Moral or ethical questions are vital because they affect our daily lives: what is the best choice we can make, the best action to take in a given situation, and ultimately, the best way to live our lives? Health ethics has contributed to moving ethics toward a more experience-based and user-oriented theoretical and methodological stance but remains in our practice an incomplete lever for human development and flourishing. This context led us to envision and develop the stance of a “living (...) ethics”, described in this inaugural collective and programmatic paper as an effort to consolidate creative collaboration between a wide array of stakeholders. We engaged in a participatory discussion and collective writing process known as instrumentalist concept analysis. This process included initial local consultations, an exploratory literature review, the constitution of a working group of 21 co-authors, and 8 workshops supporting a collaborative thinking and writing process. First, a living ethics designates a stance attentive to human experience and the role played by morality in human existence. Second, a living ethics represents an ongoing effort to interrogate and scrutinize our moral experiences to facilitate adaptation of people and contexts. It promotes the active and inclusive engagement of both individuals and communities in envisioning and enacting scenarios which correspond to their flourishing as authentic ethical agents. Living ethics encourages meaningful participation of stakeholders because moral questions touch deeply upon who we are and who we want to be. We explain various aspects of a living ethics stance, including its theoretical, methodological, and practical implications as well as some barriers to its enactment based on the reflections resulting from the collaborative thinking and writing process. (shrink)

_Changing the Subject_ is a classic critique of traditional psychology in which the foundations of critical and feminist psychology are laid down. Pioneering and foundational, it is still _the _groundbreaking text crucial to furthering the new psychology in both teaching and research. Now reissued with a new foreword describing the changes which have taken place over the last few years, _Changing the Subject _will continue to have a significant impact on thinking about psychology and social theory.

Aim The aim is to understand current research into the impact of undergraduate nursing education on the development of professional values. Background Values are evident in the professional standards for nurses and the guidelines and healthcare policies of many countries. These professional values guide decisions and behaviour and are recognised as an essential component in the professions ability to provide safe and professional care. This literature review presents the current research on the impact of education on professional values in undergraduate (...) nurse education. Design An integrative review of the findings was conducted to provide insight into the current research on the professional value development in undergraduate nurses. Data sources CINAHL, PubMed and Scopus. Review methods A literature search was undertaken within defined date parameters 2010–2021 using a systematic approach. The Preferred Reporting Items for Systematic Reviews and Meta-analysis guide PRISMA was used to guide and illustrate the process. Papers were assessed for quality using the Mixed Methods Appraisal Tool. Results Two distinct areas of inquiry were identified. (a) Changes in professional values as an outcome of undergraduate nursing education or (b) changes in professional values as an outcome of specifically designed educational content. These areas were further explored to better understand the influences of undergraduate education on students’ professional values. Conclusion There is a lack of evidence in the literature to support the premise that professional values develop in line with academic year progression; however, there is strong evidence to support the inclusion of explicit learning in undergraduate education that engages students in education specifically designed to explore and develop professional values. (shrink)

SCHOFIELD I, TOLSON D and FLEMING V. Nursing Inquiry 2012; 19: 165–176 [Epub ahead of print]How nurses understand and care for older people with delirium in the acute hospital: a Critical Discourse AnalysisDelirium is a common presentation of deteriorating health in older people. It is potentially deleterious in terms of patient experience and clinical outcomes. Much of what is known about delirium is through positivist research, which forms the evidence base for disease‐based classification systems and clinical guidelines. There is little (...) systematic study of nurses’ day‐to‐day practice of nursing patients with delirium. The aim was to uncover the kinds of knowledge that informs nurses’ care and to explicate the basis of that knowledge. Critical Discourse Analysis is underpinned by the premise that powerful interests within society mediate how social practices are constructed. Links were made between the grammatical and lexical features of nurses’ language about care in interviews and naturalistic settings, and the healthcare context. Care focused on the continuous surveillance of patients with delirium by nurses themselves or vicariously through other patients, and containment. Nurses influenced by major discourses of risk reduction and safety, constructed patients with delirium as risk objects. The philosophy of person‐centred and dignified care advocated in nursing literature and government policy is an emerging discourse, though little evident in the data. The current dominant discourses on safety must give space to discourses of dignity and compassion. (shrink)

