The traditional ‘no property’ approach of the law to human biomaterials has long been punctured by exceptions. Developments in the jurisprudence of property in human tissue in English law and beyond demonstrate that a variety of tissues are capable of being subject to proprietary considerations. Further, among commentators, there are few who would deny, given biotechnological advances, that such materials can be considered thus. Yet, where commentators do admit human biomaterials into the realm of property, it is often (...) done with an emphasis on some sort of separation from the person who is the source of those materials. One line of argument suggests that there is a difference between persons and things, which constitutes a morally justifiable distinction when it comes to property. This article examines whether the idea of separability can do the work of demarcating those objects that ought to be considered property from those that ought not to be. It argues that, despite the entailment of a separability criterion inherent in both the statutory and common law positions, and the support given to this by some commentators, it is philosophically problematic as the basis for delineating property in human tissue and other biomaterials. (shrink)

The subject of biomaterials science concerns artificial materials used in medical devices to repair or reconstruct natural human tissue damaged by disease or trauma. It embraces the emerging field of tissue engineering, where artificial materials are used as scaffolds to provide the architecture for replacement organs. As such, the field raises numerous ethical issues, which are reviewed in this paper. These include the use of animal models, the testing materials and devices in patients, and what may be viewed as (...) potential abuses, where augmentation and repair are carried out for cosmetic as opposed to clinical reasons. The paper gives detailed consideration of the recent problems of metal-on-metal hip replacements as an exemplar of some of the key ethical issues that arise in this field. (shrink)

Often the only treatment available for patients suffering from diseased and injured organs is whole organ transplant. However, there is a severe shortage of donor organs for transplantation. The goal of organ engineering is to construct biological substitutes that will restore and maintain normal function in diseased and injured tissues. Recent progress in stem cell biology, biomaterials, and processes such as organ decellularization and electrospinning has resulted in the generation of bioengineered blood vessels, heart valves, livers, kidneys, bladders, and (...) airways. Future advances that may have a significant impact for the field include safe methods to reprogram a patient's own cells to directly differentiate into functional replacement cell types. The subsequent combination of these cells with natural, synthetic and/or decellularized organ materials to generate functional tissue substitutes is a real possibility. This essay reviews the current progress, developments, and challenges facing researchers in their goal to create replacement tissues and organs for patients. (shrink)

It is common practice for biobanks and biobank researchers to seek funding from agencies that are independent of the biobank that often stipulate conditions requiring researchers to grant access and share biomaterials and data as part of the agreement, in particular, in international collaborative health research. As yet, to the author’s knowledge, there has been no study conducted to examine whether these conditions could result in the commercialization of biomaterials and data and whether such practice is considered ethical. (...) This paper therefore seeks to answer the question of whether such sharing of biomaterials and data for biobank research in exchange for funding from sponsors and funders in collaborative health research is ethically justified. The central idea of this paper is based on an argument against commodification of the body and its parts, which includes biomaterials and data and holds that it is ethically wrong to commodify humans and their body parts. The arguments against commodification of biomaterials and data explored are the Kantian approach argument as it relates to interference of commodification with human dignity which is linked to a diminished sense of personhood, an argument against commodification that is based on a dilution of altruism and lastly the communitarian approach anti-commodification argument which emphasizes a social responsibility to the common good. Arguments in support of commodification based on liberal individualism and consequentialism are also discussed. (shrink)

Background This study explored the ethical issues associated with community-based HIV testing among African, Caribbean, and Black (ACB) populations in Canada, focusing on their perceptions of consent, privacy, and the management of HIV-related data and bio-samples. Methods A qualitative community-based participatory research (CBPR) approach was employed to actively engage ACB community members in shaping the research process. The design included in-depth qualitative interviews with 33 ACB community members in Manitoba, Canada. The study was guided by a Community Guiding Circle, which (...) contributed to study design, data analysis, and interpretation. A diverse sample was recruited through community agencies, social media, and flyers, with considerations for variations in age, gender, sexual orientation, and geographical location. The study employed iterative inductive thematic data analysis. Findings Participants expressed significant concerns about the collection, sharing, and use of HIV data from healthcare encounters, revealing mistrust towards institutions like police, child welfare, and immigration accessing their health information. Their worries centered on the handling of biological samples, data misuse, potential human rights violations, HIV criminalization, deportations, challenging consent, privacy, and bodily autonomy principles. While open to contributing to medical research, they unanimously demanded greater transparency, informed consent, and control over the secondary use of their health data. Conclusions The study underscores the need for culturally safe approaches in HIV testing and ethical governance in healthcare for ACB communities. It highlights the importance of prioritizing participant empowerment, ensuring transparency, practicing informed consent, and implementing robust data security measures to balance effective HIV information management with the protection of individual rights. (shrink)

