Follow-up in the field of reproductive medicine: an ethical exploration.

RESEARCH QUESTION: What ethical implications, issues and concerns play a role in conducting follow-up studies of children born after assisted reproductive technologies (ART)? DESIGN: Literature study and relevant experiences of academic medical centres in Brussels, Belgium, and Maastricht, the Netherlands were used to identify and analyse the most pertinent ethical implications, issues and concerns. RESULTS: According to recommendations from the European Society of Human Reproduction and Embryology, follow-up (ideally long term) of children conceived through medically assisted reproduction (MAR) should be an integral part of introducing new ART. With potentially risky new ART on the horizon, these recommendations need to be taken more seriously. Apart from practical barriers, such as funding, challenges for follow-up include securing active involvement of families of children conceived through MAR, starting with parents of young children, and ideally involving consenting adolescents and adults during a large part of their lives, possibly even into the next generation. CONCLUSIONS: From an ethical viewpoint, the most pertinent issues include the proportionality of the inevitable burdens and risks for families of children conceived through MAR, and the implications of the principle of respect for autonomy. The proportionality requirement is most critical when it concerns incompetent children, who should not be included in research with more than minimal burdens and risks if there is no reasonable expectation of benefit for themselves. With respect for autonomy, we argue that, when seeking voluntary consent for participating in follow-up studies that meet the condition of proportionality, professionals may encourage members of families of children conceived through MAR to partake in follow-up research.

Monitoring functional status using a wearable real-time locating technology.

Sensor technologies enable real-time, continuous, and objective monitoring of activity and functioning in later life. In long-term care, timely assessment of functional status is needed to prevent falls and other acute events. However, the electronic forms and paper and pencil tools currently used are time-consuming and conducted too infrequently (e.g., every 6 months) to provide the sensitivity and specificity required. Staff are also unable to detect subtle changes in functioning through observation alone. The purpose of this paper is to discuss the use of a wearable real-time locating system that utilizes ultra wideband radio technology to continuously and objectively measure activity and aspects of functional status. This paper discusses the associated conceptualization and development of the scoring algorithms, raw data transformation, use of traditional paper and pencil tools and electronic health record data to validate sensor data, and other tips for those interested in this type of wearable sensor technology.

Contactless monitoring of heart and respiratory rate in anesthetized pigs using infrared thermography.

Pig experiments have played an important role in medical breakthroughs during the last century. In fact, pigs are one of the major animal species used in translational research, surgical models and procedural training due to their anatomical and physiological similarities to humans. To ensure high bioethical standards in animal trials, new directives have been implemented, among others, to refine the procedures and minimize animals' stress and pain. This paper presents a contactless motion-based approach for monitoring cardiorespiratory signals (heart rate and respiratory rate) in anesthetized pigs using infrared thermography. Heart rate monitoring is estimated by measuring the vibrations (precordial motion) of the chest caused by the heartbeat. Respiratory rate, in turn, is computed by measuring the mechanical chest movements that accompany the respiratory cycle. To test the feasibility of this approach, thermal videos of 17 anesthetized pigs were acquired and analyzed. A high agreement between infrared thermography and a gold standard (electrocardiography and capnography-derived respiratory rate) was achieved. The mean absolute error averaged 3.43 ± 3.05 bpm and 0.27 ± 0.48 breaths/min for heart rate and respiratory rate, respectively. In sum, infrared thermography is capable of assessing cardiorespiratory signals in pigs. Future work should be conducted to evaluate infared thermography capability of capturing information for long term monitoring of research animals in a diverse set of facilities.

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.

Monitoring the Monitors: Medicaid Integration of Passive Remote Monitoring Technology.

Implementation of passive remote monitoring is advancing faster than our knowledge base about appropriate and ethical use. For all the media and research attention these technologies are getting, there has been very little discussion about how they are positioned to be integrated into health plans, yet their integration is key to how they will be incorporated into social work practice. As coverage of passive remote monitoring technologies expands in Medicaid home and community-based services (HCBS), new policies that support informed decision-making, consenting processes, and regulations for ethical, appropriate use are urgently needed. Research translation often trails policy, but the rapid development and implementation of technologies that passively collect and transmit new information about older adults call for a more responsive approach. In this commentary, I describe passive remote monitoring technologies, their implementation in Medicaid HCBS, and ethical issues. I conclude with specific suggestions for policy and practice to start addressing these issues.

Challenges in Collecting Big Data in A Clinical Environment with Vulnerable Population: Lessons Learned from A Study Using A Multi-modal Sensors Platform.

Agitation is one of the most common behavioural and psychological symptoms in people living with dementia (PLwD). This behaviour can cause tremendous stress and anxiety on family caregivers and healthcare providers. Direct observation of PLwD is the traditional way to measure episodes of agitation. However, this method is subjective, bias-prone and timeconsuming. Importantly, it does not predict the onset of the agitation. Therefore, there is a need to develop a continuous monitoring system that can detect and/or predict the onset of agitation. In this study, a multi-modal sensor platform with video cameras, motion and door sensors, wristbands and pressure mats were set up in a hospital-based dementia behavioural care unit to develop a predictive system to identify the onset of agitation. The research team faced several barriers in the development and initiation of the study, namely addressing concerns about the study ethics, logistics and costs of study activities, device design for PLwD and limitations of its use in the hospital. In this paper, the strategies and methodologies that were implemented to address these challenges are discussed for consideration by future researchers who will conduct similar studies in a hospital setting.

