Nina Di Pietro

Comments and Reflections on Ethics in Screening for Biomarkers of Prenatal Alcohol Exposure

Early identification of and intervention for fetal alcohol spectrum disorder (FASD) has been shown to optimize outcomes for affected individuals. Detecting biomarkers of prenatal alcohol exposure (PAE) in neonates may assist in the identification of children at risk of FASD enabling targeted early interventions. Despite these potential benefits, complicated ethical issues arise in screening for biomarkers of PAE and these must be addressed prior to the implementation of screening programs. Here, we identify and comment, based on a North American perspective, on concerns raised in the current ethical, social, and legal literature related to meconium screening for PAE. Major ethical concerns revolve around the targeting of populations for PAE screening, consent and respect for persons, stigma and participation rates, the cost-benefit analysis of a screening program, consequences of false-positive and false-negative test results, confidentiality and appropriate follow-up to positive screen results, and the use of screen results for criminal prosecution. We identify gaps in the literature on screening for PAE, most notably related to a lack of stakeholder perspectives (e.g., parents, healthcare providers) about screening and the ethical challenges it presents.

Disclosing incidental findings in brain research: The rights of minors in decision‐making

MRI is used routinely in research with children to generate new knowledge about brain development. The detection of unexpected brain abnormalities (incidental findings; IFs) in these studies presents unique challenges. While key issues surrounding incidence and significance, duty of care, and burden of disclosure have been addressed substantially for adults, less empirical data and normative analyses exist for minors who participate in minimal risk research. To identify ethical concerns and fill existing gaps, we conducted a comprehensive review of papers that focused explicitly on the discovery of IFs in minors. The discourse in the 21 papers retrieved for this analysis amply covered practical issues such as informed consent and screening, difficulties in ascertaining clinical significance, the economic costs and burden of responsibility on researchers, and risks (physical or psychological). However, we found little discussion about the involvement of minors in decisions about disclosure of IFs in the brain, especially for IFs of low clinical significance. In response, we propose a framework for managing IFs that integrates practical considerations with explicit appreciation of rights along the continuum of maturity. This capacity‐adjusted framework emphasizes the importance of involving competent minors and respecting their right to make decisions about disclosure. J. Magn. Reson. Imaging 2013;38:1009–1013.

Rising antipsychotic prescriptions for children and youth: cross-sectoral solutions for a multimodal problem

In the past 10 years, off-label prescribing of antipsychotic medications to Canadian children and youth has risen dramatically despite a lack of strong evidence for efficacy and serious adverse effects.[1][1]–[5][2] According to Canadian pharmacoepidemiologic data, antipsychotic medications have

Evidence-Based Neuroethics for Neurodevelopmental Disorders

Many neurodevelopmental disorders affect early brain development in ways that are still poorly understood; yet, these disorders can place an enormous toll on patients, families, and society as a whole and affect all aspects of daily living for patients and their families. We describe a pragmatic, evidence-based framework for engaging in empiric ethics inquiry for a large consortium of researchers in neurodevelopmental disorders and provide relevant case studies of pragmatic neuroethics. The 3 neurodevelopmental disorders that are at the focus of our research, cerebral palsy (CP), autism spectrum disorder (ASD), and fetal alcohol spectrum disorder (FASD), bring unique and intersecting challenges of translating ethically research into clinical care for children and neonates. We identify and discuss challenges related to health care delivery in CP; neonatal neurological decision making; alternative therapies; and identity, integrity, and personhood.

A Dichotomy of Information-Seeking and Information-Trusting: Stem Cell Interventions and Children with Neurodevelopmental Disorders

Parents and primary caregivers of children with Cerebral Palsy (CP) and Autism Spectrum Disorder (ASD) are faced with difficult treatment choices and management options for their children. The potential of stem cell technologies as an interventional strategy for CP and ASD has gained attention in the last decade. Information about these interventions varies in quality, resulting in a complex landscape for parent decision making for a child’s care. Further complicating this landscape are clinics that advertise these interventions as a legitimate treatment for a fee. In this study, we surveyed individuals who considered taking their child with ASD or CP abroad for stem cell interventions on their use of different sources of stem cell related health information and their level of trust in these sources. Participants reported that while the Internet was their most frequent source of information, it was not well-trusted. Rather, information sources trusted most were researchers and the science journals in which they publish, other parents of children with CP and ASD, and healthcare providers. These findings highlight a dichotomy between information-seeking preferences and information-trusted sources. We discuss the challenges of health science communication and present innovative opportunities to increase communication with trusted and reliable sources as part of an integrated multi-pronged approach.

