Bauer, Taub, and Parsi's review of an international sample of standards on informed consent, confidentiality, commercialization, and quality of research in tissue banking reveals that no clear national or international consensus exists for these issues. The authors' response to the lack of uniformity in the meaning, scope, and ethical significance of the policies they examined is to call for the creation of uniform ethical guidelines. This raises questions about whether harmonization should consist of voluntary international standards or international (...) regulations that include an official oversight mechanism and sanctions for noncompliance, and about who should participate in the harmonization process. Moreover, the normative assumptions and political dynamics that shape global policymaking need to be addressed. This commentary explores the policy implications and normative questions raised by the idea of international ethical guidelines for the use of biotechnologies and biotechnological resources such as stored samples of human tissue. (shrink)

Based on a general review of international, representative tissue banking policies that were described in the medical, ethics, and legal literature, this paper reviews the range of standards, both conceptually and in existing regulations, relevant to four main factors:(1) commercialization, (2) confidentiality, (3) informed consent, and (4) quality of research. These four factors were selected as reflective of some of the major ethical considerations that arise in the conduct of tissue banking research. The authors emphasize that (...) any policy or ethical guidelines designed to regulate tissue bank research should address all four factors. Whenever this sort of research is conducted between several institutions or several countries, the paper suggests that the relevant entities work collaboratively to harmonize their standards. (shrink)

This paper reports on a recent symposium seminar series entitled ‘Governing genetic databases – collection, storage and use’ hosted by the Ethox Centre at the University of Oxford. It outlines the inadequacy of the current UK framework for governing genetic databases and biobanks and some of the implications of this. It then briefly describes and reflects on each of the five symposium papers.

Researchers are working to derive sperm from banked testicular tissue taken from pre-pubertal boys who face therapies or injuries that destroy sperm production. Success in deriving sperm from this tissue will help to preserve the option for these boys to have genetically related children later in life. For the twin moral reasons of preserving access and equity in regard to having such children, clinicians and researchers are justified in offering the option to the parents of all affected boys. (...) However, some parents may wish to decline the option to bank tissue from their boys because the technique may seem too unfamiliar or unusual, but over time people may become more comfortable with the technique as they have done with other novel assisted reproductive treatments. Other parents may wish to decline the option because of moral or religious reasons. A prominent natural law theory holds, for example, that the ARTs that would be involved in using sperm derived from banked tissue to produce a child are morally objectionable. Some parents might not want to bank tissue in order to shield their son from using ARTs they see as objectionable. Clinicians and researchers should respect parents who wish to decline banking tissue, but parents should ordinarily embrace choices that protect the possible interests their sons may have as adult men, including the wish to have genetically related children. (shrink)

Bio‐banking in research elicits numerous ethical issues related to informed consent, privacy and identifiability of samples, return of results, incidental findings, international data exchange, ownership of samples, and benefit sharing etc. In low and middle income (LMICs) countries the challenge of inadequate guidelines and regulations on the proper conduct of research compounds the ethical issues. In addition, failure to pay attention to underlying indigenous worldviews that ought to inform issues, practices and policies in Africa may exacerbate the situation. In (...) this paper we discuss how the African context presents unique and outstanding cultural thought systems regarding the human body and biological materials that can be put into perspective in bio‐bank research. We give the example of African ontology of nature presented by John Samwel Mbiti as foundational in adding value to the discourse about enhancing relevance of bio‐bank research in the African context. We underline that cultural rites of passage performed on the human body in majority of communities in Africa elicit quintessential perspective on beliefs about handling of human body and human biological tissues. We conclude that acknowledgement and inclusion of African indigenous worldviews regarding the human body is essential in influencing best practices in biobank research in Africa. (shrink)

The use of human tissue raises ethical issues of great concern to health care professionals, biomedical researchers, ethics committees, tissue banks and policy makers because of the heightened importance given to informed consent and patient autonomy. The debate has been intensified by high profile scandals such as the “baby hearts” debacle and revelations about the retention of human brains in neuropathology laboratories worldwide. Respect for patient’s rights seems, however, to impede research and development of clinical knowledge in contemporary (...) health care. The Common clinical endeavour argument and a Presumption for beneficial use argument suggest that the use of tissues for research and teaching in contemporary health care can respect patients and their values in multicultural communities where there are provisions for oversight and for opting not to contribute, both of which should respect the diverse views of different ethnic or cultural groups. (shrink)

