En 2014, la Suisse a ratifié la Convention des Nations Unies relative aux droits des personnes handicapées, qui établit comme l’un de ses principes directeurs la participation et l’intégration pleines et effectives des personnes handicapées dans la société. La présente étude examine l’expérience vécue et l’agentivité des personnes handicapées vivant en Suisse en ce qui concerne les stratégies d’adaptation auxquelles elles ont eu recours en réponse aux obstacles à leur participation dans des domaines de la vie tels que l’éducation, la (...) formation professionnelle et l’emploi. Vingt-six personnes représentant quatre groupes de handicaps (mobilité, visuel, psychosocial, intellectuel et développemental) et trois cohortes d’âge (nées vers 1950, 1970 ou 1990) ont participé à des entretiens semi-structurés sur le parcours de vie. Les récits montrent comment les individus ont fait face aux contraintes structurelles de leur participation de différentes manières et en fonction de leur situation individuelle. Toutefois, les stratégies d’adaptation identifiées peuvent être classées en trois grands types (adaptation, évitement et confrontation), qui représentent différentes formes d’agentivité avec des perspectives différentes de démantèlement des contraintes structurelles. L’article examine les implications théoriques et pratiques en ce qui concerne la maîtrise des contraintes structurelles et l’amélioration de l’agentivité et de la liberté de choix des personnes handicapées. (shrink)

In this paper, I argue that the asymmetrical mediated communication of the broad democratic public sphere can profitably be understood through the lens of deliberative democracy only if we adopt a system approach to deliberation. A system approach, however, often introduces a division of labor between ordinary citizens and experts. Although this division of labor is unavoidable and I believe compatible with a deliberative principle of legitimacy, it flirts with elitist theories of democracy: epistemic elites come up with the agendas, (...) ideas, and policy positions and democratic publics ratify or repudiate the agendas but do not generate or really engage with them. This I argue would violate an essential defining feature of deliberative democracy, namely that epistemic quality and equal participation are tightly linked. I turn to Habermas and his idea of a feedback loop as a possible solution to this dilemma. (shrink)

In public communication contexts, such as when a company announces the proposal for an important organizational change, argumentation typically involves multiple audiences, rather than a single and homogenous group, let alone an individual interlocutor. In such cases, an exhaustive and precise characterization of the audience structure is crucial both for the arguer, who needs to design an effective argumentative strategy, and for the external analyst, who aims at reconstructing such a strategic discourse. While the peculiar relevance of multiple audience is (...) often emphasized in the argumentation literature and in rhetorical studies, proposals for modelling multi-audience argumentative situations remain scarce and unsystematic. To address this gap, we propose an analytical framework which integrates three conceptual constructs: Rigotti and Rocci’s notion of communicative activity type, understood as the implementation of an interaction scheme into a piece of institutional reality, named interaction field; the stakeholder concept, originally developed in strategic management and public relations studies to refer to any actor who affects and/or is affected by the organizational actions and who, accordingly, carries an interest in them; the concept of participant role as it emerges from Goffman’s theory of conversation analysis and related linguistic and media studies. From this integration, we derive the notion of text stakeholder for referring to any organizational actor whose interest becomes an argumentative issue which the organizational text must account for in order to effectively achieve its communicative aim. The text stakeholder notion enables a more comprehensive reconstruction and characterization of multiple audience by eliciting the relevant participants staged in a text and identifying, for each of them, the interactional role they have, the peculiar interest they bear and the related argumentative issue they create. Considering as an illustrative case the defense document issued by a corporation against a hostile takeover attempt made by another corporation, we show how this framework can support the analysis of strategic maneuvering by better defining the audience demand and, so, better explaining how real arguers design and adapt their topical and presentational choices. (shrink)

“[A]ny truly neutral state,” writes George Sher in this important and timely new book, “must needlessly cut its citizens off from important goods”. For that reason, he argues, liberal neutrality, the view that government must remain neutral between competing conceptions of the good life, is indefensible. There is, moreover, a uniquely best, rationally defensible conception of the good life—not a subjective view that insists that all value depends on satisfying actual or hypothetical desires, but an objective view that recognizes that (...) some value depends on the realization of certain broad capacities that humans share. However, this objective or perfectionist view, as Sher calls it, is not communitarian, since it rejects the idea that society’s history or conventions must ratify its values or that civic participation or engagement in common projects must be among its recommendations. It is a liberal perfectionism, since it requires procedural and substantive liberal rights and recognizes that there are many different ways of realizing the human capacities whose exercise generates value. Hence, although government may legitimately promote the good, “the ability to promote the good is not all-or-nothing”. (shrink)

