Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May (...) 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed (...) the REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

This article focuses on three scenarios in which residual biological materials are turned into research collections during the procedure of procuring these materials for diagnostic, therapeutic or other non-research purposes. These three scenarios differ from each other primarily because they employ different models of consent: (a) precautionary consent, which may be secured during the collecting procedure; (b) the presumed consent model, which may be applied during the collection of materials; and (c) consent for research use of identifiable human (...) biological materials, which may be skipped entirely. These scenarios offer additional sources of biological samples for research purposes and at the same time seem to offer even more flexibility in terms of stringency of consent as compared with the more traditional models of broad consent in prospective research collections and the waiver of consent in retrospective research. Our discussion leads us to think that precautionary consent is preferable to presumed consent and no consent when handling issues of consent in the use of residual human biological materials for research. However, such precautionary consent should not be construed as blanket, unrestricted consent for any future use. (shrink)

The prohibition of commercialisation of the human body and its parts is not applied consistently and suffers from many exceptions in the human biological material (HBM) market. Examples include the possibility of patenting certain HBM-derived products and their commercial marketing or payments for blood donations. Thus, the current practice of marketing HBM-derived products makes the altruistic donor most vulnerable to exploitation while being deprived of benefits. There seem to be two ways to improve this state of (...) affairs. The first is to apply consistently the prohibition of commercialisation of the body and its parts to commercially marketed tissue and cell products as well. This would require limiting the possibility of financial gain associated with the processing, distribution and sale of HBM-based products. Such a solution, however, does not seem to gain wide acceptance or have a chance of implementation in the near future. Therefore, introducing more transparent rules and greater donor empowerment seems more reasonable by exempting HBM from the ban on commercialisation under certain conditions and with clear limitations. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols (...) informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

National self-sufficiency in human biological materials such as blood and organs is now commonly invoked as a goal for healthcare policy makers. Despite its history as a strategic response to the ethical hazards of global trade in human blood, the ethical dimensions of the concept have been inadequately explored. This paper introduces self-sufficiency as an ethical paradigm for policy-making and explores some of the parallels found in Aristotle’s account of autarkeia in the polis. It highlights the ethico-political (...) challenges of pursuing self-sufficiency in culturally diverse societies and suggests that the motivation of donation through solidarity rather than the use of financial incentives is consistent with contemporary and ancient versions of the self-sufficiency model. (shrink)

The use of human biological materials involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have i...

Human brain organoids are three-dimensional masses of tissues derived from human stem cells that partially recapitulate the characteristics of the human brain. They have promising applications in many fields, from basic research to applied medicine. However, ethical concerns have been raised regarding the use of human brain organoids. These concerns primarily relate to the possibility that brain organoids may become conscious in the future. This possibility is associated with uncertainties about whether and in what sense brain (...) organoids could have consciousness and what the moral significance of that would be. These uncertainties raise further concerns regarding consent from stem cell donors who may not be sufficiently informed to provide valid consent to the use of their donated cells in human brain organoid research. Furthermore, the possibility of harm to the brain organoids raises question about the scope of the donor’s autonomy in consenting to research involving these entities. Donor consent does not establish the reasonableness of the risk and harms to the organoids, which ethical oversight must ensure by establishing some measures to mitigate them. To address these concerns, we provide three proposals for the consent procedure for human brain organoid research. First, it is vital to obtain project-specific consent rather than broad consent. Second, donors should be assured that appropriate measures will be taken to protect human brain organoids during research. Lastly, these assurances should be fulfilled through the implementation of precautionary measures. These proposals aim to enhance the ethical framework surrounding human brain organoid research. (shrink)

BackgroundBalancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials and data.MethodsTwenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and (...) applicants with respect to access to HBM and data.ResultsThere was no consensus among the informants on whether the custodian of a biobank should decide upon the scientific merits and the utility of an access request. Nearly all informants agreed that a new request or an amendment to the initial request has to be submitted when an applicant wants to use leftover HBM in a new or follow-up project. Several informants felt that it might be justified to charge higher access fees to external or industrial applicants that did not contribute to the collection of HBM and data. Most informants agreed that a custodian of a biobank could request the sharing and return of research results. It was furthermore argued that some of the benefits of research projects should be fed back into biobanks.ConclusionsThe interviews revealed a rather complex web of rights and obligations allocated to the custodian and the applicant in relation to access to HBM and data stored in biobanks. Some rights and obligations are negotiated on a case-by-case basis, while others are stipulated in access arrangements. We did find a consensus on the attribution of certain general rights to the custodians and the applicant. (shrink)

