In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.

The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of specific (...) class='Hi'>consent, broad consent, blanket consent or not at all. This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population. A smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20. Of 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years. Most users indicate 1) that they find the choices they are asked to make easy to understand, 2) that the application is easy to use, and 3) that this kind of choice should be offered to people. It is possible to collect meta consent preferences in the general, adult population using a smartphone app. (shrink)

BackgroundThe advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the (...) class='Hi'>meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public’s attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec.MethodsEight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software.ResultsOur findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions.ConclusionsThis qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec. (shrink)

In a recent article, I argued that Ploug and Holm’s ‘meta-consent’ proposal should be rejected for biobank governance. This was because, although meta-consent is permissible, it is both burdensome and ethically omissible. There is no ethical reason why funders should undertake the additional costs. Ploug and Holm have sought to respond to these arguments. Here, it is noted that not only do they fail to adequately refuse the case against meta-consent, they fail to even (...) engage with the arguments, either misunderstanding them or ignoring them. In their response, Ploug and Holm unwittingly provide the basis of an even stronger case against meta-consent. They argue that broad consent has a built in tendency to expire, while also holding that broad consent should be one of the options available in meta-consent. Meta-consent thus ends up being more like dynamic consent, but, arguably, even more burdensome and costly. (shrink)

Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent, must specific reconsent be gained for each new use, or user, or is broad consent ethically adequate? Recently, Thomas Ploug and Søren Holm have developed an alternative to both specific and broad consent: what they call a meta-consent framework. On a meta- (...) class='Hi'>consent framework, participants can choose the type of consent framework they require, for different kinds of use, different types of user and so on. Meta-consent involves a distinctive kind of design of the consent process. Here it is argued, first, that although a meta-consent framework does not wrong participants, Ploug and Holm understate the likely costs and burdens of such a framework, so there are good practical reasons not to offer it. Second, although Ploug and Holm allude to some ethical considerations that might seem to ground an ethical argument for providing meta-consent, they do not offer any sound argument, and it does not wrong participants in any way to fail to offer them the opportunity to design their own consent process. (shrink)

In a recent article in theJournal of Medical Ethics,Neil Manson sets out to show that the meta-consent model of informed consent is not the solution to perennial debate on the ethics of biobank participation. In this response, we shall argue that (i) Manson’s considerations on the costs of a meta-consent model are incomplete and therefore misleading; (ii) his view that a model of broad consent passes a threshold of moral acceptability rests on an analogy (...) that misconstrues how biobank research is actually conducted and (iii) a model of meta-consent is more in tune with the nature of biobank research and enables autonomous choice. (shrink)

In this response to Neil Manson’s latest intervention in our debate about the best consent model for biobank research we show, contra Manson that the ‘expiry problem’ that affects broad consent models because of changes over time in methods, purposes, types of data used and governance structures is a real and significant problem. We further show that our preferred implementation of meta consent as a national consent platform solves this problem and is not subject to (...) the cost and burden objections that Manson raises. (shrink)

Richard Thaler and Cass Sunstein, in Nudge: Improving Decisions About Health, Wealth, and Happiness, assert that rejecting the use nudges is ‘pointless’ because ‘[i]n many cases, some kind of nudge is inevitable’. Schlomo Cohen makes a similar claim. He asserts that in certain situations surgeons cannot avoid nudging patients either toward or away from consenting to surgical interventions. Cohen concludes that in these situations, nudging patients toward consenting to surgical interventions is uncriticizable or morally permissible. I call this argument: The (...) Unavoidability Argument. In this essay, I will respond to Cohen's use of the unavoidability argument in support of using nudges during the process of informed consent. Specifically, I argue that many so-called ‘unavoidable nudges’ are, in fact, avoidable. Although my argument is directed toward Cohen's use of the unavoidability argument, it is applicable to the unavoidability argument more generally. (shrink)

Issues related to controlled human infection studies using Schistosoma mansoni (CHI-S) were explored to ensure the ethical and voluntary participation of potential CHI-S volunteers in an endemic setting in Uganda. We invited volunteers from a fishing community and a tertiary education community to guide the development of informed consent procedures. Consultative group discussions were held to modify educational materials on schistosomiasis, vaccines and the CHI-S model and similar discussions were held with a test group. With both groups, a mock (...) consent process was conducted. Fourteen in-depth key informant interviews and three group discussions were held to explore perceptions towards participating in a CHI-S. Most of the participants had not heard of the CHI-S. Willingness to take part depended on understanding the study procedures and the consenting process. Close social networks were key in deciding to take part. The worry of adverse effects was cited as a possible hindrance to taking part. Volunteer time compensation was unclear for a CHI-S. Potential volunteers in these communities are willing to take part in a CHI-S. Community engagement is needed to build trust and time must be taken to share study procedures and ensure understanding of key messages. (shrink)

As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in (...) what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research. (shrink)

The biobank consent debate is one with deeply held convictions on both the ‘broad’ and ‘specific’ side with little sign of resolution. Recently, Thomas Ploug and Soren Holm have developed an alternative to both specific and broad consent: a meta‐consent framework. The aim here is to consider whether meta‐consent provides a ‘solution’ to the biobank consent debate. We clarify what ‘meta‐consent’ actually is (arguing that the label is a misnomer and ‘ (...) class='Hi'>consent à la carte’ is more accurate). We identify problems with Ploug and Holm's arguments, and some challenges for meta‐consent. We focus on whether there is any ethical obligation to provide consent à la carte. There may seem to be so, especially if we draw upon an unclear appeal to the ethical significance of ‘respect for autonomy’. Similarly, there might seem to be an intuitive inference from the fact that ethically legitimate research requires informed consent to the conclusion that it thereby requires consent à la carte. It is shown that this line of inference is mistaken. (shrink)

Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. (...) The main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised. (shrink)

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as (...) well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss. (shrink)

In “Nudging, Bullshitting, and the Meta-Nudge”, the author responds to William Simkulet’s claim that nudging is bullshitting (according to Harry Frankfurt’s analysis of bullshit and bullshitting), and therefore nudging during the process of informed consent renders consent invalid. The author argues that nudging is not necessarily bullshitting and then explains that although this issue is philosophically interesting, practically speaking, even if nudging is bullshitting, it does not follow that nudging necessarily renders informed consent invalid. This is (...) obviously true in those situations in which nudging during the process of informed consent is unavoidable. The author concludes with a discussion of the meta-nudge and suggests that physicians can use the meta-nudge to eliminate or decrease the power of inappropriate, problematic, or undesirable nudges. (shrink)

Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the (...) ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach. (shrink)

Background Record linkage is a useful tool for health research. Potential benefits aside, its use raises discussions on privacy issues, such as whether a written informed consent for access to health records and linkage should be obtained. The authors aim to systematically review studies that assess consent proportions to record linkage. Methods 8 databases were searched up to June 2011 to find articles which presented consent proportions to record linkage. The screening, eligibility and inclusion of articles were (...) conducted by two independent reviewers. The authors carried out meta-regression, subgroup and sensitivity analyses to assess heterogeneity. Results Of the 141 studies identified, only 11 presented empirical consent proportions and were included in the systematic review. The consent proportion varied widely from 39% to 97%. Seven studies presented consent proportions of 88% or higher, one of 72%, and only three presented consented proportion equal to or lower than 53%. None of the studies' characteristics evaluated explained heterogeneity. Conclusion The results of this review show that, in general, individuals tend to consent to the use of their data for record linkage, with exceptions in specific populations or minorities. The authors believe that this, as well as the cited literature, lends support to policies that, while keeping relevant ethical controls in place, do not require individual informed consent for each and every study that relies on secondary data. (shrink)

