One of the important determinants of development during the transition to adulthood is the undertaking of social roles characteristic of adults, also in the area of finishing formal education, which usually coincides with beginning fulltime employment. In the study discussed in this paper, it has been hypothesized that continuing full-time education above the age of 26, a phenomenon rarely observed in Poland, can be considered as an unpunctual event that may be connected with difficulties in the process of identity formation. (...) Relationships between identity dimensions and identity statuses, and age and educational context were analyzed. 693 individuals aged 19-35 took part in the study. The participants attended three types of educational institutions: full-time university studies, part-time university studies, and full-time post-secondary school. Among the students of full-time university studies predictable dependencies, also in respect of highlevels of indicators of identity crisis and a high frequency of diffused identity occurrence, were observed. Such dependencies were not found in the group of full-time post-secondary school students. (shrink)

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address (...) the question of whether there should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-risk research’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees. (shrink)

Institutional review boards (IRBs) have a reputation for impeding research. This reputation is understandable inasmuch as many studies are poorly designed, exploit participants, or do not ask a relevant question , and it is entirely proper that IRBs should reject such proposals. However, IRBs also frequently reject or tamper with perfectly sound and relevant studies in the name of protecting participants from harm, in accordance with the widely accepted message that “clinical research is justified only when participants are (...) protected from excessive risks”. Here, I argue that IRBs should never reject a study because it poses too high a risk to participants, and that their role should be confined to ensuring that risks and any potential benefits are fully explained to potential participants. Everyone should have the right to participate in research without paternalistic decisions about risk being made on their behalf. (shrink)

Some early phase clinical studies of candidate HIV cure and remission interventions appear to have adverse medical risk–benefit ratios for participants. Why, then, do people participate? And is it ethically permissible to allow them to participate? Recent work in decision theory sheds light on both of these questions, by casting doubt on the idea that rational individuals prefer choices that maximise expected utility, and therefore by casting doubt on the idea that researchers have an ethical obligation not to enrol participants (...) in studies with high risk–benefit ratios. This work supports the view that researchers should instead defer to the considered preferences of the participants themselves. This essay briefly explains this recent work, and then explores its application to these two questions in more detail. (shrink)

We focus here on high-risk pediatric research with the prospect of direct benefit and point out some aspects that have raised significant debate. In particular, we call attention to disagreements related to two essential aspects of this type of research: (i) determining what constitutes a “prospect of direct benefit” in phase I trials that involve gene transfer technologies and (ii) assessing when in these trials the risk is justified by the anticipated benefit to the participant children. Although much (...) of our discussion is applicable to other types of high-risk pediatric trials, as an example of the dilemma this type of research poses we use pediatric trials that involve gene transfer technologies. We focus on clinical trials for late infantile neuronal ceroid lipofuscinosis (LINCL). Exploring the ethical implications of some of these disagreements might identify resources for determining how best to deal with the ethical concerns at stake in high-risk pediatric research. We thus offer some recommendations for responding to these concerns. (shrink)

Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance use or (...) sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee. (shrink)

Habitus has been an attractive concept for works examining body-centric practices. This article draws on interviews and 18 months of ethnographic research with high-risk climbers primarily throughout North America. An important guide to this research has been the concept of habitus. However, this article demonstrates that there are limits to habitus being used to address the moment of action. The scope of habitus ranges widely, limiting its capacity to effectively address the experience of the individual. Rather than abandoning (...) the concept, habitus can be extended through a reconceptualization drawing on the use of echoes as a metaphor. Using echoes as an allegorical mode of understanding dispositional acquisition and activation, the embodied echo can more radically and precisely explore the habitus in motion during the intensely body-centric practice of alpine climbing. This is particularly critical when exploring the use of speed as a form of safety in the alpine environment. (shrink)

