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...

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)

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.

There is little information about the content of ethics consultations in pediatrics. We sought to describe the reasons for consultation and ethical principles addressed during EC in pediatrics through retrospective review and directed content analysis of EC records at St. Jude Children's Research Hospital. Patient-based EC were highly complex and often involved evaluation of parental decision making, particularly consideration of the risks and benefits of a proposed medical intervention, and the physician's fiduciary responsibility to the patient. Nonpatient consultations provided guidance (...) in the development of institutional policies that would broadly affect patients and families. This is one of the few existing reviews of the content of pediatric EC and indicates that the distribution of ethical issues and reasons for moral distress are different than with adults. Pediatric EC often facilitates complex decision making among multiple stakeholders, and further prospective research is need.. (shrink)

Background Providing care to children with cancer is one of the most challenging areas of ethical care for nurses. Few studies have addressed nurses’ perception of the barriers to giving ethical care in oncology departments. Thus, it is essential that the ethical challenges in caregiving as perceived by oncology nurses be investigated. Objective The present study was conducted to investigate the ethical challenges as perceived by nurses in pediatric oncology units in the south of Iran. Research (...) design The present study is a qualitative work of research with a conventional content analysis design. Data were collected via individual semi-structured interviews. The collected data were analyzed using the qualitative content analysis method. Participants and research context The participants were 21 nurses from pediatric oncology units in state hospitals who were selected by purposeful sampling. Sampling continued until the data were saturated. The study lasted from April to October 2022. Findings Three main themes, promoting psychological safety in the children, respect for the dignity of the children, and expansion of support for families, and nine subthemes were extracted from the data. Ethical considerations The study’s protocol was approved by the Research Ethics Committee of the University of Medical Sciences and ethical principles were followed throughout the study. Discussion and conclusion From the nurses’ perspective, the major ethical challenges in providing ethical care in pediatric oncology units were reducing tension toward promoting the patients’ psychological safety, showing respect for the identity and dignity of the children with cancer, and expanding support of the patients’ families. By creating the right cultural and professional context and establishing proper protocols, healthcare policymakers and administrators can take effective steps toward eliminating the barriers to providing ethical care. (shrink)

In caring for pediatric patients, a multifaceted approach in decision-making is utilized. The role of the medical team in complementary and alternative medicine is controversial. In cases of conventional treatment refusal by parents in pursuit of complementary and alternative medicine, there must be balanced decision-making, autonomy, and the best interest of the child. This report highlights two illustrative cases of patients with brain tumor, whereby parents refused postoperative conventional therapy involving chemoradiotherapy, in pursuit of complementary and alternative medicine alone. (...) Parental decision-making in complementary and alternative medicine, in lieu of medical recommendations, poses an ethical and legal dilemma that may impede care of the pediatric patient and compromise outcome of oncological care. (shrink)

The treatment of life-threatening illnesses in childhood is replete with ethical issues and with clinical issues that have ethical implications. The central issues are those involved with a child's participation in the decision-making process and with communication of information about the illness and treatments to children. This article examines the questions of patient autonomy and of parental responsibility and prerogative in the context of pediatric oncology. Included in this examination of the ethical dimensions of pediatric life-threatening illness (...) is a discussion of the many related aspects involved, including medical, cultural, psychosocial, legal, and developmental. A multidimensional approach that considers the ways in which these multiple aspects interact with one another, and which focuses on establishing a strong working alliance between the health care team and the pediatric patient's family, can help to avoid or resolve potential ethical and clinical conflicts. (shrink)

