be named by the Minister of Health and Consumption for three year terms,
p.000025: with the following distribution:
p.000025:
p.000025: a) Six representatives designated by the Inter-territory Council of the National
p.000025: Health System as proposed by the autonomous communities.
p.000025: b) Six representatives of the General Administration of the State, two by the Ministry of Health and
p.000025: Consumption, two by the Ministry of Justice and two by the Ministry of Education and Science.
p.000025: 4. The President of the Commission shall be named by the Minister of Health and Consumption from
p.000025: among its members.
p.000025: 5. The Secretary of the Commission shall be a civil servant with the rank of vice-director
p.000025: general who belongs to the Institute of Health Carlos III, who will have a say but no vote.
p.000025: 6. The members of the Commission shall have access to the detailed information on the research project on
p.000025: cells and tissues that are referred to in this title, on the National Registry of Activity and
p.000025: Results of the Assisted Reproduction Centres and Services which are referred to in Law 14/2006, of 26
p.000025: May, on Assisted Human Reproduction Techniques and on the National Registry of Cell Lines.
p.000025:
p.000025: CHAPTER IV
p.000025: On the promotion and coordination of research with human embryonic cells and tissues
p.000025:
p.000025: Article 40. Promotion and coordination.
p.000025:
p.000025: 1. The promotion and coordination of research with embryonic biological samples shall be
p.000025: the responsibility of the Ministry of Health and Consumption, through the Institute of Health
p.000025: Carlos III, notwithstanding the powers that may
p.000025:
p.000025: © Inter-University Chair in Law and the Human Genome
p.000026: 26
p.000026:
p.000026:
p.000026: correspond to the autonomous communities.
p.000026: 2. The corresponding authority, via the Institute of Health Carlos III, through the procedure that
...
p.000028: could entail the revocation of the previously granted manifestation of free volition.
p.000028: 2. When the subject source has exercised his right not to know the results of a genetic analysis,
p.000028: then only that information that is
p.000028:
p.000028: © Inter-University Chair in Law and the Human Genome
p.000029: 29
p.000029:
p.000029:
p.000029: necessary for the follow up of a prescribed treatment by the doctor and that has been accepted by the
p.000029: patient shall be provided. When this information is necessary to avoid a serious damage for the health of his
p.000029: biological family, then the affected or their legally authorised representative may be
p.000029: informed. In every case, the communication shall be exclusively limited to the data necessary for these ends.
p.000029:
p.000029: Article 50. Access to genetic data by health personnel.
p.000029:
p.000029: 1. Health professionals of the centre or the establishment that stores the clinical history
p.000029: of the patient shall have access to the data recorded in it in so far as it is relevant for the
p.000029: assistance that is being provided to the patient, notwithstanding the duties of secrecy and
p.000029: confidentiality to which they are subject.
p.000029: 2. Genetic data of a personal nature can only be used for epidemiological, public
p.000029: health, research or education purposes when the interested subject has expressly provided his
p.000029: consent or when this data has been previously anonimised.
p.000029: 3. In exceptional cases and of general health interest, the corresponding authority,
p.000029: after a favourable report by the authority on data protection, may authorise the use of codified genetic data,
p.000029: always when assuring that third parties may not be able to associate the source subject.
p.000029:
p.000029: Article 51. Duty of confidentiality and the right to the protection of genetic data.
p.000029:
p.000029: 1. The personnel who have access to genetic data in the exercise of
p.000029:
p.000029: their functions shall be subject to the duty of secrecy in a permanent manner. The disclosure of personal
p.000029: genetic data to third parties is only permitted with the express written consent of the person from whom
p.000029: these proceed.
p.000029: If the publishing of the results of a research is not possible without identifying the source subjects, then
p.000029: such results may only be published with their consent.
p.000029: 2. In case of genetic analysis to several members of a family, the results shall be filed
...
p.000039: 2. The reports, proposals, recommendations and other documents drafted by the
p.000039: Spanish Committee on Bioethics may be published for the general knowledge and diffusion, in full compliance
p.000039: with the constitutionally recognised fundamental rights.
p.000039: 3. The Spanish Committee on Bioethics shall collaborate with other state and autonomous committees that
p.000039: have counselling functions on the ethical and social implications of Biomedicine and the Health
p.000039: Sciences and shall promote the communication among them, notwithstanding their respective
p.000039: functions.
p.000039:
p.000039:
p.000039: Article 79. Composition and designation of its members.
p.000039:
p.000039: 1. The Committee shall be made up of a maximum of 12 members, chosen among persons who are
p.000039: accredited and qualified in the
p.000039:
p.000039: scientific, legal and bioethical world. The aim for its composition should be the balanced presence of the
p.000039: different disciplines involved in the bioethical reflections.
p.000039: 2. The members of the Committee shall be named by the Minister of Health and Consumption, in the
p.000039: following manner:
p.000039: a) Six members, as proposed by the autonomous communities, in accordance to that agreed within the
p.000039: Interterritorial Council of the National Health System.
p.000039: b) Six members proposed by the General Administration of the State in the following proportion:
p.000039: 1st) One by the Ministry of Justice.
p.000039: 2nd) One by the Ministry of Education and Science.
p.000039: 3rd) One by the Ministry of Industry, Tourism and Commerce.
p.000039: 4th) Three by the Ministry of Health and Consumption.
p.000039: 3. The President of the Committee shall be named from among its members by the Minister
p.000039: of Health and Consumption.
p.000039: 4. The Secretary of the Committee shall be a civil servant with the rank of vice-director General belonging to
p.000039: the Institute of Health Carlos III, who shall have say but no vote.
p.000039:
p.000039: Article 80. Duration of the mandate and the exercise of the post.
p.000039:
p.000039: 1. The members of the Committee shall have a mandate of four years, renewable only once, except if they
p.000039: substitute, before the expiration of the term of another previously designated member, in which
p.000039: case their mandate shall be for the time remaining until the completion of the four years from the time
p.000039: of the naming of the original member,
p.000039:
p.000039: © Inter-University Chair in Law and the Human Genome
p.000040: 40
p.000040:
p.000040:
p.000040: without prejudice to the possibility of renovation.
p.000040: 2. Half of the members shall be renewed every two years, except the first time, which shall be
p.000040: by draw.
p.000040: 3. The members of the Committee shall cease for the following reasons:
p.000040: a) Expiration of their mandate.
p.000040: b) Resignation, which shall take effect by the mere notification to the Minister of Health and Consumption.
p.000040: c) Accorded separation by the Minster of Health and Consumption, after meeting with the interested
...
p.000040: own plans for biomedical research and shall have available, through the Sectorial Initiative on Health
p.000040: Research, a national reference framework for the better use of existing resources and the strategic
p.000040: adaptation of research to the national plans on health services.
p.000040: 2. In the elaboration of the Sectorial Initiative on Health Research, the human, material and
p.000040: budget
p.000040:
p.000040: © Inter-University Chair in Law and the Human Genome
p.000041: 41
p.000041:
p.000041:
p.000041: resources necessary to assure the regular financing of the promotion and development of quality scientific and
p.000041: technical research in biomedicine shall be taken into account.
p.000041:
p.000041: Article 83. Promotion of research activity in the National Health System.
p.000041:
p.000041: 1. Research activities must be promoted throughout the health system as a basic element for
p.000041: its progress.
p.000041: 2. The Institute of Health Carlos III shall contribute to providing the structure of the research within
p.000041: the National Health System in the terms provided in article 48 of Law 16/2003, of 28 May, on
p.000041: the Cohesion and Quality of the National Health System and shall promote and coordinate
p.000041: the research in biomedicine through the undertaking of basic and applied research, promoting
p.000041: epidemiological research, and in public health, scientific and technical accreditation and future health
p.000041: control, scientific- technical counselling and the health training and education in biomedicine.
p.000041: 3. In the ambit of the regulation on research compiled in chapter IV of Law 16/2003, of 28 May, on the
p.000041: Cohesion and Quality of the National Health System, the Ministry of Health and Consumption and the
p.000041: autonomous communities shall promote the intervention of hospitals as structuring nuclei of research
p.000041: through cooperation and as a network. The centres of primary care may participate in the research
p.000041: networks.
p.000041: 4. Public entities of research which are dependent of the General Administration of the State and of
p.000041: the autonomous communities,
p.000041:
p.000041: whether they belong to the National Health System or not, universities and enterprises and non-profit public or
p.000041: private organisations that undertake activities of research and technological development may
p.000041: participate in the undertaking of biomedical and health sciences research of the National
p.000041: Health System.
p.000041: The programs included in biomedical research may be likewise executed in collaboration
p.000041: with foreign institutions of an international nature.
p.000041: 5. The entities, enterprises and institutions that are mentioned in the previous section may
p.000041: contract scientific personnel, experts in technological development and other specialists related
p.000041: with R&D activities, in order to collaborate in the execution of those technical research and development
p.000041: activities that correspond to the Sectorial Initiative on Research, in the conditions provided in
p.000041: article 17 of Law 13/1986, of 14 April, on the General Promotion and Coordination of
p.000041: Scientific and Technical Research.
p.000041:
p.000041: Article 84. Promotion and coordination of the research training of the personnel of the
p.000041: National Health System.
p.000041:
p.000041: 1. The Public Administrations shall provide backing to the training in the field of biomedical research through
p.000041: the development of those measures provided in this Law, scholarships and financial aid programs and the
p.000041: improvement of their working conditions.
p.000041: 2. The National Council of Specialties in the Health Sciences shall promote the technological and
p.000041: methodological research and
p.000041:
p.000041: © Inter-University Chair in Law and the Human Genome
p.000042: 42
p.000042:
p.000042:
p.000042: innovation in specialised health education.
p.000042:
p.000042: Article 85. Research career in the centres of the National Health System.
p.000042:
p.000042: 1. The public administrations shall promote, within the planning framework of its human
p.000042: resources, the incorporation to the health services of research personnel in a statuary regime.
p.000042: The incorporation of research personnel in the case of centres associated to the new management
p.000042: methods of the National Health System according to Law 15/1997, of 25 April, shall be done according to its
p.000042: applicable legal regime.
p.000042: In both cases, the incorporation shall be done through legally established procedures.
p.000042: 2. The centres of the National Health System shall be able to hire temporary work personnel who are
p.000042: dedicated to research activities in accordance with the following conditions:
p.000042: a) Researchers in training, who must be licentiates or engineers having obtained the Diploma of
p.000042: Advanced Studies or an administrative document which substitutes it in accordance with
p.000042: the new structure of education adapted to the European Space for Higher Learning, for a maximum period of
p.000042: two years, that must be those following the obtaining of the diploma, in accordance with
p.000042: Royal Decree 63/2006, of 27 January, which passed the statute on research personnel in training.
p.000042: b) Researchers in a period of perfection, who shall be doctors or specialists who have achieved the
p.000042: specialised health training and who shall be hired for tasks of research in the conditions provided in
p.000042: article
p.000042:
p.000042: 17.1.b of the Law of the General Coordination for Scientific and Technical Research.
p.000042: 3. The selection and hiring of these personnel must be subject to the principles of public concurrence,
p.000042: achievements, capacity and independent scientific evaluation that are proper of the
p.000042: scientific community.
p.000042: 4. The activities undertaken in accordance with that provided in section 2 of this article,
p.000042: shall be included in the evaluation of the merits for the obtaining of a post as medical personnel in
p.000042: the health institutions of the National Health System. Likewise, the assistance activities that are
p.000042: carried out by these professionals shall also be taken into account in the professional
p.000042: promotion within the National Health System.
p.000042: 5. The Public Administrations, within their ambit of competences, shall be able to include the research
p.000042: activity as part of the merit system of the professional development of statutory personnel, in accordance
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000003: a favourable report of those research projects that require the obtaining or use of tissues, embryonic stem cells
p.000003: or other similar of human origin that are obtained through diverse techniques of cell reprogramming
p.000003: that already exist or that could be discovered in the future, as well as the development of other
p.000003: functions on scientific, ethical or legal aspects. Finally, the Spanish Bioethics Committee is
p.000003: created as the authority for the consultation of all aspects with ethical and social
p.000003: implications in the field of Medicine and Biology and is called upon to set guidelines and general
p.000003: principles for the drafting of codes of good practices in scientific research that are developed by the
p.000003: Research Ethics Committees.
p.000003:
p.000003: III
p.000003:
p.000003: © Inter-University Chair in Law and the Human Genome
p.000004: 4
p.000004:
p.000004:
p.000004: The Law expressly prohibits the creation of human pre-embryos and embryos exclusively for the purpose of
p.000004: experimentation, in accordance with the gradualist perspective on the protection of human life set out
p.000004: by our Constitutional Court in rulings such as 53/1985, 212/1996 and 116/1999, but allows the use of any
p.000004: technique for the obtaining of embryonic stem cells for therapeutic or research purposes that does not
p.000004: entail the creation of a pre-embryo or of an embryo exclusively for this purpose and in the terms provided in
p.000004: this Law.
p.000004: In reference to the use of supernumerary embryos from assisted human
p.000004: reproduction techniques, the starting point is that established by Law 14/2006, of 26 May, on Assisted
p.000004: Human Reproduction Techniques, which expressly forbids the so-called reproductive human cloning.
p.000004:
p.000004: IV
p.000004:
p.000004: This Law regulates such a broad and complex set of matters, compiled in ninety articles,
p.000004: fifteen chapters, eight titles, three additional dispositions, one repealing and five
p.000004: final dispositions.
p.000004: The general dispositions of Title I are the regulating and integrating axis of the Law. The object and
p.000004: scope of application of this Law are set out and it establishes a set of principles and guarantees for
p.000004: the protection of the rights of persons and of the legal goods involved in biomedical research.
p.000004: Regarding the object and scope of the regulation, there is clarification that the biomedical research that is
p.000004: made reference to by the regulation covers basic and clinical research and excludes clinical trials with
p.000004: medication and the implantation of
p.000004:
p.000004: organs, tissues and cells, which shall be regulated in a specific regulation.
p.000004: Regarding the system of guarantees, there is a specific list that sets the limits to the
p.000004: principle of freedom of research in favour of the dignity and identity of the human being and for the
...
p.000005: establishes the requisites for the authorisation of the research projects with embryos, foetuses and
p.000005: their biological structures.
p.000005: In Title IV, the regulation on the donation, use and research with human embryonic cells and tissues
p.000005: and other similar cells is done in full accordance to that provided in Law 14/2006 on Assisted Human
p.000005:
p.000005: © Inter-University Chair in Law and the Human Genome
p.000006: 6
p.000006:
p.000006: Reproduction Techniques which already regulates the donation of surplus ovocites and pre-embryos in
p.000006: vitro, the application of assisted reproduction techniques as well as the requisites on the use of
p.000006: these pre-embryos or their biological structures for research or experimentation.
p.000006: This is notwithstanding the compulsory favourable report which the Guarantees
p.000006: Commission for the Donation and Use of Human Cells and Tissues must issue and to the conditions,
p.000006: guarantees and requisites that are imposed to these effects in the first two chapters of Title IV.
p.000006: The first chapter of this title expressly prohibits the creation of human pre-embryos or embryos
p.000006: for experimentation and authorises the use of any technique for obtaining human stem cells for therapeutic or
p.000006: research purposes, including the activation of ovocites through nuclear transfer which doesn’t entail
p.000006: the creation of a pre-embryo or embryo in the terms defined in this Law. Chapter two regulates
p.000006: the conditions which must be met when researching with biological samples of an embryonic nature. The third
p.000006: chapter establishes the composition and function of the aforementioned Guarantees Commission, which also has the
p.000006: responsibility to provide information on researches that are listed in the Law on stem tissues and
p.000006: cells or others functionally similar or to procedures or techniques for obtaining
p.000006: these, including embryonic stem cell lines from third countries. Lastly, within chapter four, a system for
p.000006: promotion and coordination is established in this ambit of research with human embryonic cells and
p.000006: tissues, highlights the regulation of the National Bank of Cell Lines, which is
p.000006:
p.000006: afforded a structure as a network with a central node and its appointment to the Institute
p.000006: of Health Carlos III.
