The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries (...) without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria. (shrink)

Ethical aspects of management control systems are attracting increasing attention among scholars and practitioners. Much of the work centers on their aims. We complement this scholarship by applying the ethical principle of “no harm,” i.e., non-maleficence, to examine how those aims are achieved. We illustrate this approach by exploring the effects of four MCS designs on job-related stress drawing on the differentiation of stress into two dimensions: a challenge and a threat dimension. Results from a lagged field-survey with 471 managers (...) and employees from the UK and the U.S. support key predictions and offer first insights into designing MCS based on a “no harm” ethics. Our study highlights the benefits of interdisciplinary research in business ethics and hopefully encourages more work on MCS from a perspective based on the non-maleficence principle. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Today’s social, economic, ecological and political state-of-affairs, the lack of confidence in business and political leaders and the associated rise of populist parties pose new and structurally different challenges to mankind. They are likely to be deepened in the course of the implementation of the Agenda 2030 for Sustainable Development. While all societal actors are called upon to reflect on their contribution to necessary reforms, business has a particularly important role to play. Competing with integrity today means much more than (...) compliance with law and regulation. The article discusses the necessity of top manager’s reflection on values and coherent practical action and uses the World Ethos body of thought as a compass. It also draws attention to the complexity of such a values management and stresses the importance of ethical leadership. (shrink)

The aim of this work is to identify and analyze a set of challenges that are likely to be encountered when one embarks on fieldwork in linguistic communities that feature small, young, and/or non-standard languages with a goal to elicit big sets of rich data. For each challenge, we (i) explain its nature and implications, (ii) offer one or more examples of how it is manifested in actual linguistic communities, and (iii) where possible, offer recommendations for addressing it effectively. Our (...) list of challenges involves static characteristics (e.g., absence of orthographic conventions and how it affects data collection), dynamic processes (e.g., speed of language change in small languages and how it affects longitudinal collection of big amounts of data), and interactive relations between non-dynamic features that are nevertheless subject to potentially rapid change (e.g., absence of standardized assessment tools or estimates for psycholinguistic variables). The identified challenges represent the domains of data collection and handling, participant recruitment, and experimental design. Among other issues, we discuss population limits and degree of power, inter- and intraspeaker variation, absence of metalanguage and its implications for the process of eliciting acceptability judgments, and challenges that arise from absence of local funding, conflicting regulations in relation to privacy issues, and exporting large samples of data across countries. Finally, the ten experimental challenges presented cover a broad typological spectrum, encompassing both spoken and sign, extant and nearly extinct languages. (shrink)

Six individuals with experience of psychosis were interviewed about their psychotic experiences. The material was analyzed using the empirical phenomenological psychological method. The results consist of a whole meaning structure, a gestalt, entailing the following characteristics: The feeling of estrangement in relationship to the world; the dissolution of time; the loss of intuitive social knowledge; the alienation of oneself, and finally; the loss of intentionality/loss of agency. In brief, the results show that an altered perception of the self and the (...) world was an essential part of the psychotic experience where subjects described themselves as changed; something was sensed as being wrong as psychosis is perceptible but hard to communicate. The normal life-world experience was altered and reality seemed strange. Time perception seemed to be changed as temporality appeared dissolved and the experience of time was focused on the current moment excluding the future. The subjects described loss of intentionality, they were no longer agents in their actions but partly steered by others and they could feel as if their experiences were not theirs. The patients also describe problems regarding their ability to socialize and communicate with others. They seem to lose their intuitive social capacity and were prone to suspiciousness. (shrink)

