Inmaculada de Melo-Martin

Recent discussion on the need to reassess research ethics standards has called into question familiar concepts such as equipoise, coercion, undue inducement, and the protection of vulnerable subjects. Reassessment of these concepts can be useful for a variety of reasons. It can eliminate conceptual murkiness, can assist in the proposal of regulations to better protect human subjects, and can elucidate ethical concerns. In this essay, I call attention here to a different, and often neglected, reason why reassessment of research ethics concepts can be helpful. It can undermine the all-too-common practice of taking as a given the social and political conditions in which biomedical research takes place and can encourage the inclusion of broader questions about social justice, human flourishing, or about the importance of taking into account the social determinants of health and disease. I will focus on some recent attempts to reevaluate the concept of vulnerability in research ethics. I will argue that such attempts, by calling attention to the characteristics that can render participants vulnerable, can promote, rather than discourage, moral reflection about social and global justice concerns among bioethicists, policy makers, investigators, and members of Institutional Review Boards.

Embryo screening technologies offer important benefits to individuals who use them and society. These techniques can expand the reproductive options of many prospective parents and can contribute to reducing the burdens of disease and disability. Nonetheless, embryo screening techniques present individuals and societies with important ethical challenges. Here, I explore some of them. In particular, I discuss the costs for prospective parents of increased reproductive choices, as well as concerns about sanctioning problematic social norms, increasing social injustice, limiting the ways societies can tackle diseases and disabilities, and promoting the commodification of children.

Background Much like academic-industry partnerships, industry financial support of patient advocacy organizations has become very common in recent years. While financial conflicts of interest between PAOs and industry have received more attention in recent years, robust efforts to mitigate these conflicts are still limited. Main body The authors outline the possible benefits and ethical concerns that can result from financial interactions between biomedical companies and PAOs. They argue that the use of novel strategies, such as the creation of a standing ethics committee, could be helpful in managing FCOIs and ensuring the warranted trust of PAO’s constituents. Although ethics committees to address FCOIs are common in the academic context, its use by PAOs is still limited. The authors conclude by describing the process of development and implementation of such an ethics committee at the Crohn’s & Colitis Foundation. Conclusions While collaborations with industry can result in conflicts of interest, PAOs can develop strategies to address those conflicts. One such strategy is the creation of a standing independent ethics committee to guide PAOs on new and/or existing programs and protocols as they pertain to their industry relationships.

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.

Several feminist philosophers of science have argued that social and political values are compatible with, and may even enhance, scientific objectivity. A variety of normative recommendations have emerged regarding how to identify, manage, and critically evaluate social values in science. In particular, several feminist theorists have argued that scientific communities ought to: 1) include researchers with diverse experiences, interests, and values, with equal opportunity and authority to scrutinize research; 2) investigate or "study up" scientific phenomena from the perspectives, interests, and conditions of marginalized stakeholders potentially affected by the research; and 3) make gender, ethnicity, class, and geographical location "visible," or use them as categories of analysis when appropriate. Yet, more work is needed to determine what exactly these recommendations would require, and the benefits they would yield, in specific research contexts. Using the recent development of the human papillomavirus (HPV) vaccines, we examine how these three feminist recommendations would have applied. We argue that these principles would have yielded several epistemic and social benefits in the HPV case, as well as in biomedical research more generally. That is, biomedical research guided by these principles would not only be epistemically superior, but also more socially responsible

As a general claim, most philosophers of science accept that science is not value-free. The disagreements lie in the proverbial details. The essays in Current Controversies in Values and Science, edited by Kevin Elliott and Daniel Steel focus on such details. Like other volumes in the Routledge Current Controversies in Philosophy’s series, this one asks ten well-known philosophers of science to engage with various questions. Each question receives roughly positive and negative responses, though the authors’ nuanced answers make clear that the contrasting views also involve significant agreement.The first question asks whether we can distinguish epistemic from nonepistemic values. Hugh Lacey argues that such...

A new reprogenetic technology, mitochondrial replacement, is making its appearance and, unsurprisingly given its promise to wash off our earthly stains --or at least the scourges of sexual reproduction--, John Harris finds only reasons to celebrate this new scientific feat.1 In fact, he finds mitochondrial replacement techniques (MRTs) so “unreservedly welcome” that he believes those who reject them suffer from “a large degree of desperation and not a little callousness.”2 Believing myself to be neither desperate nor callous, but finding myself also no closer at all – not even after reading his article—to following Harris in welcoming these technologies wholeheartedly, it seems appropriate to respond.