The goal is to present how shared decision-making in paediatric oncology occurs from the viewpoints of parents and physicians. Eight Swiss Pediatric Oncology Group centres participated in this prospective study. The sample comprised a parent and physician of the minor patient. Surveys were statistically analysed by comparing physicians’ and parents’ perspectives and by evaluating factors associated with children’s actual involvement. Perspectives of ninety-one parents and twenty physicians were obtained for 151 children. Results indicate that for six aspects (...) of information provision examined, parents’ and physicians’ perceptions differed. Moreover, parents felt that the children were more competent to understand diagnosis and prognosis, assessed the disease of the children as worse, and reported higher satisfaction with decision-making on the part of the children. A patient’s age and gender predicted involvement. Older children and girls were more likely to be involved. In the decision-making process, parents held a less active role than they actually wanted. Physicians should take measures to ensure that provided information is understood correctly. Furthermore, they should work towards creating awareness for systematic differences between parents and physicians with respect to the perception of the child, the disease, and shared decision-making. (shrink)

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)

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group. METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers. RESULTS: (...) The authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated. (shrink)

The emotional experience and the type of communication about cancer within the family are important factors for successful coping with pediatric oncology. The main purpose is to study mother’s and children’s emotional experiences concerning cancer, whether they communicate openly about the disease, and relationships between the type of communication and the different emotions expressed by the children. Fifty-two cancer patients aged 6–14 years and their mothers were interviewed in separate sessions about the two central themes of the study: (...) emotional experiences and type of communication. Analyses of response categories were performed to subsequently compare the age-groups and the mother–child responses. According to the results, mothers expressed emotions such as fear, sadness, or anxiety, while children report sadness, pain, but also happiness. Significant positive correlations were observed between mothers’ sadness and older children’s sadness, mothers’ anxiety and children’s fear, and mothers’ anxiety and children’s happiness. Regarding communication type, mothers tend to hide information about the disease from younger children and to provide direct information to the older children. Children usually prefer to communicate their concerns to parents; however, children whose mothers convey anxiety are more likely to prefer to communicate with others. These results support the idea that parents should talk honestly with their children, explaining their illness in an age-appropriate way, and encouraging them to share their emotional experiences. Further studies are needed from a developmental perspective to understand the disease management of children and families. (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.

Background Chemotherapy and/or radiotherapy treatments may cause premature ovarian failure and irreversible loss of fertility. In the context of childhood cancers, it is now acknowledged that possible negative effects of therapies on future reproductive autonomy are a major concern. While a few options are open to post-pubertal patients, the only immediate option currently open to pre-pubertal girls is cryopreservation of ovarian tissue and subsequent transplantation. The aim of the study was to address a current gap in knowledge regarding the offer (...) of fertility preservation by Ovarian Tissue Cryopreservation for prepubescent girls with cancer, and to explore current practices and attitudes of Canadian, French and Moroccan pediatric heme oncologists. The comparative perspective is relevant since legal frameworks surrounding fertility preservation and funding offered by the healthcare system vary greatly. Methods An online survey was sent to the 45 pediatric oncology centers in Canada, France and Morocco. Results A total of 39 centers responded. OTC is offered by almost all pediatric heme oncologists in France, very few in Canada, and none in Morocco. For pediatric hematologists/oncologists who do not propose fertility preservation in Canada, the reasons are: the technique is still experimental, it is not available locally and cost of the technique for the family. 97% of Canadian and 100% of Moroccan pediatric hematologists/oncologists think OTC should be funded by the healthcare system as it is in France and in the province of Quebec in Canada. Conclusions The results of this study show tremendous diversity in the provision of OTC across countries, whereby its offer is correlated with legislation and funding. We argue that the current reality, in which this technology is often not offered to families, raises ethical issues related to justice and equity of access, as well as informed consent and future reproductive autonomy. (shrink)

Clinical trials are required in order to develop new treatments and improve both patient life expectancy and quality of life. In this respect the last 10 years proved their efficiency. However clinical research shows one of the most difficult dilemmas from an ethical point of view. Patients included in clinical trials are submitted to known and unknown risks and hazards, but rarely benefit from the results. This is even more evident when clinical trials use children who are terminally ill. The (...) core consideration becomes how far should we go with research when considering the child best interest. (shrink)

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each (...) item in a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)

