Informed Consent and Genetic Information

In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional attitude, so referentially opaque: consent is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent.     

THE FUTURE OF BIOETHICS: THREE DOGMAS AND A CUP OF HEMLOCK

In this paper I argue that bioethics is in crisis and that it will not have a future unless it begins to embrace a more Socratic approach to its leading assumptions. The absence of a critical and sceptical spirit has resulted in little more than a dominant ideology. I focus on three key issues. First, that too often bioethics collapses into medical ethics. Second, that medical ethics itself is beset by a lack of self‐reflection that I characterize here as a commitment to three dogmas. Third, I offer a more positive perspective by suggesting how bioethics may benefit from looking towards public health ethics as a new source of inspiration and direction.     

The genesis of public health ethics

As bioethics emerged in the 1960s and 1970s and began to have enormous impacts on the practice of medicine and research – fuelled, by broad socio‐political changes that gave rise to the struggle of women, African Americans, gay men and lesbians, and the antiauthoritarian impulse that characterised the New Left in democratic capitalist societies – little attention was given to the question of the ethics of public health. This was all the more striking since the core values and practices of public health, often entailing the subordination of the individual for the common good, seemed opposed to the ideological impulses of bioethics. Of what relevance is autonomy‐focused bioethics for public health, with its mix of justifications including those that are either implicitly or explicitly paternalistic or that seek to impose strictures on individuals and communities in the name of collective welfare? To examine the deep divide between the central commitments of bioethics and the values that animate the practice of public health, we focus on a series of controversies implicating the concepts of privacy, liberty, and paternalism. Recognising the role of moral values in decision‐making was a signal contribution of bioethics in its formative period. Over the past three decades a broad array of perspectives emerged under the rubric of bioethics but individualism remains central. As we commence the process of shaping an ethics of public health, it is clear that bioethics is the wrong place to start when thinking about the balances required in defence of the public's health.     

Disclosure of personal medical information: differences among parents and affected adults for genetic and nongenetic conditions

Protecting the confidentiality of medical information has been an issue of great interest in the fields of bioethics, public policy, and law. Few empirical studies have addressed patient experiences and attitudes toward disclosure of private medical information in multiple contexts such as health insurance, employment, and the family. Furthermore, it is unclear whether differences exist in experiences and attitudes about privacy between those living with a serious medical condition versus those who have a child with a medical condition. The study sought to determine whether attitudes and experiences related to medical privacy and confidentiality differ between affected adults and parents of affected children. Interviews were conducted with 296 adults and parents of children with sickle cell disease (SCD), cystic fibrosis (CF), or diabetes mellitus (DM). This cross-sectional study collected data regarding their experiences, attitudes, and beliefs concerning medical privacy and confidentiality. Multinomial logistic regression analysis was conducted on quantitative data. Qualitative analysis was conducted on data from open-ended response items. Parents disclose their child's diagnosis to others more often than affected adults disclose their own disease status. Parents are less likely than affected adults to regret their disclosure, to hope others do not find out, to have been pressured to share information, and to be asked about their disease by employers. Affected adults express greater concern about disclosure, a greater prevalence and greater fear of discrimination, and experience greater pressure from family members to disclose. Clinicians and researchers working with these populations should consider these differences in privacy and disclosure. Further study is necessary to examine the implications of these differences in attitudes and experiences concerning insurance, employment, and social interactions among persons with these conditions.     

THE VIRTUE ETHICS APPROACH TO BIOETHICS

This paper discusses the viability of a virtue‐based approach to bioethics. Virtue ethics is clearly appropriate to addressing issues of professional character and conduct. But another major remit of bioethics is to evaluate the ethics of biomedical procedures in order to recommend regulatory policy. How appropriate is the virtue ethics approach to fulfilling this remit? The first part of this paper characterizes the methodology problem in bioethics in terms of diversity, and shows that virtue ethics does not simply restate this problem in its own terms. However, fatal objections to the way the virtue ethics approach is typically taken in bioethics literature are presented in the second section of the paper. In the third part, a virtue‐based approach to bioethics that avoids the shortcomings of the typical one is introduced and shown to be prima facie plausible. The upshot is an inviting new direction for research into bioethics' methodology.     