The increasing possibilities for using tissue for research and development in genetics and biotechnology have made stored human biological materials more important than ever. Using stored human biological materials raises many legal and ethical questions. On an international level however, the use of these materials has not been regulated in a detailed manner so far. The Council of Europe recently declassified the text of the proposal for an instrument on the use of archived human (...) class='Hi'>biological materials in biomedical research for public consultation. The purpose of this paper is to comment on this document regarding its primary goal, which is to protect the rights and fundamental freedoms of the individual whose biological materials could be included in a research project. The guidelines offer good basic protection for sources of identifiable human biological materials but, surprisingly, offer no protection to sources of anonymous or anonymised materials. (shrink)

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May (...) 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

Balancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide dif..

Background: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with (...) the values underlying informed consent. Methods: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute’s requirements for consent, and the researchers’ strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Results: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors’ accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. Conclusions: We argue that while building and maintaining trusting relationships in research is important—not least in developing countries—strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out. (shrink)

In the trauma surrounding mass disasters, the need to identify victims accurately and as soon as possible is critical. DNA identification testing is increasingly used to identify human bodies and remains where the deceased cannot be identified by traditional means. This form of testing compares DNA taken from the body of the deceased with DNA taken from their personal items or from close biological relatives. DNA identification testing was used to identify the victims of the terrorist attack on (...) the World Trade Center in New York on September 11, 2001, and of the victims of the Tsunami that hit Asia on December 26, 2004. Shortly after the 9/11 attack, police investigators asked the victims' families for personal items belonging to the missing, and for DNA samples from family members themselves. The New York medical examiner's office coordinated the DNA identification testing program; however, some of the identification work was contracted out to private laboratories. (shrink)

Introduction Stored human samples and the establishment of biobanks are increasing in the world. Along with this there are the questions of ethics that arise such as the correct method of obtaining informed consent for research on stored samples and the policies involved in collaborative research using collected samples. This study is an attempt to evaluate the researchers, academics and policy makers' views on these ethical aspects. Methods This was an anonymised study involving a Sri Lankan population of researchers, (...) ethics committee members, and policy makers. A self administered questionnaire was utilised as the study instrument. The questionnaire captured four major areas of interest: demographic characteristics of respondents, their attitudes on informed consent policy, their opinion on rights of collaborating researchers, their attitudes on dealing with international differences in regulatory frameworks. Results The study included 55 responders with 40/55 agreeing that donors should receive the option of giving informed consent for future research, with 31/55 considering multiple- type consent options most appropriate. Regarding the issue of shared samples in collaborative research majority agreed that source country ethics review committee approval was necessary 53/55. Conclusion The study concludes that sample donors should be given the option of giving advance consent to unspecified future research provided that future research is approved by an ethics committee. In collaborative research, it is necessary to involve ethics committees from donor countries in the research approval process. (shrink)

This paper addresses the ethical issues of secondary uses of samples collected for identification purposes following mass disasters. It studies norms governing secondary use of samples , ultimately concluding that limited secondary research uses of these samples should be permissible.

This paper discusses the genesis of human DNA patents and the legal confusion and ramifications that ensued. Beginning in the mid-1970s with policymakers and lawmakers in the United States, confronted with an economy impacted by an oil crisis, inflation, growing and persistent unemployment and the fledgling biotechnology industry, this paper tracks the development of the practice until its banning in the US Supreme Court in June 2013. The paper raises serious questions regarding the relevance of a patent system—a system (...) that, as the patenting of naturally occurring biological materials demonstrates, is so easily manipulated through the use of legal contrivances. The paper outlines that potential future manipulation poses as a significant threat to the national economy and security of the United States if history is allowed to repeat itself in the context of biological materials. (shrink)

This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers or Specialized Programs of Research Excellence addressed the issues of consent, control over biological materials, confidentiality, and disclosure of results in protocols and consent forms for genetic research with stored biological materials. Although a majority of the documents reviewed addressed most of the issues raised in the research ethics literature, topics identified in the literature that were missing include the return of research (...) results, the right to withdraw from research involving biological materials, and the consent of children when they become legal adults. If typical, these findings suggest greater educational efforts may be needed to prompt investigators and IRBs to consider these and other issues that were either not addressed in the protocols or consent forms or were addressed inadequately. (shrink)