While positive information in the context of clinical care can lead to placebo effects, negatively framed information can have negative or nocebo effects. Extant literature documents how doctor–patient encounters are fertile ground for suboptimal interactions leading to negative experiences for ethnoracial minority patients. In their _JME_ paper, Blease presents a critical perspective on the potential for patients’ access to their doctors’ clinical notes, ‘open notes’, to engender nocebo effects. 1 In this commentary, we affirm the central claim that nocebo effects (...) could emerge ‘via negative wording or framing of health information expressed by clinicians in documentation’. The advent of electronic health records (EHR) allowed patients the unprecedented opportunity to access personal clinical documentation, giving them a window into decision making around their health. This shift is undoubtedly complex, and thus warrants a more fulsome rendering of the unique challenges faced by ethnoracial minority patients. Herein, we highlight three... (shrink)

The “gift exchange theory” articulated by Marcel Mauss, along with his core concept of a threefold obligation, is the dominant theoretical framework used to explain the majority of gift issues in marketing. This perspective assumes that some interest always lies behind gifts, such that a gift always implies a counterpart of receiving something in return. Despite the relevance of this approach in understanding the day-to-day consumer behavior, this paper presents empirical cases where the consumer is also able to give freely, (...) that is to say without implying a counterpart or even expecting it. To explain those empirical cases, we mobilize a key teaching of the Catholic Church: the “gratuitous gift” and then introduce the concept of the “need to give.” We show that gratuitousness is a relevant concept to understand most of gifts made by consumers, and we develop the normative aspect of gratuitous gift for ethical marketers. We also show that Catholic Social Teaching offers an appropriate anthropology to understand consumer behaviors motivated by this need for gratuitousness. To conclude, we propose further avenues of research. (shrink)

The lack of gender parity in philosophy has garnered serious attention recently. Previous empirical work that aims to quantify what has come to be called “the gender gap” in philosophy focuses mainly on the absence of women in philosophy faculty and graduate programs. Our study looks at gender representation in philosophy among undergraduate students, undergraduate majors, graduate students, and faculty. Our findings are consistent with what other studies have found about women faculty in philosophy, but we were able to add (...) two pieces of new information. First, the biggest drop in the proportion of women in philosophy occurs between students enrolled in introductory philosophy classes and philosophy majors. Second, this drop is mitigated by the presence of more women philosophy faculty. (shrink)

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

On March 11, 2020 the World Health Organization classified COVID‐19, caused by Sars‐CoV‐2, as a pandemic. Although not much was known about the new virus, the first outbreaks in China and Italy showed that potentially a large number of people worldwide could fall critically ill in a short period of time. A shortage of ventilators and intensive care resources was expected in many countries, leading to concerns about restrictions of medical care and preventable deaths. In order to be prepared for (...) this challenging situation, national triage guidance has been developed or adapted from former influenza pandemic guidelines in an increasing number of countries over the past few months. In this article, we provide a comparative analysis of triage recommendations from selected national and international professional societies, including Australia/New Zealand, Belgium, Canada, Germany, Great Britain, Italy, Pakistan, South Africa, Switzerland, the United States, and the International Society of Critical Care Medicine. We describe areas of consensus, including the importance of prognosis, patient will, transparency of the decision‐making process, and psychosocial support for staff, as well as the role of justice and benefit maximization as core principles. We then probe areas of disagreement, such as the role of survival versus outcome, long‐term versus short‐term prognosis, the use of age and comorbidities as triage criteria, priority groups and potential tiebreakers such as ‘lottery’ or ‘first come, first served’. Having explored a number of tensions in current guidance, we conclude with a suggestion for framework conditions that are clear, consistent and implementable. This analysis is intended to advance the ongoing debate regarding the fair allocation of limited resources and may be relevant for future policy‐making. (shrink)

