Proyecto de Real Decreto por el que se establece la regulación básica de los Comités de Ética de la Investigación en el Sistema Español de Ciencia, Tecnología e Innovación y se crea el Registro Nacional de órganos garantes de la investigación responsable

Scientific, technical, artistic and humanistic research must be carried out in a way that is compatible with respect for fundamental rights, the dignity and autonomy of individuals, equality and non-discrimination, privacy and other legal assets protected by law. Ethical evaluation is an essential guarantee to ensure the acceptability of research projects, the proportionality of their risks and benefits, the adequacy of their methodological procedures and the protection measures envisaged for the people who participate in them or who may be affected by their results.

Currently, research activity with the participation of people is carried out in a growing diversity of fields and there are methodologies that can generate relevant ethical risks. Along with biomedical research, which has specific ethical evaluation regimes, research in social and legal sciences, humanities, arts, education, economics, engineering, computer science, artificial intelligence, robotics and behavioral sciences, among others, has acquired special relevance. Interviews, surveys, observations, behavioral experiments, user studies, technology testing, and analysis of information from digital environments can affect people’s privacy, autonomy, image, voice, identity, intellectual productions, and other legitimate interests.

The use of artificial intelligence systems, emerging technologies and automated data processing tools also poses new challenges related to the quality and origin of data, biases, privacy, transparency, human supervision, security and the possibility of discrimination. These risks may become particularly relevant when minors are involved, people in situations of vulnerability or dependence, or groups that require specific guarantees.

Although universities, public research bodies and other scientific institutions have developed their own ethical evaluation mechanisms, there are differences in the organization, composition, functions, procedures and guarantees of the committees. This heterogeneity makes it necessary to establish common basic conditions that ensure the independence, technical competence, interdisciplinarity and quality of evaluations, without ignoring the particularities of the different disciplines or the competences of the bodies regulated by specific rules.

It is also necessary to strengthen the mechanisms of accreditation, monitoring, transparency and cooperation of the bodies involved in ethical evaluation and in the promotion of responsible research. The absence of a common State instrument to identify these bodies and to consult basic information on their scope of action, accreditation and operation makes it difficult for the system to be visible, for information to be exchanged and for institutions to coordinate.

Therefore, it is considered necessary to establish a regulatory framework that, together with common basic guarantees for the Research Ethics Committees, includes the creation of a National Register of Responsible Research Guarantors. This instrument will make it possible to have orderly information on the registered bodies and will facilitate the monitoring of their activity, institutional cooperation and transparency, respecting the competences of the administrations and the entities responsible.

The approval of a royal decree responds to the need to adapt the guarantees of responsible research to the evolution of scientific and technological activity and to move towards a common framework for the bodies that carry out functions of ethical evaluation and other functions related to responsible research in Spain.

Law 14/2011, of 1 June, on Science, Technology and Innovation, amended by Law 17/2022, of 5 September, strengthens the responsible, open, inclusive and transparent nature of the Spanish System of Science, Technology and Innovation and establishes the Spanish Research Ethics Committee as a State body of reference in matters of professional ethics, scientific integrity and responsible research. Likewise, the university system includes institutional mechanisms linked to the ethics and integrity of the research activity.

In this context, it is appropriate to establish common basic guarantees for the Research Ethics Committees that carry out their activity outside the areas that have a specific regulation, strengthening their independence, interdisciplinary composition, technical competence, operation and evaluation procedures. The regulation must allow the evaluation to be adapted to the nature, complexity and level of risk of each project, differentiating the applicable procedures and avoiding disproportionate administrative burdens for investigations that do not present relevant ethical risks.

Along with this, the diversity of bodies that perform functions to guarantee responsible research recommends having a State instrument that allows them to be identified and their main characteristics to be known. The creation of the National Register of Responsible Research Bodies, which is voluntary, public and state-wide, will make it possible to gather basic information on the registered bodies, including their contact details, functional, geographical and institutional scope, as well as information relating to their accreditation.

The Registry will depend on the Ministry of Science, Innovation and Universities, through the General Secretariat of Research, which will be responsible for the management and administration functions. Its configuration will make it possible to have a common reference to facilitate knowledge of the system of guarantor organs, improve the exchange of information and promote coordination with registers of similar characteristics that may be established by the autonomous communities in the exercise of their competences.