影响上海市临床医师对基因技术与生命伦理认知的因素

通过上海市临床医师问卷调查,应用Logistic模型分析临床医师对基因技术与生命伦理认知的影响因素。结果显示,临床医师的性别、年龄、学历和职称等人口学因素主要影响对基因技术优势的认知,基因工作经历、伦理委员会任职经历、对伦理与相关法规的知晓度主要影响对基因技术风险的认知。建议加强基因伦理与相关法规教育,重视部属或市属综合性医院基因技术研究与应用的管理。     

Monological versus dialogical consciousness: two epistemological views on the use of theory in clinical ethical practice

In this article, we argue that a critical examination of epistemological and anthropological presuppositions might lead to a more fruitful use of theory in clinical-ethical practice. We differentiate between two views of conceptualizing ethics, referring to Charles Taylors' two epistemological models: 'monological' versus 'dialogical consciousness'. We show that the conception of ethics in the model of 'dialogical consciousness' is radically different from the classical understanding of ethics in the model of 'monological consciousness'. To reach accountable moral judgments, ethics cannot be conceptualized as an individual enterprise, but has to be seen as a practical endeavor embedded in social interactions within which moral understandings are being negotiated. This view has specific implications for the nature and the role of ethical theory. Theory is not created in the individual mind of the ethicist; the use of theory is part of a joint learning process and embedded in a cultural context and social history. Theory is based upon practice, and serves practical purposes. Thus, clinical ethics support is both practical and theoretical.     

Relational autonomy,care, and Jehovah's Witnesses in Germany

Drawing from an ethics of care, relational approaches to autonomy have recently emerged in bioethics. Unlike individual autonomy with its emphasis on patients’ rights, choice, and self‐determination which has been the hallmark of bioethics consistent with the ideology of individualism in neoliberal democracies in Western countries, relational autonomy highlights the relatedness, interdependency, and social embeddedness of patients. By examining the mediating role that male Hospital Liaison Committee members in Germany play in facilitating care that supports Jehovah's Witnesses’ refusal of blood transfusions, this article moves beyond ‘dyadic relations’ and contexts of caregiving. It also contributes to a deeper understanding of care and relational conceptualizations of Witness patients’ autonomy globally.     

Company disclosure and consumer perceptions of the privacy implications of direct-to-consumer genetic testing

This study examines the way direct-to-consumer genetic testing (DTCGT) companies communicate privacy information and how consumers understand privacy implications of DTCGT. We first conducted an analysis of DTCGT websites to determine what information they provide regarding the treatment of consumer information and samples. 86 companies offered DTCGT services that could be purchased online from Canada. We then surveyed 415 consumers (180 had purchased, 235 considered but did not purchase DTCGT). While most websites had some privacy information, few provided sufficient information for consumers to make informed purchase decisions. Nearly half of participants reported reading the company’s privacy policy and many felt they received enough information about privacy implications, but their expectations were generally not consistent with company practices. The most common expectation was that the company would share results only with them and destroy their sample after testing. We discuss these issues regarding privacy expectations in the context of DTCGT.     

Relative Values: Perspectives on a Neuroimaging Technology From Above and Within the Ethical Landscape

In this paper we contribute to “sociology in bioethics” and help clarify the range of ways sociological work can contribute to ethics scholarship. We do this using a case study of an innovative neurotechnology, functional magnetic resonance imaging, and its use to attempt to diagnose and communicate with severely brain-injured patients. We compare empirical data from interviews with relatives of patients who have a severe brain injury with perspectives from mainstream bioethics scholars. We use the notion of an “ethical landscape” as an analogy for the different ethical positions subjects can take—whereby a person’s position relative to the landscape makes a difference to the way they experience and interact with it. We show that, in comparison to studying abstract ethics “from above” the ethical landscape, which involves universal generalizations and global judgements, studying ethics empirically “from the ground,” within the ethical landscape foregrounds a more plural and differentiated picture. We argue it is important not to treat empirical ethics as secondary to abstract ethics, to treat on-the-ground perspectives as useful only insofar as they can inform ethics from above. Rather, empirical perspectives can illuminate the plural vantage points in ethical judgments, highlight the “lived” nature of ethical reasoning, and point to all ethical vantage points as being significant. This is of epistemic importance to normative ethics, since researchers who pay attention to the various positions in and trajectories through the ethical landscape are unlikely to think about ethics in terms of abstract agency—as can happen with top-down ethics—or to elide agency with the agency of policymakers. Moreover, empirical perspectives may have transformative implications for people on the ground, especially where focus on the potential harms and benefits they face brings their experiences and interests to the forefront of ethical and policy discussion.     

