Together with large biobanks of human samples, medical registries with aggregated data from many clinical centers are vital parts of an infrastructure for maintaining high standards of quality with regard to medical diagnosis and treatment. The rapid development in personalized medicine and pharmaco-genomics only underscores the future need for these infrastructures. However, registries and biobanks have been criticized as constituting great risks to individual privacy. In this article, I suggest that quality with regard to diagnosis and treatment is (...) an inherent, morally normative requirement of health care, and argue that quality concerns in this sense may be balanced with privacy concerns. (shrink)
This volume investigates human genetic biobanking and its regulation in various Asian countries and areas, including Japan, Mainland China, Taiwan, Hong Kong, ...
Biobanks are potential goldmines for genomics research. They have become increasingly common as a means to determine the relationship between lifestyle, environmental exposures and predisposition to genetic disease. More and more countries are developing massive national scale biobanks, including Iceland, the UK and Estonia.Now several large-scale regional and national biobanks are planned in China, such as Shanghai Biobank, which is defined as a key-element in Shanghai's twelfth five-year Development Plan of Science and Technology. It is imperative that (...) the authors who are in charge of the ethical aspect of Shanghai Biobank discuss the ethical aspects of these biobanks up front. Currently there is a great deal of heterogeneity in the approaches to informed consent taken by different countries. In the article, after briefly introducing the biobanks in China, we focus on the three most common approaches: classical informed consent, tiered consent, and one-time general (or blanket) consent, and propose a version of the latter for China, based on compelling arguments. (shrink)
We argue that, in the case of research biobanks, there is a need to replace the currently used informed consent with trusted consent. Accordingly, we introduce a proposal for the structure of the latter. Further, we discuss some of the issues that can be addressed effectively through our proposal. In particular, we illustrate: i) which research should be authorized by donors; ii) how to regulate access to information; iii) the fundamental role played by a Third Party Authority in assuring (...) compliance with the reciprocal expectations and obligations of donors and scientists. Finally, we briefly analyse two issues that might represent important elements of a ‘new alliance’ between researchers and donors to which the trusted consent could pave the way: i) the correlations between needs and rights of the two parties, and ii) possible economic transactions. (shrink)
Margaret Sleeboom-Faulkner, ed. 2008. Human genetic biobanks in Asia: Politics of trust and scientific advancement Content Type Journal Article DOI 10.1007/s11673-010-9234-6 Authors Darryl Macer, UNESCO Bangkok Regional Adviser in Social and Human Sciences for Asia and the Pacific, Regional Unit for Social and Human Sciences in Asia and the Pacific (RUSHSAP) 920 Sukhumvit Road, Prakanong Bangkok 10110 Thailand Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 7 Journal Issue Volume 7, Number 2.
The unknown nature of tomorrow’s research makes informed consent in biobank research a challenge. Whether the consent given by biobank participants is ‘broad’ or ‘narrow’, the ever present question remains the same: are new activities covered by the original consent? In this article, we focus on the meaning of, and the relation between, broad consent and re-consent in biobank research. We argue that broad consent should be understood as consenting to a framework—a framework which covers aims, core conditions for acceptable (...) use, governance and how these affect participants. Changes that alter the framework in a fundamental way call for re-consent. Three biobank cases of current international interest are used to debate when re-consent is an ethical necessity: whole-genome sequencing, data sharing and commercial utilization. These reflections give us a more nuanced view on what consent is for. We claim that the introduction of broad consents in biobank research has not represented a betrayal of individual participant interests, as some critics have asserted. Broad consents combined with the possible use of re-consent are in certain settings not inferior, but rather ethically superior to narrow consents. In population-based research biobanks, they allow for a reconciliation between individual interest and public matters in society at large. (shrink)
The huge potential of biobanks/genetic databases for the research community has been recognised across jurisdictions in both publicly funded and commercial sectors. But although there is tremendous potential there are likewise potential difficulties. The long-term storage of personal health information and samples poses major challenges. This is an area is fraught with ethical and legal uncertainties. Biobanks raise many questions of the control of rights, of consent, of privacy and confidentiality and of property in human material. It is (...) thus unsurprising then that there has been a lively debate as to how biobanks should operate, the boundaries of participation and what governance structure, if any they should adopt, a debate which has been engaged in across the academic community and by funders and researchers alike. This paper asks despite the good intentions can ad hoc ethics and ethics and governance committees long term provide an effective solution to the legal and regulatory challenges arising from biobanks. (shrink)
Modern biobanks typically rely on the public to freely donate genetic data, undergo physical measurements and tests, allow access to medical records and give other personal information by questionnaire or interview. Given the demands on participants it is not surprising that there has been extensive public consultation even before biobanks in the UK and elsewhere began to recruit. This paper considers the different ways in which biobanks have attempted to engage and appeal to their publics and the (...) reaction of potential and actual donors. Whilst those organising biobanks presumably want to be as close to their publics as they need to be in order to successfully recruit and sustain participation in sufficient numbers, the closer the relationship the more obligations and expectations there are on both sides. (shrink)
The tissue biobanking of specific biological residual materials, which constitutes a useful resource for medical/scientific research, has raised some ethical issues, such as the need to define which kind of consent is applicable for biological residual materials biobanks.
