How Should Physicians Help Patients Understand Unknowns of Nanoparticle-Based Medicines?

When a patient wants to enroll in a clinical trial to gain early access to an apparently promising but unproven intervention, her physician should clarify differences between participating in research and receiving treatment to help her avoid therapeutic misconception, make a thoughtful decision, and consider relevant clinical and ethical details. These include a patient's disease and treatment experiences, needs, interests, values, the design and phase of the trial, and the nature of the intervention being studied. When an unproven intervention is a nanodrug, a physician's role is especially difficult, because though nanomedicine might offer real benefits, it can also pose unexpected or even unprecedented harms. Thus, a physician should help a patient explore possible outcomes while promoting realism, countering hype, and preserving hope.

Should Trackable Pill Technologies Be Used to Facilitate Adherence Among Patients Without Insight?

Aripiprazole tablets with sensor offer a new wireless trackable form of aripiprazole that represents a clear departure from existing drug delivery systems, routes, or formulations. This tracking technology raises concerns about the ethical treatment of patients with psychosis when it could introduce unintended treatment challenges. The use of "trackable" pills and other "smart" drugs or nanodrugs assumes renewed importance given that physicians are responsible for determining patients' decision-making capacity. Psychiatrists are uniquely positioned in society to advocate on behalf of vulnerable patients with mental health disorders. The case presented here focuses on guidance for capacity determination and informed consent for such nanodrugs.

How Should Engineered Nanomaterials Be Regulated for Public and Environmental Health?

A central ethical and policy issue regarding minimizing and managing risks of engineered nanomaterials (ENMs) is whether existing legal frameworks sufficiently protect public health and the environment. This article argues that policymakers should (1) use existing laws to regulate ENMs and the best available evidence to inform appropriate levels of regulation and (2) support additional research on risks of ENMs. Were they to do so, public health and environmental risks of ENMs could be minimized and managed without sacrificing their potential clinical, social, and economic benefits.

What Are Best Practices for Ethical Use of Nanosensors for Worker Surveillance?

Many employers now offer workers wearable or implantable devices that can monitor their health, productivity, and wellness. Nanotechnology enables even more powerful and functional monitoring capacity for these devices. A history of workplace monitoring programs suggests that, despite nanosensors' potential benefits to employers and employees, they can only be successful and sustainable when a company's motivations for offering them are acceptable and transparent to workers. This article describes 5 best practices for motivating nano-enabled worker monitoring programs that are acceptable, effective, and ethical.

Reflexões bioéticas acerca da inovação em Nanomedicamentos / Reflexiones bioéticsa acerca de la innovación en Nanomedicamentos / Bioethical Reflections on Innovation in Nanomedicines / Reflexions bioètiques sobre la innovació en nanomedicaments

A nanotecnologia vem se desenvolvendo de forma exponencial na área farmacêutica, prometendo grandes benefícios, entretanto, pode estar sujeita a riscos intrínsecos relacionados a esta ciência. Neste artigo é realizada uma reflexão acerca dos desafios enfrentados pelos órgãos regulatórios em função da ausência, ou ainda, incipiente legislação, especialmente no Brasil, visto que os documentos disponíveis em relação a regulamentação, não incluem especificações para nanomedicamentos, os quais apresentam alterações na dimensão e constituição, e consequentemente comportamento diferente de medicamentos convencionais. A contingência envolvendo o desenvolvimento de nanomedicamentos e a gestão dos riscos para a vida humana e o meio ambiente fazem com que a bioética seja invocada de forma a analisar quais os impactos decorrem deste proceso

Nanotechnology has been developing exponentially in the pharmaceutical area, promising great benefits, however, it may be subject to intrinsic risks related to this science. In this article, a reflection is made on the challenges faced by regulatory agencies due to the absence or incipient legislation, especially in Brazil, since the available documents in relation to regulation do not include specifications for nanomedicine, which present changes in the dimension and constitution, and consequently different behavior of conventional drugs. The contingency involving the development of nanomedicine and the management of the risks for human life and the environment, cause bioethics to be invoked in order to analyze the impacts of this process

