The idea of dignity seems indissociable from that of humanity, whether in its universal dimension of ‘human dignity’, or in the individual ‘dignity of the person’. This paper provides an outlook on the ethics governing the sciences and technology, in particular the biological sciences and biotechnology, and recalls the notion of ‘glory’, both human and divine, as it infuses a great part of the Middle Ages and the Renaissance cultures, just before the scientific revolution in Europe.

RESUMOO presente artigo analisa processos de alterização na biologia humana e na biomedicina. A alterização é entendida aqui como o processo cultural de produção de alteridades por meio da delimitação, rotulação e categorização das formas possíveis de ser outro, desde um determinado marco de referência sócio-histórico. Ainda que a alterização faça parte de qualquer processo de delimitação de categorias de identidade no seio de uma cultura - e, nesse sentido, possa apresentar visões do outro tanto positivas quanto negativas -, aqui (...) nos interessamos especificamente na alterização como fator de marginalização e exclusão social de diferentes grupos humanos. São analisados diversos processos de alterização operantes nos discursos e nas práticas das ciências biomédicas ao longo de sua história recente, os quais têm conduzido à exclusão social de diferentes categorias de outros, ou a tratá-los como inferiores, em pretendidas bases científicas, ou em função de determinadas práticas institucionalizadas dentro da comunidade científica. Exemplos típicos de grupos marginalizados pelas ciências ocidentais ao longo de sua história incluem as raças não europeias, as mulheres, os homossexuais e os "pobres". O principal objetivo do presente artigo é analisar, na história recente das ciências biomédicas, esses processos de alterização que têm conduzido à marginalização de tais grupos e a considerá-los como inferiores. ABSTRACTThis article analyzes processes of "othering" in human biology and biomedicine. Othering is understood here as the cultural process of production of otherness by means of the delimitation, tagging, and categorization of the possible ways of being "other" within a given socio-historical context. Although othering can be considered as a constitutive aspect of any process of delimitation of identities within a given culture - and in this sense it can present both positive and negative views of the "other" -, in the present article we are specifically interested in processes of othering that lead to the marginalization and social exclusion of different human groups. We will analyze processes of othering, which have operated in the discourses and practices of biomedical sciences throughout their recent history, that have led to the social exclusion of different categories of "others", or to treating them as inferior, and that have supposedly scientific bases or as a consequence of the institutionalization of certain practices within the scientific community. Typical examples of these "others", marginalized by the Western sciences throughout their history, are the non-European "races", women, gay and lesbian people, and the "poor". The main objective of this article is to analyze, in the recent history of the biomedical technosciences, these different processes of othering that have led to the marginalization of such "others" and to treating them as inferior. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human (...) biological resources are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (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)

In 1929 the newly-reorganized Rockefeller Foundation funded the work of a cross-disciplinary group at Harvard University called the Committee on Industrial Physiology. The committee’s research and pedagogical work was oriented towards different things for different members of the alliance. The CIP program included a research component in the Harvard Fatigue Laboratory and Elton May’s interpretation of the Hawthorne Studies; a pedagogical aspect as part of Wallace Donham’s curriculum for Harvard Business School; and Lawrence Henderson’s work with the Harvard Pareto Circle, (...) his course Sociology 23, and the Harvard Society of Fellows. The key actors within the CIP alliance shared a concern with training men for elite careers in government service, business leadership, and academic prominence. But the first communications between the CIP and the Rockefeller Foundation did not emphasize training in human biology. Instead, the CIP presented itself as a coordinating body that would be able to organize all the varied work going on at Harvard that did not fit easily into one department, and it was on this basis that the CIP became legible to the President of Harvard, A. Lawrence Lowell, and to Rockefeller’s Division of Social Sciences. The members of the CIP alliance used the term human biology for this project of research, training and institutional coordination. (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 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...

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)

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)

In recent years, the biological inheritance of what has been traditionally known as original sin has come more clearly to the fore. Examining the genetic forebears of Homo sapiens has allowed for a richer understanding of what exactly the "propagation" of original sin might really mean. The wounded imperfection of the human biological inheritance has clarified matters concerning the question of where exactly original sin comes from. Since the human experience of sentience and agency is built biologically upon (...) the shoulders of its ancestors, the human experience of being always-already bound by sin—an essential component of the meaning of original sin—comes into clearer relief. At the same time, a much richer... (shrink)

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)

