Biobanking Legislation in Spain: Advancing or Undermining Its Ethical Values?

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.

Disclosing Conflicts of Interest to Potential Research Participants: Good for Nothing?

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.

Moral Distress: What Are We Measuring?

While various definitions of moral distress have been proposed, some agreement exists that it results from illegitimate constraints in clinical practice affecting healthcare professionals' moral agency. If we are to reduce moral distress, instruments measuring it should provide relevant information about such illegitimate constraints. Unfortunately, existing instruments fail to do so. We discuss here several shortcomings of major instruments in use: their inability to determine whether reports of moral distress involve an accurate assessment of the requisite clinical and logistical facts in play, whether the distress in question is aptly characterized as moral, and whether the moral distress reported is an appropriate target of elimination. Such failures seriously limit the ability of empirical work on moral distress to foster appropriate change.

To Assess Technologies, Bioethicists Must Take Off Their Blinkers.

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.

Reproductive Embryo Editing: Attending to Justice.

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.

Being and Becoming Pregnant: Valuing Risks.

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.

Is a Video Worth a Thousand Words?

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.

Ethics Consultation in Surgical Specialties.

Multiple studies have been performed to identify the most common ethical dilemmas encountered by ethics consultation services. However, limited data exists comparing the content of ethics consultations requested by specific hospital specialties. It remains unclear whether the scope of ethical dilemmas prompting an ethics consultation differ between specialties and if there are types of ethics consultations that are more or less frequently called based on the specialty initiating the ethics consult. This study retrospectively assessed the incidence and content of ethics consultations called by surgical vs. non-surgical specialties between January 1, 2013 to December 31, 2018 using our RedCap Database and information collected through the EMR via our Clinical and Translational Science Center. 548 total ethics consultations were analyzed (surgical n = 135, non-surgical n = 413). Our results demonstrate that more surgical consults originated from the ICU, as opposed to lower acuity units (45.9% vs. 14.3%, p ≤ 0.001), and surgical patients were more likely to have a DNR in place (37.5% vs. 22.2%, p = 0.002). Surgical specialties were more likely to call about issues relating to withholding/withdrawing life-sustaining treatment (p ≤ 0.001), while non-surgical specialties were more likely to call about issues related to discharge planning (p = 0.001). There appear to be morally relevant differences between consults classified as the "same" that are not entirely captured by the usual ethics consultations classification system. In conclusion, this study highlights the unique ethical issues experienced by surgical vs. non-surgical specialties. Ultimately, our data can help ethics consultation services determine how best to educate various hospital specialties to approach ethical issues commonly experienced within their field.

Conducting epigenetics research with refugees and asylum seekers: attending to the ethical challenges.

An increase in global violence has forced the displacement of more than 70 million people, including 26 million refugees and 3.5 asylum seekers. Refugees and asylum seekers face serious socioeconomic and healthcare barriers and are therefore particularly vulnerable to physical and mental health risks, which are sometimes exacerbated by immigration policies and local social discriminations. Calls for a strong evidence base for humanitarian action have encouraged conducting research to address the barriers and needs of refugees and asylum seekers. Given the role of epigenetics factors to mediate the effect of psychological and environmental exposures, epigenetic modifications have been used as biomarkers for life adversity and disease states. Therefore, epigenetic research can be potentially beneficial to address some of the issues associated with refugees and asylum seekers. Here, we review the value of previous and ongoing epigenetic studies with traumatized populations, explore some of the ethical challenges associated with epigenetic research with refugees and asylees and offer suggestions to address or mitigate some of these challenges. Researchers have an ethical responsibility to implement strategies to minimize the harms and maximize the short and long-term benefits to refugee and asylee participants.

Primum Non Nocere: Should Gene Therapy Be Used to Prevent Potentially Fatal Disease but Enable Potentially Destructive Behavior?

Aldehyde dehydrogenase 2 (ALDH2) deficiency constitutes one of the most common hereditary enzyme deficiencies, affecting 35% to 40% of East Asians and 8% of the world population. It causes the well-known Asian Alcohol Flush Syndrome, characterized by facial flushing, palpitation, tachycardia, nausea, and other unpleasant feelings when alcohol is consumed. It is also associated with a marked increase in the risk of a variety of serious disorders, including esophageal cancer and osteoporosis. Our recent studies with murine models have demonstrated that a one-time administration of an adeno-associated virus (AAV) gene transfer vector expressing the human ALDH2 coding sequence (AAVrh.10hALDH2) will correct the deficiency state and prevent alcohol-induced abnormalities of the esophagus and bone. If successful in humans, such strategy would reduce the increased risk-associated disorders such as esophageal cancer and osteoporosis, but also prevent the Asian Alcohol Flush Syndrome. This treatment thus raises ethical concerns: although it would potentially prevent fatal disease, it could also allow affected individuals to drink alcohol without suffering the Asian Alcohol Flush Syndrome and, hence, potentially enable personal destructive behavior. Here we explore the ethical arguments against the development of a gene therapy for ALDH2 deficiency and we find them wanting. We contend that development of such treatments is ethically appropriate and should be part and parcel of the solutions offered against the condition.

Rethinking Human Embryo Research Policies.

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.

Phases of a Pandemic Surge: The Experience of an Ethics Service in New York City during COVID-19.

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.

"I Want to Do It, But I Want to Make Sure That I Do It Right." Views of Patients with Parkinson's Disease Regarding Early Stem Cell Clinical Trial Participation.

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.

When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest.

BACKGROUND: Much like academic-industry partnerships, industry financial support of patient advocacy organizations (PAOs) has become very common in recent years. While financial conflicts of interest (FCOI) 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 commercialization of the biomedical sciences: (mis)understanding bias.

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.