La nanotecnología se está desarrollando de forma exponencial en el área farmacéutica, prometiendo grandes beneficios, sin embargo, puede estar sujeta a riesgos intrínsecos relacionados a esta ciencia. En este artículo se reflexiona sobre los desafíos enfrentados por los órganos regulatorios en función de la ausencia, o aún incipiente legislación, especialmente en Brasil, ya que los documentos disponibles en relación a la reglamentación, no incluyen especificaciones para nanomedicamentos, los cuales presentan alteraciones en la dimensión y la constitución, y consecuentemente un comportamiento diferente de los medicamentos convencionales. La contingencia que involucra el desarrollo de nanomedicamentos y la gestión de los riesgos para la vida humana y el medio ambiente hacen que la bioética sea invocada para analizar qué impactos se derivan de este proceso

La nanotecnologia s'està desenvolupant de forma exponencial en l'àrea farmacèutica, prometent grans beneficis; no obstant això, pot estar subjecta a riscos intrínsecs relacionats amb aquesta ciència. En aquest article es reflexiona sobre els desafiaments que enfronten els òrgans reguladors en funció de l'absència, o d’una legislació incipient, especialment al Brasil, ja que els documents disponibles en relació a la reglamentació no inclouen especificacions per a nanomedicaments, els quals presenten alteracions en la seva dimensió i constitució, i conseqüentment presenten un comportament diferent al dels medicaments convencionals. La contingència que involucra el desenvolupament de nanomedicaments i la gestió dels riscos per a la vida humana i el medi ambient fan que la bioètica hagi de jugar un paper a fi d’analitzar quins impactes es deriven d'aquest procés

Ethical issues in nanomedicine: Tempest in a teapot?

Nanomedicine offers remarkable options for new therapeutic avenues. As methods in nanomedicine advance, ethical questions conjunctly arise. Nanomedicine is an exceptional niche in several aspects as it reflects risks and uncertainties not encountered in other areas of medical research or practice. Nanomedicine partially overlaps, partially interlocks and partially exceeds other medical disciplines. Some interpreters agree that advances in nanotechnology may pose varied ethical challenges, whilst others argue that these challenges are not new and that nanotechnology basically echoes recurrent bioethical dilemmas. The purpose of this article is to discuss some of the ethical issues related to nanomedicine and to reflect on the question whether nanomedicine generates ethical challenges of new and unique nature. Such a determination should have implications on regulatory processes and professional conducts and protocols in the future.

Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.

BACKGROUND: Obtaining valid informed consent (IC) can be challenging in first-in-human (FIH) trials in nanomedicine due to the complex interventions, the hype and hope concerning potential benefits, and fear of harms attributed to 'nano' particles. AIM: We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents. METHODS: We draw on content analysis of 46 in-depth interviews with European and North American stakeholders. RESULTS: We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons. CONCLUSION: We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.

Nanotechnology, neuromodulation & the immune response: discourse, materiality & ethics.

Drawing upon the American Pragmatic tradition in philosophy and the more recent work of philosopher Karen Barad, this paper examines how scientific problems are both obscured, and resolved by our use of language describing the natural world. Using the example of the immune response engendered by neural implants inserted in the brain, the author explains how this discourse has been altered by the advent of nanotechnology methods and devices which offer putative remedies that might temper the immune response in the central nervous system. This emergent nanotechnology has altered this problem space and catalyzed one scientific community to acknowledge a material reality that was always present, if not fully acknowledged.

Dialogar la nanoética / No disponible

No disponible

Getting nano tattoos right - a checklist of legal and ethical hurdles for an emerging nanomedical technology.