From genetic privacy to open consent

Recent advances in high-throughput genomic technologies are showing concrete results in the form of an increasing number of genome-wide association studies and in the publication of comprehensive individual genome-phenome data sets. As a consequence of this flood of information the established concepts of research ethics are stretched to their limits, and issues of privacy, confidentiality and consent for research are being re-examined. Here, we show the feasibility of the co-development of scientific innovation and ethics, using the open-consent framework that was implemented in the Personal Genome Project as an example.     

The ethics and obligations of long-term ethnographic relationships: revelatory moments and the concept of solidarity

This article reflects on an ethical and revelatory moment in the development of my long-term fieldwork relationships with people of the Lihir Islands in Papua New Guinea. Ethnographic research globally is now shaped through formal processes of ethical review, with the requirements for informed consent, privacy, and consideration of harm and beneficence. Researchers then have to put these procedures into practice, often encountering the need to weigh competing ethical principles, particularly when unforeseen events occur. Reflexivity has been argued to be crucial on these occasions. Yet both ethical codes and reflexivity fall short of managing ethical and relational implications of long-term field relationships. This article suggests that the concept of solidarity as theorized recently in bioethics may be helpful, particularly the discernment of three layers of relationship. What responsibilities might we as anthropologists have to the people we work with that go beyond procedural ethics? And how do moments such as the one described in this article shape ongoing field research?     

The Disclosure of Genetic Information: A Human Research Ethics Perspective

Increasing emphasis on genetic research means that growing numbers of human research projects in Australia will involve complex issues related to genetic privacy, familial information and genetic epidemiology. The Office of Population Health Genomics (Department of Health, Western Australia) hosted an interactive workshop to explore the ethical issues involved in the disclosure of genetic information, where researchers and members of human research ethics committees (HRECs) were asked to consider several case studies from an ethical perspective. Workshop participants used a variety of approaches to examine the complex ethical issues encountered, but did not consistently refer to the values and principles outlined in the National Statement on Ethical Conduct in Human Research (NHMRC 2007) or apply rational ethical approaches. Overall, the data suggested that both researchers and HREC members may benefit from further education and support regarding the application of ethical frameworks to the issues encountered in genetic research.     

International research ethics: progress, but not perfection

To the uninitiated researcher, bioethics can be a confusing and sometimes bureaucratic process. The recent debates in international research ethics have both increased understanding of contentious issues while extending confusion to the international arena. Here, we attempt to demystify bioethics, or more specifically international research ethics, by defining ethics in the context of morality, reviewing core Western ethical principles, and highlighting challenges in international research ethics.     