There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that (...) would alert research candidates to the ethically problematic nature of the trials. The “reasonable person” and “key information” provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the “key information” is that should be disclosed to a “reasonable person”: the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials. (shrink)

Hobbes and Butler both conjure images of an abandoned infant in their respective discussions of vulnerability. Leviathan uses this image to discuss original dominion, or natural maternal right over the child, while for Butler rights discourse produces fantasies of invulnerability that derealize other lives. However, Hobbes’s infant in nature has no rights and can only consent to being nourished. Only when able to nourish itself can it claim rights to transfer through the covenant producing a fantasy of individual invulnerability. (...) Vulnerability in the state of nature and the com- monwealth’s fantasy of invulnerability are together a counter-fantasy to the fantasies of invulnerability of Hobbes’s time, through heaven or eternal glory. In question is whether Butler, in her reimagining of community, is, like Hobbes, producing a fantasy, but a meta-fantasy that community can be taken as fantasy without derealizing the fantastic or that fantasizes an honesty about its being fantasy. (shrink)

Since the #MeToo movement, many discussions arose on the role of consent in defining rape, among academics, legal practitioners, non-governmental organisations, and at the European Union level. This debate is particularly relevant in France, where rape is a sexual act committed by violence, coercion, threat, or surprise, with no mention of consent in the Criminal Code. By conducting a meta-analysis of the discourse of the French legal literature on this topic in four criminal law reviews and ten (...) textbooks, this study offers a new perspective to this debate. Based on this analysis, the definition of rape and the role of consent is barely discussed by the literature, partly due to an equivalence drawn between the constitutive elements of the offence and the absence of consent of the victim. Yet, the relevance of consent is highly criticised, mainly by a few male academics, using primarily arguments of authority instead of a critical approach to the topic. In general, the French legal literature on the role of consent in defining rape supports rape myths and gender stereotypes. (shrink)

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and (...) doctors in the informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

In this paper, we focus on privacy risks in smart home environments and their implications for privacy and data protection. As with other Internet of Things (IoT) devices, the collection and processing of user data in smart home environments currently lack transparency and control. Smart home applications operate within the home, a space that is both morally and legally particularly protected and characterized by a implicit expectation of privacy from the user’s perspective. In contrast to these higher privacy risks, the (...) current regulatory efforts are not yet up to speed with respect to smart home environments. As an interim workaround solution, in this paper, we propose a meta-assistant for the smart home that increases users’ data autonomy and thereby their privacy. In the first section, we give a brief overview of smart home applications, their data collection mechanisms, and the implications for user privacy. Following this, we argue in the second section that consent to datafication, i.e., the prevalent legal option to obtain legal grounds for data collection and processing, in most smart home contexts is—albeit legally sufficient—morally inadequate to provide meaningful possibilities for users to exercise their data autonomy and manage their privacy. The third section introduces an interim solution, outlining the possibility of a meta-assistant, which is capable of operating all other devices—if necessary, by shutting them off completely. (shrink)

A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research. We performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, (...) in the paediatric emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis. Thirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation. Our review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps. (shrink)

Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by (...) facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests. (shrink)

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance (...) on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest. (shrink)

The use of placebo as a control condition in clinical trials of major depressive disorder and anxiety disorders continues to be an area of ethical concern. Typically, opponents of placebo controls argue that they violate the beneficent-based, “best proven diagnostic and therapeutic method” that the original Helsinki Declaration of 1964 famously asserted participants are owed. A more consequentialist, oppositional argument is that participants receiving placebo might suffer enormously by being deprived of their usual medication(s). Nevertheless, recent findings of potential for (...) suicidality in young people treated with antidepressants, along with meta-analyses suggesting that antidepressants add no significant clinical benefit over placebos, warrant a re-evaluation of the arguments against placebo. Furthermore, the nature of placebo treatment in short-term clinical trials is often not well understood, and lack of understanding can foster opposition to it. This paper will show how scientific justifications for placebo use are morally relevant. The fundamental ethical importance of placebo controls is discussed in relation to several aspects of clinical trials, including detection of adverse events, accurate assessment of clinical benefit, advancing understanding of the heterogeneity of depression and anxiety disorders and respecting informed consent requirements. Prohibiting the use of placebo controls is morally concerning in that such prohibitions allow for the possibility of serious adverse public health consequences. Moral worries that research participants receiving placebo are being unduly jeopardised will be shown to be exaggerated, especially in relation to the net benefits for end-users to be gained from the quality of data resulting from using placebo controls. (shrink)

The maternal‐fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki – the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and against the (...) controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow ‘local conditions’ to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta‐ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects. (shrink)

Conducting research in a prison setting is ethically challenging. Because history is full of unethical research conducted in prison settings, researchers are often afraid of doing research in this area. It is argued that too much emphasis has been put on the protection of prison inmates as a vulnerable population. Consequently, too little research is being conducted where the focus is on those factors which serve to make the prison population vulnerable. In this paper ethical questions, emerging when conducting a (...) study on literacy and mental health among Norwegian prison inmates, are presented and discussed. Relevant questions relate to topics which include ethical clearance of the research protocol, the consent procedure, clarification of roles and the publication of the results. The ethical questions are discussed in relation to the four principles of ‘respect for the client's rights and dignity’, ‘competence’, ‘responsibility’ and ‘integrity’ set out in the meta-code of ethics, formulated by the European Federation of Professional Psychologists Associations. The wider relationships between ethics in society, research ethics in general, and ethics when conducting research in a prison setting are also considered. (shrink)

Conducting research in a prison setting is ethically challenging. Because history is full of unethical research conducted in prison settings, researchers are often afraid of doing research in this area. It is argued that too much emphasis has been put on the protection of prison inmates as a vulnerable population. Consequently, too little research is being conducted where the focus is on those factors which serve to make the prison population vulnerable. In this paper ethical questions, emerging when conducting a (...) study on literacy and mental health among Norwegian prison inmates, are presented and discussed. Relevant questions relate to topics which include ethical clearance of the research protocol, the consent procedure, clarification of roles and the publication of the results. The ethical questions are discussed in relation to the four principles of ‘respect for the client's rights and dignity’, ‘competence’, ‘responsibility’ and ‘integrity’ set out in the meta-code of ethics, formulated by the European Federation of Professional Psychologists Associations. The wider relationships between ethics in society, research ethics in general, and ethics when conducting research in a prison setting are also considered. (shrink)

The capacity to collect and analyse data is growing exponentially. Referred to as ‘Big Data’, this scientific, social and technological trend has helped create destabilising amounts of information, which can challenge accepted social and ethical norms. Big Data remains a fuzzy idea, emerging across social, scientific, and business contexts sometimes seemingly related only by the gigantic size of the datasets being considered. As is often the case with the cutting edge of scientific and technological progress, understanding of the ethical implications (...) of Big Data lags behind. In order to bridge such a gap, this article systematically and comprehensively analyses academic literature concerning the ethical implications of Big Data, providing a watershed for future ethical investigations and regulations. Particular attention is paid to biomedical Big Data due to the inherent sensitivity of medical information. By means of a meta-analysis of the literature, a thematic narrative is provided to guide ethicists, data scientists, regulators and other stakeholders through what is already known or hypothesised about the ethical risks of this emerging and innovative phenomenon. Five key areas of concern are identified: informed consent, privacy, ownership, epistemology and objectivity, and ‘Big Data Divides’ created between those who have or lack the necessary resources to analyse increasingly large datasets. Critical gaps in the treatment of these themes are identified with suggestions for future research. Six additional areas of concern are then suggested which, although related have not yet attracted extensive debate in the existing literature. It is argued that they will require much closer scrutiny in the immediate future: the dangers of ignoring group-level ethical harms; the importance of epistemology in assessing the ethics of Big Data; the changing nature of fiduciary relationships that become increasingly data saturated; the need to distinguish between ‘academic’ and ‘commercial’ Big Data practices in terms of potential harm to data subjects; future problems with ownership of intellectual property generated from analysis of aggregated datasets; and the difficulty of providing meaningful access rights to individual data subjects that lack necessary resources. Considered together, these eleven themes provide a thorough critical framework to guide ethical assessment and governance of emerging Big Data practices. (shrink)

