What is a biological sample?
Any biological material of human origin that can be preserved. For example: blood, saliva, tissues…

Biological samples may be:

‘Anonymous biological sample’ means a sample collected without a link to the donor, so it can never be known whose sample it is. Biological samples used as control samples in biomedical research studies are usually collected in this way.

‘Encoded biological sample’ means an alphanumeric code, only known and guarded by Biobank personnel (never by researchers), is the link that would identify the donor with that sample. This collects most of the samples used in research studies.

Informed consent for sample donation
It is the document informing the donor about the nature, importance, implications and risks of the donation to the biobank, in the terms established by the Law. This document must be signed to record that the will of donors or their legal representatives will be respected so that their biological samples, clinical images and/or associated information can be used in biomedical research.
How and where can I donate samples?
Donors are most often recruited by healthcare professionals in collaborating centres (health centres, transfusion centres, blood banks, etc…) when they go for medical reasons such as a consultation or hospitalization, or for a donation of blood. The necessary selection criteria, which vary from one biobank to another, must be met. For example, there are biobanks specialized in tumors, others in healthy donors to use as controls, others in various pathologies, others in pediatric donors, etc.

In any case, you can go to the biobank/s of your region and express your interest, so that you can assess your collaboration. You can find the contact details on this website.

Who can request my samples?
Any national or international researcher or research group presenting a project previously approved by an Ethics Committee.
How is the use of my samples authorized?
The authorization for the use of their samples by the researchers is issued by two independent Biobank Committees: the Scientific Committee and the Ethics Committee.

Samples are assigned from biobanks to researchers for use in specific research projects that have been approved.

Researchers and the biobank sign an agreement/contract for the transfer and use of samples in the research project for which they request it.

In this way, the good use of its samples is guaranteed for scientifically correct projects, ensuring respect and rights of donors.

Confidentiality and processing of personal data
Based on the principles of the European General Data Protection Regulation (Regulation (EU) 2016/679) and Spanish regulations on the protection of personal data, your personal data and samples are treated with high levels of security in a pseudonymized/encoded manner so that your identity will not be disclosed to researchers.

Donors have the right to delete, oppose, portability, limitation of the processing, access and rectification of their data, as well as the right to request the destruction or anonymization of samples and/or data that have not yet been used.

They also have the right to contact the Spanish Data Protection Agency if they are not satisfied (www.aepd.es).

Ethical principles
The regulations on biobanks and biomedical research in general involving human beings are based on universal ethical principles:

  • Autonomy: Recognizes a person’s ability to make personal decisions.
    To donate samples to the biobank it is necessary to obtain the free and informed consent, which can be withdrawn, without prejudice, at any time.
  • Charity and non-malephilience: Act for the benefit of others and not cause harm and prevent it.
    The donation of samples to a Biobank does not represent a direct benefit to the donor, it is aimed at society at large.
  • Justice: Equity in the distribution of obligations and benefits. It includes rejection of discrimination on any ground.

For biobanks it has implications in particular in the selection of participants, paying special attention to ensuring the protection of the rights and well-being of vulnerable people, for example because of their inability to give informed consent.

Legal framework
The use of biological samples and associated data in biomedical research and their circulation is regulated by the following national regulations:

  • Law 14/2007, of July 3, on Biomedical Research (LIB). Download >
  • Royal Decree 1716/2011, of 18 November, laying down the basic requirements for the authorization and operation of biobanks for the purposes of biomedical research and the treatment of biological samples of human origin, and regulating the operation and organization of the National Registry of Biobanks for biomedical research. Download >
  • Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation, GDPR). Download >
  • Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights. Download >
  • Law 41/2002, of 14 November, basic regulatory of the autonomy of the patient and of rights and obligations in the field of information and clinical documentation. Download >
  • Royal Decree 65/2006 of 30 January laying down requirements for the import and export of biological samples intended for diagnosis or research in humans. Download >
  • Order SAS/3166/2009 of 16 November, replacing the annexes to Royal Decree 65/2006 of 30 January laying down requirements for the import and export of biological samples. Download >
May I know what investigations my samples are being used in?
If you want to know which research project your biological samples are being used in, you can contact the biobank to which you have donated your samples.