The legal ethics of pediatric research (original) (raw)
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Defining the Boundaries of a Right to Adequate Protection: A New Lens on Pediatric Research Ethics
The Journal of medicine and philosophy, 2017
We argue that the current ethical and regulatory framework for permissible risk levels in pediatric research can be helpfully understood in terms of children's moral right to adequate protection from harm. Our analysis provides a rationale for what we propose as the highest level of permissible risk in pediatric research without the prospect of direct benefit: what we call "relatively minor" risk. We clarify the justification behind the usual standards of "minimal risk" and "a minor increase over minimal risk" and explain why it is permissible to impose any risks at all on child participants who do not stand to benefit directly from enrollment in research. Finally, we illuminate some aspects of the concept of "best interests."
Children in Clinical Research: A Conflict of Moral Values
The American Journal of Bioethics, 2003
This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children. The first ethical issue raised by these experiments is: did the severity of illness in these children justify their exposure to short and long-term risks? The ethics of the experiments will be evaluated by referring to existing codes of medical research ethics-the Nuremberg Code, the Declaration of Helsinki, and the federal Code of Regulations. The thirteen cases presented will demonstrate that children are being used in ever more speculative experiments, often in the absence of a therapeutic intent, but a significant chance for causing harm and / or discomfort. Some of the experiments were designed to explore the mechanisms of pathology and pharmacological interventions, or the response of neurological brain receptors to chemical provocation ("challenge"). Others were designed to test the safety or efficacy of new drugs, even to test these drugs on healthy children who were hypothesized to be "at risk." Children and adolescents have been subjected to "forced dose titration" experiments that induced a spectrum of severe adverse effects, including insomnia, extreme restlessness, agitation, (akathisia) and self-injurious behavior. FDA reports show that suicide is a significant issue in psychotropic drug trials-in pediatric trials the problem is even greater. The paper aims to demonstrate how the enactment of the Better Pharmaceuticals for Children Act (incorporated into the Food and Drug Administration Modernization Act, FDAMA), set in motion a radical shift in public policy by providing huge financial incentives to pharmaceutical companies to test new or patented drugs in children. Federal policy shifted from one aimed at protecting children by setting limits on permissible research risks, to a policy aimed at broadening the inclusion of children as test subjects. It will be shown how the FDA and the Department of Health and Human Services lifted regulatory restrictions to permit research involving greater than minimal risk to be conducted on healthy children, claiming that all children are potentially "at risk" of a future condition. Children were in this way deprived of regulatory protections. An argument will be made that the approval of nontherapeutic, harmful experiments-such as exposure of toddlers to lead poison-under the current gate keeping system raises serious doubts about the sustainability of institutional review boards (IRBs) as protectors of human research subjects. Children, who are precluded from exercising the adult human's right to informed consent, are being exploited as commodities for commercial ends. It is the position of the author that nothing less than the enactment of a federal law mandating a radical overhaul of the current research review system, with independent checks and balances, will provide children the legal protections they need. Ten specific recommendations are offered to protect children from harmful experiments.
Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 2 of 2)
Pediatrics, 2017
In part 1 of this series, we discussed the historical, ethical, and legal background that provides justification for the current system of protection of subjects of human experimentation. We also discussed briefly the implementation of those principles in institutional review board (IRB) operations. In part 2, we focus on legislation dealing with pediatric research, the rules and ethics of assent, and then turn our attention to minimal-risk studies. To that end, we discuss the minimal-risk threshold and the process of balancing benefit and risk in IRB decisions for pediatric studies. We define the notion of consent waiver as well as the procedures for expedited review, management of adverse events, and amendments to approved protocol. Finally, we mention some miscellaneous issues, including central and commercial IRB, reliance agreements, biobanks, and sample shipping regulations.
2013
Even as research with children has increasingly been recognized as urgently needed for generating effective treatments for childhood diseases, drug formulations for infants and young children, and dosages appropriate for children, it has remained controversial. Scholars have engaged in heated debates over whether non-beneficial research with children is morally and legally justified. On one point, however, there has been agreement: Whether they support or criticize pediatric research, commentators generally assume that pediatric research should be justified under the “best interests of the child” legal standard. This assumption not only threatens important research and public health interventions, but it is also incorrect. This Article challenges conventional wisdom by arguing that research does not have to be in a child’s best interests to be legally permissible.The best interests standard is generally understood as the governing principle for legal decisions about children, partic...
The Journal of contemporary health law and policy, 2013
Research ethics guidelines in developing nations are a topic of great importance to a multi-disciplinary audience, and much has been written about these guidelines from clinical, legal, and ethical perspectives. However, there is little literature which provides international guidelines for vulnerable populations such as children and adolescents. Oftentimes, there are no clear, concise guidelines for inclusion of children and adolescents in research, and guidelines must be assumed or gleaned from normative ethics and theories in the form of principles. This Note will begin with an overview of research ethics rules and regulations as utilized in the United States, followed by an introduction to three primary concepts in pediatric research ethics: the assent process for children, placebo use, and defining minimal risk. After a general introduction to these concepts, we will explore practical applications of these themes within an international framework. China, Kenya, and India, will serve as examples of how pediatric research in developing nations is lightly directed by regulatory guidelines and how research is impacted by local culture.
Ethical considerations in research with children
Bangladesh Journal of Bioethics, 2014
Ethical concerns and medical advances unique to children and adolescents make pediatric research an evolving endeavor. The current regulations for clinical research are based on a combination of ethical thought and history, some of it being very tragic. This article presents the ethical and historical underpinnings of these regulations, including elaborative discussion on ethical standards in research. In addition, the article highlights that every effort should be made to actively involve children as participants in the research process and care must be taken to protect the rights of all children, as well as specific groups of children, in research activity. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18445 Bangladesh Journal of Bioethics 2014 Vol.5(1): 36-42
Children as Participants of Clinical Research
Journal of Pediatric Infection, 2017
This study presents an overview of the scientific and ethical issues pertaining to the most controversial areas of experimentation on humans (research with children subjects, risk/benefit estimation in paediatric research maturity of children to consent to medical research). Over the past decade, the questions regarding research ethics related to this issue have continuously evolved. The major objective of this paper is that each of these issues will continue to pose new ethical questions and mechanisms in relevant areas for ongoing considerations of these questions. It is essential that we are aware of the ethical issues in various paediatric research studies an continue to search for answers for the numerous ethical challenges, being aware of the vulnerability/defenselessness and capacity development of child participants.