Posts in category: Medical Countermeasures
Bioethics Commission Develops Ethical Framework—Guidance for National-Level Review of Higher Risk Pediatric Research Protocols
The central tenet of pediatric research ethics is that it should not pose greater than minimal risk (or the risks of daily life) to participants, and, when greater risk cannot be avoided in research, there must be a commensurate potential for direct benefit to pediatric participants or benefit to an identifiable class of children. Only [...]
What is anthrax vaccine adsorbed and what do we know about it?
Anthrax is an infection of the skin, intestinal tract, or lungs caused by exposure to spores of the bacterium, Bacillus anthracis. Although several types of antibiotics are approved by the U.S. Food and Drug Administration (FDA) to prevent and treat anthrax, such antibiotics do not provide long-term protection against the persistence of dormant spores. Data [...]
In Safeguarding Children, Commission provides guidance for application of section 407
Most pediatric research can be approved by an institutional review board (IRB) if it poses only minimal risk, offers the prospect of direct benefit, or yields vitally important generalizable information about the participants’ condition. When a pediatric research proposal does not fit within these confines, to move forward, it must be elevated to national-level review [...]
Community Engagement in Pediatric Medical Countermeasure Research
The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently published its report, Safeguarding Children: Pediatric Medical Countermeasure Research, in which it reviews the ethical considerations for conducting research on medical interventions that would be used to protect children in the event of a bioterror attack—also known as “medical countermeasures” (MCM). One [...]
Revisiting Research Ethics
In its most recent report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) builds on its prior work concerning human subjects research protections. In November 2010, President Obama charged the Bioethics Commission to conduct a thorough review of current protections for research participants. The Bioethics [...]
Core Principles in Safeguarding Children
In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) published the Belmont Report, which established the three central principles of human subjects research protections—respect for persons, beneficence, and justice—and implicitly endorsed a fourth principle, democratic deliberation. These foundational principles guided the Presidential Commission for the [...]
What Is “Minimal Risk” For Research with Children?
Conducting clinical research with children is necessary to ensure that children are prescribed safe and effective medications. However, children are legally prohibited and ethically unable to consent to clinical research. As a result, clinical research with children requires more careful ethical analysis and oversight. According to federal regulation, clinical research with children is generally acceptable [...]
What are Medical Countermeasures?
The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently published a report, Safeguarding Children: Pediatric Medical Countermeasure Research, addressing the ethical considerations in conducting clinical trials of medical countermeasures (MCMs) with children. The Bioethics Commission received its charge for this report from the U.S. Department of Health and Human Services Secretary, [...]
Multiple steps must be taken before ethical pediatric anthrax vaccine trials can be considered
Today the Presidential Commission for the Study of Bioethical Issues concluded that the federal government would have to take multiple steps, including additional research in adults, before anthrax vaccine trials with children could be ethically considered by the U.S. government. In its report released today, Safeguarding Children: Pediatric Medical Countermeasure Research, the Bioethics Commission responded to [...]
Commission Wraps Up Miami Meeting
For the past year the Presidential Commission for the Study of Bioethical Issues has been conducting a careful and transparent review of the ethical considerations of conducting clinical trials of medical countermeasures (MCM) with children. The examination raises many challenging and complex issues. MCM research could carry some risk in order to protect children from [...]
