We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health‐related” research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to (...) consider the instances of what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health‐related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health‐related research needed to demonstrate its effectiveness depends on the extent and successful management of such risks. Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development. (shrink)

Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold that “health-related research with humans... must (...) have social value” or the “prospect of generating the knowledge and the means necessary to protect and promote people’s health” (CIOMS... (shrink)

The revision of the Council of International Organizations of Medical Sciences (CIOMS) International ethical guidelines for health‐related research (2016) heralds a paradigm shift from the ‘protectionist’ policies that emerged following historical research atrocities of the 20th century, towards a more nuanced and inclusive approach to research participation. Adopting this modified approach will enable countries to secure the benefits of research for individuals and for society as a whole, while at the same time minimizing the potential (...) for exploitation and research‐related harms. This article considers the potential impact of Guideline 16 of the CIOMS 2016 from a New Zealand perspective, with respect to research involving adults with impaired capacity and who are incapable of giving informed consent. While the CIOMS 2016 apply a ‘minimal risk’ threshold to guide research involving adults who lack capacity to consent, New Zealand law currently adopts a ‘best interests’ standard which significantly restricts the scope of permissible research that may be performed in this context. This article argues that the CIOMS 2016 should influence change to New Zealand’s legal framework for ethical review of research. CIOMS 2016 provides useful guidance for the necessary standards and processes to enable the responsible and ethical inclusion of adults with impaired capacity in research. (shrink)

In this dissertation, I provide an account of the protections to which most captive non-human animals are morally entitled when they participate in health-related research. At least in the animal ethics literature, it is uncontroversial that the protections currently afforded to captive research animals are inadequate. This has much to do with the fact that most animals who serve as research participants are 1) sentient and, thus, have important morally considerable interests; 2) unable to provide informed consent (...) to their research participation; and 3) seriously harmed as a result of their participation. Unsurprisingly, then, a number of authors have proposed alternative sets of protections that they take to be appropriately responsive to the morally considerable interests of research animals. However, none of the alternatives proposed ensures the ethically appropriate treatment of research animals because all are demonstrably more permissive than the set of protections governing research involving children. This seems problematic given that most animal research participants, like most pediatric research participants, are sentient and unable to provide informed consent for their research participation, and, furthermore, that these are the very characteristics that render children vulnerable — and so entitled to additional protections — in the context of research. I examine a number of reasons that might be thought to justify the discrepancy between the protections afforded to these two groups of research participants, and argue that no non-speciesist justification is forthcoming. Consequently, we ought to reflect upon how the protections currently in place for pediatric research participants might be extended to most animal research participants. I argue that most pediatric research protections, when suitably amended to account for relevant differences between most children and animals, can and should be extended to most animal research participants. I also demonstrate that doing so would require that substantial changes are made to most extant animal research studies. Since this, in turn, would require a radical transformation of the research enterprise as we know it, I also gesture towards how we might get from where we currently are to a truly just research enterprise. (shrink)

Special moral, regulatory, and scientific questions surround the inclusion of children in health-related research. These questions arise from a fundamental moral tension between the obligation to expose children to research participation to ensure that they share in the benefits that arise from it and the obligation to protect them from the harms associated with their inappropriate involvement in research. This tension is felt in the development of moral and regulatory frameworks for the protection of child research (...) subjects and in the implementation and interpretation of these frameworks by institutional review boards. (shrink)

Funding broadly connotes the notion of an institution and/or institutions making money and other resources available to individual researchers and organizations to accomplish specific projects. Whi...

The paper problematises the reliability and ethics of using social media data, such as sourced from Twitter or Instagram, to carry out health-related research. As in many other domains, the opportunity to mine social media for information has been hailed as transformative for research on well-being and disease. Considerations around the fairness, responsibilities and accountabilities relating to using such data have often been set aside, on the understanding that as long as data were anonymised, no real ethical or (...) scientific issue would arise. We first counter this perception by emphasising that the use of social media data in health research can yield problematic and unethical results. We then provide a conceptualisation of methodological data fairness that can complement data management principles such as FAIR by enhancing the actionability of social media data for future research. We highlight the forms that methodological data fairness can take at different stages of the research process and identify practical steps through which researchers can ensure that their practices and outcomes are scientifically sound as well as fair to society at large. We conclude that making research data fair as well as FAIR is inextricably linked to concerns around the adequacy of data practices. The failure to act on those concerns raises serious ethical, methodological and epistemic issues with the knowledge and evidence that are being produced. (shrink)

Illness anxiety disorder, formerly known as hypochondria, has been conceptualised in the psychological literature as an anxiety disorder, and its dimensional correlate is usually referred to as hea...