Clinical trials aim to minimise participant risk and generate new clinical knowledge for the wider population. Many military agencies are now investing efforts in pushing towards developing new treatments involving Brain-Computer Interfaces, Gene Therapy and Stem Cells interventions. These trials are targeting smaller disease groups, as such they give rise to novel participant risks of harms that are largely not accommodated by existing practice. This is of most concern with irreversible harms at early trial stages, where participants may forfeit any (...) future therapy, and in personalised medicine, where the individual participant assumes all of the trial risk. Given these new experimental interventions involve high risk of irreversible harms, how much risk should patients be exposed to when participating in experimental testing of innovative technologies? Designing clinical trials which better balance risk/benefit ratios for participants is crucial. The aim of this book chapter is to suggest a new stratified risk framework aimed at minimising the risk-benefit ratio to participants in clinical trials associated with high risk of irrevocable harms. We will argue it demands a higher-level of clinical data capture at earlier trial stages than predicated by current trial doctrine; it also requires publication of all trial data to minimise risk to participants of any future trial. (shrink)

Background Clinical empathy is an essential part of healthcare, and patient-centered care models require clinical empathy to be established. Despite this, little is known about its measurement in the neonatal scenario. Research Aim To measure clinical empathy in health professionals who work with medium and high-risk neonates and build a construct of this empathy. Research Design Single-center survey study. Participants and Research Context The Jefferson Scale of Empathy for Health Professionals questionnaire was applied to health professionals who (...) work in an intensive care unit and a medium-risk unit, in Brazil. Analysis was done using descriptive statistics and a factor analysis model, to build the construct of empathy. Overall empathy was calculated, and the domains’ punctuations were analyzed and compared to the maximum punctuation possible. The study followed the STROBE checklist. Ethical Considerations This study was approved by the Research Ethics Committee of the institution. All participants signed the informed consent form. Participants’ confidentiality and anonymity were protected. Findings Median empathy was 117 (IQR 113–124). The domain of Walking in the Patient’s Shoes had lower scores and represented 77.6% of the maximum punctuation possible. The factor analysis included three factors named Understanding, Experiences, and Treatment, and Emotional Relationships, explaining 64.3% of the overall variance. The domain Walking in the Patient’s Shoes was not included in the model. Conclusions In this scenario, clinical empathy should improve. There is a need to improve the domain of Walking in the Patient’s Shoes, in this case, the neonate, and provide more empathic care to them. (shrink)

This article explores the evolution of a major longitudinal ‘high risk for schizophrenia’ research programme, started over 50 years ago, which has been largely ignored in recent debates over ‘psychosis risk’ and early intervention. Studying mainly the offspring of individuals with schizophrenia, high-risk investigators aimed to identify a range of precursors of schizophrenia in the hope that the findings would eventually facilitate effective primary prevention. Specifically, the article examines the origins and impact of the pioneering Copenhagen High-Risk Project and (...) thus provides an important contribution to the sparse historical literature on schizophrenia research, including the study of milder conditions and at-risk states in the borderlands of psychosis. (shrink)

This book examines historical approaches and current research and practice related to the education of adolescents placed at risk of school failure as a result of social and economic conditions. One major goal is to expand the intellectual exchange among researchers, policymakers, practitioners, and concerned citizens on factors influencing the achievement of poor and minority youth, specifically students in middle and high schools. Another is to encourage increased dialogue about policies and practices that can make a difference in educational (...) opportunities and outcomes for these students. Although the chapters in this volume are not exhaustive, they represent an array of theoretical and methodological approaches that provide readers with new and diverse ways to think about issues of educational equality and opportunity in the United States. A premise that runs through each chapter is that school success is possible for poor and minority adolescents if adequate support from the school, family, and community is available. *The conceptual approach places the research and practice on students placed at risk in a historical context and sets the stage for an important reframing of current definitions, research, policies, and practices aimed at this population. *Multiple research methodologies allow for comparisons across racial and ethnic groups as well as within groups, and contribute to different and complementary insights. Section III, "Focus on African-American Students," specifically addresses gender and social class differences among African-American adolescents. *Current reform strategies presently being implemented in schools throughout the United States are presented and discussed. These strategies or programs highlight how schools, families, and communities can apply research findings like the ones this book presents, thus bridging the often wide gap between social science research and educational practice. (shrink)

