[New KNMG-Code of Conduct for doctors: a guideline for professional conduct]. / Vernieuwde KNMG-Gedragscode voor artsen.

The updated KNMG-Code of Conduct for doctors is a practical and contemporary document. It forms the guideline for the professional conduct of doctors and it provides them support and something to hold on to. This article answers questions such as the status and position of the code of conduct and how it relates to the Dutch Medical Oath. The Medical Oath and the code of conduct are two different documents, each with its own status and positioning, yet they are closely linked. As part of the professional standard, it is important for every doctor to be aware of the code of conduct and to apply it in practice. Discussing the content of the code of conduct among each other is important for the ongoing evolution of the question of how you act as a good doctor.

Views on Early Diagnosis of Alzheimer's Disease Among Dutch Physicians: A Qualitative Interview Study.

BACKGROUND: Hope for future treatments to prevent or slow down dementia motivates researchers to strive for ever-earlier diagnoses of Alzheimer's disease (AD) based on biomarkers, even before symptoms occur. But is a biomarker-based early diagnosis desirable in clinical practice? OBJECTIVE: This study explores the ethical considerations that shape current clinical practice regarding early AD diagnostics and the use of biomarkers. METHODS: In this qualitative study, Dutch physicians were interviewed. Topics included physicians' views concerning early AD diagnosis in persons with no or mild cognitive impairment, physicians' considerations regarding current and expected future practices of early AD diagnosis, the use of biomarkers, and the use of the concepts preclinical and prodromal AD. We analyzed the transcripts using directed content analysis. RESULTS: 15 general practitioners, neurologists, and geriatricians in the Netherlands were interviewed. Most of them interpreted an early AD diagnosis with an early diagnosis of dementia. We identified six clusters of considerations sometimes in favor but most often against pursuing an early AD diagnosis in people with no or mild cognitive impairment that influence physicians' diagnostic decision-making: preferences and characteristics of persons, test characteristics, impact on care, type of setting, disease concepts, and issues on a societal level. CONCLUSION: The discussion concerning an early AD diagnosis based on biomarkers which is widely held in the scientific field, has not entered clinical practice structurally. A biomarker-based early diagnosis does not fit within Dutch physicians' views on what good care for people with no, subjective, or mild cognitive impairment should entail.

Prevention in the age of personal responsibility: epigenetic risk-predictive screening for female cancers as a case study.

Epigenetic markers could potentially be used for risk assessment in risk-stratified population-based cancer screening programmes. Whereas current screening programmes generally aim to detect existing cancer, epigenetic markers could be used to provide risk estimates for not-yet-existing cancers. Epigenetic risk-predictive tests may thus allow for new opportunities for risk assessment for developing cancer in the future. Since epigenetic changes are presumed to be modifiable, preventive measures, such as lifestyle modification, could be used to reduce the risk of cancer. Moreover, epigenetic markers might be used to monitor the response to risk-reducing interventions. In this article, we address ethical concerns related to personal responsibility raised by epigenetic risk-predictive tests in cancer population screening. Will individuals increasingly be held responsible for their health, that is, will they be held accountable for bad health outcomes? Will they be blamed or subject to moral sanctions? We will illustrate these ethical concerns by means of a Europe-wide research programme that develops an epigenetic risk-predictive test for female cancers. Subsequently, we investigate when we can hold someone responsible for her actions. We argue that the standard conception of personal responsibility does not provide an appropriate framework to address these concerns. A different, prospective account of responsibility meets part of our concerns, that is, concerns about inequality of opportunities, but does not meet all our concerns about personal responsibility. We argue that even if someone is responsible on grounds of a negative and/or prospective account of responsibility, there may be moral and practical reasons to abstain from moral sanctions.

Parents' Perspectives on Decisions to Participate in Pediatric Clinical Research: Results From a Focus Group Study With Laypeople.

Knowing why parents decide to consent or dissent to participation of their child in pediatric clinical research is essential to further the ethical debate concerning pediatric research. We performed this qualitative focus group study with 16 parents from the Dutch general public to explore their perspectives on decisions to participate in pediatric clinical research. Group discussion revealed the following: Parents conflate clinical research and clinical care, they do not grasp the trajectory of pediatric drug development, their protectiveness matches current research guidelines, and benefit for their child is the most important factor in their decision. Research professionals should be aware of the knowledge gap of parents, the pitfalls of jargon, and unintended false expectations.

Ethical Arguments Concerning the Use of Alzheimer's Disease Biomarkers in Individuals with No or Mild Cognitive Impairment: A Systematic Review and Framework for Discussion.

