What is a Biobank?
As defined in Royal Decree 1716/2011, a Biobank is a “public or private, non-profit establishment, which houses one or more collections of biological samples of human origin for biomedical research purposes, organized as a technical unit with criteria of quality, order and destination, regardless of which it hosts samples for other purposes”.

Biobanks are entities responsible for managing biological samples so that they can be used by researchers and obtain maximum scientific performance from them.

What are the functions of Biobanks?
  • Processing and conservation of biological samples (or derivative products) and their associated data, with quality standards.
  • Custody of biological samples and their associated data, ensuring their confidentiality and the rights of donors.
  • Assignment of biological samples and associated data for biomedical research purposes to projects that exceed the approval of the Scientific and Ethics Committees.
  • Ensuring compliance with the law in the treatment and transfer of samples and the rights it grants to donors.
  • Processing and management of the Transfer Agreements documents.
  • Encourage and support new lines of research.
What is the legislative framework for Biobank activities?
The activity of biobanks is regulated by the following regulations:

  • Law 14/2007 on Biomedical Research.
  • 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.
  • Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights.
  • Regulation (EU) 2016/679 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.
  • 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.
Why should transfers of biological samples be approved by Scientific and Ethics Committees?
Article 5 of RD1716 establishes among the minimum requirements for the authorization of a Biobank that it “is attached to two external committees: one scientific and one of ethics”. In Article 15 it establishes the functions of two committees that are the scientific and ethical evaluation of assignments, advising the scientific director of the Biobank on “the adequacy of the procedures established to ensure quality, safety and safety traceability of data and samples” in transfers to third parties from a scientific and ethical point of view, respectively. Your opinions are binding.
What costs are passed on to sample transfers?
Research samples are free and only the costs of obtaining, processing and storing them will be passed on. Rates are calculated based on the costs of obtaining the total sample. The final rate consists of the proportional cost of the sample quantity delivered. In no case, these costs give a commercial value to the sample but refer to the costs that the Biobank generates in obtaining, processing and storing them. Biobanks often have different rates for internal applicants to their Institution and for external selves, distinguishing between public and private entities, based on the institutional and/or public support that the Biobank receives for its infrastructure and operation.
What is an MTA or assignment agreement?
An MTA (Material Transfer Agreement) or sample transfer agreement is a document required by law governing the terms of the transfer of samples and data between two Institutions.

RD1716/2011, Article 33. 2.

The transfer of samples or collections of samples to biobanks and collections responsible shall be formalized by prior written agreement, … Such agreement shall be entered into by the person holding the biobank or responsible for the target collection, on the one hand, and by the person holding the biobank or responsible for the centre or the collection of origin of the samples, on the other. In cases where both parties coincide, no such agreement will be necessary.

What commitments are made by legal obligation?
RD1716/2011, Article 34. 5.

The application shall be accompanied in addition to a transfer agreement document, which shall be entered into by the person responsible for the investigation on the one hand, and the biobank or the person responsible for the collection by another, which shall provide:

(a) The obligation on the part of the recipient to ensure the traceability of the sample.

b) Guarantee of the availability of validated and health-relevant genetic information, if any, obtained from the analysis of the samples.

c) In the event that the grantor is a biobank, the commitment to observe the internal operating regulations of the grantor biobank in what is applicable.

d) The commitment to destroy or return to the biobank or responsible for the collection the excess material once the project is completed.

How do Biobanks benefit the sample applicant?
  • Guarantee of standard procedures and quality throughout the process, from obtaining samples to transfer.
  • Ensuring compliance with ethical and legal standards.
  • Advice for the best scientific use of the samples.
  • Open, transparent and competitive access to samples and data to the entire scientific community with quality and service criteria.