Brain Net Europe II, also known as a BNE Consortium, is a ‘Network of Excellence’ established in the 6th Framework Programme of Life Sciences of the European Commission.
The BNE Consortium consists of 19 brain banks across Europe. BNE is funded by the European Commission in order to carry out work with regard to its objectives. The objectives of BNE II are, among other things:
- Harmonization of neuropathological diagnostic criteria in Europe;
- Development of gold standards for quality, safety and ethics for obtaining and handling of human tissue;
- Sharing of knowledge and dissemination of the information to the neuroscientists and the general public.
The Netherlands Brain Bank is a longstanding member of the BNE Consortium and an active participant designated to carry out work with regard to the ethical and legal issues in brain banking and recruitment of donors (donor programs). Additionally, the technicians and the neuropathologist working for the NBB are actively involved in other workpackages concerning neuropathological trials, in order to standardize, harmonize and optimize the diagnostic techniques.
Workpackage ‘Legal and ethical issues in Brain Banking’
The legal and ethical issues in brain banking are numerous. Research with human tissue, genetic research and post mortem removal of organs have given rise to many controversies in the media and posed many dilemmas in the fields of law and ethics. Due to the relative novelty of these issues, the law is often lacking in clear instructions and unambiguous guidelines.
As the leader of the workpackage on legal and ethical issues, the NBB has been working on a series of documents that should provide a general ethical framework (Consortium level) and could function as a guideline on the level of the individual organization (Brain Bank level). The NBB has tried to set up a structure which focuses on globally accepted bioethical principles and international doctrine.
For this purpose a BNE Code of Conduct has been drafted by the NBB. This Draft Code of Conduct, which covers basic legal rules and bioethical principles involved in brain banking, has been based on various sources available in the field of bioethics. Such sources include laws, regulations and guidelines (Declarations, Conventions, Recommendations, Guidelines and Directives) issued by the international governmental and non-governmental key organizations, such as the Council of Europe, European Commission, World Medical Association and World Health Organization.
The Code of Conduct addresses such fundamental topics as the rights of the persons donating their tissue, the obligations of the brain bank with regard to respect and observance of such rights, informed consent, confidentiality, protection of personal data, collections of human biological material and their management, and transparency and accountability within the organization of a brain bank. As the Code of Conduct only sets a framework of ground rules and general principles, more concrete guidelines are intended to be included in another document called the Brain Bank Regulations. To support the daily practice and compliance with the above-mentioned documents, the NBB has also started drafting a set of model forms and contracts which are indispensable in the daily practice of any well-established brain bank. These forms and contracts include Informed Consent forms, Material Transfer Agreements and Confidentiality Agreements.