Research on individuals at clinical high risk for psychological and physical disorders has grown exponentially in recent years, with a variety of new screening tools and early intervention techniques being implemented. One recent example is Attenuated Psychosis Syndrome, a diagnosis for individuals who are at clinical high risk for psychosis, which was recently included in Section III of the Diagnostic and Statistical Manual of Mental Disorders. Given the focus on prevention at early stages, at-risk individuals will continue to be (...) a topic of significance not only in psychosis research but also in other illnesses. This document provides a comprehensive summary of the ethical dilemmas that clinicians or researchers may encounter in this domain, and possible actions consistent with the current Canadian Code of Ethics for Psychologists. We use clinical high risk for psychosis and the Canadian Code of Ethics for Psychologists as a way to illuminate these ethical issues; however, application to other jurisdictions and disciplines, as well as other high-risk populations, is also of relevance. (shrink)

There are complex considerations when planning to disclose an attenuated psychosis syndrome diagnosis. In this review, we evaluate ethical, legal, and clinical perspectives as well as caveats related to full, non- and partial disclosure strategies, discuss societal implications, and provide clinical suggestions. Each of the disclosure strategies is associated with benefits as well as costs/considerations. Full disclosure promotes autonomy, allows for the clearest psychoeducation about additional risk factors, helps to clarify and/or correct previous diagnoses/treatments, facilitates early intervention and bolsters communication (...) between providers but there are important considerations involving heritability, comorbidity, culture, and stigma. Non-disclosure advances nonmaleficence by limiting stigma and stress, and confusion in a sensitive developmental period but is complicated by varying patient preferences and the possibility that, as new treatments without adverse effects become available, the risk with false positives no longer justifies the accompanying loss of autonomy. Partial disclosure balances ethical considerations by focusing on symptoms instead of labels, but evidence that laypersons may interpret this information as a pseudo-diagnosis and that symptoms alone also contribute to stigma limits the efficacy of this approach. In addition, there are notable societal considerations relating to disclosure involving conservatorship, the reach of insurance companies, and discrimination. We advocate a hybrid approach to disclosure and recommend future research aimed at understanding the effects of stigma on clinical course and a renewed focus on those help-seeking cases that do not transition but remain clinically relevant. (shrink)

Growing opioid misuse in the United States has resulted in more children living with an adult with an opioid use history. Although an abundance of research has demonstrated a link between opioid misuse and negative parenting behaviors, few intervention efforts have been made to target this underserved population. The Family Check-Up has been tested in more than 25 years of research, across multiple settings, and is an evidence-based program for reducing risk behavior, enhancing parenting skills, and preventing the (...) onset of substance use. It is designed to motivate parents to engage in positive parenting practices and to change problematic parenting and has been tested across a variety of ages including early childhood and adolescence. It is highlighted in NIDA’s Principles of Substance Use Prevention for Early Childhood: A research-based guide as one of only three effective selective prevention programs for substance abuse among families with young children. Recently, we developed an online version of the FCU that has now been adapted for early childhood and families with opioid use histories. The online platform and telehealth model allow for wide-scale dissemination, ease of training with community providers, and increased public health reach for families in remote, rural areas. This is particularly important when targeting families with opioid misuse and addiction because there are high rates of addiction in remote areas, yet few services available. In this article, we describe the FCU Online and review new content in the model that targets a population of young adult parents with substance abuse histories, including opioid use. New modules include content focused on harm reduction for this high-risk population of parents, such as safety in the home, substance use while parenting, and managing conflict with partners and friends. (shrink)