Background: This article describes the overall attitudes of children, their parents, and attending physicians toward including or excluding pediatric patients in medical communication and health care decision-making processes. Methods: Fifty-two interviews were carried out with pediatric patients (n = 17), their parents (n = 19), and attending oncologists (n = 16) in eight Swiss pediatric oncology centers. The interviews were analyzed using thematic coding. Results: Parenting styles, the child's personality, and maturity are factors that have a (...) great impact upon the inclusion of children in their health care processes. Children reported the desire to be heard and involved, but they did not want to dominate the decision-making process. Ensuring trust in the parent–child and physician–patient relationships and respecting the child as the affected person were important values determining children's involvement. These two considerations were closely connected with the concern that fantasies are often worse than reality. Seeking children's compliance with treatment was a practical but critical reason for informing them about their health care. The urge to protect them from upsetting news sometimes resulted in their (partial) exclusion. Conclusions: The ethical imperative for inclusion of children in their health care choices was not so much determined by the right for self-determination, but by the need to include them. If children are excluded, they imagine things, become more isolated, and are left alone with their fears. Nevertheless, the urge to protect children is innate, as adults often underestimate children's coping capacities. (shrink)

This article provides a discussion of the limits of both narrative and culture based on a close textual analysis of the short story, “People Like That Are the Only People Here: Canonical Babbling in Peed Onk,” by Lorrie Moore. In this story, a mother describes her experiences on a pediatric oncology ward when her infant son develops Wilms' tumor. The authors examine how the story satirically portrays the spurious claims of language, story, and culture to protect us from (...) an unjust universe and then exposes their false promises. The various personal, professional, and genre-specific narratives we use to create order and coherence from the terror of serious illness are ultimately ineffective. Similarly, the superficially comforting culture of the hospital ward cares more about creating the illusion of control than it does about the suffering of sick children. Language and culture cannot make sense of human anguish, the article concludes, yet they are all we have to hold back the chaos. Mystery and uncertainty, as part of the human condition, must become part of our stories and part of our culture. (shrink)