The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/or societal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable Development only has to deal (...) with problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading-off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)
This article examines the complex and contemporary issue of the return of research results in biobanks. After suggesting the exclusion of some adjacent issues usually flanking the debate, this article reviews the current practices of biobanks on the disclosure of research results to participants. It then focuses more specifically on the debate in the literature before turning to a review of the typology of recent reforms being put forward.
It is generally assumed in research ethics that research participants have an unconditional right to withdraw from research without any detriment or reprisal. This paper analyses this right in the context of biobank research and argues that the traditional shape of the right in clinical research can be modified in biobank research without incurring significant ethical cost. The paper falls in three parts. The first part is a brief explication of the philosophical justification of the right to withdraw. The second (...) part presents a number of extant criticisms of the right. And the third and final part argues that although a right to withdraw is crucial in relation to biobank research, such a right has to be specified in a different way to the similar right in relation to clinical research. (shrink)
On 19 December 2008 the Official Journal of Belgium published the ‘Law regarding the procurement and use of human body material destined for human medical applications or for scientific research purposes’. This paper will comment on various aspects of the Law: its scope of application (what is understood by ‘body material’?); its concept of ‘residual human body material’ (with far-reaching implications for the type of consent required for research); the nature of actions with and uses of human body material that (...) are explicitly prohibited; the right of donors to be informed of relevant information revealed by the use of their body material; and the special responsibilities placed on hospital ethics committees. As will be argued in this paper, several of these provisions are highly problematic from an ethical point of view, especially those relating to consent. Meanwhile, the Minister of Public Health has asked the Belgian Advisory Committee on Bioethics for advice on the incorporation of the ‘presumed consent’ model, that applies to post mortem organ donation, into the biobank Law’s provisions on post mortem removal and use of body material. This aspect of the Law effectively extends the ‘presumed consent’ regime, both from organs to body material in general, and from therapeutic uses to research uses. (shrink)
It is now being recognized across the spectrum of bioethics, and particularly in genetics and population ethics, that to focus on the individual person, and thereby neglect communities and the goods which accrue to them, is to fail to see all the ethically significant features of a range of ethical issues. This article argues that more work needs to be done in order for bioethics to respect not only goods (such as rights and interests) of communities per se , but (...) also to recognize the difference between different types of communities and their goods. The diversity of communities and the types of communal goods which accrue to them is first outlined. Following this, a basic distinction between two such types: aggregative and corporate community goods, is explained and defended, and it is then argued argue that this distinction is necessary to understand and address what and whom is ethically at stake in any situation. This is illustrated with the example of UK Biobank, the conclusion being that if current and future individual are to be respected then communal goods of both types must be recognized and respected in an effective bioethics. (shrink)
This article provides an overview of recent contributions to the debate on the ethical use of previously collected biobank samples, as well as a country report about how this issue has been regulated in Spain by means of the new Biomedical Research Act, enacted in the summer of 2007. By contrasting the Spanish legal situation with the wider discourse of international bioethics, we identify and discuss a general trend moving from the traditional requirements of informed consent towards new models more (...) favourable to research in a post-genomic context. (shrink)
Biobanks for long-term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides the research participants (...) with some level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes. (shrink)
This paper argues that the demands of respect for autonomy in the context of biobanking are fewer and more limited than is often supposed. It discusses the difficulties of agreeing a concept of autonomy from which duties can easily be derived, and suggests an alternative way to determine what respect for autonomy in a biobanking context requires. These requirements, it argues, are limited to provision of adequate information and non-coercion. While neither of these is in itself negligible, this is a (...) smaller set of demands than is often suggested. In particular, it is argued here that securing ‘one time consent’ is consistent with respect for autonomy. Finally, the paper notes that while the demands of respect for autonomy may be less than some suppose, respecting autonomy is not the only way in which biobanks and their users may have moral duties to donors. (shrink)