BackgroundOver the past few years, five domains of importance about the current state of bioethics in Saudi Arabia have shaped the perspective of most research: doctor-patient relationship, informed consent, do-not-resuscitate, organ donation, and transplantation, medical students’ knowledge and attitudes about medical ethics curriculum. This systematic review aimed to systematically identify, compile, describe and discuss ethical arguments and concepts in the best-studied domains of bioethics in Saudi Arabia and to present cultural, social, educational, and humane perspectives. MethodsSix databases were searched (...) using Boolean operators from December 2020–June 2021. The search and report process followed the statement and flowchart of preferred reporting items for systematic reviews and meta-analyses.ResutlsThe search resulted in 1651 articles, of which 82 studies were selected for a final review and assessment. There is a gradual increase in research, whereby a substantial increase was observed from 2017. Most of the published articles focused on ‘Organ Donation & Transplantation’ with 33 articles, followed by ‘Doctor-Patient Relations’ with 18 publications. Most of the published articles were from Central Province, followed by Western Province. The authorship pattern showed a collaborative approach among researchers. The thematic analysis of keywords analysis showed that ‘Saudi Arabia,’ ‘attitude PHC,’ ‘organ donation,’ ‘knowledge and education,’ and ‘donation’ have been used the most commonly.ConclusionThis systematic quantitative synthesis is expected to guide researchers, stakeholders, and policymakers about the strengths and gaps in knowledge and attitudes regarding medical ethics in Saudi Arabia, both among the general public and health professionals. (shrink)

Background: The right of children to have their voice heard has been accepted by researchers, and there are increasing numbers of qualitative health studies involving children. The ethical and methodological issues of including children in research have caused worldwide concerns, and many researchers have published articles sharing their own experiences. Objectives: To systematically review and synthesise experts’ opinions and experiences about ethical and methodological issues of including children in research, as well as related solution strategies. Research design: The research design (...) was a systematic review of opinion-based evidence, based on the guidelines by Joanna Briggs Institute. Methods: A search of five computerised databases has been conducted in April 2014 and 2271 articles were found. After screening the titles, abstracts, full texts and appraising the quality, 30 articles were finally included in the review. A meta-aggregative approach was applied in the data analysis and synthesis process. Ethical considerations: Ethical approval is not needed as it is a systematic review of published literature. Results: Six themes were identified, including evaluating potential risks and benefits, gaining access, obtaining informed consent/assent, protecting confidentiality and privacy, building rapport and collecting rich data. The similarities and differences between research involving children and that involving adults were indicated. Conclusion: All potential incentives should be justified when designing the study. Further studies need to research how to evaluate individual capacity of children and how to balance protecting children’s right to participate and their interests in the research. Cultural differences related to researching children in different regions should also be studied. (shrink)

Researchers studying at-risk and socially disenfranchised child and adolescent populations are facing ethical dilemmas not previously encountered in the laboratory or the clinic. One such set of ethical challenges involves whether to: (a) share with guardians research derived information regarding participant risk, (b) provide participants with service referrals, or (c) report to local authorities problems uncovered during the course of investigation. The articles assembled for this special section address the complex issues of deciding if, when, and how to report or (...) provide referrals for research participants who are minors (referred to hereafter as minor research participants). This paper focuses on two factors underlying these decisions: the validity of risk estimates and meta-ethical positions on scientific responsibility. It is suggested that, before sharing information about minor research participants investigators should do the following: critically examine the diagnostic validity of developmental measures, include the scope and limitations of information sharing in informed consent procedures, and become familiar with state reporting laws. I discuss the impact of the traditionally accepted act utilitarian meta-ethical position on the investigator-participant relationship, and I recommend consideration of alternative positions as a step toward developing a research ethic of scientific responsibility and care. (shrink)

This chapter will argue that due to a lack of genuine consent, some of Russell’s practices in his romantic/sexual relationships are morally objectionable according to his own normative theory (utilitarianism) and these practices are intellectually objectionable according to his post-1913 meta-ethics (expressivism) and his understanding of rationality. On utilitarian grounds, Russell’s actions would maximize pleasure and minimize pain for all the parties affected by the relationship if the authenticity of his partners’ consent were maintained either by a (...) more or less equal social and political standing of the partners or, failing that, by the powerful partner’s exercise of the virtue of restraint; neither of these conditions was satisfied in Russell’s relationships with Vivien Eliot or Helen Dudley. On expressivist grounds, the expressions of desires upon which Russell’s romantic/sexual practices were based, such as the disregard for the humanity of women, conflict with his calls for world peace based on a concern for the well-being of humanity. (shrink)

The growing significance of social media in research demands new ethical standards and practices. Although a substantial body of literature on social media ethics exists, studies on the ethics of conducting research using social media are scarce. The emergence of new evidence sources, like social media, requires innovative methods and renewed consideration of research ethics. Therefore, we pose the following question: What are the defining characteristics of ethics papers on social media research? Following a modified version of the Preferred Reporting (...) Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol, we analyzed 34 publications based on ten variables: author gender, publication year, region, academic discipline, type, design, methodology, social media platform in focus, positionality statement, and ethical issues. Our findings suggest contemporary social media research ethics primarily reflects the ethical ideals of the Global North, with limited representation from the Global South. Women authors have published more papers than men authors. Previous studies have prioritized ethical concerns such as privacy, informed consent, and anonymity while overlooking researchers’ risks and the ethics of social media sites. We particularly emphasized the lack of researchers’ positionality statements in research. Our findings will pave the way to understanding social media ethics better, especially with the rapid growth of social media research in global scholarship. (shrink)

