The Royal Decree 432/2008 of 12 April, which restructured the ministerial departments, created the Ministry of Science and Innovation as the department responsible for the proposal and implementation of the Government's policy in Universities, scientific research, technological development and innovation in all sectors, as well as the coordination of State-owned public research bodies.

Article 5.6 of the Royal Decree 1183/2008 of 11 July, for the development of the basic organic structure of the Ministry of Science and Innovation, lists the public research bodies and agencies that depend on the Ministry of Science and Innovation, through the Secretariat of State of Research; in this relation figure, in paragraph c), the Institute of Health Carlos III.

Royal Decree 542/2009, of 7 April, which restructured the ministerial departments, has recently reformed the ministerial structure; as a result of this reform, it is currently up to the Ministry Science and Innovation, which is the top organ of the Secretariat of State for Research, the proposal and implementation of the Government's policy in the field of scientific research, technological development and innovation in all sectors, as well as the coordination of public ownership research bodies state.

In its third final provision, Royal Decree 542/2009 states that the public bodies are assigned to the ministerial departments in accordance with the distribution of competences established in this royal decree, and in the terms to be determined in the actual decrees for which the corresponding organic structure is approved. Royal Decree 1042/2009, of 29 June, for which the basic organic structure of the Ministry of Science and Innovation is developed, establishes in its article 2.7 the dependency of the Health Institute Carlos III of the Secretariat of State of Research.

The Carlos III Health Institute was created by Law 14/1986 of 25 April, General of Health. It is a public body of investigation with a self-governing body of those provided for in Article 43.1.a) of Law 6/1997, of 14 April, of the Organization and the Functioning of the General Administration of the State.

Later, Law 14/2007, of July 3, of Biomedical Research, has regulated the Institute of Health Carlos III as a fundamental instrument of the General Administration of the State for the promotion of research biomedical.

The Carlos III Health Institute is governed by the applicable legislation that is applicable to it and by its Statute, approved by Royal Decree 375/2001 of 6 April, as amended by Royal Decree 590/2005 of 20 May, and by the Royal Decree 246/2009 of 27 February.

In this royal decree, a modification of the Statute of the Institute of Health Carlos III, whose object is to adapt it to the dependency of the Ministry of Science and Innovation through the Secretariat of State of Research, the main modification being the new configuration of the Rector Council, the collegiate management body of the Carlos III Health Institute.

Also included are other changes in the updating of the statute to the current administrative dependency, the Law of Biomedical Research, and the current regulations applicable to the Carlos III Health Institute.

In its virtue, at the initiative of the Minister for Science and Innovation and on a joint proposal from the Minister of the Presidency and the Minister for Economic Affairs and Finance, after deliberation by the Council of Ministers at its meeting on 6 July November 2009,

DISPONGO:

Single item. Amendment to the Statute of the "Carlos III" Health Institute, approved by Royal Decree 375/2001 of 6 April, as amended by Royal Decree 590/2005 of 20 May.

The Statute of the Institute of Health Carlos III, approved by Royal Decree 375/2001, of 6 April, as amended by Royal Decree 590/2005, of 20 May is amended in the following terms:

One. Article 1 is worded as follows:

" Article 1. Legal nature, membership and principles of action.

1. The Carlos III Health Institute (ISCIII) is a public research body of an autonomous body, as provided for in Article 43.1.a) of Law 6/1997, of 14 April, of the Organization and the Functioning of the General Administration of the State, assigned to the Ministry of Science and Innovation through the Secretariat of State of Research, whose mission is to develop and offer scientific and technological services of the highest quality directed to the National Health System and to the society as a whole.

2. The Ministry of Science and Innovation has the strategic direction, the evaluation and control of the results of the activity of the Health Institute Carlos III, through the Secretariat of State of Research, without prejudice to the competencies attributed to the General Intervention of the State Administration regarding the evaluation and control of the results of public bodies in the state public sector.

3. The Autonomous Body Institute of Health Carlos III has a distinct public legal personality, its own assets and treasury, as well as autonomy of management and full legal capacity and to act and, within its sphere of competence, they correspond to the precise administrative powers for the fulfilment of their purposes, in the terms provided for in this Statute, except for the expropriation of power.

4. The Carlos III Health Institute will respect in its performance the principles of professional ethics and public responsibility, understood as the commitment of its staff to observe in its performance the values contained in the code of professional ethics of the ISCIII staff and the rules of conduct applicable to public employees of the General Administration of the State. The conduct of any research activity in which ISCIII is directly involved shall be subject to compliance with the principles and guarantees provided for in Article 2 of Law 14/2007 of 3 July on Biomedical Research. "

Two. Article 2 is worded as follows:

" Article 2. Legal regime.

