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)

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)

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)

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.

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.

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.

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.

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)

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...

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)

Recent advances in next generation sequencing along with high hopes for genomic medicine have inspired interest in genomic research with the newly dead. However, applicable law does not adequately determine ethical or policy responses to such research. In this paper we propose that such research stands at a crossroads between other more established biomedical clinical and research practices. In addressing the ethical and policy issues raised by a particular research project within our institution comparatively with these other practices, we illustrate (...) the moral significance of paying careful heed to where one looks for guidance in responding to ethical questions raised by a novel endeavor. (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)

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)

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.

The British Medical Association has published a new report on health and human rights in immigration detention in the UK. Locked up, locked out outlines how aspects of current detention policies and practices are detrimental to the health of those detained and the challenges doctors face in providing healthcare in the immigration detention setting. It makes a number of recommendations aimed at addressing policy and practice which impact on health and well-being, including calling for an end to the routine use (...) of detention as a means of monitoring those facing removal from the UK and for the introduction of a time limit on the length of time individuals can be detained. It also provides guidance for doctors working in these settings on some of the common ethical and professional dilemmas they may face. The report can be accessed and downloaded at www.bma.org.uk/immigrationdetention. The Government has announced its intention to review mental health legislation for England and, in relation to non-devolved issues, for Wales.1 The Government states that it is ‘committed to delivering parity of esteem between mental and physical health’, although it does not clarify the meaning of ‘parity of esteem’. Similarly, the Government states that it wants to ensure that people with mental health problems ‘are treated with dignity, and that their liberty and autonomy is respected as far as possible’. Again, the Government has not indicated the meaning of ‘as far as possible’. Although not directly mentioned in the review’s terms of reference, it must be set against the background of changing legal and ethical expectations in relation to the rights of those with mental or cognitive disorders and disabilities. The UK is a signatory to the United Nations Convention on the Rights of People with …. (shrink)

Erdoğan intensifies assault on Turkish civil society Deeply worrying reports from the Turkish Medical Association suggest that the Turkish President Recep Erdoğan is hardening his attack on civil society in Turkey, using the legitimate activities of the TTB as the flimsiest of pretexts. In January 2018, the TTB issued a short statement raising concerns about the impact on public health of Turkey’s military operation in the Kurdish-controlled region of northern Syria. It denounced the operation saying ‘No to war, peace immediately’. (...) In response to the Association’s press release, the Turkish president publicly accused the 83 000 strong TTB of being terrorist sympathisers. ‘This institution has nothing to do with Turkishness and nothing about them is worthy of the notion of Turkishness’, he said. 1 Eleven of its senior doctors, including the Association’s chairman, were later detained following an order from a Turkish prosecutor. President Erdoğan made it... (shrink)

Essex University, in association with Johns Hopkins Center for Public Health and Human Rights, has brought out a timely report highlighting the increasing global criminalisation of the provision of healthcare.1 The report, with a foreword by Professor Dainius Puras, United Nations Special Rapporteur on the right to health, explores the pressures on medical impartiality arising in large part from both global and national responses to the threat of terrorism. Both international humanitarian law, human rights law and long-established principles of medical (...) ethics—as set out in various declarations of the World Medical Association—establish an absolute principle that all people, regardless of their beliefs, affiliation or status, have rights of access to appropriate healthcare. And this right extends to wounded and sick combatants, as well as civilians, during times of armed conflict. One of the challenges in this area is that in recent years, many conflicts have become ‘asymmetric’. Contemporary conflicts seldom involve opposing state armies. Instead, they increasingly involve irregular combatants, often labelled ‘terrorists’ or ‘insurgents’ by the states they are opposing. In response to these threats, many states have developed sometimes draconian legislation outlawing terrorist groups and those offering support. The danger, outlined in some detail in the report, is that the vital distinction between the impartial provision of medical care and the criminal offence of materially aiding terrorism is lost. In 2016, largely in response to the deliberate targeting of healthcare personnel and facilities in the conflicts disfiguring the greater Middle …. (shrink)

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)

In April, the UK House of Commons Science and Technology committee published a report evaluating the readiness of the National Health Service to incorporate genomic testing into mainstream service provision.1 The committee also examined some of the research and regulatory considerations in relation to the ongoing development of genome editing. ### Genomics in the NHS The main focus of the report is the 100,000 Genomes Project and the various practical and ethical challenges associated with the planned roll-out of the Genomics (...) Medicine Service in the NHS. The 1 00 000 Genomes Project was launched in 2012 and is the first large-scale whole genome sequencing research study of its kind in the world. The overall objective is to sequence genomes from NHS patients with a rare disease and their families, and from patients with specific cancers. The study seeks to benefit patients by potentially providing a diagnosis, gain new scientific insights, increase public knowledge of genomic medicine, encourage investment, and accelerate the uptake of genomic medicine in the NHS. At the time of writing the project had sequenced over 55 000 genomes and it is expected that the full 1 00 000 will be completed by the end of 2018. Building on the success of the project NHS England announced the establishment of a national NHS Genomic Medicine Service to provide ‘comprehensive and equitable access to the latest in genomic testing and management for the whole country, regardless of condition and where people live.’2 The service is set to be operational this year. The committee acknowledged the range of potential benefits that whole genome sequencing could have for patient care, however it also highlighted that there was a currently a lack of ‘sufficiently unambiguous evidence’ for its …. (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...

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)

Complementary and alternative therapiesThere has long been debate about the degree to which conventional health professionals should work closely with complementary and alternative medicine practitioners, if patients choose treatment from both. Some doctors are trained in conventional and alternative therapies but often, liaison depends on the type of therapy, whether it is regulated by law and whether it supplements conventional methods of diagnosis and treatment or claims to provide an alternative to them. Among the therapies often used by patients to (...) supplement conventional medicine, but which do not claim to have a diagnostic purpose, are aromatherapy, massage, stress therapy, reflexology and hypnotherapy. Chinese medicine and homoeopathy are among those which are not statutorily regulated but claim to provide diagnosis and treatment. Practitioners of conventional medicine are often wary of unregulated treatments that supplant evidence-based therapy—even though not all conventional medicine has been proven by randomised controlled trials.The role of complementary and alternative therapies came under scrutiny in England in February 2010 when the Parliamentary Science and Technology Committee published a critical report on NHS funding for homoeopathy. 1 Focusing on whether government policy on homoeopathy was evidence-based, the Committee found a mismatch between the evidence and policy. Its main conclusion was that the evidence indicates that homoeopathy is not efficacious and does not produce results beyond the placebo effect. The Committee said that explanations for why homoeopathy was thought to work were implausible and that further homoeopathic clinical trials could not be justified. The amount that the NHS actually spends on homoeopathic therapies was left unclear and was subject to varying claims from the Society of Homoeopaths and the Health Minister.2 The Parliamentary report recommended that there should be a clear policy on prescribing placebos, including homoeopathic medicines, but the government has been …. (shrink)