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Order Sco/1218/2004, April 15, By Which It Established The Regulatory Bases Of The Granting Of Aid For The Promotion Programme Of The Biomedical Research And In Sciences Of The Health Of The Ministry Of Health And Consumption, For The Fulfilment

Original Language Title: ORDEN SCO/1218/2004, de 15 de abril, por la que se establecen las bases reguladoras de la concesión de ayudas del Programa de Promoción de la Investigación Biomédica y en Ciencias de la Salud del Ministerio de Sanidad y Consumo, para la realizaci

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TEXT

Law 13/1986, of 14 April, of Promotion of the Coordination of Scientific and Technical Research, provides a common frame of reference for Public Bodies with research functions and promotes, among others, the Health Sciences research.

Law 14/1986 of 25 April, General of Health, points out, among other functions of the health system, the promotion of research according to national policies of research and development. From the Ministry of Health and Consumption, the promotion activities have been carried out through the annual support of the "Carlos III" Health Institute through the Health Research Fund.

Law 16/2003, of 28 May, of Cohesion and Quality of the National Health System, points out as guiding principles for research the following: to establish measures for scientific research and innovation contribute to significantly and sustainably improve preventive, diagnostic, therapeutic and rehabilitation interventions and procedures; ensure that research and results transfer to clinical practice are develops and is scientifically supported in a demonstrable way; compliance and enforcement of rights, protection of health and the guarantee of the safety of society, patients and professionals involved in the research activity; incorporating scientific activity in the field In the European Research Area, it will be easier to carry out clinical and basic research initiatives throughout the healthcare structure of the National Health System, promoting the development of the methodology scientific and evidence-based medicine.

The National Plan for Scientific Research, Development and Technological Innovation (R & D + I) for the period 2004-2007, approved by agreement of the Council of Ministers of 7 November 2003, where the Sectoral Initiative of Health research, details in the field of its management the implementing agents, the modalities of participation and applicable financial and fiscal instruments, the principles of allocation of the management, the coordination of the actions and the evaluation and selection of proposals.

Among the different modalities of participation that it provides for, understood as mechanisms that the legislation provides for the implementing agents of R & D + I activities to access the financing of their activities and contributing to the development of the Spanish Science-Technology-Enterprise System, it is considered that scientific research and technological development projects are the fundamental mechanism by which the activity of the research groups or teams, both in the public and private sectors. This Order covers only research projects in accordance with the definitions of the Community framework for research and development aid (96/C45/06).

Among the financial instruments are considered, inter alia, the subsidy, which is the subject of these regulatory bases, such as the action to cover all or part of the costs of the activity concerned, both by means of a the percentage of total costs as a percentage of marginal costs.

Among the priority areas and programs included in the National Plan is the area of Life Sciences where the National Biomedicine Program and the National Program for Health and Welfare Technologies are located. In particular, the Ministry of Health and Consumer Affairs, through the "Carlos III" Health Institute, is one of the managing units responsible for the management of the National Biomedicine and Technologies for Health and Welfare Programs. of these regulatory bases.

Since the implementation of quality research projects contributes to regional development, the aid which is regulated by these bases, as in previous years, will be co-financed with the European Fund of Regional Development (ERDF) until 2006. In Objective 1 areas, the ERDF contribution will account for 70% of the total funding for all projects approved. In Objective 2 areas (Catalonia, Madrid, Aragón, Illes Balears, Navarra, La Rioja and the Basque Country), 50% of those projects whose beneficiaries will be located in eligible areas will be co-financed with ERDF.

The management of these grants will be governed in accordance with the general principles set out in Article 8.3 of Law 38/20003 of 17 November, General of Grants, i.e. advertising, transparency, competition, objectivity, equality and non-discrimination, effectiveness in meeting the objectives set by the Administration and efficiency in the allocation and use of public resources.

With this Order, which complies with the provisions of Article 17 of Law 38/2003, of 17 November, General of Grants, the regulatory bases of the grant of aid of the program of promotion of the Biomedical research and health sciences from the Ministry of Health and Consumer Affairs for the implementation of research projects under the National Plan for R & D + I 2004-2007.

In its virtue, prior to the report of the Department's Legal Service and the Delegated Intervention I have:

First. Object.

The purpose of this Order is to promote scientific research through the financing of research projects in biomedical disciplines promoting basic, clinical and epidemiological research, public health and research in health services, in order to contribute to scientifically based the programs and policies of the National Health System.

Second. Priorities.

