The third final provision of Law 14/2007, of July 3, of Biomedical Research, empowers the Government to dictate the provisions necessary for the development and execution of this law, among which it mentions expressly the basic requirements for the approval of biomedical centres, services and equipment relating to the procurement and use of any biological material of human origin for biomedical research purposes, and the operation and Organization of the National Register of Biobanks for Biomedical Research.

As established in Law 14/2007 of July 3, the objective of this regulation is to comply with the mandate of Articles 20.1.b) and 44.2 of the Spanish Constitution, the first of which recognizes and protects the rights to literary, artistic, scientific and technical production and creation, and the second entrusts to the public authorities the promotion of science and scientific and technical research for the benefit of the general interest. This interest has constituted the perspective from which this royal decree is dictated, in understanding that a quality investigation is one that develops with respect for the rights of the subjects involved and under certain guarantees of quality.

According to the spirit of the law, the provisions of this royal decree will apply to the use of biological samples for scientific and technical research purposes, which includes innovation and development. as the primary or secondary end of the procurement, storage or disposal of the same. The rights of the subjects will have to be respected whenever their biological material is used to obtain new scientific knowledge, confirm hypotheses, or carry out technological adaptation activities, quality controls, teaching, etc.

The scope of this research is that of biomedicine, which for the purposes of this royal decree covers the different disciplines dedicated to the study of human health, which excludes others such as forensic investigation regulated in the Organic Law 10/2007, of October 8, regulating the police database on identifiers obtained from the DNA, and in articles 326, 363 and additional provision third of the Law of Criminal Procedure.

In this royal decree, the different structures in which the research is currently developed with human biological samples in Spain are translated. Thus, the concepts "network of biobanks" and "biobank in network" are defined in a sufficiently open way to cover different organizational models and to facilitate the promoters to configure these establishments in the way that best adapt to your needs.

As provided for in Law 14/2007 of July 3, the system of authorization for the constitution and operation of the biobanks, and the basic requirements of its organization, which corresponds to the development of the Autonomous Communities and the State, while establishing special conditions for the creation of national biobanks.

The royal decree distinguishes between the general regime for the treatment of biological samples for biomedical research purposes and the specific regime to be applied when this treatment is carried out in a biobank. In both cases, it is stressed that the principles laid down in Law 14/2007 of 3 July, with a special emphasis on the need for express and written consent for the obtaining and use of the samples, are emphasized in the obligation of respect the right to privacy and self-determination, and in the gratuitousness of the whole process of the processing of the samples. The system of obtaining and using samples of deceased persons is developed, based on the principles of Law 14/2007, of July 3, and in those already established in our legal system for the use of biological material after the death under Law 30/1979 of 29 October on the extraction and transplantation of organs and their supplementary legislation. These principles relate to respect for the will of the subject in life and to solidarity and citizen participation in scientific progress.

Moreover, the distinction made in Article 70.2 of Law 14/2007 of 3 July between the scheme applicable to the collection of samples and biobanks, which is justified by the characteristics of the product, is developed. The European Commission, in particular, is a member of the European Commission in the field of health and safety at work, in order to make available to the scientific community the biological material needed for research in the best possible conditions. competitiveness and excellence of research in Spain.

On the one hand, the regime applicable to biobanks is characterized in that biological samples that are incorporated into biobanks can be used for any biomedical research, in the terms prescribed by the law, always the source or, where appropriate, his legal representatives have given their consent in these terms.

The second difference that must be emphasized is that of the possibilities of transfer to third parties of the samples: the vocation of public service of the biobanks makes it essential for its operation that the consent of the Source subject includes the assignment of the samples in terms also wider than when it comes to samples deposited in collections, since in the latter case an express consent is required for each assignment.

In order to ensure that the circulation of the samples is maintained in an environment that preserves the effective protection of the guarantees due, this royal decree identifies the possible sources of samples that can be stored in the a biobank or preserved in a collection, or directly intended for a particular research project, so that the exchange is always carried out under an agreement or agreement documented between the parties.

In accordance with Article 1.3 of Law 14/2007 of July 3, the biomedical research to which this royal decree refers includes basic and clinical research, with the exception of the latter case of the clinical trials with medicinal products and medical devices, which shall be governed by their specific rules, although biological samples of human origin that have been obtained in tests are included in the scope of this royal clinical medicinal products and medical devices, provided that they are to be used for the purpose of biomedical research.

Finally, the operation and organization of the National Register of Biobanks for Biomedical Research is established, as provided for in Law 14/2007 of 3 July, with the main aim of giving publicity to the existence of these establishments and make it easier for the scientific community to access the material they host, and to serve as a means of control.

In accordance with Directive 2006 /123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market, there is a "overriding reason of general interest" to consider the the administrative silence in the authorisation procedures provided for in this royal decree, because these are activities related to public health.

This royal decree partially develops the third final provision of Law 14/2007 of July 3, and is given in the framework of the regime established in Chapters III and IV of Title V of that Law.

In the process of this royal decree, the reports of the Ministries of Science and Innovation, Health, Social Policy and Equality, and of Territorial Policy and Public Administration, and the Spanish Agency of Data protection, and has been offered to the citizens and to the autonomous communities.

This royal decree is issued under the protection of article 149.1.15. of the Spanish Constitution, which attributes to the State exclusive competence in the promotion and coordination of scientific and technical research.

In its virtue, on a proposal from the Minister of Science and Innovation, with the prior approval of the Vice President of the Government of Territorial Policy and Minister of Territorial Policy and Public Administration, according to the Council of the State and after deliberation by the Council of Ministers at its meeting on 18 November 2011,

DISPONGO:

PRELIMINARY TITLE

General provisions

Article 1. Object.

