Research question and aim Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC’s implementation, to increase knowledge about CEC’s implementation strategy. Research design We collected quantitative data related to number and characteristics of CEC (...) activities carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC’s development and implementation process. Participants and research context The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. Ethical Considerations The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. Findings In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC’s impact on clinical practice. Conclusion Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially. (shrink)

Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences (...) of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. (shrink)

(2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. The American Journal of Bioethics: Vol. 11, No. 3, pp. 18-19.

Numerous ethical issues are raised in cancer treatment and research. Informed consent is challenging due to complex treatment modalities and prognostic uncertainty. Busy oncology clinics limit the ability of oncologists to spend time reinforcing patient understanding and facilitating end-of-life planning. Despite these issues and the ethics consultations they generate, clinical ethicists receive little if any focused education about cancer and its treatment. As the field of clinical ethics develops standards for training, we argue that a basic knowledge (...) of cancer should be included and offer an example of what cancer ethics training components might look like. We further suggest some specific steps to increase collaboration between clinical ethicists and oncology providers in the outpatient setting to facilitate informed consent and proactively identify ethical issues. (shrink)

Ethical issues in biomedical research are traditionally examined as distinct from those of clinical care. However, this traditional framing may obscure questions of equity and fairness in both rese...

Novel immune therapies are increasingly based on the molecular differentiation of disease patterns. The related clinical studies are thus more often characterized by the so-called adaptive study designs (umbrella or basket studies including platform studies), which are continuously adjusted based on novel results. This paper analyses new study designs beyond the often-postulated need for regulation in order to identify ethical problems based on typical structural features and to—whenever possible—suggest solutions. To do so, it addresses the following topics: the relationship (...) between social and scientific values of a study as well as aspects of the scientific validity of new forms of evidence; the inclusion of study subjects under the condition of relative uncertainty; specific challenges in the process of ethical approval, and ethical and practical challenges in the process of informing patients and receiving informed consent. Additionally, the topic of a potential risk–benefit assessment of such therapies is addressed. (shrink)

The development of gene expression profiling and next-generation sequencing technologies have steered oncogenomics to the forefront of precision medicine. This created a need for harmonious cooperation between clinicians and researchers to increase access to precision oncology, despite multiple implementation challenges being encountered. The aim is to apply personalised treatment strategies early in cancer management, targeting tumour subtypes and actionable gene variants within the individual’s broader clinical risk profile and wellbeing. A knowledge-generating database linked to the South African Medical (...) Research Council’s Genomic Centre has been created for the application of personalised medicine, using an integrated service and research approach. Insights gained from patient experiences related to tumour heterogeneity, access to targeted therapies and incidental findings of pathogenic germline variants in tumour DNA, provided practice-changing evidence for the implementation of a cost-minimisation pathology-supported genetic testing strategy. Integrating clinical care with genomic research through data sharing advances personalised medicine and maximises precision oncology benefits. (shrink)

Background: The number of cancer patients is constantly growing. Both WHO and IARC report that this number may reach up to 24 million new diagnosed cases in the next two decades. The proposed treatment and especially the diagnosis can have a significant impact on an individual's approach to the disease, as well as on the patient's quality of life.Objectives: The study aimed to assess the quality of life, feelings, and fear of cancer-treating oncological patients, before and during the COVID-19 pandemic.Material (...) and Methods: The study used the standardized WHOQOL quality of life questionnaire in a shortened version, the COVID-19 fear scale, and the AIS disease acceptance scale. The questionnaire survey was conducted among patients of cancer clinics. The study was conducted in two stages–before the COVID-19 pandemic and during the COVID-19 pandemic. Data from 450 correctly completed questionnaires were analyzed statistically. The obtained data were statistically processed using the Kruskal-Wallis and Mann-Whitney U test.Results: Among the surveyed patients of the cancer clinic, the quality of life during the COVID-19 pandemic decreased by 2%, compared to the period before the pandemic. The frequency of negative feelings associated with cancer increased during the COVID-19 pandemic–by 11% more men, and 4.4% of women determined the frequency of negative feelings to be 2–3 times a week. The level of fear associated with COVID-19 was moderate, with women having a higher level of fear.Conclusion: The development of the epidemic is very important in terms of public health. COVID-19 should be considered as one of the factors that bring about sudden changes in the mental health of the population, which may result from the dynamic development of this disease, dramatic media coverage, and own experiences. It has been shown that the sudden appearance of such a large stressor causes a decrease in patients' quality of life and an increase in negative feelings associated with chronic disease. (shrink)