1. All proposals for research projects should be in line with the objectives and criteria set out in the National R & D Plan 2004-2007. The priority subjects covered by this call are within the framework of the National Biomedicine Program and the National Program for Health and Welfare Technologies.

2. The research lines of the National Biomedicine Program are grouped around three sub-programs:

a) National Basic Research Subprogram in disease mechanisms and new strategies and therapeutic models, whose management will be performed primarily through the Ministry of Science and Technology's calls.

b) National Clinical Research Subprogram in diseases, clinical trials, epidemiology, public health and health services. The Ministry of Health and Consumer Affairs will be responsible for the management of the "Carlos III" Health Institute (Health Research Fund).

c) National Research Program for Pharmaceutical Research in the discovery, development and evaluation of drugs, the management of which will be carried out primarily through the Program of Promotion of Technical Research of the Ministry of Science and Technology.

3. In accordance with the objectives set out in Article 1 of this order and the management responsibilities of the Ministry of Health and Consumer Affairs mentioned above, the funding priorities in the National Biomedicine Program will be oriented fundamentally towards the National Clinical Research Subprogram in diseases, clinical trials, epidemiology, public health and health services. However, proposals may also be financed from the National Subprogrammes of Basic Research in disease mechanisms and new therapeutic and therapeutic strategies and models in discovery, development and evaluation. of medicinal products, provided that they have an orientation towards the patient or the disease, it is necessary for their funding to participate in the same researchers belonging to the Centers of the National Health System with the object of developing a strategy that approximates basic, clinical and applied research and potentiate the concept of the Hospital as a research center.

4. The research lines of the National Program for Health and Welfare Technologies are grouped around two sub-programs:

National Health Technologies and Research in Health Products Subprogram and National Program for Safety and Health at Work.

The research projects corresponding to the priorities of the National Subprogramme of "Health Technologies and Research in Healthcare Products" will be aimed at research in health services including the evaluation of health technologies and research in health outcomes.

The research projects corresponding to the priorities of the National Subprogram of "Safety and Health at Work" will be oriented to aspects related to occupational health.

5. In both National Programmes, special consideration will be given to research projects in primary care and in the field of nursing care.

6. The research projects may be of a basic, clinical, epidemiological, public health and research in health services, including prioritized evaluative research. The research projects will have a duration of one, two or three years according to the type of project, which will be specified in each call.

In each call, the research priorities will be specified in detail according to the annual work programmes of the National Plan.

7. Coordinated projects may also be submitted by two or more research groups of different entities. Within this area, the coordinated projects that can be presented in the framework of the thematic networks of cooperative research will be included.

8. The calls may include the possibility of carrying out cooperative coordinated research projects between Spanish institutions and other countries, especially Ibero-Americans.

Third. Requirements of the beneficiaries.

1. Public and private R & D centres which are not disabled for the purpose of obtaining public subsidies or for contracting with the State or other entities may be applicants and beneficiaries of the aid provided for in this Order. public.

For these purposes it is understood by:

a) Public R & D Center: Public Health Entities and Institutions, Public Universities, Public Research Bodies recognized as such by Law 13/1986 on the Promotion and General Coordination of Research Scientific and technical and, in general, any R & D centre dependent on public administrations.

b) Private R & D Centre: Private healthcare institutions and institutions, universities and other private entities, with their own legal personality, with demonstrated capacity or activity in R & D actions.

2. It may also be applicants and beneficiaries of such aid to public or private undertakings with own-risk prevention services, specialised entities acting as non-profit-making services to enterprises and mutual societies. Accidents at Work and Occupational Diseases of the Social Security that develop the functions corresponding to the prevention services in relation to their associated enterprises, in the terms established by Law 31/1995, of Prevention On 8 November ("Official State Bulletin" of the 10th day), the Royal Decree 39/1997 of 17 January approving the regulation of preventive services (Official Journal of the State of the 31) and Royal Decree 780/1998 of 30 April 1998 (BOE of 1 May) amending the previous and other provisions of development which are applicable.

3. In the case of the Centers of the National Health System that manage their research activities through the foundation of private law constituted under the provisions of Law 50/2002 of December 26, of Foundations, or other entities governed by public or private law, may apply for assistance through these entities, subject to the incorporation of the registered statutes and the authorization for the application, which shall be issued by the person responsible for the institution or by higher authority, if the latter does not have the competence for such authorisation.

4. They may submit projects, through their centre and as researchers responsible for their scientific-technical implementation, to the natural persons with a research capacity integrated into the entities referred to in points 1 and 2 of this paragraph. comply with the requirements laid down in these bases and in the relevant calls, with the exception set out in point 3 of this paragraph.