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.

Abstract 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.

Proponents of moral enhancement believe that we should pursue and apply biotechnological means to morally enhance human beings, as failing to do so is likely to lead to humanity's demise. Unsurprisingly, these proposals have generated a substantial amount of debate about the moral permissibility of using such interventions. Here I put aside concerns about the permissibility of moral enhancement and focus on the conceptual and evidentiary grounds for the moral enhancement project. I argue that such grounds are quite precarious.

The lack of public support for climate change policies and refusals to vaccinate children are just two alarming illustrations of the impacts of dissent about scientific claims. Dissent can lead to confusion, false beliefs, and widespread public doubt about highly justified scientific evidence. Even more dangerously, it has begun to corrode the very authority of scientific consensus and knowledge. Deployed aggressively and to political ends, some dissent can intimidate scientists, stymie research, and lead both the public and policymakers to oppose important public policies firmly rooted in science. To criticize dissent is, however, a fraught exercise. Skepticism and fearless debate are key to the scientific process, making it both vital and incredibly difficult to characterize and identify dissent that is problematic in its approach and consequences. Indeed, as de Melo-Martín and Intemann show, the criteria commonly proposed as means of identifying inappropriate dissent are flawed and the strategies generally recommended to tackle such dissent are not only ineffective but could even make the situation worse. The Fight Against Doubt proposes that progress on this front can best be achieved by enhancing the trustworthiness of the scientific community and by being more realistic about the limits of science when it comes to policymaking. It shows that a richer understanding of the context in which science operates is needed to disarm problematic dissent and those who deploy it. This, the authors argue, is the best way forward, rather than diagnosing the many instances of wrong-headed dissent.

Reprogenetic technologies, which combine the power of reproductive techniques with the tools of genetic science and technology, promise prospective parents a remarkable degree of control to pick and choose the likely characteristics of their offspring. Not only can they select embryos with or without particular genetically-related diseases and disabilities but also choose embryos with non-disease related traits such as sex. Prominent authors such as Agar, Buchanan, DeGrazia, Green, Harris, Robertson, Savulescu, and Silver have flocked to the banner of reprogenetics. For them, increased reproductive choice and reduced suffering through the elimination of genetic disease and disability are just the first step. They advocate use of these technologies to create beings who enjoy longer and healthier lives, possess greater intellectual capacities, and are capable of more refined emotional experiences. Indeed, Harris and Savulescu in particular take reprogenetic technologies to be so valuable to human beings that they have insisted that their use is not only morally permissible but morally required. Rethinking Reprogenetics challenges this mainstream view with a contextualised, gender-attentive philosophical perspective. De Melo-Martín demonstrates that you do not have to be a Luddite, social conservative, or religious zealot to resist the siren song of reprogenetics. Pointing out the flawed nature of the arguments put forward by the technologies' proponents, Rethinking Reprogenetics reveals the problematic nature of the assumptions underpinning current evaluations of these technologies and offers a framework for a more critical and skeptical assessment.

I argue here that critics of biological explanations of human nature are mistaken when they maintain that the truth of genetic determinism implies the end of critical evaluation and reform of our social institutions. Such a claim erroneously presupposes that our social values, practices, and institutions have nothing to do with what makes biological explanations troublesome. What constitutes a problem for those who are concerned with social justice is not the fact that particular behaviors might be genetically determined, but the fact that our value system and social institutions create the conditions that make such behaviors problematic.

The aim of this paper is to show that critics of biological explanations of human nature may be granting too much to those who propose such explanations when they argue that the truth of genetic determinism implies an end to critical evaluation and reform of our social institutions. This is the case because when we argue that biological determinism exempts us from social critique we are erroneously presupposing that our social values, practices, and institutions have nothing to do with what makes biological explanations troublesome. My argument is that what constitutes a problem for those who are concerned with social justice is not the fact that particular behaviours may be genetically determined, but the fact that our value system and social institutions create the conditions that make such behaviours problematic. Thus, I will argue that even if genetic determinism were correct, the requirement of assessing and transforming our social practices and institutions would be far from superfluous. Biology is rarely destiny for human beings and the institutions they create

