Explore the vast range of titles available.

This paper discusses the potential harms involved in biobank research and how ethical review, informed consent, withdrawals, and anonymization of samples should be handled in the light of these harms. There is less risk involved in biobank research than in human subject research; it should therefore be treated differently. In our view, anonymization should not be an automatically permissible response to requests for withdrawal. Nor should a request for withdrawal necessarily stop research on identifiable samples. Apart from not being particularly appropriate for protecting the interests of individuals, anonymization of samples has a negative impact on research. We suggest that the current view on withdrawal from research, supported by the Declaration of Helsinki and subsequent ethical guidelines, be abandoned in the context of biobank research and be replaced by an approach inspired by the Nuremberg Code. This approach requires those wishing to withdraw their samples from research to present sufficient reason for doing so. Our interpretation of ‘sufficient reason’ includes all those involving genuine, deeply felt concerns that are not based on misconceptions. Still, this underlines the fact that we all share a responsibility for health research and that no one should take withdrawal from biobank research lightly.

Background For many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Discussion Although assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Summary Previous research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated.

Objectives. To examine the relation of vaccine refusal and medical neglect under child welfare laws. Methods. We used the Westlaw legal database to search court opinions from 1905 to 2016 and identified cases in which vaccine refusal was the sole or a primary reason in a neglect proceeding. We also delineated if religious or philosophical exemptions from required school immunizations were available at the time of adjudication. Results. Our search yielded 9 cases from 5 states. Most courts (7 of 9) considered vaccine refusal to constitute neglect. In the 4 cases decided in jurisdictions that permitted religious exemptions, courts either found that vaccine refusal did not constitute neglect or considered it neglect only in the absence of a sincere religious objection to vaccination. Conclusions. Some states have a legal precedent for considering parental vaccine refusal as medical neglect, but this is based on a small number of cases. Each state should clarify whether, under its laws, vaccine refusal constitutes medical neglect.

•Given the rising rates of nonmedical exemptions from school immunizations and associated outbreaks of vaccine-preventable diseases, we examine trends in state policies aimed at reducing these rates.•We describe ethical and practical problems with current policies.•We examine efforts by states to incorporate vaccination education into exemption procedures.•In addition to educational initiatives, there are several possible remedies that could be employed by state governments interested in curbing rates of nonmedical exemptions outlined here. Parents of school-age children are increasingly claiming nonmedical exemptions to refuse vaccinations required for school entry. The resultant unvaccinated pockets in many areas of the country have been linked with outbreaks of vaccine-preventable diseases. Many states are now focused on reducing rates of nonmedical exemptions by making exemption processes more restrictive or burdensome for the exemptor. These strategies, however, pose ethical problems and may ultimately be inadequate. A shift to strategies that raise the financial liabilities of exemptors may lead to better success and prove ethically more sound. Potential areas of reform include tax law, health insurance, and private school funding programs. We advocate an approach that combines this type of incentive with more effective vaccination education.

However well intentioned, working in detention centres amounts to complicity in torture, says David Berger, but Steven Miles thinks that there are better ways to take action

ObjectivesWe set out to investigate paramedics’ views of ethics and research, drawing on experiences from Paramedic-2, a randomised controlled trial comparing epinephrine and placebo in out-of-hospital cardiac arrest (OHCA).MethodsAn interpretative phenomenological approach was adopted. A purposive sample of paramedics (n=6) from North East Ambulance Service NHS Foundation Trust were invited to a semi-structured, in-depth interview.ResultsThree superordinate themes emerged: (1) morality, (2) emotion and (3) equipoise. Some viewed Paramedic-2 as an opportunity to improve OHCA outcomes for the many, viewing participation as a moral obligation; others viewed the study as unethical, equating participation with immoral behaviour. Morality was a motivator to drive individual action. Positive and negative emotions were exhibited by the paramedics involved reflecting the wider view each paramedic held about trial participation. Those morally driven to participate in Paramedic-2 discussed their pride in being associated with the trial, while those who found participation unethical, discussed feelings of guilt and regret. Individual experience and perceptions of epinephrine guided each paramedic’s willingness to accept or reject equipoise. Some questioned the role of epinephrine in OHCA; others believed withholding epinephrine was synonymous to denying patient care.ConclusionA paucity of evidence exists to support any beneficial role of epinephrine in OHCA. Despite this, some paramedics were reluctant to participate in Paramedic-2 and relied on their personal perceptions and experiences of epinephrine to guide their decision regarding participation. Failure to acknowledge the importance of individual perspectives may jeopardise the success of future out-of-hospital trials.