The present royal decree has as its object:

a) Establish the basic requirements for the authorization and operation of biobanks for biomedical research purposes.

b) Develop the regime for the treatment of biological samples of human origin for the purposes of biomedical research provided for in Law 14 of July 3, of Biomedical Research.

c) Regular the operation and organization of the National Register of Biobanks for Biomedical Research.

Article 2. Definitions.

Without prejudice to Article 3 of Law 14/2007, of July 3, of Biomedical Research, for the purposes of this royal decree, it is understood by:

(a) "Anonymization of biological samples of human origin" means a process by which it is no longer possible to establish by reasonable means the link between a biological sample or research data and the subject to which they relate.

b) "Biobank for biomedical research purposes": public or private, non-profit establishment, which hosts one or more collections of biological samples of human origin for biomedical research purposes, organized as a technical unit with quality, order and destination criteria, regardless of which lodge samples for other purposes.

c) "Network Biobank": biobank with a single organization and a decentralized activity.

d) "National Biobank for Biomedical Research Purposes": biobank for biomedical research purposes created by the person holding the Ministry of Science and Innovation for their special general interest.

(e) "Cession of biological samples of human origin for biomedical research purposes": transfer of biological samples to a third party for biomedical research purposes.

f) "Collection of biological samples of human origin": an ordered set and with a vocation for the permanence of biological samples of human origin preserved outside the organizational scope of a biobank.

g) "Collection of biological samples of human origin for biomedical research purposes": collection of biological samples of human origin for biomedical research.

The biological samples of human origin that are kept exclusively for use in a particular research project are excluded from this concept, provided that their conservation is not extended beyond the the date of completion of that project and shall not be transferred.

(h) "Collection of biological samples of human origin maintained for exclusively personal uses": collection of biological samples of human origin maintained by natural persons in the exercise of activities exclusively Other than biomedical research. Exclusively personal activities shall be carried out outside the scope of the exercise of any professional or economic activity.

i) "biological samples of human origin preserved for use in a research project": biological samples of human origin that are kept outside the organizational scope of a biobank exclusively for their use use in a particular research project, provided that its conservation is not to be extended beyond the date of completion of that project and will not be transferred.

j) "Biobanks Network": a set of biobanks that have signed a collaboration agreement to jointly develop all or part of their activity.

k) "Responsible for the file": a natural or legal person or administrative body that shall address the requests for the exercise of the rights of access, rectification, cancellation or opposition formulated by the source, compliance with the provisions of the existing rules on the protection of personal data.

(l) "Holder of the scientific address of the biobank": a natural person, designated as such by the person who holds the biobank, on which the obligations referred to in Article 66.2 of Law 14/2007 of 3 July fall.

m) "Holder of the biobank": a natural or legal person who holds the ownership of the biobank and who takes responsibility for the purposes of this royal decree.

n) "Treatment of biological samples of human origin" means a set of operations and procedures for the collection, storage, storage, use and disposal of biological samples of human origin and, where appropriate, the data associated with them.

Article 3. Scope of application.

1. The provisions of this royal decree will apply:

(a) Biobanks for biomedical research purposes, collections of biological samples of human origin for biomedical research purposes and biological samples of human origin used in research projects, including those used in the framework of a clinical trial.

b) To biobanks, collections of biological samples of human origin and biological samples of human origin obtained for care or diagnosis, as long as all or some of the samples are to be used also with biomedical research purposes.

2. The provisions of this royal decree will not apply:

(a) to collections of biological samples of human origin maintained by natural persons for exclusively personal uses other than biomedical research, to which the legislation on the subject shall apply, where appropriate; personal data protection.

(b) To biological samples of human origin, even if ordered as a collection, and to biobanks, when the samples have been obtained and used exclusively for care purposes or for any other professional purpose alien to biomedical research.

(c) To pre-embryos and oocytes of human origin, the conservation and treatment of which shall be carried out in accordance with the provisions of Law 14/2006 of 26 May on assisted human reproduction techniques and their rules of development.

d) To clinical trials with medicinal products and medical devices, which will be governed by their specific regulations, although the biological samples of human origin that have been used are included in the scope of this royal decree. have been obtained in clinical trials with medicinal products and medical devices, after the relevant clinical trial has been completed and provided that they are part of a collection or biobank.

TITLE I

Constitution, operation, organization and closure of biobanks for biomedical research purposes

CHAPTER I

General Regime

Section 1. Authorization for the constitution and operation, inspection and closure of biobanks

Article 4. Authorisation for the establishment and operation of biobanks.

1. The establishment of a biobank for biomedical research purposes requires the prior authorisation of the competent authority.

2. The Autonomous Communities are competent to authorize the formation and operation of biobanks in their respective fields of competence, without prejudice to the powers conferred on the Ministry of Science and Innovation for the creation of National Biobanks. It is for the Autonomous Communities to determine the competent authority for such effects in their territorial scope.

3. Authorization procedures for the establishment and operation of biobanks must comply with the provisions of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Administrative Procedure. Common.

The maximum period for notification of the express resolution shall be three months from the date on which the application has entered the register of the body responsible for processing. The expiry of this maximum period without having been notified to the parties concerned shall have the effect of deducting the application to understand the administrative silence.

Article 5. Minimum requirements for the granting of authorisation for the establishment and operation of biobanks.

The minimum requirements for granting authorization for the establishment and operation of a biobank are as follows:

a) That the organization, objectives and means available to the biobank justify their biomedical interest.