Biobanks, collecting human specimen, medical records, and lifestyle-related data, face the challenge of having contradictory missions: on the one hand serving the collective welfare through easy access for medical research, on the other hand adhering to restrictive privacy expectations of people in order to maintain their willingness to participate in such research. In this article, ethical frameworks stressing the societal value of low-privacy expectations in order to secure biomedical research are discussed. It will turn out that neither utilitarian nor (...) communitarian or classical libertarian ethics frameworks will help to serve both goals. Instead, John Rawls’ differentiation of the “right” and the “good” is presented in order to illustrate the possibility of “serving two masters”: individual interests of privacy, and societal interests of scientific progress and intergenerational justice. In order to illustrate this counterbalancing concept with an example, the five-pillar concept of the German Ethics Council will be briefly discussed. (shrink)
Background The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In (...) light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. Methods We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. Results The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. Conclusion Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment. (shrink)
Biobanks correspond to different situations: research and technological development, medical diagnosis or therapeutic activities. Their status is not clearly defined. We aimed to investigate human biobanking in Europe, particularly in relation to organisational, economic and ethical issues in various national contexts. Data from a survey in six EU countries (France, Germany, the Netherlands, Portugal, Spain and the UK) were collected as part of a European Research Project examining human and non-human biobanking (EUROGENBANK, coordinated by Professor JC Galloux). A total (...) of 147 institutions concerned with biobanking of human samples and data were investigated by questionnaires and interviews. Most institutions surveyed belong to the public or private non-profit-making sectors, which have a key role in biobanking. This activity is increasing in all countries because few samples are discarded and genetic research is proliferating. Collections vary in size, many being small and only a few very large. Their purpose is often research, or research and healthcare, mostly in the context of disease studies. A specific budget is very rarely allocated to biobanking and costs are not often evaluated. Samples are usually provided free of charge and gifts and exchanges are the common rule. Good practice guidelines are generally followed and quality controls are performed but quality procedures are not always clearly explained. Associated data are usually computerised (identified or identifiable samples). Biobankers generally favour centralisation of data rather than of samples. Legal and ethical harmonisation within Europe is considered likely to facilitate international collaboration. We propose a series of recommendations and suggestions arising from the EUROGENBANK project. (shrink)
In Sweden, most patients are recruited into biobank research by non-researcher doctors. Patients' trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients' mistaken trust. There are at least three kinds of mistaken trust, each of which requires a different (...) set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient's reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good. (shrink)
Background Interest in biobanking for collection of specimens for non-communicable diseases research has grown in recent times. This paper explores the perspectives of Nigerians on donation of specimen for the biobanking research. Methods We conducted 16 Focus Group Discussions (FGD) with individuals from different ethnic, age and socio-economic groups in Kano (North), Enugu (Southeast), Oyo States (Southwest) and Abuja, the Federal Capital Territory (Central) of Nigeria. We used topic guides and prompt statements to explore the knowledge and understanding of interviewees (...) to general issues about biobanking of biospecimens, their use and specifically about role of biobanking in non-communicable diseases research. Results A total of 123 individuals participated in 16 focus group discussions in 2011. Our participants had limited knowledge of the concept of biobanking but accepted it once they were educated about it and saw it as a worthwhile venture. Half of our study participants supported use of broad consent, a quarter supported restricted consent while the remaining quarter were in favour of tiered consent. Most discussants support shipment of their samples to other countries for further research, but they prefer those collaborations to be done only with competent, ethical researchers and they would like to receive feedback about such projects. The majority preferred health care as a benefit from participation, particularly for any unexpected condition that may be discovered during the course of the research instead of financial compensation. Participants emphasized the need to ensure that donated samples were not used for research that contradicts their religious beliefs. Conclusions Our study demonstrates that our participants accepted biobanking once they understand it but there were different attitudes to elements of biobanking such as type of consent. Our study highlights the need to carefully document population attitudes to elements of modern scientific research and the consenting process. (shrink)
