Nebrija ResearchResearch Ethics Committee

Antonio de Nebrija University, fully aware of its social responsibility, established a Research Ethics Committee in 2002. Its purpose is to provide a prompt and effective response to current and future challenges related to scientific research carried out within the institution, ensuring the protection of individuals’ fundamental rights, the welfare of animals, the preservation of the environment, and adherence to the bioethical principles and commitments endorsed by the scientific community and enshrined in the University Statutes.

Activities of the Research Ethics Committee

The REC convenes periodically to review research projects submitted to various calls and to issue the required reports when necessary. It is also responsible for ensuring compliance with good research practices and for drafting reports for the University’s governing bodies on ethical issues in research and teaching whenever requested.

Requests for REC – BSC – AEC Evaluation

Does my project require review by a Committee?

• If the research involves studies with human participants, human samples, or the collection of personal data, it requires a Research Ethics Committee (REC) report.
• If the research involves biological agents or genetically modified organisms, it requires a Biosafety Committee (BSC) report.
• If the research involves experimental animals, it requires an Animal Experimentation Committee (AEC) report.

Composition

Chair

• Dr. Natalia Arias (Department of Psychology)

Secretary

• Dr. Bernhard Angele (Department of Education)

Members

• Dr. Santiago Budria (Department of Business Administration and Management)
• Dr. Nieves Cubo (Department of Computer Science)
• Dr. Rafael Barea (Department of Industrial Engineering)
• Dr. Iker López (Department of Architecture)

Alternate Members

• Andrés Arenas (Department of Business Administration and Management)
• Clara Matutano and Christian Velasco-Gallego (Department of Computer Science)
• Roberto Álvarez and Juan Jose Coble (Department of Industrial Engineering)
• Alicia Luque (Department of Education)
• Sara Uceda, María Nuñez (Department of Psychology)
• Patricia Benítez (Department of Architecture)

Roles and Responsibilities of REC Members

The Chair is responsible for:

• Presiding over Committee meetings
• Endorsing the minutes of Committee meetings
• Preparing the Committee’s annual report in collaboration with the Secretary
• Ensuring the achievement of the Committee’s objectives
• Performing all duties inherent to the position of Chair of the Research Ethics Committee

The Secretary is responsible for:

• Issuing meeting calls at the Chair’s request and preparing the corresponding notifications
• Drafting the minutes of meetings
• Issuing certified copies of decisions and agreements adopted
• Co-authoring and signing the Committee’s annual report with the Chair
• Carrying out all other duties inherent to the position of Secretary

The Members are responsible for:

• Attending the meetings to which they are summoned
• Reviewing and assessing the relevant documentation for subsequent consideration by the Committee
• Undertaking any tasks assigned by the Chair

Project Submission Deadlines

Projects must be submitted at least 10 calendar days in advance of the scheduled meeting.

Meeting Dates 2025

Submission of Applications

Applications must be submitted by sending the relevant documentation to the following email address: cei@nebrija.es.

Documentation and Forms

If the research uses data or samples from a project previously reviewed by an officially recognized Ethics Committee, the principal investigator must also provide a copy of the corresponding report(s).

Instructions for completion:

• One application must be completed for each project under review
• The principal investigator (PI) must include all ethically and/or biosafety-relevant information

Note:

• All sections of the form must be completed. References to sections or pages of the project report will not be accepted in lieu of providing information
• Queries regarding the Committees may be sent to: cei@nebrija.es

Procedure:

• The Secretariat of the Research Ethics Committee of UNNE will acknowledge receipt of the documentation prior to its review, and will request any additional documents or information if needed. Once the file is complete, it will be forwarded to the appropriate Committee(s) for evaluation.
• Following evaluation, the Committee issues a reasoned report, a copy of which is sent to the Research Ethics Committee of UNNE and to the PI or project lead.
• A Favorable Report from the corresponding Committee(s), as well as any other necessary authorizations, is a mandatory prerequisite before commencing the proposed research activity.
• Documentation: Code of Good Practice Informed Consent Guide Examples of Consent for Social Sciences or Humanities Projects Project Application Form Biomedical Project Application Form

Applicable Legislation

Personal Data Protection

Organic Law 3/2018, of December 5, on the Protection of Personal Data and the Guarantee of Digital Rights.

Royal Decree 1720/2007, of December 21, approving the Regulation for the development of Organic Law 15/1999 on the protection of personal data.

Human Participants, Samples, or Tissues

Law 41/2002, basic law regulating patient autonomy and rights and obligations regarding clinical information and documentation.

Law 14/2007, of July 3, on Biomedical Research.

Law 42/1988, of December 28, on the donation and use of human embryos and fetuses or their cells, tissues, or organs.

Royal Decree 1716/2011, of November 18, establishing the basic requirements for authorization and operation of biobanks for biomedical research, regulating the processing of biological samples of human origin, and the organization of the National Biobank Registry for Biomedical Research.

Royal Decree 1090/2015, of December 4, regulating clinical trials with medicinal products, Research Ethics Committees with medicinal products, and the Spanish Clinical Trials Registry.

World Medical Association’s Declaration of Helsinki

Universal Declaration on the Human Genome and Human Rights.

Biological Agents

Royal Decree 664/1997, of May 12, on the protection of workers against risks related to exposure to biological agents during work.

Genetically Modified Organisms

Law 9/2003, of April 25, establishing the legal framework for the contained use, deliberate release, and marketing of genetically modified organisms.

Royal Decree 178/2004, of January 30, approving the general Regulation for the implementation of Law 9/2003 on genetically modified organisms.

Artificial Intelligence

Report A9-0088/2022, on Artificial Intelligence in the Digital Era (European Parliament).

Directive 2000/43/EC on Racial Equality, Directive 2000/78/EC on Equal Treatment in Employment and Occupation, and Directives 2006/54/EC and 2004/113/EC on equal treatment between women and men in employment and in access to goods and services. These are essential to prevent certain AI algorithms from producing racial or gender bias and to ensure that probability predictions do not vary on the basis of gender or race.

Application Form for Amendments to Previously Evaluated Project Protocols

This form is to be used exclusively when introducing amendments to the protocol of a project previously reviewed by the Research Ethics and Biosafety Committees of UNNE. Only the proposed changes need to be included.