In various documents the view emerges that contemporary biotechnosciences are currently experiencing a scientific revolution: a massive increase of pace, scale and scope. A significant part of the research endeavours involved in this scientific upheaval is devoted to understanding and, if possible, ameliorating humankind: from our genomes up to our bodies and brains. New developments in contemporary technosciences, such as synthetic biology and other genomics and “post-genomics” fields, tend to blur the distinctions between prevention, therapy and enhancement. An important dimension (...) of this development is “biomimesis”: i.e. the tendency of novel technologies and materials to mimic or plagiarize nature on a molecular and microscopic level in order to optimise prospects for the embedding of technological artefacts in natural systems such as human bodies and brains. In this paper, these developments are read and assessed from a psychoanalytical perspective. Three key concepts from psychoanalysis are used to come to terms with what is happening in research laboratories today. After assessing the general profile of the current revolution in this manner, I will focus on a particular case study, a line of research that may serve as exemplification of the vicissitudes of contemporary technosciences, namely viral biomaterials. Viral life forms can be genetically modified (their genomes can be rewritten) in such a manner that they may be inserted in human bodies in order to produce substances at specific sites such as hormones (testosterone), neurotransmitters (dopamine), enzymes (insulin) or bone and muscle tissue. Notably, certain target groups such as top athletes, soldiers or patients suffering from degenerative diseases may become the pioneers serving as research subjects for novel applications. The same technologies can be used for various purposes ranging from therapy up to prevention and enhancement. (shrink)

This chapter contains sections titled: General Ethical Issues Cellular, Genetic and Tissue Engineering Biomaterials, Prostheses and Implants Biomedical Imaging and Optics Neural Engineering References and Further Reading.

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular (...) ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)

Through an examination of the bacteria that produce the cellulose, an investigation of the growing process and properties, and a discussion of an artistic exploration, one can fully grasp bio cellulose’s potential in becoming a synergist for sustainable fashion. This new creative and radical approach re-imagines the future materials for fashion and other fields requiring textile applications that are grown and renewable. Questions how textile can be created to be sustainable, biodegradable and infinitely reusable and mainly what the paradigms for (...) the new aesthetics are. The aim of this article is to convey the need for new biomaterials inspired by nature. (shrink)

Oncofertility is one of the 9 NIH Roadmap Initiatives, federal grants intended to explore previously intractable questions, and it describes a new field that exists in the liminal space between cancer treatment and its sequelae, IVF clinics and their yearning, and basic research in cell growth, biomaterials, and reproductive science and its tempting promises. Cancer diagnoses, which were once thought universally fatal, now often entail management of a chronic disease. Yet the therapies are rigorous, must start immediately, and in (...) many cases result in premature failure of the body's reproductive ability. In women, this loss is especially poignant; unlike the routine storage of sperm, which is done in men and boys facing similar treatment decisions, freezing oocytes in anticipation of fertility loss is not possible in most cases, and creating an embryo within days of diagnosis raises significant moral, social and medical challenges. Oncofertility is the study of how to harvest ovarian tissue in women facing cancer to preserve their gametes for future use with IVF, thus allowing the decisions about childbearing to be deferred and reproductive choices to be preserved. The research endeavor uses the capacity of the ovarian follicle to produce eggs in vitro . Developing the human follicle to ovulate successfully outside the body is scientifically difficult and ethically challenging. Infertility is linked to long-standing religious and moral traditions, and is intertwined with deeply contentious social narratives about women, families, illness and birth. Is the research morally permissible? Perhaps imperative if understood as a repair from iatrogenic harms? How are considerations of justice central to the work? How will vulnerable subjects be protected? What are the moral implications of the work for women, children and families? What are the implications for society if women could store ovarian tissue as a way of stopping the biological clock? What are the moral possibilities and challenges if eggs can be produced in large quantities from a stored ovarian tissue? (shrink)