Although health matters are commonly discussed in various social contexts, health-related interpersonal communication still remains a black box in health communication research. Bringing together research from the fields of health communication and interpersonal communication, we therefore examine how people communicate about health and illness in their everyday lives. Based on Channel Complementary Theory and the concept of communication repertoires, we focus on a) the communication partners, b) the communication channels, and c) the communication patterns relevant to health-related interpersonal (...) communication. We conducted a qualitative study with 22 semi-structured online interviews combined with ego-centered network maps. Findings show that a) what is discussed with whom depends on the intimacy of the relationship, topic sensitivity, and partners’ personal characteristics, b) face-to-face communication is the preferred way of communicating, and c) (a-)symmetry of roles, (in)formality, and intimacy of the relationship influence communication. (shrink)

BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of (...) genetic and health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well. (shrink)

The ethics of health incentive research—a form of public health research—are not well developed, and concerns of justice have been least examined. In this paper, we explore what potential long term harms in relation to justice may occur as a result of such research and whether they should be considered as part of its ethical evaluation. ‘Long term harms’ are defined as harms that contribute to existing systematic patterns of disadvantage for groups. Their effects are experienced on (...) a long term basis, persisting even once an incentive research project ends. We will first establish that three categories of such harms potentially arise as a result of health incentive interventions. We then argue that the risk of these harms also constitutes a morally relevant consideration for health incentive research and suggest who may be responsible for assessing and mitigating these risks. We propose that responsibility should be assigned on the basis of who initiates health incentive research projects. Finally, we briefly describe possible strategies to prevent or mitigate the risk of long term harms to members of disadvantaged groups, which can be employed during the design, conduct and dissemination of research projects. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is (...) judged to be of particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

The internet of things is increasingly spreading into the domain of medical and social care. Internet-enabled devices for monitoring and managing the health and well-being of users outside of traditional medical institutions have rapidly become common tools to support healthcare. Health-related internet of things (H-IoT) technologies increasingly play a key role in health management, for purposes including disease prevention, real-time tele-monitoring of patient’s functions, testing of treatments, fitness and well-being monitoring, medication dispensation, and health research data collection. H-IoT promises (...) many benefits for health and healthcare. However, it also raises a host of ethical problems stemming from the inherent risks of Internet enabled devices, the sensitivity of health-related data, and their impact on the delivery of healthcare. This paper maps the main ethical problems that have been identified by the relevant literature and identifies key themes in the on-going debate on ethical problems concerning H-IoT. (shrink)

The widespread use of online search engines to answer the general public’s needs for information has raised concerns about possible biases and the emerging of a ‘filter bubble’ in which users are isolated from attitude-discordant messages. Research is split between approaches that largely focus on the intrinsic limitations of search engines and approaches that investigate user search behavior. This work evaluates the findings and limitations of both approaches and advances a theoretical framework for empirical investigations of cognitive biases in (...) online search activities about health-related topics. We aim to investigate the interaction between the user and the search engine as a whole. Online search activity about health-related topics is considered as a hypothesis-testing process. Two questions emerge: whether the retrieved information provided by the search engines are fit to fulfill their role as evidence, and whether the use of this information by users is cognitively and epistemologically valid and unbiased. (shrink)

In recent years, there has been a distinct shift in the relationship between science and society. We have moved away from the classic unidirectional “deficit” model (Simis et al. 2016) focused on t...

