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Recent advances in MS-based proteomics have vastly increased the quality and scope of biological information that can be derived from human samples. These advances have rendered current workflows increasingly applicable in biomedical and clinical contexts. As proteomics is poised to take an important role in the clinic, associated ethical responsibilities increase in tandem with the impact on the health, privacy, and well-being of individuals. Here we conducted and report a systematic literature review of ethical issues in clinical proteomics. We add our perspectives from a background of bioethics, the results of our accompanying paper extracting individual-sensitive results from patient samples, and the literature addressing similar issues in genomics. The spectrum of potential issues ranges from patient re-identification to incidental findings of clinical significance. The latter can be divided into actionable and unactionable findings. Some of these have the potential to be employed in discriminatory or privacy-infringing ways. However, incidental findings may also have great positive potential. A plasma proteome profile, for instance, could inform on the general health or disease status of an individual regardless of the narrow diagnostic question that prompted it. We suggest that early discussion of ethical issues in clinical proteomics is important to ensure that eventual regulations reflect the considered judgment of the community as well as to anticipate opportunities and problems that may arise as the technology matures further.

Drugs used to provide improvement of cognitive functioning have been shown to be effective in healthy individuals. It is sometimes assumed that the use of these drugs constitutes cheating in an aca...

Kreitmair identifies seven dimensions “intended to provide guidance for consumers, developers, researchers, and ethicists to work towards ethical DTC neurotechnology” (Kreitmair 2019, 157). These a...

As Pierson and Millon (2018) correctly state, “Health research is inextricably linked to several human rights … [including] the rights to health care, the social determinants of health, and the ben...

Chimeras have been an important part of animal research for decades. Yet crossing the species barrier has always been seen as potentially morally problematic. In recent years, advances in chimeric research and the attendant possibilities-organ xenotransplantation, cognitive enhancement, and others-have given rise to further ethical concern. This contribution surveys the main ethical questions that have been discussed in the literature. We examine two arguments-from the order of nature and from human dignity-which aim to show that chimerization is inherently wrong. Finding the first untenable and the second largely inapplicable, we then turn to two unconvincing arguments designed to show that chimerization must necessarily lead to negative outcomes. Having thus found that no blanket statements can be made on the ethics of chimerization, we examine two important parameters relevant to the ethical evaluation of proposed chimeric research: the argument from moral status and from risk.

Background Animal models of human diseases are often used in biomedical research in place of human subjects. However, results obtained by animal models may fail to hold true for humans. One way of addressing this problem is to make animal models more similar to humans by placing human tissue into animal models, rendering them chimeric. Since technical and ethical limitations make neurological disorders difficult to study in humans, chimeric models with human neural tissue could help advance our understanding of neuropathophysiology. Main body In this article, we examine whether the introduction of human neural tissue and any consequent cognitive change is relevant to the way we ought to treat chimeras. We argue that changes in cognitive abilities are morally relevant to the extent that they increase the capacities that affect the moral status of any entity, including awareness, autonomy, and sociability. We posit that no being, regardless of species, should be treated in a way that is incommensurate with its moral status. Finally, we propose a framework that can be used to guide ethical assessment of research involving chimeras with advanced cognitive capacities. Conclusion We advance this framework as a useful tool for bringing relevant considerations to the forefront for those considering the ethical merit of proposed chimeric research. In doing so, we examine concepts relevant to the question of how any entity may be treated, including moral status, dignity, and capacities.

As Chattopadhyay and colleagues (Chattopadhyay et al. 2017) rightly point out, participation in and access to culture and science are internationally recognized human rights. The legal status and s...

Pharmacological cognitive enhancers (PCEs) are used in the treatment of a variety of disorders, including targeting cognitive impairment and sleep abnormalities. Evidence suggests that PCEs also enhance cognition in healthy individuals. PCEs have attracted considerable interest recently, particularly from students, academics and the military. Proponents of PCE use in healthy people argue that these substances may be used to reduce fatigue-related and work-related accidents and improve learning outcomes. In this article, safety concerns as well as ethical issues of fairness and coercion are considered. Discussion amongst experts in the field, government officials and members of society on the topic of the increasing lifestyle use of PCEs in healthy people is urgently needed.

