In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Scientists engaged in global health research are increasingly faced with barriers to access and use of human tissues from the developing world communities where much of their research is targeted. In part, the problem can be traced to distrust of researchers from affluent countries, given the history of 'scientific-imperialism' and 'biocolonialism' reflected in past well publicized cases of exploitation of research participants from low to middle income countries. To a considerable extent, the failure to adequately engage host communities, the (...) opacity of informed consent, and the lack of fair benefit-sharing have played a significant role in eroding trust. These ethical considerations are central to biomedical research in low to middle income countries and failure to attend to them can inadvertently contribute to exploitation and erode trust. A 'tissue trust' may be a plausible means for enabling access to human tissues for research in a manner that is responsive to the ethical challenges considered. Preventing exploitation and restoring trust while simultaneously promoting global health research calls for innovative approaches to human tissues research. A tissue trust can reduce the risk of exploitation and promote host capacity as a key benefit. (shrink)

One important sense of 'global ethics' concerns the applied ethical issues arising in the context of economic globalisation. This article contends that we are beginning to witness the economic commodification and, concomitantly, the globalisation, of human tissue and the human genome. Policy-makers and local research ethics committees need to be aware that the relevant ethical questions are no longer confined to their old national or subnational context. A shift from questions of personal autonomy and identity can therefore (...) be expected-towards the more problematic issues of justice, exploitation and distribution. Here we can learn from the distinctions drawn in legal philosophy, such as the notion of property as a 'bundle' of rights, from which we may choose rights favouring the interests of vulnerable populations. We may also wish to apply the distinctions drawn by Calabresi and Melamed between pure property rules, modified alienability rules, and pure non-property regimes. Global ethics also concerns issues of value disparity across cultures, directing our attention to the moral beliefs of indigenous peoples, for example, whose DNA or tissue is increasingly of commercial importance. In examining case examples from Tonga and Aotearoa/new Zealand, I will consider the impact of indigenous belief systems and of neo-colonialism on indigenous peoples' perceptions of Western researchers. It is clear that many indigenous peoples reject both the pure property system and any modifications, insisting on a pure non-property regime. How can they then be protected in a globalised market system that so far favours the opposite end of the spectrum? (shrink)

There are complex unresolved ethical, legal and social issues related to the use of human tissues obtained in the course of research or diagnostic procedures and retained for further use in research. The question of intellectual property rights over commercially viable products or procedures that are derived from these samples and the suitability or otherwise of participants relinquishing their rights to the samples needs urgent attention. The complexity of these matters lies in the fact that the relationship between intellectual (...) property rights and ownership or rights pertaining to the samples on which the intellectual property right is based may either be overlooked or taken for granted. What equally makes the matter complex is that samples may be obtained from participants in developing countries and exported to developed countries for analysis and research. It is important for research ethics committees to tread carefully when reviewing research protocols that raise such issues for purposes of ensuring that appropriate benefit sharing agreements, particularly with developing countries, are in place.This paper attempts to analyse the key questions related to ownership and intellectual property rights in commercially viable products derived from human tissue samples. Patent law is used as a point of reference as opposed to other forms of intellectual property rights such as industrial designs because it is the right that most inventors apply for in respect of human tissue-related inventions. The key questions are formulated following a systematic analysis of peer reviewed journal articles that have reported original investigations into relevant issues in this field. Most of the cases and reported studies that are referred to in this paper do not directly deal with HIV/AIDS research but the underlying principles are helpful in HIV/AIDS research as well. Pertinent questions, which members of ethics review committees should focus on in this regard are discussed and suggestions on appropriate approaches to the issues are proposed in the form of specific questions that an ethics review committee should consider. Specific recommendations regarding areas for further research and action are equally proposed. (shrink)

