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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.

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.

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.

Large international biobank studies can make substantial contributions to scientific research by validation of the biological importance of previous research and by identification of previously unknown causes of disease. However, regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress. Therefore, establishment of common ground for ethical review of biobank research is essential. In this essay, broad consent is defined on a scale between strictly specified (eg, for a specific study) and blanket consent (ie, with no restrictions regarding the purpose of the research). Future research includes that which might not be planned or even conceptualised when consent is obtained. In conclusion, broad consent and consent for future research are valid ethically and should be recommended for biobank research provided that: personal information related to research is handled safely; donors of biological samples are granted the right to withdraw consent; and new research studies or changes to the legal or ethical authority of a biobank are approved by an ethics-review board.

Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people’s autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria for broad consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material.

Background The use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at research sites in the Western Cape and Gauteng, South Africa. Methods Data were collected using a semi-structured questionnaire that captured both quantitative and qualitative information at 6 research sites in South Africa. Interviews were conducted in English and Afrikaans. Data were analysed both quantitatively and qualitatively. Results Our study indicates that while the majority of participants were supportive of providing samples for research, serious concerns were voiced about future use, benefit sharing and export of samples. While researchers view the provision of biosamples as a donation, participants believe that they still have ownership rights and are therefore in favour of benefit sharing. Almost half of the participants expressed a desire to be re-contacted for consent for future use of their samples. Interesting opinions were expressed with respect to export of samples. Conclusions Eliciting participant perspectives is an important part of community engagement in research involving biological sample collection, export, storage and future use. A tiered consent process appears to be more acceptable to participants in this study. Eliciting opinions of researchers and research ethics committee (REC) members would contribute multiple perspectives. Further research is required to interrogate the concept of ownership and the consent process in research involving biological samples.

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

Residual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method--that is, a person explicitly expresses consent to include residual tissue--or an opt-out method--that is, the tissue is stored unless a person explicitly refuses. At the moment there is a renewed interest in the appropriate method for the inclusion of residual samples in biobanks. The expansion of biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure. In this article we revisit the arguments in favor and against opt-in and opt-out methods for residual tissue research. We conclude firstly that an opt-out method is only justifiable when certain conditions are met: (1) awareness has to be raised, (2) sufficient information has to be provided, and (3) a genuine possibility to object has to be offered. An opt-out procedure that fulfills these conditions can be called a \"thick\" opt-out method. As a consequence, the dichotomy between opt-in and opt-out is less stark than usually suggested, as both methods require a certain amount of effort. Secondly, we conclude that because of the diversity of tissue and research, not every situation can be treated alike. There are at least four situations that require opt-in procedures: (1) research with higher risks or increased burdens, (2) the use of controversial or high-impact techniques, (3) research on sensitive tissue types, and (4) research involving vulnerable patients. We suggest that further interdisciplinary debate should answer the question when to opt-in or when to opt-out.