p.000006: Title V regulates other emerging matters related with the current expansive tendency of biomedical
p.000006: research, such as, the undertaking of genetic analysis, the access and use of its results, as well as
p.000006: the obtaining and use of human biological samples. In spite of the enormous difficulties to
p.000006: establish the limits between research and diagnosis in the ambit of genetic analysis, due to
p.000006: substantive and systematic coherence and in view of the important rights of persons which might be
p.000006: involved in these type of analysis, this Law could not renounce to establish a legal framework in which
...
p.000010: f. “Consent”: manifestation of the free and conscious volition that is validly emitted by a capable person or
p.000010: through an authorised
p.000010:
p.000010: representative, after adequate information has been provided.
p.000010: g. “Genetic Screening”: Public health programme aimed at identifying certain
p.000010: genetic determinants in individuals, for which an early medical intervention could lead to the
p.000010: elimination or reduction of mortality, morbidity or disabilities associated with such determinants.
p.000010: h. “Anonymous data”: registered data without a nexus to an identified or identifiable person.
p.000010: i. “Anonymised or irreversibly disassociated data”: data that can not be associated to an identified or
p.000010: identifiable person as the nexus with all information that identified the subject has been destroyed
p.000010: or because such association demands a non-reasonable effort, understood as the use of disproportionate
p.000010: amounts of time, expense and work.
p.000010: j. “Genetic data of a personal nature”: information on the hereditary characteristics of
p.000010: a person, identified or identifiable that is obtained through nucleic acid analysis or through other
p.000010: scientific analysis.
p.000010: k. “Codified or reversibly disassociated data”: data that is not associated to an identified
p.000010: or identifiable person as the information that identified that person has been
p.000010: substituted or detached using a code that permits the reverse operation.
p.000010: l. “Embryo”: phase of embryonic development from the moment in which the fertilised ovocite is found in
p.000010: the uterus of a woman until the beginning of organ genesis and which ends 56 days from the
p.000010: moment of fertilisation, with the exception of the computation of those days in which
p.000010: the development could have been stopped.
p.000010:
p.000010: © Inter-University Chair in Law and the Human Genome
p.000011: 11
p.000011:
p.000011:
p.000011: m. “Observation study”: study undertaken on individuals in reference to whom there is
p.000011: neither the modification of the treatment or intervention to which they could be subject nor a
p.000011: prescription of any other guideline that could affect their personal integrity.
p.000011: n. “Foetus”: embryo with human appearance and with its organs formed which is maturing from the 57th
p.000011: day after the moment of fertilising until the moment of birth, taking out of the computation those days
p.000011: in which the development could have been stopped.
p.000011: o. “Biological sample”: any biological material of human origin capable of conservation and
p.000011: that can hold information on the genetic endowment that is characteristic of a person.
p.000011: p. “Anonimised or irreversible disassociated biological sample”: sample which can not be associated to
p.000011: an identified or identifiable person as the nexus which had all the information that identifies the subject
p.000011: has been destroyed or because such association requires an unreasonable effort.
p.000011: q. “Non-identifiable or anonymous biological sample”: sample collected without a
p.000011: nexus with an identified or identifiable person which, as a result, its origin is unknown and is
p.000011: impossible to trace.
p.000011: r. “Codified or reversibly disassociated biological sample”: sample not associated to
p.000011: an identified or identifiable person as the information that identifies that person has been
p.000011: substituted or disassociated using a code that allows the reverse operation.
p.000011: s. “Pre-embryo”: embryo constituted in vitro that is formed by the group of cells that are the result
p.000011: of the progressive division of the
p.000011:
p.000011: ovocite from the time it is fertilised until 14 days after.
p.000011: t. “Invasive procedure”: any intervention undertaken for research purposes that involves a physical or
p.000011: psychic risk for the affected subject
p.000011: u. “Minimum risk and burden”: health impacts and discomforts that could be borne by the participating
p.000011: subject in a research and whose effects can only be of a minor and temporary nature.
p.000011: v. “Source subject”: living being, no matter his or her state of health, or deceased from whom the
p.000011: biological sample is obtained.
p.000011: w. “Processing of genetic data of a personal nature or of biological samples”: operations and
p.000011: procedures that allow the collection, storage, use and conveyance of genetic data of a personal nature or
p.000011: biological samples.
p.000011: x. “Traceability”: capacity to associate a specific biological material with registered
p.000011: information that makes reference to any step in the chain of its collection as well as through all the process of
p.000011: research.
p.000011:
p.000011: Article 4. Informed consent and the right to information.
p.000011:
p.000011: 1. The free will of persons that may participate in biomedical research or that could provide their
...
p.000017: has been carried out.
p.000017: 3. When, for whatever reason, the insurance policy doesn’t fully cover the caused damages, the promoter
p.000017: of the research, the researcher in charge and the hospital or centre in which it was carried out shall be joint
p.000017: and severally liable for them, even if there is no fault, thereby being responsible to bear the burden
p.000017: of proof. Neither the administrative authority nor the report of the Research Ethics Committee
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
p.000017: women, embryos, foetuses or children.
p.000017: b) That research of similar efficacy is not possible to be undertaken in non-pregnant women.
p.000017: c) That the research entails a minimum risk and damage for the woman and, in its case, for the
p.000017: embryo, foetus or child.
p.000017: d) That the pregnant woman, or the legal representatives of the child, in its case, provides
p.000017: their consent in the terms provided in this Law.
p.000017: 2. When research is carried out during the lactation period of a woman, special care must be taken
p.000017: in order to avoid an adverse impact on the health of the child.
p.000017:
p.000017: Article 20. Protection of persons without the capacity to provide their consent.
p.000017:
p.000017: 1. Research on a minor or a disabled person, except when a judicial ruling on
p.000017: disability establishes that the person can provide his consent to research in accordance with a
p.000017: degree of discernment, can only be
p.000017:
p.000017: © Inter-University Chair in Law and the Human Genome
p.000018: 18
p.000018:
p.000018:
p.000018: undertaken if the following conditions are met:
p.000018: a) That the results of the research can produce real or direct benefits for his health.
...
p.000021: might be achieved with the donation, its consequences, as well as the interventions
p.000021: that may be undertaken to extract embryologic or foetal cells or structures, from the placenta or
p.000021: casings, and of the risks that may be derived from these interventions.
p.000021: c) That the expulsion, spontaneous or induced, of these embryos or foetuses has been made in
p.000021: the gestating woman and that it has not been possible to maintain its vital autonomy as provided in article 28.3
p.000021: 2. In the event that the persons from whom the embryos or foetuses come from are deceased, it is
p.000021: necessary that there is no record of their express opposition. If the deceased is a minor or
p.000021: disabled
p.000021:
p.000021: © Inter-University Chair in Law and the Human Genome
p.000022: 22
p.000022:
p.000022:
p.000022: person, then the donation shall take place unless there is a record of an express opposition by those that
p.000022: exercised, in the life of the former, their legal representation.
p.000022:
p.000022:
p.000022: CHAPTER II
p.000022: Conditions for biomedical research with human embryos and foetuses
p.000022:
p.000022: Article 30. Limitations on research with live embryos and foetuses in the uterus.
p.000022:
p.000022: Interventions on the live embryo or foetus in the uterus shall be exclusively authorised when
p.000022: their purpose is diagnostic or therapeutic in its own interest, notwithstanding what is legally established on
p.000022: the voluntary interruption of a pregnancy.
p.000022:
p.000022: Article 31. Requisites on the use.
p.000022:
p.000022: 1. Research on human embryos or foetuses or their biological structures must comply with
p.000022: the following requisites:
p.000022: a) That the embryos or foetuses fit within any of the situations established in section 1 of article 28
p.000022: of this Law.
p.000022: b) That the conditions provided in article 29 on the donation of the embryos and foetuses that are going
p.000022: to be used are taken into account.
p.000022: c) That a project is drafted on the expected use and that it has a favourable report by the Guarantees
p.000022: Commission for the Donation and use of Human Cells and Tissues.
p.000022: d) That the corresponding autonomous or State authority has provided an authorisation to its
p.000022: expected use.
p.000022: 2. The team responsible for the authorised project must
p.000022:
p.000022: communicate its result both to the entity that provided the authorisation to the submitted project, as well
p.000022: as to the Guarantees Commission for the Donation and use of Human Cells and Tissues.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: TITLE IV
...
p.000022:
p.000022: Article 32. Donation of ovocites and pre-embryos.
p.000022:
p.000022: 1. Research with ovocites and pre- embryos must have the consent of the persons from whom they come from,
p.000022: who can revoke it at any moment without affecting the research undertaken.
p.000022: 2. The donation of ovocites and pre-embryos shall be governed according to that provided in Law
p.000022: 14/2006, of 26 May, on Assisted Human Reproduction Techniques.
p.000022: In the case of ovocites, the consent of the donors shall make express reference to
p.000022: its authorisation for the use of a specific technique or techniques that are going to be
p.000022: applied to the ovocites that are object of the donation. For that purpose, the health
p.000022: professionals who are responsible for the obtaining of these ovocites shall provide the donors
p.000022: the appropriate information before the granting of the consent, leaving clear written record of all of this.
p.000022:
p.000022: © Inter-University Chair in Law and the Human Genome
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023: Article 33. Obtaining of embryonic cells.
p.000023:
p.000023: 1. The creation of human pre- embryos and embryos exclusively for experimentation purposes is
p.000023: prohibited.
p.000023: 2. The use of any technique for obtaining human stem cells for therapeutic or research purposes is
p.000023: allowed, always when it does not entail the creation of a pre-embryo or an embryo exclusively for this
p.000023: purpose, in the terms provided in this Law, including the activation of ovocites through nuclear transfer.
p.000023:
p.000023:
p.000023: CHAPTER II
p.000023: On research with embryonic biological samples
p.000023:
p.000023: Article 34. Guarantees and requisites for research.
p.000023:
p.000023: 1. Research or experimentation with surplus ovocites or pre- embryos from assisted reproduction
p.000023: techniques, or their biological structures, for purposes related with the obtaining, development and use of
p.000023: embryonic stem cell lines or with other purposes not associated with the development and application of
p.000023: assisted reproduction techniques, shall be undertaken in accordance with that provided in Law 14/2006, of
p.000023: 26 May, and comply with the following requisites:
p.000023: a) That the research abides by ethical principles and the applicable legal regime, especially
p.000023: that provided in this Law and the regulation that develops it, and that it follows the principles of
p.000023: relevance, feasibility and suitability, particularly of the main researcher, of the research team
p.000023: and of the
p.000023:
p.000023: installations of the centre in which the research takes place.
p.000023: b) That it is based on a research project that is authorised by the State or autonomous authority, after
p.000023: having a favourable report by the corresponding Guarantees Commission for the Donation and Use
p.000023: of Human Cells and Tissues, in projects dealing with matters established in article 35.
...
p.000028: and can be proven. To this effect, the documents of previous instructions and, for lack of, the
p.000028:
p.000028: criteria of the closest family members of the deceased shall be consulted.
p.000028: The access by the biological family members to information derived from the genetic analysis of the
p.000028: deceased shall be limited to the genetic data relevant for the protection of their health.
p.000028: 3. In order to have access to a genetic screening, there must be an explicit and written consent of the
p.000028: person interested. The Research Ethics Committee shall determine the situations in which the consent
p.000028: may be expressed verbally. In any case, when the screening includes non-curable diseases or the benefits are
p.000028: scarce or uncertain, the consent shall always be written.
p.000028: 4. The undertaking of genetic analysis on in vivo pre-embryos or on embryos and foetuses in
p.000028: the uterus shall require the written consent of the gestating woman.
p.000028: The genetic analysis of an in vitro pre-embryo that has not been transferred shall be subject to that
p.000028: provided in the Law on Assisted Human Reproduction.
p.000028:
p.000028: Article 49. Right to Information and right not to know.
p.000028:
p.000028: 1. The subject source shall be informed on the genetic data of a personal nature that are obtained in
p.000028: the genetic analysis according to the terms in which he manifested his volition, notwithstanding the right to
p.000028: access that is established in the legislation on the protection of data of a personal nature, which
p.000028: could entail the revocation of the previously granted manifestation of free volition.
p.000028: 2. When the subject source has exercised his right not to know the results of a genetic analysis,
p.000028: then only that information that is
p.000028:
p.000028: © Inter-University Chair in Law and the Human Genome
p.000029: 29
p.000029:
p.000029:
p.000029: necessary for the follow up of a prescribed treatment by the doctor and that has been accepted by the
p.000029: patient shall be provided. When this information is necessary to avoid a serious damage for the health of his
p.000029: biological family, then the affected or their legally authorised representative may be
p.000029: informed. In every case, the communication shall be exclusively limited to the data necessary for these ends.
p.000029:
p.000029: Article 50. Access to genetic data by health personnel.
p.000029:
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Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000019: 3. A placebo may be used only if there are no methods of proven efficacy or when the withdrawal
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
p.000019: project is justified in light of new knowledge that is reached throughout its execution.
p.000019:
p.000019: © Inter-University Chair in Law and the Human Genome
p.000020: 20
p.000020:
p.000020:
p.000020: The main researchers must send to the Committee, without delay, any relevant information for the safety of the
p.000020: participating subjects.
p.000020: 2. The purpose of the aforementioned verification in the earlier section shall
p.000020: have as its finality to determine:
p.000020: a) Whether it is necessary to interrupt the research or to make changes in the project in order
p.000020: to continue.
p.000020: b) Whether the participants in the research or, where appropriate, their representatives, must
p.000020: be informed on events that may happen.
p.000020: c) Whether it is necessary to have an additional consent by the participants.
p.000020: 3. Any relevant modification in the authorised conditions for a research project shall not take place
p.000020: without the previous favourable opinion of the Research Ethics Committee and the approval of the corresponding
p.000020: authority.
p.000020: 4. Any relevant information on the participation in the research shall be made known via
p.000020: written communication to the participants or, where appropriate, to their representatives as soon as
p.000020: possible.
p.000020: 5. The Research Ethics Committee shall proceed to follow up on the compliance with that established in the
p.000020: previous section, having the duty to report the incidences that are observed by the corresponding
p.000020: authority that provided the authorisation for that research, in order that this may
p.000020: adopt the corresponding measures, in accordance with article 17 of this Law and with full
p.000020: respect to that provided in existing regulations in matters of protection of data of a personal nature.
p.000020: 6. The researcher in charge shall report the reasons for the early
p.000020:
p.000020: termination of any research project to the Research Ethics Committee and to the corresponding authority
p.000020: which provided its conformity to the research.
p.000020:
p.000020: CHAPTER V
p.000020: Management of Information Article 26. Duty to inform.
p.000020: According to that provided in article 4.5, if research would provide relevant information for the health of
...
p.000031: perform genetic analyses and that, in every case, must comply with that provided in articles 46 through 57 of this
p.000031: Law.
p.000031:
p.000031:
p.000031: CHAPTER III
p.000031: Use of human biological samples for biomedical research
p.000031:
p.000031: Article 58. Obtaining of samples.
p.000031:
p.000031: 1. The obtaining of biological samples for biomedical research shall be undertaken solely when
p.000031: the previous written consent has been obtained from the subject source and after being informed about
p.000031: the consequences and risks that this can entail for his health. The consent shall be revocable.
p.000031: 2. The consent of the subject source shall always be necessary when the aim is to use
p.000031: biological samples for biological research that have already been obtained for a different purpose,
p.000031: irrespective of whether there is an anonimisation.
p.000031: Notwithstanding this, in an exceptional manner, codified or
p.000031:
p.000031: identified samples for biomedical research may be used without the consent of the subject source when
p.000031: the obtaining of this consent is not possible or it entails a non- reasonable effort to
p.000031: the effects provided in article 3.i) of this Law. In these cases, the favourable opinion of the
p.000031: corresponding Research Ethics Committee shall be necessary, which must take into account,
p.000031: at least, the following requisites:
p.000031: a) That the research is of general interest.