There were more than 36,000 firearm-related deaths in the U.S. in 2015. Under federal law, a background check is required only for gun purchases from licensed dealers. Research suggests that some persons prohibited from owning a gun turn to private sellers, including those identified online, to attempt to obtain a firearm. State-level approaches to make it more difficult for high-risk persons to purchase or possess firearms include universal background check and gun violence restraining order laws. UBC laws, on the (...) books in 18 states as of the end of 2016, can reduce both homicide and suicide rates. After Colorado adopted a UBC law in 2013, the number of background checks conducted by private sellers for sales occurring at places other than gun shows steadily increased. GVRO laws give law enforcement and families the authority to petition a court to temporarily remove firearms from an individual who presents a danger to himself or others during times of crisis, regardless of whether that person has been diagnosed with a mental illness. California enacted a GVRO law in 2014. Data are emerging to suggest the effectiveness of GVRO-type laws at averting suicides and providing an entryway to services. (shrink)

This article shows how the ethical framing of the contemporary issue of modern slavery has evolved in UK construction, a sector in which there is a high risk of labor exploitation. It also examines how these framing dynamics have inhibited the emergence of a common framework of action to deal with the issue. We draw on both framing theory and the literature on the discursive construction of moral legitimacy. Our longitudinal analysis reveals that actors seeking to shape the debate bring (...) their own moral schemes to justify and construct the legitimacy of their frames. Actors cluster their views around five evolving frames: human rights issue (later shifting to hidden crime), moral issue, management issue (later shifting to human moral obligation), social justice issue, and decent work issue—which promote particular normative evaluations of what the issue is, who is responsible, and recommendations for action. Our study contributes to a dynamic and political understanding of the meaning making of modern slavery. We identify the antecedents and conditions that have forestalled the emergence of new patterns of action to tackle modern slavery in the UK construction sector thereby evidencing the effects of the interplay of morally competing frames on field-level change. (shrink)

With the continuous development of the stock market, designing a reasonable risk identification tool will help to solve the irrational problem of investors. This paper first selects the stocks with the most valuable investment value in the future through the random forest algorithm in the nine-factor model and then analyzes them by using the higher-order moment model to find that different investors’ preferences will make the weight of the portfolio change accordingly, which will eventually make the optimal return and risk (...) set of the composition of the portfolio change. The risk identification system designed in this paper can provide an effective risk identification tool for investors and help them make rational judgments. (shrink)

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation (...) are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

Concerns are frequently raised about the extent to which formal consent procedures actually lead to “informed” consent. As part of a study of consent to high-risk medical procedures, we analyzed in-depth interviews with 16 health care professionals working in bone-marrow transplantation in Sydney, Australia. We find that these professionals recognize and act on their responsibility to inform and educate patients and that they expect patients to reciprocate these efforts by demonstrably engaging in the education process. This expectation is largely implicit, (...) however, and when it is not met, this can give rise to trouble that can have adverse consequences for patients, physicians, and relationships within the clinic. We revisit the concept of the sick role to formalize this new role expectation, and we argue that “informed” consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness. (shrink)

Modern antiretroviral therapies are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical (...) prospect associated with participation in cure research thus look poor. Are the risks and burdens that HIV cure research places on participants so high that it is unethical, at present, to conduct it? In this paper, I answer ‘no’. I start my argument by describing a foundational way of thinking about the ethical justification for regulatory limits on research risk; I then apply this way of thinking to HIV cure trials. In offering this analysis, I confine my attention to studies enrolling competent adults and I also do not consider risks research may pose to third parties or society. Rather, my concern is to engage with the thought that some trials are so risky that performing them is an ethically unacceptable way to treat the participants themselves. I reject this thought and instead argue that there is no level of risk, no matter how high, that inherently mistreats a participant. (shrink)