(b) The person responsible for the scientific direction of the biobank and the person responsible for the file has been designated.

c) That the biobank is attached to two external committees, one scientific and one of ethics.

d) That the activity of the biobank does not involve a profit motive. However, the biobank may have an impact on the cession of each sample the costs of obtaining, ceding, maintaining, handling, processing, shipping and other similar expenses related to the samples, according to the established in Article 69.3 of Law 14/2007 of 3 July.

e) That the data file has been entered in the General Data Protection Registry of the Spanish Data Protection Agency or, where appropriate, in the register of the autonomic data protection agency that results in the competent.

f) Having the necessary facilities and means to ensure the preservation of the samples under appropriate quality conditions, including the necessary measures to preserve their integrity in the face of possible failures technicians.

g) That meets the requirements indicated in this royal decree.

Article 6. Application for authorisation for the establishment and operation of biobanks.

1. The person responsible for the biobank shall be responsible for requesting authorisation for the establishment and operation of the biobank before the competent authority.

2. The application for authorisation shall be accompanied by at least the following documentation:

a) Rules of procedure for the operation of the biobank.

b) Rules of Procedure of the Scientific and Ethics Committees, and a letter of acceptance by the members of the external committees. In the case of an approved Research Ethics Committee, the supporting documentation of this membership will replace the ethics committee's rules of procedure and the letter of acceptance of its members.

c) A strategic operational plan for the first 5 years, including the necessary resources for the proper development of biobank activity and the forecasts for its economic viability.

d) Model of cost-to-third impact for sample disposal.

e) A document supporting the registration in the General Register of Data Protection of the Spanish Data Protection Agency or, where appropriate, in the register of the autonomic data protection agency, and a description of the measures planned to protect personal data in accordance with the provisions of the legislation in force.

f) Descriptive memory that includes the location of the biobank, the characteristics of the collections, the inclusion criteria and the purposes for which they are constituted, the way in which the historical collections have been collected and the information that can be associated with the samples. It shall also include guarantees for the preservation of the samples and systems available to preserve their integrity in case of failures in storage devices.

g) Proposal for the holder of the scientific and responsible management of the biobank file.

(h) Quality management plan and biosecurity plan, which shall include, inter alia, the conditions for the transport of the biological material and the procedure for ensuring the traceability of samples and of the data.

i) Where appropriate, indication of the existence of prior communication to the Health Institute Carlos III of the data relating to the samples that integrate biobank as a collection for purposes of biomedical research preserved outside the the organizational scope of a biobank, as indicated in paragraph 2 of the single transitional provision of this royal decree, and the number of the record sheet or order number of that collection in the National Register of Biobanks for Research Biomedical.

Article 7. Duration of the authorisation for the establishment and operation of biobanks.

Without prejudice to Article 10, the authorisation shall be granted for an indefinite period.

Article 8. Amendments to the conditions and requirements that led to the granting of the authorisation.

1. Any substantial change in the conditions and requirements which led to the granting of the authorisation requires the prior authorisation of the competent authorities to authorise the establishment and operation of the biobank.

Substantial modifications are considered relative to:

a) The objectives of the biobank;

b) the organizational and material and personal means scheme;

c) ownership of the biobank;

d) the internal rules of operation of the biobank and external committees;

e) the composition of the external committees;

f) the characteristics of the collections, the inclusion criteria and the purposes for which they are constituted;

g) the information that can be associated with the samples and

h) the cost-impact model to third parties.

2. The procedures for substantial modification under the conditions and requirements which led to the granting of the authorisation shall be in accordance with the provisions of Law No 30/1992 of 26 November 1992.

The maximum period for notification of the express resolution shall be three months from the date on which the application has entered the register of the body responsible for processing. The expiry of this maximum period without having been notified to the parties concerned shall have the effect of deducting the application to understand the administrative silence.

3. Non-substantial modifications shall be immediately communicated to the competent authorities.

Article 9. Inspections.

The competent authorities shall carry out periodic inspections to ensure that biobanks comply with the conditions of installation, organisation and operation with which they were authorised.

Article 10. Revocation of the authorisation for the establishment and operation of biobanks.

1. The authorities responsible for authorising the establishment and operation of the biobank shall revoke the authorisations when any of the following conditions are met:

(a) When any of the requirements for obtaining the authorization at the time of your application are missing, or any of the documents provided for application have been declared false by a firm court judgment.

(b) When the biobank ceases to comply, after the granting of the authorization of incorporation and operation, the requirements established to be authorized, without prejudice to the provisions of Article 8.

2. The purpose of the samples stored in the biobank shall be expressly provided for in the revocation resolution, which may consist of:

a) The destruction of the samples.

b) The transfer of the samples to another biobank.

c) The preservation of samples for use in specific research projects or integrated into a collection.

3. The procedures for revoking the authorisation for the establishment and operation of biobanks shall be in accordance with the provisions of Law No 30/1992 of 26 November.

The maximum period for the express resolution to be served shall be three months from the date of the initiation agreement.

Article 11. Closure of the biobank at the request of the holder.

1. The holder of a biobank may request the closure of the biobank to the competent authority to authorise its establishment and operation.

2. In the closing resolution, the destination of the samples stored in the biobank shall be expressly provided for the holder of the same. That destination may consist of:

a) The destruction of the samples.

b) The transfer of the samples to another biobank.

c) The preservation of samples for use in specific research projects or integrated into a collection.

Section 2. Organization of Biobanks

Article 12. Holder of the biobank.

The person who holds the biobank will request authorization for its constitution and operation, as well as the modification of the authorization and the closing of the biobank, if any. It shall also be responsible for its operation, submit the annual activity report to the authorities which authorised its establishment and operation, and designate the person who holds the scientific address.

Article 13. Holder of the scientific direction of biobank.

The person holding the scientific address of the biobank will have the following obligations:

a) Velar for compliance with current legislation.

b) Maintain a log of biobank activities.

c) Ensure the quality, safety and traceability of stored data and samples and the procedures associated with the operation of the biobank.

d) Develop an annual activity report, including, among other data, a reference to the signed agreements for the collection and disposal of samples.