In this paper, we argue that the professional engineering institutions ought to develop a Declaration of Climate Action. Climate change is a serious global problem, and the majority of greenhouse gas emissions come from industries that are enabled by engineers and represented by the engineering professional institutions. If the professional institutions take seriously the claim that a profession should be self-regulating, with codes of ethics that go beyond mere obedience to the law, and if they take their own ethical codes (...) seriously, recognising their responsibility to the public and to future generations, the professional institutions ought to develop a declaration for engineers, addressing climate change. Our argument here is largely inspired by the history of the Declaration of Helsinki. The Declaration of Helsinki was created by the medical profession for the profession, and it held physicians to a higher standard of ethical conduct than was found in the legal framework of individual countries. Although it was not originally a legal document, the influence of the Declaration can be seen in the fact that it is now enshrined in law in a number of different countries. Thus, we argue that the engineering profession could, and should, play a significant role in the abatement of climate change by making changes within the profession. If the engineering profession sets strict standards for professional engineers, with sanctions for those who refuse to comply, this could have a significant impact in relation to our efforts to develop a coordinated response to climate change. (shrink)

This article re-examines and fundamentally re-assesses the symbiotic relationship between law and ethics in the governance and regulation of biobanks as a global phenomenon. Set against the two decades of experience of set-up, management and most recently granting access to biobanks to promote advances in human health, it is argued that the boundaries—and so the legitimacy—of the respective roles of ethics and law have become blurred and, potentially, blunted. The caricature of law as a tool of command and control—resulting in (...) compliance culture—is well recognised in regulation studies, but parallels with this can now also be seen within certain ethical regimes pertaining to biobanks and human health research more generally. At the same time, the ethical content of certain legal responses to biobanks can be lacking, as some legal systems seek to regulate biobanking in inflexible and unreflective ways that potentially undermine the entire enterprise. This can result in a net failure to capture adequately particular features of biobanking that make this field so potentially rich in terms of ultimate social value and human benefit. The argument is made that the interconnected, yet distinct, nature of the contributions of law and ethics must be better understood in this setting. The central message is unapologetically sceptical about the role of law in regulating biobanking, except when we see law as process. Rather, the position is advanced that more work is required to develop governance regimes that are ‘Ethics+’ : that is, rooted in the core values and principles at stake while able to adapt and accommodate the inevitable changing landscape of biobank research and practice. While ethics are always a necessary component of a robust and defensible regimes of health research, the notion of Ethics+ directs our attention to processes in which ethical discourse and engagement can be optimised to respond to particular features of biobanks and their operation. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department of (...) Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

In “Harmful Choices, the case of C, and decision making competence,” Pickering et al. offer a thought-provoking interpretation of the relationship between harm and capacity assessments by an...

Modulating connectivity measures in EEG-based neurofeedback studies is assumed to be a promising therapeutic and training tool. However, little is known so far about its effects and trainability. In the present study, we investigated the effects of up- and down-regulating SMR coherence by means of neurofeedback training on EEG activity and memory functions. Twenty adults performed 10 neurofeedback training sessions in which half of them tried to increase EEG coherence between Cz and CPz in the SMR frequency range, while the (...) other half tried to down-regulate coherence. Up-regulation of SMR coherence led to between- and within-session changes in EEG coherence. SMR power increased across neurofeedback training sessions but not within training sessions. Cross-over training effects on baseline EEG measures were also observed in this group. Up-regulation of SMR coherence was also associated with improvements in memory functions when comparing pre- and post-test results. Participants were not able to down-regulate SMR coherence. This group did not show any changes in baseline EEG measures or memory functions comparing pre- and post-test. Our results provide insights in the trainability and effects of connectivity-based neurofeedback training and indications for its practical application. (shrink)

The role of ethics committees is to protect and safeguard the rights and welfare of participants, and promote good research by providing ethical guidance to researchers. In order for ethics committees to fulfil their role and obligations, they need to have adequate understanding of the science and scientific methods used in research. Genomics is a novel and rapidly evolving research field, and identifying the ethical issues raised by it is not straightforward. Limited understanding of, and expertise in, reviewing genomic research (...) may lead ethics committees to either hamper novel research, or overlook important ethical problems. Researchers are in the best position to assist ethics committees in their efforts to remain informed about scientific advancements. (shrink)

Randomised clinical trials involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.