Table of contentsI1 Proceedings of the 4th World Conference on Research IntegrityConcurrent Sessions:1. Countries' systems and policies to foster research integrityCS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive universitySusan Patricia O'BrienCS01.2 Measures to promote research integrity in a university: the case of an Asian universityDanny Chan, Frederick Leung2. Examples of research integrity education programmes in different countriesCS02.1 Development of a state-run “cyber education program of research ethics” in (...) KoreaEun Jung Ko, Jin Sun Kwak, TaeHwan Gwon, Ji Min Lee, Min-Ho LeeCS02.3 Responsible conduct of research teachers’ training courses in Germany: keeping on drilling through hard boards for more RCR teachersHelga Nolte, Michael Gommel, Gerlinde Sponholz3. The research environment and policies to encourage research integrityCS03.1 Challenges and best practices in research integrity: bridging the gap between policy and practiceYordanka Krastev, Yamini Sandiran, Julia Connell, Nicky SolomonCS03.2 The Slovenian initiative for better research: from national activities to global reflectionsUrsa Opara Krasovec, Renata SribarCS03.3 Organizational climate assessments to support research integrity: background of the Survey of Organizational Research Climate and the experience with its use at Michigan State UniversityBrian C. Martinson, Carol R. Thrush, C.K. Gunsalus4. Expressions of concern and retractionsCS04.1 Proposed guidelines for retraction notices and their disseminationIvan Oransky, Adam MarcusCS04.2 Watching retractions: analysis of process and practice, with data from the Wiley retraction archivesChris Graf, Verity Warne, Edward Wates, Sue JoshuaCS04.3 An exploratory content analysis of Expressions of ConcernMiguel RoigCS04.4 An ethics researcher in the retraction processMichael Mumford5. Funders' role in fostering research integrityCS05.1 The Fonds de Recherche du Québec’s institutional rules on the responsible conduct of research: introspection in the funding agency activitiesMylène Deschênes, Catherine Olivier, Raphaëlle Dupras-LeducCS05.2 U.S. Public Health Service funds in an international setting: research integrity and complianceZoë Hammatt, Raju Tamot, Robin Parker, Cynthia Ricard, Loc Nguyen-Khoa, Sandra TitusCS05.3 Analyzing decision making of funders of public research as a case of information asymmetryKarsten Klint JensenCS05.4 Research integrity management: Empirical investigation of academia versus industrySimon Godecharle, Ben Nemery, Kris Dierickx5A: Education: For whom, how, and what?CS05A.1 Research integrity or responsible conduct of research? What do we aim for?Mickey Gjerris, Maud Marion Laird Eriksen, Jeppe Berggren HoejCS05A.2 Teaching and learning about RCR at the same time: a report on Epigeum’s RCR poll questions and other assessment activitiesNicholas H. SteneckCS05A.4 Minding the gap in research ethics education: strategies to assess and improve research competencies in community health workers/promoteresCamille Nebeker, Michael Kalichman, Elizabeth Mejia Booen, Blanca Azucena Pacheco, Rebeca Espinosa Giacinto, Sheila Castaneda6. Country examples of research reward systems and integrityCS06.1 Improving systems to promote responsible research in the Chinese Academy of SciencesDing Li, Qiong Chen, Guoli Zhu, Zhonghe SunCS06.4 Exploring the perception of research integrity amongst public health researchers in IndiaParthasarathi Ganguly, Barna Ganguly7. Education and guidance on research integrity: country differencesCS07.1 From integrity to unity: how research integrity guidance differs across universities in Europe.Noémie Aubert Bonn, Kris Dierickx, Simon GodecharleCS07.2 Can education and training develop research integrity? The spirit of the UNESCO 1974 recommendation and its updatingDaniele Bourcier, Jacques Bordé, Michèle LeducCS07.3 The education and implementation mechanisms of research ethics in Taiwan's higher education: an experience in Chinese web-based curriculum development for responsible conduct of researchChien Chou, Sophia Jui-An PanCS07.4 Educating principal investigators in Swiss research institutions: present and future perspectivesLouis Xaver Tiefenauer8. Measuring and rewarding research productivityCS08.1 Altimpact: how research integrity underpins research impactDaniel Barr, Paul TaylorCS08.2 Publication incentives: just reward or misdirection of funds?Lyn Margaret HornCS08.3 Why Socrates never charged a fee: factors contributing to challenges for research integrity and publication ethicsDeborah Poff9. Plagiarism and falsification: Behaviour and detectionCS09.1 Personality traits predict attitude towards plagiarism of self and others in biomedicine: plagiarism, yes we can?Martina Mavrinac, Gordana Brumini, Mladen PetrovečkiCS09.2 Investigating the concept of and attitudes toward plagiarism for science teachers in Brazil: any challenges for research integrity and policy?Christiane Coelho Santos, Sonia VasconcelosCS09.3 What have we learnt?: The CrossCheck Service from CrossRefRachael LammeyCS09.4 High p-values as a sign of data fabrication/falsificationChris Hartgerink, Marcel van Assen, Jelte Wicherts10. Codes for research integrity and collaborationsCS10.1 Research integrity in cross-border cooperation: a Nordic exampleHanne Silje HaugeCS10.3 Research integrity, research misconduct, and the National Science Foundation's requirement for the responsible conduct of researchAaron MankaCS10.4 A code of conduct for international scientific cooperation: human rights and research integrity in scientific collaborations with international academic and industry partnersRaffael Iturrizaga11. Countries' efforts to establish mentoring and networksCS11.1 ENRIO : a network facilitating common approaches on research integrity in EuropeNicole FoegerCS11.2 Helping junior investigators develop in a resource-limited country: a mentoring program in PeruA. Roxana Lescano, Claudio Lanata, Gissella Vasquez, Leguia Mariana, Marita Silva, Mathew Kasper, Claudia Montero, Daniel Bausch, Andres G LescanoCS11.3 Netherlands Research Integrity Network: the first six monthsFenneke Blom, Lex BouterCS11.4 A South African framework for research ethics and integrity for researchers, postgraduate students, research managers and administratorsLaetus OK Lategan12. Training and education in research integrity at an early career stageCS12.1 Research integrity in curricula for medical studentsGustavo Fitas ManaiaCS12.2 Team-based learning for training in the responsible conduct of research supports ethical decision-makingWayne T. McCormack, William L. Allen, Shane Connelly, Joshua Crites, Jeffrey Engler, Victoria Freedman, Cynthia W. Garvan, Paul Haidet, Joel Hockensmith, William McElroy, Erik Sander, Rebecca Volpe, Michael F. VerderameCS12.4 Research integrity and career prospects of junior researchersSnezana Krstic13. Systems and research environments in institutionsCS13.1 Implementing systems in research institutions to improve quality and reduce riskLouise HandyCS13.2 Creating an institutional environment that supports research integrityDebra Schaller-DemersCS13.3 Ethics and Integrity Development Grants: a mechanism to foster cultures of ethics and integrityPaul Taylor, Daniel BarrCS13.4 A culture of integrity at KU LeuvenInge Lerouge, Gerard Cielen, Liliane Schoofs14. Peer review and its role in research integrityCS14.1 Peer review research across disciplines: transdomain action in the European Cooperation in Science and Technology “New Frontiers of Peer Review ”Ana Marusic, Flaminio SquazzoniCS14.2 Using blinding to reduce bias in peer reviewDavid VauxCS14.3 How to intensify the role of reviewers to promote research integrityKhalid Al-Wazzan, Ibrahim AlorainyCS14.4 Credit where credit’s due: professionalizing and rewarding the role of peer reviewerChris Graf, Verity Warne15. Research ethics and oversight for research integrity: Does it work?CS15.1 The psychology of decision-making in research ethics governance structures: a theory of bounded rationalityNolan O'Brien, Suzanne Guerin, Philip DoddCS15.2 Investigator irregularities: iniquity, ignorance or incompetence?Frank Wells, Catherine BlewettCS15.3 Academic plagiarismFredric M. Litto16. Research integrity in EuropeCS16.1 Whose responsibility is it anyway?: A comparative analysis of core concepts and practice at European research-intensive universities to identify and develop good practices in research integrityItziar De Lecuona, Erika Löfstrom, Katrien MaesCS16.2 Research integrity guidance in European research universitiesKris Dierickx, Noémie Bonn, Simon GodecharleCS16.3 Research Integrity: processes and initiatives in Science Europe member organisationsTony Peatfield, Olivier Boehme, Science Europe Working Group on Research IntegrityCS16.4 Promoting research integrity in Italy: the experience of the Research Ethics and Bioethics Advisory Committee of the Consiglio Nazionale delle Ricerche Cinzia Caporale, Daniele Fanelli17. Training programs for research integrity at different levels of experience and seniorityCS17.1 Meaningful ways to incorporate research integrity and the responsible conduct of research into undergraduate, graduate, postdoctoral and faculty training programsJohn Carfora, Eric Strauss, William LynnCS17.2 "Recognize, respond, champion": Developing a one-day interactive workshop to increase confidence in research integrity issuesDieter De Bruyn, Bracke Nele, Katrien De Gelder, Stefanie Van der BurghtCS17.4 “Train the trainer” on cultural challenges imposed by international research integrity conversations: lessons from a projectJosé Roberto Lapa e Silva, Sonia M. R. Vasconcelos18. Research and societal responsibilityCS18.1 Promoting the societal responsibility of research as an integral part of research integrityHelene IngierdCS18.2 Social responsibility as an ethical imperative for scientists: research, education and service to societyMark FrankelCS18.3 The intertwined nature of social responsibility and hope in scienceDaniel Vasgird, Stephanie BirdCS18.4 Common barriers that impede our ability to create a culture of trustworthiness in the research communityMark Yarborough19. Publication ethicsCS19.1 The authors' forum: A proposed tool to improve practices of journal editors and promote a responsible research environmentIbrahim Alorainy, Khalid Al-WazzanCS19.2 Quantifying research integrity and its impact with text analyticsHarold GarnerCS19.3 A closer look at authorship and publication ethics of multi- and interdisciplinary teamsLisa Campo-Engelstein, Zubin Master, Elise Smith, David Resnik, Bryn Williams-JonesCS19.4 Invisibility of duplicate publications in biomedicineMario Malicki, Ana Utrobicic, Ana Marusic20. The causes of bad and wasteful research: What can we do?CS20.1 From countries to individuals: unravelling the causes of bias and misconduct with multilevel meta-meta-analysisDaniele Fanelli, John PA IoannidisCS20.2 Reducing research waste by integrating systems of oversight and regulationGerben ter Riet, Tom Walley, Lex Marius BouterCS20.3 What are the determinants of selective reporting?: The example of palliative care for non-cancer conditionsJenny van der Steen, Lex BouterCS20.4 Perceptions of plagiarism, self-plagiarism and redundancy in research: preliminary results from a national survey of Brazilian PhDsSonia Vasconcelos, Martha Sorenson, Francisco Prosdocimi, Hatisaburo Masuda, Edson Watanabe, José Carlos Pinto, Marisa Palácios, José Lapa e Silva, Jacqueline Leta, Adalberto Vieyra, André Pinto, Mauricio Sant’Ana, Rosemary Shinkai21. Are there country-specific elements of misconduct?CS21.1 The battle with plagiarism in Russian science: latest developmentsBoris YudinCS21.2 Researchers between ethics and misconduct: A French survey on social representations of misconduct and ethical standards within the scientific communityEtienne Vergès, Anne-Sophie Brun-Wauthier, Géraldine VialCS21.3 Experience from different ways of dealing with research misconduct and promoting research integrity in some Nordic countriesTorkild VintherCS21.4 Are there specifics in German research misconduct and the ways to cope with it?Volker Bähr, Charité22. Research integrity teaching programmes and their challengesCS22.1 Faculty mentors and research integrityMichael Kalichman, Dena PlemmonsCS22.2 Training the next generation of scientists to use principles of research quality assurance to improve data