In the case of personnel integrated into the entities described in point 2 of this paragraph, the necessary qualification must be provided for the performance of the preventive activities corresponding to the level of the staff. or be ATS-DUE of Enterprise.

5. The researchers of the "Carlos III" Health Institute will be able to present research projects through the "Carlos III" International Health and Cooperation Foundation, according to the aims of the Foundation, considering it all the effects as a beneficiary of the aid.

6. The applicant and beneficiary entities must not have been penalised or sentenced on a firm judgment to the loss of the possibility of obtaining public subsidies, whereas in both cases the period imposed by the applicant has not been fulfilled. disablement.

7. The health institutions, research centres and non-profit entities, which are beneficiaries of the grants provided for in this Order, are exempt from the need for accreditation of the tax obligations and In view of the Social Security referred to in the orders of the Ministry of Economic Affairs and Finance of 28 April 1986 and 25 November 1987, all this in accordance with the Resolution of 3 February 2004 of the Department of Collection of the Agency Tax.

Notwithstanding the foregoing, the profit-making entities will have to prove before the proposal for a concession resolution that the current is found in the fulfillment of their tax obligations and against the Social security, in such a way as to be determined regulatively.

8. To have presented the full scientific and economic final Memories of the research projects completed and financed previously by the Health Research Fund and in which the same principal investigator will appear, as the maximum date on which it coincides with the termination of the time limit for the submission of the application documentation for the aid set out in the calls.

9. In no case, they will be able to obtain the status of beneficiary the associations incurs in the causes of prohibition provided for in paragraphs 5 and 6 of article 4 of the Law of Organic Law 1/2002, of March 22, regulating the right of association.

Nor may the associations incur in Article 30.4 of the aforementioned Law be granted the status of beneficiary.

Fourth. Form and time limit for the submission of applications.

1. The interested parties shall submit a copy of the application in standard form and of the documentation required by the call in the General Register of the Health Institute "Carlos III", Calle de Sinesio Delgado, 6, 28029 Madrid, or any of the the forms provided for in Article 38.4 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

The application as well as part of the documentation will also be completed electronically, through the website of the "Carlos III" Health Institute, through the computer application, established to the effect.

2. The time limit for the submission of applications and the remaining documents required shall be one month from the day following the publication of the calls in the Official Gazette of the State. Applications for European projects (Sixth Framework Programme of the European Union) may be submitted in exceptional cases during the financial year, as the deadlines for processing aid and grants from the European Union do not coincide with the deadline. set out in the calls. The financing of these projects will be conditional on existing budgetary resources.

Fifth. Collaborating entities. -They may obtain the status of collaborating entities as provided for in Article 12-2 of Law 38/2003 of 17 November, General of Grants, provided that the circumstances provided for in the call are met. Article 12, 13, 15 and 16 of the Law referred to in Articles 12, 13, 15 and 16.

Sixth. Procedure for granting the subsidy.

1. The granting of aid shall be made in accordance with the principles of objectivity, competitive competition and advertising.

2. The call for the aid referred to in these bases will be initiated ex officio, by Resolution of the Director of the Institute of Health "Carlos III" published in the Official Gazette of the State.

3. The concession will be supported in a process of scientific-technical evaluation and a process of selection The scientific-technical evaluation will be carried out by the Technical Committees of Evaluation of the Institute of Health "Carlos III" established in the Order of the Ministry of Health and Consumer Affairs of 9 January 1998 ("Official State Gazette" of 21).

Research projects will also be evaluated by the National Assessment and Prospective Agency (ANEP) in those cases that are considered accurate by the level of funding requested, the characteristics of the project or its complexity, which will be indicated in the calls.

The results of the evaluation, as well as the incidents that may have occurred during the evaluation process, will be raised to a Selection Commission that will adjust, as to its operation, to the expected results. Chapter II of Title II of Law 30/1996 of 26 November 1996 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

4. The Selection Board shall be chaired by the Deputy Director-General for Health Research and shall consist of a minimum of six vowels, appointed by the Director of the Health Institute "Carlos III" for each call among researchers. recognized prestige of the priority areas of knowledge. The Secretary of the Commission shall be an official of the "Carlos III" Health Institute.

In the case of specific calls to address research projects evaluating health technologies, the vowels will be designated by the Director of the Health Institute "Carlos III" between health managers or research with responsibilities in the National Health System.

This Selection Commission will also be competent to rule on requests for annual extension of projects while these bases are in effect.