The Institute of Health Carlos III is governed by the provisions contained in Law 13/1986 of 14 April, of the Promotion and General Coordination of Scientific and Technical Research; by Law 14/1986, of 25 April, General of Health; by Law 16/2003, of 28 May, of Cohesion and Quality of the National Health System; by Law 14/2007, of July 3, of Biomedical Research; by Law 6/1997, of April 14, of Organization and the Functioning of the Administration General of the State; by Law 30/1992, of 26 November, of Legal Regime of Public Administrations and the Common Administrative Procedure; by Law 30/2007, of 30 October, of Contracts of the Public Sector; by Law 47/2003, of 26 November, General Budget; by Law 33/2003, of 3 November, of the Patrimony of the Administrations Public; by Law 38/2003, of 17 November, General of Grants; by this statute and, in general, by the rules that develop the aforementioned provisions and by those that are applicable. "

Three. The second and third paragraphs of Article 3 are worded as follows:

" The Carlos III Health Institute, as a scientific-technical support organ of the General Administration of the State and the various Health Services of the Autonomous Communities and in collaboration with other administrations public, develop the functions that have been or are assigned to you. It will also contribute to the vertebrate of the research in the National Health System in the terms provided for in article 48 of Law 16/2003, of 28 May, of Cohesion and Quality of the National Health System, and will promote and coordinate the research in biomedicine through the carrying out of basic and applied research, the impetus of epidemiological and public health research, scientific and technical accreditation and foresight, scientific-technical advice and training, and health education in biomedicine.

As a public research body, it will take into account the planning, promotion and coordination of biomedical and health research and innovation, in line with the guidelines and objectives proposed by the Government in the field of Scientific policy, especially in the National Plan for Scientific Research, Development and Technological Innovation, without prejudice to the competencies of the Government's Delegation for Scientific and Technological Policy. "

Four. Article 3 (1) (a) and (e) shall be worded as follows:

" a) Basic and applied research in biomedicine and health sciences, which includes its promotion and coordination through the implementation of basic and applied research; the promotion of translational biomedical research with the aim of shortening the time interval between the generation of knowledge and its application to clinical practice and health services; and the development of research activities in the field of biomedicine and health sciences at the service of the National Health System. "

"e) The development of innovations in the field of health promotion that support the programs of the General Administration of the State and the Autonomous Communities."

Five. Paragraph 1 of Article 3 (1) is incorporated with the following wording:

"h) Planning and management of biomedical and health sciences research programs included in the Strategic Health Action of the National R & D Plan + I."

Six. Article 3 (2) (b) shall be worded as follows:

"b) The coordination of the technical-scientific tasks of surveillance and the technical-scientific advice in these matters, without prejudice to the competences of other organs of the General Administration of the State."

Seven. The first subparagraph of Article 3 (4) is worded as follows:

" 4. As an Agency for the promotion and coordination of biomedical research activities in health sciences, in the framework of the Law on the Promotion and General Coordination of Scientific and Technical Research, the General Law of Health, and the Law of Biomedical Research, without prejudice to the competencies of the Government's Delegation for Scientific and Technological Policy and the Ministry of Science and Innovation: "

Eight. Article 3 (8) is worded as follows:

" 8. The Carlos III Health Institute has the consideration of its own means and technical service of the General Administration of the State and its bodies and entities governed by public law, in the matters that constitute its purposes, and will carry out the work, services, studies, projects, technical assistance, works and how many actions are entrusted to them in the form set out in this provision.

The management orders shall be compulsory for ISCIII, shall be paid out by means of the arrangements provided for in the following subparagraph, and the power for the body conferring the responsibility of the dictate the instructions required for execution.

The fee or remuneration of the charge shall cover the value of the actions in charge, taking into account for its calculation the direct and indirect costs, and reasonable margins, in accordance with the amount of the benefits, to address deviations and unforeseen events.

The amount of the fee or the remuneration shall be fixed by the holder of the Ministry of Science and Innovation.

