Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue-Based Products.

This Viewpoint discusses the death of a patient caused by unregulated biological products and efforts to encourage federal government oversight of such products.

A comparative review of human milk banking and national tissue banking programs.

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.

Human bone and amniotic membrane banking in Bangladesh for grafting: the impact of the international atomic energy agency (IAEA) programme.

The idea of establishing a human tissue bank in Bangladesh was started in 1985. However, in 2003, with the active cooperation of international atomic energy agency (IAEA) and Bangladesh Atomic Energy Commission, a tissue bank laboratory was upgraded as a unit for tissue banking and research. Due to increasing demand of allograft, this unit was transformed as an independent institute "Institute of Tissue Banking and Biomaterial Research (ITBBR)" in 2016. This is the only human tissue bank in Bangladesh, which processes human bone and amniotic membrane to provide safe and cost-effective allografts for transplantation. Importantly, banking of human cranial bone as autograft has also started at ITBBR. These processed grafts are sterilized using gamma radiation according to the IAEA Code of Practice for the radiation sterilization of tissues allografts. The amount of grafts produced by the ITBBR from 2007 to 2018 were 120,800 cc of bone chips, 45,420 cm2 of amniotic membranes, 277 vials of de-mineralized bone granules (DMB), 95 pieces of massive bones, and 134 pieces of cranial bones. Overall, 112,748 cc of bone chips, 40,339 cm2 of amniotic membranes, 174 vials of DMB, 44 pieces of massive bones, and 64 pieces of cranial bones were transplanted successfully. Nevertheless, to cope up with the modern advanced concepts of cell and tissue banking for therapeutic purpose, ITBBR is working to set up facilities for skin banking, stem cells banking including amniotic and cord blood derived stem cells and scaffold designing. To ensure the quality, safety, ethical and regulatory issues are sustainable in cell and tissue banking practices, ITBBR always works with the Government of Bangladesh for enhancing the national tissue transplantation programme within the contemporary facilities.

Legal and ethical framework for global health information and biospecimen exchange - an international perspective.

BACKGROUND: The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. MAIN TEXT: Here, the International Clinical Trial Center Network (ICN) reports the legal and ethical requirements governing data and sample exchange (DSE) across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. CONCLUSION: With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE.

Out-of-Hospital Tissue Donation: Multidisciplinary Donor Circuit in a Forensic Institute.

OBJECTIVE: We aimed to implement an out-of-hospital system of generating donors that increases donation and answers the growing demand for tissue for therapeutic purposes. MATERIAL: The Catalan Health Service issued the 4/2015 instruction promoting the integration of the donation network through collaboration with the Donor Center of Catalonia (DCC). The creation of DCC facilitated the signing of an agreement between The Blood and Tissue Bank, the Department of Justice of the Generalitat de Catalunya, the Emergency Medical System, and the Hospital Clínic Barcelona for the procurement of tissues in the Institute of Legal Medicine and Forensic Sciences of Catalonia (IMLCFC), where the autopsies of all judicial deaths in the province of Barcelona are performed. METHODS: The Emergency Medical System informed the DCC of those instances that ended with the code "deceased." DCC assessed the possible donor on arrival at the IMLCFC, checked the medical history through the shared clinical record, and obtained family consent by telephone interview. If consent was obtained, then judicial authorization was sought. RESULTS: In 2016, 152 donors of corneas were obtained (9.7% of the annual amount in Catalonia), 149 in 2017 (9.4% of the annual amount), and 133 donations in 2018. At the end of 2017, we started multitissue retrieval and obtained in 2018 a total of 76 donors. CONCLUSIONS: Out-of-hospital tissue donation in a forensic institute is possible. In less than 3 years, IMLCFC has become the third largest eye tissue contributor among the Catalan tissue donation network and the first contributor in musculoskeletal tissues in 2018.

Tailoring a rapid autopsy protocol to explore cancer evolution: a patient collaboration.