The Toolbox dialogue method enables members of heterogeneous groups to identify, share, and compare their perspectives on topics of common interest, such as research questions or complex problems (Hubbs et al. 2020). These interactions occur in dialogue, typically in relatively brief (eg, two-to four-hour) workshop settings, where participants jointly consider their responses to abstract and often philosophical statements that express positions on the topics. By expressing positions on topics that matter to the group, these statements structure a dialogue that enhances (...) mutual understanding in valuable ways. The method is valuable for heterogeneous groups because it enhances both self-understanding and mutual understanding. It does this by transforming dialogue participants into teachers and learners: teachers of their own perspective to others and learners of the perspectives of others and, to some extent... (shrink)

We apply Benacerraf’s distinction between mathematical ontology and mathematical practice to examine contrasting interpretations of infinitesimal mathematics of the seventeenth and eighteenth century, in the work of Bos, Ferraro, Laugwitz, and others. We detect Weierstrass’s ghost behind some of the received historiography on Euler’s infinitesimal mathematics, as when Ferraro proposes to understand Euler in terms of a Weierstrassian notion of limit and Fraser declares classical analysis to be a “primary point of reference for understanding the eighteenth-century theories.” Meanwhile, scholars like (...) Bos and Laugwitz seek to explore Eulerian methodology, practice, and procedures in a way more faithful to Euler’s own. Euler’s use of infinite integers and the associated infinite products are analyzed in the context of his infinite product decomposition for the sine function. Euler’s principle of cancellation is compared to the Leibnizian transcendental law of homogeneity. The Leibnizian law of continuity similarly finds echoes in Euler. We argue that Ferraro’s assumption that Euler worked with a classical notion of quantity is symptomatic of a post-Weierstrassian placement of Euler in the Archimedean track for the development of analysis, as well as a blurring of the distinction between the dual tracks noted by Bos. Interpreting Euler in an Archimedean conceptual framework obscures important aspects of Euler’s work. Such a framework is profitably replaced by a syntactically more versatile modern infinitesimal framework that provides better proxies for his inferential moves. (shrink)

Most studies investigating the relationship between cultural constructs and ethical perception have focused on individual- and societal-level values without much attention to other type of cultural constructs such as social beliefs. In addition, we need to better understand how social beliefs are linked to ethical perception and the level of analysis at which social beliefs may best predict ethical perceptions. This research contributes to the cross-cultural ethical perception literature by examining the relationship of individual-level social cynicism belief, one of five (...) universally endorsed social beliefs, together with individual social dominance orientation and the perception of unethical behavior. By means of two studies, we examine these relationships across societies that significantly differ on societal-level social cynicism belief. Using 371 business students from Russia and the U.S. in Study 1 and 268 professionals from Portugal and the U.S. in Study 2, we found that individual-level social cynicism belief was positively associated with social dominance orientation. Social dominance orientation, in turn, mediated the relationship between individual social cynicism belief and the perception of unethical behavior. Although we found significant societal-level differences in social cynicism belief in both studies, the relationships between individual-level social cynicism belief, social dominance orientation, and the perception of unethical behavior were structurally equivalent across societies in both studies, suggesting that societal-level differences did not significantly affect these relationships. Implications for cross-cultural business ethics research and practice are discussed. (shrink)

Background The fourth section of the 1967 Abortion Act states that individuals (including health care practitioners) do not have to participate in an abortion if they have a conscientious objection. A conscientious objection is a refusal to participate in abortion on the grounds of conscience. This may be informed by religious, moral, philosophical, ethical, or personal beliefs. Currently, there is very little investigation into the impact of conscientious objection on service users in Britain. The perspectives of service users are imperative (...) in understanding the real-world consequences and potential impact of conscientious objection and should be considered when creating and reviewing policies and guidelines. This research provided a platform for women and those who can become pregnant to share their experiences and opinions at a time when these voices are largely excluded in the great tradition of Western political philosophy and law-making processes. Method Five service users were interviewed using a narrative interview approach to uncover their abortion journeys and experiences of conscientious objection. Findings The findings were presented as found poems and uncovered that doctors are not always: informing service users that they have a conscientious objection to abortion, giving service users enough information to access abortion (indirect referral), treating them non-judgmentally, and providing medically correct information. Service users did not experience burdens such as long waiting times and were still able to access legal abortion. However, service users did experience negative emotional effects, as they were often left feeling scared, angry, and hopeless when they were not referred and/or were mistreated. Conclusions Findings indicate that conscientious objection could work in practice. However, it is currently failing some individuals on an emotional level, as not all doctors are adhering to guidelines. Conscientious objection in Britain needs to be addressed, to ensure service users receive fair, impartial, non-judgmental care. (shrink)