Viola and Ben, two pediatric oncology patients, need to undergo chemotherapy that might decrease their fertility. Both of them want to participate in the decisions related to their cancer treatment and fertility preservation. Should they be involved, and if so when and how?In many jurisdictions, children are not entitled to provide legally valid consent for medical decisions.1 As a result, others, usually parents, take on the role of surrogate decision-makers who act in their best interest. Still, it is (...) important to keep in mind that the age limit for competence set by legislation does not necessarily coincide with children’s clinical decision-making capacity: some children may be able to make certain health-care... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Semi-Personal Story from a Ukrainian NGO Professional (or a Semi-Professional Story from a Ukrainian Person) Living through the WarYuliya NogovitsynaI live in Kyiv with my husband and two daughters. On 24 February 2022, my husband woke me up at 5 am tapping me on the shoulder and saying, “Yulia, wake up. There are bombings outside. The war started”. [End Page 160]That day was our younger daughter’s birthday. She (...) turned six. We had planned a birthday party for her with friends, cake, candles and birthday gifts. Instead, we had to move both daughters to the bathroom where there are no windows so that broken glass did not hurt them if a missile hit.I am the Program Director at Tabletochki Charity Foundation, Ukraine’s largest childhood cancer NGO (https://tabletochki.org/en/). For 11 years before the war, we have been fostering childhood cancer care in Ukraine—through our direct assistance to families, support of pediatric oncology units, professional development of medical personnel, and advocacy.The Russian invasion of Ukraine in February 2022 dramatically changed the healthcare system landscape in Ukraine. The physical threat, treatment disruption, exposure of immunosuppressed patients to improper conditions in bomb shelters and cellars, interruption in supplies, infrastructure damage, logistics failure, and funding constraints have been among the most manifested immediate and deferred implications of the war for the health-care system in Ukraine.That said, the biggest professional challenge was uncertainty and inability to plan. You have nothing to rely on in developing at least a short-term strategy. This may sound speculative and unimportant—who bothers about uncertainty when there is a physical threat to your life? But this is a wrong perception—uncertainty paralyzes and disables long before a bullet or missile reaches you.War also brings the collapse of relationships, partnerships, and coalitions. It depletes and limits resources, whether human, financial, or emotional. Scarce resources make hospitals, healthcare professionals, and NGOs compete for patients, donors, and financing. The war and the external threat unite only for a short period of emergency response. Once the situation transitions to a protracted conflict, people and institutions start fighting for their own survival.My family stayed in Ukraine but moved to Lviv, a city in Western Ukraine, which turned into an evacuation hub for children with cancer. More than 1,000 children with cancer were evacuated and referred for treatment abroad through the SAFER Ukraine collaborative initiative by St. Jude Global, Tabletochki, West-Ukrainian Specialized Children’s Medical Center (WUSCMC), and other international and local partners.During the first months of the war, we worked hand-in-hand day and night to bring critically ill children to safety and treatment. We sent evacuation convoys from Lviv to Poland twice a week, the largest one with 71 families, included four buses and 11 ambulances. We slept 4-5 hours per day. Within two weeks, my hands and legs were trembling from constant tension, concentration, and tiredness.And even this extremely fast-responding and effective evacuation may be questioned. We have been facing an ethical dilemma—whether the safety needs of the existing patients prevail over the needs of future patients in diagnostics and treatment in Ukraine. We discussed more than once whether we should stop evacuation and referral of children to European hospitals to sustain the Ukrainian childhood cancer care system and prevent it from degradation. It is very uncomfortable to confront such questions. Could our heroic efforts to evacuate as many Ukrainian children with cancer as possible turn into an evil for future patients to come? By evacuating patients, we left pediatric oncology units empty, without work for Ukrainian pediatric oncologists, and the usual pathways for diagnostics and treatment were disrupted. A healthcare system without patients is like a cardiovascular system without blood.My family returned to Kyiv in August 2022 for our daughters to continue their schooling. There were (and still are) only five to seven kids in a class; other children left Ukraine or switched to online studies. My husband and I decided that our children will attend school offline—despite the regular missile attacks. This is a private school; we pay for it. In such a way... (shrink)

ABSTRACT In ethics, the use of empirical data has become more and more popular, leading to a distinct form of applied ethics, namely empirical ethics. This ‘empirical turn’ is especially visible in bioethics. There are various ways of combining empirical research and ethical reflection. In this paper we discuss the use of empirical data in a special form of Reflective Equilibrium (RE), namely the Network Model with Third Person Moral Experiences. In this model, the empirical data consist of the moral (...) experiences of people in a practice. Although inclusion of these moral experiences in this specific model of RE can be well defended, their use in the application of the model still raises important questions. What precisely are moral experiences? How to determine relevance of experiences, in other words: should there be a selection of the moral experiences that are eventually used in the RE? How much weight should the empirical data have in the RE? And the key question: can the use of RE by empirical ethicists really produce answers to practical moral questions? In this paper we start to answer the above questions by giving examples taken from our research project on understanding the norm of informed consent in the field of pediatric oncology. We especially emphasize that incorporation of empirical data in a network model can reduce the risk of self‐justification and bias and can increase the credibility of the RE reached. (shrink)

Parents frequently attempt to shield their children from distressing prognostic information. Pediatric oncology providers sometimes follow parental request for non-disclosure of prognostic information to children, invoking what we call the stability of the family argument. They believe that if they inform the child about terminal prognosis despite parental wishes, cohesion and family structure will be severely hampered. In this paper, we argue against parental request for non-disclosure. Firstly, we present the stability of the family argument in more detail. (...) We, then, set out the (conceptual, legal, systemic) entitativity of the family and the kind of value the stability of the family argument assumes, before we set on to critically evaluate the argument. Our analysis shows that disclosure of prognostic information to children does not necessarily destabilize the family to a greater extent than non-disclosure. In fact, a systemic perspective suggests that mediated disclosure is more likely to result in a (long-term) stability of the family than non-disclosure. It is in the interest of the family to resist the initial aversive reaction to delivering bad news. In the final part, we draw a set of recommendations on how to facilitate decision-making in face of parental request for non-disclosure. (shrink)