[The digital pill, between beneficence and vigilance: ethical stakes]. / Le médicament connecté, entre bienveillance et surveillance - Analyse des enjeux éthiques.

Since November 2017, the digital pill, which makes it possible to know whether a patient has achieved compliance or not with the treatment has become a reality. This drug can benefit the patients by helping them to better follow their treatment and avoid misuse. However, even though the use of this device requests patient consent, major questions arise regarding the respect for privacy and freedom of action. Evidently, the correct use of drugs is both a public health and economic issue, but through this digital tool, the temptation could be to implement measures to control citizens, in particular regarding the use of treatments that affect health expenditure. A too prescriptive conception of monitoring algorithms could alter the care relationship, denying the part of adaptation that a patient can legitimately claim in taking his treatment. The digital pill could be a helpful tool but it is necessary to evaluate its fair place in terms of respect for the person and adequacy with its liberties.

Leaving patients to their own devices? Smart technology, safety and therapeutic relationships.

BACKGROUND: This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. MAIN TEXT: Drawing on lessons learned from other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. CONCLUSION: This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices.

Supporting ethical use of electronic monitoring for people living with dementia: Social work's role in assessment, decision-making, and review.

Walking outdoors supports health and well-being, but some people living with dementia are at increased risk of getting lost and of harm while missing. Electronic monitoring can potentially play an important preventative role by enabling the person's location to be continuously monitored by caregivers. However, there are considerable ethical concerns arising from electronic monitoring. This paper explores these thematically, drawing attention to its implications for autonomy and liberty; privacy; dignity; the rights and needs of caregivers and families; beneficence and nonmaleficence. Following from this, key questions for consideration in social work assessment are identified. The ethical issues necessitate assessment of the person's unique circumstances and preferences and that of their caregivers, and careful ethical deliberation in decision-making. Social work can play an important role in facilitating inclusive assessment and decision-making, leading to consensus on intervening with electronic monitoring. The need for the ongoing review following implementation is discussed to track whether decisions need modification in light of the experience of usage. In conclusion, while legislative instruments and professional codes of ethics frame social work practice responses, there is need for a nuanced debate about ethical use of electronic monitoring and specific guidance to inform assessment, decision-making, and review.

What makes a good home-based nocturnal seizure detector? A value sensitive design.

A device for the in-home detection of nocturnal seizures is currently being developed in the Netherlands, to improve care for patients with severe epilepsy. It is recognized that the design of medical technology is not value neutral: perspectives of users and developers are influential in design, and design choices influence these perspectives. However, during development processes, these influences are generally ignored and value-related choices remain implicit and poorly argued for. In the development process of the seizure detector we aimed to take values of all stakeholders into consideration. Therefore, we performed a parallel ethics study, using "value sensitive design." Analysis of stakeholder communication (in meetings and e-mail messages) identified five important values, namely, health, trust, autonomy, accessibility, and reliability. Stakeholders were then asked to give feedback on the choice of these values and how they should be interpreted. In a next step, the values were related to design choices relevant for the device, and then the consequences (risks and benefits) of these choices were investigated. Currently the process of design and testing of the device is still ongoing. The device will be validated in a trial in which the identified consequences of design choices are measured as secondary endpoints. Value sensitive design methodology is feasible for the development of new medical technology and can help designers substantiate the choices in their design.

Bioethical considerations.

The clinical literature notes that pregnancy has become an expected benefit of solid organ transplant. Establishing "best practices" in the management of this particular transplant population requires careful consideration of the ethical dimensions, broadly speaking, of posttransplant pregnancies and these women's lived experiences. In this article, we present the current clinical and social science posttransplant pregnancy research. We specifically address the psychosocial and ethical issues surrounding preconception counseling and posttransplant health quality of life and mothering and suggest areas for future research.

Telecare, remote monitoring and care.

Telecare is often regarded as a win/win solution to the growing problem of meeting the care needs of an ageing population. In this paper we call attention to some of the ways in which telecare is not a win/win solution but rather aggravates many of the long-standing ethical tensions that surround the care of the elderly. It may reduce the call on carers' time and energy by automating some aspects of care, particularly daily monitoring. This can release carers for other caring activities. On the other hand, remote and impersonal monitoring seems to fall short of providing care. Monitoring may be used to help elderly users retain independence. But it may also increase the amount of information which flows from users to carers, which can result in a form of function-creep that actually undermines independence.

How do medical device manufacturers' websites frame the value of health innovation? An empirical ethics analysis of five Canadian innovations.

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology's promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate "value proposition" of their innovation and seek to respond to what they consider the key expectations of their customers. Our analysis shows that the manufacturers' framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians' and patients' expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others.

Recurrent laryngeal nerve monitoring: state of the art, ethical and legal issues.

Despite many advances in surgical techniques during the last several decades, the risk for recurrent laryngeal nerve (RLN) injury during thyroid and parathyroid surgery has only declined, not disappeared. RLN monitoring is an attempt to reduce the risk of nerve injury during thyroid and parathyroid surgery. In this article, the author discusses how to use RLN monitoring, its effectiveness, and the options available. He also highlights potential legal and ethical issues that surround the use of this method.