For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and (...) research ethics committees. This paper examines stakeholders’ perspectives of and responses to the ethical issues arising from these research practices. (shrink)

The ArgumentCell lines and other human-derived biological materials have since 1980 become valuable forms of patentable matter. This paper revisits the much-critiqued legal caseMoore v. Regents of the University of Cahfornia, in which John Moore claimed property rights in a patented cell line made from his spleen. Most work to date has critiqued the text of the decision and left the relevant scientific and technical literature unexamined. By mapping out the construction of discontinuity and continuity between human (...) body and cell line in this literature, this paper provides a novel critique of the Moore case regarding the source and mobilization of scientific information in the decision. At the same time, the elisions of the case are used to move to a larger set of questions. Comparative material from the history of the first widely used cell line, HeLa, and a discussion of the relation of the scientific and economic value of cell lines, are aimed at analysis of how new objects such as patented human cell lines come into existence through science and law, and what kinds of definitions and practices make them valued objects of contention in the first place. (shrink)

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best (...) practice MTAs involving exchange of biospecimens and data and in monitoring compliance. (shrink)

With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico-legal concepts that were deliberated and carefully adapted by a South African Institution (...) to suit the transfer of Human Biological Materials and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico-legal challenges in the South African/African context; the decisions made with regard to how the related ethico-legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries. (shrink)

BackgroundHuman biological materials are usually stored for possible future use in research because they preserve valuable biological information, save time and resources, which would have been spent on collection of fresh samples. However, use of these materials may pose ethical challenges such as unauthorized disclosure of genetic information, which can result in dire consequences for individuals or communities including discrimination, stigma, and psychological harm; has biosecurity implications; and loss of control or ownership of samples or data. To understand (...) these problems better, we evaluated the extent to which tuberculosis (TB) clinical research protocols that were used to collect and store biological materials for future use conform to the requirements stated in the Uganda national guidelines for research involving humans as participants.MethodsThis was a retrospective review of TB clinical research projects approved by the Uganda National Council for Science and Technology (UNCST) from 2011 to 2015, to examine whether they fulfilled the requirements for ethical collection and use of human materials. Data were abstracted through review of the project protocols using a template developed based on the informed consent and the Materials Transfer Agreement (MTA) requirements in the national guidelines.ResultsOut of 55 research protocols reviewed, most of the protocols 83.6% had been used to collect the stored samples (sputum, blood and sometimes urine), 28% had a section on specimen collection and 24% mentioned ownership of the biological materials. With respect to review of the consent forms used in the studies that stored materials for future use, only 9% of the protocols had a separate consent form for storage of materials, 4.5% of the consent forms explained the risks, 11.4% explained the purpose of the study while 6.8% mentioned the place of storage for the collected materials.ConclusionMany of the studies reviewed did not meet the requirements for collection and storage of biological materials contained in the national guidelines, which indicates a need to additional training on this topic. (shrink)

We will consider two Christian responses to the enormous advances in recent years in the connected sciences of genetics, evolutionary biology, and biochemistry, a dualist one by Pope John Paul II and an “emergentist” one by Arthur Peacocke. These two could hardly be more different. It would be impossible within the scope of a brief comment to do justice to these differences. What I hope to do instead is more modest: to draw attention to troublesome ambiguities in some of the (...) key concepts on which discussions of human uniqueness depend, to recall very briefly some of the difficulties philosophers have encountered in their attempts to define the relation of the human powers of mind to the material capacities of body, and finally to ask what the theological significance of all this is. (shrink)

The development of research based on human biological material has contributed to a lively debate on the concept of informed consent in these studies, particularly its scope, form and length of validity. The biggest disputes and doubts concern the range of consent for research that will be conducted in the future, whose aim and place are unknown at the time of the sample collection, as are the future researchers and the ability to use the previously collected materials (...) again. This situation raises the question of a just and prudent balance between the rights of participants in the research and the rights of researchers. New forms of consent have been proposed, which sometimes substantially diverge from the classical model in aiming towards responsible balancing between the necessity to protect the donors’ interests and the possibility of conducting research in medicine. These new concepts also find their application in legislative acts adopted internationally and in some European countries in the recent years. (shrink)

Precision medicine research involving human biological material is becoming an increasingly central component of healthcare, and its potential is quickly growing due to rapid technological progress...

