Instituto de Investigación
REACCREDITATION PROCESS
This process involves the renewal of the accreditation of Health Research Institutes, in accordance with the criteria established in Royal Decree 339/2004. It is carried out through an audit by an external evaluation committee on behalf of the ISCIII, which reviews various thematic areas, such as institutional structure, scientific output, projects, procurement, among others.
The collaboration and participation of all research groups will be required for this process.
APPLICABLE REGULATIONS
- Royal Decree 339/2004 of 27 February, on the Accreditation of Health Research Institutes, which establishes the concept of a Health Research Institute, the accreditation criteria and procedure.
In force until 5 October 2016.
- Order SCO 1245/2006 of 18 April, which develops Royal Decree 339/2004 on the Accreditation of Health Research Institutes with regard to the composition of the Evaluation Committee, the Guides to the accreditation procedure and the coordination of the actions of the authorities involved in the initiation and investigation phases of the procedure.
- RD 279/2016 Accreditation of Research Institutes (from 5 October 2016)
ACCREDITATION PROCESS
Following the audit carried out on 29 and 30 March 2012, and having fulfilled all the requirements to obtain accreditation, the Health Research Institute of Hospital Gregorio Marañón (IiSGM) was accredited by the Instituto de Salud Carlos III (ISCIII) as a Health Research Institute.
¿What is accreditation?
Law 16/2003 of 28 May on the cohesion and quality of the National Health System establishes in Article 50 that the establishment of health research institutes will be promoted through the association of research centres that will be accredited by the Ministry of Health and Consumer Affairs at the proposal of the Instituto de Salud «Carlos III» or the autonomous communities, following the procedure established by regulation.
These Health Research Institutes must arise from existing research centres and groups of proven quality which, when associated, meet the necessary requirements established in Royal Decree 339/2004, with the aim of enhancing the prestige of the Centres that make up the Institute through institutional recognition, facilitating an increase in human resources, infrastructure and new technologies to expand and consolidate the quality and quantity of research teams and lines of research.
The foundations of the RD were subsequently detailed in an Evaluation Guide, which contains a series of requirements for an institute to be accredited. These requirements are grouped around 3 areas:
- Structure and aims of the research institute and the R&D&I management system
- Scientific teams, support staff, scientific equipment and resources, and training in R&D
- Measurement, analysis, improvement, protection and dissemination of research activity
A total of 57 essential requirements and 83 recommended requirements are necessary for accreditation
Accreditation as a mark of quality would mean that the Ministry of Health, following a comprehensive on-site assessment carried out by the ISCIII, would certify that the IISGM, together with its various constituent entities, jointly carries out high-quality translational biomedical research.
This accreditation is temporary and subject to periodic quality assessments, and should be understood as a path towards improving the quality of research.
¿What are the objectives?
- To bring basic and clinical research closer together
- To promote the concept of the Hospital as a Research Centre
The Accreditation of Health Research Institutes is one of the appropriate mechanisms for achieving an increase in excellent scientific and technological knowledge and a significant critical mass of multidisciplinary scientists in Institutes formed through the linkage of different state and autonomous-community institutions, both public and private, within the National Health System.
¿What requirements must be met for accreditation?
- The entities must necessarily be teaching and research hospitals belonging to the National Health System and public and/or private R&D&I centres, including primary care research facilities.
- The existence of a legal link supporting the association of university hospitals with other research organisations
- The existence of an organisational structure, with governing bodies on which all Centres are represented
- The existence of a single management structure (support and assistance in the economic-administrative areas and acting as an OTRI) for research, separate from the healthcare and teaching management structure.
- The design of a Strategic Research Plan for the Health Research Institute, with a cooperative Scientific Project verifying intellectual interaction in research, training or clinical practice, indicating the common scientific areas, objectives and lines, as well as the various measures and actions necessary to achieve the proposed objectives.
- The establishment of an external Scientific Committee to safeguard the scientific quality of the Institute and advise the Scientific Directorate.
- The existence of common basic support services constituting the Research Support or Assistance Units.
- The design and development of a Research Training Plan linked, preferably, to postgraduate programmes.
- To have a written guide ensuring quality, ethics and good scientific practice
- To have a register containing staff affiliations
- To have a register of R&D&I activities and data
Monitoring
The accreditation of Health Research Institutes is a dynamic process subject to continuous review by all the parties involved. In this regard, accredited IISs are required to prepare an annual scientific activity report and a management report.
Legal Framework
- Royal Decree 339/2004 of 27 February, on the Accreditation of Health Research Institutes, which establishes the concept of a Health Research Institute, the accreditation criteria and procedure.
- Order SCO 1245/2006 of 18 April, which develops Royal Decree 339/2004 on the Accreditation of Health Research Institutes with regard to the composition of the Evaluation Committee, the Guides to the accreditation procedure and the coordination of the actions of the authorities involved in the initiation and investigation phases of the procedure.