A new road map for design is emerging out of interdisciplinary research across biology and design. Whilst in the second part of the twentieth century, the emergence of the digital realm altered and radically challenged conventional design and manufacturing processes, the beginning of the twenty-first century marks a strong shift towards the amalgamation of the binary code with biological systems. With advances in synthetic biology, we can now ‘biofabricate’ like Nature does. By tinkering and altering the DNA code or the (...) environment of growth of living organisms, we can effectively ‘design’ and grow new biomaterials. The role of design is shifting from working with inanimate matter such as plastic and metals to making with animate living entities such as mycelium, yeast and bacteria. This paradigm shift promises to open up new possibilities for biofabricating future intelligent materials as well as for engaging with new sustainable processes. This paper examines strategies and tools for designing with living systems and proposes a framework for design to engage with our future bio-materiality. From biofabrication experiments to synthetic biology propositions, the paper will investigate a series of design artifacts that explores strategies such as co-designing with natural organisms or actuating a new synthetic nature and develop a critique of how biodesign can help shifting towards the crafting of a future sustainable intelligent bio-materiality. (shrink)

This special issue of Science, Technology, & Human Values assembles papers that consider relations among science, ethics, and justice. The papers are drawn from a 2011 National Science Foundation-sponsored workshop that brought together interdisciplinary scholars to consider, incorporate, and attend to the meanings, uses, and social consequences of ethical questions and justice ideals in technoscientific projects. The papers included in this special issue examine key areas that emerged from this workshop, including public participation, the production of knowledge, what counts as (...) consent, ownership of biomaterials, and others. Together, the papers raise questions about new directions and articulations of power, justice, and inequalities in science and technology studies. (shrink)

This chapter argues that considerations for the welfare and interests of the dead and the philosophical attention given to them (and to posthumous harm) are self-indulgent nonsense at best, and at worst a crime against humanity. The real issues are the extent of the harm that might be caused by not using tissue, organs, cells, DNA, and other biomaterials from the dead, and the extent of the good that using such biomaterials might achieve. Of slightly less urgency is (...) of course the educational value of bodies and body parts, and even further down the pecking order is their liturgical significance and entertainment value. (shrink)

Chronic wounds, such as diabetic foot ulcers, pose significant challenges due to their prolonged inflammation state, slow vascularization, lack of supportive matrix, and frequent recurrence. Biocompatible materials like silk fibroin (SF) and collagen can be promising in chronic wound healing applications due to their biocompatibility, and ability to act as supporting matrix necessary for tissue regeneration. This study explores the development and characterization of SF-based biomaterials in various formats, including gels, lyophilized scaffolds, and films, by combining them with collagen (...) (Col) and heparin (Hep) molecules that are known for the wound-healing properties. SF gels, films, and lyophilized scaffolds were characterized for water retention capacity, porosity, contact angle, and antibacterial properties. Curcumin-loaded films reported moderate wetting behavior but were brittle, thin and hard. Freeze-dried scaffolds possessed higher water retention capacity compared to the sonicated gels and films, and showed a porous network structure, while the fabricated SF gels disintegrated in water. SF with a chelating agent demonstrated mild antibacterial properties, which were retained when combined with Collagen peptides and Heparin. The antimicrobial effect was significantly enhanced when SF+Col+Hep was added with antimicrobial agents such as Gentamicin and Ceftriaxone. The study concludes that SF-based scaffolds, particularly those incorporating collagen peptides and heparin, can be leveraged for molecular delivery application towards wound healing. Future research should focus on improving mechanical properties, measuring release kinetics of heparin and other biomolecules from SF-based lyophilized scaffolds, and conducting in vivo studies to validate the therapeutic value. (shrink)

There has been a surge in mass media reports extolling the potential for using three-dimensional printing of biomaterials to treat a wide range of clinical conditions. Given that mass media is recognized as one of the most important sources of health and medical information for the general public, especially prospective patients, we report and discuss the ethical consequences of coverage of 3D bioprinting in the media. First, we illustrate how positive mass media narratives of a similar biofabricated technology, namely (...) the Macchiarini scaffold tracheas, which was involved in lethal experimental human trials, influenced potential patient perceptions. Second, we report and analyze the positively biased and enthusiastic portrayal of 3D bioprinting in mass media. Third, we examine the lack of regulation and absence of discussion about risks associated with bioprinting technology. Fourth, we explore how media misunderstanding is dangerously misleading the narrative about the technology. (shrink)