The conjunction of wireless computing, ubiquitous Internet access, and the miniaturisation of sensors have opened the door for technological applications that can monitor health and well-being outside of formal healthcare systems. The health-related Internet of Things (H-IoT) increasingly plays a key role in health management by providing real-time tele-monitoring of patients, testing of treatments, actuation of medical devices, and fitness and well-being monitoring. Given its numerous applications and proposed benefits, adoption by medical and social care institutions and consumers may be (...) rapid. However, a host of ethical concerns are also raised that must be addressed. The inherent sensitivity of health-related data being generated and latent risks of Internet-enabled devices pose serious challenges. Users, already in a vulnerable position as patients, face a seemingly impossible task to retain control over their data due to the scale, scope and complexity of systems that create, aggregate, and analyse personal health data. In response, the H-IoT must be designed to be technologically robust and scientifically reliable, while also remaining ethically responsible, trustworthy, and respectful of user rights and interests. To assist developers of the H-IoT, this paper describes nine principles and nine guidelines for ethical design of H-IoT devices and data protocols. (shrink)

The growing importance of health systems research has opened debate about appropriate ethical frameworks and guidelines for the ethical review and conduct of health systems research. In this article we consider a detailed proposal from Hyder et al. and consider it in relation to the conventional criteria for ethics review of clinical research outlined by Emanuel et al. and argue that the Emanuel criteria can be usefully applied to the review of health systems research to supplement (...) the Hyder et al. proposals. We argue further that health systems researchers and reviewers would benefit from many of the debates that have characterized the ethics of clinical research over the past three decades. (shrink)

Background The purpose of this study was to examine whether extended use of a variety of screen-based devices, in addition to television, was associated with poor dietary habits and other health-related characteristics and behaviors among US adults. The recent phenomenon of binge-watching was also explored. -/- Methods A survey to assess screen time across multiple devices, dietary habits, sleep duration and quality, perceived stress, self-rated health, physical activity, and body mass index, was administered to a sample of US adults using (...) the Qualtrics platform and distributed via Amazon Mechanical Turk (MTurk). Participants were adults 18 years of age and older, English speakers, current US residents, and owners of a television and at least one other device with a screen. Three different screen time categories (heavy, moderate, and light) were created for total screen time, and separately for screen time by type of screen, based on distribution tertiles. Kruskal-Wallis tests were conducted to examine differences in dietary habits and health-related characteristics between screen time categories. -/- Results Aggregate screen time across all devices totaled 17.5 h per day for heavy users. Heavy users reported the least healthful dietary patterns and the poorest health-related characteristics – including self-rated health – compared to moderate and light users. Moreover, unique dietary habits emerged when examining dietary patterns by type of screen separately, such that heavy users of TV and smartphone displayed the least healthful dietary patterns compared to heavy users of TV-connected devices, laptop, and tablet. Binge-watching was also significantly associated with less healthy dietary patterns, including frequency of fast-food consumption as well as eating family meals in front of a television, and perceived stress. -/- Conclusions The present study found that poorer dietary choices, as well as other negative health-related impacts, occurred more often as the viewing time of a variety of different screen-based devices increased in a sample of US adults. Future research is needed to better understand what factors among different screen-based devices might affect health behaviors and in turn health-related outcomes. Research is also required to better understand how binge-watching behavior contributes impacts health-related behaviors and characteristics. (shrink)

In order for children to receive the best possible medical treatment, it is essential that research is conducted to discover safe and effective interventions and dosages. This article focuses on the legal and ethical implications of recruiting into health-care research minors who are not competent to consent. It considers the role played by best interests in obtaining valid parental consent for the participation of children in research, both at common law and under the Regulations that govern clinical (...) trials of medicinal products. In doing so it questions the legality of parental consent to children's involvement in research, and identifies some inconsistencies in parental understandings of best interests in relation to medical research and treatment. (shrink)

A dearth of clinical research involving children has resulted in off-licence and sometimes inappropriate medications being prescribed to the paediatric population. In this environment, recent years have seen the introduction of a raft of regulation aimed at increasing the involvement of children in clinical trials research and generating evidence-based medicinal preparations for their use. However, this regulation pays scant attention to the autonomy of competent minors. In particular, it makes no provision for the ability of competent minors to (...) consent to participate in medical research and is therefore at odds with best ethical practice. This article explores the tensions between law and ethics in relation to clinical research involving minors and concludes that greater respect should be given to the autonomy of those minors who are competent to decide for themselves. (shrink)

Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic analysis. Results (...) Four key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective. (shrink)