The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent (...) autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account. (shrink)

The practice of biobank networking—where biobanks are linked together, and researchers share human tissue samples—is an increasingly common practice both domestically and internationally. The benefits from networking in this way are well established. However, there is a need for ethical oversight in the sharing of human tissue. Ethics committees will increasingly be called upon to approve the sharing of tissue and data with other researchers, often via biobanks, and little guidance currently exists for such committees. In this paper, we provide (...) a structured approach to the ethical review of on-sharing of data and tissue for research purposes. (shrink)

Ethicists, researchers and policy makers have paid increasing attention to the ethical conduct of research, especially research involving human beings. Research performed with and by undergraduates poses a specific set of ethical challenges. These challenges are often overlooked by the research community because it is assumed that undergraduate student researchers do not have a significant impact on the research community and that their projects are not host to research posing important ethical issues. This paper identifies several features characteristic of research (...) in undergraduate environments. The paper pays special attention to selective small liberal arts colleges, an important segment of higher education in the US, and advocates integrating instruction in research ethics wherever undergraduates are engaged in research. (shrink)

Introduction Numerous guidelines and policies for ethical research practice have evolved over time, how this translates to global health practice in resource-constrained settings is unclear. The purpose of this paper is to describe how the concept of ancillary care has evolved over time and how it is included in the ethics guidelines and policy documents that guide the conduct of research in the global south with both an international focus and providing a specific example of Malawi, where the first author (...) lives and works, as a case study. Methods Discourse analysis was conducted on 34 international ethics guidelines and policy documents. Documents were purposively selected if they contained a set of key terms that reflect the concept of ancillary care. Following a process of inductive discourse analysis, five key interrelated text phrases relating to ancillary care were extracted from the documents. The evolution of these phrases over time was explored as they represented the development of the concept of ancillary care as a component of ethical health research guidance and practice. Results We found key interrelated phrases that represent discourses regarding the evolution of ancillary care including participant protection; provide care as appropriate; supererogation; patient needs prevail over science; and ancillary care as an obligation. Arguments for the provision of ancillary care were characterised by safeguarding the safety, health rights and well-being of study participants. However, despite the evolution of discourse around ethical obligations to provide ancillary care, this is rarely made explicit within guidance documents, leaving interpretive space for differential application in practice. Conclusion While there have been major changes to the ethics guidance that reflect significant evolution in the ethical conduct of research, the specific vocabulary or language used to explain the ethics of researchers' ancillary care obligations to the health needs of their research participants, lacks clarity and consistency. As a result, the concept of ancillary care continues to be under-represented in local ethical guidelines and regulations, with no clear directives for country-level research ethics committees to apply in regulating ancillary care responsibilities. (shrink)

Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation, the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we (...) set out to explore relevant ethical principles and norms. We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research. We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used. While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust. (shrink)

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 (...) to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research. (shrink)

Part of the standard protection of decisionally incapacitated research subjects is a prohibition against enrolling them unless surrogate decision makers authorize it. A common view is that surrogates primarily ought to make their decisions based on what the decisionally incapacitated subject would have wanted regarding research participation. However, empirical studies indicate that surrogate predictions about such preferences are not very accurate. The focus of this article is the significance of surrogate accuracy in the context of research that is not expected (...) to benefit the research subject. We identify three morally relevant asymmetries between being enrolled and not being enrolled in such non-beneficial research, and conclude that when there is a non-negligible probability that surrogates’ predictions are wrong, it will generally be better to err on the side of not authorizing enrollment. (shrink)

Patient participation is one of the most prevalent focus areas in the Danish healthcare debate. Patient participation is generally presented as a fundamental democratic right, and is stated in an objective language with legal requirements for healthcare professionals to ensure that patients systematically participate in their own courses of care and treatment. In the research literature, it is not clear what is meant by ‘patient participation’, and several discourses on patient participation exist side by side. This study explores how discourses (...) of patient participation unfold and are at play in the articulations in official legal and political documents and patient records relating to a Danish psychiatric context. The documents and patient records have been analyzed using a Fairclough‐inspired critical discourse approach which is concerned with how power is exercised through language. The research findings show that patient participation within Danish psychiatric healthcare is governed within a neoliberal discourse where underlying discourses; discourse of biomedicine, paternalism, management, evidence and ethics of care are embedded, and a discourse that seems to ascribe stigmatizing traits to mentally ill patients. (shrink)