The Carlos III Health Institute, acting with the character of its own means and technical service of the General Administration of the State and its bodies and entities governed by public law, will not be able to participate in public tenders. called by the contracting authorities belonging to them, without prejudice to the fact that, where no tenderer is present, the performance of the services covered by them can be made. "

Nine. Article 4 (c), (d), (h), (i) and (k) shall be worded as follows:

" c) Create foundations in accordance with Law 50/2002, of December 26, of Foundations, and Royal Decree 1337/2005, of November 11, for which the Regulation of Foundations of State Competition is approved, for the realization activities of scientific research, technological development and the provision of technical services related to the public interest of the Institute.

The accountability of the foundations will be governed by the provisions of the 129 of the General Budget Law, and their budgets will be integrated into the General Budget of the State, according to the structure to be determined their specific legislation.

d) Establish agreements, agreements and contracts with centers of the National Health System, public institutions and public health sciences and international and international health sciences, universities and institutions private activities for scientific research and technological development, for the realization of projects and activities of research, technological development, innovation and other activities of a scientific, teaching and advisory nature. "

" (h) Represent, where appropriate, the General Administration of the State to the Organs and Organisms of a national and international scientific and technological nature in the fields of competence of the Carlos Health Institute III, in coordination with the Ministry of Foreign Affairs and Cooperation, as regards the international representation it carries out, in accordance with Article 8.2.d) of Law 13/1986 of 14 April, of Promotion and Coordination General of Scientific and Technical Research.

i) To promote cooperation in the areas of its competence with the autonomous communities, through the General Council of Science and Technology and the Interterritorial Council of the National Health System. "

" k) Develop, coordinate and manage scientific research, development and technological innovation programs in biomedicine and health sciences in coordination with other departments, in accordance with the guidelines of the Government Delegation for Science and Technology Policy. "

Ten. Article 7 is worded as follows:

" Article 7. Composition of the Governing Board.

1. The Governing Council shall be composed as follows:

(a) President: the head of the Ministry of Science and Innovation.

(b) First Vice-President: the holder of the Secretariat of State of Investigation.

c) Second Vice President: the head of the Directorate of the Health Institute Carlos III.

d) Vocals:

1. Three vowels with a category of Director-General, one representing the Ministry of Foreign Affairs and Cooperation, one representing the Ministry of Industry, Tourism and Trade, and one representing the Ministry of Industry, Ministry of the Environment and Rural and Marine Affairs, appointed by the ministers of the Ministry.

2. Three vowels with a category of Director-General representing the Ministry of Science and Innovation, one of which will be the head of the Presidency of the State Agency for Scientific Research, and the other two shall be appointed by the holder of that department.

3. Three vowels with a category of Director General representing the Ministry of Health and Social Policy, appointed by the head of that department.

4. º A vowel with a category of Director General representing the Ministry of Education, designated by the head of that department.

5. Four vowels representing the Autonomous Communities, two of which will be chosen from among its members by the General Council of Science and Technology, and two others by the Interterritorial Council of the System National of Health. It shall be renewed every two years.

The vowels of the Governing Council may delegate their representation and vote to other persons at the service of the public administrations and ministries to which they represent, or of the agencies to which they are attached.

e) Secretariat: an official of the Carlos III Health Institute, with the rank of deputy director-general, appointed by the Director of the agency.

2. The holders of the Vice-Presidencies shall replace the holder of the Presidency and shall perform the duties of the Presidency in the event of vacancy, absence or illness. In the first place, the replacement shall be exercised by the holder of the first Vice-Presidency, and in his absence by the holder of the second Vice-Presidency.

3. The designation of the vowels by the General Administration of the State will be in accordance with the Organic Law 3/2007, of 22 March, for the Effective Equality of Women and Men, with respect to the balanced presence of women and men in this collegiate body. "

Once. Article 8 (3) is worded as follows:

" 3. Monitor the management developed by the Institute, without prejudice to the competences of the Ministry of Science and Innovation. "

Twelve. The first and second paragraphs of Article 10 are worded as follows:

" The Director of the Health Institute Carlos III, with the rank of Director General, is appointed and separated by royal decree agreed upon in the Council of Ministers, at the proposal of the head of the Ministry of Science and Innovation.

The Director of the Institute will be subject to the regime of incompatibilities and control of interests established by Law 5/2006, of April 10, of conflicts of interest of the members of the Government and of the high Cargos of the General Administration of the State. "

Thirteen. Article 11 (6) and (8) shall be worded as

:

" 6. Coordination of international relations and programmes and projects carried out with centres in other countries, in coordination with the Department and without prejudice to the tasks assigned to the Ministry of Foreign Affairs Foreign and Cooperation. "

" 8. To conclude all kinds of acts, conventions, agreements, contracts and management procedures on behalf of the Agency. "

Fourteen. Article 14 (2) is worded as follows:

" 2. The Director shall be dependent on the level of organic level determined in the employment relationship, the Quality and Planning Unit, the task of which is to coordinate the various centres and units of the Institute in the evaluation activities for promote their accreditation and promote a culture of quality of services, and the Support Unit which will provide advice and direct assistance to the Director. "

Fifteen. Paragraph 1 (n) of Article 15 (1) shall be deleted.