The incidence of human rights violations in mental health care across nations has been described as a “global emergency” and an “unresolved global crisis.” The relationship between mental health and human rights is complex and bidirectional. Human rights violations can negatively impact mental health. Conversely, respecting human rights can improve mental health. This article reviews cases where an explicitly human rights-based approach was used in mental health care settings. Although the included studies did not exhibit a high level of methodological rigor, the qualitative information obtained was considered useful and informative for future studies. All studies reviewed suggest that human-rights based approaches can lead to clinical improvements at relatively low costs. Human rights-based approaches should be utilized for legal and moral reasons, since human rights are fundamental pillars of justice and civilization. The fact that such approaches can contribute to positive therapeutic outcomes and, potentially, cost savings, is additional reason for their implementation. However, the small sample size and lack of controlled, quantitative measures limit the strength of conclusions drawn from included studies. More objective, high quality research is needed to ascertain the true extent of benefits to service users and providers.

Physical activity and alternate-day fasting/caloric restriction may both ameliorate aspects of the metabolic syndrome, such as insulin resistance, visceral fat mass accumulation, and cognitive impairment by overlapping mechanisms. The purpose of this study was to test the hypothesis that alternate-day caloric restriction (ADCR) with overall energy balance would reduce insulin resistance and accumulation of visceral fat, in addition to improving cognitive functions, after 8 consecutive days in bed. Healthy, lean men ( n = 20) were randomized to 1) 8 days of bed rest with three daily isoenergetic meals (control group, n = 10); and 2) 8 days of bed rest with 25% of total energy requirements every other day and 175% of total energy requirements every other day (ADCR group). Oral glucose tolerance testing, dual-energy X-ray absorptiometry (DXA) scans, magnetic resonance imaging of the abdomen and brain, V̇o2max, and tests for cognitive function were performed before and after bed rest. In addition, daily fasting blood samples and 24-h glucose profiles by continuous glucose monitoring system were assessed during the 8 days of bed rest period. Bed rest induced insulin resistance, visceral fat accumulation, and worsening of mood. No positive effects emerged from ADCR on these negative health outcomes. Compared with the control group, ADCR was associated with improved and steadier glycemic control on fasting days and higher glycemic fluctuation and indexes of insulin resistance on overeating days. In contrast to our hypothesis, the metabolic impairment induced by 8 days of bed rest was not counteracted by ADCR with overall energy balance. NEW & NOTEWORTHY Alternate-day caloric restriction without overall energy reduction does not ameliorate the metabolic impairment induced in lean men by 8 days of bed rest.

Advances in data science allow for sophisticated analysis of increasingly large datasets. In the medical context, large volumes of data collected for healthcare purposes are contained in electronic health records (EHRs). The real-life character and sheer amount of data contained in them make EHRs an attractive resource for public health and biomedical research. However, medical records contain sensitive information that could be misused by third parties. Medical confidentiality and respect for patients' privacy and autonomy protect patient data, barring access to health records unless consent is given by the data subject. This creates a situation in which much of the beneficial records-based research is prevented from being used or is seriously undermined, because the refusal of consent by some patients introduces a systematic deviation, known as selection bias, from a representative sample of the general population, thus distorting research findings. Although research exemptions for the requirement of informed consent exist, they are rarely used in practice due to concerns over liability and a general culture of caution. In this paper, we argue that the problem of research access to sensitive data can be understood as a tension between the medical duties of confidentiality and beneficence. We attempt to show that the requirement of informed consent is not appropriate for all kinds of records-based research by distinguishing studies involving minimal risk from those that feature moderate or greater risks. We argue that the duty of easy rescue—the principle that persons should benefit others when this can be done at no or minimal risk to themselves—grounds the removal of consent requirements for minimally risky records-based research. Drawing on this discussion, we propose a risk-adapted framework for the facilitation of ethical uses of health data for the benefit of society. This article is part of the themed issue ‘The ethical impact of data science’.