The controversies in Bristol, Alder Hey and elsewhere in the UK surrounding the removal and retention of human tissue and organs have led to extensive law reform in all three UK legal systems. This paper reports a short study of the reactions of a range of health professionals to these changes. Three main areas of ethical concern were noted: the balancing of individual rights and social benefit; the efficacy of the new procedures for consent; and the helpfulness for (...) professional practice of the new legislation and regulation. Recognition of these concerns may help in forging a new partnership between professionals and patients and their families. (shrink)

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

Identifiable excess surgical tissue is an important resource for medical research but we have become overly restrictive about consent requirements. I suggest we devolve consent to ethics committees for ordinary research projects involving human tissue, retaining the requirement for explicit consent only for those sensitive research situations where there is significant risk of harm to individual interests in privacy.

Biobanks are currently archiving human materials for medical research at a hitherto unprecedented rate. These valuable resources will be essential for developing ‘personalized’ medicines and for a better understanding of disease susceptibilities. However, for such scientific advances to benefit everyone, it is crucial that biobanks recruit donations from all sections of the community. Unfortunately, other initiatives, such as transplant programmes, have clearly demonstrated that ethnic minorities are under-represented. Here we suggest that this issue deserves serious consideration to avoid biobanks (...) evolving into ethnically biased archives which unwittingly promote race-specific research. Specifically, this necessitates research ethics committees engaging in a re-assessment of the relative merits of individual personal sovereignty and the common good. (shrink)

The furore over the retention of organs at postmortem examination, without adequate consent, has led to a reassessment of the justification for, and circumstances surrounding, the retention of any human material after postmortem examinations and operations. This brings into focus the large amount of human material stored in various archives and museums, much of which is not identifiable and was accumulated many years ago, under unknown circumstances. Such anonymous archival material could be disposed of, used for teaching, used (...) for research, or remain in storage. We argue that there are no ethical grounds for disposing of the material, or for storing it in the absence of a teaching or research rationale. Nevertheless, with stringent safeguards, it can be used even in the absence of consent in research and teaching. Regulations are required to control the storage of all such human material, along the lines of regulations governing anatomy body bequests. (shrink)

Purpose: To survey the attitudes of the general public in Sweden to biobank research and to discuss the findings in the light of some well-known ethical principles.Methods: A questionnaire was used to survey the opinions of the general public in Sweden, and an ethical analysis (using the principles of autonomy, non-maleficence, beneficence and justice) was performed to discuss the possible conditions of such research.Findings: Between 3 and 9% answered that they did not want their samples to be collected and stored (...) in a biobank. Many respondents required information about the purpose of the research and wanted to be able to consent or refuse. About one third of the respondents said they would have answered differently if financial gain was involved and those who commented indicated a more negative attitude. The principle of autonomy maintains that the right to self-determination should be respected, and the principles of non-maleficence and beneficence that the probable harms and benefits resulting from a particular project by using samples from a biobank should be balanced. The general public disagree about how these principles are to be balanced. Interpretation: In the light of the findings different interpretations of the situation as well as possible alternatives are discussed in this paper. (shrink)

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

Legislation that authorises controversial organ procurement strategies but ignores respect for autonomy is flawed in principle and predictably unworkable in practiceThe UK Human Tissue Act 2004,1 designed to regulate all activity involving human tissue, organs, or bodies, was introduced in the House of Commons in December 2003, received Royal Assent on 15 November 2004,2 and has been partially implemented by Commencement Orders from April 2005. The new act, which repeals and replaces the Human Tissue (...) Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989, has its origins in events of serious public concern, namely the retained organs scandals at Bristol Royal Infirmary3 and the Royal Liverpool Childrens’ Hospital.4 The act is correspondingly dominated by regulation of postmortem examinations and retention of human tissue, with consistent emphasis on the need for fully informed consent. Compliance with these requirements is now mandatory with the threat of up to three years’ imprisonment and/or fines for any deviation.The impact of the original proposals within the bill on research and the clinical practice of pathology have been carefully considered and documented,5 with subsequent amendments to ameliorate professional concerns.6 The act, however, also carries significant implications for medical practice in areas where donor recruitment for transplantation can take place, and representations on these aspects during readings of the bill7 have produced neither clarification, justification, nor amendment within the final legislation.Section 43 will make it lawful for hospital authorities “to take steps for the purpose of preserving the part for use for transplantation and to retain the body for that purpose”. The original explanatory notes for the bill8 while it proceeded through parliament implied that such action, prior to consent to transplantation being sought, was then lawful, clause 44 as section 43 …. (shrink)