Genomic analysis of tissues from rapid autopsy programmes has transformed our understanding of cancer. However, these programmes are not yet established in New Zealand. Our neuroendocrine tumour research group, NETwork!, received a request from a patient wishing to donate tumour tissues post-mortem. This viewpoint article summarises the ethical, logistical and social process undertaken to accept this patient's generous donation, and highlights the scientific and educational value of such a gift.

Protecting participants in health research: The South African Material Transfer Agreement.

The need to transfer human biological materials (HBMs) across national boundaries has become increasingly important in view of increased biobank and commercial activities globally. In light of South Africa (SA)'s history of colonisation and racial discrimination, coupled with well-known instances of exploitation of research participants in the developing world, it is critical that the management of HBMs from and to other jurisdictions is explored and regulated. Material transfer agreements (MTAs) represent an important point of departure in such a process. This article explores the need for a uniform MTA in SA and discusses some aspects of the recently gazetted national MTA, which provides a framework that can serve as a safeguard for cross-border transfer of HBMs in the absence of the National Health Act's chapter 8 regulations in this regard.

The current status of oocyte banks: domestic and international perspectives.

Two major breakthroughs in the field of assisted reproduction-oocyte donation and oocyte vitrification-have joined forces to create the rapidly emerging phenomenon of commercial egg banks (CEBs). In this review, we examine the history of this concept, the operational models, the geographical variations, and the benefits and pitfalls of CEBs, including the ethical and legal dilemmas arising from gamete mobility. We highlight future directions in the brave new world of third-party reproduction.

Regulatory aspects of tissue donation, banking and transplantation in India.

Amendments to India's Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.

Banking brain tissue for research.

Well-characterized human brain tissue is crucial for scientific breakthroughs in research of the human brain and brain diseases. However, the collection, characterization, management, and accessibility of brain human tissue are rather complex. Well-characterized human brain tissue is often provided from private, sometimes small, brain tissue collections by (neuro)pathologic experts. However, to meet the increasing demand for human brain tissue from the scientific community, many professional brain-banking activities aiming at both neurologic and psychiatric diseases as well as healthy controls are currently being initiated worldwide. Professional biobanks are open-access and in many cases run donor programs. They are therefore costly and need effective business plans to guarantee long-term sustainability. Here we discuss the ethical, legal, managerial, and financial aspects of professional brain banks.

[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

Acquisition and Reception of Primary Tissues, Cells, or Other Biological Specimens.

The use and banking of biological material for research or clinical application is a well-established practice. The material can be of human or non-human origin. The processes involved in this type of activity, from the sourcing to receipt of materials, require adherence to a set of best practice principles that assure the ethical and legal procurement, traceability, and quality of materials.

Biobanking: Relational obligations.

The nature of the relationship between the donor and donee within a biobanking framework is complex and dynamic. Issues such as ownership, rights and benefits often influence outcomes and access for researchers. In New Zealand, a raft of soft and hard law measures exist unconvincingly to govern this relationship. This article examines the current legislative provisions in New Zealand and explores possible avenues such as dynamic and broad consent, equity and contract that may provide a more appropriate framework for biobanking donors and donees.

[Skin and tissue bank: Operational model for the recovery and preservation of tissues and skin allografts]. / Banco de piel y tejidos: un modelo operativo para la recuperación y preservación de aloinjertos de piel y tejidos.

Tissue storage is a medical process that is in the regulation and homogenisation phase in the scientific world. The international standards require the need to ensure safety and efficacy of human allografts such as skin and other tissues. The activities of skin and tissues banks currently involve their recovery, processing, storage and distribution, which are positively correlated with technological and scientific advances present in current biomedical sciences. A description is presented of the operational model of Skin and Tissue Bank at INR as successful case for procurement, recovery and preservation of skin and tissues for therapeutic uses, with high safety and biological quality. The essential and standard guidelines are presented as keystones for a tissue recovery program based on scientific evidence, and within an ethical and legal framework, as well as to propose a model for complete overview of the donation of tissues and organ programs in Mexico. Finally, it concludes with essential proposals for improving the efficacy of transplantation of organs and tissue programs.

BrainNet Europe's Code of Conduct for brain banking.

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.