Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (...) (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their own research participation and cited factors that would influence their own decision to participate in, or to provide parental authorization for their child to participate in health research. Results: Completed questionnaire rates for AYAs and parents were 86 (46.5%) of 185 and 409 (65.2%) of 627, respectively. AYAs (n = 86 [67%]) and parents (n = 409 [85%]) cited that they would participate in research because it would help others. AYAs perceived pressure by their family and friends (16%) and their physician (19%). Having too much to think about at the time of accrual was an impediment to both groups (36% AYAs and 47% parents). The main deterrent for AYAs was that research would take up too much time (45%). Nonwhite parents (7 of 56 [12.5%]) were more apt to decline than white parents (12 of 32 [3.7%]; P < .01). Conclusions: AYAs identified time commitment and having too much to think about as significant impediments to research participation. Addressing these barriers by minimizing time requirements and further supporting decision-making may improve informed consent and impact on enrollment in trials. (shrink)

PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants. METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the results; reasons for and against (...) providing results; and barriers to providing results. RESULTS: Four hundred nine parents (including 19 of deceased children) and 86 adolescents responded. Most parents (n = 385; 94.2%) felt that they had a strong right to research results. For positive results, most wanted a letter or e-mail summary (n = 238; 58.2%) or a phone call followed by a letter (n = 100; 24.4%). If the results were negative, phone call (n = 136; 33.3%) or personal visits (n = 150; 36.7%) were preferred. Parents wanted the summary to include long-term sequelae and suggestions for participants (n = 341; 83.4%), effect on future treatments (n = 341; 83.4%), and subsequent research steps (n = 284; 69.5%). Understanding the researcher was a main concern about receiving results (n = 145; 35.5%). Parents felt that results provide information to support quality of life (n = 315; 77%) and raise public awareness of research (n = 282; 68.9%). Adolescents identified similar preferences. CONCLUSION: Parents of children with cancer and adolescents with cancer feel strongly that they have a right to be offered research results and have specific preferences of how and what information should be communicated. (shrink)

In May 2011, more than a decade after the International Association of Athletics Federations (IAAF) and the International Olympic Committee (IOC) abandoned sex testing, they devised new policies in response to the IAAF's treatment of Caster Semenya, the South African runner whose sex was challenged because of her spectacular win and powerful physique that fueled an international frenzy questioning her sex and legitimacy to compete as female. These policies claim that atypically high levels of endogenous testosterone in women (caused by (...) various medical conditions) create an unfair advantage and must be regulated. Against the backdrop of Semenya's case and the scientific and historical complexity of ?gender verification? in elite sports, we question the new policies on three grounds: (1) the underlying scientific assumptions; (2) the policymaking process; and (3) the potential to achieve fairness for female athletes. We find the policies in each of these domains significantly flawed and therefore argue they should be withdrawn. (shrink)

Some research is too risky to be conducted on anyone whose life expectancy is more than a few hours. Yet sometimes, the research can still be carried out using subjects who are brain dead or are soon to undergo a terminal wean, and who have articulated values that inclusion in the study can honor. So argues a team of ethicists and researchers at M.D. Anderson Cancer Center, where such research was recently undertaken.

Access to investigational drugs is a concern to patients and regulatory agencies. In order to determine potential trial participants’ views on access to investigational drugs, we surveyed one hundred people who had been referred to a phase I clinical trial. Most respondents indicated that patients had a right to investigational drugs, that the drugs should be offered only in the context of research, that getting access to these drugs is too hard, and that knowing the right people and being persistent (...) increased the likelihood of gaining access. Respondents did not think that investigational drugs should be given to anyone who wanted them, or that physicians were aware of the latest investigational agents. They most frequently recommended two allocation criteria: offering investigational drugs to those who would benefit most or were most needy; and allocating them to maximize scientific advancement. Respondents who understood the purpose of the trial were more likely to choose the second criterion. (shrink)

Even appropriate, ethically sound recommendations can generate angst. In this case, the principal investigator is concerned about the ethics consult recommendation to not inform the participan...

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.

The child was 2 years, 8 months old and weighed 25 pounds, one-fifth the weight of her mother, for whom she was to be the bone marrow donor. The mother had suffered a relapse of acute myelogenous leukemia; her physicians recommended a bone marrow transplant. The child was the closest human leukocyte antigen match and thus the best donor candidate for her mother's transplant.