One effect of late capitalism – the commodification of practically everything – is to knock down the Chinese walls between the natural and productive realms, to use a Marxist framework. Women's labour in egg extraction and ‘surrogate’ motherhood might then be seen as what it is, labour which produces something of value. But this does not necessarily mean that women will benefit from the commodification of practically everything, in either North or South. In the newly developing biotechnologies involving stem cells, (...) the reverse is more likely, particular given the shortage in the North of the egg donors who will be increasingly necessary to therapeutic cloning.Although most of the ethical debate has focused on the status of the embryo, this is to define ethics with no reference to global or gender justice. There has been little or no debate about possible exploitation of women, particularly of ovum donors from the South. Countries of the South without national ethics committees or guidelines may be particularly vulnerable: although there is increasing awareness of the susceptibility of poorer countries to abuses in research ethics, very little has been written about how they might be affected by the enormously profitable new technologies exploiting human tissue. Even in the UK, although the new Medical Research Council guidelines make a good deal of the ‘gift relationship’, what they are actually about is commodification. If donors believe they are demonstrating altruism, but biotechnology firms and researchers use the discourse of commodity and profit, we have not ‘incomplete commodification’ but complete commodification with a plausibly human face. (shrink)

Human dignity has long been used as a foundational principle in policy documents and ethical guidelines intended to govern various forms of biomedical research. Despite the vast amount of literature concerning human dignity and embryonic tissues, the majority of biomedical research uses non-embryonic human tissue. Therefore, this contribution addresses a notable lacuna in the literature: the relationship, if any, between human dignity and human tissue. This paper first elaborates a multidimensional understanding of (...) class='Hi'>human dignity that overcomes many of the shortcomings associated with the use of human dignity in other ethical debates. Second, it discusses the relationship between such an understanding of human dignity and ‘non-embryonic’ human tissue. Finally, it considers the implications of this relationship for biomedical research and practice involving human tissue. The contribution demonstrates that while human tissue cannot be said to have human dignity, human dignity is nevertheless implicated by human tissue, making what is done with human tissue and how it is done worthy of moral consideration. (shrink)

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban (...) on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles. (shrink)

Background: Sharing of tissue samples for research and disease surveillance purposes has become increasingly important. While it is clear that this is an area of intense, international controversy, there is an absence of data about what researchers themselves and those involved in the transfer of samples think about these issues, particularly in developing countries. Methods: A survey was carried out in a number of Asian countries and in Egypt to explore what researchers and others involved in research, storage and (...) transfer of human tissue samples thought about some of the issues related to sharing of such samples. Results: The results demonstrated broad agreement with the positions taken by developing countries in the current debate, favoring quite severe restrictions on the use of samples by developed countries. Conclusions: It is recommended that an international agreement is developed on what conditions should be attached to any sharing of human tissue samples across borders. (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)

The Human Tissue Act 2004 has generated considerable confusion, and is perhaps not the easiest statute to read. This paper aims to give a short guided tour of its provisions, and to highlight some of the practical issues that have already arisen since it came into operation on 1 September 2006. It does so from the point of view of University researchers, and of University RECs which may have to advise on these issues.

