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Biobanks are important resources for improving public health and individual care. Some legal frameworks can be more or less conducive to advancing the potential benefits of biobanks. The purpose of this article is to assess biobanking legislation and practices in Spain to determine how well they fare in such a regard. We focus here on some of the primary ethical values that ground relevant legislation and that we believe are consistent with promoting biobanking benefits: the value of scientific research; efficient use of scarce resources; and respect for the dignity of donors. We argue that although Spanish regulations advance these values in important ways, they also have provisions that undermine them and thus risk limiting the potential benefits of biobanks. We offer some suggestions for improvement.

The growing commercialization of science has raised concerns about financial conflicts of interest (COIs). Evidence suggests that such conflicts threaten the integrity of research and the well-being of research participants. Trying to minimize these negative effects, federal agencies, academic institutions, and publishers have developed conflict-of-interest policies. Among such policies, recommendations or requirements to disclose financial COIs to potential research participants and patients have become commonplace. Here, I argue that disclosing conflicts of interest to potential research participants fails to achieve the weighty moral goals that presumably ground such policies. This is so either because disclosure is simply a wrong means for achieving some of the goals in question or because, although disclosure could be an appropriate means for some of those goals, the way in which it is implemented prevents fulfillment of the desirable moral aim., (© 2023 by The Hastings Center. All rights reserved.)

Assessing the safety of biomedical technologies is an essential aspect of any sound ethical assessment. It is, however, not sufficient. Technologies do significantly more than what they are designed to accomplish. Bioethicists should pay more attention to the many ways in which technologies transform our world and ourselves., (© 2022 The Hastings Center.)

Bodily imagery elicits strong affective responses and is highly salient, potentially altering viewers' decision making. When clinicians engage surrogates in video calls showing the patient's body, several competing ethical issues must be considered. On the one hand, surrogates may require visual information to make informed decisions, and video technology closes crucial information gaps. On the other, video technology puts an increased amount of control in the hands of clinicians over how the patient's condition is perceived. This article explores some situations that can result in manipulation due to the affective impact of bodily images and the potential for selectivity and framing. Focusing on goals of care, the paper outlines the foremost ethical considerations for clinicians and provides recommendations for clinicians on how to reduce possible manipulation when making these video calls., (Copyright 2022 American Medical Association. All Rights Reserved.)

The use of embryonic genome editing tools is often touted as a way to ensure the birth of healthy and genetically related children. Many would agree that this is a worthy goal. Yet the purpose of this article is to argue that, if we are concerned with justice, accepting such a goal as morally appropriate commits one to rejecting the use of social resources for further development of embryo editing for reproductive purposes. This is so because there are safer and more effective means that can allow many more prospective parents to achieve the same valued goal and that can offer additional benefits., (© 2022 The Hastings Center.)

Pregnant women are insistently urged to limit or eliminate risks to their fetuses. This is done even when the risks to fetuses are only theoretical or minimal, and the health and well-being of the pregnant woman is at stake. When using reproductive and reprogenetic technologies, however, evaluations about what risks are acceptable to impose on embryos change radically. In the context of these technologies, women are not only allowed to impose risks on embryos, but actively encouraged to do so-insofar as they can be urged to use these technologies for various reasons. This article explores the problematic beliefs and social norms regarding motherhood that shape these apparently inconsistent risk evaluations.

It now seems technically feasible to culture human embryos beyond the "fourteen-day limit," which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen-day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen-day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high-quality research and public confidence in it., (© 2021 The Hastings Center.)