Glucocorticoids are understood to represent useful biomarkers of stress and can be measured in saliva, hair, and breastmilk. The collection of such biosamples is increasingly included in biobank and cohort studies. While collection is considered “non-invasive” by biomedical researchers (compared to sampling blood), community perspectives may differ. This cross-sectional, qualitative study utilising eight focus groups aimed to determine the feasibility and acceptability of collecting ostensibly “non-invasive” biological samples in Malawi. Breastfeeding women, couples, field workers, and healthcare providers were purposively sampled. (...) Data about prior understandings of, barriers to, and feasibility of “non-invasive” biosampling were analysed. Participants described biomaterials intended for “non-invasive” collection as sometimes highly sensitive, with sampling procedures raising community concerns. Sampling methods framed as physically “non-invasive” within biomedicine can consequently be considered socially “invasive” by prospective sample donors. Biomedical and community framings of “invasiveness’ can therefore diverge, and the former must respond to and be informed by the perspectives of the latter. Further, considerations of collection procedures are shaped by therapeutic misconceptions about the immediate health-related utility of biomedical and public health research. When researchers engage with communities about biosampling, they must ensure they are not furthering therapeutic misconceptions and actively seek to dispel these. (shrink)

In this article, I examine reproductive travel for sex selection with reference to two distinct technologies—MicroSort and preimplantation genetic diagnosis (PGD). Available since the 1990s for sex-linked disease avoidance, I focus here on their imbrication in an emerging global form of nonmedical, lifestyle sex selection that elicits movements of information, biomaterial, patients, providers, and equipment across borders. This web of cross-border, interclinical, and laboratory transactions raises issues highly relevant to a feminist approach to the bioethics of sex selection. International documents, (...) however, have yet to account for their implication in an increasingly stratified system of global sex selection practices. (shrink)

Background: Multi-collaborator research is increasingly becoming the norm in the field of biomedicine. With this trend comes the imperative to award recognition to all those who contribute to a study; however, there is a gap in the current “gold standard” in authorship guidelines with regards to the efforts of those who provide high quality biosamples and data, yet do not play a role in the intellectual development of the final publication. -/- Methods and findings: We carried out interviews with 36 (...) individuals working in, or with links to, biobanks in Switzerland, in order to understand how they interpret, apply and value authorship criteria in studies involving biosamples. The majority of respondents feel that authorship is an important motivating factor in working and publishing collaboratively. However, our findings suggest that in some cases, authorship guidelines are being ignored in favor of departmental standards which recognize “scientific work” as meriting authorship. -/- Conclusions: Our results support the current calls in the literature for an alternative method of crediting biomaterial contributions, in order to ensure appropriate authorship inclusion and promote collaborative research involving biobanks. (shrink)

Researchers are enthusiastically concerned about neural stem cell (NSC) therapy in a wide array of diseases, including stroke, neurodegenerative disease, spinal cord injury (SCI) and depression. Although enormous evidences have demonstrated that neurobehavioral improvement may benefit from NSC-supporting regeneration in animal models, approaches to endogenous and transplanted NSCs are blocked by hurdles of migration, proliferation, maturation and integration of NSCs. Electrical stimulation (ES) may be a selective nondrug approach for mobilizing NSCs in the central nervous system (CNS). This technique is (...) suitable for clinic application, because it is well established and its potential complications are manageable. Here, we provide a comprehensive review of the emerging positive role of different electrical cues in regulating NSC biology in vitro and in vivo, as well as biomaterial-based and chemical stimulation of NSCs. In the future, ES combined with stem cell therapy or other cues probably becomes an approach for promoting brain repair. (shrink)

