YOUNG RESEARCH SUBJECTS, OLD PROBLEMS Prof dr I.D. de Beaufort - - PowerPoint PPT Presentation

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YOUNG RESEARCH SUBJECTS, OLD PROBLEMS Prof dr I.D. de Beaufort - - PowerPoint PPT Presentation

Apr 11, 2024 107 likes •501 views

YOUNG RESEARCH SUBJECTS, OLD PROBLEMS Prof dr I.D. de Beaufort Department of Medical Ethics and Philospohy To experiment on children in ways that are not related to them as patients is already a sanitized form of barbarism which pays

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YOUNG RESEARCH SUBJECTS, OLD PROBLEMS

Prof dr I.D. de Beaufort Department of Medical Ethics and Philospohy

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  • “To experiment on children in ways that are

not related to them as patients is already a sanitized form of barbarism which pays no attention to the faithfulness-claims which a child, simply by being a normal or a sick

  • r a dying child, places upon us and

medical care.”

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Balancing between non-maleficence, dignity, beneficence and solidarity

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To use (off-label) treatments on children that have not been subject of research is, prima facie, unethical.

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NON-THERAPEUTIC PROCEDURES OR TRIALS

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MINIMAL RISK AND MINIMAL BURDEN

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  • What is minimal risk and minimal inconvenience/

burden

  • Should exceptions be allowed and when?
  • No exceptions should be allowed as a matter of

principle

  • Too difficult to decide when and which exceptions

should be allowed

  • A slippery slope
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A minor increase over minimal risk

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Stretching the notion of benefit and therapeutic

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It is therapeutic in a moral sense.

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  • It is taking a rain check on the future
  • It may justify too much!
  • Children need not be ‘mini Samaritans’
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  • We recommend Europe to adopt a policy

that is more closely related to the two factors that determine when exceptions to the minimal risk and burden can be justified: the assent of the research subjects and the value of the study.

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VIR Very Important Research

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For a study to be exceptionally valuable, the desired data much be truly indispensable for improving medical care for children.

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Strict scientific standards

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The assent of the child

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A ‘NATIONAL’ APPROACH

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ATTENTION FOR ETHICAL REVIEW TOURISM

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CHILDRENS VIEWS AND EXPERIENCES

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Focus groups with pediatricians, parents and children may be helpful.

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AWARENESS OF OTHER GROUPS OF PATIENTS