p.000031: b) That the research is undertaken by the same institution that requested the consent for
p.000031: the obtaining of samples.
p.000031: c) That the research is less effective or not possible without the identifying data of the
p.000031: subject source.
p.000031: d) That there is no record of an express objection of the subject source.
p.000031: e) That personal data is guaranteed confidentiality.
p.000031: 3. Notwithstanding that provided in article 7, an economic compensation may be established for the
p.000031: physical discomforts, expenses and other inconveniences that may be derived from the taking of the
p.000031: sample.
p.000031: 4. For health reasons, the subject source or his family may use the samples when in need, always that these are
p.000031: available and are not anonimised.
p.000031: 5. The obtaining of biological samples from minors or the disabled for biomedical research shall be
p.000031: subject to the following conditions:
p.000031: a) That the necessary measures are adopted in order to guarantee that the risk of the intervention is minimal
p.000031: for the subject source.
p.000031: b) That relevant knowledge on a disease or on the situation that is object of research and which are of vital
...
p.000035: owner
p.000035:
p.000035: © Inter-University Chair in Law and the Human Genome
p.000036: 36
p.000036:
p.000036:
p.000036: manifests his will not to continue with its activity.
p.000036: 2. This resolution shall likewise provide the destination of the stored samples of the biobank that is going
p.000036: to be closured or closed.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: TITLE VI
p.000036: Infractions, sanctions and compensations for damages
p.000036:
p.000036: Article 72. General Dispositions.
p.000036:
p.000036: 1. The infractions provided in this Law related with the obtaining and use of human cells and tissues,
p.000036: on the use of invasive procedures in biomedical research, as well as personal genetic data shall be
p.000036: the object of the corresponding administrative sanctions, after the charges are compiled in
p.000036: a case, notwithstanding the civil, criminal or other type of liability that may also arise.
p.000036: 2. The sanctioning authority regulated in this Law shall be exercised, in those cases
p.000036: not provided in this Law, it shall be in accordance with that provided in Law 30/1992 of the Legal
p.000036: regulation of Public Administrations and the Common Administrative Procedure, in Law 14/1986, of 25 April,
p.000036: General Law on Health, and Basic Law 15/1999, of 13 December, on the Protection of Data of a
p.000036: Personal Nature.
p.000036: 3. When, in the opinion of by the Administration, the infraction could be an offence or misdemeanour, the
p.000036: administrative entity shall pass it on to the Prosecutor’s Office,
p.000036:
p.000036: abstaining form continuing with the sanctioning procedure until the judicial authority has made
p.000036: a pronouncement.
p.000036: The criminal sanction shall exclude the imposition of an administrative sanction always when it
p.000036: is imposed for the same acts and in relation to the same protected public interests, though all other
p.000036: responsibilities that can be deduced from other acts or infractions that concur must be enforced.
p.000036: If the decision is that there hasn’t been an offence or misdemeanour, then the administration
p.000036: shall continue with its sanctioning proceeding, taking as its basis, where appropriate, those
p.000036: facts that the courts have considered as proven.
p.000036: 4. The administrative measures that would have been adopted in order to safe keep the right to the
p.000036: protection of health and safety of the people shall be kept as long as the judicial authority doesn’t make a
p.000036: pronouncement on such.
p.000036: 5. Very serious offences shall prescribe after three years, serious, after two and minor after six months.
p.000036: The sanctions imposed for very serious offences shall prescribe after three years, those for
...
General/Other / Dependent
Searching for indicator dependent:
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p.000034: of the procedures associated with the functioning of the biobank.
p.000034: d) To draft an annual report of activities, this shall be made available to the authority
p.000034: that granted the authorisation for the creation of the biobank.
p.000034: e) To attend the consultations or complaints that could be addressed to the biobank.
p.000034: f) To draft a document of good practices of the biobank.
p.000034: g) To draft a descriptive memory that compiles the characteristics of the collections, the criteria for the
p.000034: inclusion and the purposes for which the collection is created, the manner in which the historic collection has
p.000034: been compiled and the information that can be associated to the samples.
p.000034: 3. The person responsible for the files shall attend all requests in the exercise of the rights to
p.000034: access, rectification, cancellation or opposition that are made by the subject source, in
p.000034: accordance with that provided in the existing legislation on the protection of data of a personal
p.000034: nature.
p.000034:
p.000034:
p.000034: Article 67. National Registry of Biobanks.
p.000034:
p.000034: 1. Once the biobank is constituted in accordance with the previous procedure, the
p.000034: corresponding authority shall proceed to register it in the National Registry of Biobanks for Biomedical
p.000034: Research, which shall be dependent of the Institute of Health Carlos III. Before that, they must register in
p.000034: the Spanish Agency for the Protection of Data in accordance with existing legislation. The data in
p.000034: this Registry shall be based in that provided by the competent authorities to authorise biobanks.
p.000034: 2. Any person or entity, public or private that has one or more ordered collections of human samples or
p.000034: biological material that come from identified or identifiable persons, must likewise register in the National
p.000034: Registry of Biobanks. This requisite shall be independent of its registration in the registries of
p.000034: other institutions due to their special nature or purpose.
p.000034: 3. Once registered, The Ministry of Health and Consumption shall certify the nature and scope of
p.000034: the collection.
p.000034: 4. The following shall not be subject to the aforementioned registration: those collections kept by physical
p.000034: persons for their exclusive personal use or the samples, though ordered as a collection, that have been
p.000034: obtained for the undertaking of pertinent analysis for diagnostic purposes and, where
p.000034: appropriate, for the treatment of the subject source and that are not kept stored during a period
p.000034: longer than the fulfilment of these objectives.
p.000034:
p.000034: Article 68. Inspections and control measures.
p.000034:
p.000034: © Inter-University Chair in Law and the Human Genome
p.000035: 35
p.000035:
p.000035:
p.000035:
p.000035: The corresponding authority shall make periodic inspections to guarantee that biobanks abide by
...
p.000041:
p.000041: resources necessary to assure the regular financing of the promotion and development of quality scientific and
p.000041: technical research in biomedicine shall be taken into account.
p.000041:
p.000041: Article 83. Promotion of research activity in the National Health System.
p.000041:
p.000041: 1. Research activities must be promoted throughout the health system as a basic element for
p.000041: its progress.
p.000041: 2. The Institute of Health Carlos III shall contribute to providing the structure of the research within
p.000041: the National Health System in the terms provided in article 48 of Law 16/2003, of 28 May, on
p.000041: the Cohesion and Quality of the National Health System and shall promote and coordinate
p.000041: the research in biomedicine through the undertaking of basic and applied research, promoting
p.000041: epidemiological research, and in public health, scientific and technical accreditation and future health
p.000041: control, scientific- technical counselling and the health training and education in biomedicine.
p.000041: 3. In the ambit of the regulation on research compiled in chapter IV of Law 16/2003, of 28 May, on the
p.000041: Cohesion and Quality of the National Health System, the Ministry of Health and Consumption and the
p.000041: autonomous communities shall promote the intervention of hospitals as structuring nuclei of research
p.000041: through cooperation and as a network. The centres of primary care may participate in the research
p.000041: networks.
p.000041: 4. Public entities of research which are dependent of the General Administration of the State and of
p.000041: the autonomous communities,
p.000041:
p.000041: whether they belong to the National Health System or not, universities and enterprises and non-profit public or
p.000041: private organisations that undertake activities of research and technological development may
p.000041: participate in the undertaking of biomedical and health sciences research of the National
p.000041: Health System.
p.000041: The programs included in biomedical research may be likewise executed in collaboration
p.000041: with foreign institutions of an international nature.
p.000041: 5. The entities, enterprises and institutions that are mentioned in the previous section may
p.000041: contract scientific personnel, experts in technological development and other specialists related
p.000041: with R&D activities, in order to collaborate in the execution of those technical research and development
p.000041: activities that correspond to the Sectorial Initiative on Research, in the conditions provided in
p.000041: article 17 of Law 13/1986, of 14 April, on the General Promotion and Coordination of
p.000041: Scientific and Technical Research.
p.000041:
p.000041: Article 84. Promotion and coordination of the research training of the personnel of the
p.000041: National Health System.
p.000041:
p.000041: 1. The Public Administrations shall provide backing to the training in the field of biomedical research through
p.000041: the development of those measures provided in this Law, scholarships and financial aid programs and the
p.000041: improvement of their working conditions.
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.000002: the Law proclaims that the health, interest and well-being of the human being that participates in
p.000002: biomedical research shall prevail over the interest of society or science.
p.000002: In particular, the Law is built on the principles of the integrity of the persons and the protection of
p.000002: the dignity and identity of the human being in any biomedical research that involves the intervention
p.000002: on human beings as well as in the undertaking of genetic analysis, the processing of genetic data
p.000002: of a personal nature and of human biological samples used in research. Along these lines,
p.000002: the Law establishes the free will of a person as the foundation from which the specific rights to
p.000002: consent and to obtain previous information is derived. Likewise, it establishes the right to not
p.000002: be discriminated, the duty of confidentiality by any person that in the exercise of their duties has access to
p.000002: personal information,
p.000002:
p.000002: © Inter-University Chair in Law and the Human Genome
p.000003: 3
p.000003:
p.000003: the principle of gratuity of the donations of biological material and it sets the standards of
p.000003: quality and safety, which include the traceability of human cells and tissues and the strict compliance
p.000003: of the precautionary principle in the different activities that it regulates. In regulating
p.000003: all these matters, Basic Law 41/2002, of 14 November, on the Autonomy of the Patient and the Rights and
p.000003: Obligations in Matters of Clinical Information and Documentation and Basic Law 15/1999,
p.000003: of 13 December, on the Protection of Data of a Personal Nature have been taken into account,
p.000003: both of which are established as subsidiary in those matters that are not regulated by this Law.
p.000003: From a research point of view, the Law guarantees the freedom of research and of scientific production in the
p.000003: terms provided in article 20 of our Constitution. Furthermore, such an ambitious legal framework on advanced
p.000003: research in the field of biomedicine could not stop from bearing in mind the human,
p.000003: scientific, structural and social context in which it must develop in its daily practice, whereby
p.000003: this Law regulates the mechanisms to foster and promote, plan, evaluate and coordinate biomedical research
p.000003: from the principles of quality, efficacy and equal opportunity and in order to favour that the results of
p.000003: research are transformed into efficient therapies to combat different pathologies.
p.000003: Notably, the implantation of research in health centres as a routine practice is made easier,
p.000003: the collaboration among basic biomedical research centres and hospitals and other centres of
p.000003: the National Health System are encouraged and there is a fostering of the ties between the
p.000003:
p.000003: public and private sector through research in networks and the mobility of researchers
p.000003: and practitioners.
...
p.000005: revise and update the legal regime that was in effect before the entry of this Law,
p.000005:
p.000005: specifically Law 42/1988, of 28 December, on the donation and use of human embryos or foetuses or their
p.000005: cells, tissues or organs; and secondly, to incorporate this matter to the global approach of this new
p.000005: Law, in order to eliminate unnecessary normative dispersions related with biomedical
p.000005: research. The repeal of Law 42/1988, of 28 December, that in its time was a noteworthy legislative novelty
p.000005: of our legal regulation and was a recognised as a reference in comparative law, is a
p.000005: consequence of this.
p.000005: The title is structured in two chapters. The first regulates the conditions for the donation of human
p.000005: embryos and foetuses, among which are the prohibitions that the interruption of a pregnancy can have as
p.000005: a final purpose a donation and that the professional members of a medical team that perform the
p.000005: interruption intervene in the use of the aborted embryos or foetuses, and establishes that for the donation to
p.000005: be valid there must be a concurrence of the informed consent of the donor and the expulsion in the
p.000005: gestating women of the embryos and foetuses without possibility of maintaining its vital autonomy. The
p.000005: second chapter imposes that the research with live embryos and foetuses in the uterus shall only
p.000005: be undertaken for a diagnostic or therapeutic purpose in its own interest and
p.000005: establishes the requisites for the authorisation of the research projects with embryos, foetuses and
p.000005: their biological structures.
p.000005: In Title IV, the regulation on the donation, use and research with human embryonic cells and tissues
p.000005: and other similar cells is done in full accordance to that provided in Law 14/2006 on Assisted Human
p.000005:
p.000005: © Inter-University Chair in Law and the Human Genome
p.000006: 6
p.000006:
p.000006: Reproduction Techniques which already regulates the donation of surplus ovocites and pre-embryos in
p.000006: vitro, the application of assisted reproduction techniques as well as the requisites on the use of
p.000006: these pre-embryos or their biological structures for research or experimentation.
p.000006: This is notwithstanding the compulsory favourable report which the Guarantees
p.000006: Commission for the Donation and Use of Human Cells and Tissues must issue and to the conditions,
p.000006: guarantees and requisites that are imposed to these effects in the first two chapters of Title IV.
p.000006: The first chapter of this title expressly prohibits the creation of human pre-embryos or embryos
p.000006: for experimentation and authorises the use of any technique for obtaining human stem cells for therapeutic or
...
p.000021:
p.000021: Article 28. Donation of human embryos and foetuses.
p.000021:
p.000021: 1. Human embryos that have lost their capacity for biological development, as well as
p.000021: dead human embryos or foetuses, may be donated for biomedical research or other diagnostic,
p.000021: therapeutic, pharmacological, clinical or surgical purposes
p.000021: 2. The interruption of a pregnancy shall never have as its purpose the donation and later use of embryos,
p.000021: foetuses or their biological structures. The procedure and manner of the practice
p.000021: of the interruption of the pregnancy shall be only subject to the legal demands and limitations
p.000021: and the characteristics and circumstances that surround it.
p.000021: The professionals who are part of the medical team that undertakes the interruption of the pregnancy shall
p.000021: not intervene in the use of the aborted embryos, foetuses or their biological structures. To this effect, the
p.000021: members of the research team shall leave written record of this matter, as well as the absence of a
p.000021: conflict of interests with the medical team.
p.000021: 3. The foetuses that are prematurely and spontaneously expelled shall be clinically
p.000021: treated while they remain biologically viable with the sole purpose to favour their development and vital autonomy.
p.000021: 4. Before proceeding to any intervention on human embryos that have lost their capacity of biological
p.000021:
p.000021: development or on dead embryos or foetuses, a record shall be made by the corresponding medical
p.000021: personnel that such circumstances have taken place.
p.000021:
p.000021: Article 29. Requisites on donation.
p.000021:
p.000021: 1. Besides that established in the previous article, the donation of human embryos or foetuses or their
p.000021: biological structures for the purposes provided in this Law shall meet the following requisites:
p.000021: a) That the donor or donors of the embryos or foetuses have previously granted their express and
p.000021: written consent. If any of them is a non-emancipated minor or is disabled, then the consent of
p.000021: their legal representatives shall also be necessary.
p.000021: b) That the donor or donors or, where appropriate, their legal representatives, have been provided
p.000021: written information before the granting of their consent in relation to the purposes that
p.000021: might be achieved with the donation, its consequences, as well as the interventions
p.000021: that may be undertaken to extract embryologic or foetal cells or structures, from the placenta or
p.000021: casings, and of the risks that may be derived from these interventions.
p.000021: c) That the expulsion, spontaneous or induced, of these embryos or foetuses has been made in
p.000021: the gestating woman and that it has not been possible to maintain its vital autonomy as provided in article 28.3
p.000021: 2. In the event that the persons from whom the embryos or foetuses come from are deceased, it is
p.000021: necessary that there is no record of their express opposition. If the deceased is a minor or
p.000021: disabled
p.000021:
p.000021: © Inter-University Chair in Law and the Human Genome
p.000022: 22
p.000022:
p.000022:
p.000022: person, then the donation shall take place unless there is a record of an express opposition by those that
p.000022: exercised, in the life of the former, their legal representation.
p.000022:
p.000022:
p.000022: CHAPTER II
p.000022: Conditions for biomedical research with human embryos and foetuses
p.000022:
p.000022: Article 30. Limitations on research with live embryos and foetuses in the uterus.