When should doctors seek protective custody to override a parent’s refusal of potentially lifesaving treatment for their child? The answer to this question seemingly has different answers for different subspecialties of pediatrics. This paper specifically looks at different thresholds for physicians overriding parental refusals of life-sustaining treatment between neonatology, cardiology, and oncology. The threshold for mandating treatment of premature babies seems to be a survival rate of 25–50%. This is not the case when the treatment in question is open (...) heart surgery for a child with congenital heart disease. Most cardiologists would not pursue legal action when parents refuse treatment, unless the anticipated survival rate after surgery is above 90%. In pediatric oncology, there are case reports of physicians requesting and obtaining protective custody for cancer treatment when the reported mortality rates are 40–50%. Such differences might be attributed to differences in care, a reasonable prioritization of quality of life over survival, or the role uncertainty plays on prognoses, especially for the extremely young. Nonetheless, other, non-medical factors may have a significant effect on inconsistencies in care across these pediatric subspecialties and require further examinations. (shrink)

In ethics, the use of empirical data has become more and more popular, leading to a distinct form of applied ethics, namely empirical ethics. This ‘empirical turn’ is especially visible in bioethics. There are various ways of combining empirical research and ethical reflection. In this paper we discuss the use of empirical data in a special form of Reflective Equilibrium (RE), namely the Network Model with Third Person Moral Experiences. In this model, the empirical data consist of the moral experiences (...) of people in a practice. Although inclusion of these moral experiences in this specific model of RE can be well defended, their use in the application of the model still raises important questions. What precisely are moral experiences? How to determine relevance of experiences, in other words: should there be a selection of the moral experiences that are eventually used in the RE? How much weight should the empirical data have in the RE? And the key question: can the use of RE by empirical ethicists really produce answers to practical moral questions?In this paper we start to answer the above questions by giving examples taken from our research project on understanding the norm of informed consent in the field of pediatric oncology. We especially emphasize that incorporation of empirical data in a network model can reduce the risk of self‐justification and bias and can increase the credibility of the RE reached. (shrink)

PURPOSE: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results. METHODS: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revised and provided to 30 parents and 10 adolescents in a (...) tertiary care oncology setting. RESULTS: The content validity index for individual questions and the overall questionnaires scored as 0.86 for both questionnaires. All 30 parents and 10 adolescents who agreed to participate returned questionnaires. The majority (>95%) indicated that they had a strong or very strong right to receive results. Letter or e-mail was a satisfactory means to return results described as good or neutral (66% parents, 100% adolescents) but more participants wished face-to-face disclosure of results with negative implications (50% parents, 60% adolescents). Very few wanted results disseminated through a Web site. The majority acknowledged the need for peer-review before disclosure (60% of adolescents and parents) but did not want "to be the last to know." CONCLUSIONS: Our data suggest that pediatric oncology patients and parents of children with cancer strongly feel that they have a right to research results, and that they wish to receive these in a timely manner. (shrink)

We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP (...) studies (explanatory trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. We recommend that: (1) the inclusion/exclusion criteria distinction be abandoned; (2) eligibility criteria be explicitly justified; (3) the need for each criterion be assessed when new trials are planned; (4) criteria in phase III trials restricting patient accrual be minimized; and (5) further research be done to assess the impact of criteria on generalizability. (shrink)

In ethics, the use of empirical data has become more and more popular, leading to a distinct form of applied ethics, namely empirical ethics. This 'empirical turn' is especially visible in bioethics. There are various ways of combining empirical research and ethical reflection. In this paper we discuss the use of empirical data in a special form of Reflective Equilibrium (RE), namely the Network Model with Third Person Moral Experiences. In this model, the empirical data consist of the moral experiences (...) of people in a practice. Although inclusion of these moral experiences in this specific model of RE can be well defended, their use in the application of the model still raises important questions. What precisely are moral experiences? How to determine relevance of experiences, in other words: should there be a selection of the moral experiences that are eventually used in the RE? How much weight should the empirical data have in the RE? And the key question: can the use of RE by empirical ethicists really produce answers to practical moral questions? In this paper we start to answer the above questions by giving examples taken from our research project on understanding the norm of informed consent in the field of pediatric oncology. We especially emphasize that incorporation of empirical data in a network model can reduce the risk of self-justification and bias and can increase the credibility of the RE reached. (shrink)