We live in a time where masks are rewriting wearable protocol. It is critical to understand entwining narratives around masks from the notion of health and safety to a wider discourse between the masked and the mask, including opportunistic capitalism and climatic implications. How about a mask that breathes, that is made by organic raw materials? As we confront and question narratives of the new normalcy in the year of pandemic and hindsight, these frames have coalesced in a vision of (...) the mask as an emblem for open-source eco-consciousness-functional, accessible DIY living wearables made with biomaterials. ‘Algae Mask’ explores the symbiosis between humans and other beings, layered as second skins; this project is driven by an ardent group of art and design practitioners across the Asia-Pacific and European regions with ongoing satellite collaborations. A related film Algae Dream, on the other hand, speculates on the prototyping process and the sleek languages of market economy to smudge the fine line between fiction and reality. Within the bricolage of source videos and original footages, motivational video mock-up and authentic presentation documentation, the video essay intends to challenge audience in a multiplicity of narrations stemming from discourses of business and science. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Extra Ear:Ear on the Arm BlenderStelarc Click for larger view View full resolutionFigure 1.Blender. Teknikunst—Meat Market, Melbourne 2005. Photograph: Stelarc. Collaborator Nina Sellars stands with the Blender during an installation photograph. Text credit: K. Conden and A. Douglas. Click for larger view View full resolutionFigure 2.Blender (3D Model). Teknikunst—Meat Market, Melbourne 2005. Image: Adam Fiannaca. The installation itself stands at just over 1.6 meters high and is anthropomorphic in (...) scale and structure. Text credit: K. Conden and A. Douglas. Click for larger view View full resolutionFigure 3.Blender. Teknikunst—Meat Market, Melbourne 2005. Photograph: Stelarc. Every few minutes the Blender automatically circulates or "blends" its contents via a system of compressed air pumps and a pneumatic actuator. Text credit: K. Conden and A. Douglas.[End Page 117] Click for larger view View full resolutionFigure 4.Ear Scaffold. Los Angeles, Melbourne 2006. Photographer: Nina Sellars. The preoperative scaffolding that was surgically placed below the skin's surface of performance artist Stelarc. Text credit: R. Ferro. Click for larger view View full resolutionFigure 5.Blender (Biomaterial). Teknikunst—Meat Market, Melbourne 2005. Photograph: Cameron Jones. Both artists, Stelarc and Nina Sellars, undertook liposuction operations specifically for the purpose of this new work and have succeeded in securing the sanitized isolation and, most importantly, the legal ownership of the remnants of the procedures. Text credit: K. Conden and A. Douglas. Click for larger view View full resolutionFigure 6.Hole Hooks Forceps. As a guest at Cornell University's conference "Digital Bodies" in 2001, Stelarc spoke of his desire to implant an ear that could pick up sound. His plans become a reality in the photograph taken during surgery. Text credit: R. Ferro. Click for larger view View full resolutionFigure 7.Extra Ear: Ear on the Arm. Los Angeles, Melbourne 2006. Photographer: Nina Sellars. Stelarc's future plans are to implant Bluetooth technology into the Ear on the Arm in a subsequent surgery so that the ear will pick up sound which will be transmitted via the Internet. Text credit: R. Ferro. Click for larger view View full resolutionFigure 8.Blender (Sterile Hood). Teknikunst—Meat Market, Melbourne 2005. Photograph: Stelarc. The biomaterials are now housed within the Blender's industrial casing, on exhibition at the Meat Market Gallery B in North Melbourne until August 18. Text credit: K. Conden and A. Douglas.[End Page 118]Stelarc- Biographical NotesStelarc is an Australian artist who has performed extensively in Japan, Europe, and the USA—including new music, dance festivals, and experimental theater. He has used medical instruments, prosthetics, robotics, Virtual Reality systems, and the Internet to explore alternate, intimate, and involuntary interfaces with the body. He has performed with a THIRD HAND, a VIRTUAL ARM, a VIRTUAL BODY and a STOMACH SCULPTURE. He has acoustically and visually probed the body—having amplified brainwaves, blood-flow and muscle signals and filmed the inside of his lungs, stomach, and colon, approximately two meters of internal space. He has done twenty-five body SUSPENSIONS with insertions into the skin, in different positions and varying situations in private gallery spaces and in remote locations.For FRACTAL FLESH, as part of Telepolis in 1995, he developed a touch-screen interfaced Muscle Stimulation System, enabling remote access, actuation, and choreography of the body. Performances such as PING BODY and PARASITE (1996, 1997) probe notions of telematic scaling and the engineering of external, extended, and virtual nervous systems for the body using the Internet. In 1998 for Kampnagel, he completed EXOSKELETON—a pneumatically powered six-legged walking machine actuated by arm gestures. During 2000, he completed an EXTENDED ARM—a manipulator with eleven degrees-of-freedom that extends his arm to primate proportions and a MOTION PROSTHESIS—an intelligent, compliant servo-mechanism that enables the performance of precise, repetitive, and accelerated prompting or programming of the arms in real time. In 2002, with the collaboration of the Evolutionary and Adaptive Systems Group, COGs, University of Sussex, and TNTU, the HEXAPOD robot prototype was developed. The six-legged MUSCLE MACHINE was constructed with the assistance of The Nottingham Trent University Engineering team, using fluidic rubber muscle actuators. The PROSTHETIC... (shrink)