Data on advance directives in Brazil are lacking. This study aims to assess the understanding of oncologists regarding advance directives and the frequency with which they discuss advance directives and advance care planning with their patients in Brazil. This is an observational, descriptive and cross-sectional study, conducted with cclinical oncologists associated with the Brazilian Society of Clinical Oncology. Participants were invited to answer a questionnaire prepared by the authors. In total, 72 physicians answered the questionnaire, of which 73% (...) were under 45 years old and 56% worked in oncology for less than 10 years. Regarding the limits of intervention and end-of-life care during treatment, 54.2% of respondents reported not discussing it. Although 67% of oncologists know the term advance directives, they do not develop them with their patients and 57.2% do not perform advance care planning. Most oncologists in this study do not set advance care planning and advance directives for most patients. (shrink)

Background: Providing oncological care to children is demanding and ethical issues concerning what is best for the child can contribute to moral distress. Objectives: To explore healthcare professionals’ experiences of situations that generate moral distress in Swedish paediatric oncology. Research design: In this national study, data collection was conducted using the Swedish Moral Distress Scale-Revised. The data analysis included descriptive statistics and non-parametric analysis of differences between groups. Participants and research context: Healthcare professionals at all paediatric oncology centres (...) in Sweden were invited to participate. A total of 278 healthcare professionals participated. The response rate was 89%. Ethical considerations: In its advisory statement, the Regional Ethical Review Board decided that the study was of such a nature that the legislation concerning ethical reviews was not applicable. All participants received written information about the aim of the study and confidentiality. Participants demonstrated their consent by returning the survey. Findings: The two situations with the highest moral distress scores concerned lack of competence and continuity of personnel. All professional groups reported high levels of disturbance. Nurses rated significantly higher frequencies and higher total Moral Distress Scale scores compared to medical doctors and nursing assistants. Discussion: Lack of competence and continuity, as the two most morally distressing situations, confirms the findings of studies from other countries, where inadequate staffing was reported as being among the top five morally distressing situations. The levels of total Moral Distress Scale scores were more similar to those reported in intensive care units than in other paediatric care settings. Conclusion: The two most morally distressing situations, lack of competence and continuity, are both organisational in nature. Thus, clinical ethics support services need to be combined with organisational improvements in order to reduce moral distress, thereby maintaining job satisfaction, preventing a high turnover of staff and ensuring the quality of care. (shrink)

BackgroundClinical Ethics Support Services have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we carried out a qualitative (...) study conducting in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders’ expectations about a potential CESS to be implemented within the Institution.MethodsThe study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders’ professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory.ResultsTwenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases.ConclusionsThe interviewees showed a limited degree of ‘ethical awareness’: despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients. (shrink)

BackgroundClinical trials should be as inclusive as possible to facilitate equitable access to research and better reflect the population towards which any intervention is aimed. Informed by the UK’s National Institute for Health and Care Research (NIHR) Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE) guidance, we audited oncology trials conducted by the Clinical Trials and Statistics Unit at The Institute of Cancer Research, London (ICR-CTSU) to identify whether essential documents were overtly excluding any (...) groups and whether sufficient data were collected to assess diversity of trial participants from groups suggested by INCLUDE as under-served by research in the UK.MethodsThirty cancer clinical trials managed by ICR-CTSU and approved between 2011–2021 were audited. The first ethics approved version of each trial’s protocol, patient information sheet, and patient completed questionnaire, together with the first case report forms (CRFs) version were reviewed. A range of items aligned with the INCLUDE under-served groups were assessed, including age, sex and gender, socio-economic and health factors. The scope did not cover trial processes in participating hospitals.ResultsData relating to participants’ age, ethnic group and health status were well collected and no upper age limit was specified in any trials’ eligibility criteria. 23/30 (77%) information sheets used at least one gendered term to address patients. Most CRFs did not specify whether they were collecting sex or gender and only included male or female categories. The median reading age for information sheets was 15–16 years (IQR: 14–15 – 16–17). Socio-economic factors were not routinely collected and not commonly mentioned in trial protocols.ConclusionsNo systemic issues were identified in protocols which would explicitly prevent any under-served group from participating. Areas for improvement include reducing use of gendered words and improving readability of patient information. The challenge of fully assessing adequate inclusion of under-served populations remains, as socio-economic factors are not routinely collected because they fall beyond the data generally required for protocol-specified trial endpoint assessments. This audit has highlighted the need to agree and standardise demographic data collection to permit adequate monitoring of the under-served groups identified by the NIHR. (shrink)