(e) To tender for enquiries or complaints which may be addressed to the biobank, without prejudice to the provisions of Article 14.

f) Direct the ordinary management of the biobank.

g) Develop the biobank good practice document.

In the preparation of this document, it will be necessary to take into account, as far as possible, the recommendations issued by the main forums of international experts in the management of biological samples of human origin, and in Any case shall take into account the general principles established by the Spanish Research Ethics Committee.

h) Elaborate the modifications of the descriptive memory that collect the characteristics of the collections, the inclusion criteria and the purposes for which the collection is constituted, the way in which the historical collection and the information that can be associated with the samples.

i) Manage the transfer of samples, which will involve, among other tasks, responding to and, where appropriate, satisfying the requests to the biobank of the transfer of samples, as well as agreeing to incorporate the biobank of collections from others. centres; these functions may be delegated to other bodies or staff of the biobank.

Article 14. Responsible for the file.

The person responsible for the file will attend to requests for exercise of the rights of access to his personal data, rectification, cancellation or opposition formulated by the source subjects, in accordance with the provisions of the current rules on the protection of personal data.

Article 15. External biobank committees.

1. The external scientific and ethical committees shall be composed of each of them by a minimum of four members with sufficient knowledge in matters relating to the functions referred to in paragraphs 2 and 3 of this Article, which do not have direct participation in biobank activity.

Both committees will have internal operating regulations, which will establish appropriate mechanisms to ensure the independence and absence of conflicts of interest in the decision-making process. these committees. Where, in relation to a particular case, a direct personal or professional interest for a member of the external committees is present, the latter shall refrain from intervening.

The biobank will advertise the identity of the members that make up the external committees. The functions of the external ethics committee may be assumed by an existing Research Ethics Committee, which will implement its own regulations.

2. The functions of the Scientific Committee shall be:

(a) Carry out the scientific evaluation of the requests for the transfer of samples and data associated with them by the biobank. If the committee delivers an unfavourable opinion, the opinion shall be binding.

(b) Advise the person who holds the scientific direction of the adequacy of the established procedures to ensure the quality, safety and traceability of stored and stored data and samples. procedures associated with the functioning of the biobank, from the scientific point of view.

c) Advise the titular person of the scientific direction about the scientific aspects of the biobank good practice document.

d) Attend the holder of the scientific address on other issues that are subject to his or her consideration.

3. The functions of the ethics committee will be:

a) Conduct the ethical evaluation of the requests for the transfer of samples and data associated with them. If the committee delivers an unfavourable opinion, the opinion shall be binding.

(b) Advise the person who holds the scientific direction of the adequacy of the established procedures to ensure the quality, safety and traceability of stored and stored data and samples. procedures associated with the functioning of the biobank, from an ethical point of view.

c) Advise the person who holds the scientific direction about the ethical and legal aspects foreseen in the good practice document of the biobank.

d) Deciding the cases in which the individual sending of information to the source will be essential, in relation to the forecasts for the disposal of their samples and the results of the analyses carried out when they can be relevant to your health.

e) Attend the person who holds the scientific address on other issues that are subject to his or her consideration.

Article 16. Internal rules of operation of the biobank.

The internal operating rules of the biobank shall contain at least:

a) The criteria for the acceptance of samples in the biobank.

b) The procedure for the application of samples to the biobank and subsequent delivery thereof, in the terms provided for in this royal decree.

Article 17. Network biobank and biobanks networks.

1. Where a biobank is structured in a network, with a decentralised activity, a person responsible for its operation shall be appointed in each centre that integrates it or the area in which it is structured.

2. Where several biobanks are constituted in a network of biobanks, the operation of the biobanks shall be established in an internal regulation. The constitution, modifications and disappearance of the network shall be communicated to all the authorities which granted the authorizations to set up and operate the biobanks that make up the network.

CHAPTER II

Special regime for national biobanks

Article 18. Creation, scope of action and regulation of national biobanks.

1. The creation of a national biobank is the responsibility of the head of the Ministry of Science and Innovation.

2. National biobanks for biomedical research purposes will be created for their special general interest, which will be determined according to one of the following criteria:

a) Dimension or characteristics of the population whose samples are stored or are to be collected.

b) Nature or characteristics of the samples or techniques to be applied.

c) Research lines that constitute the purpose of the biobank.

3. The provisions of this Chapter and Articles 12, 13, 14, 15, 16 and 17 shall apply to national biobanks.

Article 19. Entitlement.

1. The ownership of the national biobanks shall be the responsibility of the General Administration of the State or the public entities and entities linked to or dependent on it. In the case of the General Administration of the State, national biobanks shall be attached to a ministerial department.

2. The ownership of a national biobank may be transferred to another body or public entity or to the General Administration of the State. In addition, within the General Administration of the State, the membership of a national biobank may be transferred to another ministerial department.

By ministerial order the conditions of the assignment and the period of validity will be established.

TITLE II

Treatment of biological samples of human origin for biomedical research purposes

CHAPTER I

General provisions

Article 20. Applicable rules.

It shall apply to the treatment of biological samples of human origin for biomedical research purposes as provided for in Chapters III and IV of Title V of Law 14/2007 of 3 July.

Article 21. Requirements for the obtention of biological samples of human origin for biomedical research purposes that entail some health risk.

When obtaining a biological sample for exclusive purposes of biomedical research leads to some health risk, either by its nature or by the characteristics of the source, the extraction of the sample must be be carried out by a professional with sufficient qualifications to carry out the type of procedure required and in a centre accredited or approved by the competent authorities to carry out diagnostic or therapeutic procedures the risk equal to or greater than the risk of such intervention.

