Donation
Donation
The sample donation protocol requires healthcare professional or researchers to notify the CBK before submitting samples from patients affected by a rare disease.
The donation process must comply with the provisions of Law 14/2007 regarding the “protection and integrity of the human being in any biomedical research that involves the performance of genetic analyses, the processing of personal genetic analyses, and biological samples of human origin” In consequence, all sample collection must be accompanied by an informed consent signed by the donor or their authorized representative, preceded by the appropriate information provided to them. This information will be provided in writing and will include the nature, importance, implications, and risks of the research, as well as the rights of donors. More specifically, the information will refer to:
- Aims of the research
- Expected benefits
- Identity of the research principal investigator
- Genetic data obtained from the analysis of the donated samples
- Mechanisms to guarantee the confidentiality of the information obtained, indicating the identity of the individuals who have access to the donor’s personal data
Laboratory Information Management Systems (LIMS) databases comprehensively collects, in addition to the personal data of the donor and the specialists who treat them, data on the following aspects:
- Clinical diagnosis
- Sample types
- Data on the types of samples available for research (DNA, RNA, fibroblasts, etc.)
- Information about the objective of the biomedical research
All the information contained in this database is treated with strict confidentiality. Access is restricted to authorized personnel and complies with the provisions of the Spanish Data Protection Act (LOPD).
The sample will be sent to the CBK in accordance with appropriate preservation and transport guidelines, accompanied by the “Biological Sample Transfer” form and a copy of the informed consent signed by the donor or their legal representative. Alternatively, the transfer form may be completed electronically through the online platform developed by Noray Bioinformatics for CBK, accessible via the website… https://www.ciberer-biobank.es/. In this case, a scanned copy of the informed consent form must be attached.
- Why donate?
- What and who can donate?
- How to donate?
- Information for donors
WHY DONATE?
Donating biological samples to biobanks is especially important for rare diseases due to their low prevalence and geographical dispersion. These donations allow us to advance our understanding of these diseases through:
- The development of biomarkers for early disease diagnosis. A rapid and well-established diagnosis allows for early treatment.
- The identification of prognostic markers that allowing to predict the course of the disease.
- Elucidating the disease-causing mechanisms and identifying therapeutic targets.
- Enabling new therapies validation.
Donors retain the right to be informed regarding the specific research applications of their samples and the ultimate disposition of the sample once the study is completed.
What and who can donate?
Human biological samples, such as urine, blood, saliva or tissue biopsies, can be donated alongside related data (age, sex, genetic studies, etc.), which isas important for research as the biological samples themselves. Samples to be donated for research can come from these main sources:
- Leftover biological material from medical tests carried out as part of the care process (diagnostic, surgical or therapeutic surplus).
- Specifically collected material
- Post-mortem material: samples obtained after death (autopsy).
Donors can be patients or healthy controls. Today, society increasingly recognizes the importance of biomedical research in achieving more effective treatments and of its active role in contributing to scientific development, enabling more personalized advances in medicine and healthcare.
HOW TO DONATE?
1
Medical consultation + Voluntary donor
2
Informed consent
3
Sample collection
4
CIBERER
Biobank
The donation procedure must comply with Law 14/2007 on biomedical research involving genetic analysis, personal genetic data, and biological samples of human origin” Consequently, all sample collection must be accompanied by written informed consent signed by the donor or their authorized representative and donors must also receive adequate information about the donation process, covering the nature, significance, implications, and risks of the research, as well as their personal rights.
The sample will be sent to the CBK, in accordance with appropriate preservation and transport guidelines. (Sample type, extraction conditions, storage and shipment to the Biobank) attaching the following information:
| Samples Donation Form | BIOLOGICAL SAMPLE DONATION FORM |
| Informed consent form signed by the donor or their legal representative | INFORMED CONSENT |
| Informed consent form for voluntary donation signed by the donor or their legal representative | INFORMED CONSENT VOLUNTARY DONATION |
Information for Donors
If you are interested in becoming a donor, you must meet the following requirements:
- Be of legal age.
- Be informed by your doctor about the possibility of donating your samples.
- Sign the informed consent form (a document describing the donation process and how the samples will be used).
The donated biological material will be stored in the CBK (Biobank) and supplied to researchers for biomedical studies. Before any samples are transferred, the corresponding projects must receive approval from both the Ethics Committee and the Scientific Committee of FISABIO-Public Health.
Donation is entirely voluntary. Donors may exercise their right to withdraw their consent at any time by notifying the physician who requested their participation. This revocation will not affect their medical care in any way and will only apply to the samples currently stored in the Biobank.
All database content is strictly confidential, and handled in full compliance with data protection laws by a limited number of authorized personnel. Both biological samples and associated clinical data are coded in the biobank using pseudonyms and are shared with researchers exclusively in an aggregated, anonymized form. Any direct personal identifiers not related to the clinical setting (name, national identity document number, town/city, hospital, etc.) are kept strictly confidential and secure, in full compliance with the Data Protection Act.
You may exercise your rights of access, rectification, erasure, and objection by contacting the physician who requested your participation in the project or by visiting us in person at the Biobank, located in the FISABIO-Public Health building, Avda. Cataluña. 21, 46020 Valencia.