The standard will therefore allow us to jointly address two complementary needs: establishing basic guarantees for the ethical evaluation of research and improving the identification, transparency and coordination of the bodies that contribute to responsible research. All of this is based on respect for the competences of public administrations and the specific regimes that are applicable.

The main objectives of the Royal Decree project are:

• Establish a common basic regulation for the creation, composition, functions, operation and accreditation of the Research Ethics Committees in the Spanish System of Science, Technology and Innovation.
• Guarantee the independence, impartiality, interdisciplinary composition and technical competence of the committees, as well as the motivation of their opinions and the proper management of conflicts of interest.
• Establish ethical evaluation procedures adapted to the nature, complexity and level of risk of each investigation, distinguishing between complete evaluation, simplified evaluation and cases of exemption or non-subjection, where appropriate.
• To strengthen the protection of the rights, dignity, autonomy, privacy, security and well-being of persons directly or indirectly involved in investigations, with special attention to minors, persons in situations of vulnerability or dependence and other groups requiring specific guarantees.
• Incorporate appropriate safeguards to assess ethical risks arising from the processing of personal data, artificial intelligence, automated systems and other emerging technologies.
• Promote transparency, the traceability of evaluations, cooperation between committees and the recognition of opinions in projects developed by several institutions, avoiding unnecessary duplication.
• Establish accreditation mechanisms to verify that the Research Ethics Committees meet the necessary conditions of independence, impartiality, technical competence, resources and proper functioning.
• Create the National Register of Responsible Research Guarantors, of a voluntary, public and state level, under the Ministry of Science, Innovation and Universities through the General Secretariat for Research.
• Determine the conditions and procedure for the registration in the Register of accredited bodies within its scope, as well as for the updating of information and the registration of resolutions relating to the loss of effects of the recognition and cancellation of registrations, in the terms provided in the norm.
• Promote the coordination and exchange of information with registers of similar characteristics that may be established by the autonomous communities, maintaining the unique and independent nature of the State Registry.
• Avoid duplication and disproportionate administrative burdens, respecting the specific ethical evaluation regimes and the competences of the bodies and administrations involved in this field.

Among the non-regulatory alternatives, it has been considered to maintain the current situation and resort to recommendations, guides of good practices, voluntary agreements or mechanisms of cooperation between the institutions and bodies that carry out functions of ethical evaluation and responsible research.

These measures can help to improve certain practices and facilitate the exchange of information, but they do not in themselves guarantee common basic conditions of organization, composition, operation and accreditation of the Research Ethics Committees. Nor do they provide a common framework for establishing a State information instrument on guarantor bodies, with defined criteria for their registration, updating and coordination with other registries.

Another alternative would be to maintain the existing institutional mechanisms, without approving a specific basic regulation. This option would not allow a homogeneous response to the current differences between committees or establish the common conditions necessary to improve the identification, transparency and monitoring of the bodies included in the field of responsible research.

It could also be chosen to regulate separately the mechanisms of ethical evaluation and the registration of guarantor organs. However, joint regulation makes it possible to establish a coherent relationship between accreditation, information on bodies and their follow-up, favouring greater coordination and avoiding the fragmentation of the instruments envisaged.

Furthermore, the regulation must respect the specific regimes applicable to certain areas of research and the competences of the legally established bodies. Consequently, a solution that replaces or alters the functions attributed by its own rules to the committees and specialized bodies is not considered adequate.

For all these reasons, the approval of a royal decree establishing common basic guarantees for the Research Ethics Committees and creating the National Register of Responsible Research Guarantors is considered more appropriate. This solution will strengthen the quality and independence of ethical evaluation, improve the identification and transparency of bodies, facilitate the exchange of information and promote institutional cooperation, maintaining procedures proportionate to the risks of each investigation.

The persons and entities potentially affected by the future regulation, as well as universities, public research bodies, health and technological centres, public and private entities of the Spanish System of Science, Technology and Innovation, ethics committees, scientific integrity bodies, public administrations and other interested agents, are invited to make their contributions on the problems identified, the proposed objectives and the possible alternatives.

The public participation period is open from 00:00 on October 26 to 23:59 on November 9, 2026.

All contributions can be made through the following email address gabinete.investigacion@ciencia.gob.es