More impetus needs to be placed on cord blood donationIn July, the Royal College of Obstetricians and Gynaecologists released a report on the uses and the potential perils of umbilical cord blood collection.1 This report has had the positive effect of drawing attention to what has hitherto been an under addressed topic of medical research and ethics. However, the focus and recommendations of the report say little about one important aspect of cord blood usage—research. Such an omission, although understandable from (...) an organisation primarily concerned with maternal and neonatal health, may nevertheless have implications for the broader applicability of the report’s recommendations, outside the immediate arena of patient care.The RCOG report deals with various aspects of cord blood collection and use—the harvesting procedure itself; cord blood transplantation treatment, either as an autologous cell transplant or as a donation for community use; and whether cord blood banking for personal use should be permitted or encouraged as a privately funded commercial enterprise. It also makes note of some of the legal and ethical issues surrounding cord blood and tissue banking more generally, concerns that will be of increasing importance as more biobanks are established worldwide. A large part of the report deals with concerns on neonatal and maternal safety and whether cord blood collection may pose a risk. These concerns may be valid and certainly, the health of mothers and children should not be compromised. The guidance provided by this report in relation to the collection procedure will undoubtedly assist maternity health professionals in this area.The main relevance of the RCOG …. (shrink)

Researchers are developing a fertility preservation technique?testicular tissue cryopreservation (TTCP)?for prepubescent boys who may become infertile as a result of their cancer treatment. Although this technique is still in development, some researchers are calling for its widespread use. They argue that if boys do not bank their tissue now, they will be unable to benefit from any therapies that might be developed in the future. There are, however, risks involved with increasing access to an investigational procedure. This article (...) examines four methods of expanding access to TTCP: (1) expansion of institutional review board (IRB)-approved research trials; (2) offering TTCP as an innovative procedure in hospitals; (3) offering TTCP as a standard practice in hospitals; and (4) commercialization of TTCP. The ethical and practical implications of each are evaluated through a comparison with umbilical cord blood banking (UCBB), a technology that has achieved widespread use based on similar claims of future benefit. (shrink)

The Human Tissue Act 2004 in the United Kingdom clearly represents not a principled approach but instead a compromise, a pragmatic approach which balances several different ethical considerations against each other. In regards to the use of tissue in research it has left much of the more difficult decisions to be made by research ethics committees on a case by case basis. In particular it is now the role of research ethics committees to decide whether research can be (...) carried out using human tissue where no consent was given for the use of this tissue in research. Likewise research ethics committees are now charged with approving of human tissue banks which then need no further ethical approval to carry out research solely using tissue from that bank. There has however been little guidance in regards to the decisions these committees must make. This paper aims to delineate these decisions and offer some philosophical guidance to research ethics committees in making these decisions. (shrink)

As the debate about research on foetal tissue transplantation progressed, medical scientists learned more about the procedure and its potential for helping persons with degenerative brain disorders such as Parkinson's disease. Increased scientific knowledge significantly influenced the political process, yet it did not by any means resolve the debate. Rather, increased medical evidence served as a lens which focused discourse on particular issues related to foetal research, such as the details of obtaining informed consent, as well as technical matters (...) related to tissue transplantation, for example, that the creation of a tissue bank was unreasonable, and that foetuses of certain ages were required for the procedure. This increased focus changed the character of the debate on foetal tissue transplantation research, and convinced some law-makers that they should encourage financial support for the research despite their anti-abortion political views.The heart of the stalemate on transplantation research lay in rigid attachment to particular arguments, which in turn resulted in the disunity of the participants; this was compounded by the lack of persuasive scientific evidence that foetal tissue transplantation could significantly benefit those with Parkinson's disease. Privately supported clinical studies answered several important clinical questions while the ban on federal support remained in effect, however, and increased scientific knowledge was soon followed by an increasingly clear analysis of the relevant issues. By the time federal support for the research was permitted, the arguments of all of the interest groups had been altered by the findings of privately supported studies.As research continues under the auspices of a somewhat more permissive administration, these refined arguments and attitudes may continue to contribute to a stronger and more clearly defined public policy. (shrink)

An increasingly unbridgeable gap exists between the supply and demand of transplantable organs. Human embryonic stem cell technology could solve the organ shortage problem by restoring diseased or damaged tissue across a range of common conditions. However, such technology faces several largely ignored immunological challenges in delivering cell lines to large populations. We address some of these challenges and argue in favor of encouraging contribution or intentional creation of embryos from which widely immunocompatible stem cell lines could be derived. (...) Further, we argue that current immunological constraints in tissue transplantation demand the creation of a global stem cell bank, which may hold particular promise for minority populations and other sub-groups currently marginalized from organ procurement and allocation systems. Finally, we conclude by offering a number of practical and ethically oriented recommendations for constructing a human embryonic stem cell bank that we hope will help solve the ongoing organ shortage problem. (shrink)

There is a widely acknowledged shortage of and an increasing demand for transplantable human organs and tissues (e.g., kidney, heart, lung, liver, cornea) in developed and developing countries around the world. In response to this need, Lott and Savulescu (2007) propose the creation of a human embryonic stem (hESC) bank to facilitate the equitable and efficient dissemination of human leukocyte anti- gen (HLA) matched tissues and organs to patients in need of replacement. Although not an unreasonable proposal, the authors go (...) on to make a much stronger claim. They argue that hESCs are such important tools for addressing the massive unmet global need for organs that it is ethically justified to require mandatory banking of spare embryos, and they argue for the use of financial (or other) inducements to procure embryos for the derivation of hESCs. (shrink)