Disclosure is a common response to conflicts of interest; it is intended to expose the conflict to scrutiny and enable it to be appropriately managed. For disclosure to be effective the receiver of the disclosure needs to be able to use the information to assess how the conflict may impact on their interests and then implement a suitable response. The act of disclosure also creates an expectation of self-regulation, as the person with the conflicting interests will be mindful of their (...) own potential biases and aware that their decisions may be monitored. This article discusses some of the problems of relying on disclosure as a solution to address conflicts of interest in research, including the added complexities around institutional conflicts of interest. The case of Dan Markingson illustrates these issues and highlights the vulnerable position relying on disclosure as a solution leaves research participants in. (shrink)

The radical changes deriving from the COVID-19 emergency have heavily upset some of the most familiar routines of daily work life. Abruptly, many workers have been forced to face the difficulties that come with switching to remote working. Basing on the theoretical framework proposed by the Job Demands-Resources model, the purpose of this paper was to explore the effect of work overload, on behavioral stress, meant as an outcome linked to the health impairment process. Furthermore, the aim of the study (...) was to explore the mediating role of job crafting, considered as a second-order construct consisting of two dimensions in the abovementioned relation. Participants were 530 workers experiencing remote working or work-from-home during the first COVID-19 lockdown in Italy. Hypotheses were explored by using three different latent variables, measured reflexively through indicators on a 5-point scale, extracted from validated questionnaires. Data analysis was performed through Structural Equation Modeling; to test the mediation, bootstrap validation was computed. Results showed that the mediation of job crafting was partial. More specifically, the direct effect between work overload and behavioral stress was positive; moreover, the indirect, negative effect through the mediation of job crafting was also significant. Therefore, results showed that job crafting can play a crucial role as a protective factor supporting the activation and adjustment of suitable resources; these resources can be useful to deal with the negative effects of work overload, particularly under the condition of heavy remote working and use of technologies, on individual outcomes. Starting from the current global scenario of the pandemic that has not yet ceased its effects, the study suggested decisive theoretical and practical implications. Accordingly, findings extended the current trends in occupational health psychology research, with special reference to the mainstream topic “work and COVID-19” in the Italian context. Finally, results can give suggestions to companies engaged in managing change, recommending that they build a collaborative workplace at the individual and collective level to implement job crafting interventions and enrich the personal and organizational resources of workers, which is useful cope with the current demands. (shrink)

Sense of Agency (SoA) is the subject of growing attention. It corresponds to the capacity to claim authorship over an action, associate specific consequences with a specific action, and it has been claimed to be a key point in the development of consciousness. It can be measured using the Sense of Agency Scale (SoAS), originally proposed by Tapal et al. (2017), who distinguished it into two-factor: Sense of Positive Agency (SoPA) and Sense of Negative Agency (SoNA). This study reports on (...) the first adaptation of the SoAS into another language, French. For this French version of the Sense of Agency Scale (F-SoAS), we analyzed responses from a sample of 517 native French-speakers. Our results indicate that the scale has good psychometric properties. Factor analysis confirm the same two-factor model as Tapal et al. (2017). However, some items were removed due to insufficient loadings with factors, leading to a short version of the scale (7-item). Furthermore, we observed gender differences that are consistent with findings in the literature. Specifically, women report higher SoNA scores and lower SoPA scores than men. We conclude by discussing possible uses and future directions for the scale. (shrink)