Article 22. Storage and conservation of biological samples of human origin.

1. Biological samples of human origin intended for biomedical research may be stored in a biobank or maintained for use in a particular research project or as a collection for the purposes of biomedical research outside the organizational scope of a biobank.

2. Purpose of obtaining the samples:

(a) Storage in a biobank: samples that are incorporated into a biobank may be used for any biomedical research in the terms prescribed by Law 14/2007 of 3 July, provided that the source or, in your case, your legal representatives have given your consent in these terms.

b) Conservation as a collection for biomedical research purposes: samples that are incorporated into a collection for biomedical research purposes preserved outside the organizational scope of a biobank can only be used for the purpose specified in the consent document, except for the new express consent of the source for another purpose.

(c) Conservation for use in a research project: samples retained for use in a particular research project may only be used in that research project, except for new research projects. express consent of the source to be used in other projects or lines of investigation, in which case they must be deposited in a biobank, or to be integrated into a collection that must be communicated to the National Registry of Biobanks for Biomedical Research in your case.

Article 23. Consent for the procurement, storage or conservation and use of biological samples of human origin.

1. The collection of the samples, their storage or storage and subsequent use shall require the prior consent of the source, in which the purposes of obtaining the samples shall be indicated.

If the purposes are several, they may appear in the same document, although the faculty of the source must be guaranteed in any case to grant their consent for each purpose independently.

2. The consent document for the procurement, storage or conservation and use of biological samples of human origin for biomedical research purposes shall contain at least the following information for the source subject:

a) Description of the research project in which the sample is to be used or of the research or lines of research for which it consents.

b) Identity of the person responsible for the investigation, if any.

(c) Indication that the donated sample may be used only in the field of the purposes referred to in Article 22 (2).

(d) Indication that the biobank and the person responsible for the research collection or project will have at the disposal of the donor all the information on the research projects in which the sample is used; the external ethics committee of the biobank or the Research Ethics Committee that evaluated the research project will decide in which cases it will be necessary to send the information individually.

e) Expected benefits of the research project or biobank.

(f) Possible disadvantages related to the donation and collection of the sample, including the possibility of contacting the source subject in order to collect additional data or samples, to provide the information provided for in paragraph (i) or other justified reasons, for which information may be requested on how to do so, as well as its ability to take a position on this.

g) Place of analysis and destination of the sample at the end of the investigation. In the event that these extremes are unknown at the moment, the commitment to report on this will be established as soon as they are known.

(h) Indication that the sample or part of it and the associated clinical data or associated in the future thereto shall be kept and, where appropriate, transferred to third parties for the purposes of biomedical research in the terms of the Law 14/2007, of July 3, and in this royal decree.

i) The possibility of obtaining information regarding his or her family's health, derived from the genetic analysis performed on his biological sample, as well as on his or her ability to make a decision in relation to his/her communication

(j) Mechanisms to ensure the confidentiality of the information obtained, indicating the identity of the persons who are to have access to the personal data of the source subject to which it is not intended submit to anonymisation processes.

(k) the right to revoke the consent, in whole or in part, to be exercised at any time, and its effects, including the possibility of destruction or the anonymisation of the sample, and that such effects shall not be extended to the data resulting from investigations that have already been carried out.

l) Possibility to include any restrictions on the use of your samples.

m) Renunciation any right of an economic, patrimonial or potestative nature on the results or potential benefits that may be derived directly or indirectly from the investigations carried out with the shows you give in for research. However, and without prejudice to Article 7 of Law 14/2007 of 3 July, an economic compensation may be fixed for the physical inconvenience, expenses and other disadvantages that may arise from the sampling.

n) In the case of storage of samples of minors, guarantee of access to the information referred to in Article 32 on the sample by the source subject when the latter reaches the age of majority.

or) That, if there is an eventual closure of the biobank or revocation of the authorization for its constitution and operation, the information on the destination of the samples will be available in the National Register of Biobanks for Biomedical Research in order to enable it to express its conformity or disconformity with the intended purpose for the samples, without prejudice to the information to be received in writing by the source before giving its consent to obtain and use the sample.

p) In case of samples used in specific research projects, and in the case of collections for biomedical research purposes preserved outside the organizational scope of a biobank, the option chosen by the subject source among the possible as the target of the sample at project completion or investigation.

3. Where the samples are to be anonymized, only the information referred to in paragraphs (a), (b), (c), (e) and (f) shall be provided.

4. The document stating the consent of the source to obtain and use its biological samples for biomedical research purposes shall be issued in three copies. One of these will be delivered to the source subject, another will be retained in the centre where the sample was obtained and the third will be retained by the biobank, or by the person responsible for the collection or investigation, as appropriate.

5. Consent may be revoked, in full or for certain purposes, at any time.

Article 24. Exceptional treatment of biological samples of human origin for biomedical research purposes in the absence of express consent of the source subject.

On an exceptional basis, the coded or identified samples may be treated for biomedical research purposes without the consent of the source subject when obtaining such consent is not possible or represents a unreasonable effort; an unreasonable effort shall be taken to involve the use of a disproportionate amount of time, expenditure and work.

In such cases, the Research Ethics Committee shall issue a favourable opinion, for which it shall take into account at least compliance with the following requirements:

(a) That there is no viable alternative for the implementation of the project with another group of samples for which consent is available.

b) That is an investigation of general interest.

(c) That the investigation, duly authorized, be carried out by the same institution that requested the consent to obtain the samples, if this is necessary.

d) In the case of samples of identified or identifiable subjects, the investigation is less effective or not possible without the identifying data of the source subject.

e) That there is no express objection from the source or its legal representative.

f) To ensure the confidentiality of personal data.

g) That the effort, time, and human, material, and economic resources needed to obtain consent have been valued.