AimTo examine the views of Guinean lay people and healthcare providers (HCPs) regarding the acceptability of HCPs’ refusal to provide care to Ebola patients.MethodFrom October to December 2015, lay people (n=252) and HCPs (n=220) in Conakry, Guinea, were presented with 54 sample case scenarios depicting a HCP who refuses to provide care to Ebola patients and were instructed to rate the extent to which this HCP’s decision is morally acceptable. The scenarios were composed by systematically varying the levels of four factors: (1) the risk of getting infected, (2) the HCP’s working conditions, (3) the HCP’s family responsibilities and (4) the HCP’s professional status.ResultsFive clusters were identified: (1) 18% of the participants expressed the view that HCPs have an unlimited obligation to provide care to Ebola patients; (2) 38% held that HCPs’ duty to care is a function of HCPs’ working conditions; (3) 9% based their judgments on a combination of risk level, family responsibilities and working conditions; (4) 23% considered that HCPs do not have an obligation to provide care and (5) 12% did not take a position.ConclusionOnly a small minority of Guinean lay people and HCPs consider that HCPs’ refusal to provide care to Ebola patients is always unacceptable. The most commonly endorsed position is that HCPs’ duty to provide care to Ebola patients is linked to society’s reciprocal duty to provide them with the working conditions needed to fulfil their professional duty.

Mass vaccination has been a successful public health strategy for many contagious diseases. The immunity of the vaccinated also protects others who cannot be safely or effectively vaccinated—including infants and the immunosuppressed. When vaccination rates fall, diseases like measles can rapidly resurge in a population. Those who cannot be vaccinated for medical reasons are at the highest risk of severe disease and death. They thus may bear the burden of others' freedom to opt out of vaccination. It is often asked whether it is legitimate for states to adopt and enforce mandatory universal vaccination. Yet this neglects a related question: are those who opt out, where it is permitted, morally responsible when others are harmed or die as a result of their decision? In this article, we argue that individuals who opt out of vaccination are morally responsible for resultant harms to others. Using measles as our main example, we demonstrate the ways in which opting out of vaccination can result in a significant risk of harm and death to others, especially infants and the immunosuppressed. We argue that imposing these risks without good justification is blameworthy and examine ways of reaching a coherent understanding of individual moral responsibility for harms in the context of the collective action required for disease transmission. Finally, we consider several objections to this view, provide counterarguments and suggest morally permissible alternatives to mandatory universal vaccination including controlled infection, self-imposed social isolation and financial penalties for refusal to vaccinate.

Both researchers and clinicians are increasingly offering genomic testing for children and adolescents, a practice which parents have generally endorsed in numerous studies. By contrast, much less effort has been devoted to understanding what minors think about genetic and genomic testing. While a small number of investigators have shown that minors with or at risk for cancer generally concur with their parents and favor testing, other studies reveal that minors are less willing to participate in genomics research. Regardless, genetic and genomic testing of minors raises of host of potential legal questions. Key issues are: (1) To what extent can minors obtain genomic tests without involvement of parents or guardians? (2) To what extent can minors refuse genomic testing? and (3) To what extent can minors obtain their own results, keep their parents from getting access to them, and limit what their parents do with their genomic test results? While a number of authors have written about legal issues in genetic testing of minors, remarkably little has been written about the legal protections of minors’ choices about genomic analysis and return of results.

In a scholarly analysis of widely held misconceptions, Gilovich provides a classification scheme of common flaws in reasoning seen in contemporary society. He broadly categorizes these flaws as having cognitive determinants or in having motivational and social determinants. In this survey, the authors examine the various claims against routine childhood and adult vaccines as made by the more public and more organized entities of the anti-vaccine movement as well as those made apparent by surveys of parents and other groups of individuals. The claims illustrate the breadth of reasoning flaws while providing a basis for anticipating and correcting them.