Donation of biological samples to the CBK

The protocol to be followed for donation of samples consists in informing the CBK of the healthcare or research professional’s intention to send one or several samples from patients affected by a rare disease.

The donation procedure has to comply with what is laid down in Act 14/2007 as regards the “protection and integrity of the human being in any biomedical research which involves carrying out genetic analyses, treatment of personal genetic data and of human biological samples. As a result of this, any collection of samples must go along with an informed consent signed by the donor or their authorized representative, preceded by the appropriate information given to them. This information shall be given in writing and include the nature, importance, implications and risks of research as well as the donors’ rights. More specifically, the information will refer to:

Purposes of the research
Expected benefits
Identity of the person responsible for the research
Genetic data obtained from the analysis of the donated samples
Mechanisms set up to guarantee the confidentiality of the information obtained, stating the identity of the persons who have had access to the donor’s personal data.

The database or LIMS (Laboratory Information Managment System) will collect exhaustively data on the following aspects, apart from the donor’s personal details and those of the referring healthcare professionals / researchers:

Clinical diagnosis
Types of samples
Data on the type of samples available for research (DNA; RNA; fibroblasts, etc.)
Information about the aim of the biomedical research.

The entire contents of this database are treated with absolute confidentiality and access to this, by a limited number of persons, complies with what is laid down in the Organic Law 15/1999, on the Protection of Personal Data (LOPD).

The sample shall be sent to the CBK, complying with appropriate transport and conservation rules, along with the form for “Donation of biological samples”, adjoining a copy of the Informed Consent document signed by the donor or their legal representative. The donation form may optionally be filled in by electronic means and sent through the bioinformatic platform developed by Noray Bioinformatics for the CBK, which can be accessed through this web portal http://www.ciberer-biobank.es/. In this case, a scanned copy of the informed consent should be enclosed.

Formulario de donación de muestras.pdf

Consentimiento informado.pdf

Tipo de muestra Condiciones de extracción Conservación y Envío al Biobanco.pdf