The objective of this study was to determine whether consent forms in oncology clinical trials of commercially available treatments inform subjects that they may be able to obtain the treatments being investigated without participating in research. We acquired consent forms from a random sample of U.S. oncology clinical trials in the ClinicalTrials.gov database. We then examined a subgroup of the sample consisting of studies in which the treatments under investigations were commercially available. Less than 20% of (...) the consent forms in that group disclosed to subjects that they may be able to obtain the treatment being investigated without participating in the study . Our results suggest that potential research subjects are frequently not informed about important alternatives to research participation in studies involving commercially available treatments, which is a violation of both ethical and regulatory standards. (shrink)

Background: It is stated that the communication and disease experiences of paediatric patients, especially paediatric oncology patients, with healthcare professionals are completely different from those of adults. Objective: The aim of this study was to determine the definitions of a good physician and good nurse provided by elementary school-age oncology patients. Research design: In this qualitative research, data were collected through semi-structured individual interviews. The data were evaluated thorough thematic analysis. Participants and research context: Eighteen children hospitalised due (...) to cancer in paediatric oncology and haematology clinics of a university hospital in Turkey. Ethical considerations: Permission to conduct the study was obtained from the Institution’s Ethics Committee. The objectives of this study were explained to the participants and families, and written consent was obtained from them. Also, participants were assured that necessary measures would be taken to protect their anonymity and confidentiality. Findings: The definitions of children were based on five main themes: interpersonal relationships, virtues, professional responsibility, security and individual characteristics. Conclusion: Children conveyed important messages to health professionals. They emphasised that a good physician and good nurse should communicate well, not only with themselves but also with their family. In addition, children were sensitive about health professionals who played with them and actively participated in the treatment by informing them about the disease. Meeting the expectations of children can be possible by improving the communication skills of physicians and nurses and by adding games and activities to the treatment and care plan. (shrink)

OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they (...) would enrol the patient in a trial and how sure they were of this decision. Demographic characteristics of the investigators were also collected. OUTCOME MEASURES: The difference in enrolment decisions between subjective and objective criteria, and the difference in the certainty associated with these decisions. RESULTS: Of 365 questionnaires sent out, 224 usable ones were returned. Compared with the objective criteria, the subjective criteria were associated with more variable enrolment decisions (p = 0.07 for the "eligible" scenario and p = 0.0001 for the "ineligible" and "uncertain" scenarios), and investigators were less sure about the decisions they made (p = 0.0001 for all scenarios). Demographic characteristics of the investigators failed to explain the observed differences. CONCLUSIONS: Subjective eligibility criteria may interfere with the conduct and interpretation of RCTs and, therefore, their use ought to be justified explicitly in the study protocol. RCT designers, funding agencies and research ethics boards have an important role in reviewing eligibility criteria for their necessity. (shrink)

Definition of the problem: A `experimental treatment' is defined as the use of a not yet approved medical treatment or product in a single patient outside the scope of regular clinical trials. Especially in oncology the patient is usually in a desperate situation and does not respond to other treatments. Even if he or she is fully informed about the risks he or she may occasionally make an irrational decision.Discussion of the problem: The moral problems in experimental treatments (...) have to do with the medical and scientific quality of the treatment and the patient-physician relationship. It is argued that there are also moral duties for pharmaceutical manufacturers and health insurrance companies.Conclusion: A regulation of experimental treatment trials is necessary both for physicians and for pharmaceutical manufacturers. (shrink)

One of the difficulties nurses experience in clinical practice in relation to ethical issues in connection with young oncology patients is moral distress. In this descriptive correlational study, the Moral Distress Scale-Paediatric Version (MDS-PV) was translated from the original language and tested on a conventional sample of nurses working in paediatric oncology and haematology wards, in six north paediatric hospitals of Italy. 13.7% of the total respondents claimed that they had changed unit or hospital due to moral (...) distress. The items with the highest mean intensity in the sample were almost all connected with medical and nursing competence and have considerably higher values than frequency. The instrument was found to be reliable. The results confirmed the validity of the MDS-PV (Cronbach’s alpha = 0.959). This study represents the first small-scale attempt to validate MDS-PV for use in paediatric oncology-ematology nurses in Italy. (shrink)