Background: The global expansion of biobanks has led to a range of bioethical concerns related to consent, privacy, control, ownership, and disclosure. As an opportunity to engage broader audiences on these concerns, bioethicists have welcomed the commercial success of Rebecca Skloot’s 2010 bestselling book The Immortal Life of Henrietta Lacks. To assess the impact of the book on discussion within the media and popular culture more generally, we systematically analyzed the ethics-related themes emphasized in reviews and articles about the (...) book, and in interviews and profiles of Skloot. Methods: We conducted a content analysis of a population of relevant English-language articles and transcripts (n = 125) produced by news organizations and publications in the U.S., Canada, Great Britain/Ireland, and Australia/New Zealand. We scored each article for the emphasis and appearance of 9 ethics-related themes. These were informed consent, welfare of the vulnerable, compensation, scientific progress, control/access, accountability/oversight, privacy, public education, and advocacy. Results: The informed consent theme dominated media discussion, with almost 39.2 percent of articles/transcripts featuring the theme as a major focus and 44.8 percent emphasizing the theme as a minor focus. Other prominent themes and frames of reference focused on the welfare of the vulnerable (18.4 percent major emphasis; 36.0 percent minor emphasis), and donor compensation (19.2 percent major; 52.8 percent minor). Ethical themes that comprised a second tier of prominence included those of scientific progress, control/access, and accountability/oversight. The least prominent themes were privacy, public education, and advocacy. Conclusions: The book has been praised as an opportunity to elevate media discussion of bioethics, but such claims should be re-considered. The relatively narrow focus on informed consent in the media discussion generated by Skloot’s book may limit the ability of ethicists and advocates to elevate attention to donor control, compensation, patenting, privacy, and other ethical issues. Still, ethicists should view the book and a pending major TV film translation as opportunities to highlight through media outreach, consultation exercises and public forums a broader range of bioethical concerns that would otherwise be under-emphasized in news coverage. Such efforts, however, need to be carefully planned and evaluated. (shrink)
BackgroundThe global expansion of biobanks has led to a range of bioethical concerns related to consent, privacy, control, ownership, and disclosure. As an opportunity to engage broader audiences on these concerns, bioethicists have welcomed the commercial success of Rebecca Skloot’s 2010 bestselling book The Immortal Life of Henrietta Lacks. To assess the impact of the book on discussion within the media and popular culture more generally, we systematically analyzed the ethics-related themes emphasized in reviews and articles about the book, (...) and in interviews and profiles of Skloot.MethodsWe conducted a content analysis of a population of relevant English-language articles and transcripts (n = 125) produced by news organizations and publications in the U.S., Canada, Great Britain/Ireland, and Australia/New Zealand. We scored each article for the emphasis and appearance of 9 ethics-related themes. These were informed consent, welfare of the vulnerable, compensation, scientific progress, control/access, accountability/oversight, privacy, public education, and advocacy.ResultsThe informed consent theme dominated media discussion, with almost 39.2 percent of articles/transcripts featuring the theme as a major focus and 44.8 percent emphasizing the theme as a minor focus. Other prominent themes and frames of reference focused on the welfare of the vulnerable (18.4 percent major emphasis; 36.0 percent minor emphasis), and donor compensation (19.2 percent major; 52.8 percent minor). Ethical themes that comprised a second tier of prominence included those of scientific progress, control/access, and accountability/oversight. The least prominent themes were privacy, public education, and advocacy.ConclusionsThe book has been praised as an opportunity to elevate media discussion of bioethics, but such claims should be re-considered. The relatively narrow focus on informed consent in the media discussion generated by Skloot’s book may limit the ability of ethicists and advocates to elevate attention to donor control, compensation, patenting, privacy, and other ethical issues. Still, ethicists should view the book and a pending major TV film translation as opportunities to highlight through media outreach, consultation exercises and public forums a broader range of bioethical concerns that would otherwise be under-emphasized in news coverage. Such efforts, however, need to be carefully planned and evaluated. (shrink)
What is privacy? What does privacy mean in relation to biobanking, in what way do the participants have an interest in privacy, (why) is there a right to privacy, and how should the privacy issue be regulated when it comes to biobank research? A relational view of privacy is argued for in this article, which takes as its basis a general discussion of several concepts of privacy and attempts at grounding privacy rights. In promoting and protecting the rights that participants (...) in biobank research might have to privacy, it is argued that their interests should be related to the specific context of the provision and reception of health care that participation in biobank research is connected with. Rather than just granting participants an exclusive right to or ownership of their health information, which must be waived in order to make biobank research possible, the privacy aspect of health information should be viewed in light of the moral rights and duties that accompany any involvement in a research based system of health services. (shrink)