Article 25. Priority of the care interests of the source subject.

1. Where the samples are obtained for initially diagnostic or therapeutic purposes, the use for investigation of the samples under no circumstances may compromise those purposes.

2. It shall be for the professionals responsible for the diagnostic or therapeutic use of the sample, with the consent of the source subject, for the assignment of a part of the sample for use in research.

3. When, for health reasons, the source or family needs it, they may make use of the samples, provided they are available and are not anonymized.

Article 26. Obtaining and using biological samples of deceased persons.

1. The obtention and use of biological samples of deceased persons may be carried out in the event that they have been provided for in life or where they have not been expressly aware of their opposition. For these purposes, the existence of prior instructions will be investigated and, in the absence of such instructions, the next of kin of the deceased will be consulted and the professionals who cared for him in the health centre, and the consultations will be put on record. performed.

Samples may only be used for biomedical research after favourable opinion of the Research Ethics Committee for the centre.

2. Persons linked to the deceased for family or similar reasons may contact those responsible for the files or treatments containing data of that deceased person for the purpose of notifying the death, sufficient accreditation of the same, and request, justifying the concurrence of a relevant interest, the cancellation of the data or the anonymisation of the samples.

Article 27. Target of the samples after the investigation or the specific research project has been completed.

The specific consent granted by the source to the sample to be incorporated into a collection for biomedical research purposes preserved outside the organizational scope of a biobank, or used in a project concrete investigation, you will preview one of the following options:

a) The destruction of the sample after the project or investigation is completed.

b) The anonymization of the biological sample for later uses.

(c) The subsequent free transfer of the sample to a biobank, provided that information is provided on the sample and on the possible purposes of use of the sample.

d) The subsequent use of the integrated sample in a collection for a line of inquiry related to the initially proposed, including by a third party through free disposal, with the warning that the specific consent of the source subject to this.

Article 28. Communication of data from collections and samples.

Those responsible for collection of samples for biomedical research purposes kept outside the organizational scope of a biobank and those who maintain biological samples for use in a research project The data relating to the collections and samples shall be communicated to the establishment on whose premises they are kept.

Article 29. Opinion of the Research Ethics Committee.

In order to carry out an investigation with biological samples of human origin, it will be necessary, in any case, for the favorable opinion of the Research Ethics Committees of the establishment in whose facilities they will be used. the samples or, failing that, of the committee to which the centre for which the person responsible for the investigation is attached is attached.

Article 30. Free donation and use of biological samples of human origin.

1. The donation and use of biological samples of human origin shall be free, in accordance with the provisions of Articles 7 and concordant of Law 14/2007 of 3 July.

2. The financial compensation which may be fixed for obtaining biological samples of human origin for the purposes of biomedical research may only strictly compensate for physical inconvenience, travel and labour costs, and other disadvantages which may be derived from the sampling, and may not be an economic incentive.

3. Any advertising or promotion activities by approved centres that encourage the donation of human tissues and cells must respect the altruistic character of the human tissue and cell donation, and may not in any case encourage the donation by the offer of economic compensation other than the strict compensation provided for in the previous paragraph.

Article 31. Use of biological samples of human origin from other countries.

Only biological samples of human origin from other countries may be used for biomedical research, where in their procurement, storage or preservation and cession have been observed, at least, in addition to the requirements laid down in the regulations relating to the entry and exit of samples in the Spanish territory, the guarantees provided for in this royal decree and other rules applicable, which shall be assessed by the Ethics Committee of the Research to evaluate the research project and, where appropriate, by the external committees of the biobank.

Article 32. Availability of the information.

1. Without prejudice to the information to be received in writing by the source before giving its consent to obtain and use the sample, the biobank, the person responsible for the collection and the person responsible for the project the use of biological samples of human origin for biomedical research purposes shall provide the source with the availability of the information relating to the use of his sample by third parties, unless the latter has been anonymised, and in particular:

a) Concrete finality of the investigation or investigations for which the sample was used.

b) Expected and achieved benefits.

c) Identity of the person responsible for the investigation.

d) duly validated and health-relevant genetic data that has been obtained from the analysis of the samples transferred.

e) Mechanisms to ensure the confidentiality of the information obtained

(f) Identity of persons who have had access to the personal data of the source subject who have not been subjected to dissociation or anonymisation processes.

2. The external ethics committee of the biobank or the Research Ethics Committee that evaluated the research project will decide in which cases it will be necessary to send the information to the source in an individualized way.

3. In the case of the use of samples of minors for biomedical research purposes, as provided for in Article 58.5 of Law 14/2007 of 3 July, the biobank and the persons responsible for the collection or the research project shall have the information referred to in paragraph 1 of this Article at the disposal of the legal representative of the source subject until the latter reaches the age of majority, and of the source subject himself from that time.

CHAPTER II

Specific regime for the treatment of biological samples of human origin for biomedical research purposes by biobanks and by responsible collections outside the organizational scope of a biobank

Article 33. Obtaining biological samples of human origin for biomedical research purposes by biobanks and responsible collections kept outside the organizational scope of a biobank.

1. Biobanks and collections responsible may obtain biological samples of human origin by cession, by obtaining the source of the source or by obtaining it from live subjects.

In any event, the procurement will be subject to the requirements laid down by Law 14/2007 of July 3, and by this royal decree.

2. The transfer of samples or collections of samples to biobanks and collections responsible shall be formalised by prior written agreement, without prejudice to Articles 10 and 11 on the express provision of the destination of the samples. samples stored in the biobank in the resolutions closing or revoking the authorisation for the establishment and operation of the biobank.

This agreement shall be signed by the person holding the biobank or responsible for the collection of destination, on the one hand, and by the person who holds the biobank or responsible for the center or collection of provenance of the samples, by another.