Die allogene Transplantation von Blutstammzellen aus dem Körper von Kindern, die der Spende nicht selbst zustimmen können, in den Körper eines kranken Geschwisterkindes wirft schwierige ethische Fragen auf. Wie kann ein risikobehafteter, fremdnütziger medizinischer Eingriff ethisch gerechtfertigt werden? In dieser Arbeit werden Argumente kritisch untersucht, nach denen das Spenderkind eine Pflicht habe, bei der Transplantation mitzumachen. Die Idee der Pflicht ist nachvollziehbar aus der Perspektive der Eltern, die zwar in einem Fürsorgekonflikt sind (ein Kind zu Gunsten der Rettung des anderen (...) verletzen zu müssen), aber selbst eine Pflicht haben, für das Leben des kranken Kindes zu kämpfen. Eine Analyse des Pflichtbegriffs zeigt jedoch, dass die Erfüllung einer Pflicht daran gebunden ist, entscheidungskompetent zu sein. Drei Wege werden untersucht, eine solche Pflicht dennochzuzuschreiben: i) die Eltern übertragenihre Pflicht auf das Kind; ii) die Interessen des Spenderkindes implizieren eine Pflicht; iii) Geschwisterkinder haben aufgrund ihrer vertrauten Familienbeziehungen Pflichten untereinander, die auch die Pflicht zu spenden beinhalten. Alle drei Zuschreibungsstrategien werden als unhaltbar kritisiert. Das Ergebnis lautet, dass die Pflicht, einem Geschwisterkind Körpergewebe zu spenden, einem nicht-einwilligungsfähigen Kind nicht zugeschrieben werden kann. Andere philosophische Ansätze zur Stammzellspende von Kindern an Familienangehörige müssten entwickelt und geprüft werden. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Advocates, Not Problem ParentsAnonymous TwoNothing could have prepared us for the shock of hearing that our son had a brain tumor.Rob* was 13½, an active, healthy eighth grader, when he developed a headache so bad he couldn’t get out of bed in the morning. We saw the pediatrician three times over the next ten days. On the third visit, after ruling out problems at home, stress at school, strep (...) throat and mono, he sent us for an MRI. When the radiology tech handed me the films and told us to drive back to the pediatrician’s office, I knew we were in trouble. Sure enough, after all the other patients had left, our long–time doctor called us into his tiny office, shut the door and fumbled with the films as he pointed to a white spot that he said was a brain tumor.So began the experience that would change the course of our lives. We remember the diagnosis in detail and relive it in slow motion. We recall packing suitcases, driving to the hospital, waiting to be seen in the emergency room, and walking through doors marked “Pediatric Hematology/Oncology” for the first time.We date everything “BC” (Before Cancer) or “AD” (After Diagnosis). We are grateful every day that [End Page 13] our son is alive, but we know he is forever changed. We are changed: Our nuclear family, our extended family, everyone who knew us and supported us at the time was affected. A pediatric cancer diagnosis is a bomb that shatters your world without warning. If you’re lucky, you can pick up a lot of the pieces, maybe even most of them, but the world you re–enter is never the one you inhabited before.Our doctor delivered the diagnosis to Rob and me at the same time. I’ve thought about this many times and perhaps one day will ask him: Why did he choose to do it that way? Was it a conscious decision or just happenstance? Was it kinder, in the long run—like pulling off a band–aid quickly—or terribly risky? What if I had collapsed at the news? I asked to step into the hall to use the phone. In a state of numbness, I called my husband. He knew we had had an MRI a few hours earlier. “Come quickly,” I said. “There’s a mass.”We chose to go to a top-ranked major medical center and were admitted that evening. A couple of days later, the discovery of tumor markers in Rob’s cerebrospinal fluid and blood confirmed a central nervous system mixed germ cell tumor. We were told he would require six cycles of chemotherapy, followed by six weeks of radiation, and possibly second–look surgery and high-dose chemo with stem cell rescue on top of that. We were given a consent form listing a catalogue of short–and long–term side effects, among them the likelihood of infertility. We were urged to start treatment as soon as possible.By sheer coincidence I had just completed a project for a small, nonprofit organization that existed to inform young adult cancer patients about their fertility rights and options. I knew that infertility concerns were usually pushed aside at diagnosis to make way for other priorities, namely the urgency of starting treatment. And that’s exactly the kind of pressure we were facing.But my husband and I were not ready to sign away our son’s fertility in what felt like a no–confidence vote, a capitulation. We needed to believe that he would survive and put this horror behind him, that he would look forward to marriage and starting a family. We were willing to cede nothing to the disease at this early stage of the game. Was this rational, naive or selfish on our part? I don’t know.The medical team seemed surprised when we asked for a delay in treatment in order to collect sperm samples. They warned that our son’s condition could decline suddenly—and that postponing treatment by even several days might be dangerous. However, at our insistence, they agreed to the delay... (shrink)