An increasingly unbridgeable gap exists between the supply and demand of transplantable organs. Human embryonic stem cell technology could solve the organ shortage problem by restoring diseased or damaged tissue across a range of common conditions. However, such technology faces several largely ignored immunological challenges in delivering cell lines to large populations. We address some of these challenges and argue in favor of encouraging contribution or intentional creation of embryos from which widely immunocompatible stem cell lines could be derived. (...) Further, we argue that current immunological constraints in tissue transplantation demand the creation of a global stem cell bank, which may hold particular promise for minority populations and other sub-groups currently marginalized from organ procurement and allocation systems. Finally, we conclude by offering a number of practical and ethically oriented recommendations for constructing a human embryonic stem cell bank that we hope will help solve the ongoing organ shortage problem. (shrink)

Although the term commodification is sometimes criticised as imprecise or overused, in fact it has a complex philosophical ancestry and can never be used too much, because the phenomena that it describes are still gaining ground. The issues that commodification raises in relation to reproductive technologies include whether it is wrong to commodify human tissues generally and gametes particularly, and whether the person as subject and the person as object can be distinguished in modern biomedicine. This chapter examines three areas (...) in which commodification is a serious concern for important reproductive technologies: the sale of eggs for IVF and research, the banking of umbilical cord blood, and the use of gestational surrogates both domestically and internationally. Sales of human eggs for IVF or research are frequently disguised as “gifts”, which conceals the very real bodily risks and harms associated with ovarian hyperstimulation and egg harvesting undergone by egg “donors.” Umbilical cord banking is a fast-growing industry, with donated cord blood trading globally at very high prices; women who consent to banking of cord blood ostensibly for the potential future benefit of their child may not be informed of the likelihood that it will be traded in commercial markets or that the method used for harvesting may increase risks of jaundice in their babies. Commercial surrogacy also exploits altruism but in addition involves wrongful sale of babies, particularly in the international context. In each example, the commodification of women’s reproductive labour is masked by the manner in which ‘the lady vanishes’ under a gift model, ignoring the true economic value of their labour. (shrink)

BackgroundUmbilical cord banks are a central component, as umbilical cord tissue providers, in both medical treatment and scientific research with stem cells. But, whereas the creation of umbilical cord banks is seen as successful practice, it is perceived as a risky style of play by others. This article examines and discusses the ethical, medical and legal considerations that arise from the operation of umbilical cord banks in Mexico.DiscussionA number of experts have stated that the use of umbilical cord goes (...) beyond the mere utilization of human tissues for the purpose of treatment. This tissue is also used in research studies: genetic studies, studies to evaluate the effectiveness of new antibiotics, studies to identify new proteins, etc. Meanwhile, others claim that the law and other norms for the functioning of cord banks are not consistent and are poorly defined. Some of these critics point out that the confidentiality of donor information is handled differently in different places. The fact that private cord banks offer their services as "biological insurance" in order to obtain informed consent by promising the parents that the tissue that will be stored insures the health of their child in the future raises the issue of whether the consent is freely given or given under coercion. Another consideration that must be made in relation to privately owned cord banks has to do with the ownership of the stored umbilical cord.SummaryConflicts between moral principles and economic interests (non-moral principles) cause dilemmas in the clinical practice of umbilical cord blood storage and use especially in privately owned banks. This article presents a reflection and some of the guidelines that must be followed by umbilical cord banks in order to deal with these conflicts. This reflection is based on the fundamental notions of ethics and public health and seeks to be a contribution towards the improvement of umbilical cord banks' performance. (shrink)

This paper explores the perspectives of women who have agreed that their umbilical cord blood may be collected for a public ‘cord blood bank’, for use in transplant medicine or research. Drawing on interview data from 27 mothers who agreed to the collection and use of their umbilical cord blood, these choices and the informed consent process are explored. It is shown that the needs of sick children requiring transplants are prominent in narrative accounts of cord blood banking, together (...) with high expectations for future applications of stem cells. Given this dynamic, a concern arises that the complex and multiple uses of tissues and related data might be oversimplified in the consent process. In conclusion, the positive finding of a commitment to mutuality in cord blood banking among these women is underlined, and its implications for the wider debate on cord blood banking are discussed. (shrink)

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research as the field debated the issues of consent, moral status, use (...) of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research (members of the IRBs, the Geron Ethicist Advisory Board, and the (...) National Bioethics Advisory Commission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