This is an exploratory paper of the ethical implications for genomic research and mental illness with specific reference to Singapore. Singapore has a unique context due to its social and political systems, and although it is a relatively small country, its population is religiously and culturally diverse. The issues that we identify here, therefore, will offer new perspectives and will also shed light on the existing literature on psychiatric genomics in society. We contextualise issues such as risk and stigma (...) in the identification and diagnosis of psychosis in the way they relate to Singaporean society, and use a current study as a case example. Genomic research has the potential to change significantly he practice of clinical medicine if, as expected, fast and inexpensive sequencing becomes a reality. It will likely also change how society thinks and acts in respect to multi-factorial diseases, conditions, traits, and syndromes that have a genetic component. Genomic research already raises a number of ethical concerns relating to the privacy of individuals, including the disclosure of research results and incidental findings, surreptitious tests, third party access to data, and the re-emergence of genetic determinism. These issues are potentially exacerbated when genomics - the study of whole genomes to understand complex illness and behavioural traits - is applied to psychiatric research, because of the stigma that is often attached to mental illness. In this paper, we discuss some of the issues that have arisen in the context of a study in Singapore that is currently investigating the genomics and biomarkers of psychosis. We argue that although a genomic study rarely creates data that is directly useful to the participant, it can have incidental benefits to the individual who is identified during the study as being at high risk of developing psychosis and its related states. Understanding these potential benefits requires us to examine the implications that this type of research may have on public understandings of genomic data and risk. (shrink)

BackgroundInternational partnerships in research are receiving ever greater attention, given that technology has diminished the restriction of geographical barriers with the effects of globalisation becoming more evident, and populations increasingly more mobile.DiscussionIn this article, we examine the merits and risks of such collaboration even when strict universal ethical guidelines are maintained. There has been widespread examples of outcomes beneficial and detrimental for both high and low –income countries which are often initially unintended.SummaryThe authors feel that extreme care and forethought (...) should be exercised by all involved parties, despite the fact that many implications from such international work can be extremely hard to predict. However ultimately the benefits gained by enhancing medical research and philanthropy are too extensive to be ignored. (shrink)

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the (...) Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

When doing research among vulnerable populations, researchers are obliged to protect their subjects from harm. We will argue that traditional ethical guidelines are not sufficient to do this, since they mainly focus on direct harms that can occur: for example, issues around informed consent, fair recruitment and risk/harm analysis. However, research also entails indirect harms that remain largely unnoticed by research ethical committees and the research community. Indirect harms do not occur during data collection, but in (...) the analysis of the data, and how the data is presented to the scientific and wider societal community. Highly stigmatized research subjects, like substance‐dependent parents, are especially at risk of encountering indirect harm, because the prejudice against them is so persistent. In this paper we discuss two forms of indirect harm. First, researchers have to be aware how their results will be preceived by society. Even when subjects are presented in an objective way, further, out of porportion stigmatization can occur. Researchers sometimes try to counteract this by whitewashing their results, at the risk of downplaying their respondents’ problems. The second risk researchers face is that their own normative judgements influence how they question such parents, report results and interpret statements. Researchers’ own normative judgements may influence the way they present their subjects. This article reviews a broad range of research that exhibits such indirect harms, discussing how and why indirect harms occur and formulating corresponding recommendations on how to prevent them. (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)

The online version of the original article can be found under doi:10.1007/s11948-007-9045-2.

Empirical data can be an extremely powerful and influential tool in bioethical research. However, when researchers or policy makers look for answers to ethical questions by engaging with empirical research, there can be a tendency (conscious or unconscious) to shape, report, and use empirical research in a way that confirms their own preferred ethical conclusions. This skewing effect - what we call ‘normative bias’ - is often so subtle it falls short of clear misconduct and thus can (...) be difficult to call out. However, we argue that this subtle influence of bias has the potential to significantly influence debate and policy around highly sensitive ethical issues and must be guarded against. In this paper we share the lessons we have learned through a journey of self-reflection around the effect that normative bias can have when reporting on and referring to empirical data relating to ethical issues. We use a variety of papers from our area of the ethics of routine prenatal screening to illustrate these subtle but often powerfully distorting effects of bias. Our aim in doing so is not to criticise the work of others, as we recognise our own normative bias, but to improve awareness of this issue, remind the need for reflexivity to guard against our own biases, and introduce a new criterion - the idea of a ‘limitation prominence assessment’ - that can work as a practical way to evaluate the seriousness of the limitations of an empirical study and thus, the risks of the study being misread or misinterpreted through superficial reading. (shrink)