Oncofertility is one of the 9 NIH Roadmap Initiatives, federal grants intended to explore previously intractable questions, and it describes a new field that exists in the liminal space between cancer treatment and its sequelae, IVF clinics and their yearning, and basic research in cell growth, biomaterials, and reproductive science and its tempting promises. Cancer diagnoses, which were once thought universally fatal, now often entail management of a chronic disease. Yet the therapies are rigorous, must start immediately, and in (...) many cases result in premature failure of the body's reproductive ability. In women, this loss is especially poignant; unlike the routine storage of sperm, which is done in men and boys facing similar treatment decisions, freezing oocytes in anticipation of fertility loss is not possible in most cases, and creating an embryo within days of diagnosis raises significant moral, social and medical challenges. Oncofertility is the study of how to harvest ovarian tissue in women facing cancer to preserve their gametes for future use with IVF, thus allowing the decisions about childbearing to be deferred and reproductive choices to be preserved. The research endeavor uses the capacity of the ovarian follicle to produce eggs in vitro. Developing the human follicle to ovulate successfully outside the body is scientifically difficult and ethically challenging. Infertility is linked to long-standing religious and moral traditions, and is intertwined with deeply contentious social narratives about women, families, illness and birth. Is the research morally permissible? Perhaps imperative if understood as a repair from iatrogenic harms? How are considerations of justice central to the work? How will vulnerable subjects be protected? What are the moral implications of the work for women, children and families? What are the implications for society if women could store ovarian tissue as a way of stopping the biological clock? What are the moral possibilities and challenges if eggs can be produced in large quantities from a stored ovarian tissue? (shrink)

The question of whether individuals retain interests or can be harmed after death is highly contentious, particularly within the context of deceased organ retrieval, retention and use. This paper argues that posthumous interests and/or harms can and do exist in the Konkomba traditional setting through the concept of ancestorship, a reputational concept of immense cultural and existential significance in this setting. I adopt Joel Feinberg’s account of harms as a setback to interests. The paper argues that a socio-culturally sensitive regulatory (...) framework does not necessarily exclude the donation of human biomaterials for transplant and science research. Indeed, when customary values are explored with open-mindedness and sensitivity it may be shown that such donation can form part of the important customs of some communities in this jurisdiction. Accordingly, a context-appropriate governance framework could utilise the cultural value of ancestorship as an incentive to encourage organ donation in the Ghanaian traditional setting. (shrink)

In recent years, cross-national collaboration in medical research has gained increased policy attention. Policies are developed to enhance data sharing, ensure open-access, and harmonize international standards and ethics rules in order to promote access to existing resources and increase scientific output. In tandem with this promotion of data sharing, numerous ethics policies are developed to control data flows and protect privacy and confidentiality. Both sets of policy making, however, pay limited attention to the moral decisions and social ties enacted in (...) the everyday routines of scientific work. This paper takes its point of departure in the practices of a Danish laboratory with great experience in international collaboration regarding genetic research. We focus on a simple query, what makes genetic material and health data flow, and which hopes and concerns travel along with them? We explore what we call the flows, the nonflows, and the overflows of material and information, and we document the work producing the flows of health data and biomaterial. We call this work “ethics work” and argue that it is crucial for data sharing though it is rarely articulated in ethics policies, remains inadequately funded, and lacks acknowledgment in policies promoting international data sharing. (shrink)

BackgroundThe success of biobanking is directly linked to the willingness of people to donate their biological materials for research and storage. Ethical issues related to patient consent are an essential component of the current biobanking agenda. The majority of data available are focused on population-based biobanks in USA, Canada and Western Europe. The donation decision process and its ethical applications in clinical populations and populations in countries with other cultural contexts are very limited. This study aimed to evaluate the decision-making (...) experience of the clinical biobank donors, as well as psychological and social motivators and deterrents of this decision and associated ethical risks.MethodsSemi-structured interviews were conducted in two medical institutions, in St Petersburg (Russia), in 2016–2017, among 13 donors of a clinical biobank (pregnant women, cardiac patients, and patients with multiple sclerosis) and three donation organisers—medical specialists involved in recruiting donors for a clinical biobank. Analysis of interview data was based on qualitative content analysis.ResultsDonors of a clinical biobank express beliefs in the absence of risks associated with the donation. The primary motivators for donating to the biobank were: prosocial, indirect reciprocity (response to or anticipation of an act in kind by a third party), intrinsic motivation (to enhance their self-esteem and satisfying their curiosity about the donation process), and comparability with personal values. A high level of trust in biomedical research and the particular physician can contribute to a favourable decision. The overall decision-making process regarding the biobank donation could be described as quick and not based on a careful reading of informed consent documents. The integration of biobank donation decision-making in the process of medical care might prompt patient to donate to biobank without proper consideration. The specific type of therapeutic misconception—the presence of unrealistic hope that donation could provide a direct benefit for a third person in need was discovered.ConclusionsPatients recruited to a clinical biobank in Russia have virtually no concerns as to the storage of their biomaterials. The donation decision is mainly motivated by prosocial attitudes and other factors that are similar to the motivating factors of blood donation. The fact of going through inpatient treatment and poor differentiation between donation for other people's benefit and for research purposes can make the process of obtaining consent more ethically problematic. (shrink)