BACKGROUND: The shift to defining Alzheimer's disease (AD) as a biological continuum, which is characterized by the presence of biomarkers instead of clinical symptoms, has sparked a widespread debate. Insight into the given arguments and their underlying moral values is crucial to ensure well-considered and appropriate AD biomarker testing in the future. OBJECTIVE: To critically review the arguments in favor of or against AD biomarker testing in people with no or mild cognitive impairment and to explicate their underlying moral values. METHODS: Seven databases were systematically searched for publications mentioning arguments of interest. Arguments are identified using qualitative data-analysis and evaluated within an ethical framework. RESULTS: Our search yielded 3,657 articles of which 34 met the inclusion criteria. We discuss the clusters of arguments separate from their evaluation and the assessment of the debate as a whole. The right to know, which derives from the moral value of respect for autonomy, is a central argument in favor of biomarker testing. On the other hand, fear of the disease and lack of a disease-modifying treatment may result in a negative balance of good over inflicted harms, which argues against its use. CONCLUSION: Critical evaluation and weighing of the given arguments in a specific context, within an ethical framework, demonstrates the necessity to differentiate between what we hope or expect from research and where we currently stand. While AD biomarkers may have an indispensable value for research, the current advantage for clinical practice appears limited.

Motivations of children and their parents to participate in drug research: a systematic review.

UNLABELLED: Information on motivations for research participation, may enable professionals to better tailor the process of recruitment and informed consent to the perspective of parents and children. Therefore, this systematic review assesses motivating and discouraging factors for children and their parents to decide to participate in clinical drug research. Studies were identified from searches in 6 databases. Two independent reviewers screened and selected relevant articles. Results were aggregated and presented by use of qualitative metasummary. 38 studies fulfilled the selection criteria and were of sufficient quality for inclusion in the qualitative metasummary. Most mentioned motivating factors for parents were: health benefit for child, altruism, trust in research, and relation to researcher. Most mentioned motivating factors for children were: personal health benefit, altruism and increasing comfort. Fear of risks, distrust in research, logistical aspects and disruption of daily life were mentioned most by parents as discouraging factors. Burden and disruption of daily life, feeling like a "guinea pig" and fear of risks were most mentioned as discouraging factors by children. CONCLUSION: Paying attention to these motivating and discouraging factors of children and their parents during the recruitment and informed consent process in drug research increases the moral and instrumental value of informed consent. WHAT IS KNOWN: • This systematic review pools the existing empirical literature on motivations of minors and their parents to consent or dissent to participation in clinical drug research. • The most mentioned motivating and discouraging factors for children and their parents to consent to participation in clinical drug research are identified aggregated and presented by use of qualitative metasummary. What is new: • This information can be used to adapt the research protocol, recruitment, and informed consent/assent process to the needs of children and their parents.

[Ethical aspects of clinical drug research in critically ill children]. / Ethische aspecten van geneesmiddelenonderzoek bij kritisch zieke kinderen.

All critically ill children admitted to a paediatric intensive care unit (PICU) receive drug treatment. However, the majority of these drugs has never been tested in these children, and their safety and efficacy have not been proven. Clinical drug research is therefore required in this patient group. While doing this research we need to balance between the advancement of knowledge--and thereby potential improvements in clinical care--and protection of a vulnerable population against harm and exploitation. The PICU environment and the vulnerable population raise specific ethical challenges and mean that the research should be designed and conducted with care. The ethical challenges are related to 4 areas: a) study design and conduct; b) informed consent from parents and children; c) burden and risk for the child; and d) research or experimental treatment. These challenges and possible solutions will be discussed in this article.

Ethics of drug research in the pediatric intensive care unit.

Critical illness and treatment modalities change pharmacokinetics and pharmacodynamics of medications used in critically ill children, in addition to age-related changes in drug disposition and effect. Hence, to ensure effective and safe drug therapy, research in this population is urgently needed. However, conducting research in the vulnerable population of the pediatric intensive care unit (PICU) presents with ethical challenges. This article addresses the main ethical issues specific to drug research in these critically ill children and proposes several solutions. The extraordinary environment of the PICU raises specific challenges to the design and conduct of research. The need for proxy consent of parents (or legal guardians) and the stress-inducing physical environment may threaten informed consent. The informed consent process is challenging because emergency research reduces or even eliminates the time to seek consent. Moreover, parental anxiety may impede adequate understanding and generate misconceptions. Alternative forms of consent have been developed taking into account the unpredictable reality of the acute critical care environment. As with any research in children, the burden and risk should be minimized. Recent developments in sample collection and analysis as well as pharmacokinetic analysis should be considered in the design of studies. Despite the difficulties inherent to drug research in critically ill children, methods are available to conduct ethically sound research resulting in relevant and generalizable data. This should motivate the PICU community to commit to drug research to ultimately provide the right drug at the right dose for every individual child.

Ethical aspects of clinical research with minors.

Over the past decades, clinical research has increasingly been subjected to ethical requirements and legal regulation. The specific focus of ethical and legal frameworks on competent adults (which serve as the paradigmatic research subject), however, has created an ambivalent attitude towards pediatric clinical research. On one hand, minors are regarded as a vulnerable population that deserves additional protection against the risks and burdens involved in clinical research. On the other hand, the population of minors should not be denied (or not get timely) access to the benefits of clinical research. In this paper, we will explore the legal regulation and ethical guidance that currently governs pediatric clinical research in the European Union and discuss the future challenges in this field. In addition, we will discuss major ethical concerns in pediatric clinical research, with a focus on the acceptability of research risks and the informed consent process. In the discussion, we will address key concerns in both regulating pediatric clinical research and implementing ethical and legal requirement in the actual pediatric research conduct.