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial (...) protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. (shrink)

BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation (...) of important information in consent forms for these trials.MethodsThe study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.ConclusionsDesigning consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding. (shrink)

In August, Amnesty International and the World Medical Association expressed concern at reports that a judge in Saudi Arabia had asked several hospitals in the country whether they could perform an operation to damage a man's spinal cord as punishment for attacking another man and leaving him paralysed. The man had already been sentenced to seven months imprisonment for the crime, the injured victim requested the further sentence under Sharia Law, which is strictly enforced across Saudi Arabia. According to reports, (...) one of the hospitals approached declined on ethical grounds. Another hospital stated that it was possible to damage the spinal cord in the way requested, but that the procedure would have to be done at a specialised hospital. 1In its statement, Amnesty International urged the authorities not to carry out the sentence, which it argued would be a grave violation of international human rights law and contravene the United Nations convention against Torture, to which Saudi Arabia is a state party. 2 The WMA expressed its support for the physicians who refused to carry out the request by the Saudi court, participation in which would constitute a severe breach of medical ethics. 3 The WMA reminded doctors that the Declaration of Tokyo clearly states that no physician should participate in the practice of torture or any other forms of cruel, inhuman or degrading procedures, whatever the offence of which the victim of such procedures is suspected, accused or guilty of. The Declaration also includes a prohibition of participation in the planning or advising for such a procedure. NHS white paperIn July 2010 the government published a White Paper outlining its plans to transform the delivery of National Health Services in England. 4 The White Paper has been described as ‘one of the biggest shake ups of the health system …. (shrink)

Psychiatry uncomfortably spans biological and psychosocial perspectives on mental illness, an idea central to Engel's biopsychosocial paradigm. This paradigm was extremely ambitious, proposing new foundations for clinical practice as well as a non-reductive metaphysics for mental illness. Perhaps given this scope, the approach has failed to engender a clearly identifiable research programme. And yet the view remains influential. We reassess the relevance of the biopsychosocial paradigm for psychiatry, distinguishing a number of ways in which it could be (re)conceived.

Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria, were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression program through the (...) National Institutes of Health aims to collect large numbers of diverse human tissues with the eventual goal of elucidating the genetic bases of common diseases through a better understanding of the relationship between genetic variation and gene expression. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority . Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed clinics. Medical information and (...) information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18 . This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes shou...

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...) the adverse events they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. (shrink)

First Published in 2002. Routledge is an imprint of Taylor & Francis, an informa company.

In February 2014, the Belgian Parliament passed legislation allowing euthanasia for terminally ill children of all ages by 86 votes to 44, with 12 abstentions. The Bill became law in early March after being signed by the King, making Belgium the first country in the world to abolish age restrictions for euthanasia. Previously, the youngest age at which euthanasia was permitted was 12 years old in The Netherlands.1Euthanasia was legalised in Belgium in 2002, and the new legislation introduces amendments to (...) the law extending euthanasia to minors in certain circumstances. Euthanasia is now permissible for children of all ages where the child has a “terminal and incurable illness”, experiences “constant and unbearable physical suffering”, and death is expected to occur within a “brief period”. The child must be deemed capable of making the decision, and have the agreement of their parents.Belgian law sets no timetable for euthanasia from the point at which the patient first expresses a wish to die. As with adults seeking euthanasia, any request must be made in writing. A physician and “outsider” brought in to give a second opinion must agree upon the diagnosis and prognosis, and a paediatric psychiatrist or psychologist must certify in writing that the child possesses “the capacity of discernment”. Following this, the child's physician must meet with the parents to inform them of the outcome of the consultation and ensure they are in agreement with the child's request. The child and the family must receive psychological care and support if so desired.The move provoked heated debate and divided the medical, legal and political professions in Belgium. A group of 160 of the country's paediatricians opposed a change in the law, citing concerns about the largely subjective assessment of the “capacity of discernment”, and drawing attention to advances in …. (shrink)

With contributions from psychiatry, psychology, neuroscience, and philosophy, this book provides the most comprehensive account to date of the interplay between biological, psychological, and social factors in mental health and their ethical dimensions.

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)

