The i+12 Institute has defined an organisational structure for the development of its functions in which government bodies, management and coordination positions, advisory bodies and other units and areas in the scientific and management areas are identified.
General organisational structure of the i+12 Institute
Scientific structure of the i+12 Institute
1. Government Bodies
The Governing Council is the Governing Body corresponding to the representation, management and administration of the Research Institute Hospital 12 de Octubre. All the entities that make up the Institute are represented in this body.
Its functions are, among others:
- Appoint and dismiss the positions in the i+12 Institute.
- Perform the supervision, inspection, surveillance and orientation of the work of the i+12 Institute, and establish the general guidelines and the strategic planning of the same.
- Approve the Strategic Plan and the operational programmes as well as the projects and the results; the Quality Plan; the budget, the appropriate reports, the inventory, as well as the financial assessment and the annual accounts; the internal regulations; the proposal of the requirements and conditions for the incorporation of new researchers and research groups and agree on the entry of new members; the proposal for the distribution of the obtained resources corresponding to it as the Institute i+12.
- Review the management system, activities and results.
- Define accreditation policies and the use of shared technology platforms based on the corresponding integration agreements; as well as training and shared knowledge policies.
Composition of the Governing Council – Download
This is the executive governing body of the Research Institute Hospital 12 de Octubre and its functions include the following.
- Review annual operating programmes and annual activity reports.
- Study budgets, the statement of accounts and other mandatory reports.
- Evaluate the performance and operation of the activities.
- Review annually the integration mechanisms of the different entities that make up the Institute.
- Perform the review of the management system, activities and results.
- Approve the proposed improvement actions.
- Be informed of the evaluation of the groups or researchers of the associated entities.
- Any other item delegated by the Governing Council.
Composition of the Delegated Commission – Download
2. Management positions
The i+12 Institute has in its organisational structure a Scientific Director, who acts as the Director of the Institute. The Director of the Institute is the person in charge of the executive direction of the same, among the other functions attributed to it.
- Prepare and develop the annual operational programmes and the annual report of researchers of the i+12 Institute.
- Prepare budgets, the statement of accounts and other mandatory reports.
- Manage the research infrastructure acquired by the i+12 Institute.
- Develop the contracting policy for research and technical personnel to assist the Institute’s research established by the Governing Council.
- Communicate and disseminate the research activities of the i+12 Institute.
- Report on public and private offers for research projects and other activities related to research.
- Be the maximum scientific representative and spokesperson of the i+12 Institute before other entities.
- Facilitate the capture of external resources.
- Ensure the Quality of Research that is carried out in the i+12 Institute, and that it is carried out in accordance with the ethical principles of behaviour, both in terms of research activities and respect for the labour rights of research and technical staff assisting in the research.
- Propose to the Delegate Committee the necessary measures for the proper functioning of the Institute and implement the decisions adopted by this Commission.
- Carry out, in addition, the functions that the Governing Council and the Delegate Commission entrust to it.
Currently, the position of Scientific Director of the i+12 Institute is held by PhD. Joaquín Arenas Barbero.
The managing body of the i+12 Institute is the FIBH12O, as stated in clause ONE.2 of the agreement creating the Institute. This Foundation develops the management activities of the i+12 Institute, and to this end, the following functions are assigned to the Foundation Management:
- Fulfil and enforce the agreements of the Governing Council and the instructions of its chair, being able to perform all kinds of acts and sign those documents necessary for this purpose.
- Manage the activities and operations of the Foundation and the Institute in general.
- Prepare and propose to the governing bodies the Annual Budget of Income and Expenses Plan and, where appropriate, the modifications that may have been made, as well as that of the Activity Report, the Stocktaking Report, the Income Account and the Inventory.
- Managing and administering, on a regular basis, the equity of the Foundation, in accordance with the attributions that in this respect have been conferred by the governing bodies, keeping the inventory updated.
- Proceed with the ordering of payments and the management of the Treasury in accordance with the criteria approved by the governing bodies, and supervise the accounting of the Foundation, monitoring the correct fulfilment of the criteria and principles that are applicable.
- Acquire the goods and services and contract the works and supplies of the Foundation within the amounts and limits that, in this respect, have been approved by the governing bodies.
- Inform quarterly regarding the activities and results of management of the Foundation.
- Develop the staff policy and, for that purpose, select the staff, sign or terminate contracts, execute the agreements of the governing bodies regarding remuneration, agree on sanctions, perform the superior leadership of the staff at the service of the Foundation and all those other actions that, in this matter, are entrusted to him.
- Maintain relations with the representative bodies of the staff or at the service of the Foundation.
- Prepare and propose the Research Plan of the Foundation and the specific programmes and projects that must be developed in its performance, submitting the project to the prior report of the Research Commission.
- Maintain the relations of the Foundation with the governing bodies of the health centre, and propose the establishment of coordination groups or commissions when necessary.
Currently, the position of Director of the Foundation for Biomedical Research of the Hospital 12 de Octubre is held by Ms. Mª Mar López Martín.
3. Advisory bodies
The Scientific Advisory Board (SAB) is the main advisory body of the i+12 Institute, whose priority mission is to ensure the scientific quality of the Institute and advise the scientific direction of the Institute.
The functions assigned to the SAB are the following:
- Issue opinions at the request of the Governing Council or the Delegate Commission.
- Assess and study the possible association of new entities to the i+12 Institute. In cases where the association of a new entity is considered positive, the CCE will ask the Scientific Management to transfer the association request to the Governing Council for its approval.
- In general, the advice of the i+12 Institute.
Composition of the Scientific Advisory Board – Download
The Research Committee of the i+12 Institute is the consultative body that supports and advises the Scientific Manager in the development of his/her functions.
The functions assigned to the Research Committee of the i+12 Institute are the following:
- Advise the Scientific Management in the research activity of the i+12 Institute.
- Plan the research activities and the scientific policy that are developed in the i+12 Institute.
- Define the priority research lines of the i+12 Institute.
- Report on the adequacy and acquisition of infrastructures.
- Report on the human resources provision.
- Control the quality of the research of the i+12 Institute.
Likewise, the Research Committee of the i+12 Institute assumes the functions of the previous advisory bodies existing in the Organisation of the Hospital Universitario 12 de Octubre and the Foundation for Biomedical Research of the Hospital 12 de Octubre.
Composition of the Research Committee – Download
Private access to the documentation of the Research Committee – Access
The objective of the Ethic Committee for Research with medicinal products (ECR) is to contribute to the protection of the rights and dignity of human beings in the research activities in which they participate and that will prevail over science, as reflected in the postulates ethics contained in the Declaration of Helsinki and its subsequent revisions, as well as in the Oviedo Convention on Human Rights and Biomedicine.
Royal Decree 1090/2015 defines the following functions of the ECR:
- Evaluate the methodological, ethical and legal aspects and the relevant modifications of clinical trials with medical products and medical devices.
- Evaluate the ethical, methodological and legal aspects and the relevant modifications of clinical research with medical devices.
- Follow up clinical trials with drugs and clinical research with medical devices. The ECR must have up-to-date information on the status of clinical trials with medicines and clinical research with medical devices carried out in its scope of action, at least once a year.
- To evaluate the methodological, ethical and legal aspects of the post-authorisation studies with medical products that are sent to them in accordance with Order 730/2004 of the Ministry of Health and Consumer Affairs of the Community of Madrid.
- Evaluate the methodological, ethical and legal aspects of other biomedical research projects that require evaluation by the ECR.