When the COVID-19 surge hit New York City hospitals, the Division of Medical Ethics at Weill Cornell Medical College, and our affiliated ethics consultation services, faced waves of ethical issues sweeping forward with intensity and urgency. In this article, we describe our experience over an eight-week period (16 March through 10 May 2020), and describe three types of services: clinical ethics consultation (CEC); service practice communications/interventions (SPCI); and organizational ethics advisement (OEA). We tell this narrative through the prism of time, describing the evolution of ethical issues and trends as the pandemic unfolded. We delineate three phases: anticipation and preparation, crisis management, and reflection and adjustment. The first phase focused predominantly on ways to address impending resource shortages and to plan for remote ethics consultation, and CECs focused on code status discussions with surrogates. The second phase was characterized by the dramatic convergence of a rapid increase in the number of critically ill patients, a growing scarcity of resources, and the reassignment/redeployment of staff outside their specialty areas. The third phase was characterized by the recognition that while the worst of the crisis was waning, its medium- and long-term consequences continued to pose immense challenges. We note that there were times during the crisis that serving in the role of clinical ethics consultant created a sense of dis-ease as novel as the coronavirus itself. In retrospect we learned that our activities far exceeded the familiar terrain of clinical ethics consultation and extended into other spheres of organizational life in novel ways that were unanticipated before this pandemic. To that end, we defined and categorized a middle level of ethics consultation, which we have termed service practice communication intervention (SPCI). This is an underappreciated dimension of the work that ethics consult services are capable of in times of crisis. We believe that the pandemic has revealed the many enduring ways that ethics consultation services can more robustly contribute to the ethical life of their institutions moving forward., (Copyright 2020 The Journal of Clinical Ethics. All rights reserved.)

Background : First-in-human clinical trials with stem cells for Parkinson's disease (PD) are on the horizon. Their epistemic success depends on ensuring the participation of a sufficient number and appropriately diverse group of patients with PD. Their ethical soundness requires that the research community ensures that subjects' decisions about whether to participate or not are consistent with participants' values, motivations, and goals. We sought to identify PD patients' knowledge, concerns, and expectations regarding early-phase stem cell research in PD. Methods : We conducted five semi-structured focus groups with patients with PD. Group discussions were recorded, transcribed, and coded to identify participants' knowledge, concerns, and expectations regarding participation in early stem cell clinical research in PD. Results : Four themes were generated from our data analysis: (1) participants' skepticism about the potential benefits of these trials; (2) their desire to obtain information about various aspects related to this research; (3) a recognition that accessing available knowledge was often difficult; and (4) the relevance of trusting relationships with various stakeholders. Conclusions : Participants expressed skepticism about the immediate impact of stem cell research. Nonetheless, such skepticism often reflected an appropriate consideration of the risks and potential benefits of participating in high-risk clinical trials. Despite their skepticism, participants were eager to learn more about stem cell research and clinical trials processes. They identified consistently trusted avenues of knowledge on these topics, but they often found it difficult to access relevant information or to determine its value.

The growing commercialization of scientific research has raised important concerns about industry bias. According to some evidence, so-called industry bias can affect the integrity of the science as well as the direction of the research agenda. I argue that conceptualizing industry's influence in scientific research in terms of bias is unhelpful. Insofar as industry sponsorship negatively affects the integrity of the research, it does so through biasing mechanisms that can affect any research independently of the source of funding. Talk about industry bias thus offers no insight into the particular epistemic shortcomings at stake. If the concern is with the negative effects that industry funding can have on the research agenda, conceptualizing this influence as bias obscures the ways in which such impact is problematic and limits our ability to offer solutions that can successfully address the concerns raised by the growing role of private funding in science.

Although shared decision-making is a standard in medical care, unilateral decisions through process-based conflict resolution policies have been defended in certain cases. In patients who do not stand to receive proportional clinical benefits, the harms involved in interventions such as cardiopulmonary resuscitation seem to run contrary to the principle of non-maleficence, and provision of such interventions may cause clinicians significant moral distress. However, because the application of these policies involves taking choices out of the domain of shared decision-making, they face important ethical and legal problems, including a recent challenge to their constitutionality. In light of these concerns, we suggest a re-conceptualization of informed non-dissent as an alternative approach in cases where the application of process-based policies is being considered. This clinician-directed communication model still preserves what is valuable in such policies and salvages professional integrity, while minimising ethical and legal challenges., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Anonymity remains the more common practice in gamete donations, but legislation prohibiting anonymity with a goal of protecting donor-conceived children's right to know their genetic origins is becoming more common. However, given the dearth of research investigating the function of anonymity for donors and recipients, it is unclear whether these policies will accomplish their goals. The aim of this study was to explore experiences with anonymity among oocyte donors and recipients who participated in an anonymous donor oocyte program and to understand the ways in which anonymity functions for them., Methods: Semistructured interviews were conducted with 50 women: 28 oocyte donors and 22 recipients who were recruited from an academic center for reproductive medicine in the United States., Results: Donors and recipients view anonymity both as a mechanism to protect the interests of all parties (recipients, donors, and donor-conceived children) and as a point of conflict. Specifically, three key areas were identified where both donors and recipients saw anonymity as having an important role: relieving anxieties about family structures and obligations; protecting their interests and those of donor-conceived children (while acknowledging where interests conflict); and managing the future., Conclusion: As gamete donation increasingly moves away from the practice of anonymity, examining why anonymity matters to stakeholders will be helpful in devising strategies to successfully implement identity-release options.