Consent to ‘personal’ genomics and privacy

Direct-to-consumer genetic tests and population genome research challenge traditional notions of privacy and consentThe concerns about genetic privacy in the 1990s were largely triggered by the Human Genome Project (HGP) and the establishment of population biobanks in the following decade. Citizens and lawmakers were worried that genetic information on people, or even subpopulations, could be used to discriminate or stigmatize. The ensuing debates led to legislation both in Europe and the USA to protect the privacy of genetic information and prohibit genetic discrimination.Notions of genetic determinism have also been eroded as population genomics research has discovered a plethora of risk factors that offer only probabilistic value…Times have changed. The cost of DNA sequencing has decreased markedly, which means it will soon be possible to sequence individual human genomes for a few thousand dollars. Notions of genetic determinism have also been eroded as population genomics research has discovered a plethora of risk factors that offer only probabilistic value for predicting disease. Nevertheless, there are several increasingly popular internet genetic testing services that do offer predictions to consumers of their health risks on the basis of genetic factors, medical history and lifestyle. Also, not to be underestimated is the growing popularity of social networks on the internet that expose the decline in traditional notions of the privacy of personal information. It was only a matter of time until all these developments began to challenge the notion of genetic privacy.For instance, the internet-based Personal Genome Project asks volunteers to make their personal, medical and genetic information publicly available so as, “to advance our understanding of genetic and environmental contributions to human traits and to improve our ability to diagnose, treat, and prevent illness” (www.personalgenomes.org). The Project, which was founded by George Church at Harvard University, has enrolled its first 10 volunteers and plans to expand to 100,000. Its proponents have proclaimed the limitations, if not the death, of privacy (Lunshof et al, 2008) and maintain that, under the principle of veracity, their own personal genomes will be made public. Moreover, they have argued that in a socially networked world there can be no total guarantee of confidentiality. Indeed, total protection of privacy is increasingly unrealistic in an era in which direct-to-consumer (DTC) genetic testing is offered on the internet (Lee & Crawley, 2009) and forensic technologies can potentially ‘identify'' individuals in aggregated data sets, even if their identity has been anonymized (Homer et al, 2008).Since the start of the HGP in the 1990s, personal privacy and the confidentiality of genetic information have been important ethical and legal issues. Their ‘regulatory'' expression in policies and legislation has been influenced by both genetic determinism and exceptionalism. Paradoxically, there has been a concomitant emergence of collaborative and international consortia conducting genomics research on populations. These consortia openly share data, on the premise that it is for public benefit. These developments require a re-examination of an ‘ethics of scientific research'' that is founded solely on the protection and rights of the individual.… total protection of privacy is increasingly unrealistic in an era in which direct-to-consumer (DTC) genetic testing is offered on the internetAlthough personalized medicine empowers consumers and democratizes the sharing of ‘information'' beyond the data sharing that characterizes population genomics research (Kaye et al, 2009), it also creates new social groups based on beliefs of common genetic susceptibility and risk (Lee & Crawley, 2009). The increasing allure of DTC genetic tests and the growth of online communities based on these services also challenges research in population genomics to provide the necessary scientific knowledge (Yang et al, 2009). The scientific data from population studies might therefore lend some useful validation to the results from DTC, as opposed to the probabilistic ‘harmful'' information that is now provided to consumers (Ransohoff & Khoury, 2010; Action Group on Erosion, Technology and Concentration, 2008). Population data clearly erodes the linear, deterministic model of Mendelian inheritance, in addition to providing information on inherited risk factors. The socio-demographic data provided puts personal genetic risk factors in a ‘real environmental'' context (Knoppers, 2009).Thus, beginning with a brief overview of the principles of data sharing and privacy under both population and consumer testing, we will see that the notion of identifiability is closely linked to the definition of what constitutes ‘personal'' information. It is against this background that we need to examine the issue of consumer consent to online offers of genetic tests that promise whole-genome sequencing and analysis. Moreover, we also demonstrate the need to restructure ethical reviews of genetic research that are not part of classical clinical trials and that are non-interventionist, such as population studies.The HGP heralded a new open access approach under the Bermuda Principles of 1996: “It was agreed that all human genomic sequence information, generated by centres funded for large-scale human sequencing, should be freely available and in the public domain in order to encourage research and development and to