Background: The banking of biological samples raises a number of ethical issues in relation to the storage,export and re-use of samples. Whilst there is a growing body of literature exploringparticipant perspectives in North America and Europe, hardly any studies have been reportedin Africa. This is problematic in particular in light of the growing amount of research takingplace in Africa, and with the rise of biobanking practices also on the African continent. Inorder to investigate the perspectives of African research participants, (...) we conducted a studywith research participants in a TB study in the Western Cape, South Africa. Methods: Semi-structured interviews were conducted using an interview guide which drew on the mostprominent themes expressed in current literature on sample storage, re-use and exportation.Interviews were conducted in Afrikaans and subsequently translated into English by the sameinterviewer. Interviews were transcribed verbatim and analysed qualitatively. Results: The results of our study indicate that the majority of participants were supportive of givingone-time consent to the storage and re-use of their samples. The concept of research being fora "good cause" was a central prerequisite. Additionally, a significant minority requested thatthey be re-contacted if a future use was not stipulated on the original consent. There was alsoconsiderable variation in how participants understood the concept of a 'good cause', withparticipants describing three distinct categories of research, of which two were generallythought to constitute 'good cause' research. Research that was for-profit was considered tofall outside the spectrum of 'good cause' research. Participants displayed confidence in theabilities of the researchers to make future decisions regarding sample use, but seemedunaware of the role of ethics committees in either this process or more generally. Conclusions: Participants expressed a wide and complex range of views about issues of sample storage andre-use, and they showed a great deal of trust in researchers. Participants' willingness to havetheir samples stored and re-used is consistent with findings from existing studies. However,in contrast to existing literature, participants were generally not in favour of for-profitresearch. Further research needs to be done to explore these ideas in other communities, bothin South Africa and other countries. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religion and the Body in Medical ResearchCourtney S. Campbell (bio)AbstractReligious discussion of human organs and tissues has concentrated largely on donation for therapeutic purposes. The retrieval and use of human tissue samples in diagnostic, research, and education contexts have, by contrast, received very little direct theological attention. Initially undertaken at the behest of the National Bioethics Advisory Commission, this essay seeks to explore the theological and religious questions (...) embedded in nontherapeutic use of human tissue. It finds that the “donation paradigm” typically invoked in religious discourse to justify uses of the body for therapeutic reasons is inadequate in the context of nontherapeutic research, while the “resource paradigm” implicit in scientific discourse presumes a reductionist account of the body that runs contrary to important religious values about embodiment. The essay proposes a “contribution paradigm” that provides a religious perspective within which research on human tissue can be both justified and limited.The retrieval and use of human tissue samples for diagnostic, therapeutic, research, and educational purposes represent further developments in scientific study of the human body as a source of medical information. Following the completion of its examination of the ethical and policy issues pertaining to human cloning in the spring of 1997, the National Bioethics Advisory Commission (NBAC) returned to the set of questions for which it had been originally constituted, including ethical issues that arise in human subjects research. One issue that proved controversial for the human genetics subcommittee of NBAC was the scientific, philosophical, and legal status of tissue and other body parts (usually surgical specimens) that had been retrieved from patients (not research subjects) who had given general consent to the use of their body materials for research and educational purposes. The subcommittee addressed questions about the adequacy of general versus specific [End Page 275] consent, the scientific merits of identifiable versus anonymous samples and claims about patient confidentiality, and the justification for patient refusals and requests that the materials be returned to the patient or discarded rather than made available for scientific research. In an effort to better understand the ramifications of research on human tissue, the subcommittee commissioned several background papers that examined these questions from ethical, legal, research, and religious perspectives. What follows is a modified version of the report on religious considerations originally presented to the genetics subcommittee of NBAC.The central question examined in this article is whether tissue banking for purposes of research presents distinctive theological issues or prompts objections from religious communities or scholars. Religious discussion of human organs and tissues has focused largely on donation for therapeutic purposes (what I describe as the “donation paradigm”); hence, there is very little direct consideration of nontherapeutic uses of such tissue. It is possible, however, to describe implications and suggest inferences by considering (1) religious attitudes to the human body and to organs, tissues, and cells removed from the body, and (2) religious discussions of modes of transfer of body parts, such as donations, offerings, sales, and abandonment. By and large, this discussion will reflect themes that emerge from the central Western religious traditions, with some attention given to Eastern and Native perspectives.The Body: Religious Holism, Scientific Reductionism, Private PropertyThe human body as an organic totality has long been the subject of theological reflection and a symbol for religious communities. However, much less attention has been devoted to the religious status of organs, tissues, cells, and DNA. The reflection of religious scholars and communities on the status of body parts has been prompted by the necessity to confront practical questions in personal and public health and in communal life, such as justifications for surgery, autopsies, organ donation, or burial. Scientific and research interest in parts of the body can sometimes conflict with religious values about bodily integrity. Indeed, E. Richard Gold cites the “disparate claims of scientific investigation and religious belief on the body” as the exemplary case of incommensurate values regarding the body. According to Gold (1996, p. 149), “The body, from a scientific viewpoint, is a source of knowledge of physical development, aging, and disease. From a religious perspective, the body is understood [End Page 276] as a sacred object, being created in the image... (shrink)

Umbilical cord blood banking is one of many biomedical innovations that confront pregnant women with new choices about what they should do to secure their own and their child’s best interests. Many mothers can now choose to donate their baby’s umbilical cord blood (UCB) to a public cord blood bank or pay to store it in a private cord blood bank. Donation to a public bank is widely regarded as an altruistic act of civic responsibility. Paying to store UCB (...) may be regarded as a “unique opportunity” to provide “insurance” for the child’s future. This paper reports findings from a survey of Australian women that investigated the decision to either donate or store UCB. We conclude that mothers are faced with competing discourses that force them to choose between being a “good mother” and fulfilling their role as a “good citizen.” We discuss this finding with reference to the concept of value pluralism. (shrink)

Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported (...) by facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests. (shrink)

Re-consent in research, the asking for a new consent if there is a change in protocol or to confirm the expectations of participants in case of change, is an under-explored issue. There is little clarity as to what changes should trigger re-consent and what impact a re-consent exercise has on participants and the research project. This article examines applicable policy statements and literature for the prevailing arguments for and against re-consent in relation to longitudinal cohort studies, tissue banks and (...) biobanks. Examples of re-consent exercises are presented, triggers and non-triggers for re-consent discussed and the conflicting attitudes of commentators, participants and researchers highlighted. We acknowledge current practice and argue for a greater emphasis on ‘responsive autonomy,’ that goes beyond a one-time consent and encourages greater communication between the parties involved. A balance is needed between respecting participants' wishes on how they want their data and samples used and enabling effective research to proceed. (shrink)

In the biomedical field, calls for the generation of new regulations or for the amendment of existing regulations often follow the emergence of apparently new research practices (such as embryonic stem cell research), clinical practices (such as facial transplantation) and entities (such as Avian Influenza/’Bird Flu’). Calls for regulatory responses also arise as a result of controversies which bring to light longstanding practices, such as the call for increased regulation of human tissue collections that followed the discovery of unauthorised (...) post-mortem organ retention. Whilst it seems obvious that new regulations should only be generated if existing regulations are inadequate (a practice referred to in this paper as ‘regulatory syncretism’), this does not always occur in practice. This paper examines the conceptual steps involved in generating regulatory responses to emerging phenomena. Two decision points are identified. First, a stance is taken as to whether the emerging phenomenon raises unique ethical or legal issues (exceptionalism versus non-exceptionalism). Second, the decision is made as to whether new regulation should be generated only for truly unique phenomena (syncretism versus asyncretism). It is argued here that it is important to make a careful assessment of novelty, followed by a reflective and deliberate choice of regulatory syncretism or asyncretism, since each type of regulatory response has advantages which need to be harnessed and disadvantages which need to be managed—something that can only occur if regulators are attentive to the choices they are making. (shrink)

This article looks at some of the chance discoveries and elegant ideas that were borne out through the availability of archived tissue samples. It then discusses some of the planned changes to the method and purpose of tissue storage and collection. The changes are in the form of new types of tissue bank, or biobank as they are conceived. These banks are part of a trend to move towards a preventative approach to public health rather than the (...) current costly interventionist model. This approach is not without its problems and it is these that threaten the unfettered continuation of the tissue archive. The sophistication of new research tools can uncover information about individuals that may have a detrimental effect on their well-being in various ways. The article analyses these possibilities in the context of how health care might develop. (shrink)

Can researchers, interested in novel ways to assess HIV seroprevalence among populations which are otherwise hidden, collect condoms that have been discarded on the ground in a public sex environment and test them for HIV? Researchers, who use other types of abandoned samples, such as discarded syringes, hair or saliva samples, or excess biological samples, confront similar issues. This review evaluates whether such abandoned tissues can be studied based on U.S. Code of Federal Regulations and literature on related issues including: (...) research involving banked tissues, blinded seroprevalence studies, and property claims that individuals might make on the samples.It also addresses broader questions of potential for stigma and risk to individuals and communities. The article concludes that the research should be permitted legally because either it does not involve human subjects, or it satisfies the requirements for waiver of consent; and that the research should also be permitted because the ethical principal of avoiding harm to individuals is fully satisfied based on a careful reading of the lessons of the tissue bank, biological property rights, and blinded seroprevalence study debates, as well as a consideration of other potential harms that might be involved. (shrink)

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone (...) in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework. (shrink)

Increasingly the body is a possession that does not belong to us. It is bought and sold, bartered and stolen, marketed wholesale or in parts. The professions - especially reproductive medicine, transplant surgery, and bioethics but also journalism and other cultural specialists - have been pliant partners in this accelerating commodification of live and dead human organisms. Under the guise of healing or research, they have contributed to a new 'ethic of parts' for which the divisible body is severed from (...) the self, torn from the social fabric, and thrust into commercial transactions -- as organs, secretions, reproductive capacities, and tissues -- responding to the dictates of an incipiently global marketplace. Breaking with established approaches which prioritize the body as 'text', the chapters in this book examine not only images of the body-turned-merchandise but actually existing organisms considered at once as material entities, semi-magical tokens, symbolic vectors and founts of lived experience. The topics covered range from the cultural disposal and media treatment of corpses, the biopolitics of cells, sperm banks and eugenics, to the international trafficking of kidneys, the development of 'transplant tourism', to the idioms of corporeal exploitation among prizefighters as a limiting case of fleshly commodity. This insightful and arresting volume combines perspectives from anthropology, law, medicine, and sociology to offer compelling analyses of the concrete ways in which the body is made into a commodity and how its marketization in turn remakes social relations and cultural meanings. (shrink)

Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of (...) factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. (shrink)

This study assessed the knowledge and perception of human biological materials (HBM) and biorepositories among three study groups in South Korea. The relationship between the knowledge and the perception among different groups was also examined by using factor and regression analyses. In a self-reporting survey of 440 respondents, the expert group was found more likely to be knowledgeable and positively perceived than the others. Four factors emerged: Sale and Consent, Flexible Use, Self-Confidence, and Korean Bioethics and Biosafety Action restriction perception. (...) The results indicate that those who are well aware of the existence of biobanks were more positively inclined to receive the Sale and Consent perception. As a result of the need for high quality HBMs and the use of appropriate sampling procedures for every aspect of the collection and use process, the biorepository community should pay attention to ethical, legal, and policy issues. (shrink)

This study assessed the knowledge and perception of human biological materials (HBM) and biorepositories among three study groups in South Korea. The relationship between the knowledge and the perception among different groups was also examined by using factor and regression analyses. In a self‐reporting survey of 440 respondents, the expert group was found more likely to be knowledgeable and positively perceived than the others. Four factors emerged: Sale and Consent, Flexible Use, Self‐Confidence, and Korean Bioethics and Biosafety Action restriction perception. (...) The results indicate that those who are well aware of the existence of biobanks were more positively inclined to receive the Sale and Consent perception. As a result of the need for high quality HBMs and the use of appropriate sampling procedures for every aspect of the collection and use process, the biorepository community should pay attention to ethical, legal, and policy issues. (shrink)

This study assessed the knowledge and perception of human biological materials (HBM) and biorepositories among three study groups in South Korea. The relationship between the knowledge and the perception among different groups was also examined by using factor and regression analyses. In a self‐reporting survey of 440 respondents, the expert group was found more likely to be knowledgeable and positively perceived than the others. Four factors emerged: Sale and Consent, Flexible Use, Self‐Confidence, and Korean Bioethics and Biosafety Action restriction perception. (...) The results indicate that those who are well aware of the existence of biobanks were more positively inclined to receive the Sale and Consent perception. As a result of the need for high quality HBMs and the use of appropriate sampling procedures for every aspect of the collection and use process, the biorepository community should pay attention to ethical, legal, and policy issues. (shrink)

'An alarming and illuminating book. The story of how we have allowed private corporations to patent genes, to stockpile human tissue, and in short to make profits out of what many people feel ought to be common goods is a shocking one. No one with any interest at all in medicine and society and how they interact should miss this book, and it should be required reading for every medical student,'--Philip Pullman.

Stem cell banks curating and distributing human embryonic stem cells have been established in a number of countries and by a number of private institutions. This paper identifies and critically discusses a number of arguments that are used to justify the importance of such banks in policy discussions relating to their establishment or maintenance. It is argued (1) that ‘ethical arguments’ are often more important in the establishment phase and ‘efficiency arguments’ more important in the maintenance phase, and (2) that (...) arguments relating to the interests of embryo and gamete donors are curiously absent from the particular stem cell banking policy discourse. This to some extent artificially isolates this discourse from the broader discussions about the flows of reproductive materials and tissues in modern society, and such isolation may lead to the interests of important actors being ignored in the policy making process. (shrink)

This paper provides a legal overview of key issues associated with donation of genetic samples and information from a donor perspective. In particular, it addresses the property status of samples as well as issues in respect of consent, privacy, commercialisation and benefit sharing. The paper highlights the need for appropriate protection and safeguards for individuals, but also, importantly, for understanding what donors actually think and want in terms of genetic research and the use of their samples and information. The paper (...) seeks to emphasise the importance of transparency and accountability in the conduct of research in order to maximise donor participation and confidence and public trust in general. (shrink)

Next SectionPreimplantation tissue typing has been proposed as a method for creating a tissue matched child that can serve as a haematopoietic stem cell donor to save its sick sibling in need of a stem cell transplant. Despite recent promising results, many people have expressed their disapproval of this method. This paper addresses the main concerns of these critics: the risk of preimplantation genetic diagnosis (PGD) for the child to be born; the intention to have a donor child; (...) the limits that should be placed on what may be done to the donor child, and whether the intended recipient can be someone other than a sibling. The author will show that these concerns do not constitute a sufficient ground to forbid people to use this technique to save not only a sibling, but also any other loved one’s life. Finally, the author briefly deals with two alternative scenarios: the creation of a human leukocyte antigen (HLA) matched child as an insurance policy, and the banking of HLA matched embryos. (shrink)