p.000022:
p.000022: Interventions on the live embryo or foetus in the uterus shall be exclusively authorised when
p.000022: their purpose is diagnostic or therapeutic in its own interest, notwithstanding what is legally established on
p.000022: the voluntary interruption of a pregnancy.
p.000022:
p.000022: Article 31. Requisites on the use.
p.000022:
p.000022: 1. Research on human embryos or foetuses or their biological structures must comply with
p.000022: the following requisites:
...
p.000035: biomedical research. Samples shall only be assigned for requests that come from research projects that have
p.000035: been scientifically approved. The request shall contain information on the project to be
p.000035: developed and the explicit commitment of the requesting centre and/or of the researchers
p.000035: who participate in the project to not use the requested material for a use different to that
p.000035: stated in the request. It must contain the approval by the scientific and ethical committees of
p.000035: the bank.
p.000035: 3. The costs of obtaining, maintenance, handling, shipping and other costs of a similar
p.000035: nature related with the samples may be passed on with the assignment of each sample. In every case,
p.000035: the quantity of the assigned samples shall be the minimum necessary for the undertaking of the project.
p.000035: 4. The obtaining, transportation, storage, handling and shipping of samples shall be done in conditions of
p.000035: biosafety in accordance with applicable legislation.
p.000035: 5. The total or partial refusal of the biobank to deliver samples which are solicited for biomedical research
p.000035: shall require a reasoned decision by
p.000035:
p.000035: the person in charge, who shall take into account the previous respective reports of the scientific director and the
p.000035: scientific and ethical committees that are mentioned in article 66.1
p.000035: 6. The assignment of samples may be accompanied by the associated clinical information, in which case the
p.000035: data shall be protected in accordance with that provided in the Law of the Autonomy of the Patient and the
p.000035: Law for the Protection of Personal Data.
p.000035:
p.000035: Article 70. Rights of the source subjects.
p.000035:
p.000035: 1. That provided in the articles of Chapter III of this title in relation with the obtaining, previous
p.000035: information, consent, confidentiality, assignment, conservation of data and samples, access to data and the
p.000035: right not to know shall be applicable to biological samples deposited in biobanks.
p.000035: 2. Notwithstanding that provided in the previous section, those biological samples that are added
p.000035: to biobanks may be used for any biomedical research, in the terms provided in this Law, always when
p.000035: the source subject, or where appropriate, his legal representatives have
p.000035: provided their consent in these terms.
p.000035:
p.000035: Article 71. Closure or closing of a biobank.
p.000035:
p.000035: 1. The competent authority may decide the closure or closing of a biobank, on its own motion or as
p.000035: requested and through a motivated resolution, in those cases in which there is non-compliance with the
p.000035: requisites established in this Law for its creation, organisation and function, or when its
p.000035: owner
p.000035:
p.000035: © Inter-University Chair in Law and the Human Genome
p.000036: 36
p.000036:
p.000036:
p.000036: manifests his will not to continue with its activity.
...
p.000036: serious offences after two and those for minor offences after a year.
p.000036:
p.000036: Article 73. Responsibilities.
p.000036:
p.000036: 1. The author shall be responsible for the different infractions.
p.000036: 2. When in accordance with the obligations provided in this Law, the compliance of the
p.000036: obligations corresponds to several persons jointly, then they shall be held joint and severally liable
p.000036: in accordance with that provide in article 130.3 of Law 30/1992, of 26 November, of the Legal Regulation
p.000036: of the Public
p.000036:
p.000036: © Inter-University Chair in Law and the Human Genome
p.000037: 37
p.000037:
p.000037:
p.000037: Administrations and the Common Administrative Procedure. The same norm shall be applicable to the
p.000037: directors of the centres or services for the non-compliance with the aforementioned obligations by the
p.000037: biomedical professionals who are under their responsibility.
p.000037:
p.000037: Article 74. Infractions.
p.000037:
p.000037: 1. Infractions shall be classified as minor, serious or very serious in accordance with the harmfulness of
p.000037: the act, the quantity of the eventual benefit obtained, the health and social alteration produced and its
p.000037: degree of intent.
p.000037: 2. Besides that provided in the General Health Law, the Law on the Protection of Personal Data, the
p.000037: Law on Assisted Human Reproduction Techniques, Basic Law on the Autonomy of the Patient and
p.000037: of the Rights and Obligations in Matters of Clinical Documentation and on other regulations passed by the
p.000037: autonomous communities, in accordance with this Law, the following infractions shall be
p.000037: considered as minor serious and very serious:
p.000037: A) Minor infractions are:
p.000037: Those that entail the non- compliance of any obligation or the violation of any prohibition
p.000037: that is provided in this Law, always when in accordance with the criteria provided in this section they
p.000037: can’t be classified as serious or very serious infractions.
p.000037: B) Serious infractions are:
p.000037: a) Non-observance of the prescriptions, conditions, requisites or previous authorisations that
p.000037: are provided in this Law for the functioning of the registries provided in this Law.
p.000037:
p.000037: b) The omission of data, consents and references required by this Law.
p.000037: c) The non-providing of data to the appropriate health authority responsible for the functioning
p.000037: of registries provided in this Law.
p.000037: d) The breach of the conditions of confidentiality of the data of the donors established in this Law.
p.000037: e) The non-fulfilment of the gratuity of the donation of pre- embryos, embryos and foetuses
p.000037: in the terms provided in this Law.
p.000037: f) The non-fulfilment of the norms and guarantees established for the transfer between countries of cells
...
p.000046: in this Law are derogated. Likewise, the following are derogated: Sections 5 and 6 of article
p.000046: 45, and articles 46, 47 and 50 of Law 16/2003 of 28 May on the Cohesion and Quality of the
p.000046: National Health System; Title VII
p.000046:
p.000046: © Inter-University Chair in Law and the Human Genome
p.000047: 47
p.000047:
p.000047:
p.000047: and Chapters II and III of title VI of Law 14/1986 of 25 April of the National Health Law;
p.000047: Additional Second Disposition of Law 14/2006 of 26 May, on Assisted Human Reproduction Techniques;
p.000047: and articles 10 and 11 of the Statute of the National Centre for Transplantation and
p.000047: Regenerative Medicine, approved by Royal Decree 176/2004 of 30 January.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: First Final Disposition.
p.000047: Competency Title.
p.000047:
p.000047: This Law is based on article
p.000047: 149.1.15 and 16 of the Spanish Constitution, which attributes to the State the exclusive competency
p.000047: in matters of promotion and general coordination of scientific and technical research and in matters of
p.000047: basis and general coordination of health matters.
p.000047: The State and the autonomous communities shall adopt, within the ambit of their
p.000047: respective competencies, those measures necessary to guarantee the effectiveness of this Law.
p.000047:
p.000047: Second Final Disposition.
p.000047: Suppletory Application.
p.000047:
p.000047: Law 41/2002 of 14 November, on the Basic Law of the Autonomy of the Patient and the Rights and
p.000047: Obligations in matters of Clinical Information and Documentation and Basic Law 15/1999 of 13 December, on the
p.000047: Protection of data of a Personal Nature, shall be applicable always when it is not incompatible with
p.000047: the principles provided in this Law.
p.000047:
p.000047: Third Final Disposition.
p.000047: Regulatory Development.
p.000047:
p.000047: The Government is granted power to dictate as many dispositions as necessary to develop and execute this
p.000047: Law and in particular to establish:
p.000047: a) The internal, intercommunity and extra community regulations on exchange and circulation of
p.000047: biological material of human origin for research purposes.
p.000047: b) The basic requisites of accreditation and authorisation of the centres, services and
p.000047: biomedical teams related with the obtaining and use of any biological material of human origin for
p.000047: biomedical research purposes.
p.000047: c) The functioning and development of the Commission on Guarantees for the Donation and
p.000047: Use of Human Cells and Tissues, which shall substitute the now in effect Commission for the Follow – Up
p.000047: and Control on the Donation and Use of Human Cells and Tissues.
p.000047: d) The functioning and organisation of a National Registry of Biobanks for
p.000047: Biomedical Research that shall be appointed to the Ministry of Health and Consumption.
p.000047:
p.000047: Fourth Additional Disposition.
p.000047:
p.000047: Subsection 2 of section A of the Annex to Law 14/2006 of 26 May, on Assisted Human Reproduction
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.000039: 3rd) One by the Ministry of Industry, Tourism and Commerce.
p.000039: 4th) Three by the Ministry of Health and Consumption.
p.000039: 3. The President of the Committee shall be named from among its members by the Minister
p.000039: of Health and Consumption.
p.000039: 4. The Secretary of the Committee shall be a civil servant with the rank of vice-director General belonging to
p.000039: the Institute of Health Carlos III, who shall have say but no vote.
p.000039:
p.000039: Article 80. Duration of the mandate and the exercise of the post.
p.000039:
p.000039: 1. The members of the Committee shall have a mandate of four years, renewable only once, except if they
p.000039: substitute, before the expiration of the term of another previously designated member, in which
p.000039: case their mandate shall be for the time remaining until the completion of the four years from the time
p.000039: of the naming of the original member,
p.000039:
p.000039: © Inter-University Chair in Law and the Human Genome
p.000040: 40
p.000040:
p.000040:
p.000040: without prejudice to the possibility of renovation.
p.000040: 2. Half of the members shall be renewed every two years, except the first time, which shall be
p.000040: by draw.
p.000040: 3. The members of the Committee shall cease for the following reasons:
p.000040: a) Expiration of their mandate.
p.000040: b) Resignation, which shall take effect by the mere notification to the Minister of Health and Consumption.
p.000040: c) Accorded separation by the Minster of Health and Consumption, after meeting with the interested
p.000040: party, due to permanent incapacity for the exercise of their function, serious non-fulfilment of
p.000040: his obligations, unexpected incompatibility or the processing for a wilful offence. To these
p.000040: effects, the opening of the stage of trial during which testimony is given shall be similar to the bill of
p.000040: indictment.
p.000040: 4. The members of the Committee shall act with independence from the authorities who proposed or named them
p.000040: and shall not be able to belong to governing entities of the Administration of the State,
p.000040: of autonomous communities or of local governments as well as to the Spanish Parliament or
p.000040: the Legislative Assemblies of the Autonomous Communities.
p.000040:
p.000040: Article 81. Functioning.
p.000040:
p.000040: 1. The Committee shall act in banc and in Standing Committees. The composition and functions of both entities
p.000040: shall be determined by regulation.
p.000040: 2. The functioning in banc and in the Standing Committees shall be developed by an internal regulation
p.000040: that shall be approved by the Committee in banc.
p.000040:
p.000040: 3. This regulation shall include, at least, the following matters:
p.000040: a) Frequency of meetings, which shall be, at least, every three months.
p.000040: b) Procedures of deliberation and the taking of decisions.
p.000040: c) Extension and limits of the duty of confidentiality of its members.
p.000040: d) Independence of its members and conflicts of interest.
p.000040: e) Election procedure of its President.
p.000040:
p.000040: TITLE VIII
p.000040: Promotion and coordination of biomedical research in the National Health System
p.000040:
...
General/Other / Other Country
Searching for indicator another country:
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p.000023: and origin and the document of the informed consent, signed by the donor, or progenitors,
p.000023: respectively.
p.000023:
p.000023: © Inter-University Chair in Law and the Human Genome
p.000024: 24
p.000024:
p.000024:
p.000024: Article 35. Report of the Guarantees Commission for the Donation and Use of Human Cells and Tissues.
p.000024:
p.000024: 1. The previous favourable report of the Guarantees Commission for the Donation and Use of Human Cells and
p.000024: Tissues shall be required for those research projects that deal, in whole or in part, with the following
p.000024: matters:
p.000024: a) Research with human pre- embryos for the derivation of cell lines, for embryologic research and for
p.000024: other research purposes, except for those related with the development and application of
p.000024: assisted reproduction techniques.
p.000024: b) Research with human embryonic stem cells
p.000024: c) The activation of ovocites through nuclear transfer for therapeutic or research purposes.
p.000024: d) Any other technique, that using in whole or in part, human biological samples, can lead to the obtaining of
p.000024: stem cells
p.000024: e) Research with embryonic cells or tissues obtained through any of the procedures mentioned in article
p.000024: 33.2.
p.000024: f) Any other line of research that includes cell material of human embryonic origin or
p.000024: other functionally similar.
p.000024: g) Research with embryonic stem cell lines that come from another country, within the EU countries or
p.000024: those outside the EU. This origin shall be specified in the project submitted for authorisation.
p.000024: 2. The authority that granted the authorisation to the research project mentioned in the earlier section,
p.000024: shall annually forward its results to the Guarantees Commission for the Donation and use of Human Cells and
p.000024: Tissues.
p.000024:
p.000024: Article 36. Access to cryopreserved ovocites and pre- embryos.
p.000024:
p.000024: The Institute of Health Carlos III shall guarantee the access to surplus cryopreserved
p.000024: pre-embryos from assisted reproduction techniques that have been donated for research purposes.
p.000024: The same criteria shall be followed with ovocites donated for research.
p.000024:
p.000024: CHAPTER III
p.000024: On the Guarantees Commission for the Donation and use of Human Cells and Tissues
p.000024:
p.000024: Article 37. Creation of the Commission.
p.000024:
p.000024: 1. A Guarantees Commission for the Donation and Use of Human Cells and Tissues is created as the association
p.000024: composed of several persons, assigned to the Institute of Health Carlos III, of a permanent and
p.000024: consultative nature, aimed at providing counsel and guidance on the research and experimentation with
p.000024: human embryonic biological samples and to contribute to the updating and dissemination of the scientific
p.000024: and technical knowledge in this matter.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000018: legal representative shall take into account the desires and objections that are previously expressed
p.000018: by the affected person. Additionally, in these cases, actions must be accordance with that
p.000018: provided in section 1 of article 4 of this Law.
p.000018: 2. When it is foreseeable that the research is not going to produce results for the direct health benefit
p.000018: of the subjects referred to in section 1 of this article, the research may be authorised in an exceptional manner
p.000018: if in addition to the requisites established in subsections b), c) and
p.000018: d) of the earlier section, the following conditions are met:
p.000018: a) That the object of the research is to contribute, through meaningful improvements of the
p.000018: understanding of the disease or the condition of the individual, to a beneficial result for other persons of
p.000018: the same age or with the same disease or conditions, within a reasonable time frame.
p.000018:
p.000018: b) That the research entails a minimum risk and burden to the participating individual.
p.000018: c) That the authorisation of the research is made known to the Ministry of the Public Prosecutor.
p.000018:
p.000018: Article 21. Research on persons unable to consent due to their clinical situation.
p.000018:
p.000018: 1. For undertaking research in situations of clinical emergency, in which the person involved may
p.000018: not provide their consent, the following specific conditions must be met:
p.000018: a) That research of comparable efficacy is not possible to be undertaken on persons who are not
p.000018: in that emergency situation.
p.000018: b) That in the event that it is not foreseeable that the research is going to produce beneficial
p.000018: results for the health of the patient, that it has the purpose to contribute in a meaningful manner
p.000018: to the understanding of the disease or the condition of the patient, with the purpose of
p.000018: benefiting other persons with the same disease or condition, always that it entails a minimum risk and discomfort for
p.000018: him.
p.000018: c) That the authorisation of the research is made known to the Ministry of the Public Prosecutor.
p.000018: 2. Any previously expressed objection by the patient that is known by the doctor in charge
p.000018: of providing assistance, by the researcher or by the Research Ethics Committee of the centre
p.000018: shall be observed.
p.000018: 3. In reference to section one of this article, research in emergency situations are considered to
p.000018: be those in which the person is not in condition to provide his consent and that, due to their state
p.000018: and the emergency of the situation, the authorisation of the legal
p.000018:
p.000018: © Inter-University Chair in Law and the Human Genome
p.000019: 19
p.000019:
p.000019:
p.000019: representatives of the patient or if there are none, of the persons who live with him is impossible to obtain on
p.000019: time.
p.000019: 4. Persons who participate in a research in an emergency situation, or where appropriate, their legal
p.000019: representatives, shall be informed in the shortest time possible of the terms provided in article 4 of
p.000019: this Law. Likewise, the consent to continue participating in the research must be obtained
p.000019: when the patient is in a condition to provide it.
p.000019:
p.000019: CHAPTER IV
p.000019: Safety and Supervision Article 22. Risk Prevention.
p.000019: 1. Besides that provided in article 18, necessary measures shall be taken in order to guarantee the
p.000019: safety of the research and to reduce the risks and discomforts for the individuals who participate.
p.000019: Medical decisions related with the health of the participating subjects in research belong to the doctor in
p.000019: charge of their assistance.
p.000019: 2. The researcher in charge of the project must accredit that the members who are part of
p.000019: the research team have the adequate qualification and experience in the ambit of the proposed research.
p.000019:
p.000019: Article 23. Evaluation of the state of health.
p.000019:
p.000019: 1. Those persons who are going to participate in the research have the duty to provide real data about their physical
...