In those cases where both parties agree, no such agreement will be required.

For the purposes of this paragraph, all centers of any kind, both public and private, will be considered as centers of provenance.

3. In the case of samples of origin, the provisions of Article 26 shall be taken into account and a prior written agreement shall be required between the biobank or the responsible for the collection of destination, on the one hand, and the establishment of origin of the shows on the other. In those cases where both parties agree, that agreement will not be necessary.

Article 34. Assignment of biological samples of human origin for biomedical research purposes by a biobank or by the person responsible for a collection for biomedical research purposes preserved outside the organizational scope of a biobank.

1. The biobank or the person responsible for a collection may give the samples to the person responsible for an investigation provided there is consent from the source for the transfer. Only samples shall be given for applications from projects research that has been scientifically approved.

In either case, the given sample quantity will be the minimum required for the project to be performed.

2. In the case of biobanks, if the consent document does not provide for the use of the sample for the research line, related to the initial proposal, which is to be developed by the person responsible for the research samples, it will be necessary for the source to give new consent.

3. The samples and the associated data shall only be transferred as a general rule in an anonymous or dissociated manner. However, in cases where the nature of the research project requires additional clinical data on the source subjects, the biobank or the collection responsible will coordinate the collection of this information with the centre where the sample was obtained, provided that the sample was not anonymised. In such cases, the application for the sample shall indicate the specific measures to be applied in order to ensure the confidentiality of personal data which may accompany the transfer.

4. The assignment shall require a request from the person responsible for the investigation, which shall include the project to be developed and the explicit commitment not to use the material requested for a different use than the one specified therein, to which the favourable opinion of the Research Ethics Committee for the project for which the samples are requested shall be accompanied.

In the event that the transferor is a biobank, the assignment shall be informed in a positive manner by the scientific and ethical committees and by the person who holds the scientific address, in the light of the application submitted. However, in cases where the Research Ethics Committee to which the opinion on the draft is to be issued is also the committee of ethics of the biobank, it will be sufficient to issue a single opinion on the project.

5. The application shall be accompanied by a transfer agreement document, which shall be signed by the person responsible for the investigation on the one hand, and the biobank or the person responsible for the collection on the other hand, in which the following shall be considered:

(a) The obligation on the part of the recipient to ensure the traceability of the sample.

b) Guarantee of the availability of validated and relevant health information for the health which, where appropriate, is obtained from the analysis of the samples.

(c) For the case of the transferor being a biobank, the commitment to observe the internal rules of operation of the donor biobank in whatever is applicable.

d) The commitment to destroy or return to the biobank or responsible for the collection the material left over after the project is completed.

6. Where the transferor is a biobank, the request for transfer may be refused where it has been reported unfavourably by any of the external committees of the biobank or by the person who holds the scientific address, or where the the person responsible for the investigation has failed to fulfil any of the commitments and obligations referred to in the previous paragraphs in previous transfers of samples of the same biobank.

The refusal of the transfer of samples shall be motivated and notified to the person who has requested it.

In the event that the biobank is a public entity, the procedure for the transfer or refusal of the transfer must be subject to the provisions of Law 30/1992 of 26 November. In this case, the applicant may, in the event of refusal of the transfer, bring the proceedings under Articles 107 et seq. of Law No 30/1992 of 26 November 1992 on the basis of whether or not the decision puts an end to the administrative procedure. as referred to in Article 109 of that law.

7. The biobank shall include in its annual memory a reference to the disposals of samples taken, which shall include the identification of the persons responsible for the investigations, the centres in which the samples and the projects of the research.

TITLE III

Operation and Organization of the National Register of Biobanks for Biomedical Research

Article 35. Nature of the National Register of Biobanks for Biomedical Research.

The National Register of Biobanks for Biomedical Research has a public and informative character.

Article 36. Dependence on the National Register of Biobanks for Biomedical Research.

The National Register of Biobanks for Biomedical Research depends on the Carlos III Health Institute, which will be responsible for its management, maintenance and updating through the unit that determines the person holding the address of the Carlos III Health Institute.

Article 37. Data enrollment in the National Register of Biobanks for Biomedical Research.

1. Information from the National Register of Biobanks for Biomedical Research shall be:

(a) Data relating to the authorisations for the establishment and operation of biobanks, as well as their amendments and to decisions to revoke the authorisation for the establishment and operation or closure of biobanks.

(b) Information relating to biobanks and their activity and to the networks of which they are a party, if any.

(c) Information relating to collections of biological samples of human origin for biomedical research purposes kept outside the organisational scope of a biobank, from identified persons or identifiable.

2. They shall be obliged to communicate the data referred to in the previous paragraph to the National Register of Biobanks for Biomedical Research:

(a) The data corresponding to paragraphs (a) and (b) must be communicated by the competent authorities to grant the authorisations of constitution and operation within two months after the notification of the resolution to the data subject or upon receipt of communications of non-substantial modifications.

(b) The data corresponding to paragraph (c) must be communicated by public or private persons or establishments having one or more collections for biomedical research purposes kept outside the organizational scope of a biobank within two months after the establishment of the collection or since the modification of the collection has occurred.

3. The registration in the National Register of Biobanks for Biomedical Research will be independent of the registration of the data in the registers of other institutions due to its special nature or purpose.

Article 38. Content and structure of the National Register of Biobanks for Biomedical Research.

The National Register of Biobanks for Biomedical Research will have the structure and content listed in the annex to this royal decree.

Article 39. Publication and dissemination of the contents of the National Register of Biobanks for Biomedical Research.

1. A catalogue containing updated information from the National Register of Biobanks for Biomedical Research will be published on the Carlos III Health Institute's website.