5. On the basis of the scientific and technical assessment carried out and taking into account the aspects mentioned in the previous point, the Selection Board, through its President, shall communicate to the instructor an interim draft resolution in which the the budget allocated to each project considered eligible shall be included, which shall be determined according to criteria of maximum effectiveness in the allocation of the available economic resources.

The instructor body will raise the Director of the Health Institute "Carlos III" proposal of the interim results relationship, which through Resolution will make public in the bulletin board of the Institute and on the website of the Instituto de Salud Carlos III (http://www.isciii.es).

In the case of a proposal for a concession, the relationship shall express the amount and distribution of the aid and, in the case of proposals for refusal, shall include the causes of the aid.

In both cases, the applicants shall have a period of ten working days from the date following the publication of the relationship referred to in the preceding paragraph, in order to present the claims they deem appropriate. Such proceedings may be waived where they do not appear in the proceedings or take into account other facts or other arguments and evidence which are adduced by the parties concerned in which case the motion for a resolution shall be Article 24 (4) of the General Law on Subsidies provides for the definitive

6. At any time in the assessment process, prior to the final grant resolution, the instructor body may collect as many reports or clarifications as necessary from both the applicant and the investigator responsible, as well as any other body or entity deemed necessary.

7. After the hearing procedure, the instructor body in the light of all the actions, will formulate the corresponding definitive proposal of the Resolution to the Director of the Institute of Health "Carlos III".

8. The proposals for a provisional and definitive resolution do not create any right in favour of the proposed beneficiary vis-à-vis the administration, while the granting decision has not been notified to it.

Seventh. Objective criteria for the grant of the grant.

1. The evaluation by the Technical Commissions will be carried out according to the following criteria:

a. Scientific-technical and methodological quality.

b. Scientific and social relevance, including the expected contributions of the project and the novelty and relevance of the objectives.

c. Feasibility of the proposal, including in this context the adequacy and capacity of the research group to comply with the planned activities, the recent contributions of the project, related to the project area, as well as the rigour in the approach and appropriate time planning of the activities.

d. Ethical aspects of the proposed research.

e. Adequacy of the financial resources to the proposed objectives.

f. Plan to disseminate and disseminate the results of the project.

g. Achievement of the objectives in the aid previously requested by the person responsible for the requested research project and by the rest of the research team in relation to the funding received.

h. Accredited co-financing of the applicant centre or other public or private entities, in particular in the research projects which consist of clinical trials.

i. The coordinated projects presented in the framework of the thematic networks of cooperative research will have special consideration, if they also incorporate new nodes associated with the same ones not included in original form in the networks constituted.

2. The Selection Board shall assess the following aspects, taking into account the outcome of the evaluation carried out by the technical committees:

a. Adequacy of projects to the priorities set out in this call.

b. Applicability and interest of the proposal for the National Health System.

c. Adequacy of the size, composition and dedication of the research team to the objectives proposed in the project. The exclusive dedication to the project by each of the team members will be highly valued, especially in the case of the top researchers. Adaptation of the three-year projects of duration and of the groups presenting them to provide adequate training in scientific research and technological development, in case they request a scholarship assignment from the aid requested.

e. Projects submitted by new or emerging research teams or which, because of their geographical location, make it necessary to take concrete action to achieve inter-territorial equity and balance, provided that there are guarantees (i) compliance with the proposed objectives.

Eighth. Amount of subsidy.

1. The amounts granted may cover all or part of the aid requested, without, in any event, accounting for the possible co-financing, exceeding the actual cost of the subsidised activity.

The amount of the fee will be determined in each case according to the evaluation and selection criteria set out in the calls. The aid granted to approved projects will be increased by 15%, as a contribution margin, which will be allocated to research expenditure of the project's implementing centre, of which at least three% will be devoted to the projects. bibliographic funds of the same.

2. The applicant is obliged to declare the aid which he has obtained or requested for the same project, both at the beginning of the file and at any time when this circumstance occurs, and shall accept any applicable minorations. for compliance with the previous paragraph.

3. The aid will be used to cover the following costs, provided that they are directly related to the implementation of the project and are duly specified in the application: staff costs and implementation costs (including the material The invention is essential for the implementation of the project, duly justified; the purchases of consumable material and other complementary expenditure, duly justified, necessary for the good end of the project, such as bibliographic material, contracting of external services, as well as travel and subsistence expenses, The following information shall be entered, duration and interest of the project, if this information is available at the time of the application.)