Disparities in Canadian indigenous health research on neurodevelopmental disorders.

Objective: To map the landscape of research on autism (ASD), cerebral palsy (CP), and fetal alcohol spectrum disorder (FASD) in Canadian Aboriginal children. Method: The authors used a detailed search strategy to identify and access publications on ASD, CP, and FASD involving Canadian Aboriginal children, families, and communities from online databases. They analyzed these materials for the type of research, stated objectives, methodologies, and the level of engagement of Aboriginal Peoples. Results: The authors found a total of 52 reports published since 1981 relevant to Aboriginal children. Of these, 51 focused exclusively on FASD. They also found a near-complete failure to acknowledge community involvement in research decisions or dissemination of results in any of the publications. Conclusions: The focus on FASD in Aboriginal children and the absence of research on the other 2 major childhood disorders are at odds with rates of these disorders across Canadian children. The authors argue that this trend violates fundamental principles ensuring equitable representation of all children regardless of background in research and access to benefits of research in health care and perpetuates stigma in an already marginalized population.

Ethical Challenges in Contemporary FASD Research and Practice.

Fetal alcohol spectrum disorder (FASD) is increasingly recognized as a growing public health issue worldwide. Although more research is needed on both the diagnosis and treatment of FASD, and a broader and more culturally diverse range of services are needed to support those who suffer from FASD and their families, both research and practice for FASD raise significant ethical issues. In response, from the point of view of both research and clinical neuroethics, we provide a framework that emphasizes the need to maximize benefits and minimize harm, promote justice, and foster respect for persons within a global context.

Pediatric Clinical Trial Activity for Antipsychotics and the Sharing of Results: A Complex Ethical Landscape

Abstract There is a recent consensus that more clinical trials are required to assess the safety and efficacy of second-generation antipsychotic medications for children and youth. This shift represents a change in ethical thinking in recent decades. Historically there has been a reluctance to include children and adolescents in medical research due to their vulnerable status; however, this has led to a situation where the benefits of evidence-based medicine have been denied due to inappropriate extrapolation of adult data. This is especially pronounced in relation to antipsychotic medications and children who have psychiatric difficulties. Targeted initiatives have been introduced worldwide to open up clinical trials in pediatric populations. In this chapter, clinical trial registry data are presented in order to characterize the current landscape of clinical trial activity for children and adolescents and antipsychotic medications. These data are summarized and discussed with reference to the ethical considerations.

A Brief History of the Science and Ethics of Antipsychotics and Off-Label Prescribing

Abstract The advent of antipsychotic medications in the mid-twentieth century ushered in a new era of psychopharmacological research and treatment that has benefited countless patients with severe, intractable mental illnesses. Over the years, however, their use to treat a variety of non-psychotic-related conditions has grown steadily, especially in children, despite evidence of unwanted negative side effects and uncertainties about their effectiveness. This chapter introduces the history of antipsychotic development and the controversies that have emerged, both from a scientific and ethical perspective. Although progress is being made, further action is needed to spur research and improve prescribing practices to ensure the safety of children receiving treatment with these powerful medications.

The brain and ethics: an introduction to research in neuroethics

The brain is a complex organ and neuroscientists are using many different methods to try to understand – and perhaps even change – how the human brain works. Before this research can take place; however, researchers must ensure that their work is ethical. In this review article, we introduce the exciting field of neuroethics and describe the three key ethical principles by which all human research studies must abide. We also describe four research studies that neuroethicists at the National Core for neuroethics have carried out to give you an idea of the range of work that is being done by those who are interested in the ethics of neuroscience and the neuroscience of ethics.