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Brain banks are used to gather, store, and provide human brain tissue for research and have been fundamental to improving our knowledge of the brain in health and disease. To maintain this role, the legal and ethical issues relevant to the operations of brain banks need to be more widely understood. In recent years, researchers have reported that shortages of high-quality brain tissue samples from both healthy and diseased people have impaired their efforts. Closer collaborations between brain banks and improved strategies for brain donation programmes will be essential to overcome these problems as the demand for brain tissue increases and new research techniques become more widespread, with the potential for substantial scientific advances in increasingly common neurological disorders.

In 2023, Henrietta Lacks’ family won a settlement from Thermo Fisher Scientific on the grounds that the company had been “unjustly enriched” by the sale of products developed with Henrietta’s cells. Given that hundreds of thousands of people have tissue stored in the United States, this article explores how today’s patients might fare if they similarly sued professionals and companies that undertake unauthorized research on or commercialization of their tissue on the grounds of conversion, unjust enrichment, lack of informed consent, breach of fiduciary duty and, where government entities are involved, Fourteenth Amendment claims. The article notes that the practices that were subsequently seen as unethical in Henrietta Lacks’ care continue in some health care institutions today. It also analyzes how research and commercialization without consent can lead to a lack of trust in the research enterprise and the unwillingness of people to participate in research.

This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first‐choice supplement to a mother's own milk both within and beyond preterm, low‐birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO‐inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth. Key messages The strong similarities with the ethical, quality and safety expectations underpinning the donation and processing of the diverse Medical Products of Human Origin (MPHO) can be harnessed to provide additional safety levels and improved donor human milk (DHM) quality. MPHO‐inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth. The need for DHM may be greatly reduced through optimal support for maternal lactation and breastfeeding Current global milk banking practices can benefit from expanded and harmonized, international guidance.

Research utilizing human tissue and its removal at post-mortem has given rise to many controversies in the media and posed many dilemmas in the fields of law and ethics. The law often lacks clear instructions and unambiguous guidelines. The absence of a harmonized international legislation with regard to post-mortem medical procedures and donation of tissue and organs contributes to the complexity of the issue. Therefore, within the BrainNet Europe (BNE) consortium, a consortium of 19 European brain banks, we drafted an ethical Code of Conduct for brain banking that covers basic legal rules and bioethical principles involved in brain banking. Sources include laws, regulations and guidelines (Declarations, Conventions, Recommendations, Guidelines and Directives) issued by international key organizations, such as the Council of Europe, European Commission, World Medical Association and World Health Organization. The Code of Conduct addresses 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. The Code of Conduct for brain banking is being adopted by the BNE network prior to being enshrined in official legislation for brain banking in Europe and beyond.

Biobanks are essential for biomedical research, particularly in the era of personalized medicine. In Germany, 36 biobanks have been established over the past decade that are connected under the German Biobank Alliance (GBA). These biobanks store high-quality biological samples along with clinical data to support research projects. Biobanks can be integrated, handling both tissue and liquid samples, or set up as separate entities depending on specific requirements.Tissue biobanking is especially complex due to the invasive nature of tissue collection and the non-replicability of the samples. Close collaboration between clinics, pathologists, IT specialists, and biobank managers is crucial to ensure the quality of samples and promote interdisciplinary research.The integration of pathology and biobanking is key, both organizationally and technically. Shared IT systems, standardized protocols, and collaborative governance structures are vital for efficient data management. Quality assurance, ethical guidelines, and data protection are critical to maintaining public trust and legal compliance.Long-term financial models are needed to ensure the sustainability of biobanks. The GBA supports emerging biobanks through its \"Starterkit\" initiative, offering guidance and best practices to help new biobanks develop.Tissue biobanks are indispensable for advancing the understanding of diseases and developing new therapies. However, they must adhere to strict ethical and legal standards to maximize their scientific and societal value.

The field of molecular biology is an important part of research into neoplastic conditions. Much of this research requires access to human tissue samples, which may need to be collected and stored in a specific way, according to the type of study for which they are intended. Anonymous clinical information about the samples enables researchers to apply results to different patient groups. Access to stored tissues is particularly important in head and neck disease research as many neoplastic conditions affecting this area have a relatively low incidence. Consequently, it may take a long time to build up enough individual cases to make a study worthwhile. We describe here the current legal, ethical and practical issues of research tissue banking, with regard to head and neck disease.

Summarises the ethical, logistical and social process undertaken to accept a patient's donation of tumour tissues post-mortem, and highlights the scientific and educational value of such a gift. Source: National Library of New Zealand Te Puna Matauranga o Aotearoa, licensed by the Department of Internal Affairs for re-use under the Creative Commons Attribution 3.0 New Zealand Licence.

Health-care research relies largely on human materials stored in highly specialised biorepositories. Medical translational research on tissues can be performed using a variety of resources in distinct situations. The best known is the secondary use of pathology archives where paraffin-embedded tissues are stored for diagnostic reasons. Another is collecting and storing frozen material obtained from leftover surgical diagnosis. Such residual tissues can either be used directly in research projects or used in the context of a clinical trial with new interventional medicinal products. The latter can make the regulations governing the use of these materials for medical research much more complicated. The use of residual materials is very distinct from biobanking projects for which tissue is specifically collected. This article describes the consequences of using residual human material from different sources in distinct situations and why signed informed consent is not always the preferred choice of individual countries regarding the use of residual material. In addition, signed informed consent is overdone when using residual tissues in medical research. We maintain that the opt-out system is a balanced choice if certain requirements are met, relating to sufficient transparency about using residual tissue for research, the purpose of such research and to the confidentiality of the data used in that research. Finally, the international exchange of samples can be based on the laws and regulations of the countries of origin. Respecting these form the basis of what can and cannot be done in the country where the research on the samples is being performed.

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles.

The use of tissue samples from children is vital to genetic research. Collections of such tissue, in so-called biobanks, can take the form of large-scale prospective cohort studies or disease-specific studies using tissue of children with that specific disease. Collections of samples gathered in a diagnostics context, such as blood spot cards, can also be used for genetic research. Research on stored tissue samples from children poses ethical questions that are different from those posed by the use of samples from adults. Also, the ethical questions raised by the participation of children in biobanks are not analogous to those raised by the participation of children in clinical trials. In this review we first give an overview of the international ethical guidelines and legal regulations concerning biobanking and minors. Next, we review the different themes that occur in the ethical literature on this subject. Specifically we focus on questions of risk and benefit, consent and assent and the return of individual results. We also discuss the concept of solidarity, which is a relatively new concept in the context of children and biomedical research. To conclude, we discuss the gaps and questions raised by the review.