Risk is the probability that within a certain time some expected negative event will take place. In medicine risk can be related to a decision or to some intrinsic factors which are associated with the probability of the occurrence of a disease. Decisions can be necessary in the individual life with respect to the question of visiting a physician or performing a certain diagnostic or therapeutic procedure. The introduction of new pharmaceutical or technical products into medical use are another set (...) of decisions which can generate certain risks. Intrinsic or inherent risk factors are a set of variables or signs and symptoms which indicate the presence of a certain probability that some disease or event, e.g., arteriosclerosis or sudden infant death syndrome, may occur. Risk is always related to judgement. In a decision process cost, effectiveness and profit can be used to estimate the magnitude of the risk to be taken. In a similar way the problems in connection with an inherent risk are primarily related to the recognition of the magnitude of risk and to the possibility of prophylactic measures.In our own area of research, the sudden infant death syndrome (SIDS) is an event where only risk factors can be observed. We point at two facts in this context: Highly complex patterns of symptoms like behaviour can better be classified by intuitive Gestalt perception. A medical procedure like induction of labour can itself become a risk factor. (shrink)

BackgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe total costs of gaining approval were 38 % of the budget for (...) a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.ConclusionsImprovements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked. (shrink)

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed (...) consent published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study as minimal risk, probably minimal risk, or probably more than minimal risk. RESULTS: Seventy studies using a waiver of/exception from informed consent were identified. A majority of reviewers classified nontherapeutic procedures in 62 studies (88.6%) as minimal risk. Reviewers classified nontherapeutic procedures in six studies (8.6%) as minimal risk or probably minimal risk. In two studies (2.9%), nontherapeutic procedures were classified as probably more than minimal risk. The intraclass correlation coefficient was 0.89 (95% CI = 0.85 to 0.93), indicating very high interrater reliability. CONCLUSIONS: Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue. (shrink)

With the advancement of human microbiome research, it is inevitable that a growing number of biobanks will include a collection of microbiota specimens to characterize the microbial communities that inhabit the human body and explore the relationships between the microbiota and their human hosts. Biobanks of human microbiota and their associated genetic information may become a valuable health resource. But, this area of research also presents ethical and social problems, some of which are distinct from those faced by (...) biobanks that store human tissue samples. This paper examines four core issues which are considered highly relevant to microbiome biobanking: the nature of human microbiome samples and how different understandings have an impact on benefit/risk evaluation, privacy, informed consent, and returning the result to participants. We argue that these issues should be addressed early on in microbiome research projects and also call for adjusting or developing new governance mechanism to better accommodate these changes. (shrink)

To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.

There has been relatively little empirical research into the causes of research misconduct. To begin to address this void, the authors collected data from closed case files of the Office of Research Integrity (ORI). These data were in the form of statements extracted from ORI file documents including transcripts, investigative reports, witness statements, and correspondence. Researchers assigned these statements to 44 different concepts. These concepts were then analyzed using multidimensional scaling and cluster analysis. The authors chose a (...) solution consisting of seven clusters: (1) personal and professional stressors, (2) organizational climate, (3) job insecurities, (4) rationalizations A, (5) personal inhibitions, (6) rationalizations B and, (7) personality factors. The authors discuss the implications of their findings for policy and for future research. (shrink)

We identify three distinct ethical problems that can arise with risk displacement. Risk displacement is the shifting of extant risk from one or more individuals to other individual(s) such that the reduction of risk to the first group is causally implicated in increasing risk to the second group. These problems are: concentration of risk in inequitable ways; transfer of risk to already vulnerable or disadvantaged populations; and exercise of undue influence over potential research participants. The first two arise in (...) both public policy and research initiatives, whereas the third is a special concern that only applies to research initiatives. We argue that when one or more of these is of high magnitude, then the study or policy intervention may be ethically wrong. Finally, we conclude that although some risk displacement is ethically permissible, researchers and policymakers still have ethical reasons to reduce the magnitude of these problems. (shrink)