Background:Many frail older persons who die in Swedish nursing homes need assisted bodily care. They must surrender their bodies to the authority of assistant nurses, which may affect their autonomy and dignity of identity. While assistant nurses claim to support older persons’ wishes, older persons claim they have to adapt to assistant nurses' routines. The provider–receiver incongruence revealed here warrants investigation.Aim:To describe the elements of assisted bodily care, as performed in a nursing home.Research design:Data were collected through thirty-nine observations of (...) assisted bodily care, analyzed with qualitative content analysis.Participants and research context:Seventeen older persons and twenty-two assistant nurses from a Swedish nursing home.Ethical considerations:The research was conducted in line with the Declaration of Helsinki, further approved by the regional ethics committee.Findings:Findings show that assisted bodily care consists of assistant nurses’ practical work, performed at a high tempo. Assistant nurses still attempt to adapt this work to the older persons’ wishes for self-determination, taking into account their day-to-day state of health. In spite of time pressure and occasional interruptions, there is room for consideration and affection in assisted bodily care.Discussion:Assistant nurses try to promote older persons’ dignity of identity, but sometimes fail, possibly due to lack of time. They nevertheless seem to know the older persons well enough to adapt the assisted bodily care according to their preferences and to support self-determination. This indicates that openness to older persons’ lifeworlds may be more important than the amount of time available.Conclusion:Nursing home contexts might benefit from adopting a person-centered palliative care perspective, highlighting the value of relationships and shared decision-making. If so, older persons and assisted nurses could agree on practices and goals in assisted bodily care beforehand. Such routines may be time-saving and beneficial to all. (shrink)

Background: Worldwide, older persons lack access to palliative care. In Sweden, many older persons die in nursing homes where care is provided foremost by assistant nurses. Due to a lack of beds, admission is seldom granted until the older persons have complex care needs and are already in a palliative phase when they move in. Objective: To describe assistant nurses’ perspectives of providing care to older persons at the end of life in a nursing home. Research design: Data were collected (...) in semi-structured individual interviews and analyzed with inductive qualitative content analysis. Participants and research context: Seven assistant nurses from a nursing home in Sweden were randomly selected. Ethical consideration: The research was approved by the local ethics committee. Results: Three main categories emerged; “Death a natural part of life”; “The older person’s well-being”; and “Care in the moment of death”; and seven sub-categories. The assistant nurses described themselves as knowing the older persons well enough to provide good end-of-life care. This was achieved by making small-talk while providing daily care. Relying on experience-based knowledge, they strove to provide end-of-life care built upon respect and engagement with the ambition to strengthen older persons’ dignity, for example, by lowering the tempo of care at the end of life, in spite of organizational restrictions. Discussion: The assistant nurses offered attentive end-of-life care, focusing upon bodily care. The existential needs of the older persons were not foregrounded. Conclusion: To develop their work, and to promote an ethical foundation for such care, assistant nurses might need support and education to be able to offer a care more in line with the aims of palliative care. Furthermore, the organization of care needs to promote, not impede, the realization of this development. (shrink)

Background: We were finding volunteers for functional magnetic resonance imaging studies with abnormalities requiring referral surprisingly frequently. The bioethics surrounding the incidental findings are not straightforward and every imaging institution will encounter this situation in their normal volunteers. Yet the implications for the individuals involved may be profound. Should all participants have review of their imaging by an expert and who should be informed? Methods: The normal volunteers that were imaged with magnetic resonance (MR) which were reviewed by a consultant (...) neuroradiologist. All participants completed a volunteer consent form in addition to a standard departmental MR safety screening form. The volunteer screening form requires the general practitioner details to be completed and asks the participant to consider closely the possibility and implications of finding an unexpected but potentially serious abnormality before signing. Results: 525 different individuals were scanned as normal volunteers, the mean age was 35-years and 330 were males. Of these 525, 46 had definite significant abnormalities (8.8%), mean age 50-years. Conclusion: We have found a high rate of incidental abnormalities amongst individuals participating in imaging studies at our institution. It is our current practice to inform the research study participant of the findings, counsel them and inform their primary care physician. We think that it is advisable for researchers utilising MR imaging of the brain to have access to trained neuroradiologists, a protocol in place to deal with this problem and take consent in a way that allows the participant to realise the possibility of an abnormal finding. (shrink)