Constitutivism argues that the source of the categorical force of the norms of rationality and morality lies in the constitutive features of agency. A systematic failure to be guided by these norms would amount to a loss or lack of agency. Since we cannot but be agents, we cannot but be unconditionally guided by these norms. The constitutivist strategy has been challenged by David Enoch. He argues that our participation in agency is optional and thus cannot be a source of (...) categorical demands. In this paper, I defend the viability of constitutivism by showing that agency is indeed a special ‘inescapable’ enterprise. Agency has the largest jurisdiction, and it is closed under rational assessment. This inescapability does not exempt constitutivism from raising the question whether agents have reason to be agents, but this question has to be taken up within agency. If this question is answered affirmatively, then—I argue—the criteria of practical correctness are self-ratifying in a non-circular way. This is sufficient to show the viability of the constitutivist strategy. Whether agents have conclusive reasons to be agents, however, is a matter to be addressed in the terms of particular versions of constitutivism. (shrink)

BackgroundFear of cancer recurrence is common amongst cancer survivors. There is rapidly growing research interest in FCR but a need to prioritize research to address the most pressing clinical issues and reduce duplication and fragmentation of effort. This study aimed to establish international consensus among clinical and academic FCR experts regarding priorities for FCR research.MethodsMembers of the International Psycho-oncology Society Fear of Cancer Recurrence Special Interest Group were invited to participate in an online Delphi study. Research domains identified in Round (...) 1 were presented and discussed at a focus group to consolidate the domains and items prior to presentation in further survey rounds aimed at gaining consensus on research priorities of international significance.ResultsThirty four research items were identified in Round 1 and 33 of the items were consolidated into six overarching themes through a focus group discussion with FCR experts. The 33 research items were presented in subsequent rounds of the delphi technique. Twenty one participants contributed to delphi round 1, 16 in round 2, and 25 and 29 participants for subsequent delphi rounds. Consensus was reached for 27 items in round 3.1. A further four research items were identified by panelists and included in round 3.2. After round 3.2, 35 individual research items were ratified by the panelists. Given the high levels of consensus and stability between rounds, no further rounds were conducted. Overall intervention research was considered the most important focus for FCR research. Panelists identified models of care that facilitate greater access to FCR treatment and evaluation of the effectiveness of FCR interventions in real world settings as the two research items of highest priority. Defining the mechanisms of action and active components across FCR/P interventions was the third highest priority identified.ConclusionThe findings of this study outline a research agenda for international FCR research. Intervention research to identify models of care that increase access to treatment are based on a flexible approach based on symptom severity and can be delivered within routine clinical care were identified as research areas to prioritize. Greater understanding of the active components and mechanisms of action of existing FCR interventions will facilitate increased tailoring of interventions to meet patient need. (shrink)

Using video recordings of one-on-one writing conferences as data, this conversation analytic study provides a sequential analysis of student-initiated question–answer sequences and demonstrates that the building of social interaction is contingent upon the composition of a turn as well as its position in the larger sequence. In particular, the article focuses on the distinct sequential environments in which students use yes/no interrogatives and yes/no declaratives. In the context of writing conference, the epistemic asymmetry between the participants is made relevant (...) throughout the session; in general, the teacher is in a more knowledgeable position, whereas the student is in a less knowledgeable position concerning writing practices. Nonetheless, students invoke a different degree of knowledge gap between the participants by using different forms of polar questions. This article illustrates how students convey their epistemic positions with different syntactic structures and how such distinct positions are ratified in the unfolding sequence. The analysis of this study contributes to finding new aspects of question–answer sequences and pedagogical practices. (shrink)