Commodification is a broad and crosscutting issue that spans debates in ethics (from prostitution to global market practices) and bioethics (from the sale of body parts to genetic enhancement). There has been disagreement, however, over what constitutes commodification, whether it is happening, and whether it is of ethical import. This chapter focuses on one area of the discussion in bioethics – the commodification of human tissue – and addresses these questions – about the characteristics of commodification, its pervasiveness, (...) and ethical significance – in order to clarify and map the commodificatory debate. The chapter does this in three parts. First, it defines commodification as the shift from “persons” to “things” and from “relationships” to services for “contract.” Second, using examples of kidney and gamete sale and commercial surrogacy, it argues that commodification is rife in bioethics. Third, it contends that commodification is an ethical problem for three key reasons: First, because it leads to exploitation; second, because some things should not be for sale; and third, because it damages social goods. The chapter concludes that commodification and commodificatory practices should be resisted. (shrink)

While providing a welcome and timely revision of the now outdated Human Tissue Act of 1961, the newly introduced Human Tissue Bill of 2004 contains a number of anomalies in its drafting that threaten to undermine its effectiveness in practice. Two examples: the first relating to the status of 'remnant or waste' tissue and the second relating to the status and use of artefacts created from collected tissue are here employed to illustrate some of (...) the definitional and categorical inconsistencies that are evident in the Bill. Having identified these, the paper then provides an analysis of how these inconsistencies may act to severely constrain the ways in which retained tissue may be lawfully employed in biomedical research and to confuse questions of who may, or may not, have formally recognised interests in types of processed human tissue. (shrink)

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

This paper discusses the legal implications of setting up two new biobanks in Belgium. The first is hospital-based and will archive tissue from patients with haematologic cancer, whereas the second is linked to a general practice based morbidity registry and will involve storage of blood samples. To date, Belgium has no specific legislation that regulates storage of human tissue and related databases. Several issues concerning the protection of individuals with regard to the processing of personal medical data (...) are discussed from the existing privacy legislation. We will address the principle of consent (broad versus specific) and the type of data recorded (anonymous, encoded and identifiable) for both biobanks. (shrink)

Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we (...) propose an alternative approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field. (shrink)

The Human Tissue Act 2004 is designed to regulate the storage and use of organs and tissues from the living, and the removal, storage and use of the same material from the deceased. It repeals much criticized legislation, including the Human Tissue Act 1961, and establishes a Human Tissue Authority to ensure compliance with the Act via a licensing and monitoring regime. When the Act comes into force, probably in April 2006, it will be (...) a criminal offence not to comply with certain provisions of the Act, and a new offence of DNA 'theft' will be introduced. Importantly, the Act places consent at the centre of the system, both from the living and from or on behalf of the deceased. (shrink)

Globally active companies are involved in the discursive construction of moral legitimacy. Establishing normative conformance is problematic given the plurality of norms and values worldwide, and is particularly difficult for companies operating in morally controversial industries. In this paper, we investigate how organizations publicly legitimize the trade of human tissue for private profit when this practice runs counter to deep-seated and widespread moral beliefs. To do so, we use inductive, qualitative methods to analyze the website discourse of three (...) types of organizations that trade in human tissue and are associated with different degrees of moral controversy with respect to tissue procurement and use. Our analysis reveals an object-oriented approach to moral legitimizing centered on the human tissue as a morally disputed good. We find that the website discourse translates human tissue into technology, constructs normative meaning around a dominant instrumental value associated with human-tissue-as-technology, and reproduces and stabilizes this meaning by six discursive mechanisms that amplify and anchor it. Moreover, the use of amplifying and anchoring discourse was greater in organizations associated with greater controversy. The results are consistent with an object-oriented sociality. (shrink)