Sixteen. The first paragraph of Article 16 is read as follows:

"corresponds to the General Subdirectorate of Applied Services, Training and Research, without prejudice to the privileges of other organs of the General Administration of the State, the exercise of the following functions:"

seventeen. Paragraph (g) of Article 16 is read as follows:

" g) The training of professionals in the field of public health and in the thematic areas of research in biomedicine and health sciences through the organs and units of the Health Institute Carlos III and the (a) the distribution of postgraduate courses in health within the framework of the European Higher Education Area. "

Eighteen. A paragraph (m) is added to Article 16 with the following wording:

"m) The management of the Health Museum."

nineteen. Article 17 (1) (a), (b) and (d) shall be worded as follows:

" a) The promotion, management, evaluation and monitoring of extramural research in health sciences with special attention to biomedical and translational health research.

b) The coordination of research activities in biomedicine and in health sciences, in relation to the National Plan for R & D + I and the Framework Programmes for Research, Technological Development and Demonstration of the Union European. "

"d) The implementation and management of a research capacity assessment system of the Research Institutes promoted by the National Health System."

Twenty. The first subparagraph of Article 18 (1) shall be read as

:

" 1. It is for the General Subdirectorate of Networks and Cooperative Research Centres to exercise the following functions: "

Twenty-one. Article 18 (1) (d) shall be worded as follows:

"d) Drive mixed units, partner centers, and research centers."

Twenty-two. The first subparagraph of Article 19 (1) shall be read as

:

" 1. It is for the General Subdirectorate of Research in Cell Therapy and Regenerative Medicine, without prejudice to the competences of other organs of the General Administration of the State, the exercise of the following functions: "

Twenty-three. A paragraph (f) is incorporated into Article 19 (1) with the following wording:

"(f) The exercise of the functions and competencies derived from the application of the Law of Biomedical Research in the subjects attributed to the Health Institute Carlos III."

Twenty-four. Article 19 (2) is worded as follows:

"The Secretariat of the Commission of Guarantees for the Donation and Use of Cells and Tissue is the responsibility of the Subdirectorate General for Research in Cell Therapy and Regenerative Medicine."

Twenty-five. The third and final paragraph of Article 21 is worded as follows:

"The creation, modification and deletion of these units shall be carried out by Order of the holder of the Ministry of Science and Innovation, after approval by the holder of the Ministry of the Presidency."

Twenty-six. Article 22 (2) is worded as follows:

" 2. The revenue and payments to be made by the Agency shall be made through the account that it maintains, either in the Banco de España, or in other credit institutions, for the opening of which shall be specified subject to the authorization of the Directorate-General of the Treasury and Financial Policy in the terms laid down in Law 47/2003 of November 26, General Budget. "

Twenty-seven. Article 23 is worded as follows:

" Article 23. Economic and financial system, accounting, intervention and financial control.

1. The economic and financial system, accounting, intervention and financial control of the Institute of Health Carlos III will be established for the Autonomous Bodies by Law 47/2003, November 26, General Budget and other provisions in force in the field.

2. Without prejudice to the audit powers conferred on the Court of Auditors by its Organic Law, and the other laws that develop its powers, the Carlos III Health Institute will be subject to the control of the General Intervention of the State administration in the terms established by Law 47/2003 of 26 November, General Budget. This control will be performed by the Delegate Intervention at the Institute under the functional dependency of the General Intervention of the State Administration.

3. Similarly, the Carlos III Health Institute will be subject to effective control, exercised by the Ministry of Science and Innovation, which will aim to verify the degree of compliance with its objectives and the proper use of the resources allocated, without prejudice to the powers corresponding to the General Intervention of the State Administration in these matters. '

Twenty-eight. Article 24 is worded as follows:

" Article 24. Recruitment.

1. The applicable legal regime for the procurement of goods and services shall be that laid down in Law 30/2007 of 30 October of Public Sector Contracts and other development regulations for the rest of the General Administration of the State.