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p.000003: the National Health System are encouraged and there is a fostering of the ties between the
p.000003:
p.000003: public and private sector through research in networks and the mobility of researchers
p.000003: and practitioners.
p.000003: From an organizational perspective, the Law creates different professional entities
p.000003: that are recognised with a specially qualified function based on its impartiality, independence,
p.000003: technical capacity and professional competency that are required to its members. On the
p.000003: one hand, Research Ethics Committees shall guarantee that each research centre that intervenes on human beings or
p.000003: biological samples of human origin does so in accordance with methodological, ethical and
p.000003: legal aspects. The Commission for the Guarantees on the Donation and Use of Human Cells and Tissues
p.000003: shall be responsible for the compulsory evaluation and providing of information of those with
p.000003: a favourable report of those research projects that require the obtaining or use of tissues, embryonic stem cells
p.000003: or other similar of human origin that are obtained through diverse techniques of cell reprogramming
p.000003: that already exist or that could be discovered in the future, as well as the development of other
p.000003: functions on scientific, ethical or legal aspects. Finally, the Spanish Bioethics Committee is
p.000003: created as the authority for the consultation of all aspects with ethical and social
p.000003: implications in the field of Medicine and Biology and is called upon to set guidelines and general
p.000003: principles for the drafting of codes of good practices in scientific research that are developed by the
p.000003: Research Ethics Committees.
p.000003:
p.000003: III
p.000003:
p.000003: © Inter-University Chair in Law and the Human Genome
p.000004: 4
p.000004:
p.000004:
p.000004: The Law expressly prohibits the creation of human pre-embryos and embryos exclusively for the purpose of
p.000004: experimentation, in accordance with the gradualist perspective on the protection of human life set out
p.000004: by our Constitutional Court in rulings such as 53/1985, 212/1996 and 116/1999, but allows the use of any
p.000004: technique for the obtaining of embryonic stem cells for therapeutic or research purposes that does not
p.000004: entail the creation of a pre-embryo or of an embryo exclusively for this purpose and in the terms provided in
p.000004: this Law.
p.000004: In reference to the use of supernumerary embryos from assisted human
p.000004: reproduction techniques, the starting point is that established by Law 14/2006, of 26 May, on Assisted
p.000004: Human Reproduction Techniques, which expressly forbids the so-called reproductive human cloning.
p.000004:
p.000004: IV
p.000004:
...
p.000014: 14
p.000014:
p.000014:
p.000014: or for the study of the molecular basis of diseases.
p.000014:
p.000014: Article 10. Promotion and quality of biomedical research.
p.000014:
p.000014: 1. The promotion of biomedical research shall be based on criteria of quality, efficacy and
p.000014: equal opportunities.
p.000014: 2. Any biomedical research must be scientifically justified, must comply with the generally
p.000014: accepted scientific criteria and must be undertaken in accordance with the adequate professional
p.000014: obligations and standards, under the supervision of a scientifically qualified
p.000014: researcher. Furthermore, it shall also be evaluated at its conclusion.
p.000014:
p.000014: Article 11. Entry and exit of biological samples.
p.000014:
p.000014: The entry and exit, both within EU countries and those outside the EU of biological samples of human
p.000014: origin for those research purposes mentioned in this Law shall be governed by the regulations that are
p.000014: established by law.
p.000014: When the biological samples come from biobanks, there shall be an additional observance of the
p.000014: conditions for a conveyance and safety that are established in title V of this law.
p.000014:
p.000014: Article 12. Research Ethics Committees.
p.000014:
p.000014: 1. The Research Ethics Committees of those centres that undertake biomedical research shall
p.000014: be duly accredited by the corresponding authority of the autonomous community to
p.000014: which they belong or, in the case of centres that belong to the General
p.000014:
p.000014: Administration of the State, by the corresponding authority of such, in order to assure its
p.000014: independence and impartiality.
p.000014: The following criteria shall be considered, at least, when accrediting a Research
p.000014: Ethics Committee: independence and impartiality of its members with regard to promoters or
p.000014: researchers of biomedical research projects, as well as its cross-disciplinary make up.
p.000014: The corresponding authorities may create Research Ethics Committees that carry out their functions in two or
p.000014: more centres that undertake biomedical research.
p.000014: 2. The Research Ethics Committee of a centre shall exercise the following functions:
p.000014: a) To evaluate the qualification of the main researcher and that of the research team as well as the
p.000014: feasibility of the project.
p.000014: b) To ponder the methodological, ethical and legal aspects of the research project.
p.000014: c) To ponder the balance of the anticipated risks with the benefits arising from the study.
p.000014: d) To watch over the compliance of the procedures that permit to assure the traceability
p.000014: of samples of human origin, notwithstanding that provided in the legislation on the protection of
p.000014: data of a personal nature.
p.000014: e) To inform, after an evaluation of the research project, of all biomedical research that
p.000014: implies interventions on human beings or that use human biological samples, notwithstanding other reports
...
p.000016: f) Measures to assure an adequate compensation in the event that the subject is damaged.
p.000016: g) Identity of the professional who is responsible for the research.
p.000016: h) Any potential future use of the results of the research, including those that are commercial.
p.000016: i) Financing source of the research project.
p.000016: In the event that these matters are not known, there is an explicit compromise to complete this
p.000016: information when available.
p.000016: 3. In the event that the future or simultaneous use of genetic data or biological samples would
p.000016: be foreseen, then the provisions of Chapters II and III of Title V of this Law shall be applicable.
p.000016: 4. Furthermore, the persons that are asked to participate in research shall be informed of the rights and
p.000016: safeguards that are provided in this Law for their protection and specifically, on their right to
p.000016: refuse to consent or to revoke it at any moment without this affecting their right to health
p.000016: assistance.
p.000016:
p.000016: CHAPTER II
p.000016: Evaluation, authorisation and assurance of the damage
p.000016:
p.000016: Article 16. Evaluation and authorisation.
p.000016:
p.000016:
p.000016: Every biomedical research that entails an invasive procedure in the human being shall be previously
p.000016: evaluated by the Research Ethics Committee with oversight of the submitted research project and
p.000016: authorised by the corresponding autonomous authority. The evaluation must be previous to the
p.000016: authorisation, favourable, duly motivated and shall take into account the scientific
p.000016: suitability of the project, its relevance, feasibility and the suitability of the main researcher and
p.000016: the research team.
p.000016: In the event that the partial results that are obtained advise a modification of the
p.000016: project, this modification shall require a favourable report by the Research Ethics Committee
p.000016: and shall be notified to the competent autonomic authority for all practical purposes.
p.000016: In the case of research projects that are undertaken in several centres, the unity of criteria and
p.000016: the existence of a sole report shall be guaranteed.
p.000016:
p.000016: Article 17. Control and Follow up Guarantees.
p.000016:
p.000016: 1. The carrying out of research shall, in every case, abide by the content of the project which
p.000016: has been granted authorisation.
p.000016: 2. The health authorities shall have at all times faculty to inspect the research, being able to have access to
p.000016: the individual clinical histories of the subjects of the study, which, in every case, they must keep
p.000016: its confidential nature.
p.000016: 3. The autonomous authority shall proceed, on its own instance or on behalf of the Research
p.000016: Ethics Committee, to the temporary suspension of the authorised research in the cases where
p.000016: the
p.000016:
p.000016: © Inter-University Chair in Law and the Human Genome
p.000017: 17
p.000017:
p.000017:
p.000017: requisites provided by this Law aren’t met and when necessary to protect the rights of citizens.
p.000017:
p.000017: Article 18. Compensation for damages and its assurance.
p.000017:
p.000017: 1. Those persons, who have suffered damages as a consequence of their participation
p.000017: in a research project, shall receive a compensation that corresponds in accordance with that provided in the
p.000017: following sections.
p.000017: 2. The undertaking of a research that entails an invasive procedure in human beings shall require the
p.000017: previous assurance of the general and special damages that could be derived for the person in whom it
p.000017: has been carried out.
p.000017: 3. When, for whatever reason, the insurance policy doesn’t fully cover the caused damages, the promoter
p.000017: of the research, the researcher in charge and the hospital or centre in which it was carried out shall be joint
p.000017: and severally liable for them, even if there is no fault, thereby being responsible to bear the burden
p.000017: of proof. Neither the administrative authority nor the report of the Research Ethics Committee
p.000017: shall release them from liability.
p.000017: 4. There is a presumption, unless otherwise proven, that the damages that affect the health of a person
p.000017: subject to research, during its undertaking and the year following its conclusion, have been
p.000017: produced as a consequence of such research. However, once the year has passed, the subject of the research shall be
p.000017: obliged to prove the damage and the nexus between the research and the damage caused.
p.000017: 5. In reference to other aspects related with the liability for the damages and its
p.000017: assurance, that which is provided on the legislation
p.000017:
p.000017: on guarantees and the rational use of medicines and health products shall be applicable.
p.000017:
p.000017: CHAPTER III
p.000017: Specific Situations
p.000017:
p.000017: Article 19. Research during pregnancy and lactation.
p.000017:
p.000017: 1. Any research in which a pregnant woman participates, which shall not produce a direct benefit for
p.000017: her, or embryo, foetus or the child after his birth shall only be authorised if the following
p.000017: conditions are met:
p.000017: a) That the aim of the research is to contribute to produce results that are for the benefit of other
...
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
p.000019: project is justified in light of new knowledge that is reached throughout its execution.
p.000019:
p.000019: © Inter-University Chair in Law and the Human Genome
p.000020: 20
p.000020:
p.000020:
p.000020: The main researchers must send to the Committee, without delay, any relevant information for the safety of the
p.000020: participating subjects.
p.000020: 2. The purpose of the aforementioned verification in the earlier section shall
p.000020: have as its finality to determine:
p.000020: a) Whether it is necessary to interrupt the research or to make changes in the project in order
p.000020: to continue.
p.000020: b) Whether the participants in the research or, where appropriate, their representatives, must
p.000020: be informed on events that may happen.
p.000020: c) Whether it is necessary to have an additional consent by the participants.
p.000020: 3. Any relevant modification in the authorised conditions for a research project shall not take place
p.000020: without the previous favourable opinion of the Research Ethics Committee and the approval of the corresponding
p.000020: authority.
p.000020: 4. Any relevant information on the participation in the research shall be made known via
p.000020: written communication to the participants or, where appropriate, to their representatives as soon as
p.000020: possible.
p.000020: 5. The Research Ethics Committee shall proceed to follow up on the compliance with that established in the
p.000020: previous section, having the duty to report the incidences that are observed by the corresponding
p.000020: authority that provided the authorisation for that research, in order that this may
p.000020: adopt the corresponding measures, in accordance with article 17 of this Law and with full
p.000020: respect to that provided in existing regulations in matters of protection of data of a personal nature.
p.000020: 6. The researcher in charge shall report the reasons for the early
p.000020:
p.000020: termination of any research project to the Research Ethics Committee and to the corresponding authority
p.000020: which provided its conformity to the research.
p.000020:
p.000020: CHAPTER V
p.000020: Management of Information Article 26. Duty to inform.
p.000020: According to that provided in article 4.5, if research would provide relevant information for the health of
p.000020: the participants, then this must be made available to them, which shall done within the framework of
p.000020: assistance that is underway, or for lack of, by providing a specific counselling.
p.000020:
p.000020: Article 27. Information on the results.
p.000020:
p.000020: 1. Once the research has concluded, the researcher in charge shall forward a summary of it to the
p.000020: corresponding authority that provided the authorisation and to the corresponding Research Ethics
p.000020: Committee.
p.000020: 2. The research results shall be communicated to the participants, always when these request so.
p.000020: 3. The researchers shall make public the general results of their research once these
p.000020: have concluded, taking into account the requirements related to data of a personal nature that are
p.000020: mentioned in article 5.5 of this Law and without detriment to the corresponding rights of intellectual and
p.000020: industrial property that could be derived from this research.
p.000020:
p.000020:
p.000020: TITLE III
p.000020:
p.000020: © Inter-University Chair in Law and the Human Genome
p.000021: 21
p.000021:
p.000021:
p.000021: On the donation and use of human embryos and foetuses, their cells, tissues or organs.
p.000021:
p.000021: CHAPTER I
p.000021: Donation of human embryos and foetuses
p.000021:
p.000021: Article 28. Donation of human embryos and foetuses.
p.000021:
p.000021: 1. Human embryos that have lost their capacity for biological development, as well as
p.000021: dead human embryos or foetuses, may be donated for biomedical research or other diagnostic,
p.000021: therapeutic, pharmacological, clinical or surgical purposes
p.000021: 2. The interruption of a pregnancy shall never have as its purpose the donation and later use of embryos,
...
p.000022:
p.000022:
p.000022: CHAPTER II
p.000022: Conditions for biomedical research with human embryos and foetuses
p.000022:
p.000022: Article 30. Limitations on research with live embryos and foetuses in the uterus.
p.000022:
p.000022: Interventions on the live embryo or foetus in the uterus shall be exclusively authorised when
p.000022: their purpose is diagnostic or therapeutic in its own interest, notwithstanding what is legally established on
p.000022: the voluntary interruption of a pregnancy.
p.000022:
p.000022: Article 31. Requisites on the use.
p.000022:
p.000022: 1. Research on human embryos or foetuses or their biological structures must comply with
p.000022: the following requisites:
p.000022: a) That the embryos or foetuses fit within any of the situations established in section 1 of article 28
p.000022: of this Law.
p.000022: b) That the conditions provided in article 29 on the donation of the embryos and foetuses that are going
p.000022: to be used are taken into account.
p.000022: c) That a project is drafted on the expected use and that it has a favourable report by the Guarantees
p.000022: Commission for the Donation and use of Human Cells and Tissues.
p.000022: d) That the corresponding autonomous or State authority has provided an authorisation to its
p.000022: expected use.
p.000022: 2. The team responsible for the authorised project must
p.000022:
p.000022: communicate its result both to the entity that provided the authorisation to the submitted project, as well
p.000022: as to the Guarantees Commission for the Donation and use of Human Cells and Tissues.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: TITLE IV
p.000022: On the obtaining and use of cells and tissues of human embryonic origin and other
p.000022: similar cells
p.000022:
p.000022: CHAPTER I
p.000022: On the use of ovocites and pre- embryos
p.000022:
p.000022: Article 32. Donation of ovocites and pre-embryos.
p.000022:
p.000022: 1. Research with ovocites and pre- embryos must have the consent of the persons from whom they come from,
p.000022: who can revoke it at any moment without affecting the research undertaken.
p.000022: 2. The donation of ovocites and pre-embryos shall be governed according to that provided in Law
p.000022: 14/2006, of 26 May, on Assisted Human Reproduction Techniques.
p.000022: In the case of ovocites, the consent of the donors shall make express reference to
p.000022: its authorisation for the use of a specific technique or techniques that are going to be
p.000022: applied to the ovocites that are object of the donation. For that purpose, the health
p.000022: professionals who are responsible for the obtaining of these ovocites shall provide the donors
...