Book Symposium on Andrew Feenberg’s Between Reason and Experience: Essays in Technology and Modernity Content Type Journal Article Pages 203-226 DOI 10.1007/s13347-011-0017-8 Authors Inmaculada de Melo-Martín, Division of Medical Ethics, Weill Cornell Medical College, New York, NY 10065, USA David B. Ingram, Loyola University Chicago, 6525 North Sheridan Road, Chicago, IL 60626, USA Sally Wyatt, e-Humanities Group, Royal Netherlands Academy of Arts and Sciences (KNAW) & Maastricht University, Cruquiusweg 31, 1019 AT Amsterdam, The Netherlands Yoko Arisaka, Forschungsinstitut für Philosophie Hannover, Gerberstrasse 26, 30169 Hannover, Germany Andrew Feenberg, School of Communication, Simon Fraser University at Harbour Centre, 515 West Hastings Street, Vancouver, BC V6B 5K3, Canada Journal Philosophy & Technology Online ISSN 2210-5441 Print ISSN 2210-5433 Journal Volume Volume 24 Journal Issue Volume 24, Number 2

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.

Living donation provides important access to organ transplantation, which is the optimal therapy for patients with end-stage liver or kidney failure. Paired exchanges have facilitated thousands of kidney transplants and enable transplantation when the donor and recipient are incompatible. However, frequently willing and otherwise healthy donors have contraindications to the donation of the organ that their recipient needs. Trans-organ paired exchanges would enable a donor associated with a kidney recipient to donate a lobe of liver and a donor associated with a liver recipient to donate a kidney. This article explores some of the ethical concerns that trans-organ exchange might encounter including unbalanced donor risks, the validity of informed consent, and effects on deceased organ donation

The argument from inductive risk has been embraced by many as a successful account of the role of values in science that challenges the value-free ideal. We argue that it is not obvious that the argument from inductive risk actually undermines the value-free ideal. This is because the inductive risk argument endorses an assumption held by proponents of the value-free ideal: that contextual values never play an appropriate role in determining evidence. We show that challenging the value-free ideal ultimately requires rejecting this assumption.

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically

Although surprising to some proponents of sex selection for non-medical reasons (Dahl 2005), a considerable amount of critical debate has been raised by this practice (Blyth, Frith, and Crawshaw 2008; Dawson and Trounson 1996; Dickens 2002; Harris 2005; Heyd 2003; Holm 2004; Macklin 2010; Malpani 2002; McDougall 2005; Purdy 2007; Seavilleklein and Sherwin 2007; Steinbock 2002; Strange and Chadwick 2010; Wilkinson 2008). While abortion or infanticide has long been used as means of sex selection, a new technology—preimplantation genetic diagnosis (PGD)—has become a highly efficient, and arguably less controversial, way of ensuring the birth of a child of a particular sex. PGD, used in combination with in vitro ..

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, this article shows that decontextualized discussions of this putative moral obligation are problematic.

We focus here on high-risk pediatric research with the prospect of direct benefit and point out some aspects that have raised significant debate. In particular, we call attention to disagreements related to two essential aspects of this type of research: (i) determining what constitutes a “prospect of direct benefit” in phase I trials that involve gene transfer technologies and (ii) assessing when in these trials the risk is justified by the anticipated benefit to the participant children. Although much of our discussion is applicable to other types of high-risk pediatric trials, as an example of the dilemma this type of research poses we use pediatric trials that involve gene transfer technologies. We focus on clinical trials for late infantile neuronal ceroid lipofuscinosis (LINCL). Exploring the ethical implications of some of these disagreements might identify resources for determining how best to deal with the ethical concerns at stake in high-risk pediatric research. We thus offer some recommendations for responding to these concerns.

It might come as a surprise to many that Spain, a country with a strong Catholic tradition that officially banned contraceptive technologies until 1978, has some of the most liberal regulations in assisted reproduction in the world. Law No. 35/1988 was one of the first and most detailed acts of legislation undertaken on the subject of assisted-conception procedures. Indeed, not only did the law permit research on nonviable embryos, it made assisted reproductive technologies available to any woman, whether married or not, through the national healthcare system.

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, this article shows that decontextualized discussions of this putative moral obligation are problematic.