The National Rare Diseases Biobank (BioNER) is led by a Scientific Director, Dr. Beatriz Martínez Delgado, and a Technical Director, Dr. Gema Gómez Mariano, who are responsible for the strategic planning, scientific management, and technical operation of the biobank. Since its establishment, the biobank was initially directed by Dr. Manuel Posada de la Paz, then Director of the Institute for Rare Diseases Research (IIER) and coordinator of the European rare disease biobank network EuroBioBank, whose work was instrumental in the creation and consolidation of BioNER as a national reference infrastructure for rare diseases.

BioNER has its own internal regulations and an internal committee composed of IIER professionals, which advises the Directorate on scientific, strategic, and organizational matters related to the biobank's activities.

In accordance with current legislation, BioNER is supported by the Research Ethics Committee (REC) of the Carlos III Health Institute (ISCIII), whose composition is available on the ISCIII institutional website, and by a Scientific Committee, responsible for evaluating the scientific quality and suitability of requests for access to biological samples.

The Ethics Committee serves both BioNER and the ISCIII National Biobank, which is dedicated to managing collections of samples associated with diseases that do not fall within the definition of rare diseases. Through their evaluation and advisory roles, these committees ensure compliance with the ethical, scientific, and legal principles governing biobank activities.