The proliferation of for-profit enterprises offering stem cell storage services for personal use illustrates one of the ways health is increasingly governed through uncertainty and speculative notions of risk. Without any firm guarantee of therapeutic utility, commercial stem cell banks offer to store a range of bodily tissues, signalling the further transformation of the living body into an accumulation strategy within biotechnology capitalism’s ‘tissue economies’. This article makes two related claims: first, it suggests that specifically gendered forms of identification (...) with the leading edge of the bioeconomy are embedded in the speculative practices of commercial stem cell banking and are particularly visible in the recent creation of a banking service for endometrial tissue marketed directly to women. Second, the article offers a novel analytic through which to explore the commercial banking of one’s own bodily tissues (or ‘autologous’ banking) through Marx’s discussion of money hoarding. The aim of the article is to thus further the conceptual claims linking emergent forms of economic and biomedical subjectivity to transformations in biotechnology capital. (shrink)

The regulation of stem cell research is an issue that has drawn much comment, criticism and even judicial arbitration in recent years. An emerging issue, addressed in this article, is how the fruits of that research-stem cell medicine-are likely to be regulated en route from lab to market. Taking account of the ethical, legal, social and safety issues raised by stem cell medicine and the goals of governance, the article explains the relevant regulatory instruments (e.g. the draft UK Stem Cell (...) Bank Code, the EU Directive on Human Tissue, the EU Directives on medical products and devices, and the Human Tissue Act 2004) and critically examines the framework they provide. (shrink)

There has been a great deal of discussion about the ethical implications of donating sperm and of the ways in which donated tissue is presented, selected, and sold for use in assisted reproduction. Debates have emerged within the academic sphere, from donor offspring and recipients, and in broader popular culture, including questions about the commodification of human tissue and the eugenic potential of selecting donors from particular demographic categories. However, the voices of donors themselves on this subject have (...) been largely silent. This paper draws on data from qualitative interviews with men who donated at a major Danish sperm bank between 2012 and 2013. It argues that many of them are indeed thinking through these complex issues. Donors’ approaches to ethical issues fell into two broad ‘types’: a pragmatic, individualistic approach which focused on more immediate personal consequences, and an ethically-driven approach in which donors considered the impact of donation on offspring and on a wider societal level. (shrink)

Human genetic research databases cast a new light on the controversial issue of which uses of the human body are morally permissible. More specifically, banking human tissue raises issues relating to the ownership of the samples that the participants have donated, to the ownership of the data that are derived through processing the donated samples, and to the management arrangements that better balance the interest of genetic research with the protection of participants' rights. Winickoff & Winickoff suggest that (...) the charitable-trust model is a superior legal arrangement for biobanking compared with private biobanking. This paper critically assesses Winickoff & Winickoff's claim by highlighting some areas of implementation where such a model could be problematic. The charitable trust is certainly an advantageous arrangement because (1) it favors the separation between control and use of the samples, (2) it provides a procedural mechanism that facilitates the participation donor groups in the biobank management and (3) it mediates the different interests that are affected. On the other hand, the charitable-trust model leaves unresolved several issues--among them the ownership of the sample, the right of withdrawal, access and funding mechanism. I conclude that further theoretical and empirical analysis is required in the area. (shrink)

The calamitous warnings of climate science have been latched onto by a growing roster of biotech start-up companies who propose to invent lab-generated meat alternatives to the ecologically disastrous livestock industry. They use solutionist hype to promote ‘sustainable’, ‘eco-friendly’, ‘cruelty-free’, ‘clean meat’. This moralized marketing, however, masks a continued reliance on animal agriculture. The fact remains that mammalian cells and tissues are grown in vitro using foetal calf serum, a blood-derived nutrient. Is it really possible to grow meat without (...) class='Hi'>banking on the bodies of nonhuman others? Might there be more tasteful material? In Bioart Kitchen: Art, Feminism and Technoscience, Lindsay Kelley asks, ‘[h]‌ow do technologies taste?’ This article proposes one answer to her prompt, centred on a technofeminist contextualization of the research-creation project, Mooncalf (2019–present). Mooncalf is a series of wet lab experiments and artistic outputs that showcase the potential viability of human menstrual serum for culturing mammalian tissue. These experiments present a direct provocation that problematizes the cellular agriculture industry as it pertains to the production of ‘clean meat’ and instead works towards a proof-of-concept ‘unclean’ meat prototype. Mooncalf is a symbolic precursor or speculative promise meant to facilitate a ‘cultural taste’ for feminist biotechnologies. (shrink)

According to estimates more than 400 biobanks currently operate across Europe. The term ‘biobank’ indicates a specific field of genetic study that has quietly developed without any significant critical reflection across European societies. Although scientists now routinely use this phrase, the wider public is still confused when the word ‘bank’ is being connected with the collection of their biological samples. There is a striking lack of knowledge of this field. In the recent Eurobarometer survey it was demonstrated that even in (...) 2010 two-thirds of the respondents had never even heard about biobanks. The term gives the impression that a systematic collection of biological samples can constitute a ‘bank’ of considerable financial worth, where the biological samples, which are insignificant in isolation but are valuable as a collection, can be preserved, analysed and put to ‘profitable use’. By studying the practices of the numerous already existing biobanks, the authors address the following questions: to what extent does the term ‘biobank’ reflect the normative concept of using biological samples for the purposes of biomedical research? Furthermore, is it in harmony with the so far agreed legal–ethical consensus in Europe or does it deliberately pull science to the territory of a new, ambiguous commercial field? In other words, do biobanks constitute a medico-legal fiction or are they substantively different from other biomedical research protocols on human tissues? (shrink)