A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards _deliberate,_ with particular attention given to the lack of transparency and opportunities for researcher recourse that characterise ethics review processes. Centered specifically (...) on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas’ (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984 ) articulation of ‘communicative action’ and Fraser’s (Social Text, 25(26), 56–80, 1990 ) consideration of ‘strong publics’ to cast consideration of the role that human ethics review boards might play in supporting university research cultures. _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ provide useful conceptual prompts for considering how ethics review boards might undertake their work. (shrink)

The high price of drugs is receiving due consideration from ethicists, policymakers, and legislators. However, much of this attention has focused on the difference between the cost of drug development and company profits and the possible laws and regulations that could limit a drug’s price once it reaches market. By contrast, little attention has been paid to the ethical implications of high drug prices for the research subjects whose bodies were essential to the drug’s development. Indeed, the future price of (...) a drug is routinely ignored and treated as unknowable during the ethical evaluation of the clinical trials that support its development. In this paper, I will argue that ignoring the future price of a drug during the research process is in tension with all three of the major principles of research ethics: it fails to show respect for the research participants, undermines the quality of risk/benefit judgements made by ethical review committees, and makes it impossible to judge future patient access and assess justice. (shrink)

Attention and disruptive behavior disorders present considerable challenges for children and their parents. These challenges have led to the development of parenting programs; however, there is a paucity of literature that discusses the ethical dilemmas parent training researchers face. This article reviews ethical principles and professional standards relevant to parent training research and provides case material to illustrate the challenge of balancing ethical adherence and empirical rigor using three ethical issues that commonly arise in parent training research. In particular, this (...) article focuses on ethical issues surrounding confidentiality in a group setting, use of control groups, and limiting changes in medication/treatment status outside of the treatment protocol. (shrink)

In a Norwegian study on how children aged 7-12 years cope during a period of serious illness within the family and on their quality of life at this time, several ethical questions became apparent. These were mainly concerned with the vulnerability of children during research, with their ability to make autonomous decisions, and with considerations regarding how to respect their right to confidentiality during the research process. In this article we approach these questions using our experience from this previous study, (...) discussing them within the framework of theories of ethics and relevant research ethical guidelines. Finally, we discuss our experience in the light of the overall purpose of this article: how to deal with the ethical dilemmas that may appear during research involving young children. (shrink)

Providing proper protection of confidentiality, by preventing personal data from falling into the hands of third parties, is one of the core responsibilities of researchers towards research participants. However, even if researchers do their best in this regard, it does not guarantee that breaches of confidentiality will be avoided. This paper addresses the case of small qualitative studies, arguing that researchers cannot guarantee their informants’ confidentiality, since that confidentiality may be compromised by actions taken by the informants themselves. In order (...) to reduce the risk of this specific threat to confidentiality, additional precautions need to be taken. Some potential solutions to the problem are suggested and discussed. (shrink)

People with dementia have previously not been active participants in research, with ethical difficulties often being cited as the reason for this. A wider inclusion of people with dementia in research raises several ethical and methodological challenges. This article adds to the emerging debate by reflecting on the ethical and methodological issues raised during an interview study involving people with dementia and their spouses. The study sought to explore the impact of living with dementia. We argue that there is support (...) for the inclusion of people with dementia in research and that the benefits of participation usually far outweigh the risks, particularly when a `safe context' has been created. The role of gatekeepers as potentially responsible for excluding people with dementia needs further consideration, with particular reference to the appropriateness of viewing consent as a primarily cognitive, universalistic and exclusionary event as opposed to a more particularistic, inclusive and context relevant process. (shrink)

This paper deals with ethical issues of particular relevance to longitudinal research involving children. First some general problems concerning information and lack of understanding are discussed. Thereafter focus is shifted to issues concerning information and consent procedures in studies that include young children growing up to become autonomous persons while the project still runs. Some of the questions raised are: When is it right to include children in longitudinal studies? Is an approval from the child needed? How should information to (...) children be handled? A general point stressed is that autonomy considerations underline the importance of adjusting the information given to meet demands. A “presumption of competence” may be needed in research involving children, in order to pay their views sufficient attention. (shrink)

