THE IMPORTANCE OF THE INSTITUTIONS OF PROPERTY RIGHTS AND INFORMED CONSENT IN THE USE OF HUMAN BIOLOGICAL MATERIAL

The paper reveals the importance of the institutions of informed consent and property rights in relations with human biological material in the light of the study of foreign legislation and judicial practice. Purpose: to analyze the social relations that arise regarding human biological material through the prism of the institutions of property rights and informed consent for the receipt, storage, transfer and disposal of human biological material. Methods: logical, historical, systemic, structural-functional, comparative, analogies and modeling are used as general scientific research methods, special legal methods are used: formal-legal, comparative-legal, interpretation, legal modeling. Results: the study on the example of court cases considered in the United States concludes that there is a need to adjust domestic law in order to regulate relations and protect the rights of subjects of relations having an impact on human biological material.

The legal status of human biological material used for research

Whether human biological material (‘HBM’) in the research context is susceptible of ownership is contested, yet under-investigated. This situation leads to legal uncertainty for local scientists and their international collaborators. This article presents a comprehensive analysis of the topic — investigating both common law and statutory law — and concludes that HBM in the research context is indeed susceptible of ownership. First, since the common law is dynamic, it should recognise the reality that HBM has become useful in the research context and should therefore treat HBM in this context as susceptible of being owned. This aligns with the general trend in comparative foreign case law. Secondly, since relevant statutes consistently use the legal-technical term ‘donation’ to denote a situation where HBM is provided by a research participant to a research institution for the purposes of research, the transfer of ownership in the donated HBM from the research participant to the research institution is a statutory requirement. This necessarily implies that HBM in the research context is indeed susceptible of ownership and, moreover, that HBM in the research context is owned by research institutions and not research participants.

South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.

Human cerebral organoids as a new legal and ethical challenge†

ABSTRACT Human cerebral organoids (HCOs) are miniature brains cultivated in a dish using pluripotent human cells that, thanks to advanced technologies, tend to reproduce the development path of the brain of an embryo in the mother’s uterus. Recent data from studies carried out in different laboratories have indicated that HCOs show complex electrical activity, are receptive to light stimuli, and can command a muscle connected to them. The presence of the main neuronal structures in them suggests that, despite currently lacking vascularization and sensory exchanges with the outside world, more developed HCOs could exhibit some rudimentary form of consciousness, specifically a minimal sentience with respect to the basic experiences of pain and pleasure. Faced with this possibility, which for many scientists is still a long way off, we have begun to reflect on how we could empirically investigate the presence of consciousness. If we were certain or had a reasonable belief that some types of HCOs are sentient, what kind of entity would we judge them to be? Would they have specific legal protection? Should they be attributed to a moral status? This article tries to give an initial answer to these two questions. On the one side, it seems that no special rights can be claimed for HCOs other than those relating to human biological material. On the other side, instead, a sentient HCO could aspire to having its moral status recognized. If this were the case, the law may have to adapt to this unprecedented situation.

ON THE ORGANIZATIONAL ASPECT OF MODERN TECHNOLOGY OF UNIVERSAL DNA REGISTRATION OF CITIZENS

Studying the practice of crime investigation indicates the need to use a forensic registration system, including a database of DNA profiles of human biological material (genomic registration) in order to increase the effectiveness of the fight against crime. Aim: the analysis of regulatory issues, technical support of genomic registration, as well as the problems of the organizational nature of the functioning of DNA counts alongside with developing ways to solve them. Methods: empirical methods of observation, comparison, description, interpretation, interpretation of legal norms, supported by the results of a survey of Ufa residents. Results: this research of various approaches, including the attitude of various segments of the population towards the idea of universal genomic registration of citizens of the Russian Federation, makes it possible to develop ways to improve the quality of detection and investigation of crimes through the thoughtful organization of forming, accumulating, processing and using a system of universal genomic registration of the population of Russia.