integrity and reliabilityRebecca Lynn Davies, Katrina LaubeCS22.3 Fostering research integrity in a culturally-diverse environmentCynthia Scheopner, John GallandCS22.4 Towards a standard retraction formHervé Maisonneuve, Evelyne Decullier23. Commercial research and integrityCS23.1 The will to commercialize: matters of concern in the cultural economy of return-on-investment researchBrian NobleCS23.2 Quality in drug discovery data reporting: a mission impossible?Anja Gilis, David J. Gallacher, Tom Lavrijssen, Malwitz David, Malini Dasgupta, Hans MolsCS23.3 Instituting a research integrity policy in the context of semi-private-sector funding: an example in the field of occupational health and safetyPaul-Emile Boileau24. The interface of publication ethics and institutional policiesCS24.1 The open access ethical paradox in an open government effortTony SavardCS24.2 How journals and institutions can work together to promote responsible conductEric MahCS24.3 Improving cooperation between journals and research institutions in research integrity casesElizabeth Wager, Sabine Kleinert25. Reproducibility of research and retractionsCS25.1 Promoting transparency in publications to reduce irreproducibilityVeronique Kiermer, Andrew Hufton, Melanie ClyneCS25.2 Retraction notices issued for publications by Latin American authors: what lessons can we learn?Sonia Vasconcelos, Renan Moritz Almeida, Aldo Fontes-Pereira, Fernanda Catelani, Karina RochaCS25.3 A preliminary report of the findings from the Reproducibility Project: Cancer biologyElizabeth Iorns, William Gunn26. Research integrity and specific country initiativesCS26.1 Promoting research integrity at CNRS, FranceMichèle Leduc, Lucienne LetellierCS26.2 In pursuit of compliance: is the tail wagging the dog?Cornelia MalherbeCS26.3 Newly established research integrity policies and practices: oversight systems of Japanese research universitiesTakehito Kamata27. Responsible conduct of research and country guidelinesCS27.1 Incentives or guidelines? Promoting responsible research communication through economic incentives or ethical guidelines?Vidar EnebakkCS27.3 Responsible conduct of research: a view from CanadaLynn PenrodCS27.4 The Danish Code of Conduct for Research Integrity: a national initiative to promote research integrity in DenmarkThomas Nørgaard, Charlotte Elverdam28. Behaviour, trust and honestyCS28.1 The reasons behind non-ethical behaviour in academiaYves FassinCS28.2 The psychological profile of the dishonest scholarCynthia FekkenCS28.3 Considering the implications of Dan Ariely’s keynote speech at the 3rd World Conference on Research Integrity in MontréalJamal Adam, Melissa S. AndersonCS28.4 Two large surveys on psychologists’ views on peer review and replicationJelte WichertsBrett Buttliere29. Reporting and publication bias and how to overcome itCS29.1 Data sharing: Experience at two open-access general medical journalsTrish GrovesCS29.2 Overcoming publication bias and selective reporting: completing the published recordDaniel ShanahanCS29.3 The EQUATOR Network: promoting responsible reporting of health research studiesIveta Simera, Shona Kirtley, Eleana Villanueva, Caroline Struthers, Angela MacCarthy, Douglas Altman30. The research environment and its implications for integrityCS30.1 Ranking of scientists: the Russian experienceElena GrebenshchikovaCS30.4 From cradle to grave: research integrity, research misconduct and cultural shiftsBronwyn Greene, Ted RohrPARTNER SYMPOSIAPartner Symposium AOrganized by EQUATOR Network, Enhancing the Quality and Transparency of Health ResearchP1 Can we trust the medical research literature?: Poor reporting and its consequencesIveta SimeraP2 What can BioMed Central do to improve published research?Daniel Shanahan, Stephanie HarrimanP3 What can a "traditional" journal do to improve published research?Trish GrovesP4 Promoting good reporting practice for reliable and usable research papers: EQUATOR Network, reporting guidelines and other initiativesCaroline StruthersPartner Symposium COrganized by ENRIO, the European Network of Research Integrity OfficersP5 Transparency and independence in research integrity investigations in EuropeKrista Varantola, Helga Nolte, Ursa Opara, Torkild Vinther, Elizabeth Wager, Thomas NørgaardPartner Symposium DOrganized by IEEE, the Institute of Electrical and Electronics EngineersRe-educating our author community: IEEE's approach to bibliometric manipulation, plagiarism, and other inappropriate practicesP6 Dealing with plagiarism in the connected world: An Institute of Electrical and Electronics Engineers perspectiveJon RokneP7 Should evaluation of raises, promotion, and research proposals be tied to bibliometric indictors? What the Institute of Electrical and Electronics Engineers is doing to answer this questionGianluca SettiP8 Recommended practices to ensure conference content qualityGordon MacPhersonPartner Symposium EOrganized by the Committee on Freedom and Responsibility in the Conduct of Science of ICSU, the International Council for ScienceResearch assessment and quality in science: perspectives from international science and policy organisationsP9 Challenges for science and the problems of assessing researchEllen HazelkornP10 Research assessment and science policy developmentCarthage SmithP11 Research integrity in South Africa: the value of procedures and processes to global positioningRobert H. McLaughlinP12 Rewards, careers and integrity: perspectives of young scientists from around the worldTatiana Duque MartinsPartner Symposium FOrganized by the Online Resource Center for Ethics Education in Engineering and Science / Center for Engineering, Ethics, and Society of the National Academy of EngineeringP13 Research misconduct: conceptions and policy solutionsTetsuya Tanimoto, Nicholas Steneck, Daniele Fanelli, Ragnvald Kalleberg, Tajammul HusseinPartner Symposium HOrganized by ORI, the Office of Research Integrity; Universitas 21; and the Asia Pacific Research Integrity NetworkP14 International integrity networks: working together to ensure research integrityPing Sun, Ovid Tzeng, Krista Varantola, Susan ZimmermanPartner Symposium IOrganized by COPE, the Committee on Publication EthicsPublication without borders: Ethical challenges in a globalized worldP15 Authorship: credit and responsibility, including issues in large and interdisciplinary studiesRosemary ShinkaiPartner Symposium JOrganized by CITI, the Cooperative Institutional Training InitiativeExperiences on research integrity educational programs in Colombia, Costa Rica and PeruP16 Experiences in PeruRoxana LescanoP17 Experiences in Costa RicaElizabeth HeitmanP18 Experiences in ColumbiaMaria Andrea Rocio del Pilar Contreras NietoPoster Session B: Education, training, promotion and policyPT.01 The missing role of journal editors in promoting responsible researchIbrahim Alorainy, Khalid Al-WazzanPT.02 Honorary authorship in Taiwan: why and who should be in charge?Chien Chou, Sophia Jui-An PanPT.03 Authorship and citation manipulation in academic researchEric Fong, Al WilhitePT.04 Open peer review of research submission at medical journals: experience at BMJ Open and The BMJTrish GrovesPT.05 Exercising authorship: claiming rewards, practicing integrityDésirée Motta-RothPT.07 Medical scientists' views on publication culture: a focus group studyJoeri Tijdink, Yvo SmuldersPoster Session B: Education, training, promotion and policyPT.09 Ethical challenges in post-graduate supervisionLaetus OK LateganPT.10 The effects of viable ethics instruction on international studentsMichael Mumford, Logan Steele, Logan Watts, James Johnson, Shane Connelly, Lee WilliamsPT.11 Does language reflect the quality of research?Gerben ter Riet, Sufia Amini, Lotty Hooft, Halil KilicogluPT.12 Integrity complaints as a strategic tool in policy decision conflictsJanneke van Seters, Herman Eijsackers, Fons Voragen, Akke van der Zijpp and Frans BromPoster Session C: Ethics and integrity intersectionsPT.14 Regulations of informed consent: university-supported research processes and pitfalls in implementationBadaruddin Abbasi, Naif Nasser AlmasoudPT.15 A review of equipoise as a requirement in clinical trialsAdri LabuschagnePT.16 The Research Ethics Library: online resource for research ethics educationJohanne Severinsen, Espen EnghPT.17 Research integrity: the view from King Abdulaziz City for Science and TechnologyDaham Ismail AlaniPT. 18 Meeting global challenges in high-impact publications and research integrity: the case of the Malaysian Palm Oil BoardHJ. Kamaruzaman JusoffPT.19 University faculty perceptions of research practices and misconductAnita Gordon, Helen C. HartonPoster Session D: International perspectivesPT.21 The Commission for Scientific Integrity as a response to research fraudDieter De Bruyn, Stefanie Van der BurghtPT. 22 Are notions of the responsible conduct of research associated with compliance with requirements for research on humans in different disciplinary traditions in Brazil?Karina de Albuquerque Rocha, Sonia Maria Ramos de VasconcelosPT.23 Creating an environment that promotes research integrity: an institutional model of Malawi Liverpool Welcome TrustLimbanazo MatandikaPT.24 How do science policies in Brazil influence user-engaged ecological research?Aline Carolina de Oliveira Machado Prata, Mark William NeffPoster Session E: Perspectives on misconductPT.26 What “causes” scientific misconduct?: Testing major hypotheses by comparing corrected and retracted papersDaniele Fanelli, Rodrigo Costas, Vincent LarivièrePT.27 Perception of academic plagiarism among dentistry studentsDouglas Leonardo Gomes Filho, Diego Oliveira GuedesPT. 28 a few bad apples?: Prevalence, patterns and attitudes towards scientific misconduct among doctoral students at a German university hospitalVolker Bähr, Niklas Keller, Markus Feufel, Nikolas OffenhauserPT. 29 Analysis of retraction notices published by BioMed CentralMaria K. Kowalczuk, Elizabeth C. MoylanPT.31 "He did it" doesn't work: data security, incidents and partnersKatie SpeanburgPoster Session F: Views from the disciplinesPT.32 Robust procedures: a key to generating quality results in drug discoveryMalini Dasgupta, Mariusz Lubomirski, Tom Lavrijssen, David Malwitz, David Gallacher, Anja GillisPT.33 Health promotion: criteria for the design and the integrity of a research projectMaria Betânia de Freitas Marques, Laressa Lima Amâncio, Raphaela Dias Fernandes, Oliveira Patrocínio, and Cláudia Maria Correia Borges RechPT.34 Integrity of academic work from the perspective of students graduating in pharmacy: a brief research studyMaria Betânia de Freitas Marques, Cláudia Maria Correia Borges Rech, Adriana Nascimento SousaPT.35 Research integrity promotion in the Epidemiology and Health Services, the journal of the Brazilian Unified Health SystemLeila Posenato GarciaPT.36 When are clinical trials registered? An analysis of prospective versus retrospective registration of clinical trials published in the BioMed Central series, UKStephanie Harriman, Jigisha PatelPT.37 Maximizing welfare while promoting innovation in drug developmentFarida LadaOther posters that will be displayed but not presented orally:PT.38 Geoethics and the debate on research integrity in geosciencesGiuseppe Di Capua, Silvia PeppoloniPT.39 Introducing the Professionalism and Integrity in Research Program James M. DuBois, John Chibnall, Jillon Van der WallPT.40 Validation of the professional decision-making in research measureJames M. DuBois, John Chibnall, Jillon Van der Wall, Raymond TaitPT.41 General guidelines for research ethicsJacob HolenPT. 42 A national forum for research ethicsAdele Flakke Johannessen, Torunn EllefsenPT.43 Evaluation of integrity in coursework: an approach from the perspective of the higher education professorClaudia Rech, Adriana Sousa, Maria Betânia de Freitas MarquesPT.44 Principles of geoethics and research integrity applied to the European Multidisciplinary Seafloor and Water Column Observatory, a large-scale European environmental research infrastructureSilvia Peppoloni, Giuseppe Di Capua, Laura BeranzoliF1 Focus track on improving research systems: the role of fundersPaulo S.L. Beirão, Susan ZimmermanF2 Focus track on improving research systems: the role of countriesSabine Kleinert, Ana MarusicF3 Focus track on improving research systems: the role of institutionsMelissa S. Anderson, Lex Bouter. (shrink)