The article presents a study of gift-giving practices in the context of the development of modern biomedicine and shows their relationship to the realization of epistemic virtues. In biomedicine, the gain and production of knowledge (the gift of knowledge) is often grounded in bodily gift (sacrifice) and donor practices. The latter are associated with a number of mishaps in the history of biomedicine, reflecting the violation of moral norms in the process of obtaining scientific data and demonstrating the need for (...) a clear differentiation of intellectual and moral virtues. An important factor in the formation of the epistemic norms of modern biomedicine has been the transformation of the values of scientific knowledge from practices of coercion to giving. As a result, the involuntary sacrifice of biomaterials to science was replaced by voluntary practices of somatic giving and informational exchange that determine the process of mutual recognition in science. It is shown that gift-giving in science is closely associated with intellectual virtues, with intellectual generosity characterizing the idea of openness in science and scientists’ intention for production and constant growth of knowledge, and can also be related to the idea of altruistic service to science, involving the exchange of received scientific data and access to free information in the network space. A number of examples of the modern digital gift ethos and the implementation of the principles of openness of knowledge and knowledge exchange in the context of the creation of biomedical expert digital platforms, the formation of social scientific networks – platforms with open access to scientific information, the development of the phenomenon of “garage” science and other “zones of exchange” experience are considered. (shrink)

BackgroundThe German Medical Informatics Initiative (MII) introduced a standardised Broad Consent (BC) form encompassing medical data, insurance data, contact information and biomaterials for health data research. This study assesses the feasibility of MII-BC in emergency departments (EDs), examining patient understanding and identifying implementation facilitators and barriers. Recommendations for implementation of MII-BC in EDs will be derived.MethodsMixed-method data were collected in EDs of four German university hospitals (UHs) using pseudonymised participant observation with a focus on patient perspective and surveys from (...) patients. Data included MII-BC acceptance rates, patient understanding, motivation to consent and implementation facilitators and barriers. Quantitative data were analysed descriptively; qualitative data underwent content analysis with deductive–inductive category formation.ResultsThe exploratory study involved 12 participant observations from four tertiary UHs, surfacing five key themes: (1) MII-BC patient information in the ED, (2) facilitators and (3) barriers in obtaining MII-BC in the ED, (4) patient perspectives on MII-BC and (5) recommendations for implementing MII-BC in EDs. Survey results (n=225) showed that most patients (89.8%) demonstrated high understanding of MII-BC patient information. Facilitators include empathetic engagement, clear communication and encouragement for questions. Hindering factors include estimating study time frames, ambient noises and study procedure interruptions. Adequate resources, such as trained staff and suitable premises, are crucial.ConclusionImplementing MII-BC in the ED is feasible with appropriate resources, though ED-specific challenges must be addressed. Successful MII-BC implementation in EDs hinges on ensuring access to comprehensible information materials, transparent communication and a calm recruitment environment.Trial registration numberDRKS00030054. (shrink)

So-called climate-ready GM crops can be of great help in adapting to a changing climate. Climate change, caused in great part by anthropogenic greenhouse gases released in the atmosphere since the industrial revolution by the developed world, is felt much stronger in the developing world, causing unexpected droughts and floods that will cause large harvest loss, leading to more hunger and malnutrition, rising death tolls and disease vulnerability. The current intellectual property regime (IPR) strikes an unfair balance between profit oriented (...) seed industry giants and low-acreage farmers. The biotechnology industry, mainly headquartered in the developed world, has started to patent new seed varieties, taking biomaterials from developing countries, with the claim, that they will be more tolerant to flood, drought, heat, and cold. Special sales contracts prohibit saving seeds from the harvest for the next season, thus forcing the farmers to buy them every season anew, which goes against traditional farming. Using a widely accepted concept of global justice, that tackles the fact that around 10% of the world's population profits from 90% of the earth's resources, and by taking into account the feasibility of a fair IPR, we will discuss three issues. First, an ethically acceptable IPR should prevent unjust and unfair assignments of property rights (e.g. patents) that completely ignore small-scale farmers inventiveness and efforts to save agrobiodiversity. As a second task, this regime should encourage globally a just distribution of the objects of innovation that are covered by patents. Third, such a regime should encourage innovations at a rate that is effective to cope with climate change. (shrink)