Authoritative school climate is a relevant and novel construct that improves the academic performance and social-emotional development of students. This study aimed to evaluate the psychometric properties of reliability and validity of the Authoritative School Climate Survey (ASCS) in a sample of Chilean adolescents. A cross-sectional study was carried out, in which 808 students from 12 schools in Chile participated (55.1% men and 44.9% women), with a mean age of 15.94 (SD= 1.32). The results obtained through exploratory and confirmatory factor (...) analyzes ratified the hypothesized structure of two correlated factors. As expected, evidence of criterion validity showed significant relationships between the measures of authoritative school climate and attitude toward institutional authority. This study provides evidence regarding the psychometric quality of the scale to assess authoritative school climate, allowing its use in the Chilean context. (shrink)

When physicians take readings of health indices such as temperature or blood pressure, the practices that physicians and patients employ in discussing the readings both reflect and propose a set of expectations regarding the level of technical medical information the patients should acquire and understand. In this article we demonstrate how physicians’ reporting practices reflect and propose the roles of paternalism or independent expertise and how patients’ responding practices either ratify or contest the roles cast by the physicians’ practices. In (...) contrast to the usual assumption that roles are relatively stable for individuals over the course of encounters, we treat role enactments as matters that are negotiated turn by turn in interaction. Physicians’ practices for reporting test results implicate various sets of expectations about the knowledge, interest, and responsibility state of each participant; patients employ responding practices that ratify or contest the expectations implicated by the physicians’ prior report. In each subsequent turn within the information exchange sequence, a speaker indicates whether the level and kind of information being exchanged is appropriate/inappropriate and sufficient/insufficient for the participants. (shrink)

This essay examines the function of the concept of human dignity (both as an inherent feature of human existence and as an ideal achievement) in the United Nations's 1948 Universal Declaration of Human Rights. It explains why the key framers of the document affirmed an inherent human dignity in order to provide an explanatory basis for the validity of universal human rights while eschewing any religious or metaphysical justification for this affirmation. It argues that the key framers, while aware of (...) the Christian anthropology informing the modern Western concept of the dignity of the person, grasped (1) that the Declaration, to be ratifiable, would need to be free of religious reference, and also (2) that the notion of inherency suffices to suggest heuristically not only a universal human nature but also, crucially, a transcendent reality in which all persons participate. (shrink)

Relying on the systematic, logical, and analytical methods, national legislation and some internationally accepted guidelines, as well as on the research conducted by the Lithuanian scientists and law practitioners, this article consistently and comprehensively deals with the problems arising in the areas of interpretation and application of tax law. The article examines the relevant tax concepts, studies the tax law system, deals with the relevant issues arising in the field of application of legal regulations on taxation, and provides a particularly (...) detailed analysis of court jurisprudence within the context of the relationship between tax and law. On the basis of the analysis conducted, it was established that the basis for the Lithuanian tax law system consists of the Constitution of the Republic of Lithuania; the Law on Tax Administration; tax laws that lay down specific taxes and of by-laws adopted on their basis; national legal regulations that contain a consideration attribute and set mandatory payments to the State budget; the Law on Customs; ratified international agreements; the European Union legal regulations to the extent they are related to the duties, import excise duty, and value added tax; and the European Union directives in respect of direct and indirect taxes and the extent to which they are related to tax administration. When relationships in public law are directly regulated by the relevant public law regulations, it is not private law regulations, but the corresponding public law regulations that must be applied. In order to determine the need for tax authorities to rely on the regulations of the Civil Code, it is necessary to state the necessity to assess legal relationships from the point of view of private law or to identify a gap in legal regulation of public law due to which the norms of the Civil Code are subsidiary. Prior to establishing the tax base, the tax authority does not have to rebut transactions in civil procedure. The taxpayer’s obligation to fulfil tax liabilities that are properly prescribed by tax laws is not called into question by unlawful acts of other persons which constitute grounds for their civil (non-contractual) liability for the damages caused. The factual circumstances of tax relations established in the court cases heard in criminal and/or administrative procedures, do not need to be proved again – they are relied on in the course of tax inspections or when hearing tax disputes. The principle of equality of taxpayers requires tax administrators to give equal treatment to the facts with respect to all participants regarding the same tax relationship and obliges taxpayers to pay taxes honestly, because non-payment of taxes is a breach of public interest and therefore of this principle. In accordance with the principle of general applicability and equality, each taxpayer has an obligation to pay taxes as prescribed in tax legislation observing the calculation and payment procedures stipulated in the tax legal regulations, whereas the amount payable as established by the tax administrator shall be regarded as well-founded to the extent that it does not exceed the criterion of equality and reasonableness. The principle of clarity of taxation requires the tax administrator to adopt clear and comprehensive decisions with respect to the taxpayer and therefore to ensure their rights and legitimate interests. In the calculation of tax by applying the principle of primacy of content over form, it is necessary to establish that a transaction, an economic deal or indeed any group thereof has been concluded for the purpose of obtaining tax benefits. (shrink)