The goal of clinical proteomics is to identify, quantify, and characterize proteins in body fluids or tissue to assist diagnosis, prognosis, and treatment of patients. In this way, it is similar to more mature omics technologies, such as genomics, that are increasingly applied in biomedicine. We argue that, similar to those fields, proteomics also faces ethical issues related to the kinds of information that is inherently obtained through sample measurement, although their acquisition was not the primary purpose. Specifically, we demonstrate the potential to identify individuals both by their characteristic, individual-specific protein levels and by variant peptides reporting on coding single nucleotide polymorphisms. Furthermore, it is in the nature of blood plasma proteomics profiling that it broadly reports on the health status of an individual—beyond the disease under investigation. Finally, we show that private and potentially sensitive information, such as ethnicity and pregnancy status, can increasingly be derived from proteomics data. Although this is potentially valuable not only to the individual, but also for biomedical research, it raises ethical questions similar to the incidental findings obtained through other omics technologies. We here introduce the necessity of—and argue for the desirability for—ethical and human-rights-related issues to be discussed within the proteomics community. Those thoughts are more fully developed in our accompanying manuscript. Appreciation and discussion of ethical aspects of proteomic research will allow for deeper, better-informed, more diverse, and, most importantly, wiser guidelines for clinical proteomics., Graphical Abstract, Highlights • Plasma proteomes can be reidentified based on protein expression levels. • Plasma proteomes can be reidentified based on variant peptides. • Plasma proteomes can contain actionable and nonactionable incidental findings. • Plasma proteomes can contain sensitive information such as pregnancy status., In Brief Due to its unbiased nature, proteomics may raise ethical and regulatory concerns. Plasma proteome samples can be reidentified given genomic information. Furthermore, plasma proteomes contain information of potential sensitive nature. Incidental findings can help diagnose unrelated but actionable disease states.

Recent advances in MS-based proteomics have vastly increased the quality and scope of biological information that can be derived from human samples. These advances have rendered current workflows increasingly applicable in biomedical and clinical contexts. As proteomics is poised to take an important role in the clinic, associated ethical responsibilities increase in tandem with impacts on the health, privacy, and well-being of individuals. We conducted and here report a systematic literature review of ethical issues in clinical proteomics. We add our perspectives from a background of bioethics, the results of our accompanying article extracting individual-sensitive results from patient samples, and the literature addressing similar issues in genomics. The spectrum of potential issues ranges from patient reidentification to incidental findings of clinical significance. The latter can be divided into actionable and unactionable findings. Some of these have the potential to be employed in discriminatory or privacy-infringing ways. However, incidental findings may also have great positive potential. A plasma proteome profile, for instance, could inform on the general health or disease status of an individual regardless of the narrow diagnostic question that prompted it. We suggest that early discussion of ethical issues in clinical proteomics can ensure that eventual health care practices and regulations reflect the considered judgment of the community and anticipate opportunities and problems that may arise as the technology matures., Graphical Abstract, Highlights • Principles of bioethics as they relate to clinical proteomics. • Systematic literature review of ethics in clinical proteomics. • Prospects for preventive proteomics profiling. • Importance of early discussion of ethical issues to ensure eventual regulations reflect the considered judgment of the community., In Brief We introduce bioethical principles and use these as operational definitions to carry out a systematic review of the literature on ethical issues in clinical proteomics. We identify 10 ethical themes across 16 studies, many of which are familiar from other fields. We therefore survey how genomics has dealt with ethical issues and regulation. We also add our own perspectives on the ethical aspects of study design and sample treatment as well as the ethical potential of preventive proteomics profiling.