The aim of this study was to gain a deeper understanding of privacy in occupational health services. Data were collected through in-depth theme interviews with occupational health professionals (n=15), employees (n=15) and employers (n=14). Our findings indicate that privacy, in this context, is a complex and multilayered concept, and that companies as well as individual employees have their own core secrets. Co-operation between the three groups proved challenging: occupational health professionals have to consider carefully in which situations and how much (...) they are entitled to release private information on individual employees for the benefit of the whole company. Privacy is thus not an absolute right of an individual, but involves the idea of sharing responsibility. The findings open up useful new perspectives on ethical questions of privacy and on the development of occupational health practices. (shrink)

Although the principle of informed consent is well established and its importance widely acknowledged, it has met with criticism for decades. Doubts have been raised for a number of different reasons. In particular, empirical data show that people regularly fail to reproduce the information provided to them. Many critics agree, therefore, that the received concept of informed consent is no more than a myth. Strategies to overcome this problem often rest on a flawed concept of informed consent. In this paper, (...) it is suggested that informed consent is a communicative act between two persons. The challenge is to elucidate the norms and constraints for successfully performing such a communicative act. The view developed here has major consequences with regard to the standards for information disclosure as well as for the general scope of informed consent. (shrink)

It has become evident that neuroimaging raises new normative questions that cannot be addressed adequately within the (in this regard unspecific) frameworks of existing research ethics. Questions that are especially troubling are, among others, provoked by incidental findings. Two questions are particularly intricate in view of incidental findings: (1) How can the research subject’s right not to know be guaranteed? And (2) should a diagnostic check of scans by a neuroradiologist become an obligatory part of neuroscientific research protocols? The present (...) paper examines these question against the background of two recent recommendations. The differentiation between difference position and similarity position serves as an analytic tool to further investigate the issue and to develop a distinct proposal for answering the questions. (shrink)

The purpose of this study was to examine how ethical approval and competing interests are addressed by medical journals in Iran. In a cross-sectional study, 151 journals accredited by the Publications Commission of the Ministry of Health and Medical Education were reviewed. Data collection was carried out by assessing journal guidelines and conducting structured phone interviews with journal managers, focusing on how ethical considerations and conflicts of interest (COI) are addressed. Overall, 135 of the 151 journals (89.4 percent) examined some (...) aspect of ethical considerations of submitted articles. Authors were required to disclose their financial sponsors by 98 journals (64.9 percent), while COI disclosure was required by 67 journals (44.4 percent). We conclude that the rate of addressing ethical considerations is not far from ideal, but the requirement for COI disclosure needs more attention. (shrink)

BackgroundBefore participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway.Methods24 PICDs from studies were collected and readability was assessed independently using the Gunning’s Fog Index and Simple Measure of Gobbledygook grading.ResultsThe mean score for the FOG and SMOG grades were 14.2 and 14.2 respectively. The mean FOG and SMOG grades were (...) 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study.ConclusionsAs the readability level of the PICDs did not match the participants’ educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD. (shrink)

Adverse health care events are a global public health issue despite major efforts, and they have been acknowledged as a complex concern. The aim of this study was to explore the construction of unsafe care using accounts of adverse events concerning the patient, as reported by patients, relatives, and health care professionals. Twenty‐nine adverse events reported in an acute care setting in a Swedish university hospital were analyzed through discourse analysis, where the construction of what was considered to be real (...) and true in the descriptions of unsafe care was analyzed. In the written reports about unsafe events, the patient was spoken of in three different ways: (a) the patient as a presentation of physical signs, (b) the patient as suffering and vulnerable, and (c) the patient as unpredictable. When the patient's voice was subordinate to physical signs, this was described as being something that conflicted with patient safety. The conclusion was that the patient's voice might be the only sign available in the early stages of adverse events. Therefore, it is crucial for health care professionals to give importance to the patient's voice to prevent patients from harm and not unilaterally act only upon abnormal physical signs. (shrink)