Medical legal partnerships address individual legal needs that can create impediments to health. Little is known about outcomes from medical legal partnerships and their relationship to access to justice. This paper reports outcomes from one medical legal partnership from the perspective of the client, with specific emphasis on impact on health and concepts related to access to justice. We suggest a conceptual model for incorporating medical legal partnerships into a broader framework about access to justice.

This book is concerned with how we should think and act in our work, leisure activities, and time utilization in order to achieve flourishing lives. The scope papers range from general theoretical considerations of the value, e.g. 'What is a balanced life?', to specific types of considerations, e.g. 'How should we cope with the effects of work on moral decision-making?'.

Medicine is often thought of as a science of the body, but it is also a science of data. In some contexts, it can even be asserted that data drive health. This article focuses on a key piece of data technology central to contemporary practices of medicine: the medical record. By situating the medical record in the perspective of its history, we inquire into how the kinds of data that are kept at sites of clinical encounter often depend on informational (...) requirements that originate well outside of the clinic, in particular in health insurance records systems. Although this dependency of today's electronic medical records on billing requirements is widely lamented by clinical providers, its history remains little studied. Following the archaeology of medicine developed by Michel Foucault in The Birth of the Clinic and expanding his methodology in light of more recent contributions to the field of media archaeology, this article excavates some of the underexplored technological conditions that help constitute today's electronic medical record. If in some contexts, it is true that data drive health, then an archaeology of medical records helps reveal how health insurance records often impact clinical care and, by extension, health and disease. (shrink)

Recollections of humanistic and transpersonal psychology’s origin’s morph into the pros and cons of humanistic/transpersonal oriented schools developing APA accredited clinical programs. This discussion dovetails with the question will ATP ever become an APA division, raising an interesting alternative for those of us considering a career in counseling: becoming a spiritual coach. Enter the issue of psychedelic therapy and the Supreme Courts decision to allow ayahuasca as a sacrament by the Uniao Do Vegetal Church, and the importance of why humanistic (...) and transpersonal psychology need to clearly map out the territories and sub-divisions of science and religion. Finally this conversation raises a concern, that Maslow’s call for a “trans-human” psychology sought to encourage creating what we now call ecopsychology. (shrink)

Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...) Documents included detailed information on IRB procedures and the duration from IRB submission until approval. They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally or locally and primary IRB approval was obtained after one, two or three review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days and appeared to be shorter after submission to local IRBs compared to central IRBs. Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. (shrink)

Background Levels of care deemed as inappropriate generate moral distress among nurses and other intensive care professionals. Inappropriate levels of care and related moral distress are frequently broached as individual and psychological phenomena, reduced to how individuals feel and think about specific cases. However, this tends to obscure the complex context in which these situations occur, and on which healthcare professionals can act. There is thus a need for a more contextual and team-level lens on inappropriate levels of care. Research (...) objective This study aims to explore and understand the issue of inappropriate levels of care in an intensive care unit (ICU) through a contextual and team-level lens. Research design Semi-structured interviews were conducted with nurses, respiratory therapists, and intensivists. Thematic analysis focused on understanding the causes and consequences of inappropriate levels of care, as well as potential avenues for improvement. This study is part of a 5-phase participatory living lab project on inappropriate levels of care conducted in the ICU of a Montreal (Quebec, Canada) hospital. This paper relates the initial phases of the project, focusing on understanding the issue, with reported events spanning from June 2022 to May 2023. Ethical considerations Ethics approval was sought and granted by the Research Ethics Board of the CIUSSS de l’Est-de-l’Île-de-Montréal. Findings/Discussion Five broad themes intrinsically related to the phenomenon of inappropriate levels of care were explored with and by participants: (1) the process of determining levels of care, (2) the distinction between appropriate and inappropriate levels of care, (3) causes of inappropriate levels of care, (4) consequences of inappropriate levels of care and (5) potential avenues for improvement. Conclusion This research provides a comprehensive understanding of inappropriate levels of care in the ICU and emphasizes the relevance of team-level explorations of complex ethical issues. (shrink)