Along with technical issues, biobanking frequently raises important privacy and security issues that must be resolved as biobanks continue to grow in scale and scope. Consent mechanisms currently in use range from fine-grained to very broad, and in some cases participants are offered very few privacy protections. However, developments in information technology are bringing improvements. New programs and systems are being developed to allow researchers to conduct analyses without distributing the data itself offsite, either by allowing the investigator to (...) communicate with a central computer, or by having each site participate in meta-analysis that results in a shared statistic or final significance result. The implementation of security protocols into the research biobanking setting requires three key elements: authentication, authorization, and auditing. Authentication is the process of making sure individuals are who they claim to be, frequently through the use of a password, a key fob, or a physical scan. Authorization involves ensuring that every individual who attempts an action has permission to do that action. Finally, auditing allows for actions to be logged so that inappropriate or unethical actions can later be traced back to their source. (shrink)

Emergency departments are challenging research settings, where truly informed consent can be difficult to obtain. A deeper understanding of emergency medical patients’ opinions about research is needed. We conducted a systematic review and meta-summary of quantitative and qualitative studies on which values, attitudes, or beliefs of emergent medical research participants influence research participation. We included studies of adults that investigated opinions toward emergency medicine research participation. We excluded studies focused on the association between demographics or consent document (...) features and participation and those focused on non-emergency research. In August 2011, we searched the following databases: MEDLINE, EMBASE, Google Scholar, Scirus, PsycINFO, AgeLine and Global Health. Titles, abstracts and then full manuscripts were independently evaluated by two reviewers. Disagreements were resolved by consensus and adjudicated by a third author. Studies were evaluated for bias using standardised scores. We report themes associated with participation or refusal. Our initial search produced over 1800 articles. A total of 44 articles were extracted for full-manuscript analysis, and 14 were retained based on our eligibility criteria. Among factors favouring participation, altruism and personal health benefit had the highest frequency. Mistrust of researchers, feeling like a ‘guinea pig’ and risk were leading factors favouring refusal. Many studies noted limitations of informed consent processes in emergent conditions. We conclude that highlighting the benefits to the participant and society, mitigating risk and increasing public trust may increase research participation in emergency medical research. New methods for conducting informed consent in such studies are needed. (shrink)