Anonymous gamete donation continues to be practised in most jurisdictions around the world, but this practice has come under increased scrutiny. Thus, several countries now mandate that donors be identifiable to their genetic offspring. Critics contend that anonymous gamete donation harms the interests of donor-conceived individuals and that protection of these interests calls for legal prohibition of anonymous donations. Among the vital interests that critics claim are thwarted by anonymous donation are an interest in having a strong family relationship, health interests, and an interest in forming a healthy identity. This article discusses each of these interests and examines what they could involve. The legislation in two countries is considered: Spain, which mandates anonymous gamete donation, and the UK, which prohibits such practice, to assess how these different legislations might or might not protect these vital interests.

First-in-human clinical trials of innovative medical procedures, such as cell transplantation for Parkinson's disease, present a variety of ethical challenges. In an era of rapidly developing stem cell technologies likely to be translated into clinical trials over the next few years, it is critical that ethical concerns be fully considered. One important undertaking is ensuring that research participants give free and truly informed consent. This will necessitate adequate disclosure of risks and benefits at a time when these are incompletely defined; ensuring understanding of a complex research protocol when there is significant possibility of therapeutic misconception; and careful determination of capacity for informed consent in patients with a neurodegenerative disorder that is known to affect cognition. Here we call attention to the ethical issues that researchers conducting these types of trials will face when trying to obtain a genuinely informed consent, and we suggest possible solutions., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

A growing number of jurisdictions hold that gamete donors must be identifiable to the children born with their eggs or sperm, on grounds that being able to know about one's genetic origins is a fundamental moral right. But the argument for that belief has not yet been adequately made.

The United States has experienced a boom in natural gas production due to recent technological innovations that have enabled natural gas to be produced from unconventional sources, such as shale. There has been much discussion about the costs and benefits of developing shale gas among scientists, policy makers, and the general public. The debate has typically revolved around potential gains in economics, employment, energy independence, and national security as well as potential harms to the environment, the climate, and public health. In the face of scientific uncertainty, national and international governments must make decisions on how to proceed. So far, the results have been varied, with some governments banning the process, others enacting moratoria until it is better understood, and others explicitly sanctioning shale gas development. These policies reflect legislature's preferences to avoid false negative errors or false positive ones. Here we argue that policy makers have a prima facie duty to minimize false negatives based on three considerations: (1) protection from serious harm generally takes precedence over the enhancement of welfare; (2) minimizing false negatives in this case is more respectful to people's autonomy; and (3) alternative solutions exist that may provide many of the same benefits while minimizing many of the harms., (© 2013.)

The commercialization of academic science has come to be understood as economically desirable for institutions, individual researchers, and the public. Not surprisingly, commercial activity, particularly that which results from patenting, appears to be producing changes in the standards used to evaluate scientists' performance and contributions. In this context, concerns about a gender gap in patenting activity have arisen and some have argued for the need to encourage women to seek more patents. They believe that because academic advancement is mainly dependent on productivity (Stuart and Ding in American Journal of Sociology 112:97-144, 2006; Azoulay et al. in Journal of Economic Behavior & Organization 63:599-623, 2007), differences in research output have the power to negatively impact women's careers. Moreover, in the case of patenting activity, they claim that the gender gap also has the potential to negatively affect society. This is so because scientific and technological advancement and innovation play a crucial role in contemporary societies. Thus, women's more limited involvement in the commercialization of science and technology can also be detrimental to innovation itself. Nevertheless, calls to encourage women to patent on grounds that such activity is likely to play a significant role in the betterment of both women's careers and society seem to be based on two problematic assumptions: (1) that the methods to determine women's productivity in patenting activities are an appropriate way to measure their research efforts and the impact of their work, and (2) that patenting, particularly in academia, benefits society. The purpose of this paper is to call into question these two assumptions.