Many contemporary thinkers of the Anthropocene, who attempt to articulate a non-modern and relational ontology, all too readily dismiss critical theory inherited from the Frankfurt School for being anthropocentric, failing to acknowledge certain basic similarities. Instead, this article argues that the scaffolding of Anthropocene thinking—the recognition of the origins of the contemporary condition of ‘loss of world’ and the hope of ‘living on in the ruins’—share much with earlier critical theorists’ recognition that the Holocaust necessitated a fundamental break with the (...) past. In reading these two sets of literatures together, we suggest we can get a better grasp of the stakes involved in the contemporary crisis of critique, and in the speculative framings enabling alternative futures to come into being. (shrink)

Climate, diet, lifestyle, and environmental settings have all been shown to modulate mood, play a role in mental disorders, and even pose a mental health risk. Can climatotherapy, in its adaptive approach aiming to restore balance among the economic, social, and ecological realms of human societies, situate itself as a therapeutic avenue for the promotion of sustainable mental health?

The precarious rights of senior citizens, especially those who are highly educated and who are expected to counsel and guide the younger generations, has stimulated the creation internationally of advocacy associations and opinion leader groups. The strength of these groups, however, varies from country to country. In some countries, they are supported and are the focus of intense interest; in others, they are practically ignored. For this is reason we believe that the creation of a network of all these associations (...) is essential. The proposed network would act as a support for the already-existing policies of the United Nations’ High Commission for Human Rights, of independent experts, and of the Global Alliance for the Rights of Older People. All three have long ago recommended the creation of a recognized instrument for uniting presently scattered efforts. The proposed network, therefore, will seek to promote the international exchange of relevant expertise, and it will reinforce the commitments and actions that single countries are currently taking to meet these objectives. For example, informative public events can be organised to promote particular support initiatives and to provide an opportunity for new members of the network to be presented. The network will promote health for senior citizens, disease prevention, senior mobility, safe free time for seniors, alimentary education, protection against new risks and dangers, as well as equity in the services necessary for seniors to adopt new information and communication technologies. In the case of retired academic members, the network will promote equality with respect to continuing use of digital technologies (particularly email), continuing access to research libraries, and the guaranteed ability for seniors to fund their own research programs and to deliver free seminars. (shrink)

The significance of private standards and associated local level initiatives in agri-food value chains are increasingly recognised. However whilst issues related to compliance and impact at the smallholder or worker level have frequently been analysed, the governance implications in terms of how private standards affect national level institutions, public, private and non-governmental, have had less attention. This article applies an extended value chain framework for critical analysis of Private Standards Initiatives (PSIs) in agrifood chains, drawing on primary research on PSIs (...) operating in Kenyan horticulture (Horticulture Ethical Business Initiative and KenyaGAP). The paper explores the legislative, executive and judicial aspects of governance in these southern PSIs highlighting how different stakeholders shape debates and act with agency. It is argued that governance is exercised ‘beyond the vertical’ in that one can identify wider horizontal processes of governance, including how the scope of key debates is constructed (especially in legislative governance) but analysis of executive governance emphasises the dominant role of the lead buyers. (shrink)

A criticism of some research involving Aboriginal people is that it is not equitable in its design or application, further disadvantaging the poor and marginalized. In Australia, much research has been done on Aboriginal people, but Aboriginal people themselves have benefited little, adding to distrust between Aboriginal and non-Aboriginal people over many years. Is it possible to take “scientific” research practices and transform them into research that can be done with a community rather than on a community? How can research (...) findings benefit Aboriginal people? This chapter shares our study of Aboriginal people’s stories of diabetes care. It is a collaborative story told by four Aboriginal Health Workers and two non-Aboriginal researchers which focuses on methodology rather than findings. We share aspects of our research which we propose values Aboriginal people and invites participation and reciprocity at design, data collection, and research translation stages. We discuss tensions which occur between the “scientific way” and the “culturally appropriate way” and describe how we resolved this. Imposing research designs and practices on Aboriginal people and communities without consideration that each community is unique has the potential to cause further harm and disempowerment. Valuing an Aboriginal way of knowing influenced all aspects of our study design and procedures. We would like to inspire others to challenge methodological norms to develop research methods with their community to allow the unique voice of their community to be heard and for this to facilitate pragmatic change leading to meaningful improvements in health. (shrink)