Background 300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. Methods The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars (...) to ratify outcomes for inclusion in the final core outcome set.. Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers. Results 36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the ‘consensus in’ criteria. 6 met ‘consensus in’ all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting ‘consensus in’ were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions. Conclusion This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research. (shrink)

The study analyses the issues of protection of national minorities from the perspective of international law. The study consists of three parts. In the first part, the author reveals the understanding of a national minority on the basis of objective and subjective features. This part focuses on such problematic issues as national minorities and citizenship, non-dominant position of a national minority. The second part of the study concentrates on international minorities as subjects of international law. The author analyses international legal (...) subjectivity of national minorities. A question is raised whether the rights of national minorities are individual or collective rights. The third part of the study focuses on the analysis of normative basis for the protection of national minorities. The author notes that the monist system exists in the Republic of Lithuania regarding the relation of international and national law. Under this system, the international treaties ratified by the Lithuanian Parliament (Seimas) are seen as an indivisible part of the legal system of the Republic of Lithuania. Therefore, the Convention for the Protection of National Minorities is an international treaty that is directly applicable in the legal system of the Republic of Lithuania. The fourth part of the study focuses on the question whether Lithuania should become a party to the European Charter for Regional or Minority Languages. Although this issue is complex and includes the problems of political, economic, legal and other nature, the author focuses on the legal analysis of the problems related to the participation in the Charter. It is emphasised that the Charter is not the only document that ensures the linguistic rights of national minorities. Under the Law on International Treaties of the Republic of Lithuania, while considering participation in the Charter, the right of treaty initiative should be implemented, and the question of efficiency of the treaty must also be solved. (shrink)

This article examines a handful of recent creative works that reflect speculatively on transgender pasts. I argue that each of these creative texts uses ontological interventions to reimagine moments in trans activist history that scholars have narrated only in terms of the attenuation of sociality and of political participation. These works do this by ratifying trans activists’ relations of reciprocity with extraordinary entities that are not often supported by secular and anthropocentric historiographies. Instead of engaging accounts of coalition work with (...) extraterrestrials, nonhuman animals, and magical powers mainly as sites of “subjugated knowledges”, these creative works all consider the political capacitations afforded by trans collaborations with other-than-human agencies. In order to make this argument, I draw from the recent body of anthropological scholarship known as the “new animism,” and consider the absence of commentary on religion and secularism within the Anglo-American posthuman turn. Ultimately, beyond offering alternatives to historical declension narratives about trans activism, these works urge scholars to consider how relations with “subaltern” agentive forces have become increasingly important to disenfranchised communities’ efforts to negotiate the political debilitations of a post-neoliberal world. (shrink)

The rite of the Mass has undergone changes that have transformed the way the faithful participated in the celebrations. On the occasion of the Second Vatican Council, there were changes which were intended to bring about a more active participation of the assembly in the liturgical act. The distance between the canticle and the liturgical rite calls for an investigation, for it is necessary that we know the reason for this happening even today. There is evidence that many chants sung (...) in celebrations are discordant with the liturgical time, and the lack of a correct understanding of the teachings of the Church may be the reason for this, since there are several ecclesial documents on the subject. The present work intends to demonstrate, through the analysis of Church documents and the ideas of renowned authors, specialists in liturgy, the importance of music having a liturgical objective. This article is a bibliographical research, which through the analysis of Church documents mainly, seeks to highlight the importance of liturgy linked to music. Since the Motu Proprio Tra le Sollecitudini, the Church has been regulating how to perform the song to achieve a true liturgical action in the Eucharistic celebration. It should not be forgotten, however, that the participation of the assembly in the Latin Mass was restricted, and there was no possibility of innovation in singing. With the Constitution Sacrosanctum Concilium, the lay participation was expanded, as well as the introduction of the vernacular in the celebrations. Subsequent Church documents have ratified the expansion of secular participation and the local language has made it possible to include new chants in celebrations, including popular ones, which were previously banned. In the Latin mass, the liturgy was more restricted to the clergy; With the council reform, the laity gained more space. Today, the Church's challenge is to preserve the liturgical meaning of singing, respecting popular cultures, but further deepening the lay liturgical-musical formation. (shrink)