The practice of sex selection for social reasons has raised serious criticism. Advocates of this practice, however, insist that objections to it are unfounded and that legal bans are ethically unjustified. Usually, proponents use a rights-based liberal approach as the framework to evaluate this practice. Under this framework, reproductive choice is a basic freedom and interference with individuals' autonomous reproductive choices is illegitimate, unless their actions are shown to seriously harm others. As persuasive as this framework might be in relation to many aspects of reproduction, I argue that it is inappropriate when dealing with sex selection for social purposes.

Despite increasing awareness of the ways in which non-epistemic values play roles in science, many scientists remain reluctant to acknowledge values at stake in their own work. Even when research clearly relates to risk assessment and establishing public policy, contexts in which the presence of values is less likely to be contentious, scientists tend to present such research as merely involving empirical questions about what the evidence is. As a result, debates over policy-related science tend to be framed as purely epistemic debates over the state of the evidence. We argue that this neglects the important ways that ethical and social values play legitimate roles in judgments about what we take to be evidence for a particular policy. Using the case of recent disputes about the relative safety of home birth, we argue that although the debate has been framed as a purely scientific one about the empirical evidence for home birth, it actually involves disagreements about underlying value assumptions. If our claims are correct, then in order to move the debate forward, scientists will need to engage in a critical discussion about the values at stake.

In a recent article, Alasdair Cochrane argues for the need to have an undignified bioethics. His is not, of course, a call to transform bioethics into an inelegant, pathetic discipline, or one failing to meet appropriate disciplinary standards. His is a call to simply eliminate the concept of human dignity from bioethical discourse. Here I argue that he fails to make his case. I first show that several of the flaws that Cochrane identifies are not flaws of the conceptions of dignity he discusses but rather flaws of his, often problematic, understanding of such conceptions. Second, I argue that Cochrane's case against the concept of human dignity goes too far. I thus show that were one to agree that these are indeed flaws that require that we discard our ethical concepts, then following Cochrane's recommendations would commit us not only to an undignified bioethics, i.e. a bioethics without dignity, but to a bioethics without much ethics at all., (© 2010 Blackwell Publishing Ltd.)

For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

Current developments in biomedicine are presenting us with difficult ethical decisions and raising complex policy questions about how to regulate these new developments. Particularly vexing for governments have been issues related to human embryo experimentation. Because some of the most promising biomedical developments, such as stem cell research and nuclear somatic transfer, involve such experimentation, several international bodies have drafted documents aimed to provide guidance to governments when developing biomedical science policy. Here I focus on two such documents: the Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being and the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being. I argue that by using human dignity as a criterion to determine the permissibility of particular human embryo research practices, these documents cannot aid in identifying research that would be contrary to human dignity. Thus, they fail to guide public policy on embryo experimentation. Their use of human dignity as a criterion makes their task of offering guidance unfeasible because the concept as used in these documents is too vague and is applied in contradictory ways. I discuss the main goals of these documents and their claims in relation to human embryo research. I then discuss how they have influenced public policy in several countries. Finally, I show that although these Council of Europe treaties attempt to serve as public policy guides in the area of embryo research, they fail to do so., (© 2009 Blackwell Publishing Ltd.)

Recent advances in biotechnologies have led to speculations about enhancing human beings. Many of the moral arguments presented to defend human enhancement technologies have been limited to discussions of their risks and benefits. The author argues that in so far as ethical arguments focus primarily on risks and benefits of human enhancement technologies, these arguments will be insufficient to provide a robust defence of these technologies. This is so because the belief that an assessment of risks and benefits is a sufficient ethical evaluation of these technologies incorrectly presupposes that risk assessments do not involve value judgements. Second, it presupposes a reductionist conception of ethics as merely a risk management instrument. Each of these assumptions separates ethical evaluation from discussion and appraisal of ends and means and thus leaves important--indeed, essential--ethical considerations out of view. Once these problematic assumptions are rejected, it becomes clear that an adequate defence of human enhancement technologies requires more than a simple balance of their risks and benefits.

