National Health System Support Services
Tumour Bank
Ethics
All neoplastic tissue accepted into the TBN will originate from the healthcare activity at the Associated Hospitals ( biopsies, surgical specimens, and necropsy samples etc.), in accordance with all procedures which guarantee ethical conduct. These can be summarised as follows:
Under no circumstances may the diagnosis of a samples be compromised by the collection of Tissue Bank.The central database will contain no information that could allow the direct or indirect identification of patients. Each Associated Hospital is responsible for maintaining the code system which guarantees anonymity.
The Associated Hospitals must present the protocols of TBN activity to their corresponding Ethical and Clinical Research Committees (ECRC), so that they may be studied and approved.
Under the current system, the identity of the patients will always remain with the Hospital, and all information sent to the database will not include any reference that would permit the direct or indirect identification of the patient. No special or additional testing will be carried out on the patient - tissue belonging to the Tissue Bank Network is surplus to the tissue originally required for standard diagnostic practises.
Our process of sample identification guarantees the anonymity of cases in the central database whereas the case is identified within each of the Hospitals belonging to the Network of Tissue Banks.
Collectively, such measures mean that informed consent is unnecessary, though in order to maintain the highest possible ethical standards, the associated Hospitals must include a paragraph in the document with the patient´s consent to surgery, confirming his/her approval that surplus tissue following histopathological diagnosis may be used confidentially for research purposes.
In certain research projects access to further data concerning the clinical history of the patient will be necessary. In such circumstances, the project Leader will have to approach the clinical services directly, once he/she has received a favourable report from the Ethics and Research Committees belonging to the various Hospitals.
These Ethics and Research Committees must approve the practises of their corresponding Hospital Tumour Banks before collaborative agreements may be signed. When a project requires the development of non-standard tissue-handling methods, the approval of the corresponding ECRC can will be mandatory.
DATA SECURITY
The computer application that supports the activity and collections belonging to the Tumour Bank Network has been developed with special attention to security mechanisms that regulate access to information. The various regulations can be summarised as follows:
Hospital databases may contain personal information revealing patient identity the patient (name, surname, Clinical Record number, Pathology Department reference, and member of staff in charge of the case, etc). All such data will be strictly coded, and will not be sent to Central Database.
To ensure correct usage of the database, each case will undergo a disassociation procedure by which an identification code will be generated that will be the only one used in the Central Database and in the samples distributed to the research scientists.
Information will be passed through a private network over an RDSI connection.
The Central Database will contain no material allowing for the identification of the patients. The strictest regulations as outlined in the Spanish Organic Law of the Regulation of Automatic Treatment of Data adhered to (record of all users, archiving records for two years, monthly reports on the revision of records, staff responsible for security, audits, user passwords, limitation on failed attempts to access the information, management of systematised magnetic software, guarantee against wrongful access, prior authorisation and record of all data-recovery processes).