PurposePrevious studies examining the relationship between health-related quality of life and speech perception ability in cochlear implant users have yielded variable results, due to a range of factors, such as a variety of different HRQoL questionnaires and CI speech testing materials in addition to CI configuration. In order to decrease inherent variability and better understand the relationship between these measures in CI users, we administered a commonly used clinical CI speech testing battery as well as two popular HRQoL questionnaires in (...) bimodal and bilateral CI users.MethodsThe Glasgow Benefit Inventory, a modified five-factor version of the GBI, and the Nijmegen Cochlear Implant Questionnaire were administered to 25 CI users. Speech perception abilities were measured with the AzBio sentence test in several conditions.ResultsHigher performance scores on the GBI general subscore were related to greater binaural speech perception ability in noise. There were no other relationships between the GBI or NCIQ and speech perception ability under any condition. Scores on many of the GBI-5F factors were substantially skewed and asymmetrical; therefore, correlational analyses could not be applied. Across all participants, binaural speech perception scores were greater than first-ear CI only scores.ConclusionThe GBI general subscore was related to binaural speech perception, which is considered the everyday listening condition of bimodal and bilateral CI users, in noise; while the more CI-specific NCIQ did not relate to speech perception ability in any listening condition. Future research exploring the relationships between the GBI, GBI-5F, and NCIQ considering bimodal and bilateral CI configurations separately is warranted. (shrink)

This article examines the responsibilities of researchers who conduct exploratory research to provide a service to vulnerable respondents. The term “service” is used to denote the provision of a tangible benefit in relation to the research question that is apart from the altruistic research benefits. This article explores what this “service” could look like, who might be responsible for providing it, and the challenges associated with such a service. The article argues that not providing a tangible benefit (...) to vulnerable research participants is inconsistent with the principle of social justice that undergirds much of the rationale for conducting health disparities research. (shrink)

ABSTRACT Although considerable attention has been given to ethical issues related to clinical research in developing countries, in particular related to HIV therapy, there has been limited focus on health systems research, despite its increasing importance in the light of current trends in development assistance. This paper examines ethical issues related to health systems research in ‘post’‐conflict situations, addressing both generic issues for developing countries and those issues specific to ‘post’‐conflict societies, citing examples from the author’s Cambodian (...) experience. It argues that the destruction of health infrastructure results in a loss of structures and processes that would otherwise protect prospective research subjects who are part of vulnerable populations. It identifies the growth of health systems research as part of a trend towards sectoral and programmatic development assistance, the emergence of ‘knowledge generation’ as a form of research linked to development, and the potential for conflict where multilateral and bilateral donors are both primary funders and users of health systems research. It also examines the position of the health system researcher in relation to the sponsors of this research, and the health system being analysed. (shrink)

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health (...) and Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

There is a growing expectation, or even requirement, for researchers to deposit a variety of research data in data repositories as a condition of funding or publication. This expectation recognizes the enormous benefits of data collected and created for research purposes being made available for secondary uses, as open science gains increasing support. This is particularly so in the context of big data, especially where health data is involved. There are, however, also challenges relating to the collection, storage, (...) and re-use of research data. This paper gives a brief overview of the landscape of data sharing via data repositories and discusses some of the key ethical issues raised by the sharing of health-related research data, including expectations of privacy and confidentiality, the transparency of repository governance structures, access restrictions, as well as data ownership and the fair attribution of credit. To consider these issues and the values that are pertinent, the paper applies the deliberative balancing approach articulated in the Ethics Framework for Big Data in Health and Research to the domain of Openness in Big Data and Data Repositories. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. (shrink)

As scholars integrate empirical approaches to ethical questions in healthcare, relational autonomy theory must inform research design and change practice. Qualitative approaches are well suited to issues where patient values play a central role, and they can be combined with relational autonomy theory to investigate the factors influencing autonomy-rich experiences. This paper draws upon my experience conducting bioethics research related to clinical trial decision-making to develop a systematic method for applying relational autonomy as a theoretical lens to qualitative (...) health research. The resultant practical guide utilizes Susan Sherwin’s theory of relational autonomy and presents an empirical method responsive to autonomy-relevant questions. (shrink)

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face (...) particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues relating to (...) the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