Why do laws and regulations marking boundaries between humans and other animals proliferate amid widespread proclamations of the waning of the species concept and the consensus that life is a continuum? Here I consider a recent spate of new guidelines and regulations in the United Kingdom and United States that work to estrange human bodies from other animals in biomedicine. Using the idea of a bioconstitutional moment to understand how state institutions deliberate over “human–animal chimeras,” I address how (...) nations differently establish separations between humans and other animals. New chimeric entities, containing human hereditary material, have consecrated regulatory ground and signify increased attention to fields of research that have long used interspecies mixing. Regulators and policy makers now find themselves in a curious position. On the one hand, they continue to regulate the estrangement between humans and other animals, but on the other, they support the creation of chimeric life––a form of life that draws into question the very basis of such separations. (shrink)

In this article two inter-related issues concerning the ongoing commercialisation of biomedical research are analyzed. One aim is to explain how scientists and clinicians at Swedish public institutions can make profits, both commercially and scientifically, by controlling rare human biological material, like embryos and embryonic stem cell lines. This control in no way presupposes legal ownership or other property rights as an initial condition. We show how ethically sensitive material (embryos and stem cell lines) have been (...) used in Sweden as a foundation for a commercial stem cell enterprise—despite all official Swedish strictures against commercialisation in this area. We also show how political decisions may amplify the value of controlling this kind of biological material. Another aim of the article is to analyze and discuss the meaning of this kind of academic commercial enterprise in a wider context of research funding strategies. A conclusion that is drawn is that the academic turn to commercial funding sources is dependent on the decline of public funding. (shrink)

BackgroundWhenever South African 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 in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health.Main bodyThe 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: Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; the SA MTA’s consent provisions are not aligned with extant law; and, similarly, its provision on donor ownership is misaligned with extant law; its creation of fictitious performance can only cause frustration on the part of an injured party; its benefit-sharing provision is vague and will have little practical effect; its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, 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.ConclusionsWhile 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. (shrink)

In the wake of three high-profile judicial decisions concerning the use of human biological materials, the editors of this collection felt in 2011 that there was a need for detailed scholarly exploration of the ethical and legal implications of these decisions. For centuries, it seemed that in Australia and England and Wales, individuals did not have any proprietary interests in their excised tissue. Others might acquire such interests, but there had been no clear decision on the rights or (...) otherwise of the persons from whom the tissue was obtained. In 2009, however, the Court of Appeal of England and Wales recognised a limited exception to this position in Jonathan Yearworth and others v North Bristol NHS Trust . In that case, the Court held that the appellants, who had deposited semen samples for freezing before they undertook treatment for cancer, had “for the purposes of a claim in negligence … ownership of the sperm which they had ejaculated”. One year later, the Supreme Court of Queensland, Australia, took a similarly property-based approach to determining how a semen sample stored shortly before death should be dealt in Bazley v Wesley Monash IVF . According to that court, the co-executors of the estate had sufficient proprietary interests in the semen to legally demand its return from the laboratory where it was held. In 2011, the New South Wales Supreme Court similarly found that the widow of a recently deceased man had a right to possession of his semen in Joceyln Edwards; Re the estate of the late Mark Edwards .In the editors’ view, these decisions signalled a turning point in the Anglo-Australian jurisprudence in this area, taking the law a step beyond the decisions of the late 20th century such as R v Kelly , in which possessory rights were found …. (shrink)

Synthetic biology presents a challenge to traditional accounts of biology: Whereas traditional biology emphasizes the evolvability, variability, and heterogeneity of living organisms, synthetic biology envisions a future of homogeneous, humanly engineered biological systems that may be combined in modular fashion. The present paper approaches this challenge from the perspective of the epistemology of technoscience. In particular, it is argued that synthetic-biological artifacts lend themselves to an analysis in terms of what has been called ‘thing knowledge’. As such, they (...) should neither be regarded as the simple outcome of applying theoretical knowledge and engineering principles to specific technological problems, nor should they be treated as mere sources of new evidence in the general pursuit of scientific understanding. Instead, synthetic-biological artifacts should be viewed as partly autonomous research objects which, qua their material-biological constitution, embody knowledge about the natural world—knowledge that, in turn, can be accessed via continuous experimental interrogation. (shrink)

Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance (...) of biobanks should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions. (shrink)

This paper investigates which of the variouslegal notions proposed for human DNA is themost appropriate from an ontological viewpoint – unique legal status, private property, commonproperty, person, or information. The focus is onthe difficulties that private property, commonproperty and person present. By usingHarré''s notion of ``file-self'''' we arguethat, ontologically, the most appropriate legalnotion to be applied is information. This hasconsequences for storage, control and use ofgenetic information as well as identifiablehuman body material.

ABSTRACT: Biological prospecting is being undertaken in the Antarctic and, as novel material starts to yield significantly higher commercial rewards, the Antarctic Treaty Consultative Parties might decide to regulate it through the Antarctic Treaty System. This will be problematic since activities are already being undertaken, patents have been filed and products developed. Furthermore, there are differing perceptions of the status of the Antarctic, with some considering it global commons and others considering it the common heritage of mankind. These (...) 2 doctrines can be inferred from the rhetoric of the Treaty and its subsequent legal instruments through which human activities, including the use of resources, are managed. However, the Antarctic Treaty System does not support either in practice because activities such as fishing and bioprospecting already return an exclusive reward for effort, with no benefit-sharing arrangements. Under the Convention on the Conservation of Antarctic Marine Living Resources, the Parties determine allowable catches for a fishery based on scientific assessment, and this may discharge them from providing access and benefit-sharing arrangements to the international community potentially available through other international law (e.g. the Law of the Sea Convention or the Convention on Biological Diversity). The major turning point in Antarctica came when the Convention on the Regulation of Antarctic Mineral Resource Activities—which acknowledged the rights of the international community—failed to enter into force. Today the international community is rewarded with a relatively healthy Antarctic environment and free access to some scientific information, which are benefiting all mankind. But the international community does not get direct financial reward from Antarctic activities because access is constrained by law and by a lack of capacity. There is no mechanism for disbursing compensation to all mankind in any case, although the Antarctic Treaty Consultative Parties could certainly rectify this if they had the will to do so. So far they have not. (shrink)

This essay in the "anthropology of science" is about how cognition constrains culture in producing science. The example is folk biology, whose cultural recurrence issues from the very same domain-specific cognitive universals that provide the historical backbone of systematic biology. Humans everywhere think about plants and animals in highly structured ways. People have similar folk-biological taxonomies composed of essence-based species-like groups and the ranking of species into lower- and higher-order groups. Such taxonomies are not as arbitrary in structure and (...) content, nor as variable across cultures, as the assembly of entities into cosmologies, materials or social groups. (shrink)

Currently, under the law of intellectual property, IP owners may exclude from use or production substances and processes that we would ordinarily consider to be products of nature. This has helped companies monopolize disease genes, and thus diagnostic testing for those diseases, and “biosimilar” products, pharmaceutical materials that mimic biological materials. Extending the current paradigm to the world of synthetic biology and nanotechnology will create further injustices in the delivery of health care to billions of people around the world. (...) As such, I advocate heading this trend off at the pass. Scientists ought to conduct basic research into the building blocks of biology and matter in the open, publishing their results, releasing knowledge into the public domain upstream so that beneficial innovation can be produced without fear of downstream litigation, and so that what ought to remain in the public domain as a matter of right (products of nature) does not become unjustly monopolized. (shrink)

The rise of precision medicine has led to an unprecedented focus on human biological material in biomedical research. In addition, rapid advances in stem cell technology, regenerative medicine and synthetic biology are leading to more complex human tissue structures and new applications with tremendous potential for medicine. While promising, these developments also raise several ethical and practical challenges which have been the subject of extensive academic debate. These debates have led to increasing calls for longitudinal governance (...) arrangements between tissue providers and biobanks that go beyond the initial moment of obtaining consent, such as closer involvement of tissue providers in what happens to their tissue, and more active participatory approaches to the governance of biobanks. However, in spite of these calls, such measures are being adopted slowly in practice, and there remains a strong tendency to focus on the consent procedure as the tool for addressing the ethical challenges of contemporary biobanking. In this paper, we argue that one of the barriers to this transition is the dominant language pervading the field of human tissue research, in which the provision of tissue is phrased as a ‘donation’ or ‘gift’, and tissue providers are referred to as ‘donors’. Because of the performative qualities of language, the effect of using ‘donation’ and ‘donor’ shapes a professional culture in which biobank participants are perceived as passive providers of tissue free from further considerations or entitlements. This hampers the kind of participatory approaches to governance that are deemed necessary to adequately address the ethical challenges currently faced in human tissue research. Rather than reinforcing this idea through language, we need to pave the way for the kind of participatory approaches to governance that are being extensively argued for by starting with the appropriate terminology. (shrink)

