The aim of Royal Decree 1527/2010 is to regulate the Guarantee Commission for the Donation and Use of Cells and Human Tissue and the Register of Research Projects.
This Commission assures the mandatory scientific, ethical and legal guarantees for research projects that require tissue samples from embryonic human origin and other similar to embryonic cells or cell lines for biomedical research.
This Commission is responsible for the evaluation of projects and provides, if applicable, a first favourable report on those researchs, among other duties.
The object of this Law, with full respect afforded to human dignity, identity and the inherent rights of a person, is the regulation of biomedical research.
This law responds to the challenges of biomedical research and tries to use its outcomes to improve collective health and welfare; it also promotes and stimulates the coordinated action among public authorities and private and public agencies and institutions engaged in research, providing them with better tools to fulfill their task.
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This decree stablishes a specific control and coordination by the assignment to a single body the task of assessing the methodological, ethical and legal aspects of research projects.
These functions of a regional committee are attributed to the Clinical Research Ethics Committee of the Center of Regenerative Medicine in Barcelona, which statutory purpose is the scientific research in Biomedicine and Health and Life Sciences, particularly in the fields of developmental biology and regenerative medicine.
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The law introduces new therapeutic options that could benefit certain specific cases. It also regulates the terms and possible disposition of cryopreserved preembryos and gametes.
This law clearly defines, exclusively confined to its own scope effects, the concept of preembryo, meaning the embryo in vitro consisting of the group of cells resulting from the progressive division of the oocyte from being fertilized until 14 days later. Furthermore, in line with the provisions of the European Constitution, it prohibits human cloning for reproductive purposes.
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This Royal Decree sets up the requirements for approval, of the relevant health authority, of those research projects which involve the use of surplus preembryos from assisted human reproduction technics.
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