In this article, we use the theory of Information Ethics to argue that deceased people have a prima facie moral right to privacy in the context of health data research, and that this should be reflected in regulation and guidelines. After death, people are no longer biological subjects but continue to exist as informational entities which can still be harmed/damaged. We find that while the instrumental value of recognising post-mortem privacy lies in the preservation of the social contract for (...) health research, its intrinsic value is grounded in respect for the dignity of the post-mortem informational entity. However, existing guidance on post-mortem data protection is available only in the context of genetic studies. In comparing the characteristics of genetic data and other health-related data, we identify two features of DNA often given as arguments for this genetic exceptionalism: relationality and embodiment. We use these concepts to show that at the appropriate Level of Abstraction, there is no morally relevant distinction between posthumous genetic and other health data. Thus, genetic data should not automatically receive special moral status after death. Instead we make a plea for ‘contextual exceptionalism’. Our analysis concludes by reflecting on a real-world case and providing suggestions for contextual factors that researchers and oversight bodies should take into account when designing and evaluating research projects with health data from deceased subjects. (shrink)

Schools have been the main context for physical activity and sedentary behavior interventions among adolescents, but there is inconsistent evidence on whether they also improve dimensions of the health−related quality of life. The aim of this study was to evaluate the effects of a school-based active lifestyle intervention on dimensions of HRQoL. A secondary aim was to verify whether sex, age, and HRQoL at baseline were moderators of the intervention effect. A cluster-randomized controlled trial was conducted at three control and (...) three intervention schools in Florianopolis, Brazil. All students from 7th to 9th grade were invited to participate. A school year intervention, designed primarily to increase PA and reduce SB, included strategies focused on teacher training on PA, SB, and nutrition, and availability of teaching materials related to these contents; environmental improvements ; and education strategies, with the availability of folders and posters regarding PA, SB, and nutrition. Participants and the research staffs were not blinded to group assignment, but a standardized evaluation protocol was applied at baseline and after the intervention using the KIDSCREEN−27 to assess HRQoL across five dimensions. Mixed linear models were performed to evaluate the effect of the Movimente intervention on the five HRQoL dimensions. Of the 921 students who answered the questionnaire at baseline, 300 and 434 completed the study in control and intervention groups, respectively. The results revealed no significant effects of the intervention on any HRQoL dimensions. A reduction of the school environment dimension was observed in both the control and intervention groups. Sensitivity analyses showed that students in the highest baseline tertiles of HRQoL in any dimension had a reduction in their respective scores from pre- to post-intervention in both school groups. In conclusion, our results demonstrated no intervention effect on HRQoL dimensions and those students with the highest levels of HRQoL at baseline on all dimensions reduced from pre to post-intervention.Clinical Trial RegistrationThe trial is registered at the Clinical Trial Registry. (shrink)

Background - Early adulthood is the developmental stage during which, for the first time, an individual can independently choose their own lifestyle. For the future health of a young adult, it is important that they incorporate healthy behaviors from different health dimensions into their lifestyle. Analyzing the foregoing issue gives rise to a fundamental question: did intensive social changes experienced after Poland’s accession to the European Union lead to changes in different aspects of a healthy lifestyle? Method - The presented (...) study involved 504 people. The research data was collected in two separate measurements in 2003 and 2013. Subjects were asked to complete sets of questionnaires which measured: health behaviors, health beliefs, social influence, intention. Results - Statistical comparison of means tests and regression equations were conducted. Results demonstrate that young adults were similarly engaged in pro-health activities in both 2003 and 2013. A detailed analysis of health lifestyle factors shows that young adults from the 2013 group care more about their diet, physical activity, and more frequently undergo preventive medical health examinations. Moreover, significant changes in healthy lifestyle factors were reported. The most important observation concerned the changes in health beliefs. Beliefs derived from a holistic-functional model of health played a major role in the 2003 group, whereas in the 2013 group beliefs close to the biomedical model of health were more important. Conclusions - Analyses demonstrate changes in detailed healthy lifestyle factors. At the same time, no significant differences in global measures of concern for one’s health were observed. Importantly, results show modifications in healthy lifestyle factors. It is suggested that the observed differences stem from the social change of the last decade. (shrink)

One-third of all human lives end in early death from poverty-related causes. Most of these premature deaths are avoidable through global institutional reforms that would eradicate extreme poverty. Many are also avoidable through global health-system reform that would make medical knowledge freely available as a global public good. The rules should be redesigned so that the development of any new drug is rewarded in proportion to its impact on the global disease burden (not through monopoly rents). This reform would bring (...) drug prices down worldwide close to their marginal cost of production and would powerfully stimulate pharmaceutical research into currently neglected diseases concentrated among the poor. Its feasibility shows that the existing medical-patent regime (trade-related aspects of intellectual property rights—TRIPS—as supplemented by bilateral agreements) is severely unjust—and its imposition a human-rights violation on account of the avoidable mortality and morbidity it foreseeably produces. (shrink)