The nano tattoo represents a nascent technology designed to be implanted in the skin to provide continuous and reliable glucose detection for diabetics. Its potential benefits are compelling not only for its ability to prevent diabetic complications and decrease related social costs, but also for its ease of use and relative patient-user comfort. This Note aims to articulate a checklist of fundamental intellectual property, bioethical and system design issues that are appropriately considered in the pre-clinical, pre-commercialization phase of nano tattoo development. Early and regular consideration of these factors can increase the odds of a societally beneficial dissemination of this device by engaging relevant researcher, medical, patient-user and patient-advocate communities concerned with its appropriate application, as well as policymaking communities focused on effectively managing diabetes-related healthcare costs. The checklist of factors includes fundamental issues and is generally applicable to nanomedical inventions. FROM THE CLINICAL EDITOR: This paper presents a comprehensive list of fundamental intellectual property, bioethical, and system design issues to be considered in the pre-commercialization phase of nanomedicine development, through the specific example of nano tattoo development. Nano tattoo is designed to be implanted in the skin to provide reliable glucose monitoring for diabetics, enabling enhanced prevention of complications and decreased socioeconomic costs.

[Meta-legal paradigms of nanomedicine]. / Paradigmas meta-jurídicos de la Nanomedicina.

Nanomedicine is the Nanotechnology applied in the field of Medicine. Nanomedicine includes a wide range of technologies applied to devices, materials, medical procedures and treatment modalities are being developed, in some cases, through the convergence of living and nonliving materials. The developments in this scientific field are the prelude of a new era in health where Nanotechnology will provide, in a short period of time, substantial benefits for the general welfare and health of people with serious and incurable diseases using other more traditional medical treatments. This is, in brief, the object of this research that has been focused in the study of the ethical-legal paradigms that should inform the developments and expectations generated by medical applications of Nanotechnology.

A portrait of nanomedicine and its bioethical implications.

This review addresses the current and future potential of nanomedicine, and its ethical considerations within the comprehensive framework of the four dimensions of medical ethics: Beneficence, Non-Maleficence, Respect, and Justice. From this perspective, the ethical considerations for nanomedicine are not novel, but have been addressed by precedents throughout the history of medicine. While these ethical challenges are not unique to nanomedicine, some require additional consideration, given the envisioned pervasive impact of nanomedicine on society.

Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field.

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern.

What is unique about nanomedicine? The significance of the mesoscale.

Unlike drugs and medical devices, for which long standing and continuously improving quality assurance/quality control infrastructures exist, many nano-based products lack well-defined standards that are useful to manufacturers and regulators. Inherent variabilities in nanoparticle sizes and shapes, their large surface-to-volume ratios, and their mesoscale interactions with subcellular structures, suggest new complexities and challenges that must be met before widespread application of nanomedicines can be expected.

Building an ethical foundation for first-in-human nanotrials.

Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.

Concepts of risk in nanomedicine research.

Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates. While significant, possibly unique risks may exist in specific nano-based products, risk may also arise from the very processes and procedures that develop, test, and oversee any novel technology. This supports recommendations to coordinate efforts through an interagency Working Group and a Secretary-level Advisory Committee to provide flexibility and sensitivity to emerging issues of concern.

Prudent precaution in clinical trials of nanomedicines.

Clinical trials of nanotechnology medical products present complex risk management challenges that involve many uncertainties and important risk-risk trade-offs. This paper inquires whether the precautionary principle can help to inform risk management approaches to nanomedicine clinical trials. It concludes that prudent precaution may be appropriate for ensuring the safety of such trials, but that the precautionary principle itself, especially in its more extreme forms, does not provide useful guidance for specific safety measures.

Beyond human subjects: risk, ethics, and clinical development of nanomedicines.

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena.

Nanomedicine first-in-human research: challenges for informed consent.

Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.

Responsible conduct in nanomedicine research: environmental concerns beyond the common rule.

Nanomedicine research raises ethical concerns beyond those covered by the Common Rule. Investigators and research institutions should comply with environmental and occupational health laws protect research staff and the environment. Though the IRB should concentrate on risks to human research participants, it should also consider risks to identifiable third parties. Investigators should also address risks to identifiable third parties. Professional and governmental organizations should deal with the long-term social, ethical, and environmental consequences of nanomedicine.