In lieu of an abstract, here is a brief excerpt of the content:MIMESIS AND EMPATHY IN HUMAN BIOLOGY William B. Hurlbut, M.D. Stanford University Thou shalt not avenge, nor bear any grudge against the children of thy people, but thou shalt love thy neighbor as thyself: I am the Lord. (Leviticus. 19:18) The light of the body is the eye: if therefore thine eye be single, thy whole body shall be full of light. But if thine eye be (...) evil, thy whole body shall be full of darkness. If therefore the light that is in thee be darkness, how great is that darkness! (Matthew. 6:22-23) On the levels both ofcommon discourse and scientific description, the concept of empathy has found renewed popularity. Like a bridge that spans disparate realms, the idea of empathy can reconnect neurophysiology with psychology and social theory, and reestablish the grounds for a natural concept of ethics. Specifically, it can connect mimetic theory with a possible basis in biology, since empathy seems to represent an extension ofmimetic processes across the animal kingdom. For this reason, empathy/mimesis might be the grounds for a concept of ethics based on natural observation. Drawn from a German term Einfühlung, which means "feeling into," empathy carries the concept of "getting into the feelings of someone else" (deWaal 79). As a medium for the formation of meaningful bonds and William Hurlbut15 sensitive associations, the concept of empathy has taken on, in popular discourse, the somewhat sentimental notion ofsympathy. In the scientific description, however, empathy is seen as the highest human expression of a broader biological capacity for mimesis that seems inextricable from the very progress ofthe phylogenetic process. Among the earliest life forms, organisms drew information from one another to pattern and coordinate such basic biological functions as reproduction and nurture. But with the increased complexity of multicellular creatures, new means of communication arose, making possible more flexible adaptation and sociability. Gradually the direct chemical coordination suitable for collectives or swarms gave way to richer and more individual communication between organisms of higher forms of differentiation. The externally evident demarcation ofthe head region, with its organs ofsensory perception and communication, evolved in parallel with internal cerebral structures capable ofprocessing more complex impressions of the surrounding environment and coordinating greater freedom of motion. These vital powers of action and awareness in turn came to be governed, guided and integrated by an inner felt sense of need, goal or purpose. As Leon Kass says, "desire, not DNA, is the deepest principle of life" (Kass 1994, 48). This quality of "inwardness" is paralleled by an equally complex differentiation and integration of the external "look" ofthe animal. This "look," which is the literal translation of the Latin root of our word species, is the result of a genetically determined plan as important as any internal vital organ. It provides the unity of form that reveals or selectively conceals the inner life of the organism. It communicates and coordinates vital information regarding sexual and other social interactions. This upward process ofcomplex integrated organization of the "inner life" and the external action and presentation of selfreaches its fullest expression in the human form. Along with upright posture and its freeing ofthe hands as tools of "gnostic touching," comes a reordering of the senses and a highly flexible, furless canvas of selfpresentation we call the face (Kass 1985, 287). Upwards through mammalian evolution there is a progressive refinement of the structures of the face that facilitate active and increasingly subtle communication and penetration into the life of the other. With more than 30 finely tuned muscles of facial expression and vocal control, human beings are capable of a wide array of communicative 16 Mimesis andEmpathy expressions of emotions and intentions. Paul Ekman claims to have discerned more than 1 8 forms of smiling, each with a distinct meaning (66). With upright posture came a retraction ofthe snout and bilateral stereoscopic vision. Sight replaced smell as the prominent sense. Whereas smell required direct chemical contact, and sound gave formless information, sight gave a knowing and accurate encounter with the form and unity ofwholes. Sight allowed rapid perception ofobjects and actions at distant horizons. The detached beholding of sight allowed a deeper and more accurate apprehension of... (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)

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)

Rates of violence in the American South have long been much greater than in the North. Accounts of duels, feuds, bushwhackings, and lynchings occur prominently in visitors’ accounts, newspaper articles, and autobiography from the 18th Century onward. According to crime statistics these differences persist today. In their book, Culture of Honor, Richard Nisbett and Dov Cohen argue that the South is more violent than the North because Southerners have different, culturally acquired beliefs about personal honor than Northerners. The South was (...) disproportionately settled by Protestant Scotch-Irish, people with an animal herding background, whereas Northern settlers were English, German and Dutch peasant farmers. Most herders live in thinly settled, lawless regions. Since livestock are easy to steal, herders seek reputations for willingness to engage in violent behavior as a deterrent to rustling and other predatory behavior. Of course, bad men come to subscribe to the same code, the better to intimidate their victims. As this arms race proceeds, arguments over trivial acts can rapidly escalate if a man—less often a woman—thinks his honor is at stake, and the resulting “culture of honor” leads to high rates of violence. Nisbett and Cohen support their hypothesis with an impressive range of data including, laboratory data, attitude surveys, field experiments, data on violence, and differences in legal codes. (shrink)

「生命倫理」は研究を不当に妨げている?ヒト由来試料を用いた研究から生じる「倫理的問題」とは何なのか?法学からのアプローチにより、現実的な規制枠組みの確立に向け、基本から問い直す。.

