The ethics of research with The ethics of research with children

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Assessing risks How are these standards interpreted and applied in practice
Survey <strong>of</strong> U.S. IRB Chairpersons (%; N=188) *Procedures performed in healthy 11 year olds* MR > MR 10 cc Blood Draw MRI Survey Sexual Activity Allergy Skin Testing Lumbar Puncture S. Shah, A. Whittle, B. Wilfond, G. Gensler, D. Wendler, How Do Institutional Review Boards Apply the Risk and Benefit Standards for Pediatric Research, 291 JAMA 476 (2004).
Page 1 and 2: The ethics of research with childre
Page 3 and 4: Case study • Researchers wanted t
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 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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