maximise its benefit to society” (HUGO, 1996). Reaffirmed in 2003 under the Fort Lauderdale Rules, the premise was that, “the scientific community will best be served if the results of community resource projects are made immediately available for free and unrestricted use by the scientific community to engage in the full range of opportunities for creative science” (HUGO, 2003). The international Human Genome Organization (HUGO) played an important role in achieving this consensus. Its Ethics Committee considered genomic databases as “global public goods” (HUGO Ethics Committee, 2003). The value of this information—based on the donation of biological samples and health information—to realize the benefits of personal genomics is maximized through collaborative, high-quality research. Indeed, it could be argued that, “there is an ethical imperative to promote access and exchange of information, provided confidentiality is protected” (European Society of Human Genetics, 2003). This promotion of data sharing culminated in a recent policy on releasing research data, including pre-publication data (Toronto International Data Release Workshop, 2009).There is room for improvement in both the personal genome and the population genome endeavoursIn its 2009 Guidelines for Human Biobanks and Genetic Research Databases, the Organization for Economic Cooperation and Development (OECD) states that the “operators of the HBGRD [Human Biobanks and Genetic Research Databases] should strive to make data and materials widely available to researchers so as to advance knowledge and understanding.” More specifically, the Guidelines propose mechanisms to ensure the validity of access procedures and applications for access. In fact, they insist that access to human biological materials and data should be based on “objective and clearly articulated criteria [...] consistent with the participants'' informed consent”. Access policies should be fair, transparent and not inhibit research (OECD, 2009).In parallel to such open and public science was the rise of privacy protection, particularly when it concerns genetic information. The United Nations Educational, Scientific and Cultural Organization''s (UNESCO) 2003 International Declaration on Human Genetic Data (UNESCO, 2003) epitomizes this approach. Setting genetic information apart from other sensitive medical or personal information, it mandated an “express” consent for each research use of human genetic data or samples in the absence of domestic law, or, when such use “corresponds to an important public interest reason”. Currently, however, large population genomics infrastructures use a broad consent as befits both their longitudinal nature as well as their goal of serving future unspecified scientific research. The risk is that ethics review committees that require such continuous “express” consents will thereby foreclose efficient access to data in such population resources for disease-specific research. It is difficult for researchers to provide proof of such “important public interest[s]” in order to avoid reconsents.Personal information itself refers to identifying and identifiable information. Logically, a researcher who receives a coded data set but who does not have access to the linking keys, would not have access to ‘identifiable'' information and so the rules governing access to personal data would not apply (Interagency Advisory Panel on Research Ethics, 2009; OHRP, 2008). In fact, in the USA, such research is considered to be on ‘non-humans'' and, in the absence of institutional rules to the contrary, it would theoretically not require research ethics approval (www.vanderbilthealth.com/main/25443).… the ethics norms that govern clinical research are not suited for the wide range of data privacy and consent issues in today''s social networks and bioinformatics systemsNevertheless, if the samples or data of an individual are accessible in more than one repository or on DTC internet sites, a remote possibility remains that any given individual could be re-identified (Homer et al, 2008). To prevent the restriction of open access to public databases, owing to the fear of re-identifiability, a more reasonable approach is necessary; “[t]his means that a mere hypothetical possibility to single out the individual is not enough to consider the persons as ‘identifiable''” (Data Protection Working Party, 2007). This is a proportionate and important approach because fundamental genomic ‘maps'' such as the International HapMap Project (www.hapmap.org) and the 1000 Genomes project (www.1000genomes.org) have stated as their goal “to make data as widely available as possible to further scientific progress” (Kaye et al, 2009). What then of the nature of the consent and privacy protections in DTC genetic testing?The Personal Genome Project makes the genetic and medical data of its volunteers publicly available. Indeed, there is a marked absence of the traditional confidentiality and other protections of the physician–patient relationship across such sites; overall, the degree of privacy protection by commercial DTC and other sequencing enterprises varies. The company 23andMe allows consumers to choose whether they wish to disclose personal information, but warns that disclosure of personal information is also possible “through other means not associated with 23andMe, […] to friends and/or family members […] and other individuals”. 