Nanotechnologies are a controversial topic, as they seem promising but also cause concern. Previous research has highlighted the potential link between nanotechnologies and other hazardous technologies. The aim of this research was to analyse the discourse on this topic by three groups of participants: laypersons, scientists and environmentalists. Thirty-four people (13 laypersons, ten scientists and eleven environmentalists) were interviewed using a semi-structured interview. Lexical and thematic analyses showed that scientists engage in explanatory discourse and perceive fewer risks than laypersons and (...) environmentalists. The latter two groups describe applications and list the main actors in the development of nanotechnologies. Environmentalists are significantly more likely to make spontaneous associations with other technologies, such as electromagnetic waves, and perceive more risks than the other two groups. Contrary to our expectations, laypersons make fewer associations with biotechnologies than experts or environmentalists. The results are discussed in terms of the interest of a qualitative approach to uncovering new objects spontaneously associated with nanotechnologies, as well as in terms of a risk governance framework. (shrink)

In order to train healthcare professionals in the announcement of serious medical diagnoses, we propose the de-sign of a section of a website that aims to enable caregivers to better control this professional activity that they dread. These diagnoses materialize through language interactions between doctors and patients that are emotion-ally charged. The analysis of these announcement interviews involves access to interactions that are as close as possible to those that take place in real work situations through role-playing. We will show (...) that the design of the website based on the architectural dimension (functional structure of the activity), the relational dimension (roles, co-constructed communication contract) and the communicational dimension (mobilized language processes) allows to identify this sensitive professional activity in its characteristic aspects. Based on a study commissioned by the Ligue contre le cancer, we will show how and in what way the identified dimensions have formative potential and we will highlight their contribution to improving the understanding of the activity and developing training materi-als. (shrink)

Background Sharing anonymized/de-identified clinical trial data and publishing research outcomes in scientific journals, or presenting them at conferences, is key to data-driven scientific exchange. However, when data from scientific publications are linked to other publicly available personal information, the risk of reidentification of trial participants increases, raising privacy concerns. Therefore, we defined a set of criteria allowing us to determine and minimize the risk of data reidentification. We also implemented a review process at Takeda for clinical publications prior to submission (...) for publication in journals or presentation at medical conferences. Methods Abstracts, manuscripts, posters, and oral presentations containing study participant information were reviewed and the potential impact on study participant privacy was assessed. Our focus was on direct and indirect identifiers, such as sex, age or geographical indicators in rare disease studies or studies with small sample size treatment groups. Risk minimization was sought using a generalized presentation of identifier-relevant information and decision-making on data sharing for further research. Additional risk identification was performed based on study participant/personnel parameters present in materials destined for the public domain. The potential for participant/personnel identification was then calculated to facilitate presentation of meaningful but de-identified information. Results The potential for reidentification was calculated using a risk ratio of the exposed versus available individuals, with a value above the threshold of 0.09 deemed an unacceptable level of reidentification risk. We found that in 13% of Takeda clinical trial publications reviewed, either individuals could potentially be reidentified or inappropriate data sharing plans could pose a data privacy risk to study participants. In 1/110 abstracts, 58/275 manuscripts, 5/87 posters and 3/58 presentations, changes were necessary due to data privacy concerns/rules. Despite the implementation of risk-minimization measures prior to release, direct and indirect identifiers were found in 11% and 34% of the analysed documents, respectively. Conclusions Risk minimization using de-identification of clinical trial data presented in scientific publications and controlled data sharing conditions improved privacy protection for study participants. Our results also suggest that additional safeguards should be implemented to ensure that higher data privacy standards are met. (shrink)