The ethics of research with The ethics of research with children

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Disclaimer • The opinions expressed are the author’sown own. They do not reflect any position or policy of any U.S. governmental entity, including the National Institutes of Health.
Case study • Researchers wanted to learn how and why the brains of children with attention deficit hyperactivity disorder (ADHD) do not develop normally. • Planned to use a device that uses magnetic fields to stimulate nerve cells in the brain. • Device hd had not been tested di in children before. bf
Page 1: The ethics of research with childre
Page 6 and 7: Case study • The researchers aske
Page 8 and 9: Problem • If you were a parent wi
Page 10 and 11: Overview 1. When to enroll children
Page 12 and 13: When to enroll children in research
Page 14 and 15: Adults first as a general rule, wit
Page 16 and 17: Adults first • May prevent childr
Page 18 and 19: 2. Parental consent & child assent
Page 20 and 21: Child assent • The U.S. Federal r
Page 22 and 23: Respectful assent process 1. Inform
Page 24 and 25: Age as a proxy for decision-making
Page 26 and 27: Can children give consent • Child
Page 28 and 29: • Age probably matters: Dissent -
Page 30 and 31: Dissent • Importantly, can overri
Page 32 and 33: International regulatory frameworks
Page 34 and 35: Minimal risk •Commonly defined as
Page 36 and 37: Risks of routine exams or tests •
Page 38 and 39: Risks of daily life standard (objec
Page 40 and 41: Is it acceptable to expose children
Page 42 and 43: Is it acceptable to expose children
Page 44 and 45: Assessing risks How are these stand
Page 46 and 47: Survey of U.S. IRB Chairpersons (%;
Page 48 and 49: 4. Recent controversy over “best
Page 50 and 51: Critique of pediatric research •
Page 52 and 53:
Should parents only allow children
Page 54 and 55:
Summary • Defining acceptable ris
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