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build ‘true research (...) teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

An action is unratifiable when, on the assumption that one performs it, another option has higher expected utility. Unratifiable actions are often claimed to be somehow rationally defective. But in some cases where multiple options are unratifiable, one unratifiable option can still seem preferable to another. We should respond, I argue, by invoking a graded notion of ratifiability.

Genetic results are usually not returned to research participants in Uganda despite their increased demand. We report on researchers’ perceptions and experiences of return of individual genetic research results. The study involved 15 in-depth interviews of investigators involved in genetics and/or genomic research. A thematic approach was used to interpret the results. The four themes that emerged from the data were the need for return of individual results including incidental findings, community engagement and the consenting process, implications and challenges (...) to return of individual results. While researchers are willing to return clinically significant genetic results to research participants, they remain unsure of how this should be implemented. Suggestions to aid implementation of return of results included reconsenting of participants before receiving individual genetic results and increasing access to genetic counseling services. Community engagement to determine community perceptions and individual preferences for the return of results, and also prepare participants to safely receive results emerged as another way to support return of results. Researchers have a positive attitude toward the return of clinically significant genetic results to research participants. There is need to develop national guidance on genetic research and also build capacity for clinical genetics and genetic counseling. (shrink)

Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with relatives after their death.

Despite the attempts to promote the inclusion of pregnant women into clinical research, this group is still widely excluded. An analysis of the “vulnerability of pregnant women” that questions deeply internalized stereotypes is necessary for finding the right balance in the protection of pregnant women as research participants. Criticism of the traditional account of vulnerability will lead to an alternative that focuses on situations rather than groups and on the obligations of responsible parties. The paper adds to the current (...) general discussion of vulnerability and at the same time addresses the specific problem of drug treatment during pregnancy. (shrink)

Although research has examined factors influencing understanding of informed consent in biomedical and forensic research, less is known about participants' attention to details in consent documents in psychological survey research. The present study used a randomized experimental design and found the majority of participants were unable to recall information from the consent form in both in-person and online formats. Participants were also relatively poor at recognizing important aspects of the consent form including risks to participants and (...) confidentiality procedures. Memory effects and individual difference characteristics also appeared to influence recall and recognition of consent form information. (shrink)

Within three of the most well-known contemporary approaches to argumentation, the notions of solo argumentation and arguing with one’s self are given little attention and are typically argued to be able to be subsumed within the dialectical aspects of the approach being propounded. Challenging these claims, this paper has two main aims. The first is to argue that while dialogical argumentation may be most common, there exists individual dialectical argumentation, which is not so easily subsumed within these theories. Second, in (...) order characterize this type of argumentation the paper also offers distinctions between the interrelated notions of dialectical, dialogical, and quasi-dialogical, reasoning and argumentation, within an individual or between multiple participants, which I hope provide useful precision for the field. (shrink)

Trust features prominently in a number of policy documents that have been issued in recent years to facilitate data sharing and international collaboration in medical research. However, it often remains unclear what is meant by ‘trust’. By exploring a concrete international collaboration between Denmark and Pakistan, we develop a way of unpacking trust that shifts focus from what trust ‘is’ to what people invest in relationships and what references to trust do for them in these relationships. Based on interviews in (...) both Pakistan and Denmark with people who provide blood samples and health data for the same laboratory, we find that when participants discuss trust they are trying to shape their relationship to researchers while simultaneously communicating important hopes, fears and expectations. The types of trust people talk about are never unconditional, but involve awareness of uncertainties and risks. There are different things at stake for people in different contexts, and therefore it is not the same to trust researchers in Pakistan as it is in Denmark, even when participants donate to the same laboratory. We conclude that casual references to ‘trust’ in policy documents risk glossing over important local differences and contribute to a de-politicization of basic inequalities in access to healthcare. (shrink)

