Who can become a donor?
Most adults can register as potential donors. You can sign up yourself, or your family can choose to donate after death, if consent is given. In some cases, small tissue samples may also be taken during diagnostic procedures, with your explicit approval.
Who has access to my tissue and data?
Only research projects that have been approved by a competent Medical Ethics Committee can obtain access to body material or pseudo-anymised data for scientific research.
The research protocols are then reviewed by a scientific committee that assesses whether the study design falls within the scope of the consent given by you for the intended scientific research.
These research projects are led by researchers affiliated with an academic centre, a healthcare institution, a non-profit organisation, a public institution or a private/commercial company. On the Informed Consent Form, you can specify whether or not you allow such access to your body material/data. Your body material/data may also be used outside Belgium in the context of projects to be approved. You can also indicate your preference in this regard on the Informed Consent Form.
Researchers who obtain body material/data must sign contracts strictly describing their access and use of this body material/data. Researchers are not permitted to further distribute, transfer or use body material/data for purposes other than those described in the research project. Researchers must also agree not to attempt to re-identify participants and to report any such attempts.
What about privacy and confidentiality?
In accordance with the Belgian law of 8 December 1992 on the protection of privacy, the Belgian law of 22 August 2002 on patients' rights and the General Data Protection Regulation (GDPR) of 25 May 2018, your privacy will be respected and your next of kin will have access to the personal data collected.
All information collected during the controlled storage of your body material will be pseudonymised (encoded), so that your data can still be linked back to your personal medical file with the correct codes. The key to these codes will be accessible only to the physicians involved who work at the participating departments of neurology and neuropathology. Only the pseudonymised (encoded) data will be used in documentation, reports, education or publications in medical journals or conferences. This means that the confidentiality of your data is always guaranteed. Both your personal data and your health data will be processed and stored for at least 20 years.
Representatives of the sponsor, auditors, the Medical Ethics Committee and the competent authorities, all bound by professional secrecy, will have direct access to your medical records in order to monitor the procedures of this scientific research, without breaching confidentiality. This can only be done within the bounds of the relevant laws. By signing the Informed Consent Form after having taken note of this explanation, you agree to this access.
More information:
What are the risks if I consent to storage of specific body material or data?
Storing your body material for future use in scientific research does not involve any risks.
The Institute Born-Bunge at the University of Antwerp is the 'custodian' of your body material and your data in the IBB-NeuroBiobank. This biobank has a Belgian accreditation number, obtained via the Federal Agency for Medicines and Health Products (FAMHP): BB190113. You and your legal representative are the 'owners' of your body material/data. This means that your next of kin can always instruct the Institute Born-Bunge to destroy your stored body material/data or to transfer it to another biobank. This can be done by contacting the IBB-NeuroBiobank manager in writing. You will receive a written confirmation stating that your body material/data has been destroyed. If your body material/data has already been used or is in use in an ongoing study, it cannot be withdrawn, but it will not be made available for other scientific research.
Personal and health data are collected during the scientific research. These data will not be passed on to third parties such as employers, insurance companies or family members, unless required by a legal procedure. Only a few authorised IBB staff members will have access to these data. Researchers requesting access to the samples or data will receive these data in encrypted form, so that identification of your person is not possible. Great care is taken to ensure the confidentiality of your data.
Where will my body matieral and clinical data be stored?
Your body material will be stored in the IBB-NeuroBiobank of the Born-Bunge Institute
Campus Drie Eiken - University of Antwerp
Universiteitsplein
Wirijk
Your clinical data will be stored in the IBB-NeuroBiobank database of the Born-Bunge Institute .
This is a secure environment, in accordance with current Belgian and European legislation.
The following standard measures are taken to guarantee the security of your data:
- Personal identifying data such as your name and date of birth are removed from any body material and reports, except when feedback is given to your treating physician.
- A unique code is assigned to each piece of body material.
- The references of your body material and your data are kept in a strictly secured database. Layered restrictions are imposed on the staff of the IBB-NeuroBiobank. These restrictions are described in the IBB-NeuroBiobank quality manual that was submitted to and approved by the UZA/UAntwerp Medical Ethics Committee with reference 19/13/166.
Are there any costs or fees involved?
Your participation in the provision and storage of your body material/data and the diagnostic examination to arrive at a definite diagnosis does not involve any additional costs for you. There is also no payment offered to participants.
Possible commercialisation: Future research involving your body material/data may give rise to new insights that could lead to the commercialisation of new therapeutic substances, agents, tests or procedures. This can be done by a university, a hospital, a commercial firm, or any combination of these three. This means that researchers and commercial firms might end up benefiting financially from your donation. Your next of kin will not be able to claim any financial benefit that might arise from this commercialisation
Will I get access to the research results?
Taking into account your medical situation, some of the examinations are considered as standard hospital care. Your treating physician will be informed of the results.
Your body material/data may also give rise to new insights in future scientific research, both in general and for your next of kin.
Feedback on general scientific findings
General scientific findings and new insights such as publications can be made available on websites of the above-mentioned neurology departments and the IBB. This overview of findings does not contain any identifying data, but is important for the rapid dissemination of scientific findings within the research community.
Feedback on individual scientific findings
Individual scientific findings are results that were discovered during a specific research project and that are potentially important for your general health or that of your offspring. These are also called incidental findings.
If such scientifically validated and clinically relevant findings could lead to either therapeutic or preventive actions regarding your health status or that of your next of kin, feedback may be provided to you. If you agree to have your next of kin informed, you can indicate this on the Informed Consent Form. Your doctor will then discuss the findings with you or your next of kin.