23andMe also announces that it might enter into commercial or other partnerships for access to its databases (www.23andme.com). deCODEme offers tiered levels of visibility, but does not grant access to third parties in the absence of explicit consumer authorization (www.decodeme.com). GeneEssence will share coded DNA samples with other parties and can transfer or sell personal information or samples with an opt-out option according to their Privacy Policy, though the terms of the latter can be changed at any time (www.geneessence.com). Navigenics is transparent: “If you elect to contribute your genetic information to science through the Navigenics service, you allow us to share Your Genetic Data and Your Phenotype Information with not-for-profit organizations who perform genetic or medical research” (www.navigenics.com). Finally, SeqWright separates the personal information of its clients from their genetic information so as to avoid access to the latter in the case of a security breach (www.seqwright.com).Much has been said about the lack of clinical utility and validity of DTC genetic testing services (Howard & Borry, 2009), to say nothing of the absence of genetic counsellors or physicians to interpret the resulting probabilistic information (Knoppers & Avard, 2009; Wright & Kroese, 2010). But what are the implications for consent and privacy considering the seemingly divergent needs of ensuring data sharing in population projects and ‘protecting'' consumer-citizens in the marketplace?At first glance, the same accusations of paternalism levelled at ethics review committees who hesitate to respect the broad consent of participants in population databases could be applied to restraining the very same citizens from genetic ‘info-voyeurism'' on the internet. But, it should be remembered that citizen empowerment, which enables their participation both in population projects and in DTC, is expressed within very different contexts. Population biobanks, by the very fact of their broad consent and long-term nature, have complex security systems and are subject to governance and ongoing ethical monitoring and review. In addition, independent committees evaluate requests for access (Knoppers & Abdul-Rahman, 2010). The same cannot be said for the governance of the DTC companies just presented.There is room for improvement in both the personal genome and the population genome endeavours. The former require regulatory approaches to ensure the quality, safety, security and utility of their services. The latter require further clarification of their ongoing funding and operations and more transparency to the public as researchers begin to access these resources for disease-specific studies (Institute of Medicine, 2009). Public genomic databases should be interoperable and grant access to authenticated researchers internationally in order to be of utility and statistical significance (Burton et al, 2009). Moreover, to enable international access to such databases for disease-specific research means that the interests of publicly funded research and privacy protection must be weighed against each other, rather than imposing a requirement that research has to demonstrate that the public interest substantially outweighs privacy protection (Weisbrot, 2009). Collaboration through interoperability has been one of the goals of the Public Population Project in Genomics (P³G; www.p3g.org) and, more recently, of the Biobanking and Biomolecular Resources Research Infrastructure (www.bbmri.eu).Even if the tools for harmonization and standardization are built and used, will trans-border data flow still be stymied by privacy concerns? The mutual recognition between countries of privacy equivalent approaches—that is, safe harbour—the limiting of access to approved researchers and the development of international best practices in privacy, security and transparency through a Code of Conduct along with a system for penalizing those who fail to respect such norms, would go some way towards maintaining public trust in genomic and genetic research (P3G Consortium et al, 2009). Finally, consumer protection agencies should monitor DTC sites under a regulatory regime, to ensure that these companies adhere to their own privacy policies.… genetic information is probabilistic and participating in population or on-line studies may not create the fatalistic and harmful discriminatory scenarios originally perceived or imaginedMore importantly in both contexts, the ethics norms that govern clinical research are not suited for the wide range of data privacy and consent issues in today''s social networks and bioinformatics systems. One could go further and ask whether the current biomedical ethics review system is inadequate—if not inappropriate—in these ‘data-driven research'' contexts. Perhaps it is time to create ethics review and oversight systems that are particularly adapted for those citizens who seek either to participate through online services or to contribute to population research resources. Both are contexts of minimal risk and require structural governance reforms rather than the application of traditional ethics consent and privacy review processes that are more suited to clinical research involving drugs or devices. In this information age, genetic information is probabilistic, and participating in population or online studies might not create the fatalistic and harmful discriminatory scenarios originally perceived or imagined. The time is ripe for a change in governance and regulatory approaches, a reform that is consistent with what citizens seem to have already understood and acted on.? Open in a separate windowBartha Maria Knoppers     