p.000023: 2. The use of any technique for obtaining human stem cells for therapeutic or research purposes is
p.000023: allowed, always when it does not entail the creation of a pre-embryo or an embryo exclusively for this
p.000023: purpose, in the terms provided in this Law, including the activation of ovocites through nuclear transfer.
p.000023:
p.000023:
p.000023: CHAPTER II
p.000023: On research with embryonic biological samples
p.000023:
p.000023: Article 34. Guarantees and requisites for research.
p.000023:
p.000023: 1. Research or experimentation with surplus ovocites or pre- embryos from assisted reproduction
p.000023: techniques, or their biological structures, for purposes related with the obtaining, development and use of
p.000023: embryonic stem cell lines or with other purposes not associated with the development and application of
p.000023: assisted reproduction techniques, shall be undertaken in accordance with that provided in Law 14/2006, of
p.000023: 26 May, and comply with the following requisites:
p.000023: a) That the research abides by ethical principles and the applicable legal regime, especially
p.000023: that provided in this Law and the regulation that develops it, and that it follows the principles of
p.000023: relevance, feasibility and suitability, particularly of the main researcher, of the research team
p.000023: and of the
p.000023:
p.000023: installations of the centre in which the research takes place.
p.000023: b) That it is based on a research project that is authorised by the State or autonomous authority, after
p.000023: having a favourable report by the corresponding Guarantees Commission for the Donation and Use
p.000023: of Human Cells and Tissues, in projects dealing with matters established in article 35.
p.000023: 2. The authorisation of research projects shall be conditioned to the project including at least
p.000023: the following elements:
p.000023: a) The authorisation by the management of the centre in which the research is going to take place as
p.000023: well as the favourable report of the corresponding Research Ethics Committee.
p.000023: b) The disclosure of the common relations and interests that exist, of whatsoever nature, or
p.000023: the absence of such, between the team and the centre that has undertaken each of the processes of assisted
p.000023: reproduction that have generated pre-embryos or that have intervened in the obtaining of the ovocites.
p.000023: c) The written compromise to provide the corresponding public authority the data that permit
p.000023: to identify and to know the conservation of the cell lines that could be obtained
p.000023: as a consequence of the development of the research.
p.000023: d) The compromise of the gratuitous conveyance of cell lines that could be obtained in
p.000023: the development of research for its use by other researchers.
p.000023: e) Where ovocites or pre- embryos are used, the indication and justification of their number
p.000023: and origin and the document of the informed consent, signed by the donor, or progenitors,
p.000023: respectively.
p.000023:
p.000023: © Inter-University Chair in Law and the Human Genome
p.000024: 24
p.000024:
p.000024:
p.000024: Article 35. Report of the Guarantees Commission for the Donation and Use of Human Cells and Tissues.
p.000024:
p.000024: 1. The previous favourable report of the Guarantees Commission for the Donation and Use of Human Cells and
p.000024: Tissues shall be required for those research projects that deal, in whole or in part, with the following
p.000024: matters:
p.000024: a) Research with human pre- embryos for the derivation of cell lines, for embryologic research and for
p.000024: other research purposes, except for those related with the development and application of
p.000024: assisted reproduction techniques.
p.000024: b) Research with human embryonic stem cells
p.000024: c) The activation of ovocites through nuclear transfer for therapeutic or research purposes.
p.000024: d) Any other technique, that using in whole or in part, human biological samples, can lead to the obtaining of
p.000024: stem cells
p.000024: e) Research with embryonic cells or tissues obtained through any of the procedures mentioned in article
p.000024: 33.2.
p.000024: f) Any other line of research that includes cell material of human embryonic origin or
p.000024: other functionally similar.
p.000024: g) Research with embryonic stem cell lines that come from another country, within the EU countries or
p.000024: those outside the EU. This origin shall be specified in the project submitted for authorisation.
p.000024: 2. The authority that granted the authorisation to the research project mentioned in the earlier section,
p.000024: shall annually forward its results to the Guarantees Commission for the Donation and use of Human Cells and
p.000024: Tissues.
p.000024:
p.000024: Article 36. Access to cryopreserved ovocites and pre- embryos.
p.000024:
p.000024: The Institute of Health Carlos III shall guarantee the access to surplus cryopreserved
p.000024: pre-embryos from assisted reproduction techniques that have been donated for research purposes.
p.000024: The same criteria shall be followed with ovocites donated for research.
p.000024:
p.000024: CHAPTER III
p.000024: On the Guarantees Commission for the Donation and use of Human Cells and Tissues
p.000024:
p.000024: Article 37. Creation of the Commission.
p.000024:
p.000024: 1. A Guarantees Commission for the Donation and Use of Human Cells and Tissues is created as the association
p.000024: composed of several persons, assigned to the Institute of Health Carlos III, of a permanent and
p.000024: consultative nature, aimed at providing counsel and guidance on the research and experimentation with
p.000024: human embryonic biological samples and to contribute to the updating and dissemination of the scientific
p.000024: and technical knowledge in this matter.
p.000024: 2. The counterpart commissions that are created in the Autonomous Communities shall be considered as
p.000024: commissions to provide support and reference to the Guarantees Commission for the Donation and use of
p.000024: Human Cells and Tissues and shall collaborate with it in the exercise of its functions.
...
p.000025: 4. The President of the Commission shall be named by the Minister of Health and Consumption from
p.000025: among its members.
p.000025: 5. The Secretary of the Commission shall be a civil servant with the rank of vice-director
p.000025: general who belongs to the Institute of Health Carlos III, who will have a say but no vote.
p.000025: 6. The members of the Commission shall have access to the detailed information on the research project on
p.000025: cells and tissues that are referred to in this title, on the National Registry of Activity and
p.000025: Results of the Assisted Reproduction Centres and Services which are referred to in Law 14/2006, of 26
p.000025: May, on Assisted Human Reproduction Techniques and on the National Registry of Cell Lines.
p.000025:
p.000025: CHAPTER IV
p.000025: On the promotion and coordination of research with human embryonic cells and tissues
p.000025:
p.000025: Article 40. Promotion and coordination.
p.000025:
p.000025: 1. The promotion and coordination of research with embryonic biological samples shall be
p.000025: the responsibility of the Ministry of Health and Consumption, through the Institute of Health
p.000025: Carlos III, notwithstanding the powers that may
p.000025:
p.000025: © Inter-University Chair in Law and the Human Genome
p.000026: 26
p.000026:
p.000026:
p.000026: correspond to the autonomous communities.
p.000026: 2. The corresponding authority, via the Institute of Health Carlos III, through the procedure that
p.000026: may be established by regulations, shall forward those research projects that must have a report issued
p.000026: by the Guarantees Commission for the Donation and Use of Human Cells and Tissues.
p.000026:
p.000026: Article 41. Registry of projects.
p.000026:
p.000026: The Institute of Health Carlos III shall be responsible for the maintenance of the
p.000026: registry of research projects, whose data shall be based on that provided by the corresponding
p.000026: authorities with power to authorise the projects, and shall have the updated information on the registry
p.000026: of pre-embryos, ovocites and cells lines available in the centres for in vitro fertilisation, in the National
p.000026: Registry of Donors and the National Bank of Cell Lines.
p.000026: This registry shall include, at least:
p.000026: a) The identifying data of the centre that is carrying out the project and the research team
p.000026: responsible for its execution.
p.000026: b) The documentation provided by the main researcher that states the objectives, protocols that are
p.000026: going to be used and the expected results of the project.
p.000026: c) The report of the Guarantees Commission for the Donation and Use of Human Cells and Tissues.
p.000026: d) The certification of the authorisation to undertake research granted by the
p.000026: corresponding authority with power to do so.
p.000026: e) At the end of the authorised research, an evaluation report by the Guarantees Commission for the
p.000026: Donation and Use of Human Cells and Tissues.
p.000026:
p.000026: Article 42. National Bank of Cell Lines.
p.000026:
p.000026: 1. The National Bank of Cell Lines shall be structured as a network, with a central node responsible
p.000026: for its coordination and shall be assigned to the Institute of Health Carlos III.
p.000026: 2. The National Bank of Cell Lines shall promote the quality and safety of the procedures over which it
p.000026: exercises its competence, shall keep the confidentiality of the data and other demands in reference
p.000026: to those acts that it carries out, in accordance with that established in Law 14/2006, of 26
p.000026: May, on Assisted Human Reproduction Techniques, and Basic Law 15/1999, of 13 December,
p.000026: on the Protection of Data of a Personal Nature, and shall act in accordance with the principles of
p.000026: precaution, proportionality and non-profit.
p.000026: 3. The Technical Commission of the National Bank of Cell Lines, whose composition and functions
p.000026: shall be determined by an order of the Minister of Health and Consumption, shall see to it that
p.000026: the access to cell lines for the execution of research projects is undertaken within those scientifically,
p.000026: ethical and legal principles in force and must have available updated information on the
...
p.000028:
p.000028: © Inter-University Chair in Law and the Human Genome
p.000029: 29
p.000029:
p.000029:
p.000029: necessary for the follow up of a prescribed treatment by the doctor and that has been accepted by the
p.000029: patient shall be provided. When this information is necessary to avoid a serious damage for the health of his
p.000029: biological family, then the affected or their legally authorised representative may be
p.000029: informed. In every case, the communication shall be exclusively limited to the data necessary for these ends.
p.000029:
p.000029: Article 50. Access to genetic data by health personnel.
p.000029:
p.000029: 1. Health professionals of the centre or the establishment that stores the clinical history
p.000029: of the patient shall have access to the data recorded in it in so far as it is relevant for the
p.000029: assistance that is being provided to the patient, notwithstanding the duties of secrecy and
p.000029: confidentiality to which they are subject.
p.000029: 2. Genetic data of a personal nature can only be used for epidemiological, public
p.000029: health, research or education purposes when the interested subject has expressly provided his
p.000029: consent or when this data has been previously anonimised.
p.000029: 3. In exceptional cases and of general health interest, the corresponding authority,
p.000029: after a favourable report by the authority on data protection, may authorise the use of codified genetic data,
p.000029: always when assuring that third parties may not be able to associate the source subject.
p.000029:
p.000029: Article 51. Duty of confidentiality and the right to the protection of genetic data.
p.000029:
p.000029: 1. The personnel who have access to genetic data in the exercise of
p.000029:
p.000029: their functions shall be subject to the duty of secrecy in a permanent manner. The disclosure of personal
p.000029: genetic data to third parties is only permitted with the express written consent of the person from whom
p.000029: these proceed.
p.000029: If the publishing of the results of a research is not possible without identifying the source subjects, then
p.000029: such results may only be published with their consent.
p.000029: 2. In case of genetic analysis to several members of a family, the results shall be filed
p.000029: and communicated to each of them in an individual manner. In case of disabled or minors, the
p.000029: information shall be provided to their tutors or legal representatives.
p.000029:
p.000029: Article 52. Conservation of data.
p.000029:
p.000029: 1. Personal genetic data shall be kept during a period of no less than five years from the date in which
...
p.000030: g) The discomforts, risks and adverse events that could be derived from the diagnostic process,
p.000030: including those associated to the taking of samples and to the therapeutic or preventive
p.000030: measures that are offered by the program.
p.000030: 7. The regulations established by this Law for genetic analysis shall be applicable to tests used in genetic
p.000030: screenings.
p.000030:
p.000030: Article 55. Genetic Counselling.
p.000030:
p.000030: 1. When a genetic analysis is undertaken for health reasons, then an appropriate genetic counselling
p.000030: must be guaranteed to the interested person, in a manner that shall be established by
p.000030: regulation, always abiding by the criteria of the person interested.
p.000030: 2. The professional who carries out or coordinates the genetic counsel must provide adequate information and
p.000030: counselling, in relation to both the transcendence of the resulting genetic diagnosis as well as the
p.000030:
p.000030: © Inter-University Chair in Law and the Human Genome
p.000031: 31
p.000031:
p.000031:
p.000031: possible alternatives that the subject may choose.
p.000031:
p.000031: Article 56. Quality Requirements.
p.000031:
p.000031: The entire process of genetic counsel and of the practice of genetic analysis for health purposes
p.000031: must be undertaken by qualified personnel and must be carried out in accredited centres that meet the
p.000031: requirements of quality that are established for this purpose by regulation.
p.000031: Article 57. Accreditation of the centres for genetic analysis.
p.000031: The corresponding autonomous or state authority shall accredit the centres, public or private, that may
p.000031: perform genetic analyses and that, in every case, must comply with that provided in articles 46 through 57 of this
p.000031: Law.
p.000031:
p.000031:
p.000031: CHAPTER III
p.000031: Use of human biological samples for biomedical research
p.000031:
p.000031: Article 58. Obtaining of samples.
p.000031:
p.000031: 1. The obtaining of biological samples for biomedical research shall be undertaken solely when
p.000031: the previous written consent has been obtained from the subject source and after being informed about
p.000031: the consequences and risks that this can entail for his health. The consent shall be revocable.
p.000031: 2. The consent of the subject source shall always be necessary when the aim is to use
p.000031: biological samples for biological research that have already been obtained for a different purpose,
p.000031: irrespective of whether there is an anonimisation.
p.000031: Notwithstanding this, in an exceptional manner, codified or
p.000031:
p.000031: identified samples for biomedical research may be used without the consent of the subject source when
p.000031: the obtaining of this consent is not possible or it entails a non- reasonable effort to
p.000031: the effects provided in article 3.i) of this Law. In these cases, the favourable opinion of the
...
p.000033: uses.
p.000033: 2. The aforementioned in the previous section is understood to be applicable in so far as
p.000033: the identification data of the sample has not been subject to anonimisation in accordance with that provided in this
p.000033: Law.
p.000033:
p.000033: Article 62. Report of the Research Ethics Committee.
p.000033:
p.000033: In every case, the favourable report of the Research Ethics Committee of the centre shall be necessary in
p.000033: order to obtain and use biological samples for biomedical research
p.000033:
p.000033: and for biodiversity studies, particularly when the use of biological samples that
p.000033: come from deceased persons has been foreseen or when the aim is to incorporate a biological
p.000033: sample to a line of research that is not related to that for which the consent was initially granted.
p.000033:
p.000033: CHAPTER IV
p.000033: Biobanks Article 63. Scientific Interest.
p.000033: The authorisation for the creation of a biobank shall require that its organisation, objectives
p.000033: and available means justify its biomedical interest.
p.000033:
p.000033: Article 64. Authorisation.
p.000033:
p.000033: 1. The Minister of Health and Consumption shall have the competence for the creation
p.000033: of national banks of biological samples that are deemed convenient for the general welfare.
p.000033: 2. The authorisation of the corresponding authority of the autonomous community shall
p.000033: be necessary for the creation of other biobanks.
p.000033:
p.000033: Article 65. Ownership.
p.000033:
p.000033: 1. The physical or legal person, public or private, that holds ownership of a biobank shall
p.000033: be responsible for it.
p.000033: 2. If there is a change in the ownership of the person responsible for the biobank, or the modification
p.000033: or broadening of the objectives of it, then that event shall be communicated to the corresponding
p.000033: authority, who, where appropriate, shall grant a new authorisation.
p.000033:
p.000033: © Inter-University Chair in Law and the Human Genome
p.000034: 34
p.000034:
p.000034:
p.000034: Article 66. Organisation of the biobank.
p.000034:
p.000034: 1. The biobank shall have a scientific director, a person responsible for the files and shall
p.000034: be assigned to two external committees, a science and an ethics, respectively that
p.000034: will assist the director of the biobank in her functions.
p.000034: 2. The director of the biobank shall have the following obligations:
p.000034: a) To enforce the existing legislation.
p.000034: b) To keep a registry of activities of the biobank.
p.000034: c) To guarantee the quality, safety and traceability of stored biological data and samples and
p.000034: of the procedures associated with the functioning of the biobank.
p.000034: d) To draft an annual report of activities, this shall be made available to the authority
p.000034: that granted the authorisation for the creation of the biobank.
p.000034: e) To attend the consultations or complaints that could be addressed to the biobank.
p.000034: f) To draft a document of good practices of the biobank.
