Basque Biobank

Informed Consents

 The informed consent for sample donation is the tool by which patients freely and consciously indicate their wish to donate after having been informed of the intended use of these samples.

 The Basque Biobank has various types of informed consent form, all of which have been approved by the Basque IRB. There are different types of informed consent form depending on the framework in which the sample is collected. They all consist of:

• A patient information sheet: this explains the aims of the project (if the samples are collected as part of a research project), the sample that will be collected from the patient, the risks inherent to the collection procedure, the benefits that will be obtained and the patient's right to cancel their participation and the means of doing so. It also explains what the Basque Biobank is, a request for approval to deposit the sample in the Basque Biobank and the possibility to request information concerning the sample.
  
  

• Informed consent, in which the donor will conform, in writing, that he/she agrees to donate a sample and whether this sample should be included in a coded or anonymised manner.

The researcher will never be aware of the patient's identity as all samples are provided by the Basque Biobank with a code that bears no relation to the donor's personal information.

The sample can be deposited in two different ways, namely CODED or ANONYMISED, depending on the donor's wishes. Coded and anonymised samples differ as follows:

• CODED SAMPLES: This means that the sample will be coded at source when collected and that if clinical data are subsequently required, the physician who collected informed consent from the donor can retrieve said donor's personal data and request the necessary information. Similarly, if results relevant to the patient's health are obtained as part of the project, the physician can retrieve the patient's personal data to inform him/her of the analytical results.
  
  

• ANONYMISED SAMPLES: All links between the code assigned to the sample and the donor's personal data are broken when the sample is collected. This means that personal data cannot subsequently be retrieved as the donor from whom the sample was collected cannot be identified. Likewise, if results relevant to the patient's health are obtained as part of the research, it is impossible to know which donor provided the sample and therefore that donor cannot be informed of the results.
  
  

Three copies of each informed consent are required: one for the donor, one for filing with the donor's medical records and the other for filing at the Basque Biobank.

The various informed consent forms available for each scenario, all of which have been approved by the Basque IRB, are explained below. Clicking on the icon or name of the consent form allows you to download that particular form:

DONATION OF SAMPLES FOR A RESEARCH PROJECT AND DEPOSITION IN THE BIOBANK
CONSENTS FORMS FOR DEPOSITION AS PART OF A RESEARCH PROJECT In this case, one sample will be collected for the project and one for the Biobank.
Consent for research projects and deposition of unused sample in the Biobank.
DONATION OF SAMPLES FOR DEPOSITION IN THE BIOBANK
CONSENT FOR DEPOSITION IN THE BIOBANK For those cases in which sample collection is of interest due to the disease concerned but for which no research project has been designed to justify said collection.	CONSENT TO DEPOSIT UNUSED SAMPLE TAKEN FOR DIAGNOSIS In these cases, a sample will be taken to diagnose the donor and any unused sample will be incorporated into the Basque Biobank.
Biobank Consent	Consent for deposition of unused diagnostic and/or therapeutic samples in the Biobank.
DONATION OF NEURONAL TISSUE FOR RESEARCH PURPOSES
PRE-MORTEM DONATION Donors or their legal representative sign the consent, prior to death, if they wish to donate to the Neurological Tissue Donation Program.	POST-MORTEM DONATION The donor's family members sign the consent when they wish to donate to the Neurological Tissue Donation Program.
Consent for donating brain tissue to the Biobank	Informed Consent for post-mortem donation