The theme of human biology recurs continually both in feminist and in anti-ferminist literature. Reflection on human biology has seemed to promise answers to the urgent questions of why women everywhere are subordinated and whether and how that subordination can be ended. Invariably, anti-feminists have justified women's subordination in terms of perceived biological differences between the sexes, and feminists have responded to their claims in a variety of ways. In this paper, I want to look critically (...) at the ways in which feminists in the liberal and Marxist traditions have responded to the biologically based challenges of anti-feminism, and to suggest an alternative way of conceptualising the relation between human biology and the social status of women. (shrink)

Human cooperation is held to be an evolutionary puzzle because people voluntarily engage in costly cooperation, and costly punishment of non-cooperators, even among anonymous strangers they will never meet again. The costs of such cooperation cannot be recovered through kin-selection, reciprocal altruism, indirect reciprocity, or costly signaling. A number of recent authors label this behavior ‘strong reciprocity’, and argue that it is: (a) a newly documented aspect of human nature, (b) adaptive, and (c) evolved by group selection. We (...) argue exactly the opposite; that the phenomenon is: (a) not new, (b) maladaptive, and (c) evolved by individual selection. In our perspective, the apparent puzzle disappears to reveal a biological and evolutionary logic to human cooperation. Group selection may play a role in theory, but it is neither necessary nor sufficient to explain human cooperation. Our alternative solution is simpler, makes fewer assumptions, and is more parsimonious with the empirical data. (shrink)

In responding to this debate, Ananth both surveys the existing literature, with special focus on the work of Christopher Boorse, and argues that a naturalistic ...

The past decade has seen a flurry of social scientific research on the use of racial categories in human genetics research. This literature has critically analyzed how U.S. race relations are being shaped by and themselves shaping research on human biological difference and disease. Recent work, however, suggests that the particular configurations of science and ethnoracial politics in the US are not exportable. Instead, research on human biology in other contexts reveals the importance of not just (...) racial categories, but national, ethnic, regional and linguistic classifications of bodies and communities... (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)

This essay explores how the human biological self is socially constructed, and rejects various truisms that define our character. Rather than being stand-alone entities, the human biological self forms what biologists call “superorganisms” and what I call “poly-super-organisms.” Thus, along with prokaryotes , viruses, and other entities, we are combined in an inseparable menagerie of species that is spread across multiple bodies. Biologists claim that only males and females are organisms. As described here, however, human sperm and (...) eggs are equally entitled to that rank. Much about human reproduction is also socially constructed. For example, contrary to scientific wisdom, humans have always reproduced both sexually and asexually. Moreover, human life does not begin between conception and birth, and neither event creates new life. In addition, some cancer cells are organisms; they are contagious entities formed by asexual human reproduction. Finally, while science universally describes humans as being living entities, accumulating evidence makes clear that the life concept is failing. In fact, much that originates from human bodies does not fall under current biological or cultural classifications.How we construct the human biological self has consequences for understanding our health, how we reproduce, and what we are. These social constructions greatly influence our views on abortion, stem-cell research, human cloning, and our post-human future. A more accurate construction of the human biological self will help us better navigate these contentious issues. (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 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)

BackgroundConcurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, (...) and benefit-sharing of biospecimens.MethodsThis qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.ResultsAreas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.ConclusionEducation is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine. (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)

BackgroundEthical and regulatory guidance on the collection and use of human biospecimens for research forms an essential component of national health systems in Sub-Saharan Africa, where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.MethodsAn extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in (...) which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens.ResultsOf the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent, ownership, reuse, storage, and export/import/transfer. Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS.ConclusionsDespite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise. (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)

Mechanistic studies may be defined as ‘an experiment, using an intervention in healthy subjects or patients, to better understand human biology and/or disease’. Such studies provide useful physiological insights into clinical conditions in humans and expand our knowledge of physiology in health and disease. Well-planned mechanistic studies are therefore a vital step in progressing drug discovery in humans. It is important in such studies that the rights and safety of research participants are preserved, while at the same time (...) not allowing lengthy and complex approval procedures to stifle and potentially prohibit this type of research. (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)

In popular lay discourse, objections to human biological enhancement technologies are sometimes expressed in terms of the charge that they are unnatural. This paper critiques the literal claim that seems to be presented here, namely that such technologies are in some ordinary sense ’unnatural' and that it follows from this they are immoral. Such a conceptual ’nature argument' is unsound. However, the paper contends that this does not mean that the charge of unnaturalness should be dismissed out of hand. (...) Rather, the charge of unnaturalness made by a non-philosophically trained public can be construed as expressive of a general attitude of conservative concern about enhancement technologies. Viewed in this way, the charge invites philosophers to take seriously the underlying empirical concerns that underpin these widespread lay reactions. (shrink)

Kant famously identified 'What is man?' as the fundamental question that encompasses the whole of philosophy. Yet surprisingly, there has been no concerted effort amongst Kant scholars to examine Kant's actual philosophy of man. This book, which is inspired by, and part of, the recent movement that focuses on the empirical dimension of Kant's works, is the first sustained attempt to extract from his writings on biology, anthropology and history an account of the human sciences, their underlying unity, (...) their presuppositions as well as their methodology. In exploring his philosophical and epistemological foundation of the human sciences, it reveals an unexpected picture of Kant, a picture of a thinker who is profoundly attentive to the diversity, detail and complexity of the human world. (shrink)