It is indispensable to store human tissues of LCH patients in tissue banks in order to gain a better understanding of the disease. The most important questions that must be addressed are:
- Is there a genetic basis for the disease ?
- Can we find some biological markers to monitor the disease and to adopt the therapy?
- Are there any molecular alterations that could serve as targets for new therapies?
Who is Organizing Banking
Each tissue bank must be professionally organized:
- Identification of the origin of each sample
- Safe conditions of storage
- Written plan for the protection of private information, including the prevention of unauthorized access to digital data
There should be a possibility to deliver tissues on demand for a precise research. The conditions of any delivery must be clearly regulated.
Regulations of Tissue Banking
Several levels of regulation exist for tissue banks:
- Ethical regulations
- Technical regulations
- Scientific regulations
They may be defined in international regulations, in national regulations, and in regulations applied in the respective institution. In case of external collaborators, both the collector and the collaborator must comply with all their international, national, and institutional regulations.
Consent from Patients and Families
Tissue banking is not possible without the patient’s informed consent. For children, the consent must be obtained from a person with parental responsibility. Nevertheless, young patients should be involved as much as possible in any decision concerning their care. For other legally incompetent patients, consent is to be obtained from a legal guardian. No person can give consent on behalf of a patient who has reached the age of 18 and is legally competent.
The informed consent must contain at least the following information:
- How tissues will be collected and stored
- How medical information about the patient will be stored
- How tissues will be used in research
- What information will be provided to researchers
- How the patient can contact the tissue bank administrator in case he wants to withdraw or modify his consent for the use in future research