Ex-vivo tissue engineering is an emerging medical technology. Its aim is to regenerate tissues and organs and to restore them to full physiological activity. Some clinical trials with human tissue engineered products have been conducted and others will follow. These trials not only have to confirm the therapeutic value of the HTEP, they also have to provide insight in its regenerative activity, its safety and long-term effects. The development of these trials is aggravated by the complexity of (...) the tissue engineering process and product. This paper investigates how this complexity influences the ethical conduct of clinical trials with HTEPs. We focus on the value and validity of the trial, the risk-benefit ratio and the protection of the trial participant. We argue that trials with HTEPs need a robust methodology. The risk-benefit ratio of a new HTEP must be determined and compared with available efficacious therapies. This requires the identification and minimisation of risks associated with tissue engineering. Finally a process as complex as tissue engineering presents serious challenges for the informed consent process, and for the protection of the trial participant during and after the trial. (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)

In Switzerland, research with identifiable human tissue samples, and/or its accompanying data, must be approved by a research ethics committee before it can be allowed to take place. However, as the demand for such tissue has rapidly increased in recent years, and biobanks have been created to meet these needs, committees have had to deal with a growing number of such demands. Detailed instructions for evaluating every kind of tissue request are scarce. Committees charged with evaluating (...) research protocols therefore sometimes face uncertainty in their decision-making. We examine how a pool of Swiss REC members deal with a number of cases involving human tissue, in order to determine the standards they adhere to, and their understanding and implementation of existing laws and guidelines. There is considerable divergence in the approaches and decisions of Swiss REC members regarding human tissue sample requests, particularly concerning the issue of informed consent. Despite recent trends towards less strict consent requirements for biosample research, many of our respondents continue to employ demanding standards for researchers. The question of informed consent, and the circumstances in which it is required, continues to result in differences of opinion. While room for local and cultural interpretation is essential to the workings of an REC, misunderstanding of existing guidelines, or an absence of regulation in sensitive areas, will only lead to suboptimal functioning of the REC itself. Our data suggests that there is uncertainty and disagreement on the question of consent for human tissue sample, which existing laws and guidelines may not fully clarify. Methods to address these uncertainties should be implemented in order to ensure efficient and harmonious review of research protocols. (shrink)

Despite its focus on consent the new Human Tissue Act 2004 allows for testing without consent where a relative could benefitIn recognition of the fact that genetic test results in people can have implications for close relatives, the new Human Tissue Act 2004 allows for a direction to access a person’s tissue so that testing can be carried out for the benefit of a relative, without the consent of that person. Clinical practice governed by common (...) law and statute, before this act, acknowledged that the disclosure, without consent, of the results of a genetic test, is ethically permissible in extreme situations for the benefit of a relative. New testing for the benefit of a relative without donor consent challenges the principle that informed or adequate consent should be obtained before a genetic test with considerable predictive powers is carried out. The debate surrounding the analogous situation of HIV testing concluded that in very rare cases, disclosure of an HIV result without consent may be justified, but testing without consent is a professional misconduct. This part of the legislation is controversial and deserves further debate. The Human Tissue Authority should take measures to limit the potential harm that can be caused by this provision.IntroductionAfter much debate, the new Human Tissue Act 2004 was passed by parliament in November 2004. Implementation of this act may be staggered, but it will be fully operational in May 2006. This act has several provisions that have implications in clinical practice for the use of stored tissue or samples containing cells. These provisions allow the Human Tissue Authority to permit access to human tissue for the purpose of obtaining scientific or medical information about a person for the benefit of another family member, without the consent of the donor . …. (shrink)

A three‐tiered legal structure of the substances constitutive of human beings can accommodate property rights in new products created by the investment of labor in human tissue.

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

This paper analyzes court rulings on tissue samples as property and critiques objections that have been raised to the recognition of DNA samples as personal property. The cases are: Moore v. Regents of the University of California (1988, 1990), Greenberg v. Miami Children’s Research Institute (2003), and Washington University v.Catalona (2007). The paper argues that it is possible for the law to support both individual privacy and property rights in DNA, recognizing nevertheless that some unresolved questions remain, including what (...) exercising those rights means on a practical level. Finally, it offers suggestions for changes in law based on those considerations. (shrink)