Taking a social identity approach to health behaviors, this research examines whether experimentally “activating” the human identity is an effective public-health strategy to curb the spread of COVID-19. Three goals of the research include examining: whether the human identity can be situationally activated using an experimental manipulation, whether activating the human identity causally increases behavioral intentions to protect the self and others from COVID-19, and whether activating the human identity causally increases behaviors that help protect vulnerable communities from (...) COVID-19. Across two preregistered experiments, results suggest the manipulation of identification with humanity had a significant but small effect on participants’ psychological bond with all humanity, but not their concern for all humanity. However, the manipulation had no causal effect on health-related behavioral intentions or helping behaviors that reduce the spread of COVID-19. Limitations, future directions, and direct benefits of the research are discussed. (shrink)

Recent scholarship has considered what, if anything, rich people owe to poor people to achieve justice in global health and the implications of this for international research. Yet this work has primarily focused on international clinical research. Health systems research is increasingly being performed in low and middle income countries and is essential to reducing global health disparities. This paper provides an initial description of the ethical issues related to priority setting, capacity-building, and the provision of post-study (...) benefits that arise during the conduct of such research. It presents a selection of issues discussed in the health systems research literature and argues that they constitute ethical concerns based on their being inconsistent with a particular theory of global justice (the health capability paradigm). Issues identified include the fact that priority setting for health systems research at the global level is often not driven by national priorities and that capacity-building efforts frequently utilize one-size-fits-all approaches. (shrink)

Before the EU General Data Protection Regulation entered into force in May 2018, we witnessed an intense struggle of actors associated with data-dependent fields of science, in particular health-related academia and biobanks striving for legal derogations for data reuse in research. These actors engaged in a similar line of argument and formed issue alliances to pool their collective power. Using descriptive coding followed by an interpretive analysis, this article investigates the argumentative repertoire of these actors and embeds the analysis (...) in ethical debates on data sharing and biobank-related data governance. We observe efforts to perform a paradigmatic shift of the discourse around the General Data Protection Regulation-implementation away from ‘protecting data’ as key concern to ‘protecting health’ of individuals and societies at large. Instead of data protection, the key risks stressed by health researchers became potential obstacles to research. In line, exchange of information with data subjects is not a key concern in the arguments of biobank-related actors and it is assumed that patients want ‘their’ data to be used. We interpret these narratives as a ‘reaction’ to potential restrictions for data reuse and in line with a broader trend towards Big Data science, as the very idea of biobanking is conceptualized around long-term use of readily prepared data. We conclude that a sustainable implementation of biobanks needs not only to comply with the General Data Protection Regulation, but must proactively re-imagine its relation to citizens and data subjects in order to account for the various ways that science gets entangled with society. (shrink)

Susan Sherwin's approach to bioethics promotes more inclusive and less oppressive sociopolitical environments within healthcare for marginalized groups. Sherwin's relational theory of autonomy endorses this aim in targeting live options as bellwethers for recognizing contexts constraining or promoting autonomy. Those contexts closing off certain options as pursuable in practice limit autonomy while those promoting a plurality of practically pursuable courses of action are autonomy enhancing. Attending to what is possible in practice is thus key to understanding how autonomy is impacted. (...) In healthcare contexts, those implicated in social structures systematically limiting autonomy sustain oppressive contexts... (shrink)

PurposeContinuous patient-reported outcomes to identify and address patients’ needs represent an important addition to current routine care. The aim of this study was to identify and determine important dimensions of health-related quality of life in routine oncological care.MethodsIn a cross-sectional qualitative study, interviews and focus groups were carried out and recorded. The interviewees were asked for their evaluation on HrQoL in general and specifically regarding cancer treatment. The material was transcribed and analyzed using qualitative content analysis based on Mayring. The (...) results were reviewed in an expert discussion.ResultsInterviews with patients and clinicians, as well as five focus groups with clinicians were conducted. Initially, nine deductive and two inductive categories on HrQoL were built. Four categories were excluded following the qualitative content analysis because they were hardly or not at all mentioned by participants. Following on from the analysis of the expert discussion, one dimension was added, and two further categories were excluded. The resulting system consisted of six dimensions: emotional health, physical ailments, autonomy, social functionality, dignity, and resources.ConclusionThe identified dimensions of HrQoL in routine oncological care were found to differ from those used in existing HrQoL measurements for patients. Further research is needed to test and evaluate the presented structure in a larger sample of cancer patients to further assess its psychometric properties. (shrink)