Die rasanten technischen Fortschritte in der Genomforschung ermöglichen heute schon die Sequenzierung des einzelnen menschlichen Genoms in wenigen Tagen und zu vertretbaren Kosten. In der Krebsforschung ermöglicht die genetische Sequenzanalyse, zunehmend die Defekte zu identifizieren, die für das Tumorwachstum bei jedem einzelnen Patienten verantwortlich sind. Auf dieser Basis können zielgerichteter Therapien entwickelt werden. Diese Forschung wirft jedoch auch neue, ethische Fragen auf. Diesen normativen Fragen widmet sich in Heidelberg das interdisziplinäre EURAT Projekt mit dem Ziel, ethisch und rechtlich informierte Lösungen (...) zu formulieren und zu etablieren.Dieser Beitrag gibt zum einen einen Überblick über die ethischen und klinischen Fragen, die für den Aufklärungs- und Einwilligungsprozess in die biobankbasierte Genomforschung relevant sind. Zum anderen wird als organisationsethische Antwort auf die Frage, wie eine Forschungsinstitution den verantwortungsvollen Umgang mit genetischen Informationen in Biobanken über die verschiedenen Berufsgruppen und beteiligten Institute hinweg sichern kann, ein Verhaltenskodex vorgestellt. Eine gut begründete, informierte Zustimmung und ein Verhaltenskodex sind beides Elemente einer „Best Practice Leitlinie“ und sollen den verantwortlichen Umgang aller beteiligten Mitarbeiter mit sensiblen genetischen Daten prägen. (shrink)

Background: Patients and their caregivers are expected to take joint responsibility for reporting symptoms and seeking medical assistance, for example, by calling oncology emergency telephones or other helplines during a cancer trajectory. Research objective: The aim was to explore the meaning of responsibility as it appeared in patients’ or caregivers’ experiences of calling an oncological emergency telephone. Design, participants and context: Inspired by qualitative description and qualitative content analysis, a secondary analysis of data from interviews with 12 participants calling (...) the oncological emergency telephone at a Danish university hospital was performed. Ethical considerations: The project observes demands for safekeeping data and all regulations concerning research ethics in agreement with the Nordic Nurses Federation and the Danish Health Act. Findings: Two main themes emerged: (1) to act responsibly as a patient or caregiver was to ‘be watchful and alert’, ‘report symptoms the right way’ and ‘do crosschecking’ and (2) to deal with the burden of responsibility was to ‘feel safe when dealing with the burden of responsibility’ and ‘be relieved from the burden of responsibility’. Discussion: Too much responsibility and a potential imbalance between healthcare professionals’ expectations and callers’ knowledge and capacity to act may place additional burdens on the callers, which may be eased by person-centred care. Conclusion: The meaning of responsibility appeared in the participants’ capacity to act, where they observed, assessed and reported symptoms and controlled prescribed treatments as well as shared or handed over the responsibility to the healthcare providers. Thus, the analysis provided essential knowledge for healthcare professionals on how patients and caregivers handle this responsibility when faced with a cancer disease that is treated on an outpatient basis. (shrink)

Multiple groups, including the National Bioethics Advisory Commission, the American Society of Clinical Oncology, the National Coalition of Comprehensive Cancer Centers, Workgroup 6 of the Summit Series on Cancer, PRIM&R, the Bell Report, and prominent ethicists have called for replacing the current system of local institutional review with central review for multisite national trials. We argue that this need is particularly acute in pediatric oncology, as shown by the experience of the Children's Oncology Group.

Medication reconciliation for pediatric oncology patientparticipants enrolled in clinical trials often reveals the use of chemical complementary medicine alongside protocol therapeutic agents. Considering the blurry delineation between clinical ethics and research ethics, this paper demonstrates how complementary medicine-related protocol violations introduce ethical questions of who should be included and excluded from clinical trials and offers recommendations on how to manage physician-patient-family interactions around these challenging issues.

Background Physicians play a fundamental role in the care of patients at the end of life that includes knowing how to accompany patients, alleviate their suffering and inform them about their situation. However, in reality, doctors are part of this society that is reticent to face death and lack the proper education to manage it in their clinical practice. The objective of this study was to explore the residents’ concepts of death and related aspects, their reactions and actions in (...) situations pertaining to death in their practice, and their perceptions about existing and necessary training conditions. Methods A qualitative approach was used to examine these points in depth based on interviews conducted with seven oncology residents. Results Participants do not have a clear concept of death and, although it is seen as a common phenomenon, they consider it an enemy to beat. The situations to which respondents react more frequently with frustration and sadness after the death of patients were when they felt emotionally involved, if they identify with the patient, in cases of pediatric patients and with patients who refuse treatment. To deal with death, participants raise barriers and attempt to become insensitive. Although residents in this study recognize the importance of training to learn how to better deal with death, it seems they are not fully invested in reaching more of it. Conclusions Participants face death in a daily basis without the necessary training, which appears to impact them more than they are willing to accept. They do not achieve their goals managing situations regarding death as well as they assume they do. Despite recognizing the need of more training and support for better coping with death, they prefer to continue to learn from their experience. Trial registration Not applicable. (shrink)