p.000034: g) To draft a descriptive memory that compiles the characteristics of the collections, the criteria for the
p.000034: inclusion and the purposes for which the collection is created, the manner in which the historic collection has
p.000034: been compiled and the information that can be associated to the samples.
p.000034: 3. The person responsible for the files shall attend all requests in the exercise of the rights to
p.000034: access, rectification, cancellation or opposition that are made by the subject source, in
p.000034: accordance with that provided in the existing legislation on the protection of data of a personal
p.000034: nature.
p.000034:
p.000034:
p.000034: Article 67. National Registry of Biobanks.
p.000034:
p.000034: 1. Once the biobank is constituted in accordance with the previous procedure, the
p.000034: corresponding authority shall proceed to register it in the National Registry of Biobanks for Biomedical
p.000034: Research, which shall be dependent of the Institute of Health Carlos III. Before that, they must register in
p.000034: the Spanish Agency for the Protection of Data in accordance with existing legislation. The data in
p.000034: this Registry shall be based in that provided by the competent authorities to authorise biobanks.
p.000034: 2. Any person or entity, public or private that has one or more ordered collections of human samples or
p.000034: biological material that come from identified or identifiable persons, must likewise register in the National
p.000034: Registry of Biobanks. This requisite shall be independent of its registration in the registries of
p.000034: other institutions due to their special nature or purpose.
p.000034: 3. Once registered, The Ministry of Health and Consumption shall certify the nature and scope of
p.000034: the collection.
p.000034: 4. The following shall not be subject to the aforementioned registration: those collections kept by physical
p.000034: persons for their exclusive personal use or the samples, though ordered as a collection, that have been
p.000034: obtained for the undertaking of pertinent analysis for diagnostic purposes and, where
p.000034: appropriate, for the treatment of the subject source and that are not kept stored during a period
p.000034: longer than the fulfilment of these objectives.
p.000034:
p.000034: Article 68. Inspections and control measures.
p.000034:
p.000034: © Inter-University Chair in Law and the Human Genome
p.000035: 35
p.000035:
p.000035:
p.000035:
p.000035: The corresponding authority shall make periodic inspections to guarantee that biobanks abide by
p.000035: the conditions of installation, organisation and functioning for which they were authorised.
p.000035:
p.000035: Article 69. Obtaining and assignment of samples.
p.000035:
p.000035: 1. The obtaining of samples shall be done in accordance with that provided in Chapter III of this
p.000035: Title.
p.000035: 2. The stored samples in a biobank shall be assigned freely to third parties who need them for use in
p.000035: biomedical research. Samples shall only be assigned for requests that come from research projects that have
p.000035: been scientifically approved. The request shall contain information on the project to be
p.000035: developed and the explicit commitment of the requesting centre and/or of the researchers
p.000035: who participate in the project to not use the requested material for a use different to that
p.000035: stated in the request. It must contain the approval by the scientific and ethical committees of
p.000035: the bank.
p.000035: 3. The costs of obtaining, maintenance, handling, shipping and other costs of a similar
p.000035: nature related with the samples may be passed on with the assignment of each sample. In every case,
p.000035: the quantity of the assigned samples shall be the minimum necessary for the undertaking of the project.
p.000035: 4. The obtaining, transportation, storage, handling and shipping of samples shall be done in conditions of
p.000035: biosafety in accordance with applicable legislation.
p.000035: 5. The total or partial refusal of the biobank to deliver samples which are solicited for biomedical research
p.000035: shall require a reasoned decision by
p.000035:
p.000035: the person in charge, who shall take into account the previous respective reports of the scientific director and the
p.000035: scientific and ethical committees that are mentioned in article 66.1
p.000035: 6. The assignment of samples may be accompanied by the associated clinical information, in which case the
p.000035: data shall be protected in accordance with that provided in the Law of the Autonomy of the Patient and the
p.000035: Law for the Protection of Personal Data.
p.000035:
p.000035: Article 70. Rights of the source subjects.
p.000035:
p.000035: 1. That provided in the articles of Chapter III of this title in relation with the obtaining, previous
p.000035: information, consent, confidentiality, assignment, conservation of data and samples, access to data and the
p.000035: right not to know shall be applicable to biological samples deposited in biobanks.
p.000035: 2. Notwithstanding that provided in the previous section, those biological samples that are added
p.000035: to biobanks may be used for any biomedical research, in the terms provided in this Law, always when
p.000035: the source subject, or where appropriate, his legal representatives have
p.000035: provided their consent in these terms.
p.000035:
p.000035: Article 71. Closure or closing of a biobank.
p.000035:
p.000035: 1. The competent authority may decide the closure or closing of a biobank, on its own motion or as
p.000035: requested and through a motivated resolution, in those cases in which there is non-compliance with the
p.000035: requisites established in this Law for its creation, organisation and function, or when its
p.000035: owner
p.000035:
p.000035: © Inter-University Chair in Law and the Human Genome
p.000036: 36
p.000036:
p.000036:
p.000036: manifests his will not to continue with its activity.
p.000036: 2. This resolution shall likewise provide the destination of the stored samples of the biobank that is going
p.000036: to be closured or closed.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: TITLE VI
p.000036: Infractions, sanctions and compensations for damages
p.000036:
p.000036: Article 72. General Dispositions.
p.000036:
p.000036: 1. The infractions provided in this Law related with the obtaining and use of human cells and tissues,
p.000036: on the use of invasive procedures in biomedical research, as well as personal genetic data shall be
p.000036: the object of the corresponding administrative sanctions, after the charges are compiled in
p.000036: a case, notwithstanding the civil, criminal or other type of liability that may also arise.
p.000036: 2. The sanctioning authority regulated in this Law shall be exercised, in those cases
p.000036: not provided in this Law, it shall be in accordance with that provided in Law 30/1992 of the Legal
p.000036: regulation of Public Administrations and the Common Administrative Procedure, in Law 14/1986, of 25 April,
p.000036: General Law on Health, and Basic Law 15/1999, of 13 December, on the Protection of Data of a
p.000036: Personal Nature.
p.000036: 3. When, in the opinion of by the Administration, the infraction could be an offence or misdemeanour, the
p.000036: administrative entity shall pass it on to the Prosecutor’s Office,
p.000036:
p.000036: abstaining form continuing with the sanctioning procedure until the judicial authority has made
p.000036: a pronouncement.
p.000036: The criminal sanction shall exclude the imposition of an administrative sanction always when it
p.000036: is imposed for the same acts and in relation to the same protected public interests, though all other
p.000036: responsibilities that can be deduced from other acts or infractions that concur must be enforced.
p.000036: If the decision is that there hasn’t been an offence or misdemeanour, then the administration
p.000036: shall continue with its sanctioning proceeding, taking as its basis, where appropriate, those
p.000036: facts that the courts have considered as proven.
p.000036: 4. The administrative measures that would have been adopted in order to safe keep the right to the
p.000036: protection of health and safety of the people shall be kept as long as the judicial authority doesn’t make a
p.000036: pronouncement on such.
p.000036: 5. Very serious offences shall prescribe after three years, serious, after two and minor after six months.
p.000036: The sanctions imposed for very serious offences shall prescribe after three years, those for
p.000036: serious offences after two and those for minor offences after a year.
p.000036:
p.000036: Article 73. Responsibilities.
p.000036:
p.000036: 1. The author shall be responsible for the different infractions.
p.000036: 2. When in accordance with the obligations provided in this Law, the compliance of the
p.000036: obligations corresponds to several persons jointly, then they shall be held joint and severally liable
p.000036: in accordance with that provide in article 130.3 of Law 30/1992, of 26 November, of the Legal Regulation
p.000036: of the Public
p.000036:
p.000036: © Inter-University Chair in Law and the Human Genome
p.000037: 37
p.000037:
p.000037:
p.000037: Administrations and the Common Administrative Procedure. The same norm shall be applicable to the
p.000037: directors of the centres or services for the non-compliance with the aforementioned obligations by the
p.000037: biomedical professionals who are under their responsibility.
p.000037:
p.000037: Article 74. Infractions.
p.000037:
p.000037: 1. Infractions shall be classified as minor, serious or very serious in accordance with the harmfulness of
p.000037: the act, the quantity of the eventual benefit obtained, the health and social alteration produced and its
p.000037: degree of intent.
p.000037: 2. Besides that provided in the General Health Law, the Law on the Protection of Personal Data, the
p.000037: Law on Assisted Human Reproduction Techniques, Basic Law on the Autonomy of the Patient and
p.000037: of the Rights and Obligations in Matters of Clinical Documentation and on other regulations passed by the
p.000037: autonomous communities, in accordance with this Law, the following infractions shall be
p.000037: considered as minor serious and very serious:
p.000037: A) Minor infractions are:
p.000037: Those that entail the non- compliance of any obligation or the violation of any prohibition
p.000037: that is provided in this Law, always when in accordance with the criteria provided in this section they
p.000037: can’t be classified as serious or very serious infractions.
p.000037: B) Serious infractions are:
p.000037: a) Non-observance of the prescriptions, conditions, requisites or previous authorisations that
p.000037: are provided in this Law for the functioning of the registries provided in this Law.
p.000037:
p.000037: b) The omission of data, consents and references required by this Law.
p.000037: c) The non-providing of data to the appropriate health authority responsible for the functioning
p.000037: of registries provided in this Law.
p.000037: d) The breach of the conditions of confidentiality of the data of the donors established in this Law.
p.000037: e) The non-fulfilment of the gratuity of the donation of pre- embryos, embryos and foetuses
p.000037: in the terms provided in this Law.
p.000037: f) The non-fulfilment of the norms and guarantees established for the transfer between countries of cells
p.000037: and tissues of human embryonic origin.
p.000037: C) Very serious infractions are:
p.000037: a) The carrying on of any intervention aimed at the introduction of a modification
p.000037: in the genome of the descent.
p.000037: b) To continue with the development in vitro of the pre- embryos beyond the limit of 14
p.000037: days after the fertilisation of the ovocite, taking away from that time that which in which it may
p.000037: have been cryopreserved.
p.000037: c) To keep living embryos and foetuses outside the uterus for any purpose other than procreation.
p.000037: d) The extraction of cells or tissues from embryos or foetuses in development of the placenta or
p.000037: casings for purposes other than diagnostic or therapeutic in the interest of these, except in
p.000037: those cases provided in Law 14/2006, of
p.000037: 26 May, on Assisted Human Reproduction Techniques.
p.000037: e) Non-fulfilment of that provided in article 33.
...
General/Other / oviedo
Searching for indicator oviedo:
(return to top)
p.000002: biobanks.
p.000002:
p.000002: II
p.000002:
p.000002: Facing this outlook, it is necessary to have available an adequate normative framework that provides
p.000002: answers to the new scientific challenges while at the same time guarantees the protection of
p.000002: the rights of the persons who could be affected by the acts of research.
p.000002: In fact, both at the international level as well as within Spanish society, some of the most
p.000002: sensitive aspects related with biomedical research have been the object of open and thorough debate,
p.000002: which has allowed to deduce principles
p.000002:
p.000002: and criteria, each time of greater acceptance, from which to create norms and regulations of behaviour
p.000002: that achieve the necessary equilibrium between the needs of researchers and the trust of society in
p.000002: scientific research. In accordance with this spirit, this Law has as one of its priority axis the assurance of
p.000002: the respect and the protection of fundamental rights and public liberties of the human being and
p.000002: other legal goods related with them which have been established in our legal regulation, notably within the Spanish
p.000002: Constitution and the Convention for the Protection of Human rights and Dignity of the Human
p.000002: Being with regard to the Application of Biology and Medicine of the Council of Europe, signed in
p.000002: Oviedo, April 4, 1997 and which entered into effect in Spain on 1, January 2000. Consequently,
p.000002: the Law proclaims that the health, interest and well-being of the human being that participates in
p.000002: biomedical research shall prevail over the interest of society or science.
p.000002: In particular, the Law is built on the principles of the integrity of the persons and the protection of
p.000002: the dignity and identity of the human being in any biomedical research that involves the intervention
p.000002: on human beings as well as in the undertaking of genetic analysis, the processing of genetic data
p.000002: of a personal nature and of human biological samples used in research. Along these lines,
p.000002: the Law establishes the free will of a person as the foundation from which the specific rights to
p.000002: consent and to obtain previous information is derived. Likewise, it establishes the right to not
p.000002: be discriminated, the duty of confidentiality by any person that in the exercise of their duties has access to
p.000002: personal information,
p.000002:
p.000002: © Inter-University Chair in Law and the Human Genome
p.000003: 3
p.000003:
p.000003: the principle of gratuity of the donations of biological material and it sets the standards of
p.000003: quality and safety, which include the traceability of human cells and tissues and the strict compliance
p.000003: of the precautionary principle in the different activities that it regulates. In regulating
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000019: where appropriate, the consultation to the doctors responsible for the medical
p.000019: assistance of the participants, to
p.000019:
p.000019: verify such extremes before the beginning of the research, in order to assure that the persons for whom
p.000019: the research entails a special risk are excluded from it.
p.000019: 2. When research involves women in a fertile age, the possible adverse impact on an unknown existing
p.000019: pregnancy or a later one, as well as on the health of the embryos, foetuses or child shall be taken into
p.000019: account.
p.000019:
p.000019: Article 24. Non-interference with necessary clinical interventions.
p.000019:
p.000019: 1. Research must not delay or deprive the participants of the preventive, diagnostic or
p.000019: therapeutic medical procedures that are necessary for their state of health.
p.000019: 2. In research associated with the prevention, diagnosis or treatment of diseases, there must be
p.000019: an assurance that the participants who are assigned to the control groups receive proven procedures of
p.000019: prevention, diagnosis or treatment.
p.000019: The researcher must place on record the extremes which are referred to in the previous section in
p.000019: the protocol of the trial that she is going to submit for evaluation and authorisation.
p.000019: 3. A placebo may be used only if there are no methods of proven efficacy or when the withdrawal
p.000019: of these methods does not entail an unacceptable risk or damage to the patient.
p.000019:
p.000019: Article 25. Verifications of the progress of research.
p.000019:
p.000019: 1. The Research Ethics Committee shall take the adequate measures in order to verify that the continuity of the
p.000019: project is justified in light of new knowledge that is reached throughout its execution.
p.000019:
p.000019: © Inter-University Chair in Law and the Human Genome
p.000020: 20
p.000020:
p.000020:
p.000020: The main researchers must send to the Committee, without delay, any relevant information for the safety of the
p.000020: participating subjects.
p.000020: 2. The purpose of the aforementioned verification in the earlier section shall
p.000020: have as its finality to determine:
p.000020: a) Whether it is necessary to interrupt the research or to make changes in the project in order
p.000020: to continue.
p.000020: b) Whether the participants in the research or, where appropriate, their representatives, must
p.000020: be informed on events that may happen.
p.000020: c) Whether it is necessary to have an additional consent by the participants.
p.000020: 3. Any relevant modification in the authorised conditions for a research project shall not take place
...
