What is a biological sample?
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
How and where can I donate samples?
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?
How is the use of my samples authorized?
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
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).
- 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To donate samples to the biobank it is necessary to obtain the free and informed consent, which can be withdrawn, without prejudice, at any time.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.
- 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 >