The use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at (...) research sites in the Western Cape and Gauteng, South Africa. (shrink)

Background and rationale Several factors that motivate individuals to participate in non-therapeutic studies have been identified. This study was conducted as limited data is available regarding these motivations from developing countries. Methods This was a single-centre study conducted over 4 months in which a questionnaire was administered to 102 healthy participants and 16 patient participants who had earlier taken part in non-therapeutic studies at our centre. Descriptive statistics and univariate analysis were used to analyse data. Results The most (...) common motivation among healthy participants was financial reward (65%) followed by altruism, free medical check up, curiosity and personal health benefit. Patient participants, however, most commonly said they consented to take part in the trial as they were ‘invited to participate by the treating physician’ (88%). In comparison with the patient participants, healthy participants were more likely to be satisfied with the financial reward (p=0.02), and recommend participation in studies to friends or relatives (p=0.0013). Conclusions The most common motivating factor to participate in non-therapeutic studies appears to be different for healthy participants (financial reward) and patient participants (invitation to participate by the physician). Participants also felt that adequate information and care was given to them during the trial, and that they would participate in future clinical studies, and would also recommend such studies to their friends. (shrink)

Controlled human malaria infection (CHMI) studies involve the deliberate infection of healthy volunteers with malaria parasites under controlled conditions to study immune responses and/or test drug or vaccine efficacy. An empirical ethics study was embedded in a CHMI study at a Kenyan research programme to explore stakeholders’ perceptions and experiences of deliberate infection and moral implications of these. Data for this qualitative study were collected through focus group discussions, in‐depth interviews and non‐participant observation. Sixty‐nine participants were involved, including CHMI (...) study volunteers, community representatives and research staff. Data were managed using QSR Nvivo 10 and analysed using an inductive‐deductive approach, guided by ethics literature. CHMI volunteers had reasonable understanding of the study procedures. Decisions to join were influenced by study incentives, trust in the research institution, their assessment of associated burdens and motivation to support malaria vaccine development. However, deliberate malaria infection was a highly unusual research strategy for volunteers, community representatives and some study staff. Volunteers’ experiences of physical, emotional and social burdens or harms were often greater than anticipated initially, and fluctuated over time, related to specific procedures and events. Although unlikely to deter volunteers' participation in similar studies in furture, we argue that the dissonance between level of understanding of the burdens involved and actual experiences are morally relevant in relation to community engagement, informed consent processes, and ongoing support for volunteers and research staff. We further argue that ethics oversight of CHMI studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context. (shrink)

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

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and (...) limits of this professional obligation to respond to incidental fndings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship. (shrink)

BackgroundCodes of conduct mainly focus on research misconduct that takes the form of fabrication, falsification, and plagiarism. However, at the aggregate level, lesser forms of research misbehavior may be more important due to their much higher prevalence. Little is known about what the most frequent research misbehaviors are and what their impact is if they occur.MethodsA survey was conducted among 1353 attendees of international research integrity conferences. They were asked to score 60 research misbehaviors according to their views on and (...) perceptions of the frequency of occurrence, preventability, impact on truth (validity), and impact on trust between scientists on 5-point scales. We expressed the aggregate level impact as the product of frequency scores and truth, trust and preventability scores, respectively. We ranked misbehaviors based on mean scores. Additionally, relevant demographic and professional background information was collected from participants.ResultsResponse was 17% of those who were sent the invitational email and 33% of those who opened it. The rankings suggest that selective reporting, selective citing, and flaws in quality assurance and mentoring are viewed as the major problems of modern research. The “deadly sins” of fabrication and falsification ranked highest on the impact on truth but low to moderate on aggregate level impact on truth, due to their low estimated frequency. Plagiarism is thought to be common but to have little impact on truth although it ranked high on aggregate level impact on trust.ConclusionsWe designed a comprehensive list of 60 major and minor research misbehaviors. Our respondents were much more concerned over sloppy science than about scientific fraud (FFP). In the fostering of responsible conduct of research, we recommend to develop interventions that actively discourage the high ranking misbehaviors from our study. (shrink)

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In (...) support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of “research results,” specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of (...) the Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)