The use of biological samples is one of the most common procedures in scientific research. Due to its nature, it is a procedure that requires special attention and it is regulated in a specific way. This is why, before starting any research, it is important to know the regulatory system and the guidelines to be followed for biological sample management.
Biological samples management has a comprehensive regulatory framework which ensures the correct use of samples and associated data.
On the one hand, there is a specific regulation which regulates medical research based on human biological samples.
Thus, Royal Decree-Law 9/2014 of July 4 is fundamental. It establishes the standards for quality and safety for donation, collecting, testing, processing, preservation, storage and distribution of human cells and tissues and approves the standards for coordination and operation for use in human are approved, is central. This decree replaces Royal Decree 1301/2006 which is repealed.
On the other hand, Law 29/2006 of July 26 regulates guarantees and rational use of medicines and health products, as well as Law 14/2007 of July 3 on biomedical research.
Royal Decree 1716/2011 of November 18 establishes the basic requirements for authorization and operation of biobanks for biomedical research purposes and the treatment of human biological samples, and regulates the functioning and organization of the National Register of Biobanks for Biomedical Research. In addition, Order ECC/1404/2013 of June 28 modifies the appendix of this Royal Decree.
In this regard, Royal Decree 65/2006 regulates, in addition, the transfer of biological samples with non-EU countries (sample import and export). This regulation is expanded with Order SAS/3166/2009 of November 16 which replaces the appendix of the Royal Decree.
On the other hand, regulations aiming to regulate the rights of the donor at the time of collecting biological samples are established. Thus, the management of personal data associated with the samples is regulated by Organic Law 15/1999 on the Protection of Personal Data (LOPD), together with Royal Decree 1720/2007, which implements said law.
Additionally, Law 41/2002 of November 14, regulates patient autonomy and the rights and obligations concerning clinical information and documentation.
Finally, there is a regulation which regulates the procedures with particular biological samples.
For example, Law 14/2006 of May 26 regulates the assisted reproductive techniques, while Royal Decree 1054/2002 of October 11 regulates the assessment process for the register, authorization and marketing of biocides.
Moreover, there may be specific regulations in each one of the Spanish Autonomous Communities. It is therefore appropriate to examine the legislation of each particular territory before implementing any process related to the management of human biological samples.
“The management of biological samples has a broad normative framework, so that the correct use of the samples and the data associated with them is ensured”
Human biological samples have numerous uses in the current outlook of scientific research. Fields as diverse as chemistry, biochemistry, immunology, hematology and microbiology use biological samples to advance in their researches.
In addition, collecting biological samples may be used for many different purposes, from the prevention and diagnosis of diseases to their treatment or research.
Regarding the circumstances in which it is possible to store biological samples, there are three options:
Biological samples may be required for a specific research project. If it is necessary to collect biological samples with this aim, a report should be written detailing the research project and justifying the need to obtain biological samples.
Further on, a sheet to inform the subject of the aim of this specific research and obtain his/her consent will be prepared. In addition, the project should be submitted to an ethics committee to obtain their approval and the site should be registered in the Spanish Data Protection Agency.
Biological samples may be kept for a registered sample collection. These samples may come from previous studies. However, the informed consent of the subject allowing for their use will be required. The collections should in turn be registered in the National Registry of Biobanks, in the “collections section”, and the approval of a central Ethics Committee should be obtained.
Another possible destination for biological samples is a registered biobank. In contrast with the two previous options, the biobank allows to store biological samples without necessarily being associated with a specific medical research. Thus, the samples obtained may be used in any research, whenever the donor has been informed and has given his/her consent.
Anyhow, there are some guidelines to be followed in the processes of sample management. On the one hand, considering that biological sample management entails access to files with personal data related to patients, the research site should be registered in the Spanish Data Protection Agency. Moreover, an audit may be conducted by the agency at the site to ensure that regulations are respected.
In this sense, there are different security levels regarding the donor data. These levels are determined based on the type of data that the files contain, they can range from the donor’s name and surname to their ideology or other data obtained for law enforcement purposes.
There are also rules to be considered regarding the transfer and transport of biological samples, which in many cases are vital for the advance in research. Thus, if the samples have to be transferred through non-EU countries, an authorization by the Directorate General for Public Health should be requested (this step may be skipped if the transfer is made between countries within the community customs territory).
To obtain this authorization, it will be necessary to detail for example the type of sample to be transported, its origin and destination as well as its intended use.
“Taking biological samples can serve a large number of purposes, from the prevention and diagnosis of diseases to the treatment or investigation thereof”
Biological sample management is a delicate procedure where particularly sensitive products are handled. This is why professionals and investigators should have the highest training and specialization in laboratory work.
At the same time, there are some recommendations to be followed when working with biological samples:
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