2. The information contained in the National Register of Biobanks will be available to the Directorate General of Public Health and Foreign Health, Ministry of Health, Social Policy and Equality.

Single additional disposition. Launch of the National Register of Biobanks for Biomedical Research.

The Carlos III Health Institute will adopt the necessary measures for the implementation of the National Register of Biobanks for Biomedical Research.

Single transient arrangement. Biobanks and pre-existing collections.

1. The collections for biomedical research purposes preserved outside the organizational scope of a biobank existing at the entry into force of this royal decree must communicate to the Health Institute Carlos III the data indicated in the paragraph 2.c) of the Annex within six months after the entry into force of this royal decree.

2. The persons responsible for the biobanks existing at the entry into force of this royal decree must request authorization for the constitution and functioning of the biobanks before the competent authority, to continue carrying out their activity as biobanks.

As long as they have not been authorized, and from the time the authorization is refused, if appropriate, the samples that make up such biobanks will be considered as part of a collection for research purposes. A biomedical conservancy outside the organisational scope of a biobank, and the provisions of Law 14/2007 of 3 July, and in this royal decree relating to such collections, including the previous paragraph of this provision, will apply to them. transient.

From the moment they are granted authorization for the constitution and operation, the provisions of Law 14/2007, of July 3, and of this royal decree concerning biobanks, will apply to them. In this case, the possible annotations that could have been made in the National Register of Biobanks for Biomedical Research were cancelled when the samples that were integrated were considered to be part of a collection for purposes. of biomedical research preserved outside the organizational scope of a biobank.

3. The biobanks existing at the entry into force of this royal decree may be recognized as national biobanks for biomedical research purposes by the Ministry of Science and Innovation, if they meet the requirements and characteristics indicated in Articles 18 and 19.

Final disposition first. Competence title.

This royal decree is dictated by the article 149.1.15. of the Spanish Constitution, which attributes to the State exclusive competence in the field of the promotion and general coordination of scientific and technical research.

Final disposition second. Regulatory enablement.

The head of the Ministry of Science and Innovation is empowered to dictate how many provisions require the application of the provisions of this royal decree, and to amend its annex, without prejudice to the regulatory development that it is appropriate for the Autonomous Communities.

Final disposition third. Entry into force.

This royal decree will enter into force six months after its publication in the "Official Gazette of the State".

Given in Madrid, on November 18, 2011.

JOHN CARLOS R.

The Minister of Science and Innovation,

GARMENDIA MENDIZABAL

ANNEX

Structure and content of the National Register of Biobanks for Biomedical Research

1. The National Register of Biobanks for Biomedical Research will have two sections, one dedicated to biobanks for biomedical research purposes, and another to the collections of biological samples of human origin for biomedical research purposes. preserved outside the organizational scope of a biobank.

2. For each record sheet, the following updated information will be available:

a) General data relating to biobanks:

1. º Order number.

2. º Enrollment Date.

3. Biobank Denomination.

4. Data of the person who holds the biobank: name and name or social name; number of the national identity card or number of foreign identity, or number of tax identification if it is a person legal status; name, name, position, sex and number of the national identity card or identity number of the legal representative, if it is a legal person; sex in the case of a natural person; e-mail; telephone number; full address.

5. Data of the person holding the scientific address: name and surname or social name; number of the national identity card or number of foreign identity, or number of tax identification if this is a legal person; name, name, position, sex and number of the national identity or identity number of the legal representative of the legal representative, in case he is a legal person; sex in the case of a natural person; e-mail address; telephone number; full address.

6. Data of the person responsible for the data file of a personal character: name and name or social name; number of the national identity card or number of foreign identity, or tax identification number in the case of a legal person; name, name, position, sex and number of the national identity card or identity number of the legal representative, if it is a legal person; sex in the case of a legal person; physical person; email address; telephone number; full address.

7. The identity and gender of the members of the external ethics committee, or the Research Ethics Committee to which it is attached.

8. The identity and gender of the members of the scientific external committee.

9. The complete address of the headquarters of the biobank.

10. Biobank email address, and web page where appropriate.

11. º Biobank phone number.

12. º Finalities of the biobank.

13. º Type and origin of the stored samples.

14. º Other records in which the biobank is enrolled.

15. º Biobanks Network of which the biobank is part, if any.

16. The Autonomous Communities in which the biobank is authorized.

(b) Data concerning the authorisations for the establishment and operation and closure of biobanks:

1. º Application Dates and grant of the authorization to build and operate.

2. The application and grant dates of the modification, and reason for the modification.

3. º Date and reason for revocation of the authorization for the constitution and operation or closure.

4. The existence of prior communication to the Health Institute Carlos III of data on samples that integrate biobank as a collection for purposes of biomedical research preserved outside the organizational scope of a biobanco, as indicated in paragraph 2 of the single transitional provision of this royal decree, where applicable, and the number of the record sheet or order number of that collection in the National Register of Biobanks for Biomedical Research.

(c) Data relating to collections of biological samples of human origin for biomedical research purposes preserved outside the organizational scope of a biobank:

1. º Order number.

2. º Enrollment Date.

3. º Data of the person responsible for the collection: name and surname or social name; number of the national identity card or number of foreign identity, or number of tax identification if it is a person legal status; name, name, position, sex and number of the national identity card or identity number of the legal representative, if it is a legal person; sex in the case of a natural person; e-mail; telephone number; full address.

4. º Finalities in the collection.

5. º Type and origin of the preserved samples.

6. º Other records in which the collection is enrolled.

3. Each registered biobank or collection will be assigned a record sheet number or order number.

4. In the event that the operation of a biobank, by virtue of its territorial location, is authorized by several Autonomous Communities, all authorizations shall be entered in a single register.