The purposes of this article were to obtain mechanical properties of the dry femur cortical bone samples through a tensile load and stress concentration factor approach and to provide simulations to predict experimental behaviors based on manipulations of certain properties and parameters of the biomaterial. Since bone samples have characteristics and geometries, the development of a mathematical model was necessary to describe the combination of stresses interacting in the bone when a tension load is applied. The samples have average diameters (...) and lengths of 0.5 and 2 inches respectively and were tested using a 10 kN Universal Tensile Machine to determine mechanical properties such as yield and ultimate stress, young module, and fracture, among others. Several simulations were conducted to evaluate failure criteria like “Von Mises”, “Tresca” and “Tsai-Wu”. Finally, was concluded that 83% of the data obtained from the 22 samples observed in the “Stress-Strain” charts showed a directly proportional relationship. (shrink)

Living organisms are the ultimate survivalists, having evolved phenotypes with unprecedented adaptability, ingenuity, resourcefulness, and versatility compared to human technology. To harness these properties, functional descriptions and design principles from all sources of biodiversity information must be collated − including the hundreds of thousands of possible survival features manifest in natural history museum collections, which represent 12% of total global biodiversity. This requires a consortium of expert biologists from a range of disciplines to convert the observations, data, and hypotheses into (...) the language of engineering. We hope to unite multidisciplinary biologists and natural history museum scientists to maximize the coverage of observations, descriptions, and hypotheses relating to adaptation and function across biodiversity, to make it technologically useful. This is to be achieved by developments in meta‐ taxonomic classification, phylogenetics, systematics, biological materials research, structure and morphological characterizations, and ecological data gathering from the collections − the aim being to identify and catalogue features essential for good biomimetic design. (shrink)

Author analyzes the phenomenon of commoditization of human body in the context of the scientific development. It is argued that since the start of the development of biotechnologies human body has become a very attractive object for economic «investments» in the majority of developed countries. Author considers some anthropological foundations of the body commodification problem and some classifications of the relationships between individuals, science and society. The following dimensions of these relationships are examined in the paper: 1) an opposition of (...) the individual and science; 2) an altruistic dimension; 3) a compensatory dimension. The “oppositional" dimension describes science as an institute that is not focused on the benefits of a certain person through the in- strumentalization and commoditization of corporality but is aimed to find the solution to some common social problems. Within the second (altruistic) dimension the individual seeks to make a contribution to the development of science and has no objection against the use of his biomaterials. A shady side of the altruistic dimension is the so-called “false altruism": a person is encouraged to donate biomaterials without any information about some possible risks and dangers for his health as well as about commercial interest of the researchers. The compensatory dimension comes from the material or moral damage compensation to the individual or his relatives for the use of his/her body (cells, substances, body parts) for biotechnological purposes. (shrink)

This article reviews the latest report from the Nuffield Council on Bioethics, Human Bodies: Donation for Medicine and Research. It argues that the report represents a notable evolution in the Council's position regarding the appropriate governance of the human body and biomaterials. It then goes on to examine in more depth one of the report's recommendations – that a pilot payment scheme for eggs for research purposes should be trialled. In particular, it looks at whether the distinctions drawn, first, (...) between eggs for research and therapeutic purposes and, secondly, between eggs for research and other biomaterials can be adequately justified. (shrink)

Novel therapies resulting from regenerative medicine and tissue engineering technology may offer new hope for patients with injuries, end-stage organ failure, degenerative disorders and many other clinical issues. Currently, patients suffering from diseased and injured organs are treated with transplanted organs. However, there is a shortage of donor organs that is worsening yearly as the population ages and new cases of organ failure increase. Scientists in the field of regenerative medicine and tissue engineering are now applying the principles of cell (...) transplantation, material science, and bioengineering to construct biological substitutes that can restore and maintain normal function in diseased and injured tissues. In addition, the stem cell field is a rapidly advancing part of regenerative medicine, and new discoveries in this field create new options for this type of therapy. For example, new types of stem cells, such as amniotic fluid and placental stem cells, that can circumvent the ethical issues associated with embryonic stem cells have been discovered. The process of somatic cell nuclear transfer and the creation of induced pluripotent cells provide still other potential sources of stem cells for cell-based tissue engineering applications. While stem cells are still in the research phase, some therapies arising from tissue engineering endeavors that make use of autologous, adult cells have already entered the clinical setting, indicating that regenerative medicine holds much promise for the future. (shrink)