The National Cancer Institute’s Thesaurus (NCIT) has been created with the goal of providing a controlled vocabulary which can be used by specialists in the various sub-domains of oncology. It is intended to be used for purposes of annotation in ways designed to ensure the integration of data and information deriving from these various sub-domains, and thus to support more powerful cross-domain inferences. In order to evaluate its suitability for this purpose, we examined the NCIT’s treatment of the kinds (...) of entities which are fundamental to an ontology of colon carcinoma. We here describe the problems we uncovered concerning classification, synonymy, relations and definitions, and we draw conclusions for the work needed to establish the NCIT as a reference ontology for the cancer domain in the future. (shrink)

Coronavirus disease 2019 can lead to respiratory failure. Some patients require extracorporeal membrane oxygenation support. During the current pandemic, health care resources in some cities have been overwhelmed, and doctors have faced complex decisions about resource allocation. We present a case in which a pediatric hospital caring for both children and adults seeks to establish guidelines for the use of extracorporeal membrane oxygenation if there are not enough resources to treat every patient. Experts in critical care, end-of-life care, bioethics, (...) and health policy discuss if age should guide rationing decisions. (shrink)

The image of “the good nurse” is mainly studied from the perspective of nurses, which often does not match the image held by patients. Therefore, a descriptive study was conducted to examine oncology patients’ perceptions of “the good nurse” and the influence of patient- and context-related variables. A cross-sectional, comparative, descriptive design was used. The sample comprised 557 oncology patients at one of six Flemish hospitals, where they were treated in an oncology day-care unit, oncology hospital (...) ward, or palliative care unit. Data were collected using the Flemish Care-Q instrument. Factor analysis summarised the most important characteristics of “the good nurse”. We reassessed the reliability and construct validity of the Flemish Care-Q and examined the influence of patient- and context-related variables on patient perceptions. Using factor analysis, we grouped the different items of the Flemish Care-Q according to three characteristics: “the good nurse” (I) has a supportive and communicative attitude towards patient and family, (II) is competent and employs a professional attitude, and (III) demonstrates personal involvement towards patient and family. Median factor scores of Factors I, II, and III, respectively, were 8.00, 9.00, and 8.00 (varying from 1, not important, to 10, very important). In order of importance, Factors II, I, and III were identified as valuable characteristics of “the good nurse”. Gender, care setting, and province were influential variables. As perceived by oncology patients, “the good nurse” has a broad range of qualities, of which competence and professionalism are the most valuable. (shrink)