In any case, it will be differentiated between the travel expenses inherent in the project and the derivatives of the diffusion of the project that can only be imputed to the second and third annuity, preferably to the latter, and that also include the costs of registration of the events in which it is intended to participate, and may only be used by the members of the research team.

4. As regards the contracting of external services and the inventive material, the content of Article 29 and 31 of Law 38/2003 of 17 November, General of Grants, shall apply.

5. The inventoried material acquired from the aid granted shall be the property of the implementing centre of the project which may be arbitrated.

the system of access to it by the researchers that is more convenient according to its management model. In the case of the Centers of the National Health System that manage their research activities through the foundation of private law constituted under the provisions of Law 50/2002 of December 26, of Foundations or the like, and request the aid through these entities, the inventive material acquired from the aid granted will be the property of the Center of the National Health System that corresponds. The inventive material will be used for research purposes throughout the period of its depreciation.

6. The structure of budget items identified in this article is binding. If, in the course of project development, and in a totally exceptional manner, changes are deemed necessary between items, these changes must be requested in advance and in a manner motivated by the investigator responsible for the project. project, with the approval of the legal representative of the center, before the General Health Research Subdirectorate that will raise the corresponding proposal to the Director of the Health Institute "Carlos III" who will decide what comes with the advice which, if any, you consider necessary.

Ninth. Competent bodies for the management, instruction and resolution of the procedure.

1. The instruction in the procedure for granting such aid shall be the responsibility of the "Carlos III" Health Institute, through the General Secretariat for Health Research and the General Secretariat, in the field of their respective competences, which carry out the necessary formalities and any other actions deemed necessary to determine, know or verify the data under which the relevant decision is to be made by the Director of the Institute of Health "Carlos III".

For these purposes, the investigator responsible for the project may be directed to the legal representative of the centre to which he himself belongs, as well as to any body or entity deemed necessary, depending on the nature of the project. of the actions to be taken.

2. Within 10 days of the date of the lifting of the final decision by the instructor, the Director of the Health Institute "Carlos III" shall give a decision on the grant or refusal which shall be reasoned according to the the assessment criteria set out in the call, by which the submissions made to the provisional relationship will be resolved.

3. This resolution will be made public in the "Carlos III" Health Institute's Bulletin Board and will be notified by the General Health Research Subdirectorate to the applicant centers, with the following determined:

a. The beneficiaries of the aid and the main researchers involved.

b. The overall amount of each aid and its breakdown in the various headings that make up the aid and the contribution margin.

c. The deadlines for submission of annual follow-up and final reports.

d. The express dismissal of the rest of the applications.

4. The maximum period for the decision of the procedure shall be six months from the publication of the notice in the Official Gazette. After that time limit, the parties concerned may understand their requests, without having been notified. The period used for the correction of deficiencies and the contribution of documents shall interrupt that period, within the meaning of Article 42.5 of Law No 30/1992 of 26 November 1992, of the Legal Regime of Public Administrations and of the Procedure Common Administrative Board, as amended by Law 4/1999 of 13 January.

The lack of a resolution within the abovementioned time limit empowers the parties concerned to understand their requests for administrative silence, in accordance with the provisions of Article 44.1 of Law 30/1992, of 26 March 1992. November.

5. Against the express or presumed decision, a replacement appeal may be brought before the same body which issued it within one month of the day following the notification of the decision, in accordance with the provisions of the 116 and 117 of the Law of Legal Regime of Public Administrations and the Common Administrative Procedure. In the case of administrative silence, the period shall be three months from the day following that in which the application is deemed to be rejected.

Alternatively, it may be used in a legal-administrative manner, in accordance with Law No 29/1998 of 13 July, within two months of the day following the notification of the decision.

In the case of administrative silence, the period shall be six months from the day following that in which the application is deemed to be rejected.

10th. Deadline and form of justification.

1. The justification for the aid will be made in accordance with the provisions of Article 30 of Law 38/2203 of 17 November, General of Grants and according to the provisions on scientific and technical monitoring of the aid. and, where appropriate, with the provisions of the rules applicable to the justification of the ERDF.

2. The monitoring of the projects shall be carried out through the annual monitoring and final memoria, completed in standard format, which are integrated by a scientific and other economic part to be submitted, inexcusably, jointly with the "Carlos III" Institute of Health with the original signatures established in each case.

Annual follow-up reports shall be submitted on the date set out in the decisions granting the aid.

The Final Memory must be submitted within three months of the completion of the project.