How are we individually and as a society to handle new and emerging technologies? This challenging question underlies much of the bioethical debates of modern times. To address this question we need suitable conceptions of the new technology and ways of identifying its proper management and regulation. To establish conceptions and to find ways to handle emerging technologies we tend to use analogies extensively. The aim of this article is to investigate the role that analogies play or may play in (...) the processes of understanding and managing new technology. More precisely we aim to unveil the role of analogies as analytical devices in exploring the "being" of the new technology as well the normative function of analogies in conceptualizing the characteristics and applications of new technology. Umbilical cord blood biobanking will be used as a case to investigate these roles and functions. (shrink)
Taiwan has a population of 23 million, of which some 500,000 are Aborigines. Recent conflicts over a national biobank as part of Taiwan's biotechnological industrial development, genetic research on Aboriginal origins, and commercialization of research findings involving Aborigines have raised a number of important ethical conflicts. These ethical conflicts involve on one hand, the importance of researchers' duties, and on the other hand, Aboriginal rights. This paper will go in three steps. First, this paper describes the three cases of ethical (...) violations of Aboriginal rights committed by Taiwanese researchers in the course of their scientific duties. After having given an account of ethical conflicts between research duties and Aboriginal rights, the paper addresses larger ethical issues underlying this Taiwanese research context. Finally, the paper considers if stronger ethical regulation could reconcile Aboriginal rights and research duties. (shrink)
This paper argues that a certain way of thinking about the function of the biobank—about what it does and is constructed for as a social institution aimed at ‘some good’—can and should play a substantial role in an effective biobanking ethic. It first exemplifies an ‘institution shaped gap’ in the current field of biobanking ethics. Next the biobank is conceptualized as a social institution that is apt for a certain kind of purposive functional definition such that we know it by (...) what it does and what it is designed to do. This purpose is then characterized further as essentially incorporating the human goods the institution is designed to serve, such that it plays a useful and indispensible role in how it should operate, i.e. in the ethics and governance of biobanking. Finally the ethical scope and limitations of such a theory is clarified by a discussion of some theoretical objections and suggested practical examples of its application. (shrink)
A research biobank is a collection of personal health and lifestyle information, including genetic samples of yet unknown but possibly large information potential about the participant. For the participants, the risk of taking part is not bodily harm but infringements of their privacy and the harmful consequences such infringements might have. But what do we mean by privacy? Which harms are we talking about? To address such questions we need to get a grip on what privacy is all about and (...) aim for a fruitful perspective on the issues of property and privacy rights in the context of biobanking. This paper argues that the limits and handling of private matters is determined in specific social relations. The crucial point is thus to determine which information and activities are or are not the legitimate concern of others. Privacy and property rights should be seen as balanced by duties, that is as inherently relational interests extending into the public sphere, rather than to see these rights as the control of an object—for instance the participant’s biobank material. (shrink)
In 2007, the Ethics and Governance Council of the UK Biobank commissioned a Report on ‘Concepts of Public Good and Pubic Interest in Access Policies’. This study considered the Biobank’s role as a ‘public good’ in respect to supporting and promoting health throughout society. However, the conditions under which access by third parties to UK Biobank are justified in the public interest have not been well considered. In this article, I propose to analyse the conditions that should allow such access. (...) My argument develops UK Biobank’s function as a ‘public good’ and in terms of its responsibilities as a public health institution; both to protect the rights of the participants and in having a role in reinforcing public goals. Although these two tasks may conflict, it is possible that resolute opposition to some third-party access demands—if properly justified in terms of a public interest—will be damaging to, rather than protective of, participants’ rights. To illustrate my argument, I consider the appropriate response to an extraordinary public emergency , such as a serious criminal investigation or disaster response, in terms of an ethical access policy. (shrink)
In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the (...) samples means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. (shrink)
Bioethics as politics -- Bioethics and the politics of expectations -- Engendering consent : bioethics and biobanks -- Missing the big picture : bioethics and stem cell research -- Testing times : bioethics and "do-it-yourself" genetics -- Governing uncertainty : the politics of nanoethics -- Beyond bioethics.
Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES (...) FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)
Genetic research aimed at understanding human health and disease is grounded in the study of genetic variation. The inclusion of research subjects with diverse ancestral backgrounds is essential for genetic and genomic research that fully explores human diversity. Large-scale cohort studies and biobanks in Europe and the United States often do not include the breadth of ethnic and racial diversity observed in their countries' citizens. This article explores the findings of a qualitative study of U.S. scientists' understanding and views (...) of the NIH Policy and Guidelines on the Inclusion of Minorities as Subjects in Clinical Research. The findings suggest that the policy restricts how scientists use racial and ethnic categories to define and report their study populations and does little to motivate their efforts to increase the inclusion of non-European ancestral populations in genetic and genomic research. (shrink)
Currently, the return of results in the domain of biobanking constitutes an ethical and legal quagmire, whether it involves population or specific clinical research studies. In light of the fact that population biobanks are often not seen as distinct from those biobanks created for disease research, as well as the uncertainty as to what “return of results” means concretely, this lexicon attempts to demystify the terminology. The terms — results, return, clinical significance, and utility — are discussed. Through (...) an analysis of international and national normative guidance on this issue, the authors propose a concordance of meaning and a simplified lexicon. (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)
RESUMEN: El uso de analogías en bioética es muy frecuente. Dado que son instrumentos especialmente eficaces desde un punto de vista retórico, resulta fundamental determinar bajo qué condiciones la formulación de analogías constituye un recurso discursivo legítimo. En este artículo, distinguimos entre usos no-discursivos y usos discursivos de las analogías, y dentro de estos últimos, entre usos explicativos y usos argumentativos. En base a esta clasificación, proponemos distintos conjuntos de criterios para determinar si una analogía particular constituye un recurso discursivo (...) legítimo o no. Para ello, ilustramos brevemente nuestra clasificación mediante algunos ejemplos tomados del reciente debate sobre los biobancos.ABSTRACT: Analogies are frequently used in bioethics. As they are particularly effective as rhetorical tools, it is essential to determine under which conditions they can be said to be a legitimate discursive resource. In this paper we distinguish between nondiscursive uses and discursive uses of analogies and, within the latter, between explanatory uses and argumentative uses. Taking this classification as a basis, we provide different sets of criteria for determining whether or not a particular analogy constitutes a legitimate discursive resource. In distinguishing between legitimate and illegitimate analogies, we briefly illustrate our classification by some examples from recent literature on biobanks. (shrink)
The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/orsocietal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable Development only has to deal with (...) problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading‐off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)
Biobanks that are run on an opt-in basis depend on people having the motivation to give and to trust in those who control their samples. Yet in the UK trust in the healthcare system has been in decline and there have been a number of health-related scandals that have received widespread media and public attention. Given this background, and the previous public consultations on UK Biobank, the paper explores the way people express their trust and mistrust in the area (...) of medical and genetic information through discussions in six focus groups held in different areas of Britain. The themes that emerged in the discussion were the special character of genetic data; the ease with which information spreads; the public/private divide in genetic research; the potential of genetic information to harm people; choice, consent and lack of control; and the difficulty of establishing trustworthy governing arrangements. The expert agenda of policy-makers and medical ethics does not address the broader concerns expressed by participants. It seems that public consultation and the language of openness and transparency may not be sufficient to establish trust in the governance of genetic databases. Donors will be asked to give freely without any return but the participants' perception of those using the samples is that they are motivated by success and profit rather than healthcare priorities. In this context altruism seems naive and even dangerous. In order to place their trust well people need evidence of a relationship with obligations and expectations on both sides. (shrink)