Eminente studioso del Rinascimento, Eugenio Garin non fu storico di carattere erudito o di vocazione strettamente filologica; al contrario interrogò i grandi autori rinascimentali muovendo da problemi teorici assai precisi. Il saggio si propone di individuare differenti periodi nella produzione scientifica di Eugenio Garin portando soprattutto alla luce i saggi degli anni '30 e degli anni '40, sorprendenti per le connotazioni di carattere spiccatamente religioso da cui sono percorsi: tanto più sorprendenti se si pensa all'immagine di Garin quale autorevolissimo esponente (...) della "cultura laica" del nostro paese impostasi negli anni '50 e durata, con poche variazioni, fino alla sua morte. L'opera consente di mettere a fuoco l'itinerario intellettuale di un personaggio come Garin; contribuisce a mostrare la complessità delle ricerche rinascimentali nella seconda metà del secolo scorso e getta luce su un capitolo essenziale della storia degli intellettuali italiani del XX secolo. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Ethics CommentaryTamra Lysaght, Senior Research FellowThe case scenario reflects the dilemmas frequently faced by researchers who discover incidental findings in the course of their studies. Indeed, the literature suggests that the prevalence of incidental findings in neuroimaging research is common,1 and a recent meta-analysis found that such findings increase significantly with age.2 Thus, given the age of the study population and increased likelihood of co-morbidities, it is puzzling (...) that the research team did not anticipate the possibility of finding an anomaly. Even more puzzling is that the reviewing IRB did not detect this omission and require that the team build a plan into the research protocol for managing incidental findings. Following international recommendations,3 such a plan would have likely included protocols for obtaining consent in dealing with an incidental finding, a procedure for evaluating the clinical relevance of the finding, and arranging for suitable follow-up care if necessary.Nevertheless, the research team, not having obtained consent to disclose an incidental finding to the participant, or not, must decide whether to break protocol and contact the participant with information that could have serious health implications for his or her health, especially if the observed lesion turns out to be cancer or some other life-threatening neuropathology. Any decision to break the research protocol should be made in consultation with the approving IRB. The principal investigator, Dr. M, who is ultimately responsible for the ethical conduct of this study, has a number of factors to consider when making this decision. First and foremost, Dr. M will need to weigh up the risks and benefits of disclosing the findings to this 72-year-old [End Page 283] research participant who is presumably already experiencing cognitive impairments, if not early stage symptoms of dementia.Numerous international scholars agree that disclosure of incidental findings should rely on the net beneficence to an individual research participant.4 Specifically, Wolf et al. argue that there should be a strong net benefit for disclosing an incidental finding, such that the information reveals a condition that is likely to be either life-threatening or grave and can be avoided or ameliorated through an intervention. In such instances, the researchers have an ethical obligation to disclose the findings and potentially follow up with clinical care. However, if there is only a net possible benefit, such that the condition is not life-threatening but may be grave or serious and cannot be avoided or ameliorated, then investigators may consider other factors, such as the respect that is owed to research participants and their needs and preferences for information about their health and well-being. Where the condition is not likely to be serious, researchers are not compelled to disclose an incidental finding.In determining the seriousness of an incidental finding, a specialist with expertise in assessing the clinical significance of MRI scans is needed to examine the participants’ images.5 In this instance, Dr. M has a neurologist on the research team who has detected the lesion but is unable to ascertain its clinical relevance without further investigation. The reasons why follow-up information is required is not detailed in the case scenario, but may have arisen because the scans were taken for research purposes and may not be clinically validated for diagnostic purposes — a possibility given the aims of the study (i.e., to elucidate the transition of minimal cognitive impairment to dementia, not brain tumours). For whatever reason, the detected lesion is only a suspected incidental finding that may or may not be life-threatening or grave. Thus, the net benefit to the participant in disclosing this unclear finding is harder to judge.Assuming that the lesion is a serious or life-threatening condition, the team may consider whether it can be avoided or ameliorated with an intervention. The cognitively impaired, although still mentally competent, participant is 72 years old and may respond poorly to a neurosurgical intervention if the diagnosis of a tumour or malignancy is confirmed. The physical and emotional distress of such a procedure may exacerbate the existing cognitive impairments, reducing the net benefit ratio of the disclosure. Indeed, the team should consider the impact that the disclosure... (shrink)