The scientific monitoring of the projects will be carried out by means of the evaluation, by the Technical Committees of Evaluation, of the degree of execution of the planned activities and the fulfillment of the proposed objectives. If such an assessment is not favourable, the financing of the project will be interrupted, with the General Health Research Subdirectorate being able to propose appropriate actions to recover the funding granted.

3. If the termination of the project is delayed for duly justified reasons, the General Health Research Subdirectorate may extend the period referred to in the previous point, in accordance with Article 49 of Law No 30/1992 of 26 November 1992, amended by Law 4/1999 of 13 January, which must be applied for and granted before the end of that period.

4. Failure to submit follow-up Memories in the established terms will also determine the interruption of funding.

5. The beneficiary will be subject to the tests carried out by the Health Institute "Carlos III", as well as the economic and financial control of the General Intervention of the State Administration and the control of the Court of Auditors, and where appropriate, as laid down in the rules applicable to the ERDF.

6. In the publications and other results to which the projects financed may take place, mention should be made of the National Plan for Scientific Research, Technological Development and Innovation (R & D + I) and the Institute of Health "Carlos III". Health research as a financial institution, quoting the reference number assigned to the project. If the project is co-financed with ERDF, the corresponding mention must be made.

11th. Payment of the aid. The amount of the annuities of the aid granted shall be paid in advance in favour of the beneficiary entities.

The payment of the first annuity of the projects will be processed on the occasion of the concession resolution. The payment of the following annuities shall be conditional on the availability of the budget, the presentation of the corresponding annual memory for the period ending and the favourable assessment of the period.

12th. Circumstances which, as a result of the alteration of the conditions under consideration for the grant of the grant, may lead to the amendment of the decision.

1. Any change in the conditions accepted by the beneficiary for the execution of the research activity, as well as the simultaneous or subsequent acquisition of additional funding, both public and private, must be communicated to the Institute 'Carlos III' Health and may give rise to changes in the terms of the grant of the research project by means of a new resolution.

2. Any change in the initial conditions for granting the aid shall require the applicant entity's reasoned request and the express authorisation of the Director of the Health Institute "Carlos III" who may obtain the reports which consider appropriate to resolve as appropriate. No amendments to the initial application may be proposed until the decision has been taken.

3. Taking into account the circumstances which may arise in the chain of management of the research projects and in order to allow the beneficiaries sufficient time to apply the grant to the purpose for which it was granted, extensions may be granted in justified cases for the implementation of the research projects and allow the passage of unspent remnants of an annuity

to another, if the regulations of the beneficiary Centers allow it, as well as to grant extension for the final justification of the projects. These authorizations will be requested by the beneficiary Centers individually for each research project, justifying the causes of the application, and will be resolved by the Director of the Health Institute "Carlos III".

13th. Compatibility or incompatibility.

1. The aid will be incompatible with other types of aid financed by the ERDF (European Regional Development Fund) for the co-financing of investments in these projects.

2. Each call shall, where appropriate, set out the incompatibilities which will affect the participation of the principal investigator and the other members of the research team in the research projects.

3. As a general rule, there will be no incompatibilities with participation in the calls for Thematic Networks of Cooperative Research, with projects obtained under the Convocation of contracts of researchers from the National Health System, with Projects under the Framework Programme of the European Community for Research, Demonstration and Technological Development activities, with the assistance financed under the PROFIT, or with projects from other international programmes or Autonomous Communities.

14th. Criteria for the graduation of possible breaches of the conditions imposed by the grant of the grant.-Failure to comply fully or partially with the conditions imposed in connection with the award of the grants will give rise to the the obligation to reintegrate the amounts received in whole or in part, plus the relevant legal interests, in accordance with the following proportionality criteria:

(a) Failure to comply with the objectives and activities of the research project will result in the total reimbursement of the grant.

(b) Failure to comply with the partial objectives or specific activities of the project shall entail the return of that part of the grant to the project.

c) The implementation of unauthorised and non-scientifically justified budgetary changes will result in the return of the diverted amounts.

(d) The non-filing, in accordance with the corresponding call, of the annual and final memory, both scientific and economic, will entail the return of the amounts received.

e) The remaining unused aid must be reintegrated in its entirety.

15th. Powers of development.-The Director of the Institute of Health "Carlos III" is empowered to make the necessary resolutions for the application of this Order, as well as to resolve the specific doubts that arise in relation to the Order.

sixteenth. Entry into force. This provision shall enter into force on the day following that of its publication in the Official Gazette of the State.

Madrid, April 15, 2004.

PASTOR JULIAN