Anouck Alary | : La transformation du sang placentaire en une précieuse source de cellules souches a donné naissance à partir des années 1990 à une industrie globale de conservation de sang de cordon ombilical faisant désormais concurrence à un large réseau de banques publiques de sang de cordon. Cet article explore les soubassements socioculturels liés à l’émergence de cette industrie et tente d’élucider les enjeux éthiques et politiques qu’elle pose. Si les banques publiques de sang de cordon sont porteuses (...) des valeurs d’altruisme et de solidarité nationale traditionnellement liées au modèle redistributif d’échange de sang et d’organes né après la Seconde Guerre mondiale, les banques privées renvoient, elles, à des formes de solidarité bien différentes. C’est effectivement sous couvert de la solidarité familiale et de la responsabilité morale des mères de protéger leurs enfants qu’elles définissent la conservation privée comme une forme d’ « assurance biologique » contre les risques à la santé de l’enfant. En permettant aux mères d’investir leurs tissus corporels à la fois dans le futur incertain de leurs enfants et dans des thérapies cellulaires expérimentales, ces banques promeuvent un nouveau modèle de participation du/de la patient.e à la coconstitution de futures innovations thérapeutiques. Nous inscrivons ce modèle de participation dans les reconfigurations contemporaines du biopolitique que le sociologue britannique Nikolas Rose voit s’incarner dans l’émergence d’une nouvelle forme de biocitoyenneté. L’article critique finalement ces services personnalisés en soulignant qu’ils ont le potentiel d’opérer de nouvelles formes de coercition sur les mères, dans un contexte sociopolitique caractérisé par une responsabilisation accrue des individus au regard de la « bonne gestion » de leurs risques à la santé. Ces services sont aussi jugés problématiques sur le plan éthique, au vu de leur incohérence avec un principe de justice distributive défendant l’accès égal pour chaque citoyen.ne à des soins de santé de base. | : Since the 1990s, the transformation of cord blood into a precious source of stem cells has given rise to a global cord blood bank industry, which is now competing with a large network of public cord blood banks. This article explores the sociocultural context surrounding the emergence of this industry and aims at elucidating the ethical and political concerns that this industry raises. Whereas public cord blood banks are purveyors of values such as altruism and national solidarity traditionally linked to the redistributive model of human blood and organ donation that emerged after World War Two, private banks engage very different forms of solidarity. It is indeed under the guise of family solidarity and mothers’ moral responsibility to do their best to protect their children that they come to define private preservation as a form of “biological insurance” against potential risks to their children’s health. By allowing mothers to invest their bodily tissues simultaneously in their children’s uncertain future and in experimental cell therapies, these banks promote a new model of patient participation in the development of future therapeutic innovations. This article analyzes this model as embedded in the contemporary reconfiguration of biopolitics that sociologist Nikolas Rose envisions as constituting a new form of biocitizenship. The paper finally casts a critical eye on these personalized services, in particular because of the new forms of social coercion on mothers that are brought about in a social and political context characterized by an increasing moral accountability of individuals with regard to the “good management” of their own health risks. These services also appear ethically problematic in relation to political demands of distributive justice—e.g., the ideal of equal access to basic health care for every citizen. (shrink)

Recent advances in medical technology, notwithstanding their potential blessings, have engendered a number of new ethical problems. Questions raised by rapidly improving techniques for the transplantation of human organs and body tissues have become especially urgent, The article tries to clarify and evaluate the main arguments advanced for and against different arrangements in this area. The first part concentrates on the problem of acquisition. The ethical status of eight ways of obtaining human body parts is investigated. The cases are derived (...) from combinations of three criteria: whether the donor consents or not; whether or not he/she is alive or dead at the time of extraction; and whether or not donors are compensated. In the second part, the problem of adjudication is treated. Three possible arrangements are examined: market, organ bank, and club. (shrink)

Despite decades of research, remaining safety concerns regarding disease transmission, heterotopic tissue formation, and tumorigenicity have kept stem cell‐based therapies largely outside the standard‐of‐care for musculoskeletal medicine. Recent insights into trophic and immune regulatory activities of mesenchymal stem cells (MSCs), although incomplete, have stimulated a plethora of new clinical trials for indications far beyond simply supplying progenitors to replenish or re‐build lost/damaged tissues. Cell banks are being established and cell‐based products are in active clinical trials. Moreover, significant advances have (...) also been made in the field of pluripotent stem cells, in particular the recent development of induced pluripotent stem cells. Their indefinite proliferation potential promises to overcome the limited supply of tissue‐specific cells and adult stem cells. However, substantial hurdles related to their safety must be overcome for these cells to be clinically applicable. (shrink)