Several have argued that the aims of scientific research are not always independent of social and ethical values. Yet this is often assumed only to have implications for decisions about what is studied, or which research projects are funded, and not for methodological decisions or standards of evidence. Using the case of the recently developed HPV vaccines, we argue that the social aims of research can also play important roles in justifying decisions about (1) how research problems are defined in drug development, (2) evidentiary standards used in testing drug "success", and (3) clinical trial methodology. As a result, attending to the social aims at stake in particular research contexts will produce more rational methodological decisions as well as more socially relevant science.

New science policy initiatives are encouraging multidisciplinary collaborations between social scientists, humanists, biomedical scientists, and engineers. Although these policy initiatives are not always clear about how such interactions should take place, the idea is that social scientists and humanists can bring a broader perspective to the table, as well as highlight a variety of matters that are often not addressed by natural scientists and engineers. This article focuses on collaborations between philosophers and biomedical scientists in order to discuss how interdisciplinary collaborations may address ethical, social, and environmental concerns in ways that lead to improvements in people's health and quality of life. The article concludes with a consideration of some of the challenges that such collaborations face.

The disclosure policies of scientific journals now require that investigators provide information about financial interests relevant to their research. The main goals of these policies are to prevent bias from occurring, to help identify bias when it occurs, and to avoid the appearance of bias. We argue here that such policies do little to help achieve these goals, and we suggest more effective alternatives.

Most agree that the recent decades-long boom in biomedical research discoveries has not had a sufficient effect on the public's health. To overcome some of the barriers to speeding clinical and translational (C/T) research, the National Institutes of Health has established the Institutional Clinical and Translational Science Award (CTSA). To explore whether the CTSA proposal addresses major C/T barriers and whether funded institutions offer adequate solutions, the authors reviewed the obstacles to C/T research described in the literature and examined the completeness of the solutions offered by the 12 initial CTSA awardees. Through an analysis of the literature, the authors categorized C/T barriers into three categories (research workforce, research operations, and organizational silos). They then analyzed each CTSA proposal regarding the types of programs offered to address these barriers. They found that, in general, institutions developed detailed programs to address research workforce and research operations barriers but had limited to no solutions for organizational silos. The authors suggest that differences in how barriers are addressed are consistent with the degree of control that CTSA centers have over these obstacles and solutions. They argue that although CTSA centers might have an important role in successfully addressing some of the barriers to C/T research, CTSA centers might ultimately have difficulties achieving their purported goal of facilitating and increasing the efficiency and speed of C/T research because of a lack of control over solutions to some important obstacles facing such research.

Discussions about whether new biomedical technologies threaten or violate human dignity are now common. Indeed, appeals to human dignity have played a central role in national and international debates about whether to allow particular kinds of biomedical investigations. The focus of this paper is on chimera research. I argue here that both those who claim that particular types of human-nonhuman chimera research threaten human dignity and those who argue that such threat does not exist fail to make their case. I first introduce some of the arguments that have been offered supporting the claim that the creation of certain sorts of chimeras threatens or violates human dignity. I next present opponents' assessments of such arguments. Finally I critically analyze both the critics' and the supporters' claims about whether chimera research threatens human dignity.

In our current political climate, decisions about whether to fund research on new stem cell lines or do chimera experiments seem to arbitrarily depend on the religious and economic interests of the administration. Not unreasonably, many scientists believe that science should be left to its own devices in determining research priorities and conducting research. When nonscientific considerations constrain research, it is claimed that values are inappropriately dictating scientific decisions. This assumes, however, that all ethical and social values are irrelevant to such decisions. Using the case of embryonic stem cell research to illustrate the debate, we argue here that this position is untenable for several reasons. First, the aims of science, particularly in the case of the biomedical sciences, cannot be completely extricated from ethical and social aims. Hence, value judgments will be necessary to assess research priorities and methodologies. Second, maintaining this position is inconsistent with actual scientific practices. Scientists already recognize that there are some ethical values that appropriately constrain research, such as in human subject experimentation. Therefore, the problem cannot be that ethical values are brought to bear on science per se but that those values are highly questionable or are imposed by those who often lack the scientific expertise necessary to understand how ethical concerns may relate to the research. Finally, we argue that to the extent value judgments must be made, consensus about such values should be reached by a diverse group of stakeholders, including scientists, community members, policymakers, and ethicists.