The European Union is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance to develop special (...) regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as “Responsible Research and Innovation”, widely claim that a diversity of considerations and issues are integrated into R&D processes. Even so, the possibility of more radically alternative constitutions of socio-technical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy. (shrink)

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making (...) study nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

Psychiatric disorders present distinct clinical challenges which are partly attributable to their multifactorial aetiology and the absence of laboratory tests that can be used to confirm diagnosis or predict risk. Psychiatric disorders are highly heritable, but also polygenic, with genetic risk conferred by interactions between thousands of variants of small effect that can be summarized in a polygenic risk score. We discuss four areas in which the use of polygenic risk scores in psychiatric research and clinical contexts could have (...) ethical implications. First, there is concern that clinical use of polygenic risk scores may exacerbate existing health inequities. Second, research findings regarding polygenic risk could be misinterpreted in stigmatising or discriminatory ways. Third, there are concerns associated with testing minors as well as eugenics concerns elicited by prenatal polygenic risk testing. Fourth, potential challenges that could arise with the feedback and interpretation of high polygenic risk for a psychiatric disorder would require consideration. While there would be extensive overlap with the challenges of feeding back genetic findings in general, the potential clinical use of polygenic risk scoring warrants discussion in its own right, given the recency of this possibility. To this end, we discuss how lay interpretations of risk and genetic information could intersect. Consideration of these factors would be necessary for ensuring effective and constructive communication and interpretation of polygenic risk information which, in turn, could have implications for the uptake of any therapeutic recommendations. Recent advances in polygenic risk scoring have major implications for its clinical potential, however, care should be taken to ensure that communication of polygenic risk does not feed into problematic assumptions regarding mental disorders or support reductive interpretations. (shrink)

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict (...) or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

Some risks have extremely high stakes. For example, a worldwide pandemic or asteroid impact could potentially kill more than a billion people. Comfortingly, scientific calculations often put very low probabilities on the occurrence of such catastrophes. In this paper, we argue that there are important new methodological problems which arise when assessing global catastrophic risks and we focus on a problem regarding probability estimation. When an expert provides a calculation of the probability of an outcome, they are really providing the (...) probability of the outcome occurring, given that their argument is watertight. However, their argument may fail for a number of reasons such as a flaw in the underlying theory, a flaw in the modeling of the problem, or a mistake in the calculations. If the probability estimate given by an argument is dwarfed by the chance that the argument itself is flawed, then the estimate is suspect. We develop this idea formally, explaining how it differs from the related distinctions of model and parameter uncertainty. Using the risk estimates from the Large Hadron Collider as a test case, we show how serious the problem can be when it comes to catastrophic risks and how best to address it. (shrink)

Risk propagation encompasses a plethora of techniques for analyzing how risk “spreads” in a given system. Albeit commonly used in technical literature, the very notion of risk propagation turns out to be a conceptually imprecise and overloaded one. This might also explain the multitude of modeling solutions that have been proposed in the lit- erature. Having a clear understanding of what exactly risk is, how it be quantified, and in what sense it can be propagated is fundamental for devising high-quality (...) risk assessment and decision-making solutions. In this paper, we exploit a previous well-established work about the nature of risk and related notions with the goal of providing a proper interpre- tation of the different notions of risk propagation, as well as revealing and harmonizing the alternative semantics for the links used in common risk propagation graphs. Finally, we discuss how these results can be leveraged in practice to model risk propagation scenarios. (shrink)

Student cheating has always been a problem in higher education, but detection of cheating has become easier with technology. As a result, more students are being caught and reported for cheating. While reporting cheating is not a negative, the rippling effects of reported cheating may be felt by some populations more than others. Thus, preventing cheating would be a preferable option for all involved.Identifying those at risk for being reported for cheating is a first step in developing preventive measures. Previous (...) research has attempted to do this through the use of self-report surveys, but such research takes considerable time and resources to conduct and suffers from low response rates and social desirability bias. To address this limitation in existing research, this study links existing data from records of other-reported cheating to university registration data in order to examine 6 cheating risk factors identified in previous research: maturity level, gender, grade point average, major, international student status, and fear of punishment. The results of the study suggest that international and transfer students, particularly those who are male, in high-risk majors, and have lower grade point averages, are in particular need of preventative education. Likewise, those faculty who teach in computer science, engineering and economics majors should do more to educate implement practices to reduce the likelihood of cheating. (shrink)