Research Ethics, Volume 18, Issue 1, Page 64-83, January 2022. Automated, wearable cameras can benefit health-related research by capturing accurate and objective information about individuals’ daily experiences. However, wearable cameras present unique privacy- and confidentiality-related risks due to the possibility of the images capturing identifying or sensitive information from participants and third parties. Although best practice guidelines for ethical research with wearable cameras have been published, limited information exists on the risks of studies using wearable cameras. The (...) aim of this literature review was to survey risks related to using wearable cameras, and precautions taken to reduce those risks, as reported in empirical research. Forty-five publications, comprising 36 independent studies, were reviewed, and findings revealed that participants’ primary concerns with using wearable cameras included physical inconvenience and discomfort in certain situations. None of the studies reviewed reported any serious adverse events. Although it is possible that reported findings do not include all risks experienced by participants in research with wearable cameras, our findings suggest a low level of risk to participants. However, it is important that investigators adopt recommended precautions, which can promote autonomy and reduce risks, including participant discomfort. (shrink)

It is increasingly recognised that evidence generated using “real-world data” is crucial for assessing the safety and effectiveness of health-related interventions. This, however, raises a number of issues, including those related to the quality of RWD, and of the scientific methods used to generate evidence from it, and the potential for those gathering and using RWD be driven by commercial, political, professional or personal self-interest. This article is an application of the framework presented in this issue of ABR. Please refer (...) to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end to demonstrate how those generating or using RWD can make use of values when deliberating about ethical issues. (shrink)

The aim of this mixed methods field study was to gain a better understanding of how psychological factors can contribute to success in intervention-induced behavior change over time. While it can be difficult to change behavior, the use of interventions means that most participants succeed in change during the intervention. However, it is rare for the immediate change to automatically transform into maintained behavior changes. Most research conducted on health-related behavior change interventions contains quantitative studies that investigate key intervention (...) components on a group level. Hence, to bring more knowledge about maintained intervention-induced behavior change, there is need for a study approach that enhances the understanding of individual participants' experiences during and after the intervention. Therefore, the present study, which was conducted in Sweden, used a mixed methods design (triangulation) consisting of pre-, post-, and follow-up quantitative data (questionnaires and body measurements) and qualitative data (interviews), where the individuals' accounts are used to broaden the understanding of the intervention and the behavior change process. All study participants were enrolled in a volitional (fee-based and non-manipulated) intervention given by certified gyms. The quantitative data collection included 22 participants who completed questionnaires and body measurements before and after the intervention, plus 13 complete body measurements 6 months after the intervention. The qualitative data included pre-interviews with 12 participants and six follow-up-interviews. The questions in both questionnaires and interviews related to expectations, efficacy, motivation, goals, achievements, behavior change, and future. Overall, the results show that levels of expectations, efficacy, and motivation cannot be used in isolation to predict maintained intervention-induced behavior change. To successfully extend and maintain immediate change, it was crucial to experience goal achievement (but not BMI change). Furthermore,enabling talkwas salient in the pre-interviews with participants reporting successful immediate (and maintained) change. By contrast, pre-interviewdisabling talkturned out to be evident in interviews, with participants not responding to follow-up. When the qualitative and quantitative results are summarized and integrated, it appears that subjective goal achievement, combined with enabling self-talk, were crucial factors in successful maintained behavior change. (shrink)

Technologic advances mean automated, wearable cameras are now feasible for investigating health behaviors in a public health context. This paper attempts to identify and discuss the ethical implications of such research, in relation to existing guidelines for ethical research in traditional visual methodologies. Research using automated, wearable cameras can be very intrusive, generating unprecedented levels of image data, some of it potentially unflattering or unwanted. Participants and third parties they encounter may feel uncomfortable or that their privacy (...) has been affected negatively. This paper attempts to formalize the protection of all according to best ethical principles through the development of an ethical framework. Respect for autonomy, through appropriate approaches to informed consent and adequate privacy and confidentiality controls, allows for ethical research, which has the potential to confer substantial benefits on the field of health behavior research. (shrink)