2. Service and supply contracts concluded by the Carlos III Health Institute which are intended to provide services or products necessary for the implementation of research, development and technological innovation or technical services projects, where the presentation and production of results derived from them is linked to scientific, technological or industrial returns which are likely to be incorporated into legal traffic and their performance has been entrusted to research teams of the body by competitive concurrency processes, with the exception of scope of the Law on Public Sector Contracts and shall be governed by the rules of Civil and Commercial Law applicable to them. "

Twenty-nine. Article 26 is worded as follows:

" Article 26. Heritage of the Agency.

1. The patrimonial regime of the Carlos III Health Institute will be established in Law 33/2003 of 3 November, a Heritage of Public Administrations.

2. In addition to the assets that are part of its own assets, the Agency shall be attached to it, for the purposes of its purposes, the property assets of the State owned by the Agency, the same of which is agreed upon, in accordance with the provisions of the Law of Assets of the Public Administrations, which shall retain their original legal status and which may only be used for the fulfilment of their purposes, corresponding to the Carlos III Health Institute's use, administration and how many prerogatives relating to the public domain are legally established. "

Thirty. The second paragraph of Article 27 is deleted.

Thirty-one. Article 28 (1), (2) and (3) shall be worded as

:

" 1. The official and statutory staff assigned to the Carlos III Health Institute, including the researcher and the research support, according to what the relations of jobs establish.

2. The research staff, scientific or technical staff engaged in the implementation of research projects and activities, as provided for in Article 17.1.a) of Law 13/1986 of 14 April, of the Promotion and General Coordination of the Scientific and Technical Research. The staff in specialized health sciences training at the Carlos III Health Institute, which will be governed by its specific regulations.

3. Staff in training and engaged in practices for their scientific and technical training, in accordance with the Staff Regulations of the investigating staff, approved by Royal Decree 63/2006 of 27 January 2006, for which it is approved the Staff Regulations of the investigating staff, and in Article 17.1.b) of Law 13/1986, of 14 April, of the Promotion and General Coordination of Scientific and Technical Research. "

Thirty-two. Article 29 is amended as follows:

" Article 29. Fellows.

As a public research body, the Institute may designate and form in its facilities all grantees are deemed appropriate, in accordance with their budgetary resources and training capacity. The scheme for the incorporation and monitoring of the trainees will be governed by the provisions of the Staff Regulations of the investigating staff, approved by Royal Decree 63/2006 of 27 January, approving the Staff Regulations of the training, by the Program for the incorporation and follow-up of Fellows of the Institute of Health Carlos III, and as established in Law 38/2003, of November 17, General of Grants.

The grant of the scholarships will not involve, in any case, employment or employment relationship with the Carlos III Health Institute or the Ministry of Science and Innovation, whatever its legal nature, nor will it imply a commitment. any subsequent incorporation of the grantees into their templates. "

Thirty-three. Article 30 is amended as follows:

" Article 30. Inventions and patents.

It is up to the Carlos III Health Institute to be entitled to the inventions made by the staff as a result of their duties. The staff shall be entitled, in any case, to participate in the benefits obtained by the Carlos III Health Institute of the exploitation or the transfer of their rights to the inventions, as provided for in the legislation in force and in the Royal Decree 55/2002 of 18 January on the exploitation and disposal of inventions carried out in the public research entities, in accordance with the provisions of Article 20 of Law 11/1986, of 20 March, of Patents. "

First transient disposition. Governing Council.

The current Governing Council will continue in the performance of its functions until the new Rector Council is established in this royal decree. In any case, the elected members of such a Council whose composition and characteristics would not have suffered variation in this royal decree will remain until further appointments.

Second transient disposition. Commission for Monitoring and Control of Donation and Use of Cells and Human Tissue.

The Commission of Guarantees for the Donation and Use of Cells and Human Tissue, as provided for in Article 37 of Law 14/1987, of July 3, of Biomedical Research, will assume its functions the Commission of Monitoring and Control of the Donation and Use of Embryonic Cells and Embryonic Tissue referred to in Royal Decree 2132/2004 of 29 October establishing the requirements and procedures for requesting the development of research projects with stem cells obtained from leftover preembryos.

Single repeal provision. Regulatory repeal.

All provisions of equal or lower rank are repealed to be opposed to what was established in this royal decree.

Final disposition first. Powers of development.

The holder of the Ministry of Science and Innovation is authorized to take the necessary measures for the development and execution of this royal decree.

Final disposition second. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on November 6, 2009.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