8. Main legal requirements affecting scientific activities

Biocat-Bio regió8.1. Responsibilities of the PRBB Centres
The directors of the Centres must provide assurances to personnel that the infrastructure complies with legal requirements and that they have the relevant authorisation to undertake any scientific activity that is subject to specific regulations. Centres will keep up to date with relevant legislation and regulations in the following areas: scientific research involving human subjects, human embryonic material and storage of human biological samples in biobanks; the use of animals in scientific research; the use of, exposure to, and storage of radioactive material, genetically modified organisms, or any other potentially dangerous biological agent; the use of geolocation and other individual identification data.

8.2. Research involving human subjects
All research protocols involving the direct participation of human subjects or based on any form of information or biological samples obtained from such subjects must always have received, as a minimum requirement, approval from the corresponding clinical research ethics committee. When research involves patients, members of the research team who are not responsible for treating the study participants must collaborate and not interfere with any decisions made by the physician responsible for treatment.

8.3. Common requirements in all research involving human subjects and/or human biological samples
Particular diligence is required in relation to all information regarding the purpose, potential discomfort/inconvenience and risks, and the benefits of the research, in obtaining the express, specific, and written consent of the participants, and in attending to the confidentiality of data, samples, and results obtained. In addition, given that in clinical research the process of data collection is complex and cannot always be repeated, the research group must pay particular attention to the quality of data collection and the procedures for data storage.

8.4. Genetic research
All research protocols that include the collection, manipulation, and/or storage of biological samples for the purposes of genetic analysis will be prepared according to the current legislation. In particular, the privacy of the subjects and their right to be informed about their personal results must be guaranteed. The consent of the participating subjects can foresee the use of samples in other projects related to the initially proposed research. Consent must be renewed whenever biological samples are to be used for purposes other than those indicated at the time they were donated.

8.5. Research involving human embryonic material
All research plans that involve collection, manipulation, and/or storage of human embryonic material must receive the corresponding permission from the Spanish Ministry of Health, following acceptance by the appropriate ethics committee for clinical research.

8.6. Research with human biological samples
All research involving the use of human tissue or other biological samples derived from humans requires the specific informed consent of the donor. Specific donor consent must also be given before research may be done on samples obtained as part of diagnostic or health care procedures.

8.7. Human samples
Human biological samples of any kind, collected as part of a research project must only be used for specific purpose stated in the donor consent form and may never be given to third parties. The Principal Investigator of the project is responsible for the collection and storage of these materials and must inform the centre about the samples and register them in the National Biobank Register.

8.8. Protection of personal data
All research plans that involve the use of institutional computer records or the preparation of databases containing information relating to individuals must guarantee the anonymity of the participants and be subject to current regulations on data protection.

8.9. Research involving experimental animals
In accordance with national and European regulations all procedures using animals must be previously approved by the Ethical Committee for Animal Research (CEEA-PRBB). All animal protocols must be carried out in an accredited animal facility.

8.10. Biosafety
All procedures involving the use of genetically modified organisms (GMOs) or biological agents or chemicals of special hazard should be presented for approval to the PRBB Biosafety Committee (CBS-PRBB) which will undertake a risk assessment of the experiment within the context of the proposed research setting and equipment.

8.11. Good laboratory practice
Non-clinical studies intended to test health or environmental safety and in which results must be presented to the competent regulatory authorities must be performed in accordance with current legislation on good laboratory practice.

 

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