Critical Qualitative Health Research seeks to deepen understandings of the philosophies, politics and practices shaping contemporary qualitative health related research. This accessible, lively, controversial introduction draws on current empirical examples and critical discussion to show how qualitative research undertaken in neoliberal healthcare contexts emerges and the complex issues qualitative researchers confront. This book provides readers with a critical, interrogative discussion of the histories and the legacies of qualitative research, as well as of the more recent calls (...) for renewed criticality in research to respond to global health concerns. Contributions further showcase a range of contemporary work engaging with these issues and the complex encounters with philosophies, politics and practices this involves; from seeking explicit engagements with posthuman ideas or detailed explorations of deeply engaged humanist approaches, to critical discussions of the politics and practices of emerging novel, digital and creative methods. This book offers postgraduate researchers, health researchers and students alike opportunities to engage more deeply with the emergent, complex and messy terrain of qualitative health related research. (shrink)

In many parts of sub-Saharan Africa, mothers impacted by the genetic condition of albinism, whether as mothers of children with albinism or themselves with albinism, are disproportionately impacted by a constellation of health-related stigma, social determinants of health, and human rights violations. In a critical ethnographic study in Tanzania, we engaged with the voices of mothers impacted by albinism and key stakeholders to elucidate experiences of stigma. Their narratives revealed internalized subjective stigma, social stigma such as being ostracized by family (...) and community, and structural stigma on account of lack of access to SDH. An analysis of health systems as SDH revealed stigmatizing attitudes and behaviours of healthcare providers, especially at the time of birth; a lack of access to timely quality health services, in particular skin and eye care; and a lack of health-related education about the cause and care of albinism. Gender inequality as another SDH featured prominently as an amplifier of stigma. The findings pose implications for research, policy, and practice. A concrete avenue to de-stigmatization of mothers impacted by albinism exists by the application of principles of human rights, particularly equality and non-discrimination; contextual analysis of cultural dynamics including relevant ontology; meaningful participation of rights-claimants, such as peer groups of mothers; and accountability of governments and their obligation to ensure access to health information as a key social determinant of the right to health. (shrink)

BackgroundExercise self-efficacy is a vital determinant of an individual’s active participation in regular exercise, and exercise is a critical component of improving health-related quality of life in dialysis patients. This study aimed to describe the relationship between exercise self-efficacy and HRQOL in dialysis patients.Materials and MethodsA cross-sectional study was conducted in Shanghai, China. Structured questionnaires distributed to the patients collected socio-demographic and disease-related information. Physical activity was assessed by a self-administered questionnaire, and the exercise self-efficacy scale was used to measure (...) exercise self-efficacy. HRQOL was evaluated by the kidney disease quality of life instrument-short form version 1.3. Data were analyzed using a univariate generalized linear model, Spearman correlation, and hierarchical multiple regression.ResultsA positive association was observed between exercise self-efficacy and HRQOL. Physical activity as a predictor variable explained 9.8% of the variance in overall HRQOL. Exercise self-efficacy explained an additional 7.1% of the HRQOL variance. In total, 24.6% of the variation in the HRQOL was explained by the socio-demographic variables, disease-related factors, physical activity, and exercise self-efficacy.ConclusionOverall, only 16.9% of the change in HRQOL was explained by physical activity and exercise self-efficacy. Future research is still needed to further explore the factors influencing the HRQOL in dialysis patients. However, this finding suggests the need to consider the importance of HRQOL and physical activity as well as exercise self-efficacy when developing intervention programs. (shrink)

Institutional Review Boards have expressed concern that research into sensitive topics such as mental disorder will cause participants undue distress. This study investigated the emotional responses of 5,220 Australians to a survey on mental-health-related discrimination. Participants were interviewed about their mental health and experiences of discrimination across 10 life domains and then the emotional impacts of the survey. Results suggested that a minority experienced a negative reaction in contrast to 88% reporting positive experiences. A mental health problem was associated (...) with both negative and positive reactions. (shrink)