Introduction: This article discusses ethical, legal and social issues raised by the collection, storage and use of DNA in forensic databases. Review: The largest and most inclusive forensic database in the world, the UK National DNA database (NDNAD), leads the worldwide trend towards greater inclusivity. The performance of the NDNAD, criteria for inclusion, legislative framework and plans for integrating forensic databases across Europe are discussed. Comparisons are drawn with UK biobank that has started collecting DNA samples linked to medical records (...) and, unlike the NDNAD, requires informed consent from volunteers, allows withdrawal of samples and only includes adults. The potential uses of research into genes associated with violent and ‘antisocial’ behaviour are discussed in the context of an increasing degree of surveillance in the UK. Conclusion: It should not be assumed that the benefits of forensic databases will necessarily override the social and ethical costs, regardless of changes to the criteria for inclusion or the permitted uses of samples and profiles. The expansion of forensic databases raises issues of relevance to the medical profession. (shrink)
New medical technologies provide us with new possibilities in health care and health care research. Depending on their degree of novelty, they may as well present us with a whole range of unforeseen normative challenges. Partly, this is due to a lack of appropriate norms to perceive and handle new technologies. This article investigates our ways of establishing such norms. We argue that in this respect analogies have at least two normative functions: they inform both our understanding and our conduct. (...) Furthermore, as these functions are intertwined and can blur moral debates, a functional investigation of analogies can be a fruitful part of ethical analysis. We argue that although analogies can be conservative; because they bring old concepts to bear upon new ones, there are at least three ways in which they can be creative. First, understandings of new technologies are quite different from the analogies that established them, and come to be analogies themselves. That is, the concepts may turn out to be quite different from the analogies that established them. Second, analogies transpose similarities from one area into another, where they previously had no bearing. Third, analogies tend to have a figurative function, bringing in something new and different from the content of the analogies. We use research-biobanking as a practical example in our investigations. (shrink)
This article considers how we should frame the ethical issues raised by current proposals for large-scale genebanks with on-going links to medical and lifestyle data, such as the Wellcome Trust and Medical Research Council's 'UK Biobank'. As recent scandals such as Alder Hey have emphasised, there are complex issues concerning the informed consent of donors that need to be carefully considered. However, we believe that a preoccupation with informed consent obscures important questions about the purposes to which such collections are (...) put, not least that they may be only haphazardly used for research (especially that of commercial interest)—an end that would not fairly reflect the original altruistic motivation of donors, and the trust they must invest. We therefore argue that custodians of such databases take on a weighty pro-active duty, to encourage public debate about the ends of such collections and to sponsor research that reflects publicly agreed priorities and provides public benefits. (shrink)
The National Institutes of Health and other federal health agencies are considering establishing a national biobank to study the roles of genes and environment in human health. A preliminary public engagement study was conducted to assess public attitudes and concerns about the proposed biobank, including the expectations for return of individual research results. A total of 141 adults of different ages, incomes, genders, ethnicities, and races participated in 16 focus groups in six locations across the country. Focus group participants voiced (...) a strong desire to be able to access individual research results. Recognizing the wide range of possible research results from a large cohort study, they repeatedly and spontaneously suggested that cohort study participants be given ongoing choices as to which results they received. (shrink)
“Offsetting” habitat destruction has widespread appeal as an instrument for balancing economic growth with biodiversity conservation. Requiring proponents to pay the nontrivial costs of habitat loss encourages sensitive planning approaches. Offsetting, biobanking, and biodiverse carbon sequestration schemes will play an important role in conserving biodiversity under increasing human pressures. However, untenable assumptions in existing schemes are undermining their benefits. Policies that allow habitat destruction to be offset by the protection of existing habitat are guaranteed to result in further loss of (...) biodiversity. Similarly, schemes that allow trading the immediate loss of existing habitat for restoration projects that promise future habitat will, at best, result in time lags in the availability of habitat that increases extinction risks, or at worst, fail to achieve the offset at all. We detail concerns about existing approaches and describe how offsetting and trading policies can be improved to provide genuine benefits for biodiversity. Due to uncertainties about the way in which restored vegetation matures, we propose that the biodiversity bank should be a savings bank. Accrued biodiversity values should be demonstrated before they can be used to offset biodiversity losses. We provide recommendations about how this could be achieved in practice. (shrink)