IntroductionThe COVID-19 pandemic required more responsibilities from teachers, including implementing prevention strategies, changes in school policies, and managing their own mental health, which yielded higher dissatisfaction in the field.MethodsA cross-sectional web survey was conducted among educators to collect information on their experiences teaching during the COVID-19 pandemic throughout the 2020–2021 academic year. Qualtrics, an online survey platform, fielded the survey from May 6 to June 8, 2021 to a national, convenience sample of 1,807 respondents.ResultsFindings revealed that overall, 43% of K-12 (...) teachers reported a greater intention to leave the profession than previously recalled prior to the COVID-19 pandemic. Intention to leave was multi-level, and associated with socio-demographic factors, individual factors, and teachers’ agency. We also found demographic disparities with respect to race and gender around teachers’ ability to provide feedback to schools on opening/closing and overall dissatisfaction with school/district COVID-19 prevention strategies implementation and policies.ConclusionThese findings are consistent with the Job-Demand and Resources Model, which posits that lack of organizational support can exacerbate job stressors, leading to burnout. Specifically, dissatisfaction with the way school policies were implemented took a toll on teachers’ mental health, leading to a desire to leave the profession. These findings are also consistent with research conducted once in-person teaching resumed in 2020–2021, specifically that the COVID-19 pandemic exacerbated preexisting teacher shortages that led to self-reported issues of stress, burnout, and retention.ImplicationsFurther research is necessary to understand the resources that may be most useful to reduce the demands of teaching in the context of the COVID-19 pandemic. Some teachers are more likely to leave the field, and educational agencies may wish to target their teacher-retention efforts with emphasis on strong employee wellness programs that help educators to manage and reduce their stress. Education agency staff may wish to review policies and practices to provide meaningful opportunities to give input to school/district decisions and enable proactive communication channels. (shrink)

Volume 20, Issue 8, August 2020, Page W12-W13.

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor’s legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and (...) in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically. (shrink)

Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...) sequencing or analysis of specific genomic conditions or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations. (shrink)

While somatic cell editing to treat disease is widely accepted, the use of human genome editing for “enhancement” remains contested. Scientists and policy-makers routinely cite the prospect of enhancement as a salient ethical challenge for human genome editing research. If preventive genome editing projects are perceived as pursuing human enhancement, they could face heightened barriers to scientific, public, and regulatory approval. This article outlines what we call “preventive strengthening research” (or “PSR”) to explore, through this example, how working to strengthen (...) individuals’ resistance to disease beyond what biomedicine considers to be the human functional range may be interpreted as pursuing human enhancement. Those involved in developing guidance for PSR will need to navigate the interface between preventive goals and enhancement implications. This article identifies and critiques three of these ideas in the interest of anticipating the wider emergence of PSR and the need for a normative approach for its pursuit. All three “candidate criteria” merit attention, but each also faces challenges that will need to be addressed as further research policy is developed. (shrink)

Background: Despite procedural innovations and increasing numbers of uterus transplant attempts worldwide, the perspectives of uterus transplant (UTx) trial participants are lacking. Methods: We conducted a mixed-methods study with women with absolute uterine factor infertility (AUFI). Participants included women who had previously contacted the Cleveland Clinic regarding the Uterine Transplant Trial and met the initial eligibility criteria for participation. In-depth interviews were conducted in conjunction with FertiQoL, a validated and widely used tool to measure the impact of infertility on the (...) quality of life of infertility patients. Results: All (n = 19) rated their overall health as good; some experienced grief and social isolation. AUFI is a life-framing experience that influences acceptance by family, partners, peers, and one’s self. UTx is a means to gain control of reproductive autonomy. UTx allows family-building and the ability to play an active role in prenatal health and well-being. Establishing and maintaining a supportive relationship is a key issue of AUFI and when considering UTx. Risks of UTx are perceived relative to risks to self/child/family posed by adoption/surrogacy. Participants had no overall preference regarding living or deceased donor. Conclusions: The ways in which women with AUFI conceptualize this condition in their lives and choices around UTx and participating in a study of the procedure are multifaceted and textured. These perspectives are critical to understanding its ethical, legal, and social implications. (shrink)

At the time of writing the COVID-19 pandemic was entering its ninth month, with nearly 800 000 recorded fatalities and 22 million infections in 188 countries and territories.1 In previous ethics briefings2 we raised concerns about the possibility that demand for life-sustaining treatment would overwhelm supply, with a consequent requirement for health professionals to make challenging triage decisions. Fortunately, to date, these have largely not been realised, although there is a possibility that countries in which containment measures have been less-successful, (...) such as South Africa, may still be required to triage.3 Despite the successful ‘flattening of the curve’ in many countries, there is a wide consensus that we remain firmly within the pandemic. Enormous practical challenges remain. It is unclear whether the pandemic will ultimately take the form of two or more successive waves, or whether the patchwork of global responses will lead to a sustained slow ‘burn’ with sporadic flare-ups.4 Areas of uncertainty include whether infection confers some immunity, how long any such immunity might last, whether effective vaccines can be developed and if seasonal temperature fluctuations alter the spread of the virus. The pandemic will also be fundamentally shaped by the decisions that governments make and the extent to which their diktats are complied with by citizens. With the – possibly temporary – retreat of urgent clinical ethics issues, such as triage, opportunities have arisen to reflect on some of the ethical questions that underlie and structure the demanding policy decisions that governments are wrestling with. One of the early questions was how to balance the complex constellation of costs and benefits associated with lockdown. Countries that …. (shrink)