This paper describes a practice innovation: the addition of formal weekly discussions of patients with prolonged PICU stay to reduce healthcare providers’ moral distress and decrease length of stay for patients with life-threatening illnesses. We evaluated the innovation using a pre/post intervention design measuring provider moral distress and comparing patient outcomes using retrospective historical controls. Physicians and nurses on staff in our pediatric intensive care unit in a quaternary care children's hospital participated in the evaluation. There were 60 patients (...) in the interventional group and 66 patients in the historical control group. We evaluated the impact of weekly meetings to establish goals of care for patients with longer than 10 days length of stay in the ICU for a year. Moral distress was measured intermittently and reported moral distress thermometer scores fluctuated. "Clinical situations" represented the most frequent contributing factor to moral distress. Post intervention, overall moral distress scores, measured on the moral distress scale revised, were lower for respondents in all categories, and on three specific items. Patient outcomes before and after PEACE intervention showed a statistically significant decrease in PRISM indexed LOS, a statistically significant increase in both code status changes DNR, and in-hospital death, with no change in patient 30 or 365 day mortality. The addition of a clinical ethicist and senior intensivist to weekly inter-professional team meetings facilitated difficult conversations regarding realistic goals of care. The study demonstrated that the PEACE intervention had a positive impact on some factors that contribute to moral distress and can shorten PICU length of stay for some patients. (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.

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)

The return of individual research results to participants raises many socio-ethical issues and is even more challenging when the participant is a child. The objective of this article is to present an overview of the few ethical guidelines and relevant literature addressing the return of individual results in pediatric research. By reviewing policies and the literature, we present some overarching considerations and delineate contextual issues in order to propose a framework.

As a matter of respect for the person, it is considered an ethical duty to offer to return research results to participants where appropriate. Nevertheless, the return of individual research results to participants raises many socio-ethical issues and greater challenges when the participant is a child. This discrepancy arises partly because the return of individual pediatric research results entails a tripartite relationship between researcher, child, and parent and is embroiled in numerous considerations.Extra caution is required in the pediatric (...) research context because children cannot generally decide whether they want to be informed of their own research results or whether the results should be disclosed to parents. Children have long been considered a special and vulnerable group, and their parents, as guardians, play a critical role in the consent process. However, with regards to the return of individual research results, this might pose a potential conflict of interest between the current or future desires of the child and those of the parents. (shrink)

Dystonia is a movement disorder that can have a debilitating impact on motor functions and quality of life. There are 250,000 cases in the United States, most with childhood onset. Due to the limited effectiveness and side effects of available treatments, pediatric deep brain stimulation has emerged as an intervention for refractory dystonia. However, there is limited clinical and neuroethics research in this area of clinical practice. This paper examines whether it is ethically justified to offer pDBS to children (...) with refractory dystonia. Given the favorable risk-benefit profile, it is concluded that offering pDBS is ethically justified for certain etiologies of dystonia, but it is less clear for others. In addition, various ethical and policy concerns are discussed, which need to be addressed to optimize the practice of offering pDBS for dystonia. Strategies are proposed to help address these concerns as pDBS continues to expand. (shrink)

Neuroimaging has provided insight into numerous neurological disorders in children, such as epilepsy and cerebral palsy. Many clinicians and investigators believe that neuroimaging holds great promise, especially in the areas of behavioral and cognitive disorders. However, concerns about the risks of various neuroimaging modalities and the potential for misinterpretation of imaging results are mounting. Imaging evaluations also raise questions about stigmatization, allocation of resources, and confidentiality. Children are particularly vulnerable in this milieu and require special attention with regards to safety (...) guidelines and modality adaptations. This article examines pediatric neuroimaging practice through an ethics lens. Most authors in the field of neuroethics focus on the future concerns of neuroimaging. In contrast, our paper examines ethical matters surrounding current clinical applications in the pediatric population. We first provide a brief overview of the neuroimaging technologies most commonly used in a pediatric clinical context and then discuss a variety of ethical issues arising from the use of these technologies. (shrink)

This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human (...) Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)