Orphaned Trigger Words
p.000001: not foreign to the interest raised by these researches and the debate it arises. In this sense, the public
p.000001: administrations are decisively supporting biomedical research and are providing important economic
p.000001: and human resources and the necessary infrastructures to foster such end. Both the
p.000001: General Administration of the State, when exercising its jurisdiction of the fostering and general
p.000001: coordination of scientific and technical research as established in article 149.1.15 of the Constitution, as
p.000001: well as the administrations of the autonomous communities, which in their statutes have unanimously
p.000001: stated their jurisdiction to foster research, are establishing structures for biomedical
p.000001: research in networks open to the participation and collaboration with private
p.000001: enterprises, with different entities of research, universities and their own centres of the National Health
p.000001: System, in order to take advantage in an efficient manner of the available resources and to
p.000001: obtain results from the contributions of the different research groups, that can be applied to the improvement of
p.000001: the
p.000001:
p.000001: © Inter-University Chair in Law and the Human Genome
p.000002: 2
p.000002:
p.000002:
p.000002: health of their citizens. In this manner, there is compliance in the field of biomedical research with
p.000002: the mandate established in article 44.2 of the Spanish Constitution that entrust the public powers to
p.000002: promote science and scientific and technical research for the general welfare.
p.000002: This law is set within this context and, on the one hand, responds to the challenges that are posed by
p.000002: biomedical research and tries to take advantage of its results for the collective health and
p.000002: well-being, while on the other, promotes and stimulates the coordinated action of the public powers and of
p.000002: the public and private entities and institutions dedicated to research, which are provided with better
p.000002: instruments to comply with their task. Furthermore and in order to achieve these objectives, the
p.000002: Law establishes regulations in areas that were not regulated up to the present, that have been so in
p.000002: a fragmented manner or that were foreign to the changes that have happened in the last years, such as genetic
p.000002: analysis, research with human biological samples, in particular of an embryonic nature, or
p.000002: biobanks.
p.000002:
p.000002: II
p.000002:
p.000002: Facing this outlook, it is necessary to have available an adequate normative framework that provides
p.000002: answers to the new scientific challenges while at the same time guarantees the protection of
p.000002: the rights of the persons who could be affected by the acts of research.
p.000002: In fact, both at the international level as well as within Spanish society, some of the most
p.000002: sensitive aspects related with biomedical research have been the object of open and thorough debate,
p.000002: which has allowed to deduce principles
p.000002:
...
p.000004: reproduction techniques, the starting point is that established by Law 14/2006, of 26 May, on Assisted
p.000004: Human Reproduction Techniques, which expressly forbids the so-called reproductive human cloning.
p.000004:
p.000004: IV
p.000004:
p.000004: This Law regulates such a broad and complex set of matters, compiled in ninety articles,
p.000004: fifteen chapters, eight titles, three additional dispositions, one repealing and five
p.000004: final dispositions.
p.000004: The general dispositions of Title I are the regulating and integrating axis of the Law. The object and
p.000004: scope of application of this Law are set out and it establishes a set of principles and guarantees for
p.000004: the protection of the rights of persons and of the legal goods involved in biomedical research.
p.000004: Regarding the object and scope of the regulation, there is clarification that the biomedical research that is
p.000004: made reference to by the regulation covers basic and clinical research and excludes clinical trials with
p.000004: medication and the implantation of
p.000004:
p.000004: organs, tissues and cells, which shall be regulated in a specific regulation.
p.000004: Regarding the system of guarantees, there is a specific list that sets the limits to the
p.000004: principle of freedom of research in favour of the dignity and identity of the human being and for the
p.000004: protection of the health and there is a specific regulation of the following: informed consent and the
p.000004: right to information, the protection of personal data and the duty of confidentiality, the non-
p.000004: discrimination due to genetic reasons or due to the refusal to undergo a genetic analysis or to
p.000004: participate in research, the gratuity of the donation and use of biological samples, the guarantee of
p.000004: the traceability and the safety in the use of cells, tissues and any biological material of human origin and
p.000004: lastly, it establishes the limits that must be abided in genetic analysis.
p.000004: Additionally, this title regulates the criteria which biomedical research must follow regarding quality,
p.000004: efficacy and equality and the Biomedical Research Committees are created as fundamental tools for the
p.000004: evaluation and follow-up of research projects. Lastly, article 3 establishes a broad list of
p.000004: definitions, which based on scient
p.000004: ific, technical and legal knowledge, aim to delimit some relevant concepts of the Law.
p.000004: The first specific matter of the Law, compiled in Title II, is dedicated to biomedical
p.000004: research that involves invasive procedures on human beings, excluding those that are merely observational.
p.000004: This regulation completes the normative framework of our legal regulation on research in which human beings are
p.000004: direct participating subjects, which already has specific regulations on
p.000004:
p.000004: © Inter-University Chair in Law and the Human Genome
p.000005: 5
p.000005:
p.000005:
p.000005: clinical trials with medications and health products.
p.000005: Its five chapters regulate, firstly, the general principles of these research, with express references
...
p.000007: Bioethics Committee, basically of a consulting nature on matters related with the ethical, legal and
p.000007: social implications on Medicine and Biology, which also represents Spain in the
p.000007: supranational and international forums and bodies that
p.000007:
p.000007: © Inter-University Chair in Law and the Human Genome
p.000008: 8
p.000008:
p.000008: are involved in Bioethics and that collaborates with other state and autonomous committees
p.000008: with counselling functions on these matters. Title VII of this Law establishes those
p.000008: provisions on its composition and functioning, which aims to guarantee its independence through the
p.000008: designation of its members from accredited qualified persons of the scientific, legal and bioethical
p.000008: world.
p.000008: Lastly, title VIII of this Law, which is particularly relevant, is aimed at the promotion and coordination of
p.000008: biomedical research within the National Health System regarding the elaboration of a sector
p.000008: initiative within the National Plan for Scientific Research and Technological Development and
p.000008: Innovation. Together with this and due to the continuous demands of certain research groups, the aim is
p.000008: a better regulation of the promotion and coordination of biomedical research in Spain. In order to
p.000008: achieve both objectives, an instrumental normative framework is created for the promotion of
p.000008: scientific research of excellence aimed to resolve the health needs of the population and particularly
p.000008: the clinical practice based on scientific knowledge within the structures of the National Health System, allowing
p.000008: the capacity to hire personnel dedicated to research activities to those centres that are part of it and
p.000008: opening the possibility that the research activity becomes an integrating part of the
p.000008: professional career of the statutory personnel. Furthermore, mobility measures are established for
p.000008: the research personnel within the general administration of the state and towards private
p.000008: entities of research through a temporary leave of absence.
p.000008:
p.000008: Additionally, the cooperation among the public and private sectors is strengthened by among
p.000008: other measures, the collaboration and participation of private entities in the execution of research
p.000008: activities of the National Health System and establishes the possibility that the personnel of these
p.000008: private entities participate in the execution of research programs of projects in the National Health
p.000008: System.
p.000008: Among those dispositions that conclude the articles of this Law, special mention must be made of the
p.000008: additional second, which revises and updates the regulation of the Institute of Health Carlos III as a basic
p.000008: instrument of the General Administration of the State for fostering biomedical research.
p.000008: The diverse provisions and regulations established in this Law offer an innovative normative set,
p.000008: which is complete and, to a great extent, capable of adapting to circumstances and situations
p.000008: to which biomedical research is foreseeable headed to in the coming years. It is a normative
p.000008: instrument that while at the same time it complies with its aim to guarantee the legal rights and
...
p.000009: legislation, and are excluded from the scope of application of this Law.
p.000009:
p.000009: Article 2. Principles and guarantees of biomedical research.
p.000009:
p.000009: The undertaking of any activity of biomedical research within this Law shall be subject to compliance with
p.000009: the following guarantees:
p.000009: a. The protection of the dignity and identity of the human being shall be protected in relation
p.000009: with any research that involves interventions on human beings in the field of
p.000009: biomedicine, thus guaranteeing every person, without any discrimination, the respect to their integrity
p.000009: and to other fundamental rights and freedoms.
p.000009: b. The health, interest and well- being of the human being who participates in biomedical research
p.000009: shall prevail over the interest of society or science.
p.000009: c. Research on human biological samples shall be undertaken in a framework
p.000009: of respect towards the fundamental rights and freedoms, guaranteeing the confidentiality in the handling of
p.000009: data of a personal nature and in biological samples, especially in the undertaking of genetic analysis.
p.000009: d. Freedom of research and of scientific production in the ambit of the biomedical sciences shall
p.000009: be guaranteed.
p.000009: e. The authorisation and development of any research project on human beings or their biological
p.000009: material shall require the previous and mandatory favourable report of the Research Ethics Committee.
p.000009: f. The research shall be undertaken in accordance with the precautionary principle in order
p.000009: to prevent and avoid risks for life and health
p.000009: g. The research shall be object of evaluation.
p.000009:
p.000009: © Inter-University Chair in Law and the Human Genome
p.000010: 10
p.000010:
p.000010:
p.000010: Article 3. Definitions.
p.000010:
p.000010: The following shall be used when interpreting this Law:
p.000010: a. “Genetic Analysis”: procedure aimed at detecting the presence, absence or variations of one or
p.000010: several segments of genetic material, which includes indirect tests to detect a gene
p.000010: product or a specific metabolite that is especially indicative of a specific genetic change.
p.000010: b. “Genetic-population analysis”: research whose object is to understand the nature
p.000010: and magnitude of genetic variations within a population or among individuals of the same group
p.000010: or different groups.
p.000010: c. “Anonimisation”: process whereby it is no longer possible to establish through reasonable means
p.000010: the nexus between the subject and her data. I t is also applicable to the biological sample.
p.000010: d. “Biobank”: public or private non-profit establishment which has a collection of biological
p.000010: samples conceived for biomedical diagnostic or research purposes and organised as a technical unit with
p.000010: criteria of quality, order and destination.
p.000010: e. “Genetic counsel”: procedure aimed at informing a person about the possible consequences for him or
p.000010: his descent about the results of a genetic analysis or screening, its advantages and risks and, where
...
p.000013: when there has been a previous and express consent of this person.
p.000013:
p.000013: Article 6. Non-discrimination.
p.000013:
p.000013: No one shall be the object of any type of discrimination on account of their genetic characteristics. Also, a
p.000013: person shall not be able to be discriminated on the basis of their refusal to undergo a
p.000013: genetic analysis to provide their consent to participate in a biomedical research or to donate biological
p.000013: material, particularly in relation with the conveyance of medical health care assistance that
p.000013: corresponds to the person.
p.000013:
p.000013:
p.000013: Article 7. Non profit.
p.000013:
p.000013: The donation and use of human biological samples shall be gratuitous, whichever its
p.000013: specific origin, and the compensations that are provided for in this Law can in no way entail a
p.000013: lucrative or commercial nature.
p.000013: Likewise, the donation implies the waiver by the donor to any right, of an economic nature or other, on the results
p.000013: that could be directly or indirectly obtained through the
p.000013:
p.000013: research that takes place with these biological samples
p.000013:
p.000013: Article 8. Traceability and safety.
p.000013:
p.000013: The traceability of cells, tissues and any biological material of human origin must be guaranteed in order
p.000013: to assure the regulations on quality and safety, abiding by the duty of confidentiality and that provided
p.000013: in Basic Law 15/19999, of 13 December on the Protection of Data of a Personal Nature.
p.000013: When researching with cells or tissues aimed for their application on the human being, the data
p.000013: to guarantee their traceability must be kept during at least thirty years.
p.000013: The activities related with biomedical research shall be undertaken with strict
p.000013: compliance with the precautionary principle in order to prevent serious risks for human life and health.
p.000013:
p.000013: Article 9. Limits on genetic analysis.
p.000013:
p.000013: 1. The protection of the rights of persons shall be assured in the undertaking of genetic analysis
p.000013: and in the treatment of genetic data of a personal nature in the health field.
p.000013: 2. Genetic analysis shall take place with criteria of pertinence, quality, equity and accessibility.
p.000013: 3. Predictive tests of genetic diseases or those that permit to identify the subject as the
p.000013: carrier of a gene responsible for a disease or tests to detect a predisposition to a genetic susceptibility of a
p.000013: disease, shall only be carried out for medical or medical research purposes and with genetic counselling,
p.000013: when indicted, or in the case of a study of inter-individual differences in the response to prescriptions and
p.000013: the genetic-environmental interactions
p.000013:
p.000013: © Inter-University Chair in Law and the Human Genome
p.000014: 14
p.000014:
p.000014:
p.000014: or for the study of the molecular basis of diseases.
p.000014:
p.000014: Article 10. Promotion and quality of biomedical research.
p.000014:
p.000014: 1. The promotion of biomedical research shall be based on criteria of quality, efficacy and
p.000014: equal opportunities.
p.000014: 2. Any biomedical research must be scientifically justified, must comply with the generally
p.000014: accepted scientific criteria and must be undertaken in accordance with the adequate professional
p.000014: obligations and standards, under the supervision of a scientifically qualified
p.000014: researcher. Furthermore, it shall also be evaluated at its conclusion.
p.000014:
p.000014: Article 11. Entry and exit of biological samples.
p.000014:
...
p.000014: Ethics Committee: independence and impartiality of its members with regard to promoters or
p.000014: researchers of biomedical research projects, as well as its cross-disciplinary make up.
p.000014: The corresponding authorities may create Research Ethics Committees that carry out their functions in two or
p.000014: more centres that undertake biomedical research.
p.000014: 2. The Research Ethics Committee of a centre shall exercise the following functions:
p.000014: a) To evaluate the qualification of the main researcher and that of the research team as well as the
p.000014: feasibility of the project.
p.000014: b) To ponder the methodological, ethical and legal aspects of the research project.
p.000014: c) To ponder the balance of the anticipated risks with the benefits arising from the study.
p.000014: d) To watch over the compliance of the procedures that permit to assure the traceability
p.000014: of samples of human origin, notwithstanding that provided in the legislation on the protection of
p.000014: data of a personal nature.
p.000014: e) To inform, after an evaluation of the research project, of all biomedical research that
p.000014: implies interventions on human beings or that use human biological samples, notwithstanding other reports
p.000014: that must be created. No research project may be authorised or developed without the previous
p.000014: and mandatory favourable report by the Research Ethics Committee.
p.000014:
p.000014: © Inter-University Chair in Law and the Human Genome
p.000015: 15
p.000015:
p.000015:
p.000015: f) To develop codes of good practices in accordance with the principles established by
p.000015: the Spanish Bioethics Committee and to manage conflicts and proceedings generated by its non-compliance.
p.000015: g) To coordinate its activities with that of similar committees of other institutions.
p.000015: h) To watch over the confidentiality and to exercise whichever other functions that
p.000015: could be assigned by the regulation in the development of this Law.
p.000015: 3. The Research Ethics Committees, in the exercise of their functions, may require
p.000015: all information that they need, and particularly that on the sources and quantity of the financing
p.000015: of the studies and the distribution of expenses.
p.000015: 4. The members of the Research Ethics Committee shall have to declare their activities and interests
p.000015: and shall abstain from taking part in the deliberations and votes in which they have a direct or indirect interest in
p.000015: the matter being examined.
p.000015:
p.000015: TITLE II
p.000015: Research that involves invasive procedures on human beings
p.000015:
p.000015: CHAPTER I
p.000015: General principles and requirements on information and consent
p.000015:
p.000015: Article 13. Consent.
p.000015:
p.000015: The carrying out of research on a person shall require the express, specific and written consent of
p.000015: the person, or their legal representative, in accordance with the general principles set out in article 4 of
p.000015: this Law.
p.000015:
p.000015: Article 14. General Principles.
p.000015:
p.000015:
p.000015: 1. Research on human beings shall only take place in the absence of another alternative with
p.000015: a comparable efficacy.
p.000015: 2. Research shall not involve disproportionate risks or discomforts for the human being in relation with
p.000015: the potential benefits that may be obtained.
p.000015: 3. Notwithstanding what was previously established in the earlier paragraph, when the
p.000015: research doesn’t have the possibility to produce results that directly benefit the health of
p.000015: the participating subject, then the research can only begin in case that it entails a minimum risk
p.000015: and burden for the subject, in accordance with the decision of the Research Ethics Committee that
p.000015: must evaluate this research.
p.000015:
p.000015: Article 15. Information to the subjects participating in the research.
p.000015:
p.000015: 1. Those persons who have been asked to participate in a research project shall previously receive the
p.000015: necessary information, duly documented and in a comprehensible manner, and
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| another country | Other Country |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| criminal | criminal |
| dependent | Dependent |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| education | education |
| embryo | embryo |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| family | Motherhood/Family |
| fertile | of childbearing age/fertile |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| incapacity | Incapacitated |
| job | Occupation |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| party | political affiliation |
| placebo | participants in a control group |
| pregnant | Pregnant |
| property | Property Ownership |
| stem cells | stem cells |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| foetus | ['foetuses'] |
| foetuses | ['foetus'] |
Trigger Words
capacity
consent
ethics
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input