Die öffentliche Diskussion um die „personalisierte Medizin“ legt nahe, dass mit diesem medizinischen Ansatz hohe Erwartungen an einen Beitrag zur klinischen Versorgung verbunden werden. Über die Wahrnehmungen und Bewertungen klinisch tätiger Ärzte ist jedoch wenig bekannt. Die vorliegende qualitative Interviewstudie gibt einen Einblick bezüglich des Einflusses „personalisierter Medizin“ auf die klinische Praxis aus ärztlicher Perspektive. Die Ärzte im vorliegenden Sample nehmen „personalisierte Medizin“ zwar als einen medizinischen Fortschritt wahr, sehen allerdings keine grundsätzliche Veränderung der bisherigen medizinischen Praxis. Als zentrales Problem (...) wird die Handhabung und Verwertung von molekulargenetischen Informationen für Diagnose und Therapie in der klinischen Praxis thematisiert. In Anbetracht der Ergebnisse muss infrage gestellt werden, ob „personalisierte Medizin“ nicht das Gegenteil von dem, was ihr Name nahe legt – eine personenorientiertere Medizin – bewirkt. Die Strategien im Umgang mit den Informationsmassen produzieren selbst neue Herausforderungen, die ein Hindernis für eine personenorientierte Medizin darstellen könnten. (shrink)

Principles of ethics -- Medical research and clinical trials -- Treatment decision making -- Palliative and end-of-life care -- Patient advocacy -- Communication and ethics -- Genetics and genomics -- The impact of ethical conflict and dilemmas on nurses -- Ethics consultation and education.

Novel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referred to scientific validity, risk-benefit balance and informed consent. Our aim is to discuss these issues in basket and umbrella trials, giving examples of two ongoing cancer trials: NCI-MATCH (National Cancer Institute – Molecular Analysis for Therapy Choice) and Lung-MAP (Lung Cancer Master Protocol) study. We discuss three ethical requirements (...) for clinical trials which may be challenged in basket and umbrella trial designs. Firstly, we consider scientific validity. Thanks to the new trial designs, patients with rare malignancies have the opportunity to be enrolled and benefit from the trial, but due to insufficient accrual, the trial may generate clinically insignificant findings. Inadequate sample size in study arms and the use of surrogate endpoints may result in a drug approval without confirmed efficacy. Moreover, complexity, limited quality and availability of tumor samples may not only introduce bias and result in unreliable and unrepresentative findings, but also can potentially harm patients and assign them to an inappropriate therapy arm. Secondly, we refer to benefits and risks. Novel clinical trials can gain important knowledge on the variety of tumors, which can be used in future trials to develop effective therapies. However, they offer limited direct benefits to patients. All potential participants must wait about 2 weeks for the results of the genetic screening, which may be stressful and produce anxiety. The enrollment of patients whose tumors harbor multiple mutations in treatments matching a single mutation may be controversial. As to informed consent – the third requirement we discuss, the excessive use of phrases like “personalized medicine”, “tailored therapy” or “precision oncology” might be misleading and cause personal convictions that the study protocol is designed to fulfill the individual health-related needs of participants. We suggest that further approaches should be implemented to enhance scientific validity, reduce misunderstandings and risks, thus maximizing the benefits to society and to trial participants. (shrink)

DNR decisions are frequently made in oncology and hematology care and physicians and nurses may face related ethical dilemmas. Ethics is considered a basic competence in health care and can be understood as a capacity to handle a task that involves an ethical dilemma in an adequate, ethically responsible manner. One model of ethical competence for healthcare staff includes three main aspects: being, doing and knowing, suggesting that ethical competence requires abilities of character, action and knowledge. Ethical competence can (...) be developed through experience, communication and education, and a supportive environment is necessary for maintaining a high ethical competence. The aim of the present study was to investigate how nurses and physicians in oncology and hematology care understand the concept of ethical competence in order to make, or be involved in, DNR decisions and how such skills can be learned and developed. A further aim was to investigate the role of guidelines in relation to the development of ethical competence in DNR decisions. Individual interviews were conducted with fifteen nurses and sixteen physicians. The interviews were analyzed using thematic content analysis. Physicians and nurses in the study reflected on their ethical competence in relation to DNR decisions, on what it should comprise and how it could be developed. The ethical competence described by the respondents related to the concepts being, doing and knowing. In order to make ethically sound DNR decisions in oncology and hematology care, physicians and nurses need to develop appropriate virtues, improve their knowledge of ethical theories and relevant clinical guidelines. Ethical competence also includes the ability to act upon ethical judgements. Continued ethical education and discussions for further development of a common ethical language and a good ethical working climate can improve ethical competence and help nurses and physicians cooperate better with regard to patients in relation to DNR decisions, in their efforts to act in the best interest of the patient. (shrink)

Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely to experience negative outcomes than similar others. The phenomenon has been seen in a range of health-related contexts—including when prospective participants are presented with the risks and benefits of participating in a clinical trial. In order to test for the prevalence of unrealistic optimism among participants of early-phase oncology (...) trials, we conducted a survey with patients over 18 years of age who were enrolled in a phase I, phase I/II, or phase II clinical cancer trial in the New York City area between August 2008 and October 2009. Participants in our study were asked to compare their own chances of experiencing a range of risks and benefits related to the trial they were enrolled in with the chances of the other trial participants. We found a significant optimistic bias in their responses. Respondents tended to overestimate the benefits of the trial they were enrolled in and underestimate its risks. In addition, we found no significant relationship between respondents’ understanding of the trial’s purpose and how susceptible they were to unrealistic optimism. Our findings suggest that improving the consent process for oncology studies requires more than addressing deficits in understanding. (shrink)

In 1972, I created the new field of clinical medical ethics (CME) in the Department of Medicine at the University of Chicago. In my view, CME is an intrinsic part of medicine and is not a branch of bioethics or philosophical ethics or legal ethics. The relationship of patients with medically trained and licensed clinicians is at the very heart of CME. CME must be practiced and applied not by nonclinical bioethicists, but rather by licensed clinicians in their routine, (...) daily encounters with inpatients and outpatients. CME addresses many clinical issues such as truth-telling, informed consent, confidentiality, surrogate decision making, and end-of-life care, while also encouraging personal, humane, and compassionate interactions between experienced clinicians and patients.The goals of CME are to improve patient care and outcomes by helping physicians and other health professionals Clinical Medical Ethics: Its History and Contributions to American Medicine Mark Siegler, Guest Editor identify and respond to clinical-ethical challenges that arise in the ordinary care of patients. As Edmund Pellegrino, Peter A. Singer, and I wrote in the first issue of The Journal of Clinical Ethics, 30 years ago: “The central goal of CME is to improve the quality of patient care by identifying, analyzing, and contributing to the resolution of ethical problems that arise in the routine practice of clinical medicine.” Similar to cardiology and oncology consultations, ethics consultations are a small component of a much larger field, and the process of consultations is certainly not at the core of cardiology or oncology or CME.In this article, I intend to discuss the origins of the field of CME, its goals and methods, the relationship between the broad field of CME and the much narrower practice of ethics consultation, the contributions of the MacLean Center at the University of Chicago in developing the field of CME, and, finally, how CME has improved the practice of medicine in the United States. (shrink)

Patient-derived xenografts are currently promoted as new translational models in precision oncology. PDXs are immunodeficient mice with human tumors that are used as surrogate models to represent specific types of cancer. By accounting for the genetic heterogeneity of cancer tumors, PDXs are hoped to provide more clinically relevant results in preclinical research. Further, in the function of so-called “mouse avatars”, PDXs are hoped to allow for patient-specific drug testing in real-time. This paper examines the circulation of knowledge and bodily (...) material across the species boundary of human and personalized mouse model, historically as well as in contemporary practices. PDXs raise interesting questions about the relation between animal model and human patient, and about the capacity of hybrid or interspecies models to close existing translational gaps. We highlight that the translational potential of PDXs not only depends on representational matching of model and target, but also on temporal alignment between model development and practical uses. Aside from the importance of ensuring temporal stability of human tumors in a murine body, the mouse avatar concept rests on the possibility of aligning the temporal horizons of the clinic and the lab. We examine strategies to address temporal challenges, including cryopreservation and biobanking, as well as attempts to speed up translation through modification and use of faster developing organisms. We discuss how featured model virtues change with precision oncology, and contend that temporality is a model feature that deserves more philosophical attention. (shrink)

Staging and stratification are two diagnostic approaches that have introduced a more dynamic outlook on the development of diseases, thus participating in blurring the line between the normal and the pathological. First, diagnostic staging, aiming to capture how diseases evolve in time and/or space through identifiable and gradually more severe stages, may be said to lean on an underlying assumption of “temporal determinism”. Stratification, on the other hand, allows for the identification of various prognostic or predictive subgroups based on specific (...) markers, relying on a more “mechanistic” or “statistical” form of determinism. There are two medical fields in which these developments have played a significant role and have given rise to sometimes profound nosological transformations: oncology and psychiatry. Drawing on examples from these two fields, this paper aims to provide much needed conceptual clarifications on both staging and stratification in order to outline how several epistemological and ethical issues may, in turn, arise. We argue that diagnostic staging ought to be detached from the assumption of temporal determinism, though it should still play an essential role in adapting interventions to stage. In doing so, it would help counterbalance stratification’s own epistemological and ethical shortcomings. In this sense, the reflections and propositions developed in psychiatry can offer invaluable insights regarding how adopting a more transdiagnostic and cross-cutting perspective on temporality and disease dynamics may help combine both staging and stratification in clinical practice. (shrink)

PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants. METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research (...) results programs. RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants. CONCLUSIONS: Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified. (shrink)

Background and AimPsycho-oncology is a cross-disciplinary and collaborative sub-specialty of oncology that focuses on the psychological, behavioral, ethical, and social aspects of cancer in clinical settings. The aim of this bibliometric study was to analyze and characterize the research productivity and trends in psycho-oncology between 1980 and 2021.MethodologyIn May 2022, the Scopus® database was searched for psycho-oncology-related publications using predetermined search keywords with specific restrictions. Lotka’s law was applied to check the authors’ productivity, while Bradford’s (...) law was used to assess the core journals in this field. The data was analyzed for different bibliometric indicators in the Biblioshiny package, an RStudio tool for bibliometric analysis.ResultsThe initial search resulted in a total of 2,906 publications. Of which, 1,832 publications were included in the final analysis, published between 1980 and 2021. The analyzed publications were written by 7,363 authors from 74 countries and published in 490 journals. There has been a significant increase in psycho-oncology-related publications after 2010. The most productive year was 2021. The annual scientific growth rate was found to be 13.9%. The most relevant leading author in terms of publications was Luigi Grassi from the University of Ferrara, Italy. Lotka’s law found that the number of authors declined as the number of papers written increased. The core journals were Psycho-Oncology, Supportive Care in Cancer, and Journal of Psychosocial Oncology. The most frequently used author’s keywords other than searching keywords were cancer, oncology, quality of life, depression, and anxiety. Recent psycho-oncology-related topics included mental health, COVID-19 infection in humans, people, pandemic, and tumor. The University of Sydney was the top-ranked institution. The leading country in terms of publications, citations, corresponding author country, and international collaboration was the United States of America. The United States had the strongest collaboration with Australia and Canada.ConclusionThe research hotspots include mental health conditions and interventions in cancer patients. We identified international collaboration and research expenditure to be strongly associated with psycho-oncology research productivity. Researchers’ collaboration, which is visible among developed countries, should be extended to low-income countries in order to expand psycho-oncology-related research and understanding. (shrink)

BackgroundIn paediatric oncology, healthcare professionals face moral challenges. Clinical ethics support services, such as moral case deliberation, aim to assist them in dealing with these challenges. Yet, healthcare professionals can have different expectations and goals related to clinical ethics support services.MethodsIn this study, the perceptions held by healthcare professionals regarding the importance of possible outcomes of MCDs, prior to implementation of MCDs, were investigated. A multisite, cross-sectional, quantitative study was performed at all six Paediatric Oncology Centres (...) in Sweden. Healthcare professionals answered the Euro-MCD instrument with 26 potential MCD outcomes using a scale from Not important to Very important. Descriptive and comparative statistical analyses were carried out.ResultsAll outcomes were rated high, i.e., between 3.12 and 3.78. More open communication, developing skills to analyse ethically difficult situations, better mutual understanding, and deciding on concrete actions were rated as most important. Understanding of ethical theories and critical examination of policies were rated less important. Most often nursing assistants rated higher and physicians lower than the other professions did. Women and participants without previous experience of MCDs perceived outcomes as more important. There were differences between centres as one centre had significantly higher, and one centre had significantly lower ratings compared to the others.ConclusionIt is clear that healthcare professionals want MCDs to improve teamwork and skills in order to analyse and manage ethically difficult situations. When comparing to previous research about important MCD outcomes, there were similarities in what healthcare professionals consider to be important when handling moral challenges regardless of country and potential differences in healthcare settings and systems, such as paediatric vs. adult care. (shrink)

This article presents results from an empirical investigation of the role and importance of ethics in the daily work of Danish oncologyphysicians and Danish molecular biologists. The study is based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company.We found that oncology (...) physicians consider ethical evaluation as part of their daily work. They discuss how to treat patients in groups and they have interdisciplinary seminars. In contrast, molecular biologists employed at the university do not think that basic research causes significant ethical problems, they do not talk about ethics in their daily work and they do not want to prioritise seminars on ethics. Molecular biologists employed in a private biopharmaceutical company do not think that basic research causes significant ethical problems, but the private company prioritises ethical evaluation. If the company behaves unethical, they will be punished by the consumers and by the investors in the last end. In general, oncology physicians working in the clinic experience a closer relationship between their daily work and ethical problems concerning human beings than molecular biologists conducting basic research. (shrink)