Many feel the Common Rule treats an unwieldy range of activities identically under the monolithic label "human subjects research." Past objections centering on the conflation of biomedical and behavioral research have gained new currency with the increase in biobanking and Internet-based research. A more nuanced approach to research is overdue. Regulation will no doubt remain a major component of any new approach. But in some research contexts, investigators and subjects should be permitted to reach voluntary, informed agreements about certain aspects (...) of their relationship.Consider the National Institutes of Health's new "Guidelines for Human Stem Cell Research."1 The guidelines owe their existence to the NIH's .. (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)
BackgroundObtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements.MethodsEmploying a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and (...) studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed.ResultsThe review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study.ConclusionsThe analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. (shrink)
Large-scale genetic databases are being developed in several countries around the world. However, these databases depend on public participation and acquiescence. In the past, information campaigns have been waged and little attention has been paid to dialogue. Nowadays, it is important to include the public in the development of scientific research and to encourage a free, open and useful dialogue among those involved. This paper is a review of community consultation strategies as part of four proposed large-scale genetic databases in (...) Iceland, Estonia, United Kingdom and Quebec. The Iceland Health Sector Database and Estonian Genome Project have followed a “communication approach” in order to address public concerns, whereas, UK Biobank and Quebec CARTaGENE have chosen a “partnership approach” to involve the public in decision-making processes. (shrink)
One interesting aspect of the Hwang-case has been the way in which this affair was assessed by academic journals such as Nature. Initially, Hwang’s success was regarded as evidence for the detrimental effects of research ethics, slowing down the pace of research in Western countries. Eventually, however, Hwang’s debacle was seen as evidence for the importance of ethics in the life sciences. Ironically, it was concluded that the West maintains its prominence in science (as a global endeavour) precisely because it (...) has its ethics in place. Bioethics was now seen as an indispensable part of quality control. In this article, I will claim that the Hwang case rather reveals that there is no reason for complacency and that there are substantial challenges awaiting us. They have to do with major transformations in the way knowledge is produced and research in the life sciences is conducted (such as the increase in pace and scale, globalisation and the growing importance of ICT and bioinformation). These transformations call for a different kind of bioethics. The focus must shift from duties of autonomous researchers concerning visible research subjects (“micro-ethics”) to responsibilities of institutionalised research networks in managing and processing large amounts of bioinformation (“macro-ethics”). Concepts such as transparency, reliability and benefit-sharing will become more important than concepts such as informed consent. Basically, it is a resurgence of the tension between the Kantian and the Hegelian view of ethics. The contours of macro-ethics will be elaborated notably as it is emerging in bioethical debates over biobanking and genetic databanks. (shrink)
Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.
Biomedical research has brought to the fore the issue of which rights and duties we have to each other and society. Several scholars have advocated reframing the notion of participation, arguing that we have a moral duty to participate in research from which we all benefit. However, less attention has been paid to how we justify and defend the concept of self-determination and what the implications are in a biomedical setting. The author discusses the value and importance of self-determination on (...) the basis of the framework of the liberal-communitarian debate. Biobank research is used as an example of a project wherein, through our participation, we confirm our sense of belonging to society and acknowledge our mutual dependence on each other. We need a richer concept of self-determination that encompasses both liberal and communitarian insights in order to make sense of the value we attach to self-determination. (shrink)
