LAUSR

The legal and ethical issues in brain banking are numerous. The post-mortem removal and retention of organs as well as research with human tissue and genetic information, have posed various 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. The ethical problems specifically involving post-mortem cell and tissue banking for research purposes are not always specifically taken into account. This means that a brain bank frequently does not qualify for a certain well-defined legal regime. Because of this and the fact that the existing regimes differ significantly throughout the world, many uncertainties arise for the initiation and management of brain banks. Guidelines on informed consent, confidentiality, financial sustainability, accountability, and transparency are conditions sine qua non for the good conduct of a professional brain bank and are briefly highlighted. The Convention on Human Rights and Biomedicine states that every person has the right of autonomy over his or her body [1]. It is therefore our conviction that we should pursue the situation where the removal of brain tissue only takes place on the basis of informed consent [2–6]. Regardless of whether the national legislation requires such consent, brain banks should implement a procedure which ensures that the donor takes an informed decision to donate tissues or organs. In a situation where the person is incapable of providing consent, a so-called ‘authorization’ procedure should be put in place. In order to disclose the etiology and pathogenesis of psychiatric and developmental brain diseases, it is unavoidable to bank tissue from incompetent persons and children, however sensitive this topic might be with the public [7, 8]. The information provided to the donor and/or next of kin should be clear and as precise as possible on the future use of the tissue [2–6]. The fact that findings can only be patented if obtained by research with tissue that was obtained on the basis of informed consent, should be kept in mind by all scientists using such tissue for research [9]. Another human right concerns confidentiality of the donor and is of equal importance [4, 5]. In order to protect this right, the tissue and data should only be used for research after identifiable parameters have been removed. At the same time, the donor or his or her relatives should be clearly informed if and how research data obtained from their tissues will be communicated, especially where it concerns genetic information. Individual data on carrier state or genetic predispositions, in certain situations should be made available to the person concerned, in particular where such data can have therapeutic consequences. It is the task of the brain bank to have the right procedure in place [4, 5]. In many cases, brain tissue collections were built up by researchers who use the collection for their own research and share the tissue they characterized with colleagues [6, 9]. Such brain tissue collections are mostly supervised by one or a few managers, are financed by research grants, and are not open-access. As opposed to tissue collections, more professional brain banks mostly run complex donor programs and aim to collect well-characterized human brain tissue to increase our understanding of the brain and brain diseases. They are aimed to be open-access for the best research groups worldwide and are mostly structurally & Inge Huitinga [email protected]