BackgroundThis study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016–2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS).MethodsWe performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by descriptive analysis. (...) Qualitative evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU’s activities and analyzed by framework analysis.ResultsQuantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs.ConclusionsOur findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU’s ethics consultation service within the local context. (shrink)

IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue, emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations. Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive (...) trance. It seems to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties.Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate. To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study ; immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/. Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661. (shrink)

Since the human genome was sequenced in 2003, exploding knowledge and new technologies in the field of genomics have given rise to the new field of precision medicine, whereby treatment is individualized to patients based on their genomic information. However, as with any new scientific advancement and technology, precision medicine has the potential to improve health outcomes but raises ethical questions, particularly in children. Using pediatric precision oncology as an example, this paper focuses on the ethical issues in the (...) integration of genomic information in the management of children with cancer. Pediatric precision oncology encompasses the use of the child’s cancer genomic information and sometimes germline genomic information to aid in diagnosis, risk stratification, and prognostication, as well as “precisely” treating the cancer using genomically guided targeted therapies. The main ethical issues discussed in this paper include the difficulty in obtaining informed consent from parents and assent from the child, due to information overload, emotional overwhelm, cognitive biases, among others; the ambiguity between research and clinical care, leading to therapeutic misconception and mis-estimation; the utility of this novel technology and its impact on scarce resources; and the potential to widen health disparities thus affecting justice. Recognizing and addressing these ethical challenges will help guide the responsible implementation and integration of precision medicine into routine pediatric clinical care. (shrink)

This article provides an ethnographic account of how Big Data biology is produced, interpreted, debated, and translated in a Big Data-driven cancer clinical trial, entitled “Personalized OncoGenomics,” in Vancouver, Canada. We delve into epistemological differences between clinical judgment, pathological assessment, and bioinformatic analysis of cancer. To unpack these epistemological differences, we analyze a set of gazes required to produce Big Data biology in cancer care: clinical gaze, molecular gaze, and informational gaze. We are concerned with the interactions (...) of these bodily gazes and their interdependence on each other to produce Big Data biology and translate it into clinical knowledge. To that end, our central research questions ask: How do medical practitioners and data scientists interact, contest, and collaborate to produce and translate Big Data into clinical knowledge? What counts as actionable and reliable data in cancer decision-making? How does the explicability or translatability of genomic Big Data come to redefine or contradict medical practice? The article contributes to current debates on whether Big Data engenders new questions and approaches to biology, or Big Data biology is merely an extension of early modern natural history and biology. This ethnographic account will highlight how genomic Big Data, which underpins the mechanism of personalized medicine, allows oncologists to understand and diagnose cancer in a different light, but it does not revolutionize or disrupt medical oncology on an institutional level. Rather, personalized medicine is interdependent on different styles of thought, gaze, and practice to be produced and made intelligible. (shrink)

We do not know how much clinical physicians carrying out clinical trials in oncology and haematology struggle with ethical concerns. To our knowledge, no empirical research exists on these questions in a Nordic context. Therefore, this study aims to learn what kinds of ethical challenges physicians in Sweden, Denmark and Finland (n = 29) face when caring for patients in clinical trials; and what strategies, if any, they have developed to deal with them. The main findings (...) were that clinical cancer trials pose ethical challenges related to autonomy issues, unreasonable hope for benefits and the therapeutic misconception. Nevertheless, some physicians expressed that struggling with such challenges was not of great concern. This conveys a culture of hope where health care professionals and patients uphold hope and mutually support belief in clinical trials. This culture being implicit, physicians need opportunities to deliberately reflect over the characteristics that should constitute this culture. (shrink)

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease , debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for (...) in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned.. (shrink)

The procedures for structuring clinical ethics case reflections in a childhood cancer care setting are presented, including an eight-step model. Four notable characteristics of the procedures are: members of the inter-professional health care team, not external experts, taking a leading role in the reflections; patients or relatives not being directly involved; the model explicitly addressing values and moral principles instead of focussing exclusively on the interests of involved parties; using a case-based (inductive) rather than principle-based (deductive) method. By discusing (...) the advantages and disadvantages of the proposed procedures, our paper aims to contribute to the literature on models and procedures for ethical analysis that can be used in clinical settings. It is suggested that our proposed procedures have some advantageous features when it comes to promoting health care staff’s learning to structure their thinking about ethical issues. (shrink)