This study investigated potential risk factors (coping, perfectionism and self-regulation) for substantial injuries in contemporary dance students using a prospective cohort design, as high-quality studies focusing on mental risk factors for dance injuries are lacking. Student characteristics (age, sex, BMI, educational program and history of injury) and psychological constructs (coping, perfectionism and self-regulation) were assessed using the Performing artist and Athlete Health Monitor (PAHM), a web-based system. Substantial injuries were measured with the Oslo Sports Trauma Research Center (OSTRC) Questionnaire (...) on Health Problems and recorded on a monthly basis as part of the PAHM system. Univariate and multivariate logistic regression analyses were conducted to test the associations between potential risk factors (i.e. student characteristics and psychological constructs) and substantial injuries. 99 students were included in the analyses. During the academic year 2016-2017, 48 students (48.5%) reported at least one substantial injury. Of all factors included, coping skills (OR: 0.91; 95% CI: 0.84–0.98), age (OR: 0.67; 95% CI: 0.46–0.98) and BMI (OR: 1.38; 95% CI: 1.05–1.80) were identified as significant risk factors in the multivariate analysis. The model explained 24% of the variance in the substantial injury group. Further prospective research into mental risk factors for dance injuries with larger samples sizes is needed to develop preventive strategies. Yet, dance schools could consider including coping skills training as part of injury prevention programs and, perhaps, providing special attention to younger dancers and those with a higher BMI through transitional programs to assist them in managing the stress they experience throughout their (academic) career. (shrink)

A core tenet of research ethics is that risks assumed by research participants are reasonable, balanced, and minimized in relation to benefit to the individual and to society. It is also generally accepted that people who cannot give their own informed consent ought only to be exposed to low risks in research, unless there is a compensating potential for direct benefit.However, there is no consensus on whether individuals should be able to voluntarily consent to high net risk (...) in research—or, in other words, to research that is not justified by direct benefits to the individual and must be justified by benefits to others in society. The Belmont Report—perhaps the most canonical document in research ethics—does not... (shrink)

The quality of doctoral-level biochemistry (N=139), botany (N=83), cellular/molecular biology (N=89), microbiology (N=134), physiology (N=101), and zoology (N=70) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: (1) program size; (2) characteristics of graduates; (3) reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); (4) university library size; (5) research support; and (6) publication records. Chapter I discusses (...) prior attempts to assess quality in graduate education, development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the biochemistry, botany, cellular/molecular biology, microbiology, physiology, and zoology programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that cellular/molecular biology programs had, on the average, the largest number of faculty and that students in cellular/molecular biology, biology, biochemistry, microbiology, and physiology received a relatively high fraction of financial support. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

Post-Normal Science as a theory links epistemology and governance. It not only focuses on problem situations where facts are uncertain, values in dispute, stakes high and decisions urgent, but also tries to develop epistemic approaches that allow for sound scientific answers. The following article addresses major epistemological challenges within a typical ‘‘wicked-problem situation’’, i.e., risk assessment of emerging technologies. Such challenges include epistemological problems intrinsic to the task of proving the absence of risk, problems related to the multi-sited production of (...) evidence and the multitude of epistemic cultures involved, the incompatibility of the various implicit objectives and the complex actor-constellations, that shape not only the way scientific knowledge is translated into action, but also which kind of knowledge is produced and which experts are listened to. To illustrate and discuss these characteristics, the article draws on an empirical study of risk research in the fields of agri-biotechnology and telecommunication technology in Germany. It concludes that although some aspects of PNS are already part of current epistemic practices in these fields, a state of ‘‘functional post-normality’’ depends upon a meaningful co-evolution between post-normal science and post-normal governance that has not yet been achieved. (shrink)