It is far from obvious that outside of highly specialized domains such as commercial agriculture, the methodology of biometrics—quantitative comparisons over groups of organisms—should be of any use in today’s bioinformatically informed biological sciences. The methods in our biometric textbooks, such as regressions and principal components analysis, make assumptions of homogeneity that are incompatible with current understandings of the origins of developmental or evolutionary data in historically contingent processes, processes that might have come out otherwise; the appropriate statistical methods (...) are those suited to random walks, not normal distributions. A valid methodology would further require that especially close attention be paid to the difference between aspects of processes that are plastic, those that encode their own histories or biographies, and the very small fraction of quantifications that can usefully and realistically be modeled as varying by colored noise around a central tendency that itself has some quantitative meaning. This point of view—that only a vanishingly small fraction of the quantitative information borne by any living organism is worth quantifying—is illustrated by some data on a human birth defect, namely, fetal alcohol syndrome. In a suggestive metaphor, the biometrician is like the pilgrim in Friedrich’s painting Der Wanderer über dem Nebelmeer, uncertain as to whether to measure the mountains or the clouds. The mountains stand for contingent history, the clouds for the subset of the data most closely matching controlled experiments suitable for quantitative biometric summary. Biometrics applies to the clouds, not the mountains. The success of statistical methods comes at the expense of all the theories that we simultaneously hold to be true about the biological materials to which they both pertain. Biometrics is thus complementary to all of the emerging reductionist sciences of biological structure. (shrink)

COVID-19 exposed flaws in the law regulating the sharing of data and human biological material. This poses obstacles to the epidemic response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and development are needed to ensure that HBM and data are shared efficiently and lawfully. Academics have suggested important legal reforms. The first is the clarification of the susceptibility of HBM and HBM derivatives to ownership, including, inter (...) alia, the promulgation of a revised version of the South African Material Transfer Agreement by the Minister of Health. This would remove uncertainty regarding the current SA MTA’s perpetual donor ownership clause. The second is the development of data trusts, the adoption of open access to research data, and the creation of an African ‘data corridor’. This would ensure that data are protected while allowing for the efficient transfer of data between researchers for the collective good and in the interest of the public. The third is the amendment of the Space Affairs Act to extend the powers of the Council of Space Affairs to include the management of data collected through the utilisation of Earth observation and geographical information systems. This would ensure the protection of outer space data, legislating its use and sharing once it lands on Earth. The implementation of these legal reforms and developments will better prepare SA to face future epidemics from a health research perspective. (shrink)

What is the relation between the material, conventional symbol structures that we encounter in the spoken and written word, and human thought? A common assumption, that structures a wide variety of otherwise competing views, is that the way in which these material, conventional symbol-structures do their work is by being translated into some kind of content-matching inner code. One alternative to this view is the tempting but thoroughly elusive idea that we somehow think in some natural language (...) (such as English). In the present treatment I explore a third option, which I shall call the "complementarity" view of language. According to this third view the actual symbol structures of a given language add cognitive value by complementing (without being replicated by) the more basic modes of operation and representation endemic to the biological brain. The "cognitive bonus" that language brings is, on this model, not to be cashed out either via the ultimately mysterious notion of "thinking in a given natural language" or via some process of exhaustive translation into another inner code. Instead, we should try to think in terms of a kind of coordination dynamics in which the forms and structures of a language qua material symbol system play a key and irreducible role. Understanding language as a complementary cognitive resource is, I argue, an important part of the much larger project (sometimes glossed in terms of the "extended mind") of understanding human cognition as essentially and multiply hybrid: as involving a complex interplay between internal biological resources and external non-biological resources. (shrink)