From Secrets of Life to the Life of Secrets: Tracing Genetic Knowledge as Genealogical Ethics in Biomedical Britain

I argue that the facts of a 'genealogical ethics' are built up over time as local moralities of information disclosure and non-disclosure. In the context of predictive genetic testing technologies, family members must discriminate between genetic information that they think is 'good' to know or make known, and knowledge that they think is 'bad' to tell and share with others. But attempts to deal with the kinship implications of genetic foreknowledge frequently entail unresolved processes of moral decision-making, both within and across the generations. Seen as embodied experiences of moral reckoning, these genealogical knowledge dilemmas also implicate a myriad of interests and divergent claims beyond the life of any one person. This article considers why a specifically anthropological formulation of 'genealogical ethics' challenges the conceptual premiss of individual autonomy underpinning the 'right to know' debates of mainstream Western bioethics.     

Bioethics for human geneticists: models for reasoning and methods for teaching.

The ethical issues raised by the Human Genome Project (HGP) and by human genetics in general are not entirely novel. In fact, the ethical issues surrounding genetic research and the provision of genetic services fit into the evolution of bioethics, a field of inquiry which has its roots in concerns of the 1970s, concerns about the dignity and self-determination of individuals and about the development of medical technologies. Although bioethics has been largely occupied with patient-centered concerns, attention is currently shifting toward socially oriented issues, such as the justice of the existing health-care system. Genetic counseling has already incorporated many of the lessons of early bioethics and, as a profession, adheres to a consultand-centered ethic which reflects the values incorporated into the doctrine of informed consent, which is a cornerstone of bioethics. The mandate of the Ethical, Legal, and Social Implications Program of the HGP--to anticipate ethical problems arising from advances in genetics and to educate the public about genetics--reflects not only the nonpaternalistic approach of early bioethics but also bioethics' increasing attention to the ethical import of systemic and institutional factors, as well as an anticipatory and preventive approach to dealing with ethical concerns. Because bioethics has so much to contribute to current consideration of ethical issues in human genetics, it is important to provide training in ethics to those working in the field. Guidelines for using a case-oriented approach are suggested.     

Public Opinion about the Importance of Privacy in Biobank Research

Concerns about privacy may deter people from participating in genetic research. Recruitment and retention of biobank participants requires understanding the nature and magnitude of these concerns. Potential participants in a proposed biobank were asked about their willingness to participate, their privacy concerns, informed consent, and data sharing. A representative survey of 4659 U.S. adults was conducted. Ninety percent of respondents would be concerned about privacy, 56% would be concerned about researchers having their information, and 37% would worry that study data could be used against them. However, 60% would participate in the biobank if asked. Nearly half (48%) would prefer to provide consent once for all research approved by an oversight panel, whereas 42% would prefer to provide consent for each project separately. Although 92% would allow academic researchers to use study data, 80% and 75%, respectively, would grant access to government and industry researchers. Concern about privacy was related to lower willingness to participate only when respondents were told that they would receive $50 for participation and would not receive individual research results back. Among respondents who were told that they would receive $200 or individual research results, privacy concerns were not related to willingness. Survey respondents valued both privacy and participation in biomedical research. Despite pervasive privacy concerns, 60% would participate in a biobank. Assuring research participants that their privacy will be protected to the best of researchers'' abilities may increase participants'' acceptance of consent for broad research uses of biobank data by a wide range of researchers.     

The birth of the empirical turn in bioethics

Since its origin, bioethics has attracted the collaboration of few social scientists, and social scientific methods of gathering empirical data have remained unfamiliar to ethicists. Recently, however, the clouded relations between the empirical and normative perspectives on bioethics appear to be changing. Three reasons explain why there was no easy and consistent input of empirical evidence in bioethics. Firstly, interdisciplinary dialogue runs the risk of communication problems and divergent objectives. Secondly, the social sciences were absent partners since the beginning of bioethics. Thirdly, the meta-ethical distinction between 'is' and 'ought' created a 'natural' border between the disciplines. Now, bioethics tends to accommodate more empirical research. Three hypotheses explain this emergence. Firstly, dissatisfaction with a foundationalist interpretation of applied ethics created a stimulus to incorporate empirical research in bioethics. Secondly, clinical ethicists became engaged in empirical research due to their strong integration in the medical setting. Thirdly, the rise of the evidence-based paradigm had an influence on the practice of bioethics. However, a problematic relationship cannot simply and easily evolve into a perfect interaction. A new and positive climate for empirical approaches has arisen, but the original difficulties have not disappeared.