Introducción: cultivar el pensamiento positivo en el ser humano es una necesidad y está relacionado estrechamente con su calidad de vida. Los estudiantes universitarios transitan por una etapa del ciclo vital individual importante, una de sus metas es lograr una profesión; tener una actitud mental optimista puede ser de gran ayuda para el alcance de sus propósitos. Métodos: se realizó una investigación de tipo descriptiva y transversal con el objetivo de determinar un sistema de acciones para alcanzar un pensamiento positivo (...) en los estudiantes universitarios desde diciembre de 2012 a julio de 2014. Se emplearon encuestas en el diagnóstico para identificar las necesidades sentidas de aprendizaje, el nivel de conocimientos sobre el tema y el estado actual de la población objeto de estudio, constituida por los 167 estudiantes del plan D de la Facultad Tecnología de la Salud de Camagüey. Se analizó la información a través del procesamiento de los datos. Se utilizaron también métodos del nivel teórico: análisis-síntesis, inducción-deducción y análisis documental. Se aplicó el consentimiento educado. Resultados: se mostró la necesidad de conocer sobre el tema y la certeza de que no muchos aplican el pensamiento positivo. Conclusiones: se reveló la necesidad de lograr una cultura de salud con la aplicación de acciones para el logro en los estudiantes del pensamiento positivo. Introduction: Nurturing positive thinking in human beings is a necessity and it's closely linked with their quality of life. University students face an important stage of their vital cycle. One of their goals is to achieve/attain a profession; that is why, to have an optimistic attitude can be of great help to reach this purpose. Methods: a descriptive and cross-sectional research was carried out in in order to determine a system of actions to develop positive thinking in university students from December 2012 to July 2014. Surveys were used in the diagnosis so as to identify the real learning necessities, the level of knowledge on the topic and the current status of the target population, which was composed by 167 students studying under curriculum D at the Health Technology School in Camagüey. The information was analyzed through the processing of data. Methods of the theoretical level were also used: analysis-synthesis, induction-deduction and documental analysis. Educated consent was obtained. Results: the necessity of knowing about this topic, as well as the certainty that not many students implement positive thinking were demonstrated. Conclusions: the necessity of acquiring knowledge on health topics was revealed through the application of actions to develop students` positive thinking. (shrink)

Antonio Rosmini (1797-1855) si profila come una delle vette filosofiche della prima metà dell'Ottocento europeo. La presente edizione di alcuni suoi inediti giovanili del 1813 (Delle laudi dell'amistà e il Dialogo tra Cieco e Lucillo), consente di gettare nuova luce sulla formazione di un intellettuale dell'epoca e sulla sua nascente sensibilità filosofico-letteraria: dalla ricerca dello stile linguistico all'esposizione delle numerose opere consultate, dal desiderio di condividere con gli altri le proprie passioni al conseguente riflettere sul senso dell'amore e dell'amicizia.

I develop a contractualist theory of just intelligence collection based on the collective moral responsibility to deliver security to a community and use the theory to justify certain kinds of signals interception. I also consider the rights of various intelligence targets like intelligence officers, service personnel, government employees, militants, and family members of all of these groups in order to consider how targets' waivers or forfeitures might create the moral space for just surveillance. Even people who are not doing anything (...) prejudicial to other states' security can be modeled as ceding rights against diagnostic collection--light touch collection limited to ascertaining if someone is likely an intelligence threat--as part of their duty to support just foreign institutions. Foreign intelligence officers could not perform the same job potential targets can reasonably demand their intelligence agencies perform on their behalf without this ceding of rights. More invasive forms of collection can only be justified if officers can reasonably model their citizens consenting to being the target of the same sort of collection by adversary states. (shrink)

The goal of the Human Genome Diversity Project (HGDP) was to reconstruct the history of human evolution and the historical and geographical distribution of populations with the help of scientific research. Through this kind of research, the entire spectrum of genetic diversity to be found in the human species was to be explored with the hope of generating a better understanding of the history of humankind. An important part of this genome diversity research consists in taking blood and tissue samples (...) from indigenous populations. For various reasons, it has not been possible to execute this project in the planned scope and form to date. Nevertheless, genomic diversity research addresses complex issues which prove to be highly relevant from the perspective of research ethics, transcultural medical ethics, and cultural philosophy. In the article at hand, we discuss these ethical issues as illustrated by the HGDP. This investigation focuses on the confrontation of culturally diverse images of humans and their cosmologies within the framework of genome diversity research and the ethical questions it raises. We argue that in addition to complex questions pertaining to research ethics such as informed consent and autonomy of probands, genome diversity research also has a cultural–philosophical, meta-ethical, and phenomenological dimension which must be taken into account in ethical discourses. Acknowledging this fact, we attempt to show the limits of current guidelines used in international genome diversity studies, following this up by a formulation of theses designed to facilitate an appropriate inquiry and ethical evaluation of intercultural dimensions of genome research. (shrink)

One of the common domains in health care in which the concept of vulnerability is used is end-of-life care, including euthanasia and assisted suicide (EAS). Since different uses and implications of the notion have been recognised in the literature on EAS, this paper aims to analyse them and reflect on who is the most vulnerable in the context of EAS. A prior exploratory review of the literature has served as a starting point for the discussion. We concluded that vulnerability is (...) a complex, multi-perspective and multi-layered concept, which implies the vulnerability of different stakeholders involved in EAS practices and vulnerability in different aspects of being human (i.e., physical, mental, moral, social and spiritual). A comprehensive understanding of the notion of vulnerability, which balances as well as complements the concept of autonomy, seems to be an indispensable element of the discourse on EAS. (shrink)

Spasticity and muscle weakness is common in children with cerebral palsy (CP). Spasticity can be treated with Botulinum Neurotoxin-A (BoNT-A), but this drug has also been reported to induce muscle weakness. Our purpose was to describe the effect on muscle strength in the lower extremities after BoNT-A injections in children with cerebral palsy. A secondary aim was to relate the effect of BoNT-A to gait pattern and range of motion. Twenty children with spastic cerebral palsy were included in the study, (...) eight girls and 12 boys (mean age 7.7 years). All were able to walk without support, but with increased muscle tone interfering with motor function and gait pattern. Sixteen children had unilateral spastic CP and four bilateral spastic CP. Twenty-four legs received injections with BoNT-A in the plantar flexor muscles. The children were tested before treatment, around six weeks after at the peak effect of BoNT-A, and at six months after treatment, with measurement of muscle strength, gait analysis and range of motion. There were no differences in muscle strength in plantar flexors of treated legs at peak effect compared to baseline. Six months after treatment, there was still no change in untreated plantar flexor muscles, but an increasing trend in plantar flexor strength in legs treated with BoNT-A. Parents reported positive effects in all children, graded as: small in three children, moderate in eight, and large in nine children. The gait analysis showed a small improvement in knee extension at initial contact, and there was a small increase in passive range of motion for ankle dorsiflexion. Two children had a period with transient weakness and pain. We found that voluntary force production in plantar flexor muscles did not decrease after BoNT-A, instead there was a trend to increased muscle strength at follow-up. The increase may be explained as an effect of the blocking of involuntary nerve impulses, leading to an opportunity to using and training the muscles with voluntary control. Adequate muscle strength is important for maintaining the ability to walk and knowledge of how a treatment affects muscle strength is useful when selecting interventions. (shrink)

We introduce a new and time-efficient memory-encoding paradigm for functional magnetic resonance imaging. This paradigm is optimized for mapping multiple contrasts using a mixed design, using auditory and visual stimuli. We demonstrate that the paradigm evokes robust neuronal activity in typical sensory and memory networks. We were able to detect auditory and visual sensory-specific encoding activities in auditory and visual cortices. Also, we detected stimulus-selective activation in environmental-, voice-, scene-, and face-selective brain regions. A subsequent recognition task allowed the detection (...) of sensory-specific encoding success activity in both auditory and visual cortices, as well as sensory-unspecific positive ESA in the hippocampus. Further, sensory-unspecific negative ESA was observed in the precuneus. Among others, the parallel mixed design enabled sustained and transient activity comparison in contrast to rest blocks. Sustained and transient activations showed great overlap in most sensory brain regions, whereas several regions, typically associated with the default-mode network, showed transient rather than sustained deactivation. We also show that the use of a parallel mixed model had relatively little influence on positive or negative ESA. Together, these results demonstrate a feasible, versatile, and brief memory-encoding task, which includes multiple sensory stimuli to guarantee a comprehensive measurement. This task is especially suitable for large-scale clinical or population studies, which aim to test task-evoked sensory-specific and